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 .
This office action is in response to the reply filed 7/14/2025.
Election/Restriction
During a telephone conversation with James Masters on 12/5/2023 a provisional election was made with traverse to prosecute the invention of Group I, claims 14-23 and 26-27. Affirmation of this election must be made by applicant in replying to this Office action. Claims 24-25 and 28-29 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Applicant’s affirmed the restriction in the reply filed 4/5/2024.
Response to Arguments
All of applicant’s arguments filed 7/14/2025 have been fully considered. In view of the amendment to claim 31, the 112(b) rejection over said claim is withdrawn.
On page 5-7, Applicant argues that JP’334 does not teach the mangosteen extract itself to have a hair growth promoting activity and therefore does not teach a method in which a hydroalcoholic extract of Garcinia mangostana is used as a hair regrowth active agent.
This is not persuasive. While JP’334 does not teach the extract to have hair growth promoting activity, JP’334 does teach a method of promoting hair growth wherein the composition comprises the claimed extract among other ingredients. While the claimed extract is not taught to be responsible for the hair growth activity, the extract is taught to be used in the claimed amounts and its well established that a compound and its properties are inseparable, as such the extract inherently has hair growth properties. It is also noted that the rejection is based on a combination of references and this combination make obvious the administration to an AA patient to promote hair regrowth the composition of JP’536 mongosteen extract, comprising isogarcinol, in the claimed amounts which are said by the claims to be effective to inhibit the JAK-STAT signaling pathway and effectively promote hair growth.
On pages 7-8, Applicant argues that Isogarcinol is an immunosuppressant, but not a Jak inhibitor. Applicant remarks that a skilled artisan reading the teachings of Chen would concluded that isogarcinol has an immunosuppressive effect.
This is not persuasive as Chen was only cited to show that isogarcinol can be effectively obtained by extracting the pericarp of mongostana with ethanol and this can be used to treat various conditions. Wang teaches isogarcinol to inhibit the jak-state signaling pathway.
Applicant argues that Wang does not teach isogarcinol directly inhibits the JAK/STAT pathway, Wang acknowledges that the effect of isogarcinol could be indirect. Applicant argues this distinction is important as Harel teaches the effect of jak-stat inhibitors on hair growth is not related to the immunosuppressive activity of Jak inhibitors. Particularly the T lymphocytes, and concludes that the effect of JAK/STAT inhibitors on hair growth is likely an intrinsic property of hair cells as such there is no motivation to combine the references.
This is not persuasive. Whether the isogarcinol acts on the Jak-STAT pathway directly or indirectly is irrelevant as Wang specially teaches isogarcinol to inhibit said pathway (pg. 9016, col. 1-2), so regardless of it being direct or indirect, the pathway is expected to be inhibited when using isogarcinol. While Wang and Harel teach different mechanisms of action and Harel teaches that inhibition is independent of the activity of lymphocytes, Harel nonetheless teaches that inhibition of JAK-STAT via topical treatment promotes rapid hair regrowth, as such, topical administration of isogarcinol taught by the prior art to inhibit the JAK-STAT pathway, would be reasonably expected to also promote hair regrowth.
Applicant argues that JP’365 discloses an extract of mangosteen that acts as a testosterone reducatase inhibitor, but does not teach administration of a hair regrowth agent. JP’536 is directed to reduction of hair loss and not hair regrowth.
This is not persuasive as JP’365 teaches the composition to have a hair growth effect (pg. 3 and table 2) thus it would have been obvious to administered the composition to a subject in need of promoting hair growth.
Applicant argues that the references do not teach amounts effective to inhibit the JAK-STAT signaling pathway.
This is not persuasive for the reasons already discussed above. The prior art teaches mangosteen extract containing isogarcinol to be effective at promoting hair growth and the prior art teaches the composition to comprise the amounts of extract as required by the instant claims and its well established that a compound and its properties are inseparable.
Maintained 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.
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.
Claim(s) 18, 20, 26-27 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2016-69334, Wang (JAFC, 2016), Cen (PLOS One, 2013), Chen (JAFC, 2017), Harel (Sci. Adv, 2015) and Kobayashi (US 2008/0044453).
The Examiner is relying on the by machine translation of JP’334 provided by the Examiner.
Regarding claims 18 and 27: JP’334 discloses a hair growth cosmetic material (reading on non-therapeutic) comprising mangosteen extract (i.e. garcinia mangosta extract) (Abs). JP’334 teaches the mongosteen extract to be used in amounts 0.0001-2% (pg. 3) in terms of solids (i.e. dry weight). JP’337 teaches the extract to be obtained using extraction solvents, preferably water, ethanol, butylene glycol and propylene glycol (pg. 2-3). The solvents can be used alone or in combination of two or more. Thus the use of water plus ethanol is prima facie obvious which reads on hydroalcoholic extract. As JP’334 teaches a hydroalcoholic extract being used in the claimed amounts, this reads on “hair regrowth active agent is a hydroalcoholic extract of Garcinia Mongostana” as a compounds and it’s properties are inseparable.
JP’334 teaches the cosmetic to be applied to the scalp of the subject (pg. 2) and teaches the cosmetic to be a hair growth agent, therefore, it would have been prima facie obvious to administer effective amounts of the cosmetic to a subject in need to promoting hair growth with a reasonable expectation of success.
Regarding claim 26: JP’334 teaches that the cosmetic can take various forms, such as lotions, gels, cream in addition to solution form (pg. 4), reading on cosmetically acceptable excipient.
Regarding claims 18 and 31: JP’334 teaches the Mangosteen extract to be obtained using extraction solvents, preferably water, ethanol, butylene glycol and propylene glycol (pg. 2-3). The solvents can be used alone or in combination of two or more. Thus the use of water plus ethanol is prima facie obvious which reads on hydroalcoholic extract. JP’334 teaches extracting Mangosteen with 200ml of 50% ethanol, thus it would have been obvious to use 50% water and 50% ethanol (equivalent to approx. 1:1 ratio (v/v)%) with a reasonable expectation of success as combinations of solvent can be used.
Claim 31 is a product-by-process claim as it defines how the hydroalcoholic extract is made. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps and “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Furthermore, “because validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed.Cir. 2009). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id at1370 (“a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim.”).
Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802,218 USPQ 289, 292 (Fed. Cir. 1983). (“a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim.”) see Amgen Inc. v. F. Hoffman-La Roche Ltd., 580F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009) at 1370).
“When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”
In the present case, the claimed product is found to be substantially the same as the product of the prior art which makes obvious a hydroalcoholic extract using water and ethanol.
However, JP’334 does not teach applying the extract in amounts effective to inhibit the JAK-STAT signaling pathway.
Wang teaches that isogarcinol is a new natural immunosuppressant extracted from Garcinia Mongostana (Abs) and teaches that there is a long history of using the fruit, especially it’s pericarp, to treat various conditions including skin and wound infections (pg. 9012, col. 1). Wang teaches that isogarcinol reduces numbers of Th1 and Th17 by inhibiting the JAK-STAT signaling pathway, it significantly reduces the production of both the Th1-related proinflammatory cytokines IFN-Υ and the TH17-related cytokine IL-17A (pg. 9016, col. 2).
Cen discusses the immunosuppressive properties of isogarcinol and teaches the use of garcinia mongostana pericarp (peel, rind and hull) as traditional medicine to treat various conditions (Abs and pg.1, col. 1). Cen teaches that isogarcinol is obtained when extracting with 75% ethanol (pg. 2, col. 1).
Chen teaches that isogarconol can be extracted from pericarp of the Garcinia Mongostana (pg. 847, col. 1).
Harel teaches that topical treatment of small-molecular inhibitors of the JAK-STAT pathway results in rapid onset of anagen and subsequent hair growth (Abs). Harel teaches that several hair growth disorders are characterized by the inability to reenter the growth phase of the hair cycle (anagen) due to hair follicle(HF) miniaturization in the case of androgenetic alopecia or immune dysfunction in the case of alopecia areata (AA). It was demonstrated that pharmacological inhibition of the Janus kinase (JAK)–signal transducer and activator of transcription (STAT) pathway promotes rapid hair regrowth in AA in both mice and humans. It was observed that topical treatment with JAK-STAT inhibitors resulted in an unusually robust hair growth, suggesting a localized effect on initiation of the hair cycle (pg. 1, col. 1).
Kobayashi teaches AA to be a Th1 cytokine-dependent autoimmune disease (Kobayashi – claim 26).
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 modify the teachings of JP’334 with those of Wang, Chen, Cen, Harel and Kobayashi. A skilled artisan would have recognized that the mangosteen extract of JP’334 could be effectively obtained by extracting mangosteen pericarp to obtain a hydroalcoholic extract comprising isogarcinol as Cen and Chen teach that isogarcinol is obtained from the pericarp and ethanol can be used as an extraction solvent. A skilled artisan would also recognize that this extract comprising isogarcinol could be effectively used to promote hair regrowth in AA patients, as such it would have been prima facie obvious to administer to an AA patient the mongosteen extract comprising isogarcinol made obvious above, in amounts effective to inhibit the JAK-STAT signaling pathway and effectively promote hair growth as Harel, Kobayashi and Wang teach that AA is a Th1 cytokine-dependent autoimmune disease which can be treated by inhibiting the JAK-STAT signaling pathway and isogarcinol is taught to be effective at inhibiting the inhibit the JAK-STAT signaling pathway and reduces the production of Th1-related proinflammatory cytokines.
Claim(s) 18, 20, 26-27 and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP H05-17365, JP 2016-69334, Wang (JAFC, 2016), Cen (PLOS One, 2013), Chen (JAFC, 2017), Harel (Sci. Adv, 2015) and Kobayashi (US 2008/0044453).
The Examiner is replying on a machine translation of JP’334 provided by the Examiner.
JP’365 teaches a composition which suppresses the overproduction of dihydrotestosterone, which causes androgenetic alopecia, acne and prostatic hypertropy. The composition comprises a 5α-reductase inhibitor containing an extract from the plant as an active ingredient. Suitable plant extracts include mangosteen (i.e. garcinia mangostana) (Abs and pg. 2).
Table 2 of JP’365 teaches the extract of mongosteen to be effective at increasing hair growth.
JP’365 teaches the cosmetic to be applied to a subject to treat and/or prevent androgenetic alopecia and teaches the mongosteen extract to be effective at promoting hair growth agents, therefore, it would have been prima facie obvious to administer the composition comprising mangosteen extract in effective amounts to a subject in need of preventing/treating alopecia by promoting hair growth with a reasonable expectation of success.
Example 2 of JP’365 teaches extracting mangosteen peel (reading on pericarp extract of instant claim 20, as evidenced Cen) with methanol. While this example uses an alcoholic extraction solvent, as discussed above, JP’365 teaches that hydroalcoholic extracts can be used effectively, thus it would be obvious to do so with a reasonable expectation of success.
Example 3 of JP’365 teaches the preparation of a cream comprising 0.1 g of the extract of example 2, cetanol, PEG 4000 and water to obtain 10g of cream (reading on dermatological excipient of instant claim 26), wherein the extract is the sole ingredient to promote hair growth, reading on instant claim 30.
Regarding claim 27: The cream comprises 0.1g of lyophilized extract (i.e. dry weight), thus the extract is present in amounts of 1%, by weight of dry extract relative to the total weight of the composition.
JP’365 teaches that each extract is a product extracted using either water, a hydrophilic organic solvent or a mixed liquid of water and a hydrophilic organic solvent such as methanol, ethanol, propanol, acetone, etc. Thus the use of water plus ethanol is prima facie obvious which reads on hydroalcoholic extract of instant claims 18.
Claim 31 is a product-by-process claim as it defines how the hydroalcoholic extract is made. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps and “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Furthermore, “because validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed.Cir. 2009). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id at1370 (“a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim.”).
Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802,218 USPQ 289, 292 (Fed. Cir. 1983). (“a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim.”) see Amgen Inc. v. F. Hoffman-La Roche Ltd., 580F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009) at 1370).
“When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”
In the present case, the claimed product is found to be substantially the same as the product of the prior art which makes obvious a hydroalcoholic extract using water and ethanol.
JP’365 fails to teach the method to be a non-therapeutic method of promoting hair growth.
JP’334 discloses a hair growth cosmetic material (reading on non-therapeutic) comprising mangosteen extract (i.e. garcinia mangosta extract) (Abs).
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 modify the teachings of JP’365 with those of JP’334. One of skill in the art would have recognized that its known in the art to use mangosteen extract in both therapeutic and non-therapeutic methods (i.e. cosmetics) for promoting hair growth, therefore, it would have been prima faice obvious to use the composition of JP’334 as a cosmetic in a non-therapeutic method to promote hair growth with a reasonable expectation of success.
However, the above references do not teach applying the extract in amounts effective to inhibit the JAK-STAT signaling pathway.
Wang teaches that isogarcinol is a new natural immunosuppressant extracted from Garcinia Mongostana (Abs) and teaches that there is a long history of using the fruit, especially it’s pericarp, to treat various conditions including skin and wound infections (pg. 9012, col. 1). Wang teaches that isogarcinol reduces numbers of Th1 and Th17 by inhibiting the JAK-STAT signaling pathway, it significantly reduces the production of both the Th1-related proinflammatory cytokines IFN-Υ and the TH17-related cytokine IL-17A (pg. 9016, col. 2).
Cen discusses the immunosuppressive properties of isogarcinol and teaches the use of garcinia mongostana pericarp (peel, rind and hull) as traditional medicine to treat various conditions (Abs and pg.1, col. 1). Cen teaches that isogarcinol is obtained when extracting with 75% ethanol (pg. 2, col. 1).
Chen teaches that isogarconol can be extracted from pericarp of the Garcinia Mongostana (pg. 847, col. 1).
Harel teaches that topical treatment if small-molecular inhibitors of the JAK-STAT pathway results in rapid onset of anagen and subsequent hair growth (Abs). Harel teaches that several hair growth disorders are characterized by the inability to reenter the growth phase of the hair cycle (anagen) due to hair follicle(HF) miniaturization in the case of androgenetic alopecia or immune dysfunction in the case of alopecia areata (AA). It was demonstrated that pharmacological inhibition of the Janus kinase (JAK)–signal transducer and activator of transcription (STAT) pathway promotes rapid hair regrowth in AA in both mice and humans. It was observed that topical treatment with JAK-STAT inhibitors resulted in an unusually robust hair growth, suggesting a localized effect on initiation of the hair cycle (pg. 1, col. 1).
Kobayashi teaches AA to be a Th1 cytokine-dependent autoimmune disease (Kobayashi – claim 26).
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 modify the teachings of the above references with those of Wang, Chen, Cen, Harel and Kobayashi. A skilled artisan woujld have recognized that the mangosteen extract of JP’334 could be effectively obtained by extracting mangosteen pericarp to obtain a hydroalcoholic extract comprising isogarcinol as Cen and Chen teach that isogarcinol is obtained from the pericarp and ethanol can be used as an extraction solvent. A skilled artisan would also recognize that this extract comprising isogarcinol could be effectively used to promote hair regrowth in AA patients, as such it would have been prima facie obvious to administer to an AA patient the mongosteen extract comprising isogarcinol made obvious above, in amounts effective to inhibit the JAK-STAT signaling pathway and effectively promote hair growth as Harel, Kobayashi and Wang teach that AA is a Th1 cytokine-dependent autoimmune disease which can be treated by inhibiting the JAK-STAT signaling pathway and isogarcinol is taught to be effective at inhibiting the inhibit the JAK-STAT signaling pathway and reduces the production of Th1-related proinflammatory cytokines.
Conclusion
No claims are allowable.
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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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613