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 Election/Restriction filed on June 18, 2025 is acknowledged.
Claims 1-23 are pending in this application.
Restriction
Applicant’s election without traverse of Group VI (claims 22-23) in the reply filed on June 18, 2025 is acknowledged.
Applicant has elected to following:
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. It appears that there was a misunderstanding on the election of species. On page 7 of the Election/Restriction mailed on April 17, 2025, the Examiner requested the following:
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. The Examiner has selected SEQ ID NO: 7 for a single disclosed species of a FULLY defined peptide sequence to search. Alzheimer disease was searched, as indicated by the election of species above.
Restriction is deemed to be proper and is made FINAL in this office action. Claims 1-21 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claims. Claims 22-23 are examined on the merits in this office action.
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.
Rejections
U.S.C. 112
5. 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.
6. Claims 22-23 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 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 a therapeutically effective amount of the composition comprising a peptide or mimetic thereof comprising amino acid sequence having at least 70% sequence identity to SEQ ID NO: 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15, wherein the peptide has a length of at least 10 amino acid residues to the subject in need thereof. The generic statements amino acid sequence having at least 70% sequence identity to SEQ ID NO: 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15, wherein the peptide has a length of at least 10 amino acid residues 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: 90 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. Instant SEQ ID NO: 6 is the last 90 residues of instant SEQ ID NO: 1. At least 70% of instant SEQ ID NO: 1 is 179 * 0.7 = 125.3, which implies that 126 residues out of 179 must be the same. Thus, 53 residues may be different from instant SEQ ID NO: 1. Instant SEQ ID NO: 3 is a 213 residue protein. Thus, at least 70% sequence identity of 213 is 213 * 0.7 = 149.1. This implies that 150 residues must be the same and 63 residues may be different. Instant SEQ ID NO: 6 is a 90 residue protein sequence. At least 70% of instant SEQ ID NO: 6 is 90 * 0.7 = 63, which implies that 63 residues must be the same. Thus, 27 residues may be different from instant SEQ ID NO: 6. Instant SEQ ID NOs: 7-15 are residues within instant SEQ ID NO: 6. Again, instant SEQ ID NOs: 7-14 are all 10 residue peptide sequences; instant SEQ ID NO: 15 is a 9 residue peptide 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 70% sequence identity to SEQ ID NOs: 1-4 and 6-15, wherein the peptide has a length of at least 10 amino acid residues. 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 70% sequence identity to instant SEQ ID NO: 1 is: 5320 = 3.1 x 1034 possibilities; for at least 70% sequence identity to instant SEQ ID NO: 3 is: 6320 = 9.7 x 1035 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.
Improper Markush
7. Claims 22-23 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).
U.S.C. 102
8. 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.
9. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
10. Claim(s) 22-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chakraborty et al (US Patent No. 9303079).
11. Chakraborty et al teach a protein sequence comprising instant SEQ ID NO: 7 (see SEQ ID NO: 8271, see residues 90-100). The SEQ ID NO: 8271 of Chakraborty et al is 128 residues in length, thus meets the limitation of “the peptide has a length of at least 10 amino acid residues”. Chakraborty et al further teach that the mRNAs and their encoded polypeptides may be used for treatment of any of a variety of diseases, disorders, and/or conditions…neurological disorders (e.g., Alzheimer’s disease, H7untington’s disease, autism, Duchene muscular dystrophy)…(see column 241, lines 37-59), and teach a method for treating…neurological diseases…(see column 242, lines 59-67), meeting the limitation of instant claims 22-23.
Patents and applications are relevant as prior art for all they contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Nonpreferred embodiments constitute prior art. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). See M.P.E.P. §2123.
Therefore, Chakraborty et al anticipates instant claims 22-23.
CONCLUSION
No claim is allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
9/22/2025
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