Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
The preliminary amendment of 13 December 2024, in which claims 1-34 have been cancelled, and new claims 35-39 are pending in the instant application.
Claims 35-39 are being examined on their merits herein.
Priority
This application is a Continuation of United States Application No. 17/936,562, filed September 29, 2022, now abandoned, which is a Continuation of United States Application No. 17/025,156, filed September 18, 2020, now abandoned, which is a Continuation of United States Application No. 14/147,376, filed January 3, 2024, now abandoned, which claims the benefit of priority to United States Provisional Applications No. 61/611,232, filed March 15, 2012; 61/748,603, filed January 3, 2013; 61/780,074, filed March 13, 2013; 61/779,953 filed March 13, 2013; 61/831,981, filed June 6, 2013; and 61/831,795, filed June 6, 2013; and is a continuation in part application of:
1) U.S. Patent Application No. 13/831,396, filed March 14, 2013, and International Patent Application No. PCT/IB2013/001170, filed March 14, 2013;
2) U.S. Patent Application No. 13/499,501, filed September 10, 2012, which is a 371 of International Patent Application No. PCT/IB2010/02612 filed October 1, 2010,
which claims the benefit of priority to United States Provisional Applications No. 61/248,144, filed October 2, 2009; 61/322,148, filed April 8, 2010; 61/349,911, filed May 31, 2010; 61/385,385, filed September 22, 2010; 61/331,126, filed May 4, 2010; and 61/380,568 filed September 7, 2010;
3) U.S. Patent Application No. 13/499,727, filed September 10, 2012, which is a 371 of International Patent Application No. PCT/IB2011/01374, filed May 4, 2011,
International Patent Application No. PCT/IB2010/002617, filed October 1, 2010,
International Patent Application No. PCT/IB2010/002612, filed October 1, 2010, and
International Patent Application No. PCT/IB/2010/002613, filed October 1, 2010, which
claims the benefit of priority to United States Provisional Applications No. 61/388,884, filed October 1, 2010; 61/385,385, filed September 22, 2010; 61/380,568, filed September 7, 2010; 61/349,911, filed May 31, 2010; and 61/331,126, filed May 4, 2010;
4) U.S. Patent Application No. 13/100,724, filed May 4, 2011, which is a continuation in part application of:
A) International Application No. PCT/IB2010/002612, filed October 1, 2010, which claims the benefit of priority to United States Provisional Applications No. 61/248,144, filed October 2, 2009; 61/322,148, filed April 8, 2010; 61/349,911, filed May 31, 2010; 61/385,385, filed September 22, 2010; 61/331,126, filed May 4, 2010; 61/388,884, filed October 1, 2010; and 61/380,568, filed September 7, 2010;
B) U.S. Patent Application No. 13/100,724, filed May 4, 2011, which is a continuation in part application of International Application No. PCT/IB2010/002617, filed October 1, 2010, which claims the benefit of priority to United States Provisional Applications No. 61/248,144, filed October 2, 2009; 61/322,148, filed April 8, 2010;
61/349,911, filed May 31, 2010; 61/385,385, filed September 22, 2010; 61/331,126, filed May 4, 2010; 61/388,884, filed October 1, 2010; and 61/380,568 filed September 7, 2010; and
C) U.S. Patent Application No. 13/100,724, filed May 4, 2011, which is a continuation in part application of International Application No. PCT/IB2010/002613, filed October 1, 2010, which claims the benefit of priority to United States Provisional Applications No. 61/248,144 filed, October 2, 2009; 61/322,148, filed April 8, 2010; 61/349,911, filed May 31, 2010; 61/385,385, filed September 22, 2010; 61/331,126, filed May 4, 2010; 61/388,884, filed October 1, 2010; and 61/380,568, filed September 7, 2010;
5) U.S. Patent Application No. 13/499,475, filed September 14, 2012, which is a 371 of International Patent Application No. PCT/IB2010/002617, filed October 1, 2010, which claims the benefit of priority to United States Provisional Applications No. 61/248,144, filed October 2, 2009, United States Provisional Application No. 61/322,148, filed April 8, 2010, United States Provisional Application No. 61/349,911, filed May 31, 2010, United States Provisional Application No. 61/385,385, filed September 22, 2010, United States Provisional Application No. 61/331,126, filed May 4, 2010, United States Provisional Application No. 61/380,568, filed September 7, 2010, and United States Provisional Application No. 61/388,884, filed October 1, 2010; and
6) U.S. Patent Application No. 13/499,709 filed September 10, 2012, which is a 371 of International Patent Application No. PCT/IB2010/002613, filed October 1, 2010, and claims the benefit of priority to United States Provisional Application No. 61/248,144, filed October 2, 2009, United States Provisional Application No. 61/322,148, filed April 8, 2010, United States Provisional Application No. 61/349,911, filed May 31, 2010, United States Provisional Application No. 61/385,385, filed September 22, 2010, United States Provisional Application No. 61/331,126, filed May 4, 2010, United States Provisional Application No. 61/380,568, filed September 7, 2010, and United States Provisional Application No. 61/388,884, filed October 1, 2010.
Information Disclosure Statement
No information disclosure statement (IDS) has been submitted.
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 38, 39 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 38 depends on claim 35 and recites that the hydrophobic solvent comprises two or more of a soybean oil, a coconut oil […]. Yet, claim 35 recites that the hydrophobic solvent comprises a soybean oil. There is no antecedent basis for the other components of the hydrophobic solvent listed in claim 38, beyond soybean oil, of claim 38, in claim 35. Claim 38 should be amended to recite that the hydrophobic solvent further comprises a coconut oil, […].
The same analysis applies to claim 39.
Appropriate correction is required.
Claim Rejections- 35 USC 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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 35-39 are rejected under 35 U.S.C. 103(a) as being unpatentable over Eini et al. (US 6,911,211 of 28 June 2005, cited in PTO-892), in view of Mead et al. (US 3,849,569 of 19 November 1974, cited in PTO-892), Tamarkin (US 2005/0186147, cited in PTO-892) and Korting et al. (Skin Pharmacol Physiol 2009, 22, 287-294, published online 25 September, 2009, cited in PTO-892).
Eini (US 6,911,211) discloses a non-foam composition useful to treat a skin disease (column 5, lines 10-11) comprising:
(d) an antibiotic such as a tetracycline, (column 13, line 22-23 line) and
a carrier comprising
at least one hydrophobic solvent, which includes at least one plant-derived oil such as, for example, soybean oil, where the hydrophobic solvent is present at 75-99% by weight of the composition (claim 41), which is within the range in the instant claims,
a wax,
c) a rheology modulator which is at least one fatty alcohol, or at least one fatty acid, or combinations thereof,
said composition being semi-solid at ambient temperature, hydrophobic by nature, free of surfactant, as in instant claims, and waterless (Eini Examples 4, 7, 8), which corresponds to a water activity (Aw) value of 0.6 or less, which overlaps with the ranges in instant claims 35, 36, 37.
The concentration of tetracycline antibiotic in the composition (Example 4) is 0.99% wt., which is close to the value 1% in instant claims 35, 36; or (Example 7) is 2.34% wt., which is within the range in instant claims 35, 36.
Eini does not teach a foam composition comprising minocycline.
Eini teaches that upon addition of a fatty alcohol (called “solidifying agent,” column 7, lines 63-67), such as behenyl alcohol or stearyl alcohol or mixtures thereof (column 8, lines 4-6) or of a fatty acid such as stearic acid (column 8, lines 15-16), to a liquid hydrophobic solvent (column 6, lines 56-57), the resulting carrier is semi-solid at rest and liquefies upon application of shear forces thereto, i.e. has thixotropic properties (column 7, lines 63-67). Eini teaches that fatty alcohols such as behenyl alcohol/stearyl alcohol or fatty acids such as stearic acid are rheology modulators in a therapeutic composition comprising a tetracycline antibiotic and a hydrophobic solvent, the role of behenyl alcohol/stearyl alcohol/stearic acid being to increase the viscosity of said composition and to make it thixotropic.
Eini teaches that the “solidifying agent” (i.e. rheology modulator) includes additionally or alternatively (column 7, lines 49-53) a fatty alcohol, such as behenyl alcohol (column 8, lines 1-9), and/or a fatty acid such as stearic acid (column 8, lines 14-24).
Eini teaches the hydrophobic solvent includes at least one plant-derived oil such as, for example, soybean oil, coconut oil, at least one mineral oil, (column 8, lines 51-62), and Eini specifically teaches cyclomethicone as a non-volatile silicone oil emollient (column 20, line13) in the composition. These are components recited in instant claim 38.
Eini teaches tetracyclin (Example 4) as specific antibiotic added to a semi-solid carrier; Eini broadly an antibiotic agent (column 5, line 22) selected from tetracyclines (column 5, line 33, column 17, line 8) as a biologically active substance in the composition, such biologically active substance, which may be a single drug or a combination of drugs (column 9, lines 36-37), being spread in the carrier (column 9, line 38).
Eini teaches (column 3, lines 18-26) that said topical compositions or carriers that are semi-solid at rest and which liquefy upon application of shear forces thereto, are highly advantageous because they are applied as a semi-solid onto the affected area of the skin and then turn into a liquid upon spreading, resulting in faster absorption and less greasiness and stickiness compared to compositions/carriers having undesirable flow properties (column 3, lines 1-4).
Eini teaches that the compositions of the invention, being hydrophobic by nature, will facilitate an enhanced rate of penetration of the antibacterial agents into the hydrophobic environment of the sebaceous gland (column 13, lines 9-12). Eini teaches (column 13, lines 31-35) that the intrinsic antibacterial and anti-inflammatory effects of the fatty alcohols and fatty acids of the compositions of the invention provide a synergistic effect that results in better therapeutic response to treatment.
Eini does not teach a foam composition comprising a propellant and a pre-foam formulation comprising minocycline antibiotic, as in instant claim 36, neither does he teach a method of treating rosacea with said composition, as in instant claims 35, 37-39.
Eini does not specifically teach a wax comprising a hydrogenated castor oil or/and beeswax in the composition, as in instant claims.
Mead teaches (US 3,849,569) pharmaceutical preparations for topical administration (column 4, line 20) containing an antibiotic (column 3, lines 51-52, example 4), hydrophobic solvents such as mineral oils, mixtures of vegetable oils such as soybean oil (column 3, lines 13-30), as in instant claim 38, and thickening agents (rheology modulators) such as hydrogenated castor oil (Example 4, column 4), beeswax (column 3, lines 30-33), as in instant claim 39.
Tamarkin (US 2005/0186147) discloses a foamable cosmetic or pharmaceutical carrier composition (which contains water and surfactant) which is practically in a flowing liquid state, having viscosity between about 100 CPS and about 10,000 CPS ([0015]), suitable for topical administration ([0005]), useful to treat, for example, rosacea [0160], comprising antibacterial drugs such as tetracyclines [0123], hydrophobic solvent [0009], and a gelling agent/rheology modulator [0057]. Tamarkin teaches [0017] that the foamable carrier composition, when mixed with a propellant substance, produces a lightweight breakable foam suitable for facile application to the skin.
Korting et al. (Skin Pharmacol Physiol 2009, 22, 287-294) teach (page 289, left column, third paragraph) second-generation tetracyclines, including minocycline, as being most frequently and most successfully used in the treatment of rosacea.
It would have been obvious to use soybean oil, coconut oil, cyclomethicone, mineral oil as hydrophobic solvent in a composition taught by Eini, because soybean oil, coconut oil, cyclomethicone, or mineral oils have all been disclosed by Eini as hydrophobic solvents to be used interchangeably or as mixtures in such compositions.
It would have been obvious to a person of ordinary skill in the art to use hydrogenated castor oil, alone or in combination with beeswax, as a rheology modulator/wax in a composition taught by Eini, in combination with at least one fatty alcohol or/and at least one fatty acid. The person of ordinary skill in the art would have been motivated to use hydrogenated castor oil (and beeswax) as the rheology modulator, because Mead teaches hydrogenated castor oil, beeswax as rheology modulators in similar topical compositions comprising an antibiotic and a hydrophobic solvent such as a vegetable oil, and Eini teaches that fatty alcohols (such as behenyl alcohol), fatty acids (such as stearic acid), combinations of a fatty alcohol and a fatty acid, and waxes, such as beeswax, are "solidifying agents" which increase viscosity of liquid hydrophobic solvents in a composition. Thus, the person of ordinary skill in the art would have added hydrogenated castor oil to a composition taught by Eini, with the expectation that combining two or three “solidifying agents” and using said combination as a rheology modulator to increase the viscosity of a hydrophobic solvent would result in a desired rheologic effect, i.e. modulation of viscosity. Since all composition components herein are known to be useful as solidifying agents (rheology modulators), it is considered prima facie obvious to combine them into a single composition useful for the same purpose. At least additive effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Furthermore, it would have been obvious to add an antibiotic which is minocycline to the carrier above. The person of ordinary skill in the art would have been motivated to add a tetracycline antibiotic which is minocycline to a carrier comprising a rheology modulator and a hydrophobic solvent, because similar topical compositions comprising a tetracycline antibiotic, a rheology modulator and a hydrophobic solvent had been taught by Eini to be semi-solid and thixotropic. Further, regarding claims 35, 37-39, since Korting teaches second-generation tetracyclines, including minocycline, as being most frequently and most successfully used in the treatment of rosacea, it would have been obvious to prepare such a composition comprising minocycline and use said composition to treat rosacea, with a reasonable expectation of success.
.
It would have been obvious to measure the viscosity of the resulting pre-foam composition, and, if the composition was free-flowing, it would have been obvious to add a propellant to generate a foaming composition. The expectation in modifying Eini's composition to form the pressurized foamable composition (comprising a propellant) as instantly claimed would have been reasonable to the skilled artisan. Tamarkin teaches that foamable compositions have preferred viscosities between 1000 CPS and 5000 CPS. It would have been obvious to a person of ordinary skill in the art to measure the viscosity of the composition, and, if said viscosity (which is a property of the composition) were within the range taught by Tamarkin, add a propellant to form a foaming composition.
Thus, based on the combined 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 would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, absent a clear showing of evidence to the contrary.
For all the reasons stated above, claims 35-39 are rejected as prima facie obvious.
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.
Claim 36 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims 1, 8, 9, 12, 16, 20 of U.S. patent 10,835,613 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1, 8, 9, 12, 16, 20 of U.S. patent 10,835,613 render obvious instant claim 36.
Claims 1, 8, 9, 12, 16, 20 of U.S. patent 10,835,613 recite a foam composition comprising the same components (c) a minocycline, (a) a combination of at least one fatty alcohol, at least one fatty acid and at least one wax, (b) at least one hydrophobic solvent, where the composition is free of surfactant, as in the instant claim; claim 9 recites that the fatty alcohol comprises stearyl alcohol, cetostearyl alcohol, behenyl alcohol and myristyl alcohol; claim 12 recites that the hydrophobic solvent comprises soybean oil.
The composition in claims 1, 8, 9, 12, 16, 20 of U.S. patent 10,835,613 contains the same ingredients as a composition of instant claim 36.
As such, instant claim 36 is rejected.
Claim 36 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims 1, 9, 10, 13, 17 of U.S. patent 10,821,187 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1, 9, 10, 13, 17 of U.S. patent 10,821,187 render obvious instant claim 1.
Claims 1, 9, 10, 13, 17 of U.S. patent 10,821,187 recite a foam composition comprising the same components (c) a minocycline, (a) a combination of at least one fatty alcohol, at least one fatty acid and at least one wax, (b) at least one hydrophobic solvent, where the composition is free of surfactant, as in the instant claim; claim 10 recites that the fatty alcohol comprises stearyl alcohol, cetostearyl alcohol, behenyl alcohol and myristyl alcohol; claim 13 recites that the hydrophobic solvent comprises soybean oil, coconut oil, cyclomethicone and mineral oil.
The composition in claims 1, 9, 10, 13, 17 of U.S. patent 10,821,187 contains the same ingredients as a composition of instant claim 36. It would have been obvious to measure the viscosity of the composition, which is an inherent property of the composition.
As such, instant claim 36 is rejected.
Claim 36 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. patent 10,265,404 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-18 of U.S. patent 10,265,404 render obvious instant claim.
Claims 1-18 of U.S. patent 10,265,404 are drawn to an oleaginous composition comprising the same components (c) a minocycline, (a) a combination of at least one fatty alcohol, at least one fatty acid and at least one wax, (b) at least one hydrophobic solvent, where the composition is free of surfactant, as in the instant claim; claim 8 recites that the fatty alcohol comprises stearyl alcohol, cetostearyl alcohol, behenyl alcohol and myristyl alcohol; claim 11 recites that the hydrophobic solvent comprises soybean oil, coconut oil, cyclomethicone and mineral oil; claims 1 and 17 recite beeswax as wax in the composition.
The composition of claims 1-18 of U.S. patent 10,265,404 contains the same ingredients as a composition of instant claim 36. It would have been obvious to measure the viscosity of the composition, which is an inherent property of the composition.
As such, instant claim 36 is rejected.
Claim 36 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims 1, 4, 5, 7, 8, 12, 13, 14, 20-25 of U.S. Patent 8,618,081 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1, 4, 5, 7, 8, 12, 13, 14, 20-25 of U.S. Patent 8,618,081 render obvious the instant claim.
Claims 1, 4, 5, 7, 8, 12, 13, 14, 20-25 of U.S. Patent 8,618,081 are drawn to a composition comprising a first rheology modulator comprising a pharmaceutical or a cosmetic active agent at least part of which is suspended in the therapeutic composition; and a carrier comprising:
a) a second rheology modulator for example (iii) a combination of: at least one fatty alcohol, at least one fatty acid, and at least one wax; and
b) at least one hydrophobic solvent;
the carrier being otherwise free of or containing less than 0.1% by weight of surfactant; wherein the at least one wax comprises a hydrogenated castor oil; wherein the viscosity of the therapeutic composition is at least about 30% higher than the viscosity of a first partial composition comprising the carrier without the first rheology modulator; and is higher than the viscosity of the first rheology modulator and the at least one hydrophobic solvent without the second rheology modulator; and
wherein the viscosity of the first partial composition is less than about 25,000 cPs at room temperature. Claims 4, 5 recite minocycline (as in the instant claims) as the first rheology modulator pharmaceutical active agent; claim 22 recite the fatty alcohol selected from behenyl alcohol, stearyl alcohol, cetyl alcohol, myristyl alcohol, and cetostearyl alcohol; the fatty acid is stearic acid; the wax is beeswax; claim 23 recites a composition of claim 1 comprising behenyl alcohol, stearyl alcohol, myristyl alcohol, cetostearyl alcohol; stearic acid; beeswax; claims 24, 25 recite that the hydrophobic solvent comprises mineral oil.
A composition of claims 1, 4, 5, 7, 8, 12, 13, 14, 20-25 of U.S. Patent 8,618,081 renders instant claim 36 obvious because it contains similar ingredients.
As such, instant claim 36 is rejected.
Claim 36 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims 1, 2, 10, 14, 19, 24, 27, 29, 35 of U.S. Patent 8,865,139 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1, 2, 10, 14, 19, 24, 27, 29, 35 of U.S. Patent 8,865,139 render obvious instant claim.
Claims 1, 2, 10, 14, 19, 24, 27, 29, 35 of U.S. Patent 8,865,139 are drawn to a composition comprising a tetracycline antibiotic which is, for example, minocycline (in claims 19, 24, 27); (b) at least one viscosity modifying agent that is a combination of at least one fatty alcohol, at least one fatty acid and at least one wax; (a) at least one hydrophobic solvent; claim 35 recites that the composition is free of surfactant; claim 10 recites that the fatty alcohol is, for example, stearyl alcohol, cetyl alcohol, behenyl alcohol, myristyl alcohol (instant elected species); the fatty acid is, for example, octadecanoic acid (stearic acid); the wax comprises beeswax (claim 14); claim 2 recites that the viscosity of the composition is at least 30% higher than the viscosity of the carrier without the tetracycline antibiotic, and is higher than the viscosity of the hydrophobic oil and the tetracycline antibiotic without the viscosity modifying agent.
A composition of claims 1, 2, 10, 14, 19, 24, 27, 29, 35 of U.S. Patent 8,865,139 renders instant claim 36 obvious because it contains similar ingredients.
As such, instant claim 36 is rejected.
For similar reasons, instant claim 36 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims of U.S. Patents 8,871,184; 9,675,700; 10,213,512; 10,322,186; 10,463,742; 10,610,599; 12,138,311, and is provisionally rejected over claims of co-pending US patent application 18/910,954.
Claim 36 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claim 1 of U.S. Patent 10,398,641 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent 10,398,641 render obvious instant claim.
Claim 1 of U.S. Patent 10,398,641 recites a foamable composition drawn to a composition comprising (iii) minocycline; (ii) about 10% to about 22% by weight of a foamer complex comprising: about 3.5% w/w of cetostearyl alcohol; about 2% w/w to about 4% w/w of stearic acid; about 1.8% w/w to about 3.3% w/w of myristyl alcohol; about 1% w/w to about 3% w/w of hydrogenated castor oil; about 1% w/w to about 3% w/w of beeswax; about 1% w/w to about 2% w/w of stearyl alcohol; and about 0.5% w/w to about 1.5% w/w of behenyl alcohol; (i) about 70% to about 90% by weight of a hydrophobic solvent comprising: about 50% w/w of soybean oil; about 16.5% w/w to about 30.7% w/w of coconut oil; about 3.5% w/w to about 6.5% w/w of cyclomethicone; and about 1% w/w to about 6% w/w of light mineral oil. The claim is silent regarding the presence of a surfactant in the composition.
The composition in claim 1 of U.S. Patent 10,398,641 contains the same ingredients as a composition of instant claim 36. It would have been obvious to measure the viscosity of the composition, which is an inherent property of the composition.
As such, instant claim 36 is rejected.
For similar reasons, instant claim 36 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims of U.S. Patents 10,849,847; 11,324,691; and is provisionally rejected over claims of co-pending US patent application 18,925,760.
Claims 35, 37-39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims 1, 2, 10, 14, 19, 24, 27, 29, 35 of U.S. Patent 8,865,139 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1, 2, 10, 14, 19, 24, 27, 29, 35 of U.S. Patent 8,865,139 render obvious instant claim.
Claims 1, 2, 10, 14, 19, 24, 27, 29, 35 of U.S. Patent 8,865,139 are drawn to a composition comprising a tetracycline antibiotic which is, for example, minocycline (in claims 19, 24, 27); (b) at least one viscosity modifying agent that is a combination of at least one fatty alcohol, at least one fatty acid and at least one wax; (a) at least one hydrophobic solvent; claim 35 recites that the composition is free of surfactant; claim 10 recites that the fatty alcohol is, for example, stearyl alcohol, cetyl alcohol, behenyl alcohol, myristyl alcohol (instant elected species); the fatty acid is, for example, octadecanoic acid (stearic acid); the wax comprises beeswax (claim 14); claim 2 recites that the viscosity of the composition is at least 30% higher than the viscosity of the carrier without the tetracycline antibiotic, and is higher than the viscosity of the hydrophobic oil and the tetracycline antibiotic without the viscosity modifying agent.
A composition of claims 1, 2, 10, 14, 19, 24, 27, 29, 35 of U.S. Patent 8,865,139 contains similar ingredients as in the instant claims.
The Specification of U.S. Patent 8,865,139 teaches that a composition of the invention is effective to treat, for example, rosacea.
As such, instant claims 35, 37-39 are rejected.
For similar reasons, instant claims 35, 37-39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims of U.S. Patents 8,871,184; 9,675,700; 10,213,512; 10,463,742; 10,610,599; 10,835,613.
Claims 35-39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 2-15, 17-18, 20 of U.S. patent application 18/462,080 (notice of allowance mailed, cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 2-15, 17-18, 20 of U.S. patent application 18/462,080 render obvious instant claims.
Claims 2-15, 17-18, 20 of U.S. patent application 18/462,080 are drawn to a method of treating rosacea with a foam composition comprising the same components (c) a minocycline at 0.2 to 20% wt. of the composition (which overlaps with the range in the instant claims), (a) a combination of at least one fatty alcohol, at least one fatty acid and at least one wax, (b) at least one hydrophobic solvent, where the composition is free of surfactant, and waterless, as in the instant claims; claim 10 recites that the fatty alcohol comprises stearyl alcohol, cetostearyl alcohol, behenyl alcohol and myristyl alcohol; claim 13 recites that the hydrophobic solvent comprises soybean oil, coconut oil, cyclomethicone and mineral oil (as in instant claim 38); claim 14 recites that the hydrophobic solvent is present at 60% to 95% wt. of the composition, which overlaps with the range in the instant claims.
The method of claims of U.S. patent application 18/462,080 is for the treatment of the same skin disease, rosacea, as in the instant claims, with a foam composition containing the same ingredients as a composition of instant claims.
As such, instant claims 35-39 are rejected.
Claims 35-39 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims 22, 23, 25, 27-37, 40-44 of co-pending U.S. patent application 18/653,025 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 22, 23, 25, 27-37, 40-44 of co-pending U.S. patent application 18/653,025 render obvious the instant claims.
Claims 22, 23, 25, 27-37, 40-44 of co-pending U.S. patent application 18/653,025 are drawn to a method of treating rosacea (one of two skin diseases treated) by topically administering a composition comprising the same components (c) a tetracycline antibiotic at 0.2 to 20% wt. of the composition (which overlaps with the range in the instant claims), claims 25, 27 recite minocycline as the tetracycline antibiotic; (a) an adjuvant comprising at least one wax; (b) at least one hydrophobic solvent, where the composition comprises less than 0.1% wt. of surfactant, and less than 2% wt. water; claims 28, 29 recite that the wax comprises hydrogenated castor oil, as in instant claims, and/or beeswax, as in instant claim 39; claims 30, 31 recite that the adjuvant further comprises at least one fatty alcohol which comprises stearyl alcohol, behenyl alcohol or myristyl alcohol or mixtures thereof; claim 37 recites that the hydrophobic solvent comprises soybean oil, coconut oil, cyclomethicone and mineral oil (as in instant claim 38); claim 44 recites that the hydrophobic solvent is present at 70% to 90% wt. of the composition, which overlaps with the range in the instant claims; claims 42-43 recite that the composition is a foam; claim 40 recites that the composition is free of surfactant, as in the instant claims.
The method of claims 22, 23, 25, 27-37, 40-44 of co-pending U.S. patent application 18/653,025 is for the treatment of the same skin disease, rosacea, as in the instant claims, with a foam composition containing the same ingredients as a composition of instant claims.
As such, instant claims 35-39 are rejected.
Claims 35-39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable at least over claims 1-30 of U.S. Patent 10,322,186 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-30 of U.S. Patent 10,322,186 render obvious instant claim.
Claims 1-30 of U.S. Patent 10,322,186 are drawn to a method of treating rosacea comprising administering a waterless foam composition comprising minocycline and a foamable carrier comprising: a) at least one hydrophobic oil; and b) an agent comprising (i) at least one fatty alcohol and at least one wax; (ii) at least one fatty acid and at least one wax; (iii) at least one fatty alcohol, at least one fatty acid, and at least one wax; (iv) a wax comprising a hydrogenated oil; or (v) a combination of two or more waxes, wherein the composition does not contain a surfactant; claim 10 recites that the fatty alcohol is, for example, stearyl alcohol, cetyl alcohol, behenyl alcohol, myristyl alcohol (instant elected species); the fatty acid is, for example, octadecanoic acid (stearic acid); the wax comprises beeswax (claim 14); claim 2 recites that the viscosity of the composition is at least 30% higher than the viscosity of the carrier without the tetracycline antibiotic, and is higher than the viscosity of the hydrophobic oil and the tetracycline antibiotic without the viscosity modifying agent.
The method of claims 1-30 of U.S. Patent 10,322,186 is for the treatment of the same skin disease, rosacea, as in the instant claims, with a foam composition containing the same ingredients as a composition of instant claims.
As such, instant claims 35-39 are rejected.
For similar reasons, instant claims 35-39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-23 of U.S. Patent 12,138,311.
Conclusion
Claims 35-39 are rejected.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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