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 .
DETAILED ACTION
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-14, and 33-37 have an effective filing date of 30OCT2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/05/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Restriction/Election
In the response filed on 7/15/2026, Applicant elected without traverse:
Group I, claims 1-14
Species
Wet age-related macular degeneration
Anti-GDF15 antibody AF957
Status of Claims
Claims 1-14, and 33-37 are currently pending and presented for examination on the merits.
Claims 4 and 10 are amended.
Claims 33-37 are new.
Claims 15-32 are canceled.
Claims 6, 10-14, and 33-36 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected species.
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, and 7- 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the claims are inclusive of a genus of a GDF15 modulator, or substance inhibiting the action of GDF15. However, the written description in this case only sets forth the anti-GDF15 antibody AF957, and antibodies comprising SEQ ID NOs (i.e., SEQ ID NOs: 1, 7, 13 and 16, 18, 22). The specification does not disclose, and the art does not teach, the genus of a GDF15 modulator, or substance inhibiting the action of GDF15, as broadly encompassed in the claims.
The specification discloses the GDF15 modulator reduces and/or inhibits the activity of GDF 15 and/or the activity of the biological pathway of GDF 15. However, the written description only reasonably conveys the anti-GDF15 antibody AF957, and antibodies comprising SEQ ID NOs (i.e., SEQ ID NOs: 1, 7, 13 and 16, 18, 22). A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”
The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. See Ariad, 598 F.3d at 1354-55 (“Regardless whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods... the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity so as to ‘satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.’”) (internal citation omitted); see also Univ. of Rochester v. G.D. Searle& Co., Inc., 358 F.3d916,918 (Fed.Cir.2004) (applying the same analysis to assess written description for claims to a “method for selectively inhibiting” a particular enzyme by administering a functionally defined compound, i.e., a “non-steroidal compound that selectively inhibits activity” of the gene product for that enzyme).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genus. That is, the specification provides neither a representative number of GDF15 modulators that encompass the genus of GDF15 modulators, or substance inhibiting the action of GDF15, nor does it provide a description of structural features that are common to the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus. “[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) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. Further, in view of Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) and the Office’s February 2018 memo clarifying written description guidance for claims drawn to antibodies, the 2008 Written Description Training Materials are outdated and should not be relied upon as reflecting the current state of law regarding 35 U.S.C. 112. Further, a “newly characterized antigen” test flouts basic legal principles of the written description requirement (Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017)). Adequate written description of a newly characterized antigen alone is not considered adequate written description of a claimed antibody to that newly characterized antigen. Where an antibody binds to an antigen tells one nothing about the structure of any other antibody. Also, see the Board’s recent decision in Appeal 2017-010877 (claims to “A monoclonal antibody that binds a conformational epitope formed by amino acids 42-66 of SEQ ID NO:1”).
The functional requirements of the claimed antibodies is the sort of wish list of properties which fails to satisfy the written description requirement because “antibodies with those properties have not been adequately described.” Centocor, 636 F.3d at 1352.
The “claims merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad Pharmaceuticals, Inc. v. EliLilly and Co.,598 F.3d 1336, 1353 (Fed. Cir. 2010).
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure of the anti-GDF15 antibody AF957, and antibodies comprising SEQ ID NOs (i.e., SEQ ID NOs: 1, 7, 13 and 16, 18, 22) is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over De Roulet et al (WO 2020206363 A1).
In regard to claims 1-4, and 7, De Roulet et al teaches a method of treating fibrosis and mitochondrial diseases [Abstract]. De Roulet et al further teaches mitochondrial disease is macular degeneration [0146]. De Roulet et al further teaches EP-0035985 reduced the expression of GDF15 [0067].
One of ordinary skill in the art, before the effective filing date, would have been motivated to use De Roulet’s method of treating fibrosis and macular degeneration comprising administering EP-0035985, reducing the expression of GDF15. It would have been prima facie obvious to use De Roulet’s methods for a method to treat macular degeneration by administering EP-0035985, because De Roulet teaches administering EP-0035985, decreasing GDF15, and treating macular degeneration.
Claims 1-4, 7-9, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over De Roulet et al (WO 2020206363 A1) as applied to claims 1-4, and 7 above, and further in view of Lerner et al (WO 2014100689 A1, IDS 02/05/2026).
The teachings of De Roulet are discussed above.
De Roulet et al does not teach the GDF15 modulator is an antibody. However, this deficiency is made up in the teachings of Lerner et al.
In regard to claims 8, 9, and 37, Lerner et al teaches antibodies that bind and inhibit the activity of GDF15 [Abstract]. Lerner et al further teaches the antibody against GDF15 is AF957 [0251]. At [0008], Lerner et al. teach humanized antibodies.
One of ordinary skill in the art, before the effective filing date, would have been motivated to combine De Roulet’s method of treating fibrosis and macular degeneration comprising administering EP-0035985, reducing the expression of GDF15, with Lerner’s method of inhibiting the activity of GDF15 by using anti-GDF15 antibody AF957. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine De Roulet and Lerner’s methods for a method to treat ocular tissue fibrosis and macular degeneration by administering anti-GDF15 antibody AF957, because De Roulet teaches administering EP-0035985, decreasing GDF15, and treating fibrosis and macular degeneration, and Lerner teaches inhibiting GDF15 activity by using anti-GDF15 antibody AF957.
Claims 1-5, 7-9, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over De Roulet et al (WO 2020206363 A1) and Lerner et al (WO 2014100689 A1, IDS 02/05/2026), as applied to claims 1-4, 7-9, and 37 above, and further in view of Ishida et al (The Role of GDF15 in EMT of Retinal Pigment Epithelial Cells, Proceedings of the 136th Kinki Regional Meeting of the Japanese Pharmacological Society, 42 pgs, 2019, IDS 02/05/2026).
The teachings of De Roulet and Lerner are discussed above.
The cited references do not specifically teach wet age-related macular degeneration. However, this deficiency is made up in the teachings of Ishida et al.
In regard to claim 5, Ishida et al teaches that the addition of GDF15 to retinal pigment epithelium (RPE) causes the morphological and characteristics of the cells and epithelial-mesenchymal transition (EMT) [Method & Consideration]. Ishida et al further teaches GDF15 is a representative disease-susceptibility factor for neovascular age-related macular degeneration [Background & Method].
One of ordinary skill in the art, before the effective filing date, would have been motivated to combine De Roulet and Lerner’s method of treating fibrosis and macular degeneration comprising administering EP-0035985, reducing the expression of GDF15, with Ishida’s method of decreasing GDF15 in RPE cells to decrease age-related macular degeneration EMT. It would have been prima facie obvious to use De Roulet and Ishida’s methods for a method to treat wet age-related macular degeneration by administering a GDF15 modulator, because De Roulet teaches administering EP-0035985, decreasing GDF15, and treating fibrosis and macular degeneration. Furthermore, Ishida teaches decreasing GDF15 inhibits RPE cells EMT.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/ Examiner, Art Unit 1642
/NELSON B MOSELEY II/ Primary Examiner, Art Unit 1642
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