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 .
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 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.
DETAILED ACTION
Status of claims
The amendment filed on 12/29/2025 is acknowledged. Claims 1-12 have been withdrawn. Claims 13-26 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 12/29/2025 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the claim objection of claim 25 rejections from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New ground of rejections necessitated by Applicant’s amendment
The new limitation necessitates the following new ground of rejection.
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.
Claims 13-26 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains 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(s), at the time the application was filed, had possession of the claimed invention.
Claims 13 and 26 introduce new matter as the claim recites the limitation: "wherein the immobilized enzyme comprises at least 10 weight percent of the protease enzyme”. There is no support in the specification for this limitation. The limitation of: “wherein the immobilized enzyme comprises at least 10 weight percent of the protease enzyme” was not described in the specification as filed, and person skilled in the art would not recognize in the applicant’s disclosure a description of the invention as presently claimed. There is no guidance in the specification to select wherein the immobilized enzyme comprises at least 10 weight percent of the protease enzyme” and from MPEP 2163.06: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments. Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application. Claims 14-25 are rejected as dependent claims of a rejected claim.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following.
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 13, 14, 19, 20, 24, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chavan (US 2011/0177052 A1).
Chavan meets all of the limitations of claims 13, 14, and 26. Chavan discloses a topical wound debridement composition comprising
one or more stabilized proteases crosslinked to a carbomer via an amine reactive crosslinking reagent (100% by weight of proteases, within the new limitation of ≥10% by weight of immobilized proteases relative to total immobilized enzymes, carbomer as the claimed support matrix material in the instant claim 13, and the claimed crosslinked immobilized proteases enzyme in the instant claim 13 and immobilized proteases derived from proteases, crosslinker, and polyfunctional material in the instant claim 26 according to the instant specification page 11, 1st and 2nd paragraph) (abstract and claims 1 and 23);
wherein the stabilized proteases are stable at 25 °C (the claimed being stable to temperatures of ≥25 °C in the instant claim 13) (figure 3).
Although Chavan is silent about the crosslinked proteases substantially resisting degradation or deactivation in the wound (the instant claim 13) and maintaining at least 50% of its initial activity after storage for at least 4 months at −20 – 50 °C (the instant claim 14); the crosslinked proteases are the same as the claimed immobilized protease enzyme, as a result of the crosslinked proteases being the same crosslinked proteases as claimed, the crosslinked proteases would necessarily have the claimed properties, whether expressly recognized by Chavan or not. Please refer to MPEP 2112.01 II:
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Chavan meets all of the limitations of claims 19 and 20. Chavan discloses the debridement composition being in form of ointment (salve) and bandage, i.e., encompass ointment contained in a bandage (paragraph 53).
Chavan meets all of the limitations of claims 24 Chavan discloses the composition further comprising antimicrobial agents, anti-inflammatory agents, thickeners (paragraph 55).
Response to Applicants’ arguments:
Applicant’s arguments are addressed in the modified rejection above (newly underlined).
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 13-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chavan (US 2011/0177052 A1) in view of Salamone et al. (US 2016/0199459 A1).
The teachings of Chavan are discussed above and applied in the same manner.
Chavan does not specify the composition further comprising a non-immobilized enzyme (the instant claim 15); a further immobilized enzyme on the same support and not on the same support in the instant claims 16-18; the antimicrobial including antiviral (the instant claim 21), the thickeners including aloe vera (the claimed topical analgesic or anesthetic in the instant claims 22 and 23), and NSAID’s (non-steroidal anti-inflammatory agents in the instant claim 25).
This deficiency is cured by Salamone et al. who teach a debridement composition comprising a non-proteolytic enzyme adsorbed on a natural or synthetic polymer, etc., (a further immobilized enzyme) and a proteolytic enzyme (a non-immobilized enzyme) (paragraph 21 and claim 19), viscosity builders including aloe vera (paragraph 36), dialkylsulfosuccinates having anti-viral properties (paragraph 86), and non-steroidal anti-inflammatory agents (paragraph 88).
It would have been prime facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to modify the composition taught by Chavan to add a non-proteolytic enzyme immobilized on a polymer and a non-immobilized proteolytic enzyme taught by Salamone et al. It is generally considered to be prime facie obvious to combine compounds each of which is taught by the prior art to be useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for adding them flows from their having been used individually in the prior art, from their belonging to same category, and from them being recognized in the prior art as useful for the same purpose of debriding wound. Since the immobilized enzymes includes an enzyme other than immobilized proteases, the immobilized proteases would be <100% by weight of the total immobilized enzymes which overlaps with the claimed ≥10% by weight in the instant claim 13 and 26. A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection. The claimed range of immobilized proteases relative to the total immobilized enzymes is ≥10% by weight and the range of immobilized proteases relative to the total immobilized enzymes taught in the prior art is <100% by weight and therefor, includes the claimed range. Please refer to MPEP 2144.05.II.A:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
With regard to the limitations of additional immobilized enzyme being on the same support and not on the same support, these limitations are alternative design choices while explicit motivation for an alternative design choice is not needed for an obviousness rejection to stand. See Ex parte Ahuja, the Board showed that explicit motivation for an alternative design choice is not needed for an obviousness rejection to stand. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Chavan and Salamone et al. to specify the viscosity builders including aloe vera (the claimed topical analgesic or anesthetic), the anti-inflammatory including NSAID’s; and the anti-microbial agents including an antiviral agent in the composition taught by Chavan. A topical composition for debriding wound comprising aloe vera, NSAID’s, and an antiviral agent was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Applicant’s arguments are addressed in the modified rejection above (newly underlined).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 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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/HONG YU/
Primary Examiner, Art Unit 1614
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