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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/08/2026 has been entered.
Status of Claims
The amendments and arguments filed on 05/08/2026 are acknowledged and have been fully considered. Claims 1-11 are now pending. Claim 1 is amended.
Claims 1-11 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over CN 107849596 A (Wang, 2018; machine translation from PE2E via FIT provided) in view of Ozeki (2002).
In regards to claims 1-2, Wang teaches a collagen particle wherein the particle is about 10-250 microns (see Wang, abstract; claim 1). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 5, the composition is taught to be used in a subcutaneous stimulation test and injection tests (see Wang, page 11, Embodiment 2 1 of collagen particle sensitivity test).
In regards to claims 6-11, it is noted that the method of claim 1 is a method of inducing hair follicle neogenesis or angiogenesis in a subject, not a method of preparing the collagen particle and therefore if the art teaches the same collagen particle, then the method by which it is made is not relevant. However, it is further pointed out that in this case, Wang does teach a method that is substantially identical to the method in claim 6. It is taught that that collagen particle is made by processing the skin of an animal that has a thickness of 0.1 to 1 mm by treating the animal skin with a supercritical fluid, such as supercritical carbon dioxide, at a pressure of 100-500 bar, more specifically 350 bar, at a temperature of 30-50°C, more specifically at 40°C, for a time of about 20 minutes to 5 days (see Wang, page 6 to a page 7, paragraph 2). The animal skin is then taught to be treated with a de-ionized treatment by being placed in a hydrogen peroxide solution (see Wang, page 8, paragraph 4). This is followed by the step of another supercritical fluid processing step using similar conditions as the first super critical fluid processing step (i.e., using supercritical carbon dioxide, pressure of 100-500 bar at 30-50°C for 20 minutes to 5 days) (see Wang, page 8, paragraph 5). It is taught that this step includes the use of a cosolvent such as ethanol (see Wang, page 8, paragraph 5). The final step is taught to be granulating collagen to produce collagen particles suitable for administration by injection, under a liquid nitrogen condition through cutting or grinding to form particles of 10-250 microns (see Wang, page 8, paragraph 6).
It is also taught that the skin is subjected to a sodium hydroxide solution for about 1 hour (see Wang, page 6, paragraph 12). It is not taught that this step is done following the first supercritical fluid processing step. However, it is taught that the acellular processing step (i.e., the supercritical fluid processing step) is done to remove cellular material on the animal skin and the alkali reagent treatment (i.e., sodium hydroxide treatment) is done to remove hair and/or fatty residue (see Wang, page 6, final two paragraphs). It would be within the purview of one with ordinary skill in the art to rearrange these two steps to have the sodium hydroxide treatment follow the supercritical fluid treatment as both are for ridding the animal skin of impurities of the same nature. Further, the order of performing processing steps is prima facie obvious in the absence of new or unexpected results. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results). See MPEP 2144.04 IV (C).
Wang is silent on the collagen particles being used to induce hair follicle neogenesis or angiogenesis in a subject.
Ozeki teaches a collagen hydrogel comprising vascular endothelial growth factor (VEGF) for subcutaneous implantation which has a significant angiogenetic effect in the skin tissue and promoted hair follicle growth in mice (see Ozeki, abstract and introduction).
In regards to claims 1-11, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Wang and Ozeki to formulate the instant method as claimed as Ozeki teaches that injectable collagen and VEGF are known to promote hair follicle growth through subcutaneous implantation and Wang teaches that the collagen particles are used to treat skin conditions such as wounds and other tissue damage (see Wang, page 9, paragraphs 1 and 3). It would be obvious to one with ordinary skill in the art to combine the teachings of Wang and Ozeki to treat skin where hair follicles are present in order to promote hair follicle growth according to the method of promoting hair follicle growth (see Ozeki, materials and methods) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regards to claims 3-4, it is noted that the amount of drug is clearly a result effective variable that must be determined based on a variety of factors including the age, body weight, and health of the patient, the condition(s) to be treated and their severity, the route(s) of administration, the particular drug(s) used, adverse drug effects or toxicity, clinical response to treatment, etc., and is routinely optimized by the skilled artisan. Applicant is advised that recitation of dosages, without more, is generally insufficient to patentably distinguish over the prior art.
Response to Arguments
Applicant's arguments filed 05/08/2026 have been fully considered but they are not persuasive.
In regards to applicant’s arguments that the amendment of the claim language from “comprising” to “consisting of” limits the scope of the claims to administering a particle of only collagen, it is pointed out that this is not quite correct. The language has been amended so that the method of inducing hair follicle neogenesis or angiogenesis in a subject is limited to administering collagen particles, however there is no limitation on what the collagen particles comprise. As such, the inclusion of VEGF is still allowed within the limitations of claim as written. It is suggested to add a limitation that limits the contents of the collagen particle as well (e.g., “wherein the collagen particle consists of collagen), that is within the teachings of the disclosure to avoid any new matter issues as well.
The rejections are maintained over the prior art.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 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, Bethany Barham can be reached at 571-272-6175. 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.
/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
Prosecution Insights