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 .
Claim Objections, warning
Applicant is advised that should claim 4 be found allowable, claim 7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. (Claims 4 and 7 are presently identical.) When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant is advised that should claim 12 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. (Claims 12 and 13 are presently identical.) When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Objections
Claim 18 is objected to because of the following informalities: for grammatical reasons, in the last line of the claim, the indefinite article a, which precedes the noun subject, should properly be the definite article: the.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2 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.
It is unclear how a diabetic wound is a model of impaired wound healing (“…in diabetic wounds or other models of impaired wound healing…”). A diabetic wound is a diabetic wound, not a model of impaired would healing.
Claim 3 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.
The term relevant (“…relevant in inflammation…”) is a relative term which renders the claim indefinite. The term 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. What is, or is not, relevant in inflammation will depend entirely upon the criteria utilized for making such a determination, and thus on the circumstances and rational for the determination. The term would appear, to a significant degree, to encompass a wholly subjective determination of what is, or is not, relevant in inflammation.
Clarification is in order.
Claim 6 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.
There is insufficient antecedent basis for the limitation “…the myristoylated protein…” in the claim.
The examiner respectfully suggests the claim should properly depend from claim 5 (not claim 1).
Claim 8 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.
The claim is unclear because there appears to be a lacuna in the text (“…wherein the serine protease inhibitor serine protease inhibitor belonging to the serpin family…”).
The examiner respectfully suggests that the clause should properly be: …wherein the serine protease inhibitor is a serine protease inhibitor belonging to the serpin family….
Claim 14 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.
The term enriched (“…enriched in EVs…”) is a relative term which renders the claim indefinite. The term 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. What constitutes, or does not constitute, being enriched would seem to be a wholly subjective determination.
Clarification is in order.
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.
Claims 1-3, 10-13 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Macromolecular Research (2018), 26(8), pp. 709-716.
The reference teaches an extracellular vesicle (EV) composition of mesenchymal stem cell-derived exosomes, which encapsulate the recombinant fusion protein Tat-MT, and which when administered as an appropriately formulated pharmaceutical composition, can significantly affect the cell viability of hypoxic cardiomyocytes (utilized as a model of myocardial infarction i.e. of impaired wound healing) due to synergistic anti-apoptotic and regenerative effects (abstract; page 709, 1 Introduction; page 710, column 1, 1st and 2nd full paragraphs; page 711, Scheme 1; page 714, column 1, 3.4. Cellular uptake of Exo/Tat-MT). EV diameters span an approximately continuous range of approximately 30-190 nm (page 712, column 1, 1st full paragraph and Figure 1D).
Claim 3 is included in this rejection because the protein MT (metallothionein) is intrinsically involved in the inflammatory response (as is well-known in the art evidenced by, for instance: Mediators of Inflammation (2009), Vol. 2009, Article ID 101659, 7 pages).
Claim 17 is included in this rejection because the administered composition, and its container or means of administration, can be thought of, essentially, as “[a] kit comprising the pro-reparative EV composition of claim 1.” Note that during patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification. (See MPEP 2111.)
Allowable Subject Matter
Claims 4, 5, 7 (a duplicate of 4), 9 and 19-21 are objected to as being dependent upon, or ultimately dependent upon, a rejected base claim, but whose subject matter would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 2/9/2026