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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
The information disclosure statement (IDS), dated 01/10/2024, comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Response to Restriction
Applicant's response to restriction requirement and election of group I corresponding to claims 1-2 and 4-17, without traverse, in the reply filed on 08/10/2026 is acknowledged.
The examiner also acknowledges applicants response to election of species and providing a single species for the claimed compound.
Examiner also acknowledges applicants’ election of cytokine storm syndrome and SEQ ID NO:1 as a species for the elected group. Claims 1-2, 4-8 and 11-17 read on the elected species.
Claims 9-10 and 18-19 and 21-22 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The claims 1-2 and 4-17, in light of elected species, are examined on merits in this office action.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2, 4-8 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yates-Binder (US2019/0298802A1) in view of Lechowicz (Journal of Clinical Medicine, 2020, 9, 1917, 1-20), George (The Lancet Respiratory Medicine, 2020; 8, 807-815), Yang (J Allergy Clin Immunol, July 2020, vol.146, No. 1, 119-127; see applicants filed IDS dated 01/10/2024).
For claims 1-2:
Yates-Binder teaches a method of treating or inhibiting the development of fibrosis in a subject comprising administering to the subject a therapeutically effective amount of a peptide or a composition comprising the peptide, wherein the peptide is represented by SEQ ID NO:1 [see abstract; 0014; and claims 14-22].
In the above teachings, SEQ ID NO:1 is identical to applicants elected SEQ ID NO:1.
Differences between Yates-Binder and instant claims are as follows:
(i) Yates-Binder is silent on fibrosis is associated with SARS-CoV-2 in their disclosure.
(ii) Yates-Binder is also silent on cytokine storm syndrome.
With regard to (i) and (ii) of above, fibrosis is one of the diseases associated with COVID-19 and SARS-CoV-2 and these both in turn associated with cytokine storm syndrome, as evidenced from the following art:
Lechowicz teaches that COVID-19 and SARS-CoV-2 cause a wide range of symptoms, mainly respiratory infection and one possible complication of pulmonary involvement in COVID-19 is pulmonary fibrosis. [see abstract]. Further, Lechowicz teaches cytokines overexpression in fibrosis levels in COVID-19 and SARS [see Table 2], which can be interpreted as cytokine storm syndrome.
George teaches that symptoms associated with COVID-19 are diverse, ranging from mild upper respiratory tract symptoms to server respiratory distress syndrome, and major risk factors for severe COVID-19 ae shared with idiopathic pulmonary fibrosis. [see abstract].
Yang teaches that SARS-CoV-2 infection triggers cytokine storm and results in an increase in various cytokines, and further teaches that thirty cytokines including both proinflammatory and anti-inflammatory cytokines were found to be significantly elevated upon admission, indicating that cytokine storm occurred in COVID-19 patients following SARS-CoV-2 infection [see left column in page 125].
Based on the above teachings, it is clear that fibrosis and cytokine storm syndrome are associated with COVID-19 and SARS-CoV-2. Both Lechowicz and George teach antifibrotic therapy for treating patients suffering from COVID or SARS. Yates-Binder teaches treating or inhibiting the development of fibrosis by administering SEQ ID NO:1, and so the teachings of Yates-Binder can be extrapolated or expected to treat cytokine syndrome associated with SARS-CoV-2, since both SARS and COVID-19 triggers cytokine storm. Further, cytokine storm is expected in fibrosis in a subject having SARS or COVID-19, since it is associated with both SARS and COVID-19.
For claims 4-6:
In the teachings of Lechowicz and George the SARS CoV-2 is interpreted as current and can also be prior SARS-CoV-2 infection, since at least one day can also read ‘within the last six months’. Yang teaches that cytokine storm occurred in COVID-19 patients following SARS-CoV-2 infection [see left column in page 125]. It appears that these limitations are trivial to the claimed subject matter.
For claim 7:
Yang teaches that plasma IP-10 levels are elevated in COVID-19 [see abstract].
For claim 8:
See For claims 1-2 above.
For claim 11:
Yates-Binder teaches at least two proteins for their disclosed method of treating fibrosis [see claim 14 and 18].
For claims 12-13:
Yates-Binder teaches that a carrier protein can be included in their synthetic peptide [see 0093]. Yates-Binder silent on heparin, however, this limitation is application to non-elected species, such as heart related diseases.
For claim 14:
Yates-Binder teaches pharmaceutically acceptable carriers for their composition [see 0076]
For claims 15-16:
Lechowicz teaches that a humanized monoclonal antibody is expected to have a beneficial effect on coronavirus patients with severe lung damage and elevated interleukin six levels [see 5th paragraph in page 9]. Therefore, it is obvious to include monoclonal antibodies in the claimed method and also can extrapolate it to other known monoclonal antibodies.
For claim 17:
Yates-Binder suggests oxygen therapy [see 0148].
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants claimed peptide, and link between fibrosis/cytokine storm and COVID-19/SARS, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
Motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
A combination of prior art references is only proper if a person of ordinary skill in the art (POSA) at the time of the invention, faced with the same problem, would have been motivated to combine their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the references are not distinct from that of the present claimed invention.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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