CTNF 18/670,928 CTNF 88183 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 12-151 AIA 26-51 12-51 Status of Claims Claims 32-54 are pending. This is the first office action on the merits. Information Disclosure Statement The IDSs filed 5/22/2024 (x3) have been reviewed. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged. Election/Restrictions Applicant’s election of species with traverse in the reply dated October 21, 2025 is noted. Specifically, Applicants elect arylated hyaluronic acid as the hydrogel, thiolated poly(ethylene glycol) as the crosslinking agent, and growth factors as the compound or single combination of compounds. The traversal is on the basis that there is no serious burden on the Examiner for the election of species to be required because multiple species can be searched and examined together without serious burden. This argument is found to be persuasive and the species election is hereby withdrawn. Claims 32-54 are examined on their merits as to all species. Claim Objection Claim 40 is objected to because of the following informalities: The claim appears to be missing an article before the word “microbeads”. It is suggested that claim 40 be amended to recite “, the microbeads”. Claim 43 is objected to because of the following informalities: The claim appears to be repeating the phrase “wherein the pores”. It is suggested that claim 43 be amended to delete “, wherein the pores”. Claim Rejections - 35 USC §112(b) 07-30-02 AIA 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. 07-34-01 Claim 41-42, 49-50 and 51-52 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. 15-22 Claim 41 is rejected under 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 applicant regards as the invention. Claim 41 is rejected for the recitation of “the surface”. Claim 41 depends from claim 38 but claim 38 does not recite “a surface”, so there is also insufficient antecedent basis for this limitation in the claim. There is also no recitation of “a surface” in claim 32 either. There is however a recitation of “a surface” in claim 40. For the purposes of this office action, claim 41 will be interpreted as depending from claim 40. 07-34-01 Claim 42 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 42 recites the limitation “wherein the pores are present comprising 80% of the pores having an average pore diameter on the surface that is at least about 5 microns”. This phrase is vague and confusing and it is not clear what “wherein the pores are present comprising 80% of the pores having an average pore diameter on the surface that is at least about 5 microns.” This phrase is not defined nor explained in the specification and cannot be determined by reference to any other claims. As a result, one of ordinary skill in the art would not be reasonably apprised of how to determine what this phrase means. Claims 49-50 are rejected under 35 USC 112(b) for reciting “substantially”. The phrase “substantially” in claim 49 is a relative term which renders the claim indefinite. The phrase “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree. It is unclear to what degree the water mass can be replaced or what the concentration the microbeads is that is present. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One skilled in the art, therefore, would not be reasonably apprised of the metes and bounds of the claims. Additionally, claim 49 should not recite “(as measured by weight)” in line 2. Since the claim is referencing water mass lost, this phrase is confusing and contradictory. This recitation makes the claim unclear and confusing. It is not clear how the water lost is being measured, by mass or by weight. This phrase is not defined nor explained in the specification and cannot be determined by reference to any other claims. As a result, one of ordinary skill in the art would not be reasonably apprised of how to determine what this phrase means. Furthermore, the as measured by weight is in parenthesis so it is unclear whether the clam even requires as measured by weight or not. For the purposes of this office action, it will be assumed that water mass lost is being referred to. 15-22 Claim 51 is rejected under 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 applicant regards as the invention. Claim 51 is rejected for the recitation of “the compounds”. Claim 51 recites “one or more compounds” in lines 1-2. It is unclear whether one, several, of all of the compounds are being referred to by “the compounds”, so there is insufficient antecedent basis for this limitation in the claim. It is suggested that claim 51 be amended to recite “the one or more compounds” in line 2. Claim 51 is also rejected for reciting the limitation “wherein the compounds have therapeutic effects, vascularization effects, anti-vascularization effects, anti-inflammatory effects, anti-bacterial effects, antihistamine effects and combinations thereof.” This phrase is vague and confusing and it is not clear whether the compounds are supposed to have one of the effects or all of the effects. It is suggested that Applicants recite “or” a combination thereof, or combinations thereof. This phrase is not defined nor explained in the specification and cannot be determined by reference to any other claims. As a result, one of ordinary skill in the art would not be reasonably apprised of how to determine what this phrase means. Claim 52 is rejected as depending from claim 51. Closest Prior Art The claimed method is nonobvious over the closest prior art. The closest prior art to the claimed invention is Gref US 2004/0013626 (1/22/2004) in view of Park (KR 2007-0073008 (7/10/2007), Mao US 2012/0267810 (10/25/2012) and Martin WO 2017/031167 (2/23/2017). Gref teaches a method of making particles comprising a crosslinked hyaluronic acid network covalently linked to polycaprolactone in which the method comprised introducing a functionalized hyaluronic acid covalently linked to polycaprolactone to liquid and heating it. (See Gref claim 34). Gref teaches the particles are crosslinked but does not teach how this crosslinking occurs. Gref does not teach substantially non-spherical microbeads, that the polycaprolactone is in fiber form or a thiolated PEG as a crosslinker. These deficiencies are made up with the teachings of Park, Mao and Martin. Park teaches that for an injectable crosslinked hyaluronic acid composition used for drug delivery, the crosslinking is achieved by functionalizing the hyaluronic acid by acrylating it and then using 30 mg/ml thiolated PEG as a crosslinker. (See pages 3 and 5). Martin teaches that for an injectable composition formed from hyaluronic acid covalently attached polycaprolactone (see page 4), the polycaprolactone is formed from fibers with a length of tens to hundreds of microns. (See pages 2, 19 and 51). Martin teaches that pores in a hyaluronic acid matrix facilitate cell migration into the matrix. Mao teaches non-spherical particles and how they are beneficial for drug delivery. However, the prior art does not render the claimed invention nonobvious because Gref does not teach any method in which the functionalized hyaluronic acid covalently linked to polycaprolactone is mixed with thiolated PEG or any crosslinker, for that matter, and reacting them or physically modulating the bulk composite to form non-spherical microbeads. Additionally, Gref teaches particles with a less than 2-3 micrometer diameter which is not the claimed 50 to about 300 micrometers along the longest dimension as claimed. Mao does not teach a composition of any type that may contain the non-spherical particles. With respect to obviousness-type double patenting, the instant application is directed to method claims that in a divisional application filed from U.S. Patent Application No. 16/515819 that resulted from a Restriction Requirement in the parent Application No. 15/515819 which issued as U.S. Patent No. 12,036,339. The instant claimed method of making substantially non-spherical microbeads comprising a crosslinked functionalized hyaluronic acid network covalently linked to a plurality of caprolactone fibers of the recited dimensions are the only claims directed to making such non-spherical microbeads using the claimed method. Conclusion Claims 32-39, 44-50 and 53-54 are allowed. Claims 40 and 43 are objected to. Claims 41-42 and 51-52 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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. 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. /SARAH ALAWADI/Primary Examiner, Art Unit 1619 SARAH CHICKOS Examiner Art Unit 1619 Application/Control Number: 18/670,928 Page 2 Art Unit: 1619
Prosecution Insights