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 .
Claim Status
Applicant’s submission filed 12/12/2025 has been received and entered. Claims 1-20 have been cancelled. Claims 21-26 have been new added. Accordingly, claims 21-26 are pending and under current examination.
Declaration under 37 CFR 1.132
The declaration submitted on 12/12/2025 by Dr. Amit Patel has been considered. Dr. Patel
states his study regarding using platelet rich plasma (PRP), bone marrow derived mesenchymal stem cells (BMC) and low-level laser irradiation (LLLT) for the treatment of androgenetic alopecia (Appendix A), a significant improvement in hair density is found in BMC+PRP+LLLT group. Meanwhile, the VEFG secretion and FoxP3+ T regulatory cells are also increased in BMC+PRP+LLLT group.
The declared study is presented as evidence for “unexpected results” (see Remarks, p6-7), which states that the effects including increasing hair density (figure 1), VEGF secretion (figure 2), FoxP3+ T regulatory cells (figure 3) in BMC + PRP + LLLT group is more than the merely additive of the effect of BMC group and PRP group. For instance, BMC + PRP + LLLT group had about a 72% improvement in hair density from baseline, while PRP group showed about a 26% percent improvement and BMC group showed about a 31% improvement, therefore BMC + PRP + LLLT group (72%) had more than the additive of the effect of BMC group and PRP group (57%). However, the argument is not persuasive since the comparation lacks the data from LLLT group as a control to show whether the BMC + PRP + LLLT group has an effect greatly increased than the additive of BMC group, PRP group and LLLT group. In addition, prior arts Gentile et al. teach PRP treatment may increase hair density by 39.7% (see p8, Table 1, Gupta et al.), Ibrahim et al. (as presented in new grounds of rejection) teach BMMC treatment increase hair density by ~ 28% (see p23, Table 4), and Avci et al. teach LLLT can stimulate hair growth, which is possible to increase the hair density for ~17% (see i.e., p149, left column). Therefore it is not considered as “unexpected” for achieving 72% in BMC + PRP + LLLT group.
Furthermore, Applicant argues that declared study is unexpected in light of the teaching of Gentile, which refers using adipose tissue as an alternative source of stem cells. Applicant first argues that Gentile teaches away the using of the bone marrow derived stem cells (see Remarks, p5), then argues Dr. Patel’s study of using bone marrow derived stem cells is unexpected (see Remarks, p7).
Applicant’s arguments have been fully considered but they are not persuasive. Regarding the argument about “teach away”, MPEP 2123 states: “[D]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)”. In instant case, Gentile et al. clearly teach that adipose tissue derived stem cell is an “alternative” of bone marrow derived stem cell (p19), through the bone marrow derived stem cells are not preferred to use because the amount is not as much as adipose tissue derived stem cells. While referring “AD-MSCs and stromal vascular fraction cells (SVFs) are essential for the activation of the scalp’s ESCs”, it is NOT excluding the effect of bone marrow derived stem cells on androgenic alopecia through the pathway of “activation of the scalp’s ESCs” or other pathways. Indeed, as stated in the new grounds of rejection, using bone marrow for the treatment of androgenic alopecia is evidenced by Ibrahim et al. (J Dermatolog Treat. 2018 Aug;29(5):431-440.). Therefore Gentile et al. do not teach away the using of bone marrow derived stem cells, and the declared study is not considered “unexpected” from the teaching of Gentile et al. evidenced by Ibrahim et al..
Status of Prior Rejection/Response to Arguments
The rejection to claims 4-7 and 13 under 35 U.S.C. 112(b) is withdrawn:
The cancellation of claims 4-7 and 13 renders the rejection thereto moot. The rejection is withdrawn.
The rejection to claims 1-20 under 35 U.S.C. 112(a) is withdrawn:
The cancellation of claims 1-20 renders the rejection thereto moot. The rejection is withdrawn.
The rejection to claims 1, 3, 5, 9, 12, 16 and 17 under 35 U.S.C. 103 as being unpatentable over Gentile et al., as evidenced by Braun et al. and Bater et al., in view of Schafer et al. is withdrawn:
The rejection to claims 1-3, 5, 9, 12, 16 and 17 under 35 U.S.C. 103 as being unpatentable over Gentile et al., as evidenced by Braun et al. and Bater et al., in view of Schafer et al., further in view of Avci et al. is withdrawn:
The rejection to claims 1, 3-5, 9, 12, 16 and 17 under 35 U.S.C. 103 as being unpatentable over Gentile et al., as evidenced by Braun et al. and Bater et al., in view of Schafer et al., further in view of Paradisi et al. is withdrawn:
The rejection to claims 1, 3, 5, 6, 9, 12, 16 and 17 under 35 U.S.C. 103 as being unpatentable over Gentile et al., as evidenced by Braun et al. and Bater et al., in view of Schafer et al., further in view of Schostarez et al. is withdrawn:
The rejection to claims 1, 3, 5, 7-9, 12, 16 and 17 under 35 U.S.C. 103 as being unpatentable over Gentile et al., as evidenced by Braun et al. and Bater et al., in view of Schafer et al., further in view of Ali et al., as evidenced by Weiss et al. is withdrawn:
The rejection to claims 1, 3, 5, 9, 10, 12, 16 and 17 under 35 U.S.C. 103 as being unpatentable over Gentile et al., as evidenced by Braun et al. and Bater et al., in view of Schafer et al., further in view of Wang et al. is withdrawn:
The rejection to claims 1, 3, 5, 9, 11, 12, 16 and 17 under 35 U.S.C. 103 as being unpatentable over Gentile et al., as evidenced by Braun et al. and Bater et al., in view of Schafer et al., further in view of Anz et al. is withdrawn:
The rejection to claims 1, 3, 5, 9, 12-17 under 35 U.S.C. 103 as being unpatentable over Gentile et al., as evidenced by Braun et al. and Bater et al., in view of Schafer et al., further in view of Solomon et al. is withdrawn:
The rejection to claims 1, 3, 5, 9, 12 and 16-20 under 35 U.S.C. 103 as being unpatentable over Gentile et al., as evidenced by Braun et al. and Bater et al., in view of Schafer et al., further in view of Andia et al. is withdrawn:
The cancellation of claims 1-20 renders the rejection thereto moot. The rejection is withdrawn.
New grounds of rejection are necessitated by Applicant’s amendments.
New grounds of Rejection
New Claim Objections
Claim 21 is objected to because of the following informalities: claim 21 recites “leuko-depleted”, “leuko” is an abbreviation. When an abbreviation is first time introduced in the claim, it should be accompanied by its full description.
Appropriate correction is required.
New Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-26 are newly rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites “a mammal suffering from androgenic alopecia”. However, the Specification fails to show support to the limitation “mammal”. The specification has no recitation “mammal”. The background in the Specification refers to adult human, therefore the recitation “patient” in the following part of the Specification is interpreted as a human suffers from, i.e., androgenic alopecia. Human is a species of mammal, while mammal is a much broader limitation which comprises around six thousand species, there is no support that all or a representative number of mammals are disclosed in instant invention.
This is a new matter rejection necessitated by Applicant’s amendment. Claims 22-26 depend from, at least, claim 21, and thus inherit the deficiency and are rejected on the same basis.
New 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 21-23 and 26 are newly rejected under 35 U.S.C. 103 as being unpatentable over Gentile et al. (Int J Mol Sci. 2020 Apr 13;21(8):2702), as evidenced by Ibrahim et al. (J Dermatolog Treat. 2018 Aug;29(5):431-440), in view of Avci et al. (Lasers Surg Med. 2014 Feb;46(2):144-51).
Gentile et al. conduct a systematic literature review, the effectiveness of an autologous regenerative therapy focused exclusively on platelet-rich plasma (PRP) treatment for androgenic
Alopecia (AGA) was evaluated, with the conclusion that PRP was effective in promoting hair growth (HG) in most articles (p2).
Regarding claim 1, the preamble “increasing hair density in a mammal suffering from androgenic alopecia” is considered as an intended use. The preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation to be given patentable weight and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02. Gentile et al. teach using PRP in androgenetic alopecia (p11, Section 2.3). Gentile et al. teach the not-activated PRP (A-PRP) and autologous activated PRP (AA-PRP) injections (e.g., inter-follicular infiltration to AGA-affected regions, p14, parag 2) and massage of PRP on the scalp. Gentile et al. also teach different types of PRP preparations depending on their cell content and fibrin architecture, including Leukocyte-poor PRP (LP-PRP) or pure platelet-rich plasma (P-PRP), which is PRP without leukocytes and with a low-density fibrin network after activation (p12, parag 7-8). The “PRP without leukocytes” is leuko-depleted platelet. This teaching reads on “a method comprising: a) identifying a mammal suffering from androgenic alopecia (i.e., a patient with androgenetic alopecia)” and “c) injecting leuko-depleted platelet rich plasma to the target area” in instant claim.
In addition, Gentile et al. teach autologous adult stem cell-based therapy (p19, Section 4.2), the adipose tissue (AT) is identified as an effective alternative source of stem cells (SCs) with respect to bone marrow (BM), both for cellular wealth and expansion potential (p19, parag 2). This teaching indicates that bone marrow derived mesenchymal stem cells are as effective as AT for stem cell-based therapy in the treatment of androgenic alopecia. The eligibility of bone marrow derived stem for the treatment of androgenetic alopecia can also be evidenced by Ibrahim et al.. Ibrahim et al. teach the safety and efficacy of the use of autologous bone marrow derived mononuclear cells (BMMC, including stem cells) as compared to follicular stems cells (FSC) for the management of resistant cases of alopecia areata and androgenetic alopecia (p6, parag 3). Injection of BMMCs and FSCs gave significant improvement in androgenetic alopecia (AGA) and alopecia areata (AA) with no statistically significant difference between both methods. It showed increase in hair width as well as hair density after six months of single SC injection therapy in all groups of patients (p14, parag 1 and 5). This teaching reads on “b) injecting bone marrow derived mesenchymal stem cells to a target area on the mammal determined to have thinner than normal hair density”. Gentile et al. do not teach d) administering low-level laser irradiation onto the target area after the mesenchymal stem cells and platelet rich plasma are injected. However, this was disclosed by Avci et al..
Avci et al. teach surveys the evidence for low-level laser therapy (LLLT) applied to the scalp as a treatment for hair loss and discusses possible mechanisms of actions (p144, left column).
Regarding claim 21, Avci et al. teach LLLT stimulated hair growth in mice subjected to chemotherapy-induced alopecia and also in alopecia areata (p144, left column).
Given that Gentile et al. teach providing PRP (e.g., leuko-depleted PRP) and stem cells (e.g., bone marrow derived mesenchymal stem cells) for stimulating new hair growth, Avci et al. teach LLLT stimulates hair growth, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use low-level laser irradiation after the mesenchymal stem cells and platelet rich plasma are injected, for the predictable result of stimulating new hair growth. The combined effect would have been expected to be greater than the effect of either treatment individually because the PRP, bone marrow derived mesenchymal stem cells and LLLT work in different manners (e.g., PRP provide growth factors (see Table 3, p13), bone marrow mononuclear cell/aspirate population provide stem cells for the treatment, while LLLT may through other mechanism such as stimulating epidermal stem cells in the hair follicle bulge, see p144, left column). The reason to combine the different therapies would be to improve overall effect of stimulating new hair growth. See MPEP 2143(I)(A).
Regarding claim 22, Gentile et al. teach preparing A-PRP from a large volume of peripheral blood (p11, parag 8).
Regarding claim 23, Gentile et al. teach autologous adult stem cell-based therapy (p19, parag 2), indicates the used stem cells (e.g., bone marrow derived mesenchymal stem cells) for the treatment of androgenic alopecia is autologous.
Regarding claim 26, Gentile et al. teach the effectiveness of an autologous regenerative therapy
focused exclusively on PRP treatment for androgenic alopecia (AGA), which includes using leuko-depleted PRP (p2, parag 7, and p12, parag 8), reads on the PRP including leuko-depleted PRP is autologous.
Claims 21-26 are newly rejected under 35 U.S.C. 103 as being unpatentable over Gentile et al. (Int J Mol Sci. 2020 Apr 13;21(8):2702), as evidenced by Ibrahim et al. (J Dermatolog Treat. 2018 Aug;29(5):431-440), in view of Avci et al. (Lasers Surg Med. 2014 Feb;46(2):144-51), as applied to claims 21-23 and 26, further in view of Schafer et al. (J Transl Med (2019) 17:115).
The teaching of Gentile et al. and Avci et al. is set forth above.
Regarding claims 24-25, Gentile et al. and Avci et al. do not teach bone marrow derived mesenchymal stem cells are administered within a bone marrow concentrate aspirated from a donor, and the stem cells are autologous. However, such was disclosed by Schafer et al. at the time of instant invention.
Schafer et al. analyze and compare progenitor cell composition and growth factors in bone marrow aspirate concentration (BMAC) prepared from single donors and processed concurrently by two commercially available systems versus unprocessed marrow aspiration, hypothesize that the BMAC systems will concentrate progenitor cell populations when compared to unprocessed BM without a meaningful loss of cell viability (p2, left column).
Regarding claim 24, Schafer et al. teach human BM aspirate contains mesenchymal stem/stromal cells (MSCs) (p2, left column).
Regarding claim 25, as discussed above, autologous adult stem cell-based therapy (p19, parag 2), and Schafer et al. teach human BM aspirate contains mesenchymal stem/stromal cells (MSCs) (p2, left column).
Given that Gentile et al. teach using PRP and stem cell-based therapy for stimulating new hair growth, Avci et al. teach LLLT stimulates hair growth, and Schafer et al. teach human BM aspirate contains mesenchymal stem/stromal Cells (MSCs), it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of PRP, bone marrow mononuclear cell/aspirate population which contain stem cells and LLLT for the treatment of androgenetic alopecia, for the predictable result of stimulating new hair growth. The combined effect would have been expected to be greater than the effect of either treatment individually because PRP, the bone marrow mononuclear cell/aspirate population and LLLT work in different manners (e.g., PRP provide growth factors (see Table 3, p13), bone marrow mononuclear cell/aspirate population provide stem cells for the treatment, while LLLT may through other mechanism such as stimulating epidermal stem cells in the hair follicle bulge, see p144, left column). The reason to combine the different therapies would be to improve overall effect of stimulating new hair growth. See MPEP 2143(I)(A).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699