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 . The amendment filed on 09/09/2025 has been entered. Claims 4, 7, 10, 12, 16-20, 22-24, 26-37, 39-114, 116, 117, 120-148, 151-165, and 167-173 are cancelled. Claims 1-3, 5, 6, 8, 9, 11, 13-15, 21, 25, 38, 115, 118, 119, 149, 150, and 166 are pending in this application. Claims 5, 9, 21, 38, 115, 118, 119, 149, 150, and 166 are withdrawn. Claims 1-3, 6, 8, 11, 13-15, and 25 are currently under examination.
Priority
This application is a 371 of PCT/US2020/067232 filed on 12/28/2020 and claims the benefit of US PRO 62/953,925 filed on 12/26/2019.
Election/Restrictions
Applicant's election without traverse of Group I invention (claims 1-3, 5, 6, 8, 9, 11, 13-15, 21, and 25) and species (A solution with an acidic pH of about 5.0 as the collagen state, e.g., claim 3; Additional step of neutralizing the macromolecular matrix to a pH of about 7, after mixing the collagen homogeneously throughout the crosslinked hyaluronic acid, e.g., claim 8) in the reply filed on 09/09/2025 is acknowledged. Claims 5, 9, 21, 38, 115, 118, 119, 149, 150, and 166 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1-3, 6, 8, 11, 13-15, and 25 are currently under examination.
Information Disclosure Statement
Two IDSs filed on 06/24/2022 and 04/09/2024 have been considered.
Claim Objections
Claims 3 and 14 are objected to because of the following informalities: In claim 3, change the incorrect recitation “comprises a pH” (line 2) to “has a pH” because two or more pH values cannot present at the same time. In claim 14, change the incorrect recitation “comprises a concentration” (lines 1 to 2) to “has a concentration” because the “comprises” is open-ended and includes two or more salt concentrations at the same time; and delete the excessive recitation “between” (line 4). Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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.
(I) Claims 1-3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (J Microbiol Biotech 25(3):399-406, 2015, hereinafter referred to as Kim ‘2015, also listed in IDS filed on 06/24/2022).
With regard to structural limitations “a method comprising: (i) providing a crosslinked hyaluronic acid, (ii) providing collagen; and (iii) physically mixing the collagen (or in a soluble state; or as a solution in an acidic pH of about 5.0 or about 5.0 to about 7.0, in which the “about” is defined as “when referring to a measurable value is meant to encompass variations of +20 % or +10 %” in the Specification) into the crosslinked hyaluronic acid (or with a buffer), homogeneously, thereby forming a macromolecular matrix” (claims 1-3 and 6):
Kim ‘2015 disclosed hyaluronic acid/collagen (HA/COL) composite hydrogels prepared by blending 2% HA and 2% COL at two different ratios (10:1 and 5:1) using a PT 1200E homogenizer. Preparation of HA and Umbilical-Cord-Derived COL: The cross-linked HA was HyaFilia (CHA Meditech Co. Ltd., Daejeon, Korea), which is of non-animal origin and cross-linked using 1, 4-butanediol diglycidyl ether. It is granular with a mean particle size of 479 μm. Type I collagen (pH 6.5 ± 1.0, viscosity 4–40 × 105 cP) was isolated from a human umbilical cord. Supernatant proteins were precipitated with 2.4M NaCl for 12 h. The mixture was clarified at 15,000 ×g for 30 min at 4oC, and the pellet was subsequently desalted and concentrated using an ultrafiltration system (page 401, left col., para. 2; page 400, right col., para. 2).
Thus, these teachings of Kim ‘2015 anticipate Applicant’s claims 1-3 and 6 because (a) the claimed pH of about 5.0 or about 5.0 to about 7.0 is equivalent to “pH of 6.0 or 6.0 to 8.4” or “pH of 5.5 or 5.5 to 7.7” for the “about” to be +20 % and +10 %, respectively; (b) collagen precipitates at 2.4M NaCl and becomes soluble after desalting; and (c) a buffer is for maintaining pH of 6.5 ± 1.0, described above.
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.
(II) Claims 1-3, 6, 8, 11, 13-15, and 25 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Abramson et al. (US 2007/0020225, Jan. 25, 2007, hereinafter referred to as Abramson ‘022) incorporated by Wallace et al. (US 4,803,075, Feb. 7, 1989, hereinafter referred to as Wallace ‘075, also listed in IDS filed on 04/09/2024).
With regard to structural limitations “a method comprising: (i) providing a crosslinked hyaluronic acid, (ii) providing collagen; and (iii) physically mixing the collagen (or in a soluble state; or as a solution in an acidic pH of about 2.0 or about 2.0 to about 7.0, in which the “about” is defined as “when referring to a measurable value is meant to encompass variations of +20 % or +10 %” in the Specification; or as fibrillated collagen, prepared with at least one salt of about 20 mM to about 200 mM anion comprising H2PO4- or Cl-) into the crosslinked hyaluronic acid (or with a buffer), homogeneously, thereby forming a macromolecular matrix (or further neutralizing the macromolecular matrix to a pH of about 7; or further adding un-crosslinked hyaluronic acid)” (claims 1-3, 6, 8, 11, 13-15, and 25):
Abramson ‘225 disclosed a collagen composition further comprises hyaluronic acid. The inclusion of hyaluronic acid can facilitate the migration of fibroblasts into or through a collagen composition. The collagen composition comprising hyaluronic acid can be prepared by contacting a collagen composition with hyaluronic acid under any suitable conditions apparent to one of skill in the art. In further embodiments, the hyaluronic acid of the composition is cross-linked. In certain embodiments, compositions comprising hyaluronic acid can comprise from 0.1:99.9 to 99.9:0.1 hyaluronic acid:collagen on a weight/weight basis. Collagen compositions comprising non-crosslinked hyaluronic acid, and processes for their preparation, are described extensively in U.S. Pat. Nos. 4,803,075 and 5,137,875, the contents of which are hereby incorporated by reference in their entireties (page 6/28, [0053 and 0054]). In one embodiment, the collagen compositions are useful, for example, for augmenting or replacing tissue of a mammal. In further embodiments, the collagen can be fibrillar collagen. In still further embodiments, the collagen can be acid soluble collagen. Techniques for preparing atelopeptide collagen, fibrillar collagen and acid soluble collagen are discussed. In certain embodiments, the collagen composition is fibrillated at 3-3.5 mg/ml collagen, 30 mM sodium phosphate, pH 7.2, at about 32°C for about 20-24 hours. Optionally, the collagen composition can be washed one or more times, for example, in 20 mM Na2HPO4 and 130 mM NaCl, pH 7.4. In Example 1, the supernatant or filtrate of acid solubilized placenta collagen is added to a tall and narrow clear glass or plastic container. The NaCl concentration of solution is brought to 0.7 M NaCl where typically a white precipitate forms. The resulting precipitate is dissolved in 5 times the volume of 10 mM HCl (pH 2-2.3), and the salt precipitation above is repeated, resulting sample to contain about 5 mM acetic acid in ~10 mM HCl, followed by diafiltration to concentrate the sample with more 10 mM HCl until the acetic acid concentration reaches <1 mM and the sample starts to become viscous (page 4/28, [0039 and 0042]; page 9/28, [0089]; pages 25/28 to 26/28, [0251-0254]). Wallace ‘075 (incorporated by reference here) disclosed an injectable suspension comprising a biomaterial that provides the bulk of the implant and a biocompatible fluid that acts as a lubricant to improve the injectability of the biomaterial suspension. By way of example, when the biomaterial is the sheared lightly crosslinked collagen and the lubricant is uncross-linked methylated or succinylated collagen, the weight fraction of lubricant will normally be in the range of 0.1% to 3%. If hyaluronic acid is used in place of uncross-linked collagen, the weight fraction will usually be in the range of 0.3% to 0.5%. The biomaterial and lubricant are combined in a manner that provides a homogeneous mixture. For instance, the two components may be mixed homogeneously by repeated passages through pumps or by repeated transfer from one syringe to another through a small diameter interconnecting channel (page 8/13, col. 2, lines 25-30; page 9/13, col. 4, lines 43-66).
Thus, these teachings of Abramson ‘225 incorporated by Wallace ‘075 anticipate Applicant’s claims 1-3, 6, 8, 11, 13-15, and 25 because (a) the preparation of a collagen composition comprising crosslinked hyaluronic acid of Abramson ‘225 is incorporated by the reference of Wallace ‘075 for homogeneously repeated passages through pumps or syringes, (b) collagen is soluble at pH 2 to 2.3 with the presence of NaCl, (c) collagen is fibrillated in sodium phosphate or along with NaCl at pH 7.2 or 7.4, and (d) neutralization occurs automatically after mixing the acidic hyaluronic acid with fibrillated collagen at pH 7.2 or 7.4, described above. Or, in an alternative, skilled artisan would follow the teachings of Abramson ‘225 incorporated by Wallace ‘075 to prepare a composition, for example, for augmenting or replacing tissue of a mammal, by homogeneously mixing the human collagen with crosslinked hyaluronic acid, described above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YIH-HORNG SHIAO whose telephone number is (571)272-7135. The examiner can normally be reached Mon-Thur, 08:30 am to 07:00 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, Deirdre (Renee) Claytor can be reached at 571-272-8394. 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.
/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691