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 .
Status of the Claims
Claims 1-17 were originally filed April 12, 2022.
The preliminary amendment received April 12, 2022 canceled claims 3-7, 12-15, and 17; amended claim 16; and added new claims 18-21.
The amendment received February 18, 2025 amended claim 1.
The amendment received September 2, 2025 amended claims 1 and 8 and canceled claim 2.
Claims 1, 8-11, 16, and 18-21 are currently pending.
Claims 1 and 8 are currently under consideration.
Election/Restrictions
Applicants elected, without traverse, Group I (claims 1, 2, and 8-10) in the reply filed on February 18, 2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 11, 16, and 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected products and methods, there being no allowable generic or linking claim.
Applicants elected, without traverse, FGFR1, SEQ ID NO: 1, and an injection dosage form as the species in the reply filed on February 18, 2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 9 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 18, 2025.
Please note: claim 10 is withdrawn due to the dependency on withdrawn claim 9.
Priority
The present application is a 371 (National Stage) of PCT/CN2020/134550 filed December 8, 2020 which claims foreign priority to China 201911254125.6 filed December 10, 2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicants cannot rely upon the certified copy of the foreign priority application to overcome any rejection of record because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
See claim 11. Claim 11 was not amended to include a SEQ ID NO: in the response received September 2, 2025.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
See Figure 1A. While the response received September 2, 2025 stated that the drawings were amended, no drawings were found in the response received September 2, 2025.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification Amendments
Please carefully review MPEP § 714 and 37 CFR 1.121 regarding making amendments to the specification. Amendments to the specification are not exhibits of evidence (see 37 CFR 41.154 and 37 CFR 42.63).
Withdrawn Objections
The objection to claim 1 regarding the verbose claim language is withdrawn due to the amendment received September 2, 2025.
The objection to claims 1 and 2 regarding P48 is withdrawn in view of the amendment received September 2, 2025.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Please note: emphasis is added regarding the present claim language.
Withdrawn Rejections
The rejection of claims 1, 2, and 8 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 is withdrawn in view of the amendment received September 2, 2025.
The rejection of claims 1, 2, and 8 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 is withdrawn in view of the amendment received September 2, 2025.
The rejection of claims 1, 2, and 8 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 is withdrawn in view of the amendment received September 2, 2025.
The rejection of claim 2 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 is withdrawn in view of the cancellation of the claim in the amendment received September 2, 2025.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 102
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.
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. China 102453079 published May 16, 2012 (translation provided with the current Office Action – utilized for citation, Chinese version provided with the Restriction Requirement mailed on December 20, 2024).
For present claims 1 and 8, Li et al. teach Leu-Ser-Pro-Pro-Arg-Tyr-Pro alone or with a Gly-Gly-Gly-Ser linker attached (i.e. Leu-Ser-Pro-Pro-Arg-Tyr-Pro-Gly-Gly-Gly-Ser) which may be amidated (i.e. NH2 at the C-terminus) (please refer to the entire specification particularly the abstract; pages 3-6, 9-11; claims).
Therefore, the present claims are anticipated by the teachings of Li et al.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Li et al. for claims 1 and 8 were considered but are not persuasive for the following reasons.
Applicants contend that since the peptide disclosed by Li et al. is an 11mer which has an additional Leu at the N-terminus, that the teachings of Li et al. do not read on the 10mer as presently claimed.
Applicants’ arguments are not convincing since the teachings of Li et al. anticipate the peptide of the instant claims. Present independent claim 1 reads “comprising the amino acid sequence of Ser-Pro-Pro-Arg-Tyr-Pro-Gly-Gly-Gly-Ser-NH2 (SEQ ID NO: 1)”. As specifically stated in the present and the previous Office Actions, a peptide comprising the amino acid sequence is interpreted as requiring the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions (see the sequence interpretation section above). Thus, the 11mer with a single additional N-terminal amino acid reads on the present claims. In addition, Li et al. teach peptides similar to Leu-Ser-Pro-Pro-Arg-Tyr-Pro-Gly-Gly-Gly-Ser can be readily screened for activity (see page 4 of the translation).
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.
Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharya et al. U.S. Patent Application Publication 2018/0333432 published November 22, 2018 and Li et al. China 102453079 published May 16, 2012 (translation provided with the current Office Action – utilized for citation, Chinese version provided with the Restriction Requirement mailed on December 20, 2024).
For present claims 1 and 8, Bhattacharya et al. teach LSPPRYP (please refer to the entire specification particularly Table 1 and SEQ ID NO: 7).
However, Bhattacharya et al. do not teach a GGGS linker or C-terminal amidation.
For present claims 1 and 8, Li et al. teach Leu-Ser-Pro-Pro-Arg-Tyr-Pro alone or with a Gly-Gly-Gly-Ser linker attached (i.e. Leu-Ser-Pro-Pro-Arg-Tyr-Pro-Gly-Gly-Gly-Ser) which may be amidated (i.e. NH2 at the C-terminus) (please refer to the entire specification particularly the abstract; pages 3-6, 9-11; claims).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. providing a GGGS flexible linker which does not alter function of the peptide and increased stability/half-live via C-terminal amidation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilization of flexible GGGS linkers and C-terminal amidation) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Bhattacharya et al. and Li et al. for claims 1 and 8 were considered but are not persuasive for the following reasons.
Applicants contend that since the peptide disclosed by Bhattacharya et al. and Li et al. is a 7mer which has an additional Leu at the N-terminus, that the teachings of Bhattacharya et al. and Li et al. do not read on the 6mer as presently claimed. Applicants also assert that “the shorter peptide” of P64 taught by Bhattacharya et al. does not bind FGFR1. Applicants contend that the addition of the GGGS linker does not confer the ability of binding to FGFR1, but that C-terminal “animation” (i.e. interpreted as amidation) does confer the ability to bind FGFR1. Again, it is AMIDATION, NOT ANIMATION. The peptide is not a cartoon. While “technical effects” does align with animation, it is being interpreted as a functional effect. Applicants contend that Li et al. teaches away from making SPPRYPGGGS-NH2 because of other teachings of extending half-life (e.g. adding polymers, adding albumin; i.e. other than NH2). Applicants argue that C-terminal amidation extends the half-life of the presently claimed peptide.
Applicants’ arguments are not convincing since the teachings of Bhattacharya et al. and Li et al. render the peptide of the instant claims prima facie obvious.
Present independent claim 1 reads “comprising the amino acid sequence of Ser-Pro-Pro-Arg-Tyr-Pro-Gly-Gly-Gly-Ser-NH2 (SEQ ID NO: 1)”. As specifically stated in the present and the previous Office Actions, a peptide comprising the amino acid sequence is interpreted as requiring the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions (see the sequence interpretation section above). Thus, the 11mer taught by Li et al. and the 7mer taught by Bhattacharya et al. with a single additional N-terminal amino acid reads on the present claims. In addition, Li et al. teach peptides similar to Leu-Ser-Pro-Pro-Arg-Tyr-Pro-Gly-Gly-Gly-Ser can be readily screened for activity (see page 4 of the translation).
It is unclear how P64 is shorter since applicants argued that the peptide taught by Bhattacharya et al. is longer by a single amino acid. In addition, Bhattacharya et al. specifically teaches that LSPPRYP binds FGFR1 (see Table 1). No where in Bhattacharya et al. or the present specification is P64 referred to. Therefore, it is unclear what P64 is. Applicants should refer to specific sequences and not arbitrary names. It is inconceivable how amidation would result in specific binding. Amidation is art recognized to increase stability and peptide half-life, amidation would not result in specific binding to FGFR1. See Shi et al., 2022, Strategies to Optimize Peptide Stability and Prolong Half-Life, Peptide Therapeutics, 47: 163-182. The specific binding to FGFR1 is due to LSPPRYP and/or SPPRYP. In addition, evidence should be provided in a declaration and NOT simply in the attorney arguments. See MPEP § 716. The first figure shows that P9 and P48 bind FGFR1 (if that is actually what the arbitrary “response” is).
Truncation of peptides and library screening to determine the functional fragments is well-known in the prior art. Li et al. teach that peptides similar to Leu-Ser-Pro-Pro-Arg-Tyr-Pro-Gly-Gly-Gly-Ser can be readily screened for activity (see page 4 of the translation).
Li et al. teaches that the carboxyl group at the C-terminus is also preferably amidated, that is, the chemical group at the C-terminus is -CONH2 (see page 5 of the translation).
"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." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See 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."
A declaration regarding the “large number of peptide derivatives, but none of them were capable of retaining the ability to bind to FGFR1” would be necessary instead of attorney argument. See MPEP § 716.
C-terminal amidation is well-known in the art to increase peptide half-life. See Shi et al., 2022, Strategies to Optimize Peptide Stability and Prolong Half-Life, Peptide Therapeutics, 47: 163-182.
Again, applicants should provide sequences and NOT arbitrary names. It is noted that applicants FINALLY provided a correlation between sequences and arbitrary names on page 11 of the response received September 2, 2025. Applicants should also number the pages of the response.
Bhattacharya et al. specifically teaches that LSPPRYP binds FGFR1 (see Table 1).
P9 (LSPPRTPGGGS-NH2) and P48 (SPPRTPGGGS-NH2) are the most relevant peptides to compare. See page 8 of the response received September 2, 2025. However, the present claims still read on P9 (LSPPRTPGGGS-NH2).
The graph on page 10 of the response received on September 2, 2025 should be provided in a declaration. Attorney argument can not be relied on. See MPEP § 716.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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