DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In the amendment filed on 07/17/2026 Applicant amended claims 1, 4, 11-13, 15, 19, 26 and 27,and added the new claim 30. Claims 6-10 were canceled. Claims 1-5, 11-23 and 26-30 are pending; claims 27-29 remain withdrawn from prosecution for being drawn to non-elected subject matter. Claims 1-5, 11-23, 26 and 30 are examined.
Status of drawings
In the remarks submitted on 07/17/2026 Applicant argued: “Applicant notes that the published application (US 2023-0321209 Al) does not include Figure 14. Figure 14 was included in the Drawings as originally filed on March 3, 2023. On that same date, Replacement Drawings were filed together with remarks identifying figures for which replacement sheets were being submitted. Figures 9 and 14 were not identified for replacement. Figure 9 appears in the publication, whereas Figure 14 does not. Applicant respectfully requests that Figure 14, as originally filed, be treated as part of the application and included in any patent issuing from this application.” While understanding Applicant’s request, since the submission of 03/03/2023 did not comprise Figures 9 and 14, it would be advisable for a resubmission of the whole set of figures and thus the publication of all figures would be certain.
Withdrawn claim rejections
Claim Rejections - 35 USC § 103
The rejection of claims 1-5, 11-13 and 17-19 under 35 U.S.C. 103 as being unpatentable over Liao et al., Capasso et al. and in further view of Kozel et al. (U.S. 9,310,365) is withdrawn in view of the persuasive arguments of Applicant.
Maintained and new claim rejections necessitated by amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 11-23, 26 and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members.
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Lastly, even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876.
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), it is noted that to show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358).
Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361).
The claims are drawn to an attenuated Mycobacterium bovis of the strain Bacillus
Calmette-Guerin (BCG), wherein said BCG is coated with a plurality of peptide antigens capable of eliciting an immune reaction against a cancer in a human and wherein said plurality of peptide antigens are attached to said BCG using a poly-lysine or poly-arginine peptide linker. The peptide antigens are represented by SEQ ID NOs: 14-17 or 56 and the peptides may also have 61-99% identity to these sequences.
The specification discloses the use of an attenuated BCG coated with Trp-2, gp100 or AH1 peptide antigens, attached to the bacteria by a poly-lysine peptide linker, to treat melanoma or colon cancer cells xenografted in mice.
The art is aware of the involvement of the antigens gp100 and Trp-2 in melanoma and of the antigen AH1 in colon cancer. The art is not aware of using the
above mentioned peptide antigens for treating other types of cancers.
Cancer is a group of disease diseases that comprises a vast number of types
(each type of cell in the organisms may develop characteristics associated with the
defining properties of the cancer cells. As indicated supra, the Specification presents evidence of using constructs that comprise only gp100, Trp-2 and AH1 for treating xenografted mice with melanoma cancer cells and CT26 (colon cancer cells). The methods treating just two cancers is not representative for the number of approximate 300 of possible cancers.
With respect with the peptide % identity, this adds a vast amount of variability in the structure of the peptide and thus, having just three peptide structures, does not represent a representative number of the immense number of possible structures.
One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genera.
Claims 1-5, 11-23 and 26 remain and claim 30 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for compositions used for treating melanoma and colon cancer, does not reasonably provide enablement for treating other cancers. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
On page 8 of the Remarks Applicant argues that: “… claims are enabled at least because (1) the specification provides ample working examples of eliciting immune reactions against disparate cancer types …”. Further, Applicant contends that: ” Melanoma and
colon cancer were deliberately selected because they are disparate cancer types. Applicant
submits that the in vivo data in FIGS. 9 and 10 shows a comparable response regardless of
tumor type, thereby demonstrating that the claimed technology is capable of eliciting an
immune reaction regardless of cancer type. Further, this effect has been supported by showing
that macrophages can cross-present another, different, cancer peptide (SIINFEKL a highly
immunogenic cancer peptide model)”.
The arguments were carefully considered but not found persuasive because, firstly, as indicated supra, the constructs were used to treat just two types of cancer: melanoma and colon cancer. The broadest breath for the claims might be considered treating cancers that express the three cancer markers indicated (only gp100, Trp-2 and AH1). With respect to SIINFEKL peptide, which is considered by Applicant as a highly
immunogenic cancer peptide model, Examiner differs from Applicant interpretation, since this particular peptide is one of the most studied immunodominant epitopes in immunology, widely used as a model antigen to investigate antigen processing, MHC class I presentation, and CD8⁺ T cell responses and is not a cancer peptide model.
With respect to the Declaration of Lukacz Kuryk under Rule 132, which provides data demonstrating that the claimed technology can be used to treat a range of infectious diseases, the declaration is moot in view of the amendments to the claims.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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