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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on 02/04/2024 has been entered.
Priority
The present application is a continuation of U.S. Patent Application No. 16/150,007, filed October 2, 2018, now allowed, which is a continuation of U.S. Patent Application No. 15/970,339, filed May 3, 2018, now issued as U.S. Patent 10,307,360 on June 4, 2019, which is a continuation of U.S. Patent Application No. 13/986,854, filed June 12, 2013, now issued as U.S. Patent 9,987,213 on June 5, 2018, which claims priority to and the benefit of U.S. Patent Application No. 61/689,808, filed June 13, 2012.
Claim Status
Claims are 1, 2, 7-11, 15, and 21-30 are pending and under examination. Claims 3-6, 12-14, 16-20, 31, and 32 are canceled.
Action Summary
Claims 1, 2, 7-11, 15, and 21-30 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in light of the claim amendment.
Claims 1, 2, 7-11, 15, and 21 rejected under 35 U.S.C. 103 as being un-patentable over Saeedi et al (Journal of Dermatological Treatment, 2007; 18: 271-274) in view of Qin (CN101332174 A) and Farthing et al (Br J Dermatol. 1982 Nov;107(5):559-64), are withdrawn in light of the claim amendment.
Claims 1, 2, 7-11, 15, and 22-30 rejected under 35 U.S.C. 103 as being un-patentable
Saeedi et al (Journal of Dermatological Treatment, 2007; 18: 271-274) in view of Qin (CN101332174 A) and Farthing et al (Br J Dermatol. 1982 Nov;107(5):559-64) as applied to claims 1, 2, 7-11, 15, and 21 above, in further view of Woodward et al (US2008/0070988 B2) and Rethore et al (US2010/0190853 A1), are withdrawn in light of the claim amendment.
Claims 1, 2, 7-11, 15, and 21-30 rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9.987,213 B2 in view of Qin (CN101332174 A) and Farthing et al (Br J Dermatol. 1982 Nov;107(5):559-64), Woodward et al (US2008/0070988 B2), and Rethore et al (US2010/0190853 A1), are maintained.
Claims 1, 2, 7-11, 15, and 21-30 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,307,360 B2 in view of Qin (CN101332174 A) and Farthing et al (Br J Dermatol. 1982 Nov;107(5):559-64), Woodward et al (US2008/0070988 B2), and Rethore et al (US2010/0190853 A1), are maintained.
Claims 1, 2, 7-11, 15, and 21-30 rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,020,336 B2 in view of Qin (CN101332174 A) and Farthing et al (Br J Dermatol. 1982 Nov;107(5):559-64), Woodward et al (US2008/0070988 B2), and Rethore et al (US2010/0190853 A1), are 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Claims 1, 2, 7-11, 15, and 22-30 are rejected under 35 U.S.C. 103 as being un-patentable over Saeedi et al (Journal of Dermatological Treatment, 2007; 18: 271-274) in view of Qin (CN101332174 A), Farthing et al (Br J Dermatol. 1982 Nov;107(5):559-64), Woodward et al (US2008/0070988 B2), and Rethore et al (US2010/0190853 A1).
Saeedi teaches a method of promoting and enhancing the growth of beard hair to young men with beta-thalassemia major comprising the step of applying a transdermal gel formulation (topical) containing 2.5% testosterone, ethanol, preserved water, methyl and propyl paraben to the beard area of the young (less than 18 and greater than 18 years of age and serum testosterone levels (normal or subnormal according to the Tanner stage). (See Abstract and page 272, and first column.) The application morning and night and the duration of 6 months of treatment implies repeated application of the gel every day for six months until desired hair growth results. Moreover, Saeedi teaches the serum testosterone levels of controls and cases were 9.5 (+/-5.7 mean +/-SD) and 10.5 (+/-9.6 ng/L), respectively; the number of terminal hairs (per cm2) in cases 29.8 (+/- 13.6) was significantly higher than that of controls 13.9 (+/- 13.2) (See Abstract.) The control group is considered healthy individual that benefit from the hair growth promoting effect of the testosterone gel. While Table 1 of Saeedi teaches a mean age of 20.3 (+/-3.1) and a mean serum testosterone level of 10.2 (+/- 90.6) as the preferred patient, page 272 and first column of Saeedi teaches the patient were divided into two randomized groups and two blocks (Subgroups) in every group, according to age (less than or equal to 18 and greater than 18) and serum testosterone level (normal or subnormal according to the Tanner stage. Patients with age greater than 18 and tanner stage greater than 4 according to the Abstract are considered adult human males who have completed puberty. While Saeedi does not teach ethanol is a penetration enhancer, the instant specification is evidenced that ethanol is a penetration enhancer. (See page 21, last paragraph.) Moreover, Saeedi teaches the transdermal administration of testosterone allows approximation of the natural testosterone pattern of serum testosterone found in healthy men and wherein said transdermal formulation is thought to be superior than oral administration. (See page 271, second col, first paragraph.) Furthermore, Saeedi teaches the study showed that 2.5 % testosterone gel was effective in inducing the transformation of beard area hairs to terminal hairs, see page 273, first col, last para. Since ethanol is used in the formulation of Seedi et al. and since said formulation was effective to stimulate terminal beard hairs, the concentration of ethanol in the formulation taught would be considered a concentration formulated so as to deliver the testosterone to the air follicle bulb matrices, but testosterone not significantly absorbed into the systemic circulation. Lastly, Saeedi et al. teaches the transdermal administration of testosterone allows approximation of the natural endogenous pattern of serum testosterone found in healthy men and has been show to produce positive effects on fatigue, mood and sexual function, see page 271, right col.
Saeedi does not teach one or more androgen (DHT) and purified water (claim 21). Moreover, Saeedi does not teach a nonsteroidal alopecia treatment agent (claim 22) where said agent is minoxidil (claim 23) in the amount of about 2% to about 5% w/v (claim 24). Additionally, Saeedi, Qin, and Farthing do not teach a non-steroidal hair growth promoter prostamide (claim 25) where said prostamide is bimatoprost (claim 26) in the amount recited in claims 27 and 28. Furthermore, Saeedi, Qin, and Farthing do not teach a prostaglandin analog (claim 29) where said prostaglandin analog is travoprost (claim 30).
Qin teaches a method of teaching primary, secondary, and elderly hypogonadism disease comprising administration to the skin are a formulation comprising dihydrotestosterone (DHT) in the percentage by weight of 0.7% and a penetration enhancer, see claims 1, 8, and 9, wherein the formulation can be in the form of solutions, suspensions, emulsions, gels, ointments, creams, pastes and patches and wherein the skin includes the chest. (See claim 10 and Abstract.) Moreover, Qin teaches the penetration enhancer exemplified is ethanol with the addition of purified water. (See Example 6, page 4.) The patient population includes middle aged men and a 20 years old male, and the administration is topical. (See page 4, lines 3-12.) Qin teaches the DHT gel is applied to the skin are until the desired effect that is the hypogonadism effect is achieved. (See page 4, lines 1-15.)
Farthing teaches suggest that T and DHT may have independent roles in the control of male facial hair growth, i.e., T for hair follicle priming and DHT for promotion of linear growth. (See Abstract.)
Woodward teaches on the background section that minoxidil has hair growth-stimulating effect. (See page 5, first column and lines 14-16.) Woodward also teaches bimatoprost is administered in the amount of 0.03% by weight. (See claim 2.) Moreover, Woodward teaches bimatoprost stimulates hair follicle. (See page 7; lines 28-32.)
Rethore teaches travoprost medicament compositions for non-daily topical application are useful for simulating or inducing the growth and/or decreasing the loss and/or increasing the density and/or reducing the heterogeneity in the diameter of human hair shafts/follicles, see Abstract. Moreover, Rethore teaches travoprost is a prostaglandin analogue. (See paragraph [0047].)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to combine the method of Saeedi with the method of Farthing, the method of Woodward along with that set forth by Rethore to give an additional method for promoting beard hair growth because each is taught by the prior art to be useful for the same purpose (i.e., promoting beard hair growth). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Moreover, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together because Farthing teaches Testosterone and DHT may have independent roles in the control of male facial hair growth, i.e., T for hair follicle priming and DHT for promotion of linear growth. The additional method from the combined methods would include purified water. Further, adjustment of the amount of minoxidil and the amount of bimatoprost to the claimed amounts would be well within the skill of an ordinary artisan and are obvious since these amounts are result effective parameters (i.e., hair growth stimulating effect). Since the prior art teaches minoxidil and bimatoprost are effective for promoting hair growth, one would easily be able to calculate the optimal amounts that achieve the desired facial hair growth promoting effect. Finally, a person of ordinary skill in the art would reasonably have expected to be successful because each method was shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
With respect to the limitations of claims 7-10; these limitations simply express the intended outcome or results of the method step positively recited. Sine the method step of the prior art is the same as claimed, the intended outcome or result would necessarily be present absent evidence to the contrary.
Applicant’s Arguments
Applicant argues that the references fail to provide any guidance or motivation relating to the method and formulation used therein that is currently claimed. The rejection lacks any rationale as to why one of ordinary skill in the art would be motivated to identify the various claimed features and the art provides no guidance or that would have directed one of skill toward those features.
Examiner’s response
In response, Applicant’s argument is not persuasive because the cited references in combination clearly provides the motivation and/or the rationale to combined the method of Saeedi with the method of Farthing, the method of Woodward along with that set forth by Rethore to give an additional method for promoting beard hair growth because each is taught by the prior art to be useful for the same purpose (i.e., promoting beard hair growth). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Applicant’s Arguments
Applicant argues that one of ordinary skill in the art who is familiar with Saeedi would not be prompted to make significant changes to Saeedi's method of treatment to add one or more additional other androgens and one or more active ingredients as claimed. Specifically, the combination of Saeedi, Qin and Farthing does not teach the additional ingredients now claimed (one or more active ingredients are selected from the group consisting of minoxidil, bimatoprost, other prostamides, prostaglandin analogs travoprost, and latanoprost). The addition of Woodward and Rethore to Saeedi, Qin, and Farthing does not remedy the deficiencies as the references fail to provide any guidance or motivation relating to the method as currently claimed. The rejection lacks any rationale as to why one of ordinary skill in the art would be motivated to identify the various claimed features and the art provides no guidance or that would have directed one of skill toward those features.
Examiner’s response
In response, Applicant’s argument is not persuasive because the cited references in combination clearly provides the motivation and/or the rationale to combined the method of Saeedi with the method of Farthing, the method of Woodward along with that set forth by Rethore to give an additional method for promoting beard hair growth because each is taught by the prior art to be useful for the same purpose (i.e., promoting beard hair growth). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Double Patenting
The non-statutory 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 non-statutory 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); 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 non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 7-11, 15, and 21-30 remain rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9.987,213 B2 in view of Qin (CN101332174 A) and Farthing et al (Br J Dermatol. 1982 Nov;107(5):559-64), Woodward et al (US2008/0070988 B2), and Rethore et al (US2010/0190853 A1).
The claims of the U.S. patent teach a method for promoting or enhancing facial hair growth, comprising topically administering an effective amount of a pharmaceutically acceptable formulation of dihydrotestosterone to a target skin area, which is the mustache region, beard region, or both of an adult human male, who has completed puberty, and who is unable to grow full beards and mustaches, and wherein the target skin area has sparse mature terminal hair and the human male has a level of circulating total serum testosterone that is within a normal physiologic reference range, thereby promoting or enhancing growth of mature terminal hair at the target skin area; and wherein the concentration of dihydrotestosterone in the dihydrotestosterone formulation is selected from the group consisting of (i) ranges from about 0.5% to about 25%, weight to weight, (ii) ranges from about 0.5% to about 25%, weight to volume, and (iii) ranges from about 0.5% to about 25%, volume to volume. Moreover, the U.S. patent claims teach the dihydrotestosterone formulation comprises benzalkonium chloride in a range of about 0.2 mg/mL to 0.5 mg/mL, see claim 13. The dihydrotestosterone formulation comprises as a further active ingredient an additional androgen, wherein the additional androgen is testosterone, see claims 8 & 9. The formulation is in the form of a liquid, lotion, cream, ointment, gel, foam, aerosol, or spray, see claim 7. The U.S. patent claims teach the dihydrotestosterone formulation comprises one or more dermal penetration enhancement agents that optimize hair shaft absorption of the topically applied dihydrotestosterone formulation and absorption into the hair follicle structures in a targeted manner and then lead to the drug delivery of the topically applied dihydrotestosterone via the hair shaft and via the hair follicle structures to the hair follicle bulb and the dermal papilla cells of the hair follicle located in the hair follicle bulb; and wherein hair follicle structures can be reservoirs for applied formulations, see claim 11, wherein a dermal penetration enhancement agent comprises methanol, ethanol, propanol, isopropanol, or any combination thereof; and wherein the dihydrotestosterone formulation is delivered to the hair follicle by trans-epidermal diffusion in a targeted manner, see claim 12, wherein the dihydrotestosterone formulation comprises sodium chloride, dibasic sodium phosphate, citric acid, purified water, or any combination thereof, see claim 13. While the U.S. patent claims teach the adult male is healthy, the adult male of the U.S. patent claims is considered to be healthy since there is no teaching of any disease or condition or disorder.
The claims of the U.S. patent do not teach dihydrotestosterone (DHT) in the amount claimed. Moreover, the claims of the U.S. patent do not teach a nonsteroidal alopecia treatment agent (claim 22) where said agent is minoxidil (claim 23) in the amount of about 2% to about 5% w/v (claim 24). Additionally, the claims of the U.S. patent do not teach do not teach a non-steroidal hair growth promoter prostamide (claim 25) where said prostamide is bimatoprost (claim 26) in the amount recited in claims 27 and 28, and a prostaglandin analog (claim 29) where said prostaglandin analog is travoprost (claim 30).
Qin teaches a method of teaching primary, secondary, and elderly hypogonadism disease comprising administration to the skin are a formulation comprising dihydrotestosterone (DHT) in the percentage by weight of 0.7% and a penetration enhancer, see claims 1, 8, and 9, wherein the formulation can be in the form of solutions, suspensions, emulsions, gels, ointments, creams, pastes and patches and wherein the skin includes the chest. (See claim 10 and Abstract.) Moreover, Qin teaches the penetration enhancer exemplified is ethanol with the addition of purified water. (See Example 6, page 4.) The patient population includes middle aged men and a 20 years old male, and the administration is topical. (See page 4, lines 3-12.) Qin teaches the DHT gel is applied to the skin are until the desired effect that is the hypogonadism effect is achieved. (See page 4, lines 1-15.)
Farthing teaches suggest that T and DHT may have independent roles in the control of male facial hair growth, i.e., T for hair follicle priming and DHT for promotion of linear growth. (See Abstract.)
Woodward teaches on the background section that minoxidil has hair growth-stimulating effect. (See page 5, first column and lines 14-16.) Woodward also teaches bimatoprost is administered in the amount of 0.03% by weight. (See claim 2.) Moreover, Woodward teaches bimatoprost stimulates hair follicle. (See page 7; lines 28-32.)
Rethore teaches travoprost medicament compositions for non-daily topical application are useful for simulating or inducing the growth and/or decreasing the loss and/or increasing the density and/or reducing the heterogeneity in the diameter of human hair shafts/follicles, see Abstract. Moreover, Rethore teaches travoprost is a prostaglandin analogue. (See paragraph [0047].)
It would have been prima facie obvious for a person of ordinary skill in the art at the time of the invention was filed to combine the method disclosed by the claims of the U.S. patent with the method taught by Saeedi in view of Qin, and Farthing and the method of Woodward along with that set forth by Rethore because each is taught by the prior art to be useful for the same purpose (i.e., promoting facial hair growth including beard). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, adjustment of the amount of minoxidil and the amount of bimatoprost to the claimed amounts would be well within the skill of an ordinary artisan and are obvious since these amounts are result effective parameters (i.e., hair growth stimulating effect). Since the prior art teaches minoxidil and bimatoprost are effective for promoting hair growth, one would easily be able to calculate the optimal amounts that achieve the desired facial hair growth promoting effect. Finally, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
With respect to the limitations of claims 7-10; these limitations simply express the intended outcome or results of the method step positively recited. Sine the method step of the prior art is the same as claimed, the intended outcome or result would necessarily be present absent evidence to the contrary.
Claims 1, 2, 7-11, 15, and 21-30 remain rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,307,360 B2 in view of Qin (CN101332174 A) and Farthing et al (Br J Dermatol. 1982 Nov;107(5):559-64), Woodward et al (US2008/0070988 B2), and Rethore et al (US2010/0190853 A1).
The claims of the U.S. patent teach a method for promoting or enhancing facial hair growth, comprising daily and topically administering an effective amount of a pharmaceutically acceptable fixed combination of dihydrotestosterone and testosterone to a target skin area, which is the mustache region, beard region, or both of an adult human male, who has completed puberty, and who is unable to grow full beards and mustaches, and wherein the target skin area has sparse mature terminal hair and the human male has a level of circulating total serum testosterone that is within a normal physiologic reference range, thereby promoting or enhancing growth of mature terminal hair at the target skin area, see claims 1, 2, 4, and 10. Moreover, the U.S. patent claims teach the dihydrotestosterone formulation comprises benzalkonium chloride in a range of about 0.2 mg/mL to 0.5 mg/mL, see claim 6. The formulation is in the form of a liquid, lotion, cream, ointment, gel, foam, aerosol, or spray, see claim 3. The U.S. patent claims teach the dihydrotestosterone formulation comprises one or more dermal penetration enhancement agents that optimize hair shaft absorption of the topically applied dihydrotestosterone formulation and absorption into the hair follicle structures in a targeted manner and then lead to the drug delivery of the topically applied dihydrotestosterone via the hair shaft and via the hair follicle structures to the hair follicle bulb and the dermal papilla cells of the hair follicle located in the hair follicle bulb; and wherein hair follicle structures can be reservoirs for applied formulations, see claim 4, wherein a dermal penetration enhancement agent comprises methanol, ethanol, propanol, isopropanol, or any combination thereof; and wherein the dihydrotestosterone formulation is delivered to the hair follicle by trans-epidermal diffusion in a targeted manner, see claim 5, wherein the dihydrotestosterone formulation comprises sodium chloride, dibasic sodium phosphate, citric acid, purified water, or any combination thereof, see claim 7. While the U.S. patent claims teach the adult male is healthy, the adult male of the U.S. patent claims is considered to be healthy since there is no teaching of any disease or condition or disorder.
The claims of the U.S. patent do not teach dihydrotestosterone (DHT) in the amount claimed. Moreover, the claims of the U.S. patent do not teach a nonsteroidal alopecia treatment agent (claim 22) where said agent is minoxidil (claim 23) in the amount of about 2% to about 5% w/v (claim 24). Additionally, the claims of the U.S. patent do not teach do not teach a non-steroidal hair growth promoter prostamide (claim 25) where said prostamide is bimatoprost (claim 26) in the amount recited in claims 27 and 28, and a prostaglandin analog (claim 29) where said prostaglandin analog is travoprost (claim 30).
Qin teaches a method of teaching primary, secondary, and elderly hypogonadism disease comprising administration to the skin are a formulation comprising dihydrotestosterone (DHT) in the percentage by weight of 0.7% and a penetration enhancer, see claims 1, 8, and 9, wherein the formulation can be in the form of solutions, suspensions, emulsions, gels, ointments, creams, pastes and patches and wherein the skin includes the chest. (See claim 10 and Abstract.) Moreover, Qin teaches the penetration enhancer exemplified is ethanol with the addition of purified water. (See Example 6, page 4.) The patient population includes middle aged men and a 20 years old male, and the administration is topical. (See page 4, lines 3-12.) Qin teaches the DHT gel is applied to the skin are until the desired effect that is the hypogonadism effect is achieved. (See page 4, lines 1-15.)
Farthing teaches suggest that T and DHT may have independent roles in the control of male facial hair growth, i.e., T for hair follicle priming and DHT for promotion of linear growth. (See Abstract.)
Woodward teaches on the background section that minoxidil has hair growth-stimulating effect. (See page 5, first column and lines 14-16.) Woodward also teaches bimatoprost is administered in the amount of 0.03% by weight. (See claim 2.) Moreover, Woodward teaches bimatoprost stimulates hair follicle. (See page 7; lines 28-32.)
Rethore teaches travoprost medicament compositions for non-daily topical application are useful for simulating or inducing the growth and/or decreasing the loss and/or increasing the density and/or reducing the heterogeneity in the diameter of human hair shafts/follicles, see Abstract. Moreover, Rethore teaches travoprost is a prostaglandin analogue. (See paragraph [0047].)
It would have been prima facie obvious for a person of ordinary skill in the art at the time of the invention was filed to combine the method disclosed by the claims of the U.S. patent with the method taught by Saeedi in view of Qin, and Farthing and the method of Woodward along with that set forth by Rethore because each is taught by the prior art to be useful for the same purpose (i.e., promoting facial hair growth including beard). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, adjustment of the amount of minoxidil and the amount of bimatoprost to the claimed amounts would be well within the skill of an ordinary artisan and are obvious since these amounts are result effective parameters (i.e., hair growth stimulating effect). Since the prior art teaches minoxidil and bimatoprost are effective for promoting hair growth, one would easily be able to calculate the optimal amounts that achieve the desired facial hair growth promoting effect. Finally, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
With respect to the limitations of claims 7-10; these limitations simply express the intended outcome or results of the method step positively recited. Sine the method step of the prior art is the same as claimed, the intended outcome or result would necessarily be present absent evidence to the contrary.
Claims 1, 2, 7-11, 15, and 21-30 remain rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,020,336 B2 in view of Qin (CN101332174 A) and Farthing et al (Br J Dermatol. 1982 Nov;107(5):559-64), Woodward et al (US2008/0070988 B2), and Rethore et al (US2010/0190853 A1).
The claims of the U.S. patent teach a method for promoting and enhancing facial hair growth in an adult human male who has completed puberty and has a level of circulating androgen hormones that are within a normal physiologic reference range, wherein said adult human male is unable to grow a full beard and/or mustache but otherwise has classic male secondary sex characteristics, comprising topically administering an effective amount of a pharmaceutically acceptable formulation of testosterone (T) to a target skin area, which is the mustache region, beard region, or both of said adult human male, and wherein the target skin area has sparse mature terminal hair, thereby promoting or enhancing growth of mature terminal hair at the target skin area; wherein said adult human male does not have a genetically determined lower level of intracellular 5 alpha reductase and does not have a genetically determined lower number of androgen receptors, see claim 1. The administration is repeated daily until desired hair growth results, see claim 2. Moreover, the U.S. patent claims teach the dihydrotestosterone formulation comprises benzalkonium chloride in a range of about 0.2 mg/mL to 0.5 mg/mL, see claim 6. The formulation is in the form of a liquid, lotion, cream, ointment, gel, foam, aerosol, or spray, see claim 3. The U.S. patent claims teach the dihydrotestosterone formulation comprises one or more dermal penetration enhancement agents that optimize hair shaft absorption of the topically applied dihydrotestosterone formulation and absorption into the hair follicle structures in a targeted manner and then lead to the drug delivery of the topically applied dihydrotestosterone via the hair shaft and via the hair follicle structures to the hair follicle bulb and the dermal papilla cells of the hair follicle located in the hair follicle bulb; and wherein hair follicle structures can be reservoirs for applied formulations, see claim 4, wherein a dermal penetration enhancement agent comprises methanol, ethanol, propanol, isopropanol, or any combination thereof; and wherein the dihydrotestosterone formulation is delivered to the hair follicle by trans-epidermal diffusion in a targeted manner, see claim 5, wherein the dihydrotestosterone formulation comprises sodium chloride, dibasic sodium phosphate, citric acid, purified water, or any combination thereof, see claim 7. While the U.S. patent claims teach the adult male is healthy, the adult male of the U.S. patent claims is considered to be healthy since there is no teaching of any disease or condition or disorder.
The claims of the U.S. patent do not teach dihydrotestosterone (DHT) in the amount claimed. Moreover, the claims of the U.S. patent do not teach a nonsteroidal alopecia treatment agent (claim 22) where said agent is minoxidil (claim 23) in the amount of about 2% to about 5% w/v (claim 24). Additionally, the claims of the U.S. patent do not teach do not teach a non-steroidal hair growth promoter prostamide (claim 25) where said prostamide is bimatoprost (claim 26) in the amount recited in claims 27 and 28, and a prostaglandin analog (claim 29) where said prostaglandin analog is travoprost (claim 30).
Qin teaches a method of teaching primary, secondary, and elderly hypogonadism disease comprising administration to the skin are a formulation comprising dihydrotestosterone (DHT) in the percentage by weight of 0.7% and a penetration enhancer, see claims 1, 8, and 9, wherein the formulation can be in the form of solutions, suspensions, emulsions, gels, ointments, creams, pastes and patches and wherein the skin includes the chest. (See claim 10 and Abstract.) Moreover, Qin teaches the penetration enhancer exemplified is ethanol with the addition of purified water. (See Example 6, page 4.) The patient population includes middle aged men and a 20 years old male, and the administration is topical. (See page 4, lines 3-12.) Qin teaches the DHT gel is applied to the skin are until the desired effect that is the hypogonadism effect is achieved. (See page 4, lines 1-15.)
Farthing teaches suggest that T and DHT may have independent roles in the control of male facial hair growth, i.e., T for hair follicle priming and DHT for promotion of linear growth. (See Abstract.)
Woodward teaches on the background section that minoxidil has hair growth-stimulating effect. (See page 5, first column and lines 14-16.) Woodward also teaches bimatoprost is administered in the amount of 0.03% by weight. (See claim 2.) Moreover, Woodward teaches bimatoprost stimulates hair follicle. (See page 7; lines 28-32.)
Rethore teaches travoprost medicament compositions for non-daily topical application are useful for simulating or inducing the growth and/or decreasing the loss and/or increasing the density and/or reducing the heterogeneity in the diameter of human hair shafts/follicles, see Abstract. Moreover, Rethore teaches travoprost is a prostaglandin analogue. (See paragraph [0047].)
It would have been prima facie obvious for a person of ordinary skill in the art at the time of the invention was filed to combine the method disclosed by the claims of the U.S. patent with the method taught by Saeedi in view of Qin, and Farthing and the method of Woodward along with that set forth by Rethore because each is taught by the prior art to be useful for the same purpose (i.e., promoting facial hair growth including beard). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, adjustment of the amount of minoxidil and the amount of bimatoprost to the claimed amounts would be well within the skill of an ordinary artisan and are obvious since these amounts are result effective parameters (i.e., hair growth stimulating effect). Since the prior art teaches minoxidil and bimatoprost are effective for promoting hair growth, one would easily be able to calculate the optimal amounts that achieve the desired facial hair growth promoting effect. Finally, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
With respect to the limitations of claims 7-10; these limitations simply express the intended outcome or results of the method step positively recited. Sine the method step of the prior art is the same as claimed, the intended outcome or result would necessarily be present absent evidence to the contrary.
Claims 1, 2, 7-11, 15, and 21-30 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,833,238 B2 in view of
Saeedi et al (Journal of Dermatological Treatment, 2007; 18: 271-274), Woodward et al (US2008/0070988 B2), and Rethore et al (US2010/0190853 A1). Although the claims at issue are not identical, they are not patentably distinct from each other.
The U.S. patent claims teach a method for promoting and enhancing chest hair growth in an adolescent human male or adult human male who has a normal level of circulating total serum testosterone (T) androgen hormone that is within a normal physiologic reference range, wherein said human male is unable to grow chest hair, comprising topically administering an effective amount of a pharmaceutically acceptable formulation of dihydrotestosterone (DHT) to a targeted skin surface area of the human male, and wherein said targeted skin surface area has sparse mature terminal hair growth to promote and enhance growth of mature terminal hair at the targeted skin surface area, wherein said adult human male does not have a genetically determined lower level of intracellular 5 alpha reductase and does not have a genetically determined lower number of androgen receptors. (See claim 1.) said administration is repeated daily until desired hair growth results. (See claim 2.)
The U.S. patent claims do not teach Testosterone. Moreover, the claims of the U.S. patent do not teach a nonsteroidal alopecia treatment agent (claim 22) where said agent is minoxidil (claim 23) in the amount of about 2% to about 5% w/v (claim 24). Additionally, the claims of the U.S. patent do not teach do not teach a non-steroidal hair growth promoter prostamide (claim 25) where said prostamide is bimatoprost (claim 26) in the amount recited in claims 27 and 28, and a prostaglandin analog (claim 29) where said prostaglandin analog is travoprost (claim 30).
Saeedi teaches a method of promoting and enhancing the growth of beard hair to young men with beta-thalassemia major comprising the step of applying a transdermal gel formulation (topical) containing 2.5% testosterone, ethanol, preserved water, methyl and propyl paraben to the beard area of the young (less than 18 and greater than 18 years of age and serum testosterone levels (normal or subnormal according to the Tanner stage). (See Abstract and page 272, and first column.) The application morning and night and the duration of 6 months of treatment implies repeated application of the gel every day for six months until desired hair growth results. Moreover, Saeedi teaches the serum testosterone levels of controls and cases were 9.5 (+/-5.7 mean +/-SD) and 10.5 (+/-9.6 ng/L), respectively; the number of terminal hairs (per cm2) in cases 29.8 (+/- 13.6) was significantly higher than that of controls 13.9 (+/- 13.2) (See Abstract.) The control group is considered healthy individual that benefit from the hair growth promoting effect of the testosterone gel. While Table 1 of Saeedi teaches a mean age of 20.3 (+/-3.1) and a mean serum testosterone level of 10.2 (+/- 90.6) as the preferred patient, page 272 and first column of Saeedi teaches the patient were divided into two randomized groups and two blocks (Subgroups) in every group, according to age (less than or equal to 18 and greater than 18) and serum testosterone level (normal or subnormal according to the Tanner stage. Patients with age greater than 18 and tanner stage greater than 4 according to the Abstract are considered adult human males who have completed puberty. While Saeedi does not teach ethanol is a penetration enhancer, the instant specification is evidenced that ethanol is a penetration enhancer. (See page 21, last paragraph.) Moreover, Saeedi teaches the transdermal administration of testosterone allows approximation of the natural testosterone pattern of serum testosterone found in healthy men and wherein said transdermal formulation is thought to be superior than oral administration. (See page 271, second col, first paragraph.) Furthermore, Saeedi teaches the study showed that 2.5 % testosterone gel was effective in inducing the transformation of beard area hairs to terminal hairs, see page 273, first col, last para. Since ethanol is used in the formulation of Seedi et al. and since said formulation was effective to stimulate terminal beard hairs, the concentration of ethanol in the formulation taught would be considered a concentration formulated so as to deliver the testosterone to the air follicle bulb matrices, but testosterone not significantly absorbed into the systemic circulation. Lastly, Saeedi et al. teaches the transdermal administration of testosterone allows approximation of the natural endogenous pattern of serum testosterone found in healthy men and has been show to produce positive effects on fatigue, mood and sexual function, see page 271, right col.
Woodward teaches on the background section that minoxidil has hair growth-stimulating effect. (See page 5, first column and lines 14-16.) Woodward also teaches bimatoprost is administered in the amount of 0.03% by weight. (See claim 2.) Moreover, Woodward teaches bimatoprost stimulates hair follicle. (See page 7; lines 28-32.)
Rethore teaches travoprost medicament compositions for non-daily topical application are useful for simulating or inducing the growth and/or decreasing the loss and/or increasing the density and/or reducing the heterogeneity in the diameter of human hair shafts/follicles, see Abstract. Moreover, Rethore teaches travoprost is a prostaglandin analogue. (See paragraph [0047].)
It would have been prima facie obvious for a person of ordinary skill in the art at the time of the invention was filed to combine the method disclosed by the claims of the U.S. patent with the method taught by Saeedi and the method of Woodward and Rethore because each is taught by the prior art to be useful for the same purpose (i.e., promoting facial hair growth including beard). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, adjustment of the amount of minoxidil and the amount of bimatoprost to the claimed amounts would be well within the skill of an ordinary artisan and are obvious since these amounts are result effective parameters (i.e., hair growth stimulating effect). Since the prior art teaches minoxidil and bimatoprost are effective for promoting hair growth, one would easily be able to calculate the optimal amounts that achieve the desired facial hair growth promoting effect. Finally, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
With respect to the limitations of claims 7-10; these limitations simply express the intended outcome or results of the method step positively recited. Sine the method step of the prior art is the same as claimed, the intended outcome or result would necessarily be present absent evidence to the contrary.
Applicants argue that the inclusion of the limitations of claims 5 and 31 into claim 1 renders all the double patenting rejections withdrawn.
In response, Applicant’s argument is not persuasive because the new double patenting rejections set forth above clearly remedy the deficiencies of Qin, Farthing, Woodward and Rethore.
Applicant’s Arguments
Applicant argues that the references fail to provide any guidance or motivation relating to the method as currently claimed. The rejection lacks any rationale as to why one of ordinary skill in the art would be motivated to identify the various claimed features and the art provides no guidance or that would have directed one of skill toward those features.
Examiner’s response
In response, Applicant’s argument is not persuasive because the cited references and the U.S. patent claims in combination clearly provides the motivation and/or the rationale to combined the method of the U.S. patent, Saeedi with the method of Farthing, the method of Woodward along with that set forth by Rethore to give an additional method for promoting beard hair growth because each is taught by the prior art to be useful for the same purpose (i.e., promoting beard hair growth). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Conclusion
Claims are 1, 2, 7-11, 15, and 21-30 are allowed.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628