DETAILED ACTION
Status of Application
The response filed 06/01/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 79-80, 86, 88-89 have been amended.
Claims 71-90 are pending in the case.
Claims 79-81, 86-87 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant has previously elected Group II for the examination. The species election for the component/solubilizer/surfactant is phosphatidylcholine (such as lecithin) and the election for the number of solvents was 2 and for it to be isopropyl alcohol and propylene glycol which is now amended into the independent claim, which was previously expanded to one with the solvents either ethanol and water, which is moot with the amendment to the instant claims; the number of solvents is expanded to 3 or 4 (with the two of isopropyl alcohol and propylene glycol in the independent claim, and further adding the solvent of ethanol and/or water as recited in the dependent claim).
Applicant’s arguments to Momin are moot as a result of amendment.
All grounds not addressed in the action are withdrawn or moot as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
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.
Claim 86 is 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 86 recites polysorbate 60 emulsifying polymer (along with the trademark/trade name “Simulgel INS 100” in parentheses) which is unclear as polysorbate 60 is already an emulsifying polymer wherein is it meant to be a description of the polysorbate? Additionally, the trademark is unclear as 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, 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 and does not seem to be representative of polysorbate 60. For purposes of examination it is treated as polysorbate 60 (i.e. Tween 60).
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, 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.
Claims 79-81, 87 are rejected under 35 U.S.C. 103 as being unpatentable over Kamal (EP 2745841) in view of Xinyu et al. (CN 102048679) and Fawzi et al. (U.S. Pat. 4783450).
Rejection:
Kamal teaches a skin composition comprising black cumin oil (Nigella sativa seed) which contains thymoquinone, olive oil, tea tree (Melaleuca alternifolia) oil, cocoa butter, vitamin A or its derivative, and vitamin B12 or its derivative (abstract, [12]). The composition forms include ointments [23] and ointment bases including solvents, thickening/gelling agents, emulsifiers, penetration enhancers [22]. An example of an ointment base including propylene glycol and water ([22], see full document specifically areas cited).
Kamal does not teach the inclusion of isopropanol or phosphatidylcholine but does teach the inclusion of ointment bases with propylene glycol and water, thickening/gelling agents, emulsifiers, and penetration enhancers.
Xinyu et al. teaches that ointment bases are known to include an oily base and water soluble base components such as propylene glycol, Tween (polysorbate), and ethanol; with penetration enhancers like isopropanol [56-60].
Fawzi et al. teach lecithin as a penetration enhancer through the skin (phosphatidylcholine, abstract) and useful from about 2-about 40% preferably from about 5-about 10% (Col. 2 line 25-27).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate isopropanol and lecithin as suggested by Xinyu et al. and Fawzi et al. and produce the claimed invention; as it is prima facie obvious to incorporate known ointment base components and penetration enhancers at their known useful amounts (i.e. lecithin) to an ointment for their known purpose with a reasonable expectation of success absent evidence of criticality for the specific components. It is noted that instant claim 87 is set forth in the form of product-by-process claims, which are considered product claims by the Office. Applicants are reminded that process limitations cannot impart patentability to a product that is not patentably distinguished over the prior art. In re Thorpe et al. (CAFC 1985), supra; In re Dike (CCPA 1968) 394 F2d 584, 157 USPQ 581; Tri-Wall Containers, Inc. v. United States et al. (Ct Cls 1969) 408 F2d 748, 161 USPQ 116; In re Brown et al. (CCPA 1972) 450 F2d 531, 173 USPQ 685; Ex parte Edwards et al. (BPAI 1986) 231 USPQ 981.
Claim 86 is rejected under 35 U.S.C. 103 as being unpatentable over Kamal (EP 2745841) in view of Xinyu et al. (CN 102048679) and Fawzi et al. (U.S. Pat. 4783450) as applied to claims 79-81, 87, further in view of Rowe et al. (Polyoxyethylene Sorbitan Fatty Acids Esters).
Rejection:
The teachings of Kamal in view of Xinyu et al. and Fawzi et al. are addressed above.
Kamal in view of Xinyu et al. and Fawzi et al. does not teach the specific Tween/polysorbate 60 but does teach the inclusion of Tween/polysorbate.
Rowe et al. teaches that polysorbates present in various molecular weights including polysorbate 60 (Table III and Table II).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate polysorbate 60 as suggested by Rowe et al. and produce the claimed invention; as it is prima facie obvious to incorporate known forms of Tween/polysorbate to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the specific form.
Claims 79-81 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Halwani et al. (U.S. Pat. Pub. 2016/0101124) in view of Xinyu et al. (CN 102048679).
Rejection:
Halwani et al. teaches an aminoglycoside- thymoquinone composition comprising thymoquinone and an aminoglycoside antibiotic in a liposome with phospholipids like 1,2-Distearoyl-sn-Glycero-3-Phosphocholine (DSPC), 1,2-Dipalmitoyl-sn-Glycero-3-Phosphocholine (DPPC), or 1,2-Dimyristoyl-sn-Glycero-3-Phosphocholine (DMPC, all phosphatidylcholines) (abstract, [13]). The composition can be in topical forms like ointments ([19-20], see full document specifically areas cited).
Halwani et al. does not expressly teach the inclusion of a thickening/gelling agent, isopropanol, propylene glycol but does teach an aminoglycoside- thymoquinone liposome composition with phosphatidylcholines/phospholipids (i.e. DMPC) and that the liposomes can be in ointments.
Xinyu et al. teaches that ointment bases are known to include an oily base and water soluble base components such as petrolatum, propylene glycol, Tween (polysorbate), and ethanol; with penetration enhancers like isopropanol and propylene glycol ; and are general about 10-about 90% of a composition [56-60].
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate propylene glycol, isopropanol, Tween and ethanol.as suggested by Xinyu et al. and produce the claimed invention; as it is prima facie obvious to incorporate known components for an ointment for their known purpose with a reasonable expectation of success absent evidence of criticality for the specific components. It is also prima facie obvious to optimize the amount of the ointment base with the active at their known useful amounts (i.e. about 10-90% ointment base =about 90-about 10% active aminoglycoside- thymoquinone liposomes) to attain the desired therapeutic profile (i.e. about 0.1-10%% thymoquinone) with a reasonable expectation of success absent evidence of criticality for the claimed values). It is noted that instant claim 87 is set forth in the form of product-by-process claims, which are considered product claims by the Office. Applicants are reminded that process limitations cannot impart patentability to a product that is not patentably distinguished over the prior art. In re Thorpe et al. (CAFC 1985), supra; In re Dike (CCPA 1968) 394 F2d 584, 157 USPQ 581; Tri-Wall Containers, Inc. v. United States et al. (Ct Cls 1969) 408 F2d 748, 161 USPQ 116; In re Brown et al. (CCPA 1972) 450 F2d 531, 173 USPQ 685; Ex parte Edwards et al. (BPAI 1986) 231 USPQ 981.
Claim 86 is rejected under 35 U.S.C. 103 as being unpatentable over Halwani et al. (U.S. Pat. Pub. 2016/0101124) in view of Xinyu et al. (CN 102048679) as applied to claims 79-81 and 87 above, further in view of Rowe et al. (Polyoxyethylene Sorbitan Fatty Acids Esters).
Rejection:
The teachings of Halwani in view of Xinyu et al. are addressed above.
Halwani in view of Xinyu et al. does not teach the specific Tween/polysorbate 60 but does teach the inclusion of Tween/polysorbate.
Rowe et al. teaches that polysorbates present in various molecular weights including polysorbate 60 (Table III and Table II).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate polysorbate 60 as suggested by Rowe et al. and produce the claimed invention; as it is prima facie obvious to incorporate known forms of Tween/polysorbate to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the specific form.
Conclusion
Claims 79-81, 86-87 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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