DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on July 6, 2026, is acknowledged. Therefore, claims 1-15 are presently pending, with claims 16-20 withdrawn from active consideration as being drawn to the non-elected invention. Accordingly, claims 1-15 are presently under examination.
Information Disclosure Statement
3. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification Objections
4. The instant specification is objected to for the following reasons:
a. There are trademarks in this application that do not meet the requirements.
The use of the term (e.g., “R&D systems” and “Sigma” at page 27), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Applicant should review the specification for other trademarks and make corrections as required.
Claim Rejections - 35 USC § 102
5. 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claims 1, 7, and 9-11 are rejected under 35 U.S.C 102 (a)(2) as anticipated by Plikus (WO 2018/175630 A1, published September 27, 2018).
Claim 1 is directed to a method of promoting hair growth in a subject, comprising providing a composition containing a therapeutically effective amount of thymic stromal lymphopoietin (TSLP) to a subject in need thereof, thereby promoting hair growth in the subject.
Claim 7 is directed to the method of claim 1, wherein the subject has experienced a skin injury.
Claim 9 is directed to the method of claim 1, wherein the subject has a hair disorder.
Claim 10 is directed to the method of claim 9, wherein the hair disorder is alopecia.
Claim 11 is directed to a method of promoting hair growth in a subject, comprising providing a composition containing a therapeutically effective amount of thymic stromal lymphopoietin (TSLP) to a subject, wherein the subject has alopecia, and wherein the composition is provided to the subject following a microneedling procedure performed on the subject.
Claim interpretation: the term “skin injury” recited in instant claims 7-8 is given its broadest reasonable interpretation in view of the instant specification. The specification recites at para. [0043] “[i]n some embodiments, the subject has alopecia and the subject has experienced a skin injury (e.g. microneedling)”; and at para. [0030] “[e]xemplary skin injuries include injuries caused by physical stimuli including burns, wounds, punctures, scrapes, scratches, etc. Additional exemplary skin injuries include injuries due to medical interventions/therapeutic agents, such as skin injury in response to chemotherapy, radiation therapy, and the like.” Accordingly, for the purposes of examination, the term skin injury is interpreted to include microneedling and other injuries caused by medical interventions.
Plikus is directed to methods of treating hair loss by delivering factors derived from senescent cell to the hair loss affected area (see the abstract). Plikus discloses that hair loss is alopecia at para. [0003]. Plikus recites at para. [0005]: “In some embodiments, a method for enhancing or inducing hair growth in a subject at an area affected by hair loss is provided. In some embodiments, the methods include delivering at least one senescence associated secretory phenotype (SASP) factor, or at least one senescent cell or cell type that secretes said at least one SASP factor, to the subject at the area affected by hair loss.” Table 1 of Plikus includes TSLP as a SASP factor. Plikus contemplates that the SASP factor should be comprised in a composition (see, e.g., Plikus claim 29). Therefore, Plikus teaches a method of promoting hair growth in a subject, comprising providing a composition containing a therapeutically effective amount of thymic stromal lymphopoietin (TSLP) to a subject in need thereof, thereby promoting hair growth in the subject. (Claims 1 and 9-10)
Plikus further teaches topical delivery of the SASP factor (e.g., TSLP) following application of a microneedle device (see, e.g., Plikus at para. [0006]-[0007]). Said microneedle device causes a skin injury. (Claims 7 and 11)
Accordingly, Plikus anticipates claims 1, 7, and 9-11.
7. Claims 1-2 and 7-12 are rejected under 35 U.S.C 102 (a)(2) as anticipated by Tankovich (US 20170252373 A1, published September 7, 2017).
Claim 1 is directed to a method of promoting hair growth in a subject, comprising providing a composition containing a therapeutically effective amount of thymic stromal lymphopoietin (TSLP) to a subject in need thereof, thereby promoting hair growth in the subject.
Claim 2 is directed to the method of claim 1, wherein the composition is provided to the subject subcutaneously.
Claim 7 is directed to the method of claim 1, wherein the subject has experienced a skin injury.
Claim 8 is directed to the method of claim 7, wherein the composition is provided to the subject subcutaneously at an area of injured skin.
Claim 9 is directed to the method of claim 1, wherein the subject has a hair disorder.
Claim 10 is directed to the method of claim 9, wherein the hair disorder is alopecia.
Claim 11 is directed to a method of promoting hair growth in a subject, comprising providing a composition containing a therapeutically effective amount of thymic stromal lymphopoietin (TSLP) to a subject, wherein the subject has alopecia, and wherein the composition is provided to the subject following a microneedling procedure performed on the subject.
Claim 12 is directed to the method of claim 11, wherein the composition is administered subcutaneously at one or more microneedling sites.
Tankovich is directed to treatments for hair loss (e.g., Title: “Combination therapy for the treatment of hair loss”). Tankovich discloses that hair loss is alopecia at para. [0005]. Claim 1 of Tankovich recites: A method for treating hair loss in a subject comprising administering to a target site on the subject at least one stem cell factor and at least one vasodilator, wherein administering the at least one stem cell factor and at least one vasodilator treats hair loss in the subject. e.g., para. [0040], [0042], and [0050] of Tankovich states that the stem cell factor can be TSLP. (Claims 1 and 9-10)
Tankovich further discloses the stem cell factor (i.e., TSLP) can be formulated for injection, and administered subcutaneously at the target site at para. [0047]. (Claim 2)
Tankovich further discloses the target site can be can have a skin injury at e.g., Tankovich claim 17: “wherein the target site is treated with at least one of radiofrequency, laser energy, ultrasonic energy, a mechanical oscillator, dermabrasion device, dermabrasion particles, needle, and a needle roll before administering one or more of the at least one stem cell factor.” Since a needle roll is microneedling, Tankovich therefore discloses microneedling the target site followed by subcutaneous administration at the microneedling / target site. Tankovich also discloses the subject may have undergone a hair transplantation procedure (i.e., injury) at para. [0029]. (Claims 7-8 and 11-12).
Accordingly, Tankovich anticipates 1-2 and 7-12.
Claim Rejections - 35 USC § 103
8. 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.
9. 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.
10. Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Plikus (WO 2018/175630 A1, published September 27, 2018), in view of Rogaine product sheet (published December 8, 2021) and R&D Systems product sheet for recombinant human TSLP (published September 26, 2018), and as evidenced by Nair et al. ("A simple practice guide for dose conversion between animals and human." Journal of basic and clinical pharmacy 7.2 (2016): 27; provided by Applicant), and further in view of Barman et al. (US 12263323 B2, published April 1, 2025; filed September 24, 2021).
Claim 1 is directed to a method of promoting hair growth in a subject, comprising providing a composition containing a therapeutically effective amount of thymic stromal lymphopoietin (TSLP) to a subject in need thereof, thereby promoting hair growth in the subject.
Claim 2 is directed to the method of claim 1, wherein the composition is provided to the subject subcutaneously.
Claim 3 is directed to the method of claim 1, wherein the therapeutically effective amount of TSLP is about 0.01 µg/kg to about 20 µg/kg.
Claim 4 is directed to the method of claim 3, wherein the therapeutically effective amount of TSLP is about 0.025 µg/kg to about 10 µg/kg.
Claim 5 is directed to the method of claim 4, wherein the therapeutically effective amount of TSLP is about 0.5 µg/kg to about 5 µg/kg.
Claim 6 is directed to the method of claim 4, wherein the therapeutically effective amount of TSLP is about 1 µg/kg to about 3 µg/kg.
Claim 7 is directed to the method of claim 1, wherein the subject has experienced a skin injury.
Claim 8 is directed to the method of claim 7, wherein the composition is provided to the subject subcutaneously at an area of injured skin.
Claim 9 is directed to the method of claim 1, wherein the subject has a hair disorder.
Claim 10 is directed to the method of claim 9, wherein the hair disorder is alopecia.
Claim 11 is directed to a method of promoting hair growth in a subject, comprising providing a composition containing a therapeutically effective amount of thymic stromal lymphopoietin (TSLP) to a subject, wherein the subject has alopecia, and wherein the composition is provided to the subject following a microneedling procedure performed on the subject.
Claim 12 is directed to the method of claim 11, wherein the composition is administered subcutaneously at one or more microneedling sites.
Claim 13 is directed to the method of claim 11, wherein the therapeutically effective amount of TSLP is about 0.01 µg/kg to about 20 µg/kg.
Claim 14 is directed to the method of claim 13, wherein the therapeutically effective amount of TSLP is about 0.025 µg/kg to about 10 µg/kg.
Claim 15 is directed to the method of claim 14, wherein the therapeutically effective amount of TSLP is about 0.5 µg/kg to about 5 µg/kg.
Claim interpretation: the term “skin injury” recited in instant claims 7-8 is given its broadest reasonable interpretation in view of the instant specification. The specification recites at para. [0043] “[i]n some embodiments, the subject has alopecia and the subject has experienced a skin injury (e.g. microneedling)”; and at para. [0030] “[e]xemplary skin injuries include injuries caused by physical stimuli including burns, wounds, punctures, scrapes, scratches, etc.. Additional exemplary skin injuries include injuries due to medical interventions/therapeutic agents, such as skin injury in response to chemotherapy, radiation therapy, and the like.” Accordingly, for the purposes of examination, the term skin injury is interpreted to include microneedling and other injuries caused by medical interventions.
Plikus is directed to methods of treating hair loss by delivering factors derived from senescent cell to the hair loss affected area (see the abstract). Plikus discloses that hair loss is alopecia at para. [0003]. Plikus recites at para. [0005]: “In some embodiments, a method for enhancing or inducing hair growth in a subject at an area affected by hair loss is provided. In some embodiments, the methods include delivering at least one senescence associated secretory phenotype (SASP) factor, or at least one senescent cell or cell type that secretes said at least one SASP factor, to the subject at the area affected by hair loss.” Table 1 of Plikus includes TSLP as a SASP factor. Plikus contemplates that the SASP factor should be comprised in a composition (see, e.g., Plikus claim 29). Therefore, Plikus teaches a method of promoting hair growth in a subject, comprising providing a composition containing a therapeutically effective amount of thymic stromal lymphopoietin (TSLP) to a subject in need thereof, thereby promoting hair growth in the subject. Plikus further teaches topical delivery of the SASP factor (e.g., TSLP) following application of a microneedle device (see, e.g., Plikus at para. [0006]-[0007]). Said microneedle device causes a skin injury (Claims 1, 7, 9-11). Plikus also teaches that Finasteride is a prominent hair-loss treatment at para. [0049]; and that SASP factors may be purchased commercially at para. [0069].
Plikus does not explicitly disclose the therapeutically effective amounts recited in instant claims 3-6 and 12-15 or subcutaneous administration.
The R&D Systems product sheet for recombinant human TSLP is cited for its recommendation to reconstitute the TSLP at 100 µg/ml. The Rogaine product sheet is cited for its recommendation to apply 1 ml to the scalp. The average human weights 60 kg, as evidenced by Nair et al. at Table 1. Therefore, applying 1 ml of 100 µg/ml TSLP to the scalp of a 60 kg person results in a dose of ((100 µg/ml x 1 ml) / 60 kg) = 1.66 µg/kg, which is encompassed by all of the instantly claimed therapeutically effective amounts.
Additionally, Barman et al. is broadly directed to methods of treating alopecia and promoting hair growth at areas of bald scalp, including microneedling and hair growth formulations such as minoxidil (e.g., Rogaine; see Barman et al. at introduction (col. 1, ln. 20-30) and claim 1). Barman et al. teaches administering topical hair growth formulation from about 10 µg/kg to about 20 µg/kg at col. 55, ln. 4-26. Barman et al. further teaches regarding treatment regiments with hair growth-promoting agents at col. 97, ln. 14-23: “[i]t is understood that the precise dosage and duration of treatment may vary with the type of treatment, and the age, weight, and condition of the patient being treated, and may be determined empirically using known testing protocols or by extrapolation from in vivo or in vitro test or diagnostic data. It is further understood that for any particular individual, specific dosage regimens should be adjusted over time according to the individual need and the professional judgment of the person administering or supervising the administration of the formulations.” Therefore, Barman et al. teaches that it is routine to optimize the dosage of growth-promoting agents based on the subject population and treatment type. Barman et al. further teaches administering the hair growth formulation following microneedling at claim 9; that microneedling (i.e., integumental perturbation) cause superficial wounding to the area of skin on which hair growth is desired at col. 10 ln. 35-67; that “depending on the formulation used, a subcutaneous or orally administered hair growth-promoting agent may be preferred in order to achieve a controlled release of hair growth-promoting agent from the blood to the skin.” at col. 53, ln. 8-12; and about local delivery subcutaneously to target systemically hair growth-promoting agent to desired follicles at col. 83, ln. 9-15. Therefore, Barman et al. also teaches administering the hair growth-promoting agent subcutaneously at microneedling sites following microneedling.
It would be prima facie obvious to at the time the invention was made to use the TSLP dosages as taught by the Rogaine and TSLP product sheets in the method of treating hair loss of Pilkus because Pilkus has demonstrated a method for enhancing or inducing hair growth in a subject at an area affected by hair loss, comprising: delivering at least one senescence associated secretory phenotype (SASP) factor (including TSLP, Table 1) and (Example 3). One of ordinary skill in the art would be motivate to use TSLP in the dosages as set forth in the product sheets and Barman et al. in a method of treating hair loss with a reasonable expectation of success because the product sheets teach dosages for treating hair loss and Barman et al. further expounds on uses of hair growth-promoting agents, e.g. Rogaine, and recommends a dose that overlaps those recited in instant claims 3-4 and 13-14, and shows that it is routine to further optimize the dose administered based on the subject population and treatment type and Barman et al. further teaches regarding treatment regiments with hair growth-promoting agents at col. 97, ln. 14-23: “[i]t is understood that the precise dosage and duration of treatment may vary with the type of treatment, and the age, weight, and condition of the patient being treated, and may be determined empirically using known testing protocols or by extrapolation from in vivo or in vitro test or diagnostic data. It is further understood that for any particular individual, specific dosage regimens should be adjusted over time according to the individual need and the professional judgment of the person administering or supervising the administration of the formulations.” Therefore, Barman et al. teaches that it is routine to optimize the dosage of growth-promoting agents based on the subject population and treatment type.
Additionally, it would be obvious that the dosages used to treat hair loss can clearly be a result effective parameter that a person having ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employee. MPEP 2144.05 states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989) (Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990) (Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997) (Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.")”
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that “The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results.” The combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Accordingly, Plikus, in view of Rogaine and R&D Systems product sheets, and as evidenced by Nair et al., and further in view of Barman et al., renders claims 1-15 obvious.
Conclusion
11. No claim is allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON R SCHWECHTER whose telephone number is (571)272-1270. The examiner can normally be reached M-Th 7-5 EST.
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/BRANDON R SCHWECHTER/
Examiner, Art Unit 1674
/VANESSA L. FORD/ Supervisory Patent Examiner, Art Unit 1674
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