DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Preliminary Amendment filed 21 February 2024, Applicant did not amend the claims. Claims 1-11 are pending.
Claim Objections
Claim 2 is objected to because of the following informality: There is no period at the end of the claim. Appropriate correction is required.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 2-7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor regards as the invention.
Regarding claim 2, the phrase “and variations thereof” is unclear. Which amino acid sequences qualify as variations of SEQ ID NO:1? In other words, where is the boundary between variants and non-variants? MPEP § 2173.05(b)(1) (terms of degree). The specification of the present application provides no guidance on identifying variants of SEQ ID NO:1. Additionally, persons having ordinary skill in the art can reasonably differ at to which sequences qualify as variants of SEQ ID NO:1 and, conversely, which do not. MPEP § 2173.04 (“a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim)”). Consequently, claim 2 is indefinite.
Regarding claims 3-7, what is a N-isopropylacrylamide (NIPAAm) hydrogel? Is it a hydrogel that is synthesized using NIPAAm as the only monomer? Page 2 of the specification, as originally filed, does not answer this question with clarity. Is the remaining percentage, which is undefined, primarily water (the liquid vehicle)? Moreover, it is unclear how a hydrogel (genus) can comprise a NIPAAm hydrogel (species). By way of analogy, does a motor vehicle (genus) comprise a truck (species)? The answer is “no.” Rather, the motor vehicle is a truck.
Claim Rejections - 35 U.S.C. 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 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 1 and 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ma (WO 2021/150383 A1) in view of Hara (JP 2010/120874 A).
Ma is directed to “cosmeceutical compositions for and methods of improving the appearance of skin.” Abstract.
Ma discloses: “The compositions of the invention are suitable for use as wound dressings. The ROS-scavenging copolymer (optionally in admixture with MG53) can be administered to a wound in dry form, whereby it will absorb body fluid and become a hydrogel that then solidifies at the site of the wound. The ROS-scavenging copolymer (optionally in admixture with MG53) can be administered to a wound in hydrogel form, whereby it then solidifies at the site of the wound. The copolymer provides reduced collage[n] formation (FIG. 8), increased follicle density (FIG. 9), and faster wound size reduction (FIG. 7) as compared to an untreated wound. The copolymer in combination with MG53 provides even further reduced collage[n] formation, further increased follicle density, and even faster wound size reduction as compared to an untreated wound.” (Emphasis added) Para. [099].
Ma discloses: “An MG53-containing composition of the invention provides improved healing of diabetic ulcers and diabetes-related skin conditions as compared to a saline-based aqueous composition containing the same amount of MG53.” (Emphasis added) Para. [048].
Ma discloses that the hydrogel can be administered to reduce scarring. Para. [043]; see also page 40 at claim 31.
However, Ma is silent as to whether the hydrogel can further comprise a TGF-β receptor II inhibitor. Consequently, Ma does not satisfy claim 1 of the present application. As explained below, Hara compensates for this deficiency.
Hara, which published in Japanese, is directed to diphenylmethyl piperazine derivatives having inhibitory action against TGF-βII type receptors. Abstract. The examiner obtained an English machine translation of Hara using Google Patents. Unless otherwise indicated, all citations refer to that translation, which accompanies this Office action.
Hara teaches that “an object of the present invention is to provide a compound having a TGF-bII type receptor inhibitory action in order to suppress scar formation.” (Emphasis added) Page 2/12.
Hara teaches: “The present invention relates to a diphenylmethyl heterocyclic derivative suitable for pharmaceuticals, and more particularly to a diphenylmethyl heterocyclic derivative useful for scar treatment.” (Emphasis added) Page 2/12.
Hara teaches: “Since the diphenylmethyl heterocyclic derivative and/or salt thereof of the present invention has an excellent TGFβIIR inhibitory effect, scar formation can be suppressed by containing it in a topical skin preparation and administering it. Scar formation inhibition means content including an action for preventing the already formed scar from further development and an action for preventing the scar that will be generated from occurring. In order to achieve such an effect, it is preferable that 0.1 to 50% by mass of such a compound is contained in an external preparation for skin and an appropriate amount is transdermally administered once to several times a day.” (Emphasis added) Page 6/12.
Before the effective filing date of the claimed invention, Hara would have motivated a person having ordinary skill in the art to add an effective amount of a diphenylmethyl heterocyclic TGF-β receptor II inhibitor taught therein to the ROS-scavenging hydrogel of Ma, in an effort to enhance the hydrogel’s ability to suppress scar formation, and thereafter topically apply the modified hydrogel to a diabetic ulcer or other diabetic skin wound in the course of routine experimentation. Therefore, claim 1 is prima facie obvious.
Regarding claim 3, Applicant is referred to claims 1-6 and 12 of Ma. Pages 37-38.
Regarding claims 4-6, Ma discloses: “The content of boronate ester-based copolymer in the cosmeceutical composition can vary widely according to the desired clinical (cosmetic) effect. In some embodiments, the boronate ester-based copolymer is present in the cosmeceutical composition at a concentration of up to about 10% wt or at a range of about 4% to about 10% wt. The remaining content of the cosmeceutical comprises liquid vehicle (in an amount sufficient to render a syringeable (low viscosity) hydrogel) and optionally one or more cosmeceutical excipients.” (Emphasis added) Para. [0029]. The boronate ester-based copolymer contains the monomers, one of which is NIPAAm, i.e., N-isopropylacrylamide. Para. [023]. Applicant is referred to MPEP 2144.05(I), which provides: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”
Regarding claim 7, Applicant is referred to claim 3 of Ma. Page 37; see also para. [098].
Regarding claims 8 and 9, Ma discloses that the hydrogel can accommodate, for example, from 1 µg/ml to 100 µg/ml of active pharmaceutical ingredients. Para. [0101]; see also para. [0143] (exemplifying 1 µg/ml). Additionally, Applicant is referred to page 6/12 of Hara, which is quoted above. The foregoing teachings are sufficient to establish prima facie obviousness on the basis of routine dose optimization. MPEP § 214405(II)(A) (“‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’”), quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Regarding claim 10, Applicant is referred to paragraph [028] and Figures 7A-7C of Ma.
Regarding claim 11, Applicant is referred to paragraphs [022]-[023] and [018] of Ma.
Conclusion
Claims 1-11 are rejected.
Claim 2 is also objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
21 March 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611