DETAILED ACTION
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 .
Response to Amendment
This office action is responsive to the amendment filed on 10/14/25. As directed by the amendment: claim 11 and 26 have been amended. Claims 1-10 have been previously cancelled. Claims 14-21 were previously withdrawn and claims 23-25, 29 and 30 have been cancelled.
Thus, claims 11-13, 22, 26-28, 31-36 are still pending in this application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 11-13, 22, 26-28 and 31-36 are rejected under 35 U.S.C. 103 as being unpatentable over Barman et al (US 20140079686 A1) in view of Barrows (US 20120276188 A1) in view of Levi et al (US 20130209528 A1) and further in view of Lowry et al (US 20200157093 A1).
Regarding claim 11, Barman et al disclose a microneedle (para 0255 and 0435), comprising a composition (para 0437- drug formulation into microneedle) comprising:
(a) hydrophilic polymer network (para 0402 and 0546);
(b) a natural product (para 0408- liposome is a natural product); and
(c) a small molecule hair growth agent (para 0121 and 0123).
Barman et al fail to disclose the hydrophilic polymer network comprises a keratin hydrogel wherein the keratin hydrogel is crosslinked via intermolecular disulfide bonds.
However, Barrows discloses a composition for hair growth (para 0011, 0046 and abstract) wherein the hydrophilic polymer network comprises a keratin hydrogel wherein the keratin hydrogel is crosslinked via intermolecular disulfide bonds (para 0002, 0008, 0024, 0043 and claim 12).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Barman et al and incorporate the teachings of Barrows to have said polymer comprising a keratin hydrogel because Keratin is used to provide a firm, flexible and useful composition (see abstract) and it is known to be hair treatment that can make hair smooth and shiny.
Barrows fails to disclose wherein the keratin hydrogel is a hydrogel prepared from an aqueous solution comprising between about 5 weight % (wt%) and about 20 wt% keratin and between about 0.1 wt% and about 1 wt% cysteine.
However, Barrows discloses the hydrogels may be prepared in a variety of shapes and sizes (para 0042 and 0053) and the hydrogel comprises at least about 40% w/w water (claim 10).
It appears that the composition of Barrows would operate equally well with the claimed range. Further, applicant has not disclosed that the range claimed solves any stated problem or is for any particular purpose, indicating simply that the keratin hydrogel is a hydrogel prepared from an aqueous solution comprising between about 5 weight % (wt%) and about 20 wt% keratin and between about 0.1 wt% and about 1 wt% cysteine (specification page 4, lines 18-24).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the disclosure of Barrows to have keratin hydrogel prepared from an aqueous solution comprising between about 5 weight % (wt%) and about 20 wt% keratin and between about 0.1 wt% and about 1 wt% cysteine because it appears to be an arbitrary consideration which fails to patentably distinguish over Barrows.
Barman et al fail to disclose the natural product comprises exosomes but teach the administration of a pharmaceutical composition comprising one or more hair growth-promoting agents may be combined with one or more additional treatments with an active ingredient such as nanoparticles (para 0388 and 0408).
However, Levi et al teach the use of pharmaceutical composition to promote or enhance wound healing or hair growth using exosome (see abstract and para 0015 and 0047).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Barman et al and incorporate the teachings of Levi et al to make said composition comprises exosome as exosomes derived from and secreted by stem cells such as mesenchymal stem cells are capable of promoting or enhancing hair growth and may be used in the preparation of dosage forms to promote hair growth, as desired by the user (see para 0041 and 0047).
Barman et al fail to teach said small molecule hair growth agent is 2-cyano-3-(1- phenyl-1 H-indol-3-yl)-2-propenoic acid (UK5099) but disclose hair growth-promoting agents for use, alone or in combination, in accordance with this aspect include but are not limited to: agents affecting prostaglandins, such as Prostaglandin F2.alpha. analogs, e.g. latanoprost (trade name Xalatan), travoprost (trade name Travatan), tafluprost, etc (see para 0121).
However, Lowry et al disclose methods of promoting hair growth or treating conditions or disorders affecting hair growth (abstract) comprises administrating a composition (see para 0046) wherein the small molecule hair growth agent comprises UK5099 (para 0053, 0146 and 0150).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Barman et al in and incorporate the teachings of Lowry et al to have the small molecule hair growth agent to be UK5099. UK-5099 is a well-established pharmacological inhibitor of the mitochondrial pyruvate carrier and is known to promote lactate production to stimulate hair growth (para 0146).
Regarding claim 12, Barman et al in view of Barrows and Levi et al and Lowry et al disclose a microneedle array comprising a plurality of microneedles of claim 11 (para 0259).
Regarding claim 13, Barman et al in view of Barrows and Levi et al and Lowry et al disclose a skin patch comprising the microneedle array of claim 12, wherein said patch comprises a protective backing layer, a removable backing layer or a backing layer comprising a skin compatible adhesive (para 0314 and 0408, dermal patch is an example of skin patch).
Regarding claim 22, Barman et al in view of Barrows and Levi et al and Lowry et al disclose the microneedle array of claim 11,
Levi et al further disclose wherein the natural product comprises mesenchymal stem cell (MSC)-derived exosomes (para 0041).
Regarding claim 26, Barman et al in view of Barrows and Levi et al and Lowry et al disclose the limitations of claims 11 but fail to expressly disclose wherein the keratin hydrogel is a hydrogel prepared from an aqueous solution comprising about 8 weight % keratin and/or about 0.4 wt% cysteine.
However, Barrows discloses the hydrogels may be prepared in a variety of shapes and sizes (para 0042 and 0053) and the hydrogel comprises at least about 40% w/w water (claim 10).
It appears that the composition of Barrows would operate equally well with the claimed range. Further, applicant has not disclosed that the range claimed solves any stated problem or is for any particular purpose, indicating simply that the keratin hydrogel is a hydrogel prepared from an aqueous solution comprising between about 8 weight % keratin and/or about 0.4 wt% cysteine (specification page 4, lines 18-24).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the composition of Barrows to have keratin hydrogel prepared from an aqueous solution comprising about 8 weight % keratin and/or about 0.4 wt% cysteine because it appears to be an arbitrary consideration which fails to patentably distinguish over Barrows.
Regarding claim 27, Barman et al in view of Barrows and Levi et al and Lowry et al disclose the microneedle of claim 11, wherein the hydrophilic polymer network comprises: (i) a crosslinked hydrophilic polymer wherein the crosslinked hydrophilic polymer is other than keratin; and (ii) keratin or a derivative thereof (para 0402 and 0425).
Regarding claim 28, Barman et al in view of Barrows and Levi et al and Lowry et al disclose the microneedle of claim 27, wherein the crosslinked hydrophilic polymer is selected from the group consisting of methacrylated hyaluronic acid (m- HA) or another glucosaminoglycan or copolymer or derivative thereof; polyvinyl alcohol (PVA) or a copolymer or derivative thereof; a polysaccharide; a poly(amino acid), a protein other than keratin; polyvinyl pyrrolidone (PVP); a poly(alkylene glycol) or a poly(alkylene oxide); poly(hydroxyalkyl methacrylamide), a polyhydroxy acid; combinations thereof, and copolymers thereof (para 0402).
Regarding claim 31, Barman et al in view of Barrows and Levi et al and Lowry et al disclose the microneedle of claim 11, wherein the small molecule hair growth agent is encapsulated in a nanoparticle comprising a biodegradable polymer (para 0295, 0408 and 0479).
Regarding claim 32, Barman et al in view of Barrows and Levi et al and Lowry et al disclose the microneedle of claim 31, wherein the biodegradable polymer is polylactic-co-glycolic acid (PLGA) (para 0479, 0529 and 1094).
Regarding claim 33, Barman et al in view of Barrows and Levi et al and Lowry et al disclose the limitations of claim 11 but fail to explicitly disclose the composition comprises between about 0.01 milligrams (mg) and about 2 mg exosomes.
However, Levi et al disclose a composition (abstract- exosome) to promote hair growth wherein the composition comprises between about between 0.0001mg to 100g exosomes (para 0253).
Levi et al do not explicitly disclose the composition comprises between about 0.01 milligrams (mg) and about 2 mg exosomes.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Levi et al from between 0.0001mg and 100g to between 0.01mg to 2mg as applicant appears to have placed no criticality on the claimed range (see spec, page 5, lines 12-13) indicating the composition “may” be within the claimed range) and since it has been held 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”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 34, Barman et al in view of Barrows and Levi et al and Lowry et al disclose the limitations of claim 11 but fail to explicitly teach the microneedle of claim 11, wherein the composition comprises between about 0.05 micrograms (pg) and about 1 mg of the small molecule hair growth agent.
However, Barman et al disclose amount of hair growth-promoting agent is administered such that the target concentration of hair growth-promoting agent in the skin is 0.1 nM to 1 nM, 1 nM, etc.…(para 0372) and in para 1036- 0.500 grams of Minoxidil in 20ml vial.
Barman et al disclose in (para 0372) that the target concentration of hair growth-promoting agent is Nm(nanomole). Depending on the hair growth agent used in said composition, one could calculate the molecular weight of the hair growth agent which is used to calculate its mass.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the composition of Barman et al by making the composition comprises between about 0.05 micrograms (pg) and about 1 mg of the small molecule hair growth agent as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 35, Barman et al in view of Barrows and Levi et al and Lowry et al disclose the limitations of claims 11 and 12 but fail to explicitly disclose wherein each of said plurality of microneedles has a length of between about 400 and about 1000 micrometers.
However, Barman et al disclose in para 0259 that the microneedle array can disrupt skin at a depth of 100 microns to 4000 microns.
It appears that the microneedle array of Barman et al would operate equally well with the claimed range. Further, applicant has not disclosed that the range claimed solves any stated problem or is for any particular purpose, indicating simply that the plurality of microneedles has a length of between about 400 and about 1000 micrometers.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the microneedle length of Barman et al to have plurality of microneedles has a length of between about 400 and about 1000 micrometers because it appears to be an arbitrary consideration which fails to patentably distinguish over Barman et al.
Regarding claim 36, Barman et al in view of Barrows and Levi et al and Lowry et al disclose the limitations of claims 11, 12 and 35 but fail to explicitly disclose wherein each of said plurality of microneedles has a length of about 600 micrometers and/or a base diameter of about 300 micrometers.
However, Barman et al disclose in para 0259 that the microneedle array can disrupt skin at a depth of 100 microns to 4000 microns.
It appears that the microneedle array of Barman et al would operate equally well with the claimed length. Further, applicant has not disclosed that the length claimed solves any stated problem or is for any particular purpose, indicating simply that the plurality of microneedles has a length of about 600 micrometers and/or a base diameter of about 300 micrometers.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the microneedle of Barman et al to have plurality of microneedles has a length of about 600 micrometers and/or a base diameter of about 300 micrometers because it appears to be an arbitrary consideration which fails to patentably distinguish over Barman et al.
Response to Arguments
Applicant's arguments filed 10/14/25 have been fully considered but they are not persuasive.
In response to applicant's argument that “Thus, the keratin hydrogel being a hydrogel prepared from an aqueous solution comprising between about 5 weight-% (wt%) and about 20 wt% keratin and between about 0.1 wt% and about 1 wt% cysteine is not an arbitrary consideration as asserted by the Patent Office”, examiner respectfully disagree because Barrows discloses the keratin hydrogel and the preparation of the keratin hydrogel is considered to be an arbitrary consideration as the phrase "wherein the keratin hydrogel is a hydrogel prepared from an aqueous solution comprising between 5 to 20% keratin and 0.1 to 1% cysteine” are product by process limitations.
In response to applicant's argument that “none of these references particularly teach or suggest every element of claim 11”, it is noted that the features upon which applicant relies (i.e., it can be demonstrated that keratin can facilitate cell proliferation by comparing the cell viabilities between the empty HMN and PBS control, as well as between UK5099 or the exosomes-loaded HMN patch and the corresponding pure cargoes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/FATIMATA SAHRA DIOP/ /BHISMA MEHTA/Examiner, Art Unit 3783 Supervisory Patent Examiner, Art Unit 3783