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 .
Election/Restrictions
Applicant’s election without traverse of group III, claims 1-3, 6-9, and 12-15, drawn to a peptide comprising or consisting essentially of SEQ ID NO: 1 and a pharmaceutical composition comprising the peptide in the reply filed on November 19, 2025 is acknowledged. Applicant’s election of species of SEQ ID NO: 1 without traverse is acknowledged. 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 § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 4, 5, 16-20, 24, and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 19, 2025.
Claims 1-3, 6-9, and 12-15, drawn to the elected species is currently under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The priority date is June 19, 2020.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on December 16, 2022, October 19, 2023, April 15, 2024, March 25, 2025, and October 21, 2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Drawings
The drawings were received on December 16, 2022. These drawings are acceptable.
The drawings are objected to because there is reference to color drawings in the brief description of the drawings, particularly description of figure 5.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Specification
The disclosure is objected to because of the following informalities:
Figure 5 refers to color drawings. Suggest removing reference to color drawings or petition for color drawings.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Appropriate correction is required.
Claim Objections
Claims 1-3 are objected to because of the following informalities: Claims 1 and 2 are drawn to non-elected subject matter. Suggest removing reference to SEQ ID NO: 2.
Claims 1-3, 6, and 8 are objected to because the sequence identifier should be identified as SEQ ID NO: instead of SEQ ID No:.
Claim 1 is objected to because of the following informalities: Claim 1 is drawn to non-elected subject matter. Suggest removing reference to “ or consisting of”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-3, 6-9, and 12-15 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.
In claim 1, it is unclear what the difference is between a peptide comprising and a peptide consisting essentially of in the claim. The peptides appear to be the same. Clarification is requested as to the structural difference being claimed. Suggest removing consisting essentially of in claim 1.
In claim 8, it is unclear if the peptide comprises the amino acid sequence of SEQ ID NO: 1 or an amino acid sequence from the peptide shown in SEQ ID NO: 1. Clarification is requested. Suggest “…wherein the peptide comprises SEQ ID NO: 1 and wherein the tyrosine at position 32….”
Claims dependent on a rejected claim are rejected for failing to cure the indefiniteness.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The 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.
Claim(s) 1, 7, 9, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UniProtKB/TrEMBL ID Q4R1A2_HAELO; GenBank: BAE00175.1 printout provided (4/15/2024 IDS; NPL document #C32).
The Q4R1A2_HAELO record discloses a polypeptide sequence identified as GenBank: BAE00175.1 that has 100% identity with SEQ ID NO: 1. The protein is identified as Madanin-like from Haemaphysalis longicornis (Bush tick). The peptide comprises SEQ ID NO: 1. See sequence alignment below.
Query Match 100.0%; Score 322; Length 79;
Best Local Similarity 100.0%;
Matches 60; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 YPESDSAKDDGNQEKEKALLVKVQERSDDGDYDEYDNDETTHTPDPSAPTARPRIREHQA 60
Db 20 YPESDSAKDDGNQEKEKALLVKVQERSDDGDYDEYDNDETTHTPDPSAPTARPRIREHQA 79
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Claim(s) 1-3, 7-9, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watson et al. (12/16/2022 IDS, NPL document #C16).
Watson et al. disclose MadL2 in Figure 1. The sequence is 100% identical to SEQ ID NO: 1. Watson et al. chemically synthesize MadL2 with sulfated tyrosine residues at positions 32, 35, and dual sulfated tyrosine modifications (see entire document, particularly page 13874, Results section, and figures 2 and 3).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over UniProtKB/TrEMBL ID Q4R1A2_HAELO and Chudzinksi-Tavassi et al. (U.S. 12,187,785 B2).
The Q4R1A2_HAELO record discloses a polypeptide sequence identified as GenBank: BAE00175.1 that has 100% identity with SEQ ID NO: 1. The protein is identified as Madanin-like from Haemaphysalis longicornis (Bush tick). The peptide comprises SEQ ID NO: 1. See sequence alignment above in 35 U.S.C. 102(a)(1) rejection. Madanin-1, a small cysteine-free protein isolated from the salivary gland of ticks, acts as a competitive thrombin inhibitor.
Chudzinksi-Tavassi et al. disclose a class of proteins that inhibit thrombin, particularly direct thrombin inhibitors that can be used as anticoagulant agents (see entire document, particularly col. 2, line 28-31).
Therefore, it would have been obvious to the person having ordinary skill in the art to manufacture a pharmaceutical composition comprising the peptide, with a pharmaceutically effective carrier, diluent, or excipient as currently claimed, because Chudzinksi-Tavassi et al. disclose the use of peptide thrombin inhibitors as anticoagulant agents.
Conclusion
No claims are allowed.
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/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655