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
This application filed 12/13/2023 claims priority from provisional application 63433789, filed 12/20/2022 and provisional application 63540688, filed 09/27/2023.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Status of Claims
The claim amendments and arguments filed on 06/03/2026 are acknowledged and have been fully considered. Claims 3 and 5-6 are cancelled. Claims 1, 4, 7 are currently amended. Claims 1, 2, 4, 7 and 8 are now pending and will be examined on the merits herein.
Objections/Rejections Withdrawn
Objections and/or rejections not reiterated from previous Office Action are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
Claims 1, 2, 4, 7 and 8 are rejected under 35 U.S.C. 103 as being obvious over Kavin G. Shah et al., hereinafter Shah (Kavin G. Shah et al., Intensive Care Med (2012) 38:128–136) in view of Weng-Lang Yang et al., hereinafter Lang (Weng-Lang Yang et al., Critical Care (2015) 19-375) further in view of Relly Brandman et al., hereinafter Brandman (Relly Brandman et al., The Journal of Biological Chemistry vol.282, No. 6, pp. 4113–4123, February 9, 2007).
The applied reference has a common Applicant and Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, embodiments of the specification disclose all peptides from the mouse discoidin domain 2 (C2) of MFG-E8 (see page 8, line 29). Shah teaches MFG-E8 treatment in an animal model of sepsis (see Introduction , page 129, last 3 lines). Specifically, Shah teaches administration of rhMFG-E8 to male Sprague-Dawley rats, and attenuation of liver injury markers (i.e. tissue injury) after CLP (cecal ligation and puncture) (see Result 1 on page 129; Table 1).
Shah does not teach peptides with ‘RGD’ selected from the group consisting of one or more of MOP3, MOP3H, MOP8 and MOP14.
Yang teaches MFG-E8 derived smaller peptides as a therapeutic strategy for treating sepsis (Introduction, last line). Yang teaches that MFG-E8 contains an ‘RGD’ motif involved in cell-cell and cell-matrix interactions and hypothesized that MFG-E8-derived short peptides (MSP) flanking its RGD motif could provide protection against organ injury in sepsis. As noted in Yang, the EGF-like domain in MFG-E8 contains as ‘RGD’ motif (Introduction 3rd paragraph, 7th line).
Brandman teaches peptides derived from the C2 domain of protein kinase C. Brandman teaches that because homologs of the C2 domain are present in over 60 different proteins, many of which are signaling proteins, peptide generation is likely to provide new means to affect the functions of C2-containing proteins (see page 4121, last paragraph). Brandman teaches that peptides corresponding to short sequences within the C2 domain with isoenzyme-selective activities suggests that other short peptides derived from that domain may have such activities (see page 4114). Brandman teaches that the C2 derived peptides are conjugated with the TAT sequence for cell penetration (page 4114, Fig 2). Brandman teaches that these rationally derived peptides are selective and effective in regulating biological activities as peptide agonists and antagonists and may have potential as drug leads (page 4113, last paragraph).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to generate rationally derived peptides comprising ‘RGD’ as specifically suggested Yang, of the C2 domain as suggested in Brandman, since preserving the RGD sequence could provide protection against organ injury and sepsis (see Abstract-Introduction, last line). One motivated to combine the teachings of the prior art, would have a reasonable expectation of success, as generation of derived peptides, as suggested in Brandman, have potential as drug leads (page 4113, last paragraph) and the teachings in Yang and Shah disclose MFG-E8 roles in sepsis and organ injury. Thus, one would have recognized that applying the teaching of Shah and Yang to the method of Brandman, would have yielded predictable results to generate short peptides from the C2 domain comprising the ‘RGD’ motif, to serve as useful pharmacological tools or even drug leads for human diseases (see page 4121, last paragraph) (See MPEP § 2143 I(A)(D)).
Regarding claim 2, as noted in the obviousness rationale above, , it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to generate rationally derived peptides comprising ‘RGD’ as specifically suggested Yang, of the C2 domain as suggested in Brandman, for treatment of sepsis and organ injury as suggested in Shah and Yang.
Regarding claim 4, the obviousness rationale has been set forth above under rejection for claim 1.
Regarding claim 7, Shah teaches intravenous administration of MFG-E8 in saline (see Supplementary materials and methods, page 2) (i.e. pharmaceutically acceptable carrier) and increasing doses of MFG-E8 20, 40, 80, 160 µg/kg BW for sepsis study (i.e. therapeutically effective amount).
Regarding claim 8, the teachings of Shah, Yang and Brandman have been set forth above. Accordingly, it is obvious to combine the teachings of Shah, Yang and Brandman and include one or both of MOP3 and MOP3H which are short peptides generated from the sequence of the C2 domain. One would recognize that combining the teachings would have yielded predictable results and a reasonable expectation of success, as generation of rationally derived peptides from the C2 domain as suggested in Brandman, has potential as drug leads for human diseases and treatment of sepsis and organ injury (page 4113, page 4121, last paragraph).
Response to Arguments
Applicant's arguments filed 06/03/2026 have been fully considered but they are not persuasive.
Applicant argues that inventors demonstrate superior properties for the peptides specified in claim 1 and in amended claim 7. The Examiner would like to remind the Applicant that the burden is on the Applicant to establish results are unexpected and significant. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
“[E]evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978). Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977). Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967) (resultant decrease of dental enamel solubility accomplished by adding an acidic buffering agent to a fluoride containing dentifrice was expected based on the teaching of the prior art); Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App. & Inter. 1989).
Applicant argues that the cited references provide no teaching, suggestion , or motivation for treating sepsis in amended claim 7. However, the rejection of record is that it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Shah, Yang and Brandman to generate rationally derived peptides comprising ‘RGD’ as specifically suggested Yang, of the C2 domain as suggested in Brandman, for treatment of sepsis and organ injury as suggested in Shah and Yang.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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