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 .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.
Election/Restrictions
Applicant’s election without traverse of group I (method of treatment) using SEQ ID 1 to treat humans with Covid 19 in the reply filed on 19 Sept, 2025 and the phone call with Weston Gould, applicant’s representative, on 6 Oct, 2025 is acknowledged.
Applicants have elected treating Covid 19 in humans with SEQ ID 1. A search was conducted for that invention, and references rendering it obvious were found. As a result, claims 1, 2, 9, 10, 16, and 17 were examined and claims 3-8, 11-15, and 18 have been withdrawn from consideration.
Claims Status
Claims 1-18 are pending.
Claims 1-10 and 16-18 have been amended.
Claims 3-8, 11-15, and 18 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 Sept, 2025.
Drawings
The drawings are objected to because fig 7b has sequences without associated SEQ ID number. The MPEP states that "It should be noted that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, the sequence must still be included in the sequence listing and the sequence identifier ("SEQ ID NO:X") must be used, either in the drawing or the brief description of the drawings” (MPEP 2422.02). 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 it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
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) 1, 2, 9, 10, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (Clin. Immunol. (March 2020) 214 article 108393) in view of Kalle et al (WO 2011036442, cited by applicants), with evidentiary support from Lan et al (Nat (May 2020) 581 p215-230).
Zhang et al discuss anti-inflammatory drugs to treat people with severe Covid 19 (title). As evidenced by Lan et al, this virus has a spike protein (title), and so is an S protein virus. Patients suffer from extremely high inflammatory parameters (1st page, 2nd column, 2nd paragraph) and hypercoagulability (2nd page, 1st column, 1st paragraph) with some patients showing severe thrombosis and DIC (2nd page, 2nd column, 5th paragraph). Anti-inflammatory therapy is suggested to help prevent further injury from the virus (3d page, 1st column, 1st paragraph). A number of clinical trials are mentioned using different anti-inflammatory agents (p3, 2nd column, 4th, 5th , and 6th paragraphs, 4th page, 1st column, 4th paragraph). Some cases have ARDS and DIC (2nd page, 1st column, 6th paragraph).
The difference between this reference and the examined claims is that this reference does not use a polypeptide of claims 1, 16, or 17 to treat the disorder.
Kalle et al discuss fragments of thrombin to treat or prevent inflammation and/or excessive coagulation of blood (abstract). A preferred embodiment is SEQ ID 2 (p6, 4th paragraph), identical with SEQ ID 1 of the examined claims, and applicant’s elected species. Inflammation from viral RNA is mentioned as something that can be reduced (p15, 8th paragraph, continues to p16, 1st paragraph). The polypeptides are particularly suited to treatment of conditions where the combined inhibition of both inflammatory and coagulant processes is desirable, such as DIC and ARDS (p18, 5th paragraph). Mention is made of use in combination with anti-viral treatments (p19, 1st paragraph), indicating use in patients suffering from a viral infection.
Therefore, it would be obvious to treat the inflammation and coagulopathies of the Covid 19 of Zhang et al with the peptide of Kalle et al, as that peptide is described as useful for treating these disorders, including ARDS and DIC, which Zhang et al states are found in severe cases. As Kalle et al implies that the therapy is useful in viral infections, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Zhang et al discusses treatment of an S protein virus with anti-inflammatory agents, while Kalle et al renders obvious administering SEQ ID 1. Thus, the combination of references renders obvious claims 1, 16, and 17.
The S protein virus of Zhang et al is SARS CoV2, a coronavirus, rendering obvious claim 2.
As the sequence of Kalle et al is a general anti-inflammatory agent, it will necessarily reduce inflammation from various causes, rendering obvious claims 9 and 10.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
first rejection
Claims 1, 2, 9, 10, 16, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 13 of copending Application No. 19/151,427 in view of Cox (Science News, 27 April, 2020).
Competing claim 4 describes a method of reducing scarring, comprising administering a polypeptide identical with that of examined claim 1. Competing claim 13 lists a Markush group of peptides, including SEQ ID 1, identical with SEQ ID 1 of the examined claims.
The difference between the competing claims and the examined claims is that the competing claims do not mention Covid 19.
Cox discusses lung damage from Covid 19 (title). Lung abnormalities in some patients will harden into scar tissue (3d page, 2nd paragraph, continues to 4th page, 1st paragraph).
Therefore, it would be obvious to use the polypeptide of the competing claims to treat or prevent the scarring caused by Covid 19, as described by Cox. As treatment of scars is the goal of the competing claims, an artisan in this field would attempt this therapy with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
second rejection
Claims 1, 2, 9, 10, 16, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26, 34, 41, and 44 of copending Application No. 17/783,958 (US 20230127258) in view of Zhang et al (Clin. Immunol. (March 2020) 214 article 108393)
Competing claim 26 describes peptides identical with those of examined claim 1, while competing claim 34 describes a Markush group of sequences, including SEQ ID 1 (identical with SEQ ID 1 of the examined claims. Competing claims 41 and 44 describe using these sequences to treat disorders, specifically, inflammatory disorders.
The difference between the competing claims and the examined claims is that the competing claims do not discuss S protein virus infections.
Zhang et al discuss anti-inflammatory drugs to treat people with severe Covid 19 (title). As evidenced by Lan et al, this virus has a spike protein (title), and so is an S protein virus. Patients suffer from extremely high inflammatory parameters (1st page, 2nd column, 2nd paragraph) and hypercoagulability (2nd page, 1st column, 1st paragraph) with some patients showing severe thrombosis and DIC (2nd page, 2nd column, 5th paragraph). Anti-inflammatory therapy is suggested to help prevent further injury from the virus (3d page, 1st column, 1st paragraph). A number of clinical trials are mentioned using different anti-inflammatory agents (p3, 2nd column, 4th, 5th , and 6th paragraphs, 4th page, 1st column, 4th paragraph). Some cases have ARDS and DIC (2nd page, 1st column, 6th paragraph).
Therefore, it would be obvious to use the polypeptides of the competing claims to treat the Covid 19 of Zhang et al, as they are linked via treatment of inflammation. As Zhang et al is a subgenus of the disorders of the competing claims, an artisan in this field would attempt this therapy with a reasonable expectation of success.
third rejection
Claims 1, 2, 9, 10, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No.8,735,353 in view of Zhang et al (Clin. Immunol. (March 2020) 214 article 108393)
Competing claim 1 describes a Markush group of sequences, including SEQ ID 3 (identical with SEQ ID 1 of the examined claims with the 4 C terminal amino acids deleted), for treating inflammation and coagulation of blood in a patient. Competing claim 4 describes using these sequences to treat disorders, including ARDS and DIC.
The difference between the competing claims and the examined claims is that the competing claims do not discuss S protein virus infections.
Zhang et al discuss anti-inflammatory drugs to treat people with severe Covid 19 (title). As evidenced by Lan et al, this virus has a spike protein (title), and so is an S protein virus. Patients suffer from extremely high inflammatory parameters (1st page, 2nd column, 2nd paragraph) and hypercoagulability (2nd page, 1st column, 1st paragraph) with some patients showing severe thrombosis and DIC (2nd page, 2nd column, 5th paragraph). Anti-inflammatory therapy is suggested to help prevent further injury from the virus (3d page, 1st column, 1st paragraph). A number of clinical trials are mentioned using different anti-inflammatory agents (p3, 2nd column, 4th, 5th , and 6th paragraphs, 4th page, 1st column, 4th paragraph). Some cases have ARDS and DIC (2nd page, 1st column, 6th paragraph).
Therefore, it would be obvious to use the polypeptides of the competing claims to treat the Covid 19 of Zhang et al, as they are linked ARDS and DIC. As Zhang et al is a subgenus of the disorders of the competing claims, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658