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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 19, 2026 has been entered.
In that response, claims 1, 15, and 23 were amended. Claims 1-13, 15-18, and 23 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Specification
The disclosure is objected to because of the following informalities: in the table at para.[0126] the units for amphotericin B and vancomycin are denoted “n/a”. Appropriate correction is required.
The use of the term “Cellerate”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 2 is objected to because of the following informalities: typo in “collagen-base”.
Claim 3 is objected to because of the following informalities: “at least 50 wt%” should be “50 wt% to 99.995 wt%” as the former is technically broader than the “25 wt% to 99.995 wt%” in claim 1 due to the “at least”. A “the” or “said” should precede “hydrolyzed” in line 2.
Claim 4 is objected to because of the following informalities: “at least 0.005 wt%” should be “0.005 wt% to 50 wt%” as the former is technically broader than the “25 wt% to 99.995 wt%” in claim 1 due to the “at least”.
Appropriate corrections are required.
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.
Claim(s) 1, 3, 4, 10, and 17 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Makeeva (Makeeva, A.A., et al.., Biopolymer Controlled Release Systems Based on Hydrolyzed Collagen: Cryoforming, Structure, and Properties, Moscow University Chemistry Bulletin, Published: 11 July 2024, Vol. 79, No. 3, pp. 175–181).
Makeeva teaches dioxidine/hydrolyzed collagen systems comprising 0.5 g of dioxidine mixed with 0.5 to 5.0 g of hydrolyzed collagen (p.176 Experimental; see entire document including title; abstract). The system was obtained by freeze drying the mixture in distilled water, which removes the water and crosslinks the hydrolyzed collagen. Thus the system comprised various concentrations of hydrolyzed collagen and dioxidine, including 50% hydrolyzed collagen + 50% dioxidine. The system was obtained as a dried film or disk (p.176). Makeeva discusses application of collagen matrices for wound healing, and “targeted delivery and controlled release of” of medicaments such as gentamicin (p.175 rt. col.-p.176 left col.).
Regarding claim 10, for product claims, “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”. MPEP §2112.01(I). Therefore Makeeva’s composition would have exhibited the kill rate in claim 10.
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 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.
Claim(s) 1-10, 15-18, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Makeeva (Makeeva, A.A., et al.., Biopolymer Controlled Release Systems Based on Hydrolyzed Collagen: Cryoforming, Structure, and Properties, Moscow University Chemistry Bulletin, Published: 11 July 2024, Vol. 79, No. 3, pp. 175–181, available at https://link.springer.com/article/10.3103/S0027131424700147) in view of Pepito (US 2023/0310538).
Makeeva does not expressly teach the antibiotics in claims 2 and 5-9 or the components in claims 15, 16, 18, and 23.
Pepito teaches including “antibiotics (such as tetracycline, streptomycin, and cephalosporin)…” in a “composition with low molecular weight hydrolyzed collagen” (abstract; see title; paras.0065, 0067; claims 15, 16). Cephalosporin is a beta-lactam, streptomycin is an aminoglycoside. The composition is used for “tissue repair and wound healing” and “take a physical form used in topical administration, such as a …powder…, or a topically applied patch… an injectable liquid or an orally ingestible liquid.” (Para.0048 (emphasis added)). The antibiotics further speed the healing process, decrease scarring and increase tissue strength” (para.0040; see para.0043). The “composition may include about 1% by weight to about 99% by weight hydrolyzed collagen” (para.0035). Other suitable components include those in claims 15, 16, and 23, e.g., chondroitin (paras.0040-41, 0055). Pepito further teaches a gel form comprising about 1 wt.% water (para.0063).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Makeeva and Pepito as recited in the instant claim(s). The skilled person would have been motivated to do so because both are drawn to wound healing compositions comprising hydrolyzed collagen and antibiotic agents, and Pepito teaches further suitable antibiotics and components. The selection of a known material or mechanism based on its suitability for its intended use supports a prima facie obviousness determination. MPEP §2144.07 (citations omitted).
Regarding claim 6 it is noted that each antibiotic has a range of therapeutic dose, and the relative amounts to include in a combination would depend on the particular components in the combination, which the claims do not recite. The recited expansive range of ratio among any, unspecified two antibiotics in claim 6 is not considered as overcoming prima facie obviousness.
Regarding claims 7-9 it is noted that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Applicant has not demonstrated any criticality of including multiple antibiotic components by comparative experimental results. See MPEP § 2144.04 (IV)(B)(citations omitted).
Claim(s) 1, 3, 4, 10-13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Makeeva (Makeeva, A.A., et al.., Biopolymer Controlled Release Systems Based on Hydrolyzed Collagen: Cryoforming, Structure, and Properties, Moscow University Chemistry Bulletin, Published: 11 July 2024, Vol. 79, No. 3, pp. 175–181, available at https://link.springer.com/article/10.3103/S0027131424700147) in view of Salamone (US 2016/0101165).
Makeeva does not specifically teach a vicinal diol and a chelating agent in claims 11-13.
Salamone is drawn to debridement compositions for necrotic tissues (title; abstract). Salamone teaches including “biocidal monoalkyl glycol, glycerol alkyl ether, and monoacyl glycerol at a combined concentration of from 0.05 wt % (500 ppm) to 4 wt %...” (para.0086; see paras.0087-89). The compositions “may further comprise a chelating agent at a concentration of from 0.01 weight % to 1 weight %” as an antimicrobial stabilizing agent (paras.0096, 0158).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Makeeva and Salamone and include the vicinal diols and chelating agents as recited in the instant claim(s). The skilled person would have been motivated to do so because Salamone teaches that the vicinal diols are biocidal and chelating agents help stabilize the composition.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-13, 15-18, and 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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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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/H. SARAH PARK/Primary Examiner, Art Unit 1614
