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
The present application claimed no benefit to any provisional, non-provisional, or foreign patent documents. The filing date of the present application is considered the effective filing date, 9/1/2023.
Claim Objections
Claim 1 is objected to because of the following informalities: wound misspelled as “would”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
The present claims are drawn to the genus of “C-C motif ligand 7 (CCL7) antagonists” used to inhibit CCL7 activity to promote wound healing. The written description requirement for a claimed genus is satisfied through sufficient description of a representative number of species to show the inventor was in possession of the claimed genus. As described in the specification, “CCL7 antagonist” includes any entity that upon administration results in inhibition or downregulation of a biological activity associated with CCL7 in a subject (pg. 8 [0043]).
The present claims further limit the possible CCL7 antagonists as a CCL7 neutralizing antibody, CCL7 RNA interference agent, a C-C chemokine receptor type 1 (CCR1) antagonist, a C-C chemokine receptor type 2 (CCR2) antagonist, a C-C chemokine receptor type 3 (CCR3) antagonist, a C-C chemokine receptor type 5 (CCR5) antagonist, and a combination thereof. However, the specification only mentions the use of a neutralizing CCL7 antibody and a siCCL7 compound. Further, it is known that CCL7 activity is capable of acting through all four receptors individually (Chang et al., 2022, Fig. 1 see also pg.2).
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). The present application discloses a species of inhibiting CCL7 activity by neutralizing the CCL7 molecule itself. The application provides no evidence or instruction on how the inhibition or blocking of one or multiple chemokine receptors would effectively inhibit CCL7 activity when it is capable of binding to other receptors. A person of ordinary skill in the art would not be able to predict the use of chemokine receptor antagonists to inhibit CCL7 activity to promote wound healing as claimed by the applicant.
Therefore, a person of ordinary skill in the art would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xie (Xie, J Cell Mol Med, 2021;25:7280-7293).
In regard to claim 1, Xie discloses a method for improving wound healing, comprising administering an effective amount of a chemokine C-C motif ligand (CCL7) antagonist to a subject in need thereof to inhibit CCL7 activity (abstract). It is noted that Xie is used to treat a mice model of abdominal aortic aneurysm. The specification provides a broad definition for “wound” which includes wounds caused by pathology. Abdominal aortic aneurysm is a chronic vascular disease characterized by luminal dilation of the abdominal aorta that results in rupture without appropriate clinical intervention (Xie at 7280). Therefore, claim 1 is anticipated by Xie.
In regards to claim 2, the limitations of claim 1 are disclosed through claim 1 as discussed above. Xie further discloses the use of a CCL7 neutralizing antibody, and a CCL7 RNA interference agent (pg. 16 [0074], pg. 19 [0088]).
In regard to claim 3, Xie discloses the limitations of claim 1 as discussed above. Xie further discloses the wound being a chronic wound (Xie at 7280).
In regard to claim 5 and 6, Xie discloses the limitations of claim 1 as discussed above. Xie further discloses the effective amount of a CCL7 antagonist from 0.01 µg/kg to 100mg/kg, and 0.1 µg/kg to 1 mg/kg, respectively (Xie at 7281).
In regard to claim 7, Xie discloses the limitations of claim 1 as discussed above. Xie further discloses the CCL7 antagonist administered by intraperitoneal injection (Xie at 7281).
In regard to claims 8-14, Xie discloses the limitations of claim 1 as discussed above. The subject matter of claims 8-14 are all directed towards the results following administration but do not require any additional steps for the method. Therefore claims 8-14 are anticipated by Xie.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/214,178 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they recite the method of administering a CCL7 antagonist to a subject in need thereof to inhibit CCL7 activity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 5-7, and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, and 8-12 of U.S. Patent No. 20240425576 A1 in view of Alavi (Alavi, A. et al., J Am Acad Dermatol 2014 Jan; 70(1):1.e1-18).
In regard to claim 1, the reference application recites a method of administering CCL7 antagonists for the inhibition of CCL7 activity. However, it does note recite the use of this method to improve wound healing but to prevent and treat peripheral arterial disease (PAD).
Alavi teaches PAD is a contributory factor to diabetic foot ulcer (DFU) which is a wound that develops through the pathophysiology of Diabetes Mellitus (Alavi pg. 1.e11). The prevention or treatment of PAD would also contribute to the prevention or treatment of any downstream conditions, including DFU.
It would be obvious to a person of ordinary skill in the art to use a method for treating PAD to improve a DFU. The present application particularly discloses that diabetic wounds, including DFU, are the definitive “wound” of the present invention. Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date to use the method disclosed in both applications for the prevention or treatment of PAD and the improvement of wounds.
In regard to claims 2, 5-6, 7 and 11-12 of the present application, the subject matter of the claims matches the reference application claims 2 and 8-12, respectively. Therefore, they are all rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liang (Liang, M. et al., 2000, J Bio Chem, 275:25; 19000) teaches the administration of a CCR1 antagonist that inhibits binding of CCL7 (Liang, abstract). Sayyed (Sayyed, S., et al., 2011, Kidney Intern’l, 80:68) teaches the administration of a CCR2 antagonist that can block binding to CCR2, which would inhibit binding by CCL7 (Sayyed, abstract). Sabroe (Sabroe, I., 2000, J Biol Chem, 275(34):25985-25992) teaches the administration of a CCR3 antagonist which would block binding to CCR3 and inhibit CCL7 activity (Sabroe at 25985). Joy (Joy, M. et al., 2019, Cell, 176(5):1143-1157) teaches the administration of a CCR5 antagonist which would block binding to CCR5 and inhibit CCL7 activity (Joy, abstract).
In summary, claims 1-14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY DUNN whose telephone number is (571)272-5825. The examiner can normally be reached Monday-Friday 8-4:30.
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/LINDSAY DUNN/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644