DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 07/26/2023, are acknowledged. Claims 1-19 are pending in this action. Claims 1-19 have been amended. Claims 1-19 are currently under consideration. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a 371 of PCT/CZ2022/050006, filed January 25, 2022, which claims benefit of foreign priority to CZPV2021-32, filed January 26, 2021. No English translations of the certified copy of application has been received. Failure to provide a certified translation may result in no benefit being accorded for the non-English application. 37 CFR 41.154(b) and 41.202(e).
Inventorship
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.
Specification
The lengthy specification (36 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The specification comprises acronyms without proper definition, e.g., “UM” (Page 2); “RGD” (Page 4); “SEM” (Page 11); “GPC” (Page 14); “DS”, “RH” (Page 16). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The structure of the recited substituent “COCHCH furyl” (e.g., Page 6) is unclear. If applicant implies the use of “-CO(CH=CH)-furyl” that should be clearly stated in the specification. Clarification is required.
The specification comprises typographic errors, e.g., “Ibuprofen, Naproxen, Cetirizine, …, Brilliant Green, Fluorescein Isocyanate, Curcumin or Methylene Blue” (e.g., Page 8) that need to be corrected to “ibuprofen, naproxen cetirizine, …, brilliant green, fluorescein isocyanate, curcumin or methylene blue”. Appropriate correction is required.
List of cited documents (Pages 35-36) should be removed from the specification. MPEP 608.01. If Applicant wants these references to be printed in the patent, the applicant should submit them in the form of information disclosure statement to be considered by examiner. MPEP § 609.04(a) states "the list may not be incorporated into the specification but must be submitted in a separate paper." Further, it is noted that the publications recited in the instant application should be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). Appropriate correction is required.
Claim Objections
Claims 1, 3, 6-10, 13, 16-18 are objected to because of the following informalities:
Claim 1 comprises the typographic error “in the range from 82, 000 g/mol to” that needs to be corrected to “in the range of from 82, 000 g/mol to” (see claim 2). Similar is applied to other constituents recited in claim 1, as well as to claims 6-10, 13, 16-17.
Claim 3 comprises the typographic error “Ibuprofen, Naproxen, Cetirizine” that needs to be corrected to “ibuprofen, naproxen cetirizine”.
Claim 18 comprises the typographic error “for a period of 50 to” that needs to be corrected to “for a period of from 50 to”.
Appropriate correction is required.
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.
Claims 1-19 are 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the substitutes “O R2”, “O R1” that are not reasonably clear. Is it a physical or chemical interaction between “O” and “R”? These substitutes were interpreted as best understood as “OR2” and/or “OR1” (see formular III). Clarification is required.
Claim 1 recites the limitation “R1 is … COCHCH furyl” that is unclear, because the valency of C-atoms is not clear. This limitation was interpreted as best understood as “R1 is … CO(CH=CH)-furyl” (see CZ 304977B6 as an example). Clarification is required.
Claim 1 discloses nanofibers comprising “a crosslinked photocurable ester derivative of hyaluronic acid or salt thereof” and further recites the limitation “forms cyclobutene circle of formular II” that is not reasonably clear. First, it is unclear what constituent forms the structure defined by formular II. Second, the instant claim discloses R4-substitue as a main chain of hyaluronic acid. Does this limitation imply the present of non-modified hyaluronic acid, OR it discloses the crosslinking of photocurable ester derivative of hyaluronic acid or salt thereof of formular I”? Clarification is required.
Claim 3 recites the limitation “at least one active agent that comprises” that is not reasonably clear. Does this limitation define “active agent” as a mixture of compounds? Similar is applied to the limitation “biological agent selected from the group containing”. Applicant is advised to use the proper Markush group language, i.e., “selected from the group consisting of A, B, …and C”. Clarification is required.
Claim 3 is unclear and indefinite, because said claim recites a broad range/limitation together with a narrow range/limitation (i.e., preferably) that falls within the broad range/limitation in the same claim. Therefore, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. MPEP § 2173.05(c). Similar is applied to claims 4-10, 13, 16-19 regarding the limitations preferably, more preferably, most preferably. Clarification is required.
Claim 11 (dependent on claim 1) recites the limitation “The means of claim1, wherein a porosity thereof is maintained for 72 hours”. In the present case, it is noted that independent claim 1 does not disclose porous means. Therefore, it is unclear how claim 11 narrows the scope of the claim upon which it depends. Clarification is required.
Claim 12 discloses a method of manufacturing the means of claim 1 by electrostatically spinning the hyaluronic acid derivatives and polyethylene oxide to form nanofibers. In the present case, the instant method claim is not reasonably clear, because it is not clearly stated when (at what step) the formed nanofibers should be photocured by crosslinking. Further, it is noted that the limitation “photocured by crosslinking” is unclear. This limitation was interpreted as best understood as “nanofibers were crosslinked by UV irradiation”. Clarification is required.
Claims 2, 14, 15 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Conclusion
Claims 1-19 are rejected, but would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The prior art does not teach nanofibrous material based on two types of hyaluronic acid derivatives as instantly claimed, wherein said nanofibrous material has a mechanically resistant nanofibrous structure that is stable in aqueous solution, and can be used for wound healing cover. Applicant teaches that said material has an absorption capacity of at least 1000% after one hour of soaking in water or the aqueous solution, and/or maintains a stable shape for at least 72 hours after compete soaking in water or the aqueous solution.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615