Thursday, June 29, 2023 New referral to the Enlarged Board by T 0438/19 - is product on the market prior art if undue burden to analyse composition? (G 1/23)

 T 0438/19 of 27-06-2023 referred the following questions to the Enlarged Board of Appeal for decision:

1. Is a product put on the market before the date of filing of a European patent application to be excluded from the state of the art within the meaning of Article 54(2) EPC for the sole reason that its composition or internal structure could not be analysed and reproduced without undue burden by the skilled person before that date?

2. If the answer to question 1 is no, is technical information about said product which was made available to the public before the filing date (e.g. by publication of technical brochure, non-patent or patent literature) state of the art within the meaning of Article 54(2) EPC, irrespective of whether the composition or internal structure of the product could be analysed and reproduced without undue burden by the skilled person before that date?

3. If the answer to question 1 is yes or the answer to question 2 is no, which criteria are to be applied in order to determine whether or not the composition or internal structure of the product could be analysed and reproduced without undue burden within the meaning of opinion G 1/92? In particular, is it required that the composition and internal structure of the product be fully analysable and identically reproducible?

The decision discusses alleged conflicting or at least diverging application of G 1/92, as well as G 1/92 itself, in detail. The reasons from the decision are cited below (no changes made except for highlighting in color).

The referral is pending under G 1/23 "solar cell".

Tuesday, May 22, 2018 T 1409/16 - Either...or?

If a claim uses "either...or" wording in respect of two (mathematical) inequalities, should this be read in the sense that either the first or the second inequality has to be fulfilled, but not both ("exclusive or"), or should this be interpreted as to imply that the first inequality, the second inequality or both have to be met ("inclusive or") - i.e., corresponding to "and/or" wording? And is the answer to this question affected by the presence of a dependent claim using "conventional" "and/or" wording?
Furthermore, if a certain fraction derived from a prior art polymer has properties that fall within the scope of the claims, does this polymer then make the composition as claimed available to the public?

In this opposition appeal, claim 1 as maintained during proceedings before the Opposition Division reads:

"1. A composition being a laundry treatment composition or component thereof, comprising:
- a substituted cellulose having a degree of substitution, DS, of from 0.01 to 0.99 and a degree of blockiness, DB, such that either DS+DB is of at least 1.00 or DB+2DS-DS^2 is of at least 1.20 and
- a laundry adjunct ingredient."

The Appellant (Opponent 1; party as of right Opponent 2 did not make any submissions) argued that the "either...or" wording had to be clearly read such that only one of the inequalities of claim 1 should be fulfilled (exclusive), but not both - particularly in view of dependent claim 10, wherein explicit "and/or" (inclusive) wording was used (albeit relating to other features). According to the Appellant, such an exclusive "either...or" interpretation of claim 1 would however not be supported by the description, arguably disclosing substituted cellulose compounds fulfilling either none or both (as in the Examples) of the two inequalities according to claim 1.

The Board found that in principle both "exclusive disjunctions" and "inclusive disjunctions" may be expressed by the "either...or" wording as used in claim 1. As such, claim 1 is ambiguous and needs to be construed taking into account the contents of the entire patent in suit. In this regard, the Board considered that particularly the Examples, disclosing compounds fulfilling both inequalities, would make it clear that in fact an inclusive "or" is implied by the claims, meaning that at least one of the inequalities should be met. The Board held that the "either ... or" wording could only be considered as expressing an exclusive "or" in cases where the two situations referred to are, due to their very nature, mutually exclusive, i.e. incompatible with each other

The Board further found that, citing G 1/92, fractionation - as performed by the Appellant - of a commercially available product in order to arrive at a fraction having properties falling within the scope of the claims, amounts to reverse engineering based on hindsight to reveal extrinsic ("extrinsic" within the meaning of G 1/92) characteristics that point beyond the product per se. Information revealed by following such a deliberate fractionation procedure does not correspond to what can be considered to having been made available to the public by an analysis of the chemical composition.

Tuesday, April 11, 2017 T 1543/12 - Multiple ranges in claim, are all combinations supported?

Many independent combinations are possible

Claim 1 in this opposition comprises a number of ranges. Individually, each of the ranges is supported by the application, but there may be combinations of the ranges that are not. Is such a claim properly supported over its entire width? The board thinks it is.  

Claim 1 in the pending requests contained a number of ranges:

1. A method for preparing a dry granulated product containing L-lysine and having the following composition:
L-lysine content in solid matter: 40 to 85% by weight equivalent ratio of anion/L-lysine 0.68 to 0.95 moisture content: 5% by weight or less (...)

Reasons for the Decision

(...)

4. Insufficiency of disclosure (Article 100(b) EPC)

4.1 The Appellant objected that the subject-matter of claim 1 could not be carried out over the whole range claimed. The claimed process is directed to the preparation of products covering the whole range of claimed lysine contents. However, it was not possible to produce lysine products having a lysine content of 85% and an equivalent ratio of more than 0.71, although an equivalent ratio of 0.68 to 0.95 was claimed.

4.2 According to Article 100(b) EPC, the European patent must disclose the invention in a manner sufficiently clear and complete for it to be carried out by the skilled person.

4.3 In the present case the process according to claim 1 is characterized to produce a L-lysine product. This product is inter alia characterized by a moisture content up to 5% by weight, of a L-lysine content in the final product of 40 to 85% by weight and an equivalent ratio of anion/L-lysine of 0.68 to 0.95. Therefore, any L-lysine fulfilling these three parameters is a product according to the invention. In order to be carried out over the whole range claimed, it is only necessary that each value within the claimed ranges can be achieved individually. It is, however, not a requirement of Article 83 EPC, that each and every possible combination of all individual limiting values within the claimed ranges can be achieved. The example given by the Appellant is technically impossible, since a product comprising 85% by weight of L-lysine can only comprise 15% by weight of an anion forming compound, which in the present case is hydrochloric or sulfuric acid. It follows that depending on the molecular weight of the acid used in the process the ratio of anion/L-lysine can reach only certain theoretical values within the claimed range. The skilled person knows, that both the L-lysine content in the final product and the achievable ratio of anion/L-lysine are dependent on each other and cannot vary independently over the whole range of values claimed for each of these two parameters.

4.4 Therefore, the Board concludes that the European patent discloses the invention in a manner sufficiently clear and complete for it to be carried out by a skilled person in the sense of Article 83 EPC.

(...)

This decision T 1543/12 (pdf) has European Case Law Identifier:  ECLI:EP:BA:2016:T154312.20160419. The file wrapper can be found here. Photo by Bill Ferngren (Braite), via PixaBay under a CC0  license (no changes made).

Sunday, August 07, 2016 T 1727/12 Sufficiency of disclosure for a broad claim

In this decision the Board has to go into different forms of lack of disclosure. The Board is not a big fan of the British term ‘Biogen sufficiency’ and goes back to the original decision T 409/91 and terminology used in that decision (“the patent monopoly should be justified by the actual technical contribution to the art”). 

In opposition proceedings, Art.84 cannot be used in this respect. In the opinion of the Board, the opposition division has not been convincing in proving that Art.83 was violated. In particular, the opposition division believed that features of dependent claims 3-5 were required for the invention of claim 1, but the division did not come up with options which the skilled person would not know how to carry out. The burden of proof was thus not met.

The Board remitted the case back to the opposition division for further prosecution. No oral proceedings were held, since the request "In the event that the Patent is not to be maintained in the form in which it was granted, the Proprietor requests oral proceedings" does not cover the situation wherein the Board does not take a final decision on the case itself but remits the case.

Tuesday, July 26, 2016 T 803/12 - No right to two instances

In continuation of the patent being revoked in opposition due to lack of sufficiency of disclosure, the proprietor appeals the decision. The proprietor requests the case to be remitted to the Opposition Division as he is of the opinion the his right to be heard has been violated and that he is entitled to be heard in two instances according to Art. 32 of the TRIPS agreement and based on Art. 125 EPC, Furthermore, the proprietor requests the Board to order a correction of the minutes of the oral proceedings before the Opposition Division.

The Board disagrees with the proprietor in all aspects. The case is not remitted, the minutes are not corrected and the patent remains revoked.

Tuesday, May 31, 2016 T 2182/11 - Lack of clarity is no lack of sufficiency

Vague and broad, who can object to that?

In this opposition appeal, the opponent tried to raise insufficient disclosure objections (Art. 83 EPC) based on broad or vague terms in the granted patent claim. Below are the relevant portions of the main claim.

A sanitary napkin adapted to be worn in a crotch portion of an undergarment, said sanitary napkin having opposed longitudinally extending side edges and a longitudinal axis and comprising:
(...)
b) an absorbent system under said cover layer, said absorbent system having an absorbent width of at least 64 mm;
(...)
f) said absorbent system including at least a pair of preferential bending zones that extend along said longitudinal axis and are adjacent to respective side edges of the sanitary napkin, said preferential bending zones register with respective linear, longitudinally extending adhesive zones, this construction allowing said sanitary napkin to fold at said preferential bending zone in response to lateral compression applied to said napkin and permitting said napkin to acquire a three-dimensional deformation profile,
 (...)

Arguing insufficiency without experimental data is always hard. This attempt also failed, as the board considered the potential problems in the claim to fall under clarity, which is not a ground for opposition.

Sunday, November 08, 2015 T 0895/13 Insufficient disclosure for a medicine

The Board, in an opposition appeal, examines the requirements for disclosure of a medicament. It confirms that the principle defined in T 609/02, for a Swiss type of claim, also apply to a further medical use claim defined under Art.54(5) EPC2000. Applying this principle, the Board concludes that the invention is insufficiently disclosed (Art.83 EPC).
In doing so, the Board also makes clear that the assessment of the technical effect provided by the claimed subject-matter was to be made in the context of the assessment of sufficiency of disclosure and not under inventive step as was done by the Opposition Division.

Friday, August 07, 2015 T 1602/10 - Those generalisation days are truly over

Here, the Board comes to the same conclusion as the ED albeit with another reasoning. Where the ED stated that the patent could not be granted because the disclosure showed that EAE mice treated with anti-TIM-3 antibodies exhibited exacerbated disease, which was not considered a therapeutic benefit and which therefore did not enable the skilled person to carry out the claimed invention (Art 83 EPC) [because an anti-cancer effect was claimed]. The Board on the other hand also denies patentability under Art 83 EPC but because cancer is not a single disease, not all cancers exhibit a TIM-3 mediated immune response and antibodies can have agonistic as well as antagonistic effects. It was concluded that in view of the potentially opposite actions of anti-TIM-3 antibodies, the skilled person would not have considered it plausible that substantially all embodiments of the invention defined in claim 1 were capable of being realised. The treatment of a single antibody in a single type of cancer does in this case not provide evidence in support of the entire scope.

Summary of Facts and Submissions

I. An appeal was filed by the patent applicant (appellant) against the decision of the examining division to refuse European patent application No. 03 723 627. The application, entitled "Compositions and methods related to TIM-3, a Th1-specific cell surface molecule" was filed as an international patent application and published as WO 03/063792.

II. The examining division dealt with a main and an auxiliary request. Claims 5 and 6 of the main request were held to concern an invention which was not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, contrary to Article 83 EPC. The same objection was held to apply to the subject-matter of claim 5 of the auxiliary request. These were the sole objections leading to the refusal of the application. The reason given for the refusal was that, although the application disclosed that mice with experimental autoimmune encephalomyelitis (EAE) treated with anti-TIM-3 antibodies exhibited exacerbated disease, this was not a therapeutic benefit and did not enable the skilled person to carry out the claimed invention.

It was held that post-published evidence of reduction of tumour growth in a tumour model by treatment with anti-TIM-3 antibody could not remedy the deficiency because sufficiency of disclosure had to be established at the filing or priority date of the application, as the case may be. Post-published documents could only be used to back up disclosures already made in the patent application but could not establish sufficiency of disclosure on their own.

III. With the statement of grounds of appeal, the appellant submitted a main and three auxiliary claim requests.

IV. With a letter dated 16 February 2015, in response to a communication of the board, the appellant filed a new main claim request replacing all previous claim requests.

V. Oral proceedings before the board were held on 17 March 2015. At the end of these proceedings, the chairwoman announced the decision of the board.

VI. The final request of the appellant was that the decision of the examining division be set aside and that a patent be granted on the basis of the set of claims filed as main request together with the letter dated 16 February 2015.

VII. Claims 1 and 2 of the sole request read:

"1. A TIM-3 binding molecule wherein the TIM-3 binding molecule is an antibody specific for TIM-3 or is a fragment of an antibody specific for TIM-3, for use in the treatment of cancer in a subject.

2. The TIM-3 binding molecule for use as claimed in claim 1, wherein said TIM-3 binding molecule binds to an extracellular region of TIM-3."

[...]

IX. The arguments of the appellant can be summarised as follows:

The experimental results disclosed in the application related to administering an antibody against TIM-3 in vivo in a mouse model of experimental autoimmune encephalitis (EAE) which is a model of the human autoimmune disorder multiple sclerosis. In an autoimmune disease a subject's own antibodies react with host tissues or the immune effector T cells are autoreactive to endogenous self-peptides and cause destruction of tissue, i.e. an anti-self response. The inventors discovered that administration of an antibody against TIM-3 resulted in more severe clinical disease and increased mortality in the EAE model. The inventors further found that these animals had increased inflammation in the central nervous system (CNS), and that the demyelinating lesions in the mice treated with antibody to TIM-3 were filled with activated macrophages (Example 6). Further examination of immune cell populations taken from the EAE model mice led to the inventors' discovery that macrophages from mice administered TIM-3 antibody showed increased proliferation and expressed increased levels of MHC Class II antigens, these being indicative of increased ability to present antigen. Both these parameters were measurements of the activation status of a macrophage, which is a type of antigen-presenting immune cell. Together, these data would have been understood by a person skilled in the art to be clearly indicative of an enhanced or increased immune response in animals treated with an anti-TIM-3 antibody. The application therefore demonstrated the suitability of a TIM-3 specific antibody for enhancing an immune response which includes an immune response mounted against a cancer antigen. The enhancement of the immune response by administration of anti-TIM-3 antibodies was of a general and non-specific nature. In the case of cancer, the skilled person knew from the prior art, for example from document D1, that macrophage activation was critical for the induction of immune responses to microbes as well to certain tumor cells. From document D2 (page 207, "Introduction") the skilled person knew that "the monocyte/macrophage system exhibits a wide array of powerful effector mechanisms that may be harnessed for therapeutic effect against infection and malignancy." The specification would have been considered in the light of the knowledge that monocyte-mediated immunity was active against malignancy. Post-published evidence also supported an inherent effect of the TIM-3 inhibitor in cancer models (WT3 sarcoma, TRAP-C1 prostate sarcoma) and some PD-1 blockade synergy (document D3) and EL4 lymphoma (document D4, see page 1386, Fig. 2B). The skilled person would have therefore had no doubt that the invention could be carried out as claimed. On the subject of whether the generation of a de novo immune response by anti-TIM-3 treatment was sufficiently disclosed, the appellant argued that, in fact, no generation of a de novo immune response was needed. The immune system carried out constant immune-surveillance, nascent cancers being naturally disposed of by activated macrophages. Disease was said to arise only when this surveillance failed. Administration of anti-TIM-3 antibodies acted to release a kind of "brake" on the immune system. Finally, it was pointed out that similar claims to second medical uses of compounds for the treatment of cancer in general had been accepted as meeting the requirements of Article 83 EPC, for instance in decisions T 1616/09 of 27 August 2014 and T 1492/09 of 9 January 2014 and T 1918/06 of 10 March 2010.

Reasons for the Decision

Main request [...]

Claim 1

4. The subject-matter of claim 1 is an antibody specific for TIM-3 or a TIM-3 specific fragment thereof, for the specific use of "treatment of cancer in a subject". The claim is therefore directed to a second medical use as foreseen by Article 54(5) EPC.

5. TIM-3 is a transmembrane protein which is preferentially expressed on differentiated Th1 cells and is termed "T cell Immunoglobulin and Mucin domain-containing molecule-3" (see the description of the application, page 1, paragraph 1 and page 2, paragraph 3).

6. The antibody of claim 1, specific for TIM-3 or a TIM-3 specific fragment thereof, may bind different epitopes of the target protein. For instance, claim 2 specifies that the antibody binds to an extracellular region of TIM-3.

7. Antibodies may have different biological effects, depending on their particular binding specificity, for instance, they may be agonistic or antagonistic. The description of the application on page 59 provides several possible explanations of the effect of anti-TIM-3 treatment on a subject: "[...] a cognate interaction between non-T cells and TIM-3-expressing Thl cells is affected by anti-TIM-3 treatment, resulting in the expansion and activation of CD11b+/F4/80+ macrophages. Several possible mechanisms may explain this finding: a) Anti-TIM-3 may cross-link TIM-3 protein on the surface of differentiated Th1 cells in vivo and amplify the production of pro-inflammatory cytokines (e. g., IFN-gamma and TNF), which in turn may induce activation of macrophages ; b) anti-TIM-3 antibody could enhance migration of differentiated Thl cells into the brain where these cells may increase the cellular influx of macrophages from the circulation; c) anti-TIM-3 could block a cognate interaction of TIM-3 with its potential inhibitory ligand on macrophages, thus leading to enhanced macrophage activation in the presence of pro-inflammatory cytokines produced by Thl cells".

8. The mechanism set out under (a) may be seen as an agonistic type mechanism, in which anti-TIM-3 binding triggers a signalling cascade, while that given under (b) is an antagonistic mechanism with the effects due to the blocking of the interaction of a ligand with its receptor.

9. The antibodies of the claim are for the treatment of cancer in a subject. Cancer is not a single disease with a single underlying mechanistic cause but is a collective term for a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body, see the description of the application, page 20, last paragraph: "Cancers include, but are not limited to, basal cell carcinoma, biliary tract cancer; bladder cancer; bone cancer; brain and CNS cancer; breast cancer; cervical cancer; choriocarcinoma; colon and rectum cancer; connective tissue cancer; cancer of the digestive system; endometrial cancer; esophageal cancer; eye cancer; cancer of the head and neck; gastric cancer; intra-epithelial neoplasm; kidney cancer; larynx cancer; leukemia; liver cancer; lung cancer (e.g. small cell and non-small cell); lymphoma including Hodgkin's and non-Hodgkin's lymphoma; melanoma; myeloma; neuroblastoma; oral cavity cancer (e.g. lip, tongue, mouth, and pharynx); ovarian cancer; pancreatic cancer; prostate cancer; retinoblastoma; rhabdomyosarcoma; rectal cancer; cancer of the respiratory system; sarcoma; skin cancer; stomach cancer; testicular cancer; thyroid cancer; uterine cancer; cancer of the urinary system, as well as other carcinomas and sarcomas."

10. In summary, claim 1 is directed to an anti-TIM-3 antibody or a TIM-3 specific fragment thereof, with any type of specificity for treatment of any type of cancer.

Sufficiency of disclosure - Article 83 EPC

11. Article 83 EPC requires that the claimed subject-matter is disclosed in the application "in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art".

12. The experimental evidence provided in the application relates inter alia to mice having experimental autoimmune encephalomyelitis (EAE), a Thl-dependent autoimmune disease being a widely accepted model for multiple sclerosis. The data provided in the examples show that the Th1-specific cell surface protein TIM-3 is involved in regulating the level of T-cell trafficking to target tissues and macrophage activation in these mice (description of the application, page 1, lines 5 to 11 and Examples 5 to 16). Example 6 shows that an existing autoimmune reaction triggered by immunisation with encephalitogenic proteolipid protein (PLP) is exacerbated by administration of an anti-TIM-3 antibody.

13. The board concludes that, from the evidence provided in the application, the skilled person would have considered it plausible that an extant immune reaction, such as that existing in the EAE mice, could be amplified by administration of anti-TIM-3 antibodies.

14. The evidence provided in the application does not concern establishment of a de novo immune response to a tumour antigen or to any other antigen.

15. The skilled person at the priority date knew that

i) cancer cells were "self" cells, ii) an immune response to self antigens was the exception to the rule (cf. description of the application, page 40, lines 7 to 29) and iii) there were a wide range of different cancers with diverse underlying causes (see point 9.9. above).

16. In view of the above it is considered that the skilled person would not have considered that the disclosure of the application makes it plausible that it would be possible to generate a de novo immune response to cancers where there was no established native response. Moreover, the skilled person would not have believed that substantially all cancer types inherently generate a Th1, TIM-3 mediated immune response and be treatable by administration of anti-TIM-3 antibodies. It is noted that the post-published documents submitted by the appellant support this conclusion, see point 23.23. below.

17. Thus, the subject-matter of claim 1 does not meet the requirements of Article 83 EPC with respect to the whole scope claimed in relation to the disease to be treated.

18. Secondly, anti-TIM-3 antibodies do not all have the same specificity or functionality (see points 6.6. and 7.7. above). The particular antibodies used in the examples of the application are termed "8B.2C12" and "25F.1D6" (see Example 1) and were not deposited with a recognised depositary institution according to Rule 31(a) EPC. It was not disclosed in the application whether the interaction of TIM-3 with its not yet identified ligand (see Example 17) was blocked or activated by the antibody to achieve the claimed therapeutic effect. In view of the potentially opposite actions of anti-TIM-3 antibodies, the skilled person would not have considered it plausible that substantially all embodiments of the invention defined in claim 1 were capable of being realised (c.f. Case Law of the Boards of Appeal of the EPO, 7th edition, II.C.6.1.2).

19. Thus, the subject-matter of claim 1 lacks sufficient disclosure to be carried out by the skilled person over the entire claimed scope with respect to the specificity of the anti-TIM-3 antibody to be used in the claimed medical use.

[...]

23. With respect to the evidence provided in the form of post-published documents, the board notes that document D3 provides evidence which confirms the board's earlier conclusion (see point 17.17. above) on the insufficiency of disclosure of the application with respect to de novo carcinogenesis. Document D3 reports "an extensive characterization of the therapeutic activity and mechanism of action of an anti-mouse TIM-3 mAb [monoclonal antibody] against experimental and carcinogen-induced tumors" (see the abstract). The anti-TIM-3 antibodies used were specifically antagonistic antibodies (see page 3541, "Tumor models"). Anti-TIM-3 was reported to display only modest prophylactic (page 3546, column 2, final paragraph) and therapeutic activity (page 3547, paragraph 1) against a small fraction of carcinogen-induced sarcomas (13%). In the discussion section (page 3550, column 1) it is stated "We have shown that dramatic therapeutic effects are not observed with monotherapies (including anti-PD1 or anti-TIM3) in this model [of de novo carcinogenesis]. This is despite the fact that anti-PD1 is an extremely promising therapeutic in some human cancers".

24. In summary, document D3 discloses that anti-TIM-3 antibodies fail to successfully treat the majority (87%) of induced sarcomas (see the sentence bridging pages 3546 and 3547).

25. Document D4 reports inter alia that "treatment of EL-4 tumor-bearing mice with anti-TIM-3 Ab resulted in delayed tumor progression coincident with lower frequency of CD11b**(+)Gr-1**(+) cells (Fig. 2B)" (see page 1386, column 2, penultimate sentence).

26. However, in view of the diversity of cancer types (see point 9.9. above), evidence of successful treatment of one tumour type with a specific antibody ("clone 5D12") does not provide evidence in support of the entire scope claimed. Moreover, even if the disclosure of document D4 were to be considered as evidence of the successful treatment of cancer, a particular post-published disclosure relating to a particular antibody and a specific type of cancer cannot remedy a problem of general lack of sufficient disclosure at the priority date (see also decision T 609/02 of 27 October 2004, Reasons 9).

[...]

29. In view of the above, the board concludes that the subject-matter of claim 1 is not disclosed in the application in a manner sufficiently clear and complete for it to be carried out by the skilled person and therefore does not meet the requirements of Article 83 EPC.

Order

For these reasons it is decided that:

The appeal is dismissed.

This decision has European Case Law Identifier: ECLI:EP:BA:2015:T160210.20150317 and can be found here. The file wrapper can be found here. Photo "Antibody" (link) by Jim obtained via Flickr under CC BY 2.0 license.

Wednesday, June 24, 2015 T 2068/11 - The Budapest Treaty, also in far away countries

This decision deals with a lack of sufficiency of disclosure under Art 83 EPC (R 28 EPC 1973 and R 31 EPC 2000) as far as the deposit of microorganisms (in this case a new Lactobacillus delbrueckii strain isolated from Japanese milk) under the Budapest Treaty is concerned. 

A deposit under national law (here: Japan) is insufficient to consider it equivalent to a deposit under the Budapest Treaty, even though R 28 EPC 1973 does not mention or refer to the Budapest Treaty, and even though it does not refer to national laws for incorporation of  the Budapest Treaty. Hence, when converting a deposit under national law to a deposit under the Budapest Treaty, the applicant better makes sure that this conversion takes place before the date of filing of the European patent application. Or even better, deposit the material directly under the Budapest Treaty before the PCT application is filed.

Interestingly, the Board notes that decision T 815/90 is outdated and that the decision therein - to give the applicant the benefit of the doubt - was probably a result due to lack of guidance in 1984 on how to correctly deposit biological material under the Budapest Treaty, which was solved by the issue of the (clear) 1986 guidance.

Summary of Facts and Submissions

I. European patent application No. 05720034.7, filed on 4 March 2005, is based on international patent application PCT/JP2005/003762. It claims priority rights from Japanese patent application No. 2004059912, which was filed on 4 March 2004 and published on 15 September 2005. Entry into the European regional phase took place on 2 October 2006. The European patent application was published on 29 November 2006.

II. The applicant (appellant) filed an appeal against the decision of the examining division to refuse the European patent application. The examining division decided that the main request and the first auxiliary request before it did not meet the requirements of Article 83 EPC in conjunction with Rule 31 EPC (former Rule 28 EPC 1973), and that the second and third auxiliary request did not meet the requirements of Article 83 EPC.

Tuesday, May 19, 2015 T 1164/11 - Use the force

This Examination appeal concerns a medical apparatus for cutaneous administration of medicaments, i.e., through the skin. The main claim in the appeal reads:

 
"A medical apparatus for cutaneous administration of medicaments comprising:
- a supporting frame (100);
- an energy emitter (9) in engagement with the frame (100) and active on the molecules of at least one medicament to cause penetration of same into a skin region to be treated (10); (...) said energy emitter (9) being an electromagnetic wave generator (11) emitting a laser light of a wavelength comprised in the range of 600 to 650 nm."

The board has its doubts whether such a electromagnetic wave generator can really  be  active on the molecules of a medicament to cause penetration into a skin region. The board  evaluates if there is a plausible explanation of the claimed effect and, in the absence thereof, the available evidence.

Friday, February 06, 2015 T 2001/12 - Insufficiency, clarity or inventive step

Can an objection of insufficient disclosure under Article 83 be based on an argument that the application would not enable a skilled person to achieve a non-claimed technical effect? What are the consequences of a doubt that the invention as claimed is capable of solving the problem defined in the application? Does it make a difference if the question arises because the claim fails to specify those features which are disclosed in the application as being essential for providing the solution to the problem, or because, having regard to the prior art, and irrespective of what may be asserted in the description, it does not appear credible that the invention as claimed would actually be capable of solving the problem? The Board of Appeal provided a thorough analysis and guidance in this decision. 

Summary of Facts and Submissions

I. The appeal is against the decision of the Examining Division refusing European patent application No. 08 764 638 "because the main request does not meet the requirements of Article 83 EPC, Article 84 EPC, and Article 54 EPC, and because the auxiliary request does not meet the requirements of Article 83 EPC and Article 84 EPC."

II. The following documents [...]

III. In the letter stating the grounds of appeal the appellant requested that the decision under appeal be set aside and that a patent be granted on the basis of the main request or one of auxiliary requests I-VI, all filed with the said letter.

IV. Claim 1 according to the main request reads as follow:

"A memory device (1), comprising at least:

a first semiconductor region (100) having a length (Lg), a first surface (100A), and a cross-section surrounded by the first surface (100A);

a memory means (300) provided on the first surface (100A), wherein the memory means (300) is a multilayered insulation film; and

a gate (400) provided on the memory means (300);

wherein an equivalent sectional radius (r) of the cross-section of the first semiconductor region (100) is defined as a radius of curvature of a circle having the same cross-sectional area as the cross-section; and

an equivalent silicon oxide film thickness (tm) of the memory means (300) is defined as a sum of values of thickness of each layer of the multilayered insulation film, wherein each value of thickness is the film thickness of said layer multiplied by dielectric constant of silicon oxide and divided by dielectric constant of said layer;

and wherein the equivalent sectional radius (r) of the cross-section of the first semiconductor region (100) is equal to or smaller than the equivalent silicon oxide film thickness (tm) of the memory means (300);

characterized in that

the equivalent silicon oxide film thickness (tm) of the memory means (300) is 20 nm-to 6nm."

V. The Examining Division argued essentially as follows:

[...]

VII. The appellant argued essentially as follows:

[...]

Reasons for the Decision

1. The appeal is admissible.

[...]

3. Main Request: Article 83 EPC 1973

3.1 Paragraph [0011] of the description begins as follows:

- "According to to the above-mentioned configuration, the equivalent sectional radius r is set to be equal to or smaller than the equivalent oxide film thickness tm of the memory means".

This relationship between the equivalent sectional radius and the equivalent oxide film thickness is included in claim 1 of the main request.

Paragraph [0011] then continues:

- "and therefore it becomes possible to realize a memory device which can reduce the voltage for writing and erasing to approximately 70% or less of the program voltage of a conventional planar type device."

This feature, which is not comprised in claim 1 of the main request, is central to the objection under Article 83 EPC made in the contested decision.

In particular, by comparing Examples 1 and 2 of the present application with the disclosures of documents D2 and D8, the Examining Division came to the conclusion that it was not credible that the invention defined by claim 1 of the main request would achieve the technical effect of reducing the voltage for writing and erasing to approximately 70% or less of that of a conventional planar type device. For this reason the Examining Division judged that the requirements of Article 83 EPC were not met.

3.2 Hence, a first question which arises is whether the allegation that the claimed invention is incapable of achieving the above-mentioned effect would - even if true - justify refusing the application for failure to meet the requirements of Article 83 EPC.

3.3 In Decision G 1/03 (OJ, 2004, 413) the Enlarged Board of Appeal stated the following:

- "a lack of reproducibility of the claimed invention ... may become relevant under the requirements of inventive step or sufficiency of disclosure. If an effect is expressed in a claim, there is lack of sufficient disclosure. Otherwise, ie if the effect is not expressed in a claim but is part of the problem to be solved, there is a problem of inventive step (T 939/92, OJ EPO 1996, 309)." (See Reasons, point 2.5.2.)

This passage has since been cited in other decisions; for example in T 1079/08 the point is made as follows:

- "In Decision G 1/03 (OJ, 2004, 413) the Enlarged Board of Appeal indicated that a lack of reproducibility of the claimed invention is relevant under the requirements of sufficiency of disclosure if the technical effect is a technical feature of the claim, since then it is a feature characterising the subject-matter claimed (see point 2.5 of the reasons)." (T 1079/08, Reasons, point 4).

The same point had been made in earlier decisions, for example in T 939/92 (cited by the Enlarged Board in the above excerpt from G 1/03), and in T 260/98 (also citing T 939/92) in which the following conclusion was drawn:

- "However, since the claims only specify a reduced abrasiveness and do not require any synergistic activity of the components, the question as to whether or not such a synergic effect is achieved by the claimed printing inks is not relevant to the issue of sufficiency, although it may properly arise under Article 56 EPC, if this technical result turns out to be the sole reason for the alleged inventiveness of the printing inks (T 939/92 of 12 September 1995, Headnote point 2 and Reasons Nos. 2.4 to 2.6, OJ EPO 1996, 309)." (T 260/98, Reasons, point 3.6.6.)

3.4 It is therefore the consistent position of the boards that an objection of insufficient disclosure under Article 83 EPC 1973 cannot legitimately be based on an argument that the application would not enable a skilled person to achieve a non-claimed technical effect.

In the present case, the technical effect in question is the reduction of the writing and erasing voltage to approximately 70% or less of the program voltage of a conventional planar type device. Achieving this effect is not part of the invention defined by claim 1 of the main request, and hence the Examining Division's objection that the application as a whole does not disclose features which would enable this effect to be obtained does not constitute a valid objection under Article 83 EPC 1973.

3.5 The Board therefore judges that claim 1 of the main request complies with the requirements of Article 83 EPC 1973.

4. Article 84 EPC 1973

4.1 The Examining Division also found that since claim 1 of the main request did not define features which would enable the above-mentioned effect to be obtained, the requirements of Article 84 EPC 1973 were not met, since the claims did not recite all the features essential for the definition of the invention.

4.2 Article 84 EPC requires that the claims are clear, concise and supported by the description. According to established case law of the boards, Article 84 EPC is to be interpreted as requiring that the claims indicate all essential features of the invention (see Case Law of the Boards of Appeal, 7th edition 2013, II.A.3.2).

In the decision T 32/82, the matter was put as follows:

- "Article 84 EPC requires amongst other things that the claims, which define the matter for which protection is sought (i.e. the object of the invention as implied by Article 52(1) EPC) be clear. The Board of Appeal considers that this has to be interpreted as meaning not only that a claim from a technical point of view must be comprehensible, but also that it must define clearly the object of the invention, that is to say indicate all the essential features thereof.

- "As essential features have to be regarded all features which are necessary to obtain the desired effect or, differently expressed which are necessary to solve the technical problem with which the application is concerned." (see T 32/82 OJ 1984, 354, Reasons, point 15.)

In the decision T 133/85 the point was made as follows:

- "A claim which does not include a feature which is described in the application (on the proper interpretation of the description) as an essential feature of the invention, and which is therefore inconsistent with the description, is not supported by the description for the purpose of Article 84 EPC." (T 133/85, headnote I).

This requirement to eliminate inconsistency between the claims and the description also implies that where an invention has been presented in the description in terms of a modification of prior art which is cited or otherwise acknowledged in the application, the modifying features must be seen as essential (see e.g. T 813/03, point 5.1).

Hence, if the claims do not comprise a feature which is described in the application as essential, or which is disclosed in the description as being indispensable for solving the problem defined in the application, then an objection under Article 84 EPC 1973 may properly arise.

Examination for compliance with this requirement does not entail, and is independent of, a comparison of the claimed invention with the prior art, other than to determine whether there is consistency between the claims and the description in relation to any prior art cited in the application with respect to which the invention has been disclosed.

4.3 By contrast, the determination of the objective contribution of the claimed invention, i.e. having regard to the totality of the prior art, and in particular the objectively identified closest prior art, forms part of the examination for inventive step.

If, as a result of the comparison with the prior art, objective doubts arise that the claimed invention would actually be capable of solving the problem defined in the application (whatever may be asserted in the description), then an objection under Article 56 EPC 1973 may be raised, possibly requiring a reformulation of the problem (see e.g. T 400/98, points 4.3 - 4.3.6, and Case Law, op. cit. I.D.4.3.2).

This is also consistent with the passage cited from G 1/03 under point 3.3, above, in which a lack of reproducibility the claimed invention (i.e. a failure of the claimed features to deliver the effect aimed for) is seen to represent, in the case of an effect which is not expressed in a claim but is part of the problem to be solved, "a problem of inventive step".

4.4 In summary, a doubt that the invention as claimed is capable of solving the problem defined in the application may have the following consequences:

- If the question arises because the claim fails to specify those features which are disclosed in the application as providing the solution to the problem, then the description and claims are inconsistent in relation to the definition of the invention, and an objection under Article 84 EPC 1973 may properly arise that the claims do not contain all the essential features necessary to specify the invention.

- If this is not the case, but, having regard to the prior art, and irrespective of what may be asserted in the description, it does not appear credible that the invention as claimed would actually be capable of solving the problem, then an objection under Article 56 EPC 1973 may be raised.

4.5 In the light of the above analysis, the Board is called upon to decide whether the Examining Division was correct in concluding that the claim 1 of the auxiliary request (essentially corresponding to claim 1 of the present main request) failed to meet the requirements of Article 84 EPC in that it did "not recite all the features essential for the definition of the invention". The Board's answer to this question is no, for two reasons.

4.6 Firstly, in the section entitled "Problem to be Solved by the Invention" (paragraphs [0007]-[0009]), several problems are mentioned, including providing a "memory device which can reduce the voltage for writing and erasing".

However, although providing a writing/erasing voltage of approximately 70% or less of that of a conventional planar type device is mentioned in the description, achieving this effect is not stated to be the problem to be solved by the invention, either in paragraphs [0007]-[0009] or elsewhere. There is therefore no basis for arguing that features necessary to achieve this degree of reduction are essential to the definition of the invention.

4.7 Secondly, even if it were accepted that the technical problem underlying the invention is to provide a writing/erasing voltage of approximately 70% or less compared to a conventional planar type device, according to the application this degree of reduction is achieved by ensuring that "the equivalent sectional radius r is set to be equal to or smaller than the equivalent oxide film thickness tm of the memory means" (see e.g. paragraph [0011]).

Since this feature is indisputably comprised in claim 1 of the main request, no legitimate objection could be raised under Article 84 EPC 1973 that claim 1 lacks a feature presented in the description as essential to solving the problem.

4.8 The actual objection of the Examining Division was that, in the light of document D2 (cited in the International Search Report) and document D8 (cited by the Examining Division), and despite the assertions in the description of the present application, it was not considered technically credible that the devices of the present application did in fact reduce the writing/erasing voltage to 70% or less than that of a conventional planar type device.

In the light of the analysis presented above, the Board takes that view that while such an argument might conceivably be of relevance in an examination of inventive step under Article 56 EPC 1973, it is not relevant to the question of compliance with the requirements of Article 84 EPC 1973.

4.9 The remaining objection against claim 1 under Article 84 EPC 1973 (mentioned under point 24.1 of the section "Additional Comments") is that in the case of a hollow semiconductor region, claim 1 does not provide a clear definition of which "first surface" (internal or external) is meant.

In the opinion of the Board, however, it is clear that the external surface is intended. Claim 1 of the main request defines:

- "a first semiconductor region (100) having a length (Lg), a first surface (100A), and a cross-section surrounded by the first surface (100A)".

Hence the "cross-section surrounded by the first surface" is a cross-section of the first semiconductor region. Taking the first surface to mean the internal surface of a hollow semiconductor region would imply that the cross-section of the semiconductor region would enclose none of the actual semiconductor material, but only the hollow interior region. It would be clear to the skilled person from the wording of the claim that this is not what is intended.

4.10 Claim 1 of the main request is therefore judged to meet the requirements of Article 84 EPC 1973.

5. Further Procedure

5.1 No objection of lack of novelty was raised against the subject-matter of claim 1 of the first auxiliary request then on file, nor does the Board see any reason to raise such an objection against the (broadly similar) subject-matter of claim 1 of the present main request in the light of the prior art currently on file.

5.2 In view of the statement in the contested decision that "no supplementary European search report has been established for the present application and no further search for relevant prior art has been conducted during the written procedure", the Board considers that the Examining Division's proposal that "it would be appropriate to return the file to the division for a detailed search and examination to be conducted" is sensible. Hence it is appropriate for the Board to exercise its discretionary power under Article 111(1) EPC 1973 to remit the case to the department of first instance for further prosecution.

5.3 In the section headed "Additional Comments" (said not to form part of the reasons for which the application was refused) the Examining Division briefly indicated its view (under point 25.1) that the subject-matter of claim 1 of the first auxiliary request did not involve an inventive step with respect to document D5/D5a. The Board finds it appropriate to refrain from commenting on this matter for the following reasons.

If, following the search mentioned above, the document D5/D5a is confirmed as the closest prior art in the remitted procedure and the Examining Division maintains its view on inventive step, then the applicant would be entitled to a full explanation of this objection in terms of the problem-solution approach, and taking into account any counter-arguments of the applicant (for example, those presented in the notice of appeal). For the Board to decide this matter in the present decision would deprive the appellant of two instances on the issue. Moreover, the search may reveal new relevant prior art which may either become the starting point for examination, or have a bearing on the argument starting from D5/D5a.

5.4 Hence, for the avoidance of any doubt, the Board has decided only that claim 1 of the main request filed with the notice of appeal satisfies the requirements of Article 84 EPC 1973 and Article 123(2) EPC, and that in respect of the invention defined in claim 1 of the main request filed with the notice of appeal the application meets the requirements of Article 83 EPC 1973.

All other matters remain to be decided by the Examining Division in the remitted procedure.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The case is remitted to the department of first instance for further prosecution.

Headnote

An objection of insufficient disclosure under Article 83 EPC 1973 cannot legitimately be based on an argument that the application would not enable a skilled person to achieve a non-claimed technical effect (point 3.4).

A doubt that the invention as claimed is capable of solving the problem defined in the application may have the following consequences:

a) If the question arises because the claim fails to specify those features which are disclosed in the application as providing the solution to the problem, then the description and claims are inconsistent in relation to the definition of the invention, and an objection under Article 84 EPC 1973 may properly arise that the claims do not contain all the essential features necessary to specify the invention.

b) If this is not the case, but, having regard to the prior art, and irrespective of what may be asserted in the description, it does not appear credible that the invention as claimed would actually be capable of solving the problem, then an objection under Article 56 EPC 1973 may be raised (point 4.4).

This decision has European Case Law Identifier: ECLI:EP:BA:2015:T200112.20150129. The whole decision can be found here (pdf). The file wrapper can be found here. Photo "Impossible object" by Till Krech obtained via Flickr under CC BY 2.0 license (no changes made).

Thursday, January 29, 2015 T 1480/12 - A lesson for a lazy representative

The Examining Division refused the application (main request, first and second auxiliary requests) for lack of an inventive step. A third auxiliary request of the appellant for the grant of a patent on the basis of a new claim 1 consisting of a merge of claims 1 and 19 according to the second auxiliary request was not admitted into the procedure under Rule 137(3) EPC, as such a claim was not considered to overcome the Article 56 EPC objection. The examining division held that the request, though not presented in writing, was sufficiently clear for the division to decide on admissibility. The applicant appealed the decision - with the statement setting out the grounds of appeal the appellant requested that the decision under appeal be set aside and that a patent be granted on the basis of (substantially) the same main, first, second and third auxiliary request. The applicant did however not present the third auxiliary request as amended application documents in accordance with the formal requirements of Rule 50 EPC, despite being informed of the necessity. As he did not, the Board did not give consent to admit it into the procedure. The decision gives no clue why the representative was too lazy to make a true third auxiliary request.

Summary of Facts and Submissions

I. The appeal is against the refusal of application [...] for lack of an inventive step, Article 56 EPC, (main request, first and second auxiliary requests) over documents [...].

A third auxiliary request of the appellant for the grant of a patent on the basis of a new claim 1 consisting of a merge of claims 1 and 19 according to the second auxiliary request was not admitted into the procedure under Rule 137(3) EPC, as such a claim was not considered to overcome the Article 56 EPC objection. The examining division held that the request, though not presented in writing, was sufficiently clear for the division to decide on admissibility.

II. With the statement setting out the grounds of appeal of 19 June 2012, the appellant requested that the decision under appeal be set aside and that a patent be granted on the basis of the following:

Main request, first and second auxiliary request:

Claims 1 to 19 according to the appellant's main request titled "Requête principale" / Première requête subsidiaire" /  Deuxième requête subsidiaire" filed with letter dated 18 November 2011, or

Third auxiliary request:

Claim 1 recited in the statement setting out the grounds of appeal dated 19 June 2012 on pages 27 and 28.

III. A summons to oral proceedings was issued by the board, provided with an annexed communication in which a provisional opinion of the board on the matter was given.

Regarding the appellant's requests in the statement setting out the grounds of appeal, the appellant was informed that, in order to be considered, new requests should be provided with amended application documents in accordance with Rule 50 EPC. No such amended application documents were filed in respect of the third auxiliary request.

Furthermore, the appellant was informed that it appeared that claim 1 according to the appellant's main request, as well as the first and second auxiliary requests lacked clarity, contrary to Article 84 EPC, and doubts existed as to whether the requirements of Article 83 EPC were met.

Moreover, the appellant was informed that it appeared that the subject-matter of claim 1 of all requests lacked an inventive step in the sense of Article 56 EPC over document D1. In particular, claim 1 was considered to contain both technical features and non-technical features pertaining to the fields of schemes for doing business and administrative schemes, the features making no contribution to the technical character of the invention not supporting the presence of an inventive step.

IV. With a letter dated 1 December 2014, the board was informed that the appellant would not be attending the oral proceedings.

No arguments were provided by the appellant in response to the board's observations.

V. Oral proceedings were held on 10 December 2014 in the absence of the duly summoned appellant.

VI. Claim 1 of the appellant's main request [...]

VII. Claim 1 of the appellant's first auxiliary request [...]

VIII. Claim 1 of the appellant's second auxiliary request [...]

IX. The appellant submitted with the statement setting out the grounds of appeal in substance the following arguments:

[...]

Moreover, the examining division should have accepted the third auxiliary request for the reasons already stated for the other requests.

Reasons for the Decision

1. The appeal is admissible.

2. Absence of the duly summoned appellant

The duly summoned appellant did not attend the oral proceedings, as announced. The proceedings were continued without him, as provided for in Rule 71(2) EPC 1973.

In accordance with Article 15(3) RPBA, the appellant was treated as relying only on its written case.

The board was in a position to decide at the conclusion of the oral proceedings, since the case was ready for decision (Article 15(5) and (6) RPBA) and the voluntary absence of the appellant was not a reason for delaying the decision (Article 15(3) RPBA).

3. Main request

3.1 Clarity, sufficiency of disclosure

Claim 1 of the main request defines "a comparator, to compare the entered profiling information to selections made by other users with similar profiles".

It is, however, unclear how profiling information (such as age etc. (cf description, page 19, lines 11 to 13)) should be compared to selections (eg songs) made by other users with similar profiles.

Accordingly, claim 1 lacks clarity, contrary to Article 84 EPC.

Moreover, as the above does not become clear from the description and drawings either, the application as a whole does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, contrary to the requirement of Article 83 EPC.

The above was noted in the communication annexed to the summons to oral proceedings. The appellant did not submit any arguments in response.

In view of the above, the appellant's main request is not allowable.

4. First and second auxiliary requests

The above also applies with respect to claim 1 and the remaining application documents according to the appellant's first and second auxiliary requests.

Accordingly, the appellant's first and second auxiliary requests are not allowable either.

5. Third auxiliary request

As a third auxiliary request, the appellant requested the grant of a patent on the basis of a claim 1, consisting of a merge of claims 1 and 19 according to the second auxiliary request, recited in the statement setting out the grounds of appeal on pages 27 to 28.

In the communication annexed to the summons to oral proceedings before the board, the appellant was informed that, in order to be considered, new requests should be provided with amended application documents in accordance with Rule 50 EPC.

No such amended application documents were filed in respect of the third auxiliary request, neither before the examining division, nor with the statement setting out the grounds of appeal, nor in response to the communication of the board annexed to the summons to oral proceedings.

Rule 50(1) EPC, in particular in conjunction with Rule 49 EPC, requires amended application documents, such as amended claims, to be presented on separate sheets and meeting certain form requirements. This is essential for further processing of the application, and, not least, avoids any doubts about what exactly is requested to be granted. As such, the board views critically the procedure followed by the examining division, deciding on the third auxiliary request based merely on an indication of the applicant of a merging of claims without any concrete claim being actually filed. In particular, in view of the fact that no amended application documents were filed at all in respect of the third auxiliary request in the first-instance proceedings, the board deemed it necessary in the present case to insist on the filing of proper amended application documents before proceeding to consider any such request. As noted above, no amended application documents were filed in respect of the third auxiliary request in response to the communication of the board annexed to the summons to oral proceedings.

Moreover, it is noted that since claim 1 as recited in the statement setting out the grounds of appeal contains the same unclear feature as claim 1 of the main request, it does not overcome the above objections under Articles 84 and 83 EPC.

For the above reasons, no consent is given to the amendment according to the appellant's third auxiliary request, in accordance with Rule 137(3) EPC.

Order

For these reasons it is decided that:

The appeal is dismissed.

This decision has European Case Law Identifier:  ECLI:EP:BA:2014:T148012.20141210. The whole decision can be found here. The file wrapper can be found here. Photo "Lazy day"by Mike Norton obtained via Flickr under CCBY 2.0 license.