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 September 1, 2026, is acknowledged.
Claims 3-6, 9, 11-15, 21, 24-25, 29 and 32 have been amended.
Claims 1-7, 9, 11-15, 19, 21, 23-25, 29 and 32 are pending in this application.
Restriction
Applicant's election with traverse of following species:
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in the reply filed on September 1, 2026 is acknowledged. The traversal is on the ground(s) that
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. Applicant further argues:
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. This is not found persuasive because the independent claim encompasses more than just a composition comprising a peptide having SEQ ID NO: 5. The independent claim 1 encompasses all variants thereof (instant SEQ ID NO: 5 is a 16mer peptide sequence) wherein a variant peptide hast at least 85% homologous to SEQ ID NO: 5, wherein the variant peptide does not contain mutation at tyrosine 12 residue of SEQ ID NO: 5. Thus, the only defining structure of instant claim 1 is that the SEQ ID NO: 5 has a tyrosine at position 12. The dependent claims do not clarify the variant of SEQ ID NO: 5, since the claims do not define the content of SEQ ID NO: 5. For example, claim 6 recites that “…the variant peptide of SEQ ID NO: 5 does not contain substitution of methionine with norleucine.” Instant SEQ ID NO: 5 has the sequence CRAMISYGGADYKXIC, wherein X is N-methyl Arginine. Thus, the dependent claim 6 only indicates that the residue at position 4 (methionine) cannot be norleucine substitution. Therefore, Applicant’s arguments are not persuasive.
The requirement is still deemed proper and is therefore made FINAL. A search was conducted on the elected species, SEQ ID NO: 5, and this appears to be free of prior art. A search was extended to a sequence at least 85% identity to SEQ ID NO: 5, and prior art was found. Claims 1-7, 9, 11-15, 19, 21, 23-25, 29 and 32 are examined on the merits in this office action.
Please note: instant SEQ ID NOs: 9-13 are as follows: ARAMISYGGADYKXIC (9); CRAMISYGGADYKXIC (10); XCRAMISYGGADYKXIC (11); XCRXMISYGGADYKXXC (12); XCRAMIXYGGXDYKXIC (13). Instant SEQ ID NO: 5 is CRAMISYGGADYKXIC, wherein X is N-methyl Arginine.
Objections
6. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “Embodiments relate to peptides that binds with molecules of programmed death protein-1...” at line 1 of the abstract. Applicant should correct these informalities. See MPEP 608.01(b). For example, the abstract is recommended to be amended to recite, “Peptides that bind with molecules…are described.”
7. The drawings are objected to because the drawings disclose peptide sequences and they are missing the corresponding sequence identifiers (e.g., see Fig 3B, Fig. 8). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
8. The specification is objected to for referring to sequences without also identifying them by the sequence identifier assigned to them in the sequence listing as required by 37 CFR 1.821(d). The specification discloses peptide sequences, and these are missing their respective sequence identifiers. For example, Fig. 3B and Fig. 8 of instant specification US 2024/0327493 A1 disclose peptide sequences, but these are missing their sequence identifiers. The examiner would like to bring the applicant’s attention to the following excerpt from MPEP §2422.03:
37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application. This requirement is also intended to permit references, in both the description and claims, to sequences set forth in the "Sequence Listing" by the use of assigned sequence identifiers without repeating the sequence in the text of the description or claims. Sequence identifiers can also be used to discuss and/or claim parts or fragments of a properly presented sequence. For example, language such as "residues 14 to 243 of SEQ ID NO:23" is permissible and the fragment need not be separately presented in the "Sequence Listing." Where a sequence is embedded in the text of an application, it must be presented in a manner that complies with the requirements of the sequence rules.
The applicant is therefore required to amend the specification to comply with 37 CFR 1.821(d).
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.
9. Claims 1-7, 9, 11-15, 19, 21, 23-25, 29 and 32 are objected to for the following: Claim 1 recites, “…wherein a variant peptide has at least 85 homologous to SEQ ID No. 5, wherein the variant peptide does not contain mutation at tyrosine 12 residue of SEQ ID NO. 5.” Applicant is required to correct this to recite “A composition comprising a peptide comprising SEQ ID NO: 5 and a variant thereof, wherein a variant peptide is at least 85% homologous (or alternatively, has at least 85% homology) to SEQ ID NO: 5, wherein the variant peptide does not contain a mutation at residue 12 of SEQ ID NO: 5.” Additionally, claim 1 recites “SEQ ID NO. 5” and “SEQ ID No. 5” (see lines 1 and 3 for SEQ ID NO. 5 and line 2 for SEQ ID No. 5). Applicant is required to correct the SEQ ID No. 5 in line 2 to “SEQ ID NO: 5” for consistency.
10. Claims 1-4, 6, 12, 14, 19, 21, 23-24, 29 and 32 recite sequence identifiers as SEQ ID NO. 5. There are multiple periods in the claims. There can only be one period at the end of the claim. Applicant is required to correct the sequence identifier as “SEQ ID NO: 5”, for example.
11. Claim 25 recites, “The composition of claim 24…SEQ ID NO. 12 or 13.” To be consistent throughout the claim, Applicant is required to correct this to recite, “…SEQ ID NO: 12 or SEQ ID NO: 13.”
12. Claim 29 recites, “The composition of claim 1, wherein the variant peptide does not contain mutation at 2, 4, 11, 13, or 14 residues of SEQ ID NO. 5.” Applicant is required to correct this to, “…wherein the variant peptide does not contain a mutation at position 2, 4, 11, 13 or 14 of SEQ ID NO: 5.”
13. Claim 32 recites, “The composition of claim 1, wherein the variant peptide does not contain mutation at 2, 4, and 11-14 residues of SEQ ID NO. 5.” Applicant is required to correct this to, “…wherein the variant peptide does not contain a mutation at position 2, 4, and 11-14 of SEQ ID NO: 5.”
Rejections
U.S.C. 112(b)
14. 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.
15. Claims 1-7, 9, 11-15, 19, 21, 23-25, 29 and 32 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.
16. Claim 1 recites, “A composition comprising at peptide having SEQ ID NO: 5 and its variant thereof, wherein a variant peptide has at least 85% homologous to SEQ ID No. 5, wherein the variant peptide does not contain mutation at tyrosine 12 residue of SEQ ID NO. 5.” The metes and bounds of the claim is unclear. It is unclear what peptide variants are encompassed within the “a variant peptide has at least 85% homologous to SEQ ID No. 5…” The term “homologous” is not the same as the term “identity”. As evidenced by Kanduc reference (Journal of Peptide Science, 2012, 18: 487-494), “‘homology’ is a concept of quality…two sequences possess a certain level of similarity. Similarity is thus a quantitative property. Homologous proteins or nucleic acid segments can range from highly similar to not recognizably similar” (see p. 487, left column). Kanduc reference teaches that “The term ‘homology’ pertains to comparative studies. Homology indicates an ancient common origin and temporal evolution and refers to structural characteristics…’homology’ retains the original meaning of ‘having a common evolutionary origin’…It is important to note that homologous structures do not imply sequence similarity as a necessary condition” (see p. 488, left column, “Homology: Definition and Measurement by Comparative Modeling”). Kanduc reference teaches that “Similarity is a quantitative property…There are two ways to measure sequence similarity: (1) percent identity and (2) percent similarity” (see p. 488, left column, “Similarity and Identity: Definition and Measurement Based on Quantification”). Therefore, a sequence that is homologous may not have any sequence similarity to a certain sequence. Therefore, it is unclear what peptide variant sequences are encompassed within “a variant peptide has at least 85% homologous to SEQ ID No. 5”. Because claims 2-7, 9, 11-15, 19, 21, 23-25, 29 and 32 depend from indefinite claim 1 without clarifying the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
U.S.C. 112(d)
17. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
18. Claims 24-25 and 32 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
19. Claim 24 recites, “The composition of claim 1, wherein the variant peptide of SEQ ID NO. 5 comprises one or more residues that allow formation of a disulfide or thioether bond.” Claim 24 depends from claim 1. Claim 1 recites, “A composition comprising a peptide having SEQ ID NO: 5 and its variant thereof, wherein a variant peptide has at least 85% homologous to SEQ ID No. 5…” Instant SEQ ID NO: 5 is a 16 residue peptide sequence. If 85% is read as at least 85% sequence identity to SEQ ID NO: 5, then 16 x 0.85 = 13.6, thus, 14 residues should be the same. The recitation of “one or more residues” encompasses more than the allotted number of difference(s) between instant SEQ ID NO: 5. Therefore, claim 24 is broader than claim 1.
20. Claim 25 recites, “The composition of claim 24, wherein the variant peptide comprises SEQ ID NO. 9, SEQ ID NO. 10, SEQ ID NO. 11, SEQ ID NO. 12 or 13.” Claim 25 depends from claim 24, which depends from claim 1. Claim 1 recites, “A composition comprising a peptide having SEQ ID NO: 5 and its variant thereof, wherein a variant peptide has at least 85% homologous to SEQ ID No. 5…” Instant SEQ ID NO: 5 is a 16 residue peptide sequence. If 85% is read as at least 85% sequence identity to SEQ ID NO: 5, then 16 x 0.85 = 13.6, thus, 14 residues should be the same. SEQ ID NOs: 9-13 are as follows: ARAMISYGGADYKXIC (SEQ ID NO: 9); CRAMISYGGADYKXIC (SEQ ID NO: 10); XCRAMISYGGADYKXIC (SEQ ID NO: 11); XCRXMISYGGADYKXXC (SEQ ID NO: 12); XCRAMIXYGGXDYKXIC (SEQ ID NO: 13). Instant SEQ ID NO: 5 has the sequence: CRAMISYGGADYKXIC. Instant SEQ ID NOs: 12 and 13 have more than 2 residues that are different from instant SEQ ID NO: 5. Thus, instant claim 25 is broader than instant claim 1. Claim 25 does not further limit instant claim 1.
21. Claim 32 recites, “The composition of claim 1, wherein the variant peptide does not contain mutation at 2, 4, and 11-14 residues of SEQ ID NO. 5.” Claim 32 depends from claim 1. Claim 1 recites, “A composition comprising a peptide having SEQ ID NO: 5 and its variant thereof, wherein a variant peptide has at least 85% homologous to SEQ ID No. 5…” Instant SEQ ID NO: 5 is a 16 residue peptide sequence. If 85% is read as at least 85% sequence identity to SEQ ID NO: 5, then 16 x 0.85 = 13.6, thus, 14 residues should be the same. However, mutation at 2, 4 and 11-14 implies that 6 residues do not have mutations. Thus, 16 - 6 = 10 residue mutations. Therefore, claim 32 does not further limit instant claim 1.
U.S.C. 112(a)
22. 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.
23. Claims 1-7, 9, 11-15, 19, 21, 23-25, 29 and 32 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 composition comprising at peptide comprising SEQ ID NO: 5 and a variant thereof, wherein a variant peptide is at least 85% homologous to SEQ ID NO: 5, wherein the variant peptide does not contain mutation at residue 12 of SEQ ID NO: 5. The generic statements a variant peptide is at least 85% homologous to SEQ ID NO: 5, wherein the variant peptide does not contain mutation at residue 12 of SEQ ID NO: 5 do not provide ample written description for the compounds since the claims do not describe a structural features that is required to maintain the function of the peptide variant. 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 1 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 peptide bonds, and make up the class of peptides. 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 homologous peptide sequences. 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 form peptide bonds.
The specification discloses the following: “The term “homologous” as used herein refers to the degree of identity or similarity between sequences of two amino acid sequences, i.e. peptide or polypeptide sequences…In an embodiment, the variant sequence is about 85%, 88%, 90%...99% or more homologous to SEQ ID NO. 1 to SEQ ID NO. 14. IN an embodiment, the variant sequence is about 85%, 88%, 90%, 95%, 99% or more homologous to SEQ ID NO. 5” (see paragraph [0099] of instant specification US 2024/0327493). Table 1 discloses instant SEQ ID NOs: 1-14. The specification does not describe any peptides that are “homologous” to instant SEQ ID NO: 5. Description of SEQ ID NOs: 1-4 and 6-14 is not sufficient to encompass numerous other peptides/proteins that belong to the same genus. For example, there are varying lengths, varying amino acid compositions, and numerous distinct qualities that make up the genus. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed.
For example, Kanduc reference (Journal of Peptide Science, 2012, 18: 487-494) teaches that “‘homology’ is a concept of quality…two sequences possess a certain level of similarity. Similarity is thus a quantitative property. Homologous proteins or nucleic acid segments can range from highly similar to not recognizably similar” (see p. 487, left column). Kanduc reference teaches that “The term ‘homology’ pertains to comparative studies. Homology indicates an ancient common origin and temporal evolution and refers to structural characteristics…’homology’ retains the original meaning of ‘having a common evolutionary origin’…It is important to note that homologous structures do not imply sequence similarity as a necessary condition” (see p. 488, left column, “Homology: Definition and Measurement by Comparative Modeling”). Kanduc reference teaches that “Similarity is a quantitative property…There are two ways to measure sequence similarity: (1) percent identity and (2) percent similarity” (see p. 488, left column, “Similarity and Identity: Definition and Measurement Based on Quantification”). Therefore, a sequence that is homologous may not have any sequence similarity to a certain sequence.
Additionally, Marabotti et al (Bioinformatics, 2010-, 26(19): 2498) teach that “Homology” has a well-defined meaning when referred to proteins: ‘two homologous proteins have a common origin’ and so it is not possible to associate the term to an adjective as low or high, or indicate a degree of homology with a number, as an example a percentage value (see p. 2498, left column, 2nd full paragraph).
Therefore, Applicant was not in possession of a composition comprising a peptide comprising SEQ ID NO: 5 and a variant thereof, wherein a variant peptide has at least 85% homology to SEQ ID NO: 5.
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.
Closest Art of Interest
Liotta et al (US 2022/0064259 or issued as US Patent No. 12,331,096) teach the following peptides
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(see paragraph [0019] of ‘259 or column 3, lines 23-36 of ‘096). Liotta et al teach peptide sequence that is similar to instant SEQ ID NO: 5. The peptides of Liotta et al (see SEQ ID NO: 1 and SEQ ID NO: 2) teach peptides that comprises the sequence GGADYKRITV and GGADYKRITC, respectively. Although Liotta et al teach “variant thereof,” Liotta et al do not teach that arginine at position equivalent to instant SEQ ID NO: 5) 14 and 15, respectively, is N-methyl arginine. Instant SEQ ID NO: 5 has the sequence CRAMISYGGADYKXIC, wherein X is N-methyl arginine.
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
9/15/2026
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