DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 10/21/2025 is acknowledged. Applicant also elects the species soy phosphatidylcholine as the component/solubilizer/surfactant in combination with thymoquinone, the number of solvents to be 2 with the additional election of the solvents to be isopropyl alcohol and propylene glycol. Upon review, the election of the soy phosphatidylcholine is expanded to any phosphatidylcholine (also known an lecithin); and the number of solvents is expanded to one and expanded to include ethanol and water (along with isopropyl alcohol, propylene glycol).
Status of Application
Applicant has elected Group II in response to restriction requirement and elected the species soy phosphatidylcholine as the ingredient with thymoquinone, and the number of solvents to be 2 which are isopropyl alcohol and propylene glycol, for the examination.
Upon review, the election of the soy phosphatidylcholine is expanded to any phosphatidylcholine (also known an lecithin); and the number of solvents is expanded to one and expanded to include ethanol and water.
Due to restriction, based on election of Group II and the species elections above, claims 71-78, 82-85, 88-90 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 71-90 are pending.
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 .
Claim Objections
Claim 86 is objected to because of the following informalities: the claim recites “Guar gum” which is improperly capitalized (rather than guar gum). Appropriate correction is required.
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 contains the trademark/trade name “Simulgel INS 100”. 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, 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 the polymer and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 79-80, 86-87 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Momin et al. (IN 201301740 I3) as evidenced by PeaceHealth (Lecithin/Phosphatidyl Choline).
Rejection:
Momin et al. teaches a gel composition comprising Nigella sativa oil which contains thymoxamine, clotrimazole, cholesterol, soy lecithin - lecithin is also known as phosphatidylcholine as evidenced by PeaceHealth (Abstract, Page 2 paragraphs 1-3, Page 4 last paragraph-Page 5 first paragraph, Page 7-Page 8 1st paragraph, Page 9 4th paragraph-Page 12 2nd paragraph).
Momin et al. exemplifies the gel composition comprising Nigella sativa oil (thymoxamine), soya lecithin (phosphatidylcholine), clotrimazole, cholesterol (in 10% Nigella sativa oil), hydroalcoholic water (water and ethanol (solvents)), carbopol 940 (gelling agent, example 1 and 3, see full document specifically areas cited).
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.
All the critical elements are taught by the cited reference and thus the claims are anticipated.
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.
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Momin et al. (IN 201301740 I3) as evidenced by PeaceHealth (Lecithin/Phosphatidyl Choline) as applied to claims 79-80, 86-87 above, in view of Amin et al. (Black Cumin (Nigella sativa) and Its Active Constituent, Thymoquinone: An Overview on the Analgesic and Anti-inflammatory Effects).
Rejection:
The teachings of Momin et al. as evidenced by PeaceHealth are addressed above.
Momin et al. as evidenced by PeaceHealth does not recite the amount of thymoquinone in the composition but does recite the inclusion of Nigella sativa oil (i.e. 6.66%w/w and cholesterol in 10% Nigella oil), and that it contains thymoquinone and most of the biological activity of the Nigella sativa plant is showed by the oil consistent like thymoquinone.
Amin et al. teaches that the essential oil extracted from black cumin (Nigella sativa) has about 18-24% thymoquinone (Page 9 Col 1 last paragraph-Col. 2 1st paragraph).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at a thymoquinone content of 0.1-10%w/w as suggested by Amin et al. and produce the claimed invention; as Momin et al. as evidenced by PeaceHealth teaches the inclusion of Nigella sativa oil at values like the exemplified 6.66%w/w with cholesterol in 10% Nigella oil - and that the Nigella sativa oil contains thymoquinone, and Amin et al. establishes that Nigella sativa oil (black seed oil) contains about 18-24% thymoquinone wherein it would be obvious that the composition would contain about 1.2-1.6%w/w (6.66% x 0.18, 6.66 x 0.24) falling within the instant claims with a reasonable expectation of success.
Conclusion
Claims 79-81, 86-87 are rejected.
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.
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, Brian 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GIGI G HUANG/Primary Examiner, Art Unit 1613