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 .
DETAILED ACTION
This Office Action is responsive to the Response to Election/Restriction and Amendment filed 06/11/2026, wherein claim 11 is amended and claims 17-20 are added.
Claims 1-20 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of Group I, the composition, in the reply filed on 06/11/2026, is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1-11 are examined on the merits herein.
Claim Objections
Claim 10 is objected to because of the following informalities:
In claim 10, “DMSO” should be replaced with - -dimethyl sulfoxide (DMSO)- -.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by US2020/0297705 to Patel (effectively filed 03/19/2019, PTO-892).
Patel teaches oral liquid formulation of tacrolimus (title, abstract).
Patel specifically exemplifies the following compositions:
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, wherein propylene glycol is a solvent/carrier and glycerin is a solvent/carrier.
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., wherein propylene glycol is a solvent/carrier and polyethylene glycol is a solvent/carrier.
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(pgs. 12-13, Examples 4-6), wherein in samples 1 and 14, mineral oil is a solvent/carrier and water is a solvent/carrier, and wherein in Example 6 capric/caprylic triglycerides, diisopropyl adipate, and isopropyl myristate are solvent/carrier and water is a solvent/carrier.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over US2020/0297705 to Patel (effectively filed 03/19/2019, PTO-892).
Patel is applied to claim 1 as discussed above.
Regarding claims 2-3, Patel differs in that it does not teach ethyl alcohol as the solvent.
Patel teaches alcohols, such as ethanol, polyols such as glycerin, propylene glycol, polyethylene glycols, and oils as solvents ([0023]; pg. 9, claims 2, 7).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective fling date of the instantly claimed invention, to substitute the glycerin, propylene glycol, polyethylene glycol, or oil solvent in the exemplified compositions of Patel, with ethanol (ethyl alcohol), to arrive at instant claims 2-3. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because Patel teaches ethanol, glycerin, propylene glycol, polyethylene glycol, or oil as solvents useful in its compositions, and substituting equivalents known for the same purpose is prima facie obvious, see MPEP 2144.06.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over CN102579437 (published 2011, PTO-892).
‘437 teaches a composition comprising 0.001-0.5wt% tacrolimus, 0.2-10wt%phospholipid, 10-60wt% alcohol, 0-0.5wt%cholesterol, and the balance of water, wherein the composition is an aqueous liquid (claim 1; “Summary of the Invention”).
‘437 exemplifies compositions comprising tacrolimus, ethanol, and water (Examples 1-2, 5, ) and exemplifies a composition comprising tacrolimus, polyethylene glycol, and water (Examples 3-4).
‘437 further exemplifies a composition comprising tacrolimus, ethanol, propylene glycol, and water (Example 6).
While ‘437 teaches a composition comprising tacrolimus, solvent, and carrier, it differs from that of instant claim 1 in that it does not teach the specific %w/w of tacrolimus, solvent, and carrier.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the %w/w of tacrolimus, solvent, and carrier, in the compositions of ‘437, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-‘437 teaches 0.001-0.5wt% tacrolimus, 0.2-10wt%phospholipid (carrier), 10-60wt% alcohol (solvent), 0-0.5wt%cholesterol, and the balance of water (carrier), and
-in the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
The optimization of known amounts for known agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 2-3, ‘437 exemplifies ethanol (ethyl alcohol) as a solvent (see the examples above and claim 4).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over CN102579437 (published 2011, PTO-892), as applied to claims 1-3 above, and further in view of Wong (What are propylene and butylene glycol, and are they safe, published 2018, PTO-892).
CN’437 is applied to claims 1-3 above and incorporated herein.
The compositions of CN ‘437 differ from that of instant claim 4 in that it does not teach 1,3-propanediol as the carrier.
Wong teaches that propylene glycol sometimes refers to 1,3-propanediol, but usually refers to 1,2-propanediol, and that 1,3-propanediol is usually referred to as propanediol. Wong teaches that 1,3-propanediol is becoming more popular in cosmetics since propylene glycol has been on watchlists (pg. 2)
Wong provides the structures of the compounds:
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(pg. 2).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select 1,3-propanediol as the alcohol in the composition of CN ‘437, to arrive at instant claim 4. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-CN ‘437 exemplifies propylene glycol as the alcohol,
-Wong teaches that propylene glycol can refer to 1,2-propanediol and 1,3-propanediol,
-Wong teaches 1,3-propane diol as preferred carrier to 1,2-propanediol (propylene glycol) because it is on less watchlists, and
-a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties," In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963), MPEP 2144.09.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a similar tacrolimus formulation.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over CN102579437 (published 2011, PTO-892), as applied to claims 1-3 above, and further in view of Herkal (Study of Therapeutic Comparison of Tacrolimus 0.1% and Minoxidil 2% in Alopecia Areata, published 2013, PTO-892) and Mohan (Association of Vitiligo and Alopecia Areata with Atopic Dermatitis a Systematic Review and Meta-analysis, published 2015, PTO-892).
CN’437 is applied to claims 1-3 above and incorporated herein.
The compositions of CN ‘437 differ from that of instant claim 5 in that they do not teach minoxidil.
Herkal teaches that combining minoxidil 2% solution and tacrolimus 0.1% ointment may yield a better clinical response for treating patchy alopecia areata (abstract).
CN ‘437 teaches its compositions is for the treatment of atopic dermatitis or atopic eczema (pg. 3).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add 2% minoxidil to the composition of CN ‘437, to arrive at instant claim 5. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Herkal teaches that it is known to combine tacrolimus and minoxidil ointments for the treatment of alopecia areata,
-CN ‘437 teaches its compositions for the treatment of atopic dermatitis,
-Mohan teaches that patients with alopecia areata have significantly increased risk for AD (abstract), and
-CN ‘437 teaches its compositions as alcohol based and superior to ointments, which have an unpleasant viscosity, unpleasant greasiness, and are not easy to clean (pg. 3).
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a formulation that treats both atopic dermatitis and alopecia areata, and which is free from oily bases.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over CN102579437 (published 2011, PTO-892), as applied to claims 1-3 above, and further in view of Pappas (Compatibility of Tacrolimus Ointment with Corticosteroids Ointments of Varying Potencies, published 2009, PTO-892).
CN’437 is applied to claims 1-3 above and incorporated herein.
The compositions of CN ‘437 differ from that of instant claims 6-8 in that they do not teach clobetasol propionate.
Pappas teaches the coadministration of tacrolimus and clobetasol propionate for the treatment of atopic dermatitis (abstract; pgs. 140-141). Pappas teaches the formulation as comprising 0.05% clobetasol and 0.1% tacrolimus (“Methods”).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add 0.5% clobetasol to the composition of CN ‘437, to arrive at instant claims 6-8. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Pappas teaches the combination of tacrolimus and clobetasol propionate for the treatment of steroid responsive atopic dermatitis,
-CN ‘437 teaches its compositions for the treatment of atopic dermatitis,
-Pappas teaches that tacrolimus is often administered with corticosteroids, such as clobetasol propionate (abstract).
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a single formulation that combines tacrolimus and corticosteroids, and which specifically treats steroid responsive atopic dermatitis.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over CN102579437 (published 2011, PTO-892) in view of Herkal (Study of Therapeutic Comparison of Tacrolimus 0.1% and Minoxidil 2% in Alopecia Areata, published 2013, PTO-892) and Mohan (Association of Vitiligo and Alopecia Areata with Atopic Dermatitis a Systematic Review and Meta-analysis, published 2015, PTO-892), as applied to claims 1-3 and 5 above, and further in view of Alsaheb (Lactic acid applications in pharmaceutical and cosmeceutical industries, published 2015, PTO-892).
CN ‘437, Herkal and Mohan are applied as discussed above and incorporated herein.
The composition of the combination of CN ‘437, Herkal and Mohan differs from that of instant claim 9 in that the composition does not contain lactic acid.
Alsaheb teaches lactic acid as an organic acid well known in the cosmetic and pharmaceutical industry as a pH regulator, and which has further application as a skin hydrator, an antimicrobial, a skin lightener, a moisturizer, and for use in controlled drug delivery systems (pgs. 729-730, Introduction; pgs. 731, last two paragraphs-733).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add lactic acid to the composition of the combination of CN ‘437, Herkal, and Mohan, to arrive at instant claim 9. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-CN ‘437 teaches that pH adjusting agents can be added to its compositions, and
-Alsaheb teaches lactic acid as known in the cosmetic and pharmaceutical arts as a pH regulator.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a composition with a regulated pH.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over CN102579437 (published 2011, PTO-892) in view of Herkal (Study of Therapeutic Comparison of Tacrolimus 0.1% and Minoxidil 2% in Alopecia Areata, published 2013, PTO-892) and Mohan (Association of Vitiligo and Alopecia Areata with Atopic Dermatitis a Systematic Review and Meta-analysis, published 2015, PTO-892), as applied to claims 1-3 and 5 above, and further in view of Walker (The role of percutaneous penetration enhancers, published 1996, PTO-892).
CN ‘437, Herkal and Mohan are applied as discussed above and incorporated herein.
The composition of the combination of CN ‘437, Herkal and Mohan differs from that of instant claim 10 in that the composition does not contain DMSO.
Walker teaches DMSO as an effective penetration enhancer that promotes permeation by reducing skin resistance to drug molecules or by promotion of drug partitioning from the dosage form. DMSO denatures the intercellular structural proteins of the stratum corneum, promotes lipid fluidity by disruption of the ordered structure of the lipid chains, and alters the physical structure of the skin by elution of lipid, lipoprotein, and nucleoprotein structures of the stratum corneum (pg. 297, 3.1.)
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add DMSO to the composition of the combination of CN ‘437, Herkal, and Mohan, to arrive at instant claim 10. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-CN ‘437 teaches topical pharmaceutical formulations, and
-Walker teaches DMSO as an effective penetration enhancer in topical pharmaceutical formulations.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a composition with enhanced penetration of tacrolimus and minoxidil.
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 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/apply/applying-online/eterminal-disclaimer.
Claims 1 and 5 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 11-12, 14-15, 17 of copending Application No. 17/302,781 (claim set of 05/26/2026, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘781 claims an injectable, i.e., liquid, composition comprising about 0.25-1.5%w/w minoxidil, about 8%-15%w/w castor oil derivative (solvent), and a pharmaceutically acceptable carrier (claim 1).
See [0012] of the ‘781 specification which teaches that “about” means plus or minus 10%.
‘781 claims the composition as additionally comprising 0.001-5% w/w tacrolimus (claims 2-4).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 11 is allowed.
REASONS FOR ALLOWANCE
The following is an examiner' s statement of reasons for allowance:
The instantly claimed composition is novel and non-obvious over the prior art.
The closest prior art is Patent No. US2020/0297705 to Patel and CN102579437 (published 2011, PTO-892), as detailed above.
These references do not teach their compositions as comprising tofacitinib, minoxidil, clobetasol, lactic acid, DMSO, or 1,3-propanediol, which are distinct features of the instantly claimed composition.
Therefore, the prior art neither anticipates nor reasonably makes obvious the claimed composition and therefore, the claimed composition is deemed novel and unobvious over the
prior art.
Conclusion
Claim 11 is allowed.
Claims 1-10 are rejected.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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