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 .
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “expanded” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 11 and 15 are ejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The terms “enhancing” and “improving” are relative terms which render the claims indefinite. The terms are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 12-14 and 16-18 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims all depend, or ultimately depend, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims 12-14 and 16-18 are also, therefore, indefinite.
Claim Rejections - 35 USC § 102
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 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, 2, 4, 9, 11-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by European Journal of Pharmaceutics and Biopharmaceutics (2014), 88, pp. 64-74.
The reference teaches nanofibers, produced from chitosan and poly(ethylene oxide) by electrospinning, loaded with platelet-rich plasma (abstract). The reference explicitly states that the platelets can be considered as endogenous living depots of a wide range of growth factors including, explicitly: IGF (i.e. the family of IGF, which necessarily includes IGF-1) and HGF (page 64, column 2, text line 15; page 65, column 1, text line 5). That is, the reference teaches an electrospun nanofiber, comprising at least one polymer, and which comprises IGF-1 and HGF.
The reference further teaches that the nanofiber polymer may be inter alia poly(caprolactone) (page 70, column 1, The impact of electrospinning on biological activity of PRP). The nanofibers were electrospun onto glass coverslips which fit into the cell culture plates utilized for in vitro cell culture experiments. That is, the reference teaches a composition comprising one or more nanofibers and a pharmaceutically acceptable carrier (i.e. the water of the cell culture).
The reference further teaches that platelet-rich plasma therapy has already proven effective in promoting the healing of inter alia chronic skin wounds such as diabetic and pressure ulcers (page 65, column 1, text line 8). The reference explicitly suggests that the experimentally demonstrated favorable in vitro properties of platelet-rich electrospun nanofibers have potential in wound healing applications (page 73, column 2, text line 7).
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Biomaterials (2011), 32, pp. 565-578.
The reference teaches the promotion of myocardial repair by the sequential delivery of IGF-1 and HGF from an injectable alginate biomaterial in a mouse model of myocardial infarction (abstract; page 569, column 2, Discussion; page 577, column 1, Conclusions). That is, the reference teaches a method for treating a wound and/or enhancing or improving wound healing comprising administering IGF-1 and HGF to the wound site.
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Stem Cells International (Volume 2012), article ID: 915160 (7 pages).
The reference teaches a method of utilizing IGF-1 and HGF sustained release from gelatin hydrogel microspheres for the clinical regeneration of damaged brain tissue by injection close to the injured tissue in a murine stroke model (abstract; page 3, column 1, Results and Discussion). That is, the reference teaches a method for treating a wound and/or enhancing or improving wound healing comprising administering IGF-1 and HGF to the wound site.
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.
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 10, 14 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over European Journal of Pharmaceutics and Biopharmaceutics (2014), 88, pp. 64-74.
Inventor teaches an expanded structure comprising one or more nanofibers, comprising at least one polymer, and which comprises IGF-1 and HGF (claim 10). Inventor further teaches a method for treating a wound and/or enhancing or improving wound healing comprising administering the one or more nanofibers to the wound site wherein the nanofibers are contained within a bandage, dressing or aerogel (claim 14). Inventor further teaches a method for treating a wound and/or enhancing or improving wound healing comprising administering IGF-1 and HGF to the wound site wherein the IGF-1 and HGF are contained within a bandage or dressing (claim 17) or an aerogel (claim 18). Finally, inventor teaches a bandage, dressing or aerogel comprising IGF-1 and HGF (claim 19).
European Journal of Pharmaceutics and Biopharmaceutics (2014), 88, pp. 64-74 has been outlined above (102 rejection).
Inventor principally distinguishes over the cited art in that incorporation of the prior art nanofibers into conventional wound dressings (such as bandages and aerogels) is explicitly taught. However, as the cited art makes explicitly clear, the experimentally demonstrated favorable in vitro properties of platelet-rich electrospun nanofibers have potential in wound healing applications (page 73, column 2, text line 7). That being the case, one of ordinary skill (a highly skilled individual such as a clinical or laboratory physician), before the effective filing date of the instant invention, would have found it obvious to incorporate the prior art nanofibers into conventional wound dressings such bandages (i.e. extended structures) and aerogels. And one of ordinary skill in the art would have done so with a reasonable expectation of success, given the explicit suggestion in the cited art to do so.
Allowable Subject Matter
Claim 3, 5-8 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 7/22/2026
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