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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 44, 74-81, 87-91, drawn to a composition comprising testosterone, classified in A61K9/0014.
II. Claims 82-86 and 92, drawn to a method of treating HSDD, classified in A61K31/568.
The inventions are independent or distinct, each from the other because:
Inventions invention group I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process for using the product as claimed can be practiced with another materially different product, for example, Flibanserin pill.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
A different field of search is required.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
During a telephone conversation with Robert Ward on 09/08/2026 a provisional election was made without traverse to prosecute the invention of invention group I, Claim 44, 74-81, 87-91. Affirmation of this election must be made by applicant in replying to this Office action. Claims 82-86 and 92 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim 44, 74-92 are pending, claim 44, 74-81, 87-91 are under examination.
Priority
Acknowledge is made that this application is continuation of US patent application 17255022, filed on 12/22/2020; which is national stage of international patent application PCT/US19/40510, filed on 07/03/2019, which claims priority from US provisional application 62/694365, filed on 07/05/2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/22/2024 and 04/01/2022 is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 74 and 90 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 74 and 90 contain the trademark/trade name Azone and Transcutol. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a source of goods and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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 of this title, 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 nonobviousness.
Claims 44, 74-79, 87-90 are rejected under 35 U.S.C. 103 as being unpatentable over Kottayil et al. (US20170296484).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Kottayil et al. teaches A polymeric bio-adhesive film forming topical spray formulation providing a modified, pulsatile ( e.g., biphasic) release of the active agent(s) once the solvent evaporates and the film sets, e.g., on human skin is disclosed (abstract). certain preferred embodiments, the film forming topical spray formulation of the invention comprises from about 1 % to about 50% hydrophilic film forming polymer
(s), from about 0.05% to about 35% active agent(s), from about 0.05% to about 50% permeation enhancer, and from about 0.01 % to about 30% optional additional pharmaceutically acceptable excipients (as described herein), in a hydroalcoholic solvent (page 7, [0065]). The preferred film forming polymer includes an effective amount of a hydrophilic polymer to provide the desired release of active agent as described herein. In preferred embodiments, the film forming polymer comprises from about 1 % to about 50% of the topical spray formulation, (page 7, [0072-0073]). In certain preferred embodiments, the formulation further comprises from about 1 % to about 50% of a drug crystal precipitation inhibiting agent which prevents or substantially prevents the drug(s) included in the formulation from precipitating. The amount of the drug crystal precipitation inhibiting agent may be based on visual inspection of the film for the presence of drug crystals after solvent evaporation and film uniformity (page 7, [0076]). In certain embodiments, up to about 35% of the film forming polymer may be comprised of a hydrophobic polymer. Suitable hydrophobic polymers include Poly(methacrylicacid, methyl methacrylate) 1:2, methacrylic acid copolymer type A
(Eudragit L100®), methacrylic acid copolymer type B (Eudragit Sl00®), and the like (page 8, [0077-0078]). The preferred solvent for the polymeric film forming
topical spray formulation includes ethanol, isopropyl alcohol, acetone, n-butanol, methylene chloride, methylene dimethyl ether, water, hydroalcoholic system alone and or in combination of two or more solvents. The solvent concentration
in the topical spray formulation can vary between about 20% to about 99% of the formulation. Preferably, the solvent is a hydroalcoholic solvent (page 8, [0082]). In certain preferred embodiments, the polymeric film forming topical spray formulation further comprises an effective amount one or more permeation enhancers which
allows a sufficient amount of the dose of the drug(s) to permeate through the skin. Preferred permeation enhancers include isopropyl myristate, Oleic acid, polyethylene glycol and mixture thereof. The polyethylene glycol includes PEG300 and PEG 400 (page 8-9, [0083-0084]). The composition may further comprise one or more additional components selected from the group consisting of solubilizers, plasticizers, and water soluble additives. Preferred plasticizers include triethyl citrate, dimethyl isosorbide, acetyltributyl citrate, castor oil, propylene glycol, and polyethylene glycol, or any two or more of the above in combination (page 9, [0092-0093]). In most applications, optimal viscosities of the system of the invention will range from about 10 to about 2,000,000 centipoise, preferably from about 0.3 to 1000 centipoise, and more preferably from about 0.5 to about 100 centipoise, at 37° C. While the benefit of the invention is realized over a broad range of elevated viscosities, the optimal viscosities will be different for different applications (page 9, [0094]). In certain preferred embodiments, the active agent(s) (drug (s)) is a steroid, such as estrogen, estradiol, norethindrone, levonorgestrel, ethinylestradiol, norelgestromin, testosterone, and mixtures thereof. The composition contains preferably up to about 30% of the at least one medicament (drug), more preferably up to about 10% of the at least one drug and most preferably up to about 5% of the at least one drug (page 11, [0110, 0112]). In addition to the active agent(s) (e.g., local anesthetic), the polymeric film forming topical spray formulation may additionally include physiologically acceptable components such as sodium chloride and like materials conventionally used to achieve isotonicity with typical body fluids, pH buffers to establish a physiologically compatible pH range and to enhance the solubility of the anesthetic present, vasoconstrictors such as epinephrine, preservatives, stabilizers and antioxidants and the like (page 9, [0088]). The composition is in the form of solution. Emulsion or suspension (claim 9).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Kottayil et al. is that Kottayil et al. does not expressly all the limitation in one embodiment.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Regarding claims 44, 74-76, 79 and 90, Kottayil et al. teaches a liquid polymeric film forming topical spray formulation comprising testosterone at about 0.05% to about 10%; penetration enhancer such as oleic acid and polyethylene glycol and mixture thereof; ethanol as solvent; film forming excipient such as Poly(methacrylic acid, methyl methacrylate) 1:2 and Eudragit L100® (Poly(methacrylic acid, methyl methacrylate) 1:1 according to applicant’s specification); plasticizer polyethylene glycol (washability enhancer according to applicant’s specification) and drug crystal precipitation inhibiting agent. Since Poly(methacrylic acid, methyl methacrylate) 1:1 (or 1:2) is recited in dependent claim 74, it must meet all the properties requirement of film forming excipients such as solubility in water and ethanol. Furthermore, Kottayil et al. teaches drug crystal precipitation inhibiting agent, the composition is capable of prevent crystallization of estradiol and testosterone when applied to skin. Kottayil et al. teaches the composition forming a film after applied to skin and is silent about washable which is regarded as inherent property of prior art composition. Since prior art teaches the same or substantially same applicant’s claimed composition, this same or substantially same composition is expected to have the same property such as washable.
Regarding claim 77, Kottayil et al. teaches polyethylene glycol (including PEG 400) as penetration enhancer and also plasticizer. Since PEG 400 is known and polyethylene glycol in the composition, it is obvious to use PEG 400 as polyethylene glycol as penetration enhancer and also plasticizer.
Regarding claim 78, Kottayil et al. is silent about water vapor transmission rate, which is regarded as inherent property of prior art composition. Since prior art teaches the same or substantially same applicant’s claimed composition, this same or substantially same composition is expected to have the same property. MPEP 2112.I. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
Regarding claims 87-88, Kottayil et al. teaches viscosity about 0.5 to about 100 centipoise, encompassing applicant’s claimed range.
Regarding claim 89, the storage of the claimed composition is not limiting because there is no structurally difference between the claimed composition in a container and prior art composition.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 80-81 and 91 are rejected under 35 U.S.C. 103 as being unpatentable over Kottayil et al. (US20170296484), as applied for the above 103 rejection for claims 44, 74-79, 87-90, in view of Birrenbach (US6803063) and Morgan et al. (US8357393).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Kottayil et al. teaching has already been discussed in the above 103 rejection an is incorporated herein by reference.
Birrenbach teaches cosmetic composition (abstract) in the form of emulsion for spray, and the composition also comprises buffer substances in the pH range of about from 4 to 8, preferably of about from 5.5 to 7.0, or agents for adjusting the pH to such a value (e.g. tromethamine or triethanolamine) (column 4, line 1-35).
Morgan et al. teaches transdermal composition (abstract), and the preferred dermal penetration enhancers includes: fatty acids, fatty acid esters, fatty alcohols and octyl salicylate (octisalate). The composition is topical spray in one embodiment (column 6, line 15-45).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Kottayil et al. is that Kottayil et al. do not expressly teach tromethamine and octisalate. This deficiency in Kottayil et al. is cured by the teachings of Birrenbach and Morgan et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kottayil et al., as suggested by Birrenbach and Morgan et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to include tromethamine and octisalate because they are suitable ingredients in the topical spray composition. MPEP 2144.07. Under guidance from Kottayil et al. teaching buffer agent and penetration enhancer in the composition, Birrenbach teaching tromethamine as suitable buffer agent in spray cosmetic composition; Morgan et al. teaching octyl salicylate (octisalate) as suitable penetration enhancer; it is obvious to include tromethamine and octisalate and produce instant claimed invention with reasonable expectation of success.
Regarding claim 91, prior art teaches about 20% to about 99% solvent such as ethanol and penetration enhancer octisalate.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory 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 nonstatutory 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 nonstatutory 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 44, 74-81, 87-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12186326. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches a composition comprising about 0.1% w/w to about 25% w/w testosterone; one or more penetration enhancers selected from the group consisting of 1-dodecylazacycloheptan-2-one, Glycerol Monooleate, Isopropyl Myristate, Octisalate, Oleic Acid, and diethylene glycol monoethyl ether; one or more solvents selected from the group consisting of Acetone, Ethanol and Isopropyl Alcohol; about 1% to about 10% of one or more film forming excipients selected from the group consisting of Methacrylic Acid and Methyl Methacrylate Copolymer 1:1, Methacrylic Acid and Methyl Methacrylate Copolymer 1:2, Poly (butylmethacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methyl methacrylate 1:2:1, Hypromellose, Hydroxypropyl Cellulose, and Ethyl Cellulose; one or more washability enhancers, wherein the washability enhancer, and thus teaches each limitation of applicant’s claimed invention, and one artisan in the art would immediately recognize obvious variance of instant claimed invention over patented subject matter.
Claims 44, 74-81, 87-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11523994. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches a composition comprising about 10% about 25% w/w testosterone; one or more penetration enhancers selected from the group consisting of azone, glycerol monooleate, isopropyl myristate, octisalate, oleic acid, and diethylene glycol monoethyl ether; one or more solvents selected from the group consisting of acetone, ethanol, and isopropyl alcohol; about 4% to about 8% of one or more film forming excipients selected from the group consisting of methacrylic acid and methyl methacrylate copolymer 1:1, methacrylic acid and methyl methacrylate copolymer 1:2, poly(butylmethacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate 1:2:1, hydroxypropyl cellulose, ethyl cellulose, butyl ester of methyl vinyl ether/maleic anhydride copolymer, and polyvinyl acetate-povidone polymer; one or more washability enhancers, wherein the washability enhancer, and thus teaches each limitation of applicant’s claimed invention, and one artisan in the art would immediately recognize obvious variance of instant claimed invention over patented subject matter.
Claims 44, 74-81, 87-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 122208169. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches a composition comprising about 10% about 25% w/w testosterone; one or more penetration enhancers selected from the group consisting of azone, glycerol monooleate, isopropyl myristate, octisalate, oleic acid, and diethylene glycol monoethyl ether; one or more solvents selected from the group consisting of acetone, ethanol, and isopropyl alcohol; about 4% to about 8% of one or more film forming excipients selected from the group consisting of methacrylic acid and methyl methacrylate copolymer 1:1, methacrylic acid and methyl methacrylate copolymer 1:2, poly(butylmethacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate 1:2:1, hydroxypropyl cellulose, ethyl cellulose, butyl ester of methyl vinyl ether/maleic anhydride copolymer, and polyvinyl acetate-povidone polymer; one or more washability enhancers, wherein the washability enhancer, and thus teaches each limitation of applicant’s claimed invention, and one artisan in the art would immediately recognize obvious variance of instant claimed invention over patented subject matter.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
Prosecution Insights