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 .
Amendment after Non-final office action filed on February 2, 2026 is acknowledged.
Claims 1-21 have been cancelled.
New claims 24-41 have been added.
Claims 22-41 are pending in this application.
Withdrawn Rejection
Rejection of claims 22-23 under 35 U.S.C. 102(a)(1) as being anticipated by Chakraborty et al (US Patent No. 9303079, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims.
Maintained Objections
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Maintained and Revised Rejections
35 U.S.C. 112(a)
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 22-41 remain/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 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. This rejection is maintained and revised in view of Applicant’s amendment to the claims.
The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a method for treating a neurodegenerative or other proteinopathy in a subject in need thereof, the method comprising administering to the subject in need thereof a therapeutically effective amount of
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. The generic statements
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do not provide ample written description for the compounds since the claims do not describe a single structural feature. The specification does not clearly define or provide examples of what qualify as compounds of the claimed invention.
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable claim 22 is broad generics with respect all possible compounds encompassed by the claims. The possible structural variations are limitless to any class of peptide or a peptide-like molecule that can form an amide bond, and make up the class of peptide or peptide mimetics. It must not be forgotten that the MPEP states that if a peptide is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus since the specification does not provide any examples of peptide mimetics. The specification is void of organic molecules that functions as a peptide-like molecule that qualify for the functional characteristics claimed as a peptide or a peptide-like molecule or other peptidic molecules, and other synthetic peptide or peptide-like molecule that can function as peptide and peptide mimetics.
Instant SEQ ID NO: 1 is a 179 residue protein sequence; instant SEQ ID NO: 2 is a 201 residue protein sequence; instant SEQ ID NO: 3 is a 213 residue protein sequence; instant SEQ ID NO: 4 is a 179 residue protein sequence; instant SEQ ID NO: 78 is a 253 residue protein sequence; instant SEQ ID NO: 5 is a 20 residue protein sequence; instant SEQ ID NO: 6 is a 90 residue protein sequence; instant SEQ ID NO: 7 is a 11 residue peptide sequence; instant SEQ ID NOs: 8-14 are 10 residue peptide sequences; instant SEQ ID NO: 15 is a 9 residue peptide sequence. At least 95% of instant SEQ ID NO: 1 is 179 * 0.95 = 171, which implies that 171 residues out of 179 must be the same. Thus, 8 residues may be different from instant SEQ ID NO: 1. Instant SEQ ID NO: 3 is a 213 residue protein. Thus, at least 95% sequence identity of 213 is 213 * 0.95 = 202.35. This implies that 203 residues must be the same and 10 residues may be different. Instant SEQ ID NO: 78 is a 253 residue protein sequence. At least 95% of instant SEQ ID NO: 78 is 253 * 0.95 = 240.35, which implies that 241 residues must be the same. Thus, 12 residues may be different from instant SEQ ID NO: 78. For a peptide fragment comprising either a C-terminal half or an N-terminal half of any one of SEQ ID NOs: 1, 2, 3, 4, 5…or 78, instant SEQ ID NO: 1 is a 179 residue protein sequence; instant SEQ ID NO: 2 is a 201 residue protein sequence; instant SEQ ID NO: 3 is a 213 residue protein sequence; instant SEQ ID NO: 4 is a 179 residue protein sequence; instant SEQ ID NO: 78 is a 253 residue protein sequence. The specification is limited to instant SEQ ID NOs: 1-4 and 6-15. Instant specification describes the following:
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(see paragraphs [0081]-[0084]). The working examples do not describe any peptide mimetics. Description of SEQ ID NOs: 1-4 and 6-15 is not sufficient to encompass numerous other peptides and peptide mimetics that belong to the same genus of at least 95%% sequence identity to SEQ ID NOs: 1-4, 6, and 67-78, and a peptide fragment comprising either a C-terminal half or an N-terminal half of any one of SEQ ID NOs: 1-4, 6 and 67-78. For example, there are varying lengths, varying amino acid compositions, and numerous distinct qualities that make up the genus. Since there are 20 naturally occurring amino acids, and a peptide having at least 95% sequence identity to instant SEQ ID NO: 1 is: 820 = 1.152 x 1018 possibilities; for at least 95% sequence identity to instant SEQ ID NO: 3 is: 1020 = 1.0 x 1020 possibilities; and at least 95% sequence identity to instant SEQ ID NO: 78 is: 1220 = 3.8 x 1021 possibilities. Additionally, as indicated by Yampolsky et al (Genetics, 2005, 170: 1459-1472), a peptide/protein activity can drastically change with a single amino acid substitution/mutation. The exchangeability rate is shown in Table 3 or Yampolsky et al. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Response to Applicant’s Arguments
Applicant argues that, “The peptides now recited in the claims are clearly defined and explicitly disclosed in the present specification (see, e.g., paras. [0046]-[0053]), and the specification clearly describes using these peptides to treat neurodegenerative diseases or other proteinopathies (see, e.g., para. [0048]). Applicant argues:
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Applicant’s arguments have been fully considered but are not found persuasive. The claims have been amended to recite a peptide variant comprising at least 95% sequence identity to any one of SEQ ID NOs: 1-4, 6 and 67-78, and a peptide fragment comprising a C-terminal half or an N-terminal half of any one of SEQ ID NOs: 1-4, 6 and 67-78. The paragraphs [0046]-[0053] of instant specification only define a specific peptide sequence (e.g., SEQ ID NOs: 1-4 and 6-15). The specification does not clearly define what amino acids are required to have the same function and activity as instant SEQ ID NOs: 1-4 and 6-15. For example, instant SEQ ID NO: 1 is a 179 residue protein sequence. Thus, a sequence having at least 95% sequence identity of SEQ ID NO: 1 (179 * 0.95 = 171) requires that 171 residues out of 179 must be the same. Thus, 8 residues may be different from instant SEQ ID NO: 1. Again, since there are 20 naturally occurring amino acids, there are 820 = 1.152 x 1018 possibilities. Additionally, the specification has not clearly defined what residues are required and what residues can be deleted and substituted, the possibilities are vast. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed. Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. The rejection is deemed to be proper and is maintained and revised herein.
MARKUSH
Maintained and Revised in view of Applicant’s amendment to the claims
11. Claims 22-25 and 40-41 remain/are rejected on the judicially created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F. 2d 716, 721-22 (CCPA 1980) and Ex parte Hazumi, 3 USPQ 2d 1059, 1060 (BPAI 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The compounds claimed do not share a common structural feature and a common use. For example, Instant SEQ ID NOs: 1-4 and 6-15 do not share a common sequences. For example, SEQ ID NO: 7 has the sequence MEDRSKTTNTW; instant SEQ ID NO: 8 has the sequence VLHMDGENFR; and instant SEQ ID NO: 15 has the sequence NREIPEIAS. There is no common core amino acid sequences shared by the sequences.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR 41.31 (a)(1) (emphasis provided).
Response to Applicant’s Arguments
12. Applicant argues that, “The peptides recited in the current claims are likewise “not repugnant to scientific classification.” Indeed, the peptides are FAIM proteins or fragment thereof, which share substantial sequence homology and common structural features. To a person skilled in the art, it would be “clear from their very nature” that the claimed peptides indeed share numerous structural similarities/features.”
13. Applicant’s arguments have been fully considered but are not found persuasive. The claims have been amended to recite a peptide variant comprising at least 95% sequence identity to any one of SEQ ID NOs: 1-4, 6 and 67-78, a peptide fragment comprising a C-terminal half or an N-terminal half of any one of SEQ ID NOs: 1-4, 6 and 67-78, and a peptide fragment comprising an amino acid sequence that is up to 90 amino acid residues in length and comprises any one of SEQ ID NOs: 5 and 7-15. The specification does not clearly define what amino acids are required to have the same function and activity as instant SEQ ID NOs: 1-4 and 6-15. For example, instant SEQ ID NO: 1 is a 179 residue protein sequence. Thus, a sequence having at least 95% sequence identity of SEQ ID NO: 1 (179 * 0.95 = 171) requires that 171 residues out of 179 must be the same. Thus, 8 residues may be different from instant SEQ ID NO: 1. Again, since there are 20 naturally occurring amino acids, there are 820 = 1.152 x 1018 possibilities. When sequences are compared between instant SEQ ID NO: 7 and 8, for example, MEDRSKTTNTW and VLHMDGENFR, only a single amino acid is shared by the two peptide sequence (see bold type above). One of ordinary skill in the art by comparing just the sequences of instant SEQ ID NO: 7 and 8, one cannot determine that the two peptide sequence share a “homology” and are from the FAIM protein. Additionally, when the peptide variances and N- and C-terminal residues are deleted, the protein/peptide sequence would not necessarily share a common core structure/sequence. Therefore, the rejection is deemed to be proper and is maintained and revised herein.
New Objection
14. Claim 22 is objected to for the following: Claim 22 recites, “…(i) a peptide…; (ii) a peptide variant…; (iii) a peptide fragment comprising…(ii) a peptide fragment comprising…” The “(ii)” is recited twice in the claim. Applicant is required to correct this error to recite, “(iv)”.
New Rejections
U.S.C. 112(b)
15. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
16. Claims 22-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
17. The term “C-terminal half or an N-terminal half” in claim 1 (iii) is a relative term which renders the claim indefinite. The term “C-terminal half or an N-terminal half” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what is encompassed by the term “C-terminal half or an N-terminal half” of SEQ ID NOs: 1, 2, 3, 4…or 78. Instant SEQ ID NO: 1 is a 179 residue protein sequence; instant SEQ ID NO: 2 is a 201 residue protein sequence; instant SEQ ID NO: 3 is a 213 residue protein sequence; instant SEQ ID NO: 4 is a 179 residue protein sequence; instant SEQ ID NO: 78 is a 253 residue protein sequence. The metes and bounds of the claim is unclear. It is unclear what portion of the protein, e.g., SEQ ID NO: 1 having 179 residues is the N-terminal half and what portion of SEQ ID NO: 1 is the C-terminal half. Instant specification does not clearly define what portion(s) is encompassed within “C-terminal half or N-terminal half”. Because claims 23-41 depend from indefinite claim 22 without clarifying the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
35 U.S.C. 112(a)
New Matter Rejection
18. 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.
19. Claims 22-41 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 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.
The claims are drawn to a method for treating a neurodegenerative or other proteinopathy in a subject in need thereof…(ii) a peptide fragment comprising an amino acid sequence that is up to 90 amino acid residues in length and comprises any one of SEQ ID NOs: 5, 7, 8, 9, 10, 11, 12, 13, 14 or 15.” The claims in question recite a “sequence that is up to 90 amino acid residues in length”.
Lack of Ipsis Verbis Support
20. The specification is void of any literal support for the “up to 90” amino acid residues in length claimed. In the context of substrate, the word “up to 90” is not present anywhere in the specification. The words “up to” was searched in the context of “amino acid residues in length”. Instant specification discloses the following: “As will also be understood by one skilled in the art all language such as “up to,” “at least,” “greater than,” “less than,” and the like, include the number recited and refer to ranges which can be subsequently broken down into subranges as discussed above” (see paragraph [0216]). In regards to “residues”, the specification discloses that “In any embodiment, the peptide may have a length of at least 10 amino acid residues. In any embodiment, the peptide may have a length of at least 15, at least 20, at least 25, at least 30, at least 40, or at least 50 amino acid residues” (see paragraph [0048]). However, “a peptide fragment comprising an amino acid sequence that is up to 90 amino acid residues” is not found in the instant specification.
Lack of Implicit or Inherent Support
21. “While there is not in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” See MPEP 2163. Thus support can be furnished implicitly or inherently for a specifically claimed limitation. However, the specification lacks any implicit or inherent support for the claimed “up to 90 amino acid residues in length”. As explained above, there is no support for any concept of “up to 90 amino acid residues in length” in the specification.
Closest Art
22. Mintz et al (US Patent No. 7745391) teach an 81 residue protein sequence that comprises instant SEQ ID NOs:10-15: SEQ ID NO: 10 (see SEQ ID NO: 772717, residues 23-32), SEQ ID NO: 11 (see SEQ ID NO: 772717, residues 33-42), SEQ ID NO: 12 (see SEQ ID NO: 772717, residues 43-52), SEQ ID NO: 13 (see SEQ ID NO: 772717, residues 53-62), SEQ ID NO: 14 (see SEQ ID NO: 772717, residues 63-72), and SEQ ID NO: 15 (see SEQ ID NO: 772717, residues 73-81).
CONCLUSION
No claim is 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 JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
5/20/2026
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