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
Filed information disclosure statements (IDS) 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 1-13 and 32, without traverse, in the reply filed on 18th Feb 2026 is acknowledged.
The examiner also acknowledges applicants response to election of species and providing a nematode anticoagulant protein c2 (NAPc2) as a species for the inhibitor.
Claims 14-31 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 1-13 and 32 are examined to the extent they read elected species 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 1-13 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Moons (Journal of American College of Cardiology, 2003, vol.41, No.12, 2147-2153) in view of Pawlinski (Journal of Thrombosis and Haemostasis, 2009, 7, 288-289).
For claim 1:
Moons teaches that recombinant NAPc2 is a potent inhibitor of the tissue factor/factor VIIa complex, which has the potential to reduce the risk of thrombotic complications in coronary artery disease and further teaches that to this point, rNAPc2 has been shown to be very effective in reducing the incidence of deep venous thrombosis without hemostatic compromise when administered prophylactically in patients undergoing knee arthroplasty. In addition, the formation of a complex with factor X results in a biologic half-life of rNAPc2 of ≥50 h. The importance of TF/factor VIIa in coronary thrombosis suggests that rNAPc2 could be effective in the treatment of patients with acute coronary syndromes. As the majority of these patients undergo percutaneous coronary interventions (PCIs), we first performed a phase II, dose-ranging study with four escalating dosages of rNAPc2 in patients undergoing elective coronary angioplasty to evaluate the safety of the drug and its ability to inhibit thrombin generation. [See abstract; right column in page 2147].
Difference is that Moons is silent on PAR2 signaling pathway. This can be cured from the teachings of Pawlinski, see below.
Pawlinski teaches that inhibition of the TF–FVIIa complex may reduce pathologic PAR2 signaling and in general, PAR2 signaling has been shown to be proinflammatory. For instance, PAR2 activation on endothelial cells and macrophages induces the expression of proinflammatory cytokines, including interleukin (IL)‐1β, tumor necrosis factor‐alpha and IL‐6. Furthermore, leukocyte rolling and adhesion is reduced in PAR2 knockout mice. These data would support the hypothesis that TF–FVIIa‐dependent PAR2 signaling contributes to myocardial infarction during I/R injury by increasing the inflammatory response. Further states that “consistently with this notion, our preliminary results indicate that infarct size is significantly reduced in PAR2‐deficient mice as compared to wild‐type controls”. [See 3rd paragraph in right column in page 288 and 1st paragraph in left column in page 289].
So, based on the teachings of Pawlinski, NAPc2 in the teachings of Moons expected to inhibit the pathway of PAR2, since NAPc2 inhibits TF/FVIIa as evidenced from Moons and in turn TF/FVIIa inhibits PAR2 as evidenced from Pawlinski.
For claim 2:
Moons teaches NAPc2 inhibits TF/FVIIa, which is associated with heart diseases, such as thrombosis etc., but explicitly does not recited applicants recited ones which are associated with hear failures. Even if Moons is ignored on this limitation, Pawlinski teaches myocardial infarction and I/R injury.
For claims 3-6:
The recited limitations are properties of inhibitor and pathways. Since applicants claimed pathway and inhibitor are identical to that of prior art, the recited properties are expected, absent evidence to the contrary.
For claims 7-13:
Moons teaches NAPc2, which is identical to applicants elected species, and also reads claims 7-13.
For claim 32:
The recited limitations are properties of inhibitor. Since applicants claimed inhibitor is identical to that of prior art, the recited property is expected, absent evidence to the contrary.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, properties of applicants individual components in the claimed method and their association with heart diseases etc., 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.
The 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.
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
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
