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
Acknowledgment is made of applicant's claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) based upon application EP22202774 filed in Europe on October 20, 2022. The petition under 37 CFR 1.55 or request under PCT Rule 26bis.3 to restore the right of priority was granted on February 16, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 20, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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.
Claims 5, 7, 9-12, and 14 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation 1 mg/ml to 10 mg/ml and also recites 5 mg/ml to 1 mg/ml and 5 mg/ml to 500 mg/ml, which are narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
The term “about” in claims 5, 7, and 9 is a relative term, which renders the claim indefinite. The term “about” 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.
The phrases “more preferably” and “most preferably” in claim 5 and the term “preferably” in claim 14 render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 10-11 are included in this rejection for being dependent from a rejected base claim and for failing to cure the indefiniteness.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 12-13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 20130150285, published June 13, 2013 (“Gold”; instant PTO-892).
With respect to claims 1-2, Gold teaches therapeutic compositions comprised of calreticulin or a functional fragment or derivative thereof for the treatment acute and chronic wounds ([0009], [0021], [0035], [0086]). Calreticulin can be embedded or complexed chemically or ionically to any polymer or natural matrix that can be applied to a cutaneous wound [0029]. The composition may further comprise hydrogels and hyaluronic acid [0155]. This composition of Gold can be administered topically [0157], which reads on instant claim 2.
Gold teaches human calreticulin [0109], which reads on instant claim 3.
Gold teaches rabbit calreticulin amino acid sequence of SEQ ID NO: 7 [0109], which is 99% identical to instant SEQ ID NO: 1 (see alignment, where Query 1 is instant SEQ ID NO: 1 and Sbjct 1 is Gold SEQ ID NO: 7).
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For the topical application, the calreticulin composition can be administered at a range from about 0.001 mg to about 1 g per application [0154], which overlaps with the concentrations of instant claim 5.
Gold teaches that the topical formulation comprising calreticulin may be in sprayable form [0160] or applied as a gel [0155], which reads on instant claim 6.
The composition comprising calreticulin may be sterilized or mixed with preservatives [0160], which reads on instant claim 12. The composition may further comprise a growth factor [0021], antibacterial agents, or analgesics [0164], which reads on instant claim 13.
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20130150285, published June 13, 2013 (“Gold”) in view of Hui et al, published April 2, 2018 (instant PTO-892).
The teachings of Gold are discussed above. Gold does not teach the limitations of instant claims 7-11 and 14.
Hui et al teaches hydrogel compositions comprising the therapeutic agent acid fibroblast growth factor (aFGF), carbomer, and human serum albumin (pg 1661, section I; pg 1662, section 2.1), as in instant claims 8-10. aFGF promotes wound repair and improves the quality of wound healing (pg 1661, section I). In the aFGF composition, the concentration of the polymeric material carbomer is at 0.3-0.8 w % (Table 1 on pg 1662) and the concentration of 0.2% human serum albumin is 2 mg/ml (pg 1662, column 2, para 0) (Table 1 on pg 1662), which lie within the ranges polymeric material and serum albumin of instant claims 7 and 9, respectively.
The stability of the composition of Hui et al was assessed at -20 °C, 5 °C, and 25 °C (pg 1662, column 2, section 2.5), as in the storage temperatures of instant claim 14.
Although Gold nor Hui et al explicitly recite the limitation wherein the serum albumin protein is recombinant, it is the Office’s position that this species within the serum albumin protein genus can be at once envisaged from the prior art because the species within this genus (e.g., plasma derived and recombinant) are sufficiently limited and well delineated; see MPEP 2131.02(III) and In re Petering (wherein the courts determined that a reference describing a generic formula encompassing about 20 compounds was found to anticipate each of the 20 species without specifically naming them).
Given that Gold teaches a composition comprising calreticulin protein and polymeric materials for topical wound treatment and further given that Hui et al teach compositions comprising a therapeutic and carbomer hydrogel and serum albumin protein for topical wound treatment, it would have been obvious to one of ordinary skill in the art to substitute the therapeutic aFGF of Hui et al with the calreticulin protein of Gold. The motivation comes from Hui et al, who teaches that the topically administered therapeutic composition further comprising carbomer and serum albumin achieved much better biostability than a composition without carbomer (pg 1667, Section 5). KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses combining prior art elements according to known methods to yield predictable results; the combination is obvious unless its application is beyond that person's skill. It would have been within the technical grasp of the ordinary artisan to apply the calreticulin protein in the improved composition of Hui et al to obtain predictable results. Such amounts to combining prior art elements according to known methods to achieve predictable outcomes. In the absence of unexpected results or a teaching away in the prior art, the claims are obvious over the combined teachings of Gold and Hui et al.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
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