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 .
Election/Restrictions
Applicant’s election without traverse of Group IV, claims 43, 44, 45, 46, 58-65, in the reply filed on 7/23/2026 is acknowledged.
Claims 1-10, 13-16, 18, 22, 32, 25, 38, 39, 40, 41, 42, 57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/23/2026.
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.
Claim 60 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.
Claim 60 recites wound dressing comprising an alginate hydrogel that is configured to release a therapeutic dose of the recombinant RNA to the wound for a delivery period. Thus, claim requires the wound dressing comprising an alginate hydrogel to have a structure that allows for the recited function of release of “a therapeutic dose of the recombinant RNA to the wound for a delivery period”. However, it is unclear what structure allows for this function. The specification provides no guidance regarding how the wound dressing and/or the alginate hydrogel were configured to achieve the said function. The method disclosed is mixing alginate hydrogel with a therapeutic dose of recombinant RNA (Figure 5) however no specific structure is disclosed for the alginate hydrogel itself that allows it to release a therapeutic dose of any specific delivery period. For the purpose of compact prosecution, the claim(s) 60 is/are interpreted as a wound dressing comprising an alginate hydrogel comprising a therapeutic dose of the recombinant RNA.
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.
Claim(s) 43, 44, 46, 58-65 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horscroft et al (US 2020/0149026 A1, May 14, 2020).
Regarding claims 43 and 44, Horscroft discloses a method of increasing expression of a therapeutic protein, such as FGF2, and treating a wound in a subject by administering a recombinant RNA encoding a therapeutic protein, such as FGF2, to the wound that would increase the expression of FGF2 in the wound thereby treating the wound ([0050], [0053], [0054], [0060], [0071-0074], [0399], [0401], [0449], [0451], [0528], [0536], [0543]; Example 2-6). Horscroft identifies several therapeutic proteins that show clinical improvement in wound-healing, identifying FGF2 as one [0008].
Regarding claim 46, 61, 62, Horscroft discloses diabetes associated ulcer wounds in humans and methods using animal models with diabetic wounds ([0005]; Example 2-6).
Regarding claim 58 and 59, Horscroft discloses embodiments wherein the recombinant RNA is provided in the form of a wound dressing comprising alginate hydrogel [0449, 520-525]. Such an embodiment would result in topical administration, as required by claim 63.
Regarding claim 60, in view of 112b interpretation above, in disclosing a wound dressing comprising an alginate hydrogel comprising the recombinant RNA for the treatment of a wound which would require delivery of RNA at a therapeutic dose, Horscroft anticipates claim 60.
Regarding claim 64, Horscroft discloses a method of treating a wound in a subject, wherein diabetes associated ulcer wounds are disclosed ([0005]; Example 2-6). Horscroft’s method comprises administering a recombinant RNA encoding a therapeutic protein, such as FGF2, to the wound ([0050], [0053], [0054], [0060], [0071-0074], [0399], [0401], [0449], [0451], [0528], [0536], [0543]; Example 2-6), wherein in some embodiments the recombinant RNA is provided in the form of a wound dressing [0449, 520-525] and the recombinant RNA molecule can be comprised in a LNP [462, 497]. When administering the recombinant RNA in the form of a wound dressing, Horscroft discloses a wound contacting layer for placement on the wound, thus discloses applying the wound dressing to the wound ([0520]).
Regarding claim 65, Horscroft discloses wound dressing comprising alginate hydrogels [0449, 520-525] comprising recombinant RNA molecule encoding therapeutic proteins, such as FGF2, ([0050], [0053], [0054], [0060], [0071-0074], [0399], [0401], [0449], [0451], [0528], [0536], [0543]); wherein the recombinant RNA molecule can be comprised in a LNP [462, 497]. Such a wound dressing would inherently comprise at least some of the therapeutic present throughout the hydrogel. The claim recites intended use of the wound dressing as “for treating a diabetic ulcer wound” According to MPEP 2111.02, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. The intended use recited in claim 65 does not appear to impart any structure to the claimed product. Therefore, in teaching the structure of the wound dressing Horscroft anticipates the claim.
Therefore, Horscroft anticipates the claims.
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) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horscroft in view of Theocharidis et al (Single Cell Transcriptomic Landscape of Diabetic Foot Ulcers. bioRxiv 2021.03.11.434413; this version posted March 12, 2021.).
Regarding claim 45, Horscroft teaches a method of increasing expression of at least one therapeutic proteins and treating a wound in a subject by administering at least one recombinant RNA encoding therapeutic proteins to the wound thereby treating the wound ([0050], [0053], [0054], [0060], [0071-0074], [0399], [0401], [0449], [0451], [0528], [0536], [0543]; Example 2-6). Horscroft identifies several therapeutic proteins that show clinical improvement in wound-healing, identifying FGF2 as one [0008].
Furthermore, Horscroft teaches that their method comprises “at least two, three, four, five, six, seven, eight, nine, ten, eleven, twelve or more RNAs” wherein the more than one RNA could be administered in a time-staggered manner i.e. sequentially [0450-452].
Although Horscroft teaches several therapeutic protein for wound healing, such as FGF2, Horscroft does not teach an additional polypeptide listed in the claim.
However, other polypeptides listed in the claim were expected to have therapeutic effect in wound healing.
Theocharidis teaches a single cell RNAseq data comparing samples from diabetic foot ulceration with control samples from intact skin from diabetes patients and non-diabetes subjects (Introduction, last para). Theocharidis identifies fibroblasts that are enriched in healing wounds (HE-Fibro) specifically identifying subcluster 3 that is a ‘sender’ cell population enriched in CHI3L1 that signals the remaining ‘healer’s HE-Fibro to the wound site (page 17-18, bridge para). Theocharidis teaches that CHI3L1 is a secreted glycoprotein (page 12, para 1) that when overexpressed in fibroblasts in vitro increase their adhesion to extracellular matrix and reduce migration (page 19-20, bridging para). Taken together, Theocharidis teaches CHI3L1 as a potential therapeutic protein that plays a key role in wound repair by attracting ‘healer’s HE-Fibro to the wound site and/or increase adhesion of ‘sender’ HE-Fibro to the wound site.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include RNA encoding CHI3L1 in the method of Horscroft. An ordinary artisan would be motivated to include RNA encoding CHI3L1 in Horscroft’s method to improve the therapeutic effect of Horscroft’s method since an ordinary artisan reasonably expects, based on Theocharidis’s teachings, that CHI3L1 expression at the wound site would attract ‘healer’s HE-Fibro to the wound site and/or increase adhesion of ‘sender’ HE-Fibro to the wound site.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the
contrary.
Conclusion
Relevant art not relied upon for instant rejection: Castleberry et al (US 2014/0302116 A1, Oct. 9, 2014) and Kearney et al (US 10,016,524 B2, Jul. 10, 2018) both teach methods for making wound dressings for nucleic acid delivery.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATASHA DHAR whose telephone number is (571)272-1680. The examiner can normally be reached M-F 8am-4pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras Jr. can be reached at (571)272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATASHA DHAR/Examiner, Art Unit 1632
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