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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous office action has been withdrawn pursuant to 37 CFR 1.114.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 23 January 2026 has been entered.
The Request for Continued Examination filed has been considered. The following information has been made of record in the RCE filed for the instant application:
1. Claims 1-29 have been canceled. These were canceled in a previous filing.
2. New Claims 69-70 have been added.
3. Claims 32, 54-59, 61-63, and 65-67 have been amended.
4. Remarks drawn to rejections under 35 USC 112, 103 and double patenting.
The following rejections have been overcome:
5. The rejection of Claims 55, 57-58, 61-62 and 65-66 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and the rejection of Claims 32, 54, 57, 61 and 65 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, have been overcome by amendments.
The rejection of Claims 30-68 under 35 U.S.C. 103 as being unpatentable over Wiebensjo et al (US 2019/0000740 A1; of record) in view of Lowe et al (J Am Acad Dermatol, 2001, 45, 930-933; of record) and further in view of Rohrich et al (Plast Reconstr Surg Glob Open, 2019, 7, 1-10; of record), Towne et al (US 2017/0182191 A1; of record) and Allenfall et al (US 2016/0317620 A1; of record) has been replaced by the new art rejection under 35 USC 103 in view of applicant’s arguments and amendments.
Claims 30-70 are pending in the case. Support for the amendments and new claims is seen at paras 0005-0006, 0040, 00070-00073 and 00089 in the specification as originally filed.
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 70 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 70 recites divinyl sulfonate as one of the crosslinking agents. Doe applicant intend divinyl sulfone? The claim is examined as drawn to divinyl sulfone as a crosslinking agent.
Claim Rejections - 35 USC § 103
Claims 30-70 are rejected under 35 U.S.C. 103 as being unpatentable over Hideo et al (JP 2015040173 A; Machine English Translation, pages 1-17; cited in IDS filed 1/23/2026) in view of Wiebensjo et al (US 2019/0000740 A1; of record) and further in view of Towne et al (US 2017/0182191 A1; of record) and Allenfall et al (US 2016/0317620 A1; of record).
Hideo’s invention is drawn to a composition for hair growth (Abstract; as in claims 30, 48, 50, 52). Hideo teaches a method of stimulating hair growth in a mammalian patient via administration of a composition comprising hyaluronic acid. The composition uses hyaluronic acid as an active agent (page 2, see under sub-title: Tech-Problem and under Tech-Solution-4th para; page 16, Test Example 4; method and active agent recited in claims 30, 48, 50, 52). The concentration of hyaluronic acid for hair growth is in the range of 0.00001 to 3.0% by weight, and preferably 0.001 to 1% by weight (page 4, sixth full para; concentration of HA as in claims 30-32, 48, 50 and 52).
Hideo et al does not teach injection of the composition between about 400 microns to about 2mm deep into the skin of a patient and in the vicinity of a hair follicle as in claims 30 and does not teach the limitations of claims 33-47, 49, 51, and 53-70.
Wiebensjo et al teaches a method of treating hair loss using an injectable hyaluronic acid composition via administering it into the skin of a patient (paras 0017, 0076-0079; method and active agent as in claims 30, 48, 50, 52, and limitation of claims 49, 51 and 53). The HA may be crosslinked using divinyl sulfone as the crosslinking agent (para 0020; as in claims 33 and 69; para 0024 as in claim 70). Due to its significant liquid content, crosslinked HA is structurally flexible and similar to natural tissue (para 0027). In view of this teaching, the artisan would adjust the density of crosslinking as in claim 33 for the purpose of optimization. Wiebensjo also suggest other crosslinking agents (para 0024). In view of this the applicant will find it obvious to use the other crosslinking agents recited in claim 70 to look for alternative crosslinking agents for adjusting the crosslinking density. According to Wiebensjo the HA can be obtained from various sources of animal and non-animal origin and has a molecular weight in the range of 0.1-10MDa (para 0022). This is a suggestion to use HA having molecular weights in this range, which includes the molecular weight range as in claims 34-35 in the composition of Hideo, use the teachings of Wiebensjo regarding injecting into the skin, and use crosslinked HA and the molecular weight of HA in the composition of Hideo.
Towne et al teaches the use of microneedles contained in an array of rollers (aka Dermaroller) for delivering agents below the skin (as in claim 30). The needles are 500 micrometers in height. This means it will inject an agent to about 500 microns below the skin. The use of the roller typically results in a perforation density of 240 perforations/cm2 (paras 0241-0242; microneedle as in claim 45). In view of this teaching, one of ordinary skill in the art would use the microneedle technique for delivering the HA composition of Hideo into the dermal layer of the skin as in claim 30 and 45, and adjust the needle length for insertion as in claims 30, 60, 64 and 68, the number of injections and depth of the needles into the skin in order to administer a plurality of injections in the range recited in claim 40 for the purpose of optimization. Towne teaches a method of laser ablation and radiofrequency thermal ablation to enhance penetration of injected medication into the skin layers (para 0241; limitations of claims 43-44). The artisan will find it obvious to use this technique in the method of Hideo to ensure that the HA composition administered via microneedles penetrates the skin.
Allenfall teaches a method of administering a composition for hair growth to a patient comprising administering a composition comprising HA and a CD44 binding ligand. The ligand can be osteopontin (abstract; paras 0007, 0023-0026; the ligand as in claims 46-47, 54, 57, 61, and 65). Even though Allenfall teaches the use of HA as an excipient, one of ordinary skill in the art would administer a combination of HA and osteopontin in the claimed method of hair growth since HA is also a hair growth stimulant as taught by Hideo and Wiebensjo. Since HA in the claimed concentration is taught for stimulating hair growth and administration via injection is also known in the art, it should bind to a CD44 receptor of the hair follicle without causing an inflammatory response in the skin as in claim 30.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to administer a composition comprising HA for stimulating hair growth and via injection as claimed since HA in the claimed concentration range is known in the art for stimulating hair growth via injection into the skin. The artisan would also adjust the frequency of administration as in claims 36-39 for the purpose of optimization. The artisan will find it obvious to apply iontophoresis and electroporation t the skin in order to make sure the HA composition goes through the skin and bind to the receptor of the hair follicle where it is needed (as in claims 41-42). It would be obvious to provide the HA composition in the form of microemulsion or nanoemulsion as in claims 55-56, 58-59, 62-63 and 66-67 as alternative forms for injection. Hideo teaches the use of low molecular weight HA in the claimed concentration for stimulation of hair growth. Wiebensjo teaches injection of HA composition wherein molecular weight of HA is in the range recited in claims 34-35. Therefore it would be obvious to the artisan to substitute the HA having the molecular weight range taught by Wiebnsjo (as in claims 34-35) in the composition of Hideo and use the same concentration range taught by Hideo and administer it via injection using the technique of Towne to a patient in need of hair growth stimulation as claimed.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, hyaluronic acid is known to be used for stimulating hair growth. Thus, it is obvious to combine prior art elements and improve the method of the prior art to yield predictable results by administering the HA composition via injection in the claimed amounts to a subject in need of hair growth.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
Method improvement is the motivation. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
Response to Applicant’s Arguments
The art rejection under 35 USC 103 as above is made of record in view of the amendments and applicant’s remarks.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 30-70 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,337,993 (‘993) in view of Hideo et al (JP 2015040173 A; Machine English Translation, pages 1-17; newly cited; cited in IDS filed 1/23/2026) and further in view of Wiebensjo et al (US 2019/0000740 A1; of record), Towne et al (US 2017/0182191 A1; of record) and Allenfall et al (US 2016/0317620 A1; of record). Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Independent Claim 30 is drawn to a method of stimulating hair growth in a skin of the patient in need thereof, comprising administering a sufficient concentration of hyaluronic acid up to about 0.08 wt%, wherein the composition is injected between about 400 microns to about 2mm deep into the skin and in the vicinity of a hair follicle. Independent claim 48 is drawn to the same method wherein the concentration of HA is between 0.001wt% to 0.04 wt%. Independent claim 50 is drawn to the same method wherein the concentration of HA is about 0.04 wt% to about 0.06 wt%. Independent claim 52 is drawn to the same method wherein the concentration of HA is about 0.06 wt% to about 0.08 wt%. Dependent claims 31-47, 49, 51, 53-70 recite limitations drawn to percent of the hyaluronic acid in the composition, crosslinked density of the hyaluronic acid, molecular weight of the hyaluronic acid, frequency of administration, plurality of injections and the number of injections per cm2 of skin, further application of iontophoresis, electroporation, laser ablation and radiofrequency thermal ablation, applying a microneedle device, osteopontin as the CD44 binding agent, injecting the composition on the dermal layer of the skin, further components, depth of the injection and the composition as nanoemulsion and microemulsion, droplet size and crosslinking agents.
Independent Claim 1 of ‘993 is drawn to a method of stimulating hair growth in a skin of a patient by administering a composition of hyaluronic acid (HA) to the skin wherein the concentration of hyaluronic acid is about 1mcg/mL to about 250mcg/mL. Dependent claims 3-17 recite limitations drawn to the molecular weight range of the HA, crosslinked density of HA, concentration range for the HA, injection into the dermal layer of the skin, injection depth into the skin, plurality of injections in a surface area range of the skin, using iontophoresis, electroporation and laser ablation and radiofrequency thermal ablation techniques and using a microneedle device, and the composition further containing a CD-44 ligand which is osteopontin. Independent claim 18 is drawn to a method of administering a composition for hair growth in a patient via injection of a composition of HA wherein the concentration of hyaluronic acid is about 1mcg/mL to about 250mcg/mL. Dependent claims 19-29 recite limitations drawn to the molecular weight range of the HA, crosslinked density of HA, concentration range for the HA, injection into the dermal layer of the skin, injection depth into the skin, plurality of injections in a surface area range of the skin, using a microneedle device, and the composition further containing a CD-44 ligand which is osteopontin.
The claims of ‘993 differ from the instant claims in that instant independent claims are drawn to a concentration of HA to be administered of up to 0.08 wt%, whereas ‘993 recites a concentration range of about 1mcg/mL to about 250mcg/mL, which converts to 0.0001wt% to about 0.025 wt %.
The teachings of the secondary references are set forth above.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention that the concentration taught in the prior art could be modified and employed in the methods recited in claims 30, 48, 50 and 52.
In the instant case ‘993 teaches performing each of the steps and the active agent used in the method applicant claims. Although the claims of ' 993 employ a narrow lower concentration range of HA, one of ordinary skill in the art would readily recognize that the scheme taught by '993 could be modified with regard to concentration and employed in the claimed method with a reasonable expectation of success. The use of known active agents in methods of treatment taught in the prior art is not seen to render the instantly claimed method unobvious over the art. Once the method has been shown to be old, the burden is on the applicant to present reason or authority for believing that the use of a higher concentration range would affect the operability of the claimed method.
Response to Applicant’s Remarks
Regarding the double patenting rejection of record applicant has requested that they will consider filing a terminal disclaimer upon indication that the claims are in a condition for allowance.
The filing of a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s/patents claims is necessary. Since neither has been made of record the rejection is being maintained.
Conclusion
1. Pending claims 30-70 are rejected.
2. Claims 1-29 have been canceled.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693