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
Applicant’s response to the restriction/ election requirement from 3/5/2026 is acknowledged. Applicant has elected the invention of Group II, claims 68-73. Applicant has further made the following species election.
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Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
On further consideration of the art, the election of species requirement is hereby withdrawn. The restriction/ election requirement is hereby MADE FINAL. Claims 68-73 are pending, and have been examined herewith across their breadth.
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 68-73 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 68 is directed to “[a] method for maintaining or improving nutritional status of a human or animal subject having or at risk of having a viral-mediated disorder…” This limitation is vague and ambiguous and subject to many different interpretations because Applicant’s claims define it to encompass one or more of highly disparate conditions that are not known to have common etiology and/or pathology, to include, inter alia, maintaining, strengthening or improving (innate) immune function or status or health, reducing the duration and/ severity of symptoms associated with respiratory disease, providing cognitive benefits, such as strengthening or improving cognitive function, mental focus, mental acuity and memory, strengthening or improving functional capacity or endurance performance or reducing fatigue, strengthening or improving emotional well-being, strengthening or improving alertness, strengthening or improving concentration, and providing energy. (See, e.g., [0012]).
Claim 71 is further rejected as vague and indefinite for the following reasons. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 71 recites the broad recitations family Coronaviridae and family Orthomyxoviridae, and the claim also recites (e.g, MERS-CoV, SARS-CoV, SARS-CoV-2) and (e.g.., Influenza A, Influenza B), respectively, which are the narrower statements of the ranges/limitations. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
(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.
Claims 68, 71 and 73 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by WO 2016014699 A1 to Lamb et al. (“Lamb”, of record).
Claim interpretation
The Examiner incorporates by reference her interpretation of Applicant’s claims from the 35 U.S.C. 112(b) rejection above.
Rejection
Claim 10 of Lamb is directed to an antiviral treatment composition, the composition comprising: synthetic cinnamaldehyde; and one or more essential oils from the Lamiaceae family. Claim 16 is directed to the composition of claim 10, wherein the essential oil fraction comprises two or more natural essential oils and synthetic cinnamaldehyde, wherein the combined essential oils and synthetic cinnamaldehyde comprise at least 20% carvacrol, at least 15% thymol, and at least 20% cinnamaldehyde. See also Table 1, which discloses a specific composition, which includes, inter alia, thymol and para-cymene [0035]:
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Lamb further discloses the specific combination of carvacrol, thymol and para-cymene (“wherein some of the primary species can include about 30% to about 50% thymol, about 18% to about 31 % para-cymene, about 2% to about 5% caryophyllen, about 1% to about 5% carvacrol, and about 2% to about 4% linalool.” [0036]; “In the examples, "Synergy Essence" refers to an EO composition comprising about 60.4% carvacrol, about 10.8% thymol, about 9.9% paracymene, and about 18.9% secondary natural EO constituents. [0072]).
Per Lamb, the ratio of the EO fraction to the one or more additional components in a composition can depend on several factors such as administration method, and the nutritional/health needs and/or palate of a consuming subject, among others. ([0027]).
Claim 26 is directed to a method of inhibiting a virus within a subject or system, the method comprising: administering a treatment composition to one or more of a subject and system, wherein the treatment composition comprises one or more of thyme essential oil, oregano essential oil, and cinnamon essential oil; and an emulsifier, wherein the one or more essential oils are present as an emulsion and the average particle size of the one or more essential oils in the emulsion is less than about 25 microns. Claim 27 is directed to the method of claim 26, wherein the cinnamon essential oils comprise synthetic cinnamaldehyde. Claim 29 recites wherein the subject comprises one or more of humans, swine, bovine, horses, fowl, shrimp, fish, and deer. Claim 28 recites wherein the virus comprises any virus included in Baltimore Classification groups I through VII. The Specification provides that these groups include, inter alia, "hand foot and mouth disease" virus, porcine respiratory & reproductive syndrome virus, influenza viruses, transmissible gastroenteritis coronavirus and dairy coronavirus. ([0030]).
Per Lamb, suitable EOs can include from within the Monarda genus, and a non-limiting list of suitable species can include, e.g., Monarda fistulosa, [0043]. “Many EO compositions comprise an EO fraction comprising an effective amount of carvacrol, an effective amount of thymol, an effective amount of cinnamaldehyde, an effective amount of paracymene, or combinations thereof. . . Suitable EOs can include EOs from the Cinnamomum genus, EOs from the Origanum genus, EOs from the Thymus genus, EOs from the Monarda genus (e.g., M. citriodora, M. clinopodioides, M. didyma, M. fistulosa, M. media, M. punctata), EOs from the Trachyspermum genus (e.g., T. ammi), EOs from the Nigella genus (e.g., N. sativa), and combinations thereof.” ([0051]). EOs can further be derived from coconut. ([0017]).
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 691 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2016014699 A1 to Lamb et al. (“Lamb”, of record), as applied to claims 68, 71 and 73 above, and further in view of US 20160213727 to Rohlfsen (“Rohlfsen”).
Claim interpretation
The Examiner incorporates by reference her interpretation of Applicant’s claims from the 35 U.S.C. 112(b) rejection above.
Rejection
Lamb is discussed in the 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above.
Lamb does not explicitly disclose a composition comprising four or more of the components, to include thymoquinone. It is noted that this disclosure is implicit in Lamb, nonetheless, as further evidenced by Rohlfsen.
As noted in the 35 USC 102 rejection, Per Lamb, suitable EOs can include from within the Monarda genus, and a non-limiting list of suitable species can include, e.g., Monarda fistulosa. ([0043]). “Many EO compositions comprise an EO fraction comprising an effective amount of carvacrol, an effective amount of thymol, an effective amount of cinnamaldehyde, an effective amount of paracymene, or combinations thereof. . . Suitable EOs can include EOs from the Cinnamomum genus, EOs from the Origanum genus, EOs from the Thymus genus, EOs from the Monarda genus (e.g., M. citriodora, M. clinopodioides, M. didyma, M. fistulosa, M. media, M. punctata), EOs from the Trachyspermum genus (e.g., T. ammi), EOs from the Nigella genus (e.g., N. sativa), and combinations thereof.” ([0051]).
Rohlfsen discloses that “Thymoquinone (TQ) and Thymohydroquinone (THQ) are essential oils that are also present in the Monarda fistulosa plant (see Rohlfsen, U.S. Pat. No. 9,073,824). Thymoquinone has recently been discovered to have specific effects on some mammalian cancers and is a phytochemical found in the plant Nigella sativa and several other plants.” ([0013]).
Rohlfsen discloses a method for cultivating Monarda for production of thymoquinone and thymohydroquinone includes seeding or plug planting Monarda fistulosa and/or Monarda didyma plants. Such isolated compounds include thymoquinone, thymol, carvacrol and para-cymene.
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(p. 6, Table 2).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of Lamb and Rohlfsen in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so because Lamb discloses Applicant’s claimed combination of three ingredients- thymol, carvacrol and para-cymene- for practicing Applicant’s claimed method, and further discloses that they can be derived from EOs, which include EOs from the Cinnamomum genus, EOs from the Origanum genus, EOs from the Thymus genus, EOs from the Monarda genus (e.g., M. citriodora, M. clinopodioides, M. didyma, M. fistulosa, M. media, M. punctata), EOs from the Trachyspermum genus (e.g., T. ammi), EOs from the Nigella genus (e.g., N. sativa), and combinations thereof. Rohlfsen discloses a method for cultivating Monarda for production of thymoquinone and thymohydroquinone includes seeding or plug planting Monarda fistulosa and/or Monarda didyma plants. Such isolated compounds include thymoquinone, thymol, carvacrol and para-cymene, which encompasses all of Applicant’s claimed ingredients.
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2016014699 A1 to Lamb et al. (“Lamb”, of record), as applied to claims 68, 71 and 73 above, and further in view of Osborn, What Is Monolaurin?, Mar 8, 2019, available at https://www.healthline.com/health/monolaurin (“Osborn”).
Claim interpretation
The Examiner incorporates by reference her interpretation of Applicant’s claims from the 35 U.S.C. 112(b) rejection above.
Rejection
Lamb is discussed in the 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above.
Lamb does not explicitly disclose a composition comprising a monoglyceride, such as monolaurin. It is noted that this disclosure is implicit in Lamb, nonetheless, as further evidenced by Osborn.
Per Lamb, suitable EOs can include ones derived from coconut. ([0017]).
Osborn discloses that monolaurin can be taken daily as a dietary supplement, and that it is derived from coconut fat, fresh shredded coconut, coconut milk and cream. Per Osborn, coconut oil and certain coconut products contain approximately 50 percent lauric acid. Per Osborn, monolaurin is many times more effective than lauric acid at killing viruses and bacteria. Osborn discloses that its antiviral effects include against HIV, measles, herpes simplex-1, vesicular stomatitis, visna virus and cytomegalovirus.
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of Lamb and Osborn in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so because Lamb discloses Applicant’s claimed combination of three ingredients- thymol, carvacrol and para-cymene- for practicing Applicant’s claimed method, and further discloses that they can be derived from EOs, which include EOs from coconut. Osborn discloses . Such isolated compounds include thymoquinone, thymol, carvacrol and para-cymene, which encompasses all of Applicant’s claimed ingredients.
Claim Objections
Claim 72 is objected to as dependent on a rejected base claim, but would be allowable if written in independent claim format.
.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
1 Applicant’s claim 69 requires a minimum of four ingredients. Accordingly, a curcuminoid was not addressed, as not required by the claims. It is noted, however, there are is prior art on this ingredient as well, to include from Applicant’s IDS from 2/1/2023.