DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's preliminary amendment filed on 09/05/2024 is acknowledged.
Claims 14-18, 20, 22-23 and 30-31 are pending.
3. 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.
4. Claims 14-18, 20, 22-23 and 30-31 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claims 14 and 20 are indefinite in the recitation of A2AP “activity,” because it is unclear which A2AP activities are within the scope of the claims.
(ii) Claim 20 is indefinite in the recitation of “subject in need thereof,” because the subject population is not defined.
(iii) Claim 20 is further indefinite in the circular recitation of “a pharmaceutical composition comprising [...] the pharmaceutical composition,” because it is unclear what subject matter is defined by the recitation.
(iv) Claim 31 is indefinite in the recitation of “a low dose,” because “low” is a relative term not defined by the claim.
(v) Claims 15-18, 20, 22-23 and 30-31 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
5. The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
6. Claims 20, 22-23 and 30-31 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contain(s) subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not provide a sufficient enabling description of a method for treating a generically recited “disease or disorder,” or of a method for “preventing” any disease or disorder.
The specification does not enable one of skill in the art to make and use the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
A person of ordinary skill in the art would have been aware of the enormous variety of pathological processes in terms of etiology, pathogenesis, and molecular and cellular mechanisms, and so a great majority of diseases would not be treatable by any single therapeutic intervention. In the absence of sufficient guidance, direction, or working examples in the present disclosure, it is at best unpredictable whether a given disease out of a practically infinite number of diseases encompassed by the scope of the generic recitation of “disease or disorder,” is treatable by the claimed method; thus the experimentation left to those skilled in the art would be unnecessarily, and improperly, extensive and undue.
In the medical context, preventing a disease involves identifying healthy human subjects susceptible the disease, applying the treatment, and, after a sufficiently long period of time has elapsed, ascertaining that the absence of the disease in the subjects is due to the treatment and not some other factors. Therefore, the burden of enabling a method of preventing a disease is much greater than that of enabling a method of treating a disease, due to the inherent difficulty of identifying healthy human subjects susceptible the disease, and especially the hurdle of proving that the administered treatment was the factor that resulted in prevention of the disease.
The specification does not appear to provide working examples, guidance or direction as to how one skilled in the art would screen the population to select the subjects in need of prevention a disease, or the protocol to be utilized in order to establish the efficacy of the claimed treatment in preventing these conditions. Accordingly, the entire scope of experimentation required to develop methods of preventing diseases as claimed is left to those skilled in the art, the present claims and disclosure amounting to nothing more than an invitation to the skilled artisan to invent such methods.
7. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
8. Claims 14-18, 20, 22-23 and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12215168 (cited on IDS) alone, or in view of Singh et al. (2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of US ‘168.
Claims 1-12 of US ‘168 are directed to an anti-A2AP antibody comprising the same CDRs as the anti-A2AP antibody encoded by nucleic acids recited in instant claims 14 and 20. Since the antibody is recombinantly produced, nucleic acids encoding the antibody, vectors, host cells, and methods of producing the antibody are inherent in the recitation of the antibody. Accordingly, instant claims 14-18 are anticipated by US ‘168 claims.
The subject matter of instant claims 20, 22-23 and 30-31 would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention over the claims of US ‘168 in view of Singh et al. (2020).
Singh teaches that targeting α2AP by monoclonal antibodies is a novel paradigm for preventing thrombosis and dissolution of thrombi without compromising safety (p. 5).
Singh reviews that α2AP inhibitors have been shown to enhance fibrinolysis in several different animal models of venous thrombosis, pulmonary embolism and ischemic stroke, and a monoclonal antibody inhibitor of α2AP synergistically increased fibrinolysis by tissue plasminogen activator (tPA) and other types of plasminogen activators increasing the potency of these agents by 20–80-fold (Id). Anti-α2AP monoclonal antibody TS23 enhances the dissolution of pulmonary emboli with a potency similar to higher dose tPA, though unlike tPA, TS23 does not increase arterial or venous bleeding (Id). TS23 has been tested in Phase I trials in humans (NCT03001544) and Phase II trials are planned (Id). These teachings would have provided both the motivation and the expectation of success for those of ordinary skill in the art before the effective filing date of the claimed invention to use the anti-A2AP antibody recited in anti-A2AP for treatment of thrombotic and embolic conditions recited in instant claim 22, alone or in combination with tPA.
9. Claims 14-18, 20, 22-23 and 30-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18026089, published as US 20240010750 (cited on IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of USSN ‘089, which recite (claim 5, subclause (i)) an anti-A2AP antibody comprising the same CDRs as the anti-A2AP antibody encoded by nucleic acids recited in instant claims 14 and 20. USSN ‘089 further recites nucleic acids encoding the antibody, vectors, host cells, and methods of producing the antibody (claims 14-16 and 18), as well as methods of treating diseases associated with ischemic events due to vessel occlusion comprising administering the anti-A2AP antibody (claim 22).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644