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 .
Notice of New Examiner
This case has been transferred to a new examiner for continued examination. Any further communications regarding this case may be directed to the contact information included in the conclusion of this office action.
Election/Restrictions
Claims 1-17 are pending in the instant application. Applicant’s election without traverse of Group I, Claims 1-15 and 18, and curcumin of Claims 8 and 10 in the reply filed on 3 December 2025 is acknowledged. Claims 10 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. The requirement is still deemed proper and is therefore made FINAL. Claims 1-9, 11-15, and 17 are being examined on the merits.
Information Disclosure Statement
The listing of references in the specification (e.g., page 12, lines 21-27) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the term CUREmin-ACTIF® and Tween 20/80, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 15 is objected to under 37 CFR 1.75 as being a substantial duplicate of Claim 17. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 1-9, 11-15, and 17 are objected to because of the following informalities:
In Claim 1, the phrase “resveratrol and at least one gingerol, in addition to” should instead read --resveratrol, at least one gingerol, and at least one pharmaceutically or nutraceutically acceptable adjuvant or additive--.
In Claim 2, the phrase “comprising resveratrol and a combination of gingerols” should instead read --further comprising a combination of gingerols--.
In Claims 5 and 7, the phrase “selected from” should instead read --selected from the group consisting of--.
In Claim 6, the phrase “the combination of” should be removed.
In Claim 14, the phrase “oral or parenteral or topical” should instead read --orally, parenterally, or topically--.
In Claim 17, the phrase “Combination preparation” should instead read --The combination preparation--.
All other claims depend directly or indirectly from the objected claims and are, therefore, also objected to, for the reasons set forth above. 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.
Claims 3, 4, 7-9, 11-15, and 17 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.
Claims 3, 12, and 13 recite the limitation "total ginger extract matrix" or “total ginger extract matrixes of the ginger rhizome.” There is insufficient antecedent basis for this limitation in the claim. Additionally, this limitation is recited in Claim 4, which is dependent upon rejected Claim 3, and it is unclear what is meant by “total ginger extract matrix.” Since the total ginger extract matrix is obtained via supercritical carbon dioxide extraction (e.g., as in Claim 4 and page 1-2 of the specification), it is being assumed for the purposes of examination that a “total ginger extract matrix” is merely any supercritical carbon dioxide extract of ginger.
Regarding Claim 4, the phrase “obtained from a supercritical carbon dioxide extraction” is unclear because there is no further indication of what is being extracted.
Regarding Claim 7, the phrase “wherein the gingerols further comprise shogaols” is indefinite because shogaols are a different compound than gingerols and thus it is unclear how the gingerols comprise shogaols. Phrasing such as “wherein the composition further comprises shogaols” would help clarify the claim.
Regarding Claims 8 and 9, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
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 9 recites the broad recitation “5 to 25% (w/w)”, and the claim also recites “5 to 15% (w/w)” and “7 to 13% (w/w),” which are the narrower statement of the range/limitation. 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.
Regarding Claim 9, the phrase “in relation to resveratrol” is indefinite because it is unclear how the percentage of gingerol or combination of gingerols is relating to the resveratrol. Is the percentage of gingerol(s) 5% of the percentage of resveratrol? Or is there another relationship? Clarity is necessary, and it is suggested that the values be presented as a weight ratio in order to help clarify the relationship between the compounds.
Claims 11-13 recite the limitation “the active compounds.” There is insufficient antecedent basis for this limitation in the claim.
Regarding Claims 11-13, 15, and 17, the phrase "namely" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
Claim 14 recites the limitation “the pharmaceutical composition.” There is insufficient antecedent basis for this limitation in the claim.
Appropriate clarification is necessary.
Regarding Claims 15 and 17, attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). To expedite prosecution, the claims have been instantly treated as mere intended uses. Clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-3 and 5-9 are directed to a natural product (i.e., a law of nature/a natural phenomenon). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception – i.e., as drafted, the claims read upon a product of nature (i.e., a law of nature/a natural phenomenon) for the following reasons:
Claims 1-3 and 5-9 are drawn to a composition (for the intended use for treating various conditions of Claims 15 and 17) formed entirely from natural ingredients including resveratrol (as an active agent for anticancer, cardioprotective, antimicrobial, antiaging, blood-sugar lowering, anti-inflammatory, and neuroprotective effects) obtainable from various plants, including red grapes (e.g., Specification, pages 4-5), gingerols (as an active agent for antioxidant, anti-inflammatory, antimicrobial, anticancer, neuroprotective, cardiovascular protective, respiratory protective, anti-obesity, antidiabetic, anti-nausea, and antiemetic effects) obtainable from ginger (Specification, pages 6-7) and at least one pharmaceutical or nutraceutical acceptable adjuvant and additives (such as sugar; e.g., Specification, page 11); and in some embodiments, further including curcumin, which are present in cucuma plants (Specification, page 9). The claimed composition is not markedly different from its naturally-occurring counterparts because there is no indication that the composition has any characteristics or properties that are different from the naturally-occurring counterparts (including the natural compounds found therein). The cited claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements.
Furthermore, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) and the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials. While Claims 6 and 9 require certain amounts of components in the active ingredient or composition, there is no indication that the amounts claimed result in a markedly different characteristic for the composition as compared to components found in nature. Additionally, while Claim 7 requires shogaols which are formed when gingerol is dehydrated during drying or heating, this process could naturally occur when a ginger rhizome is exposed to the sun and dried out.
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterparts (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please note that combining natural extracts (such as from two or more plants) does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. – 333 U.S. 127 (1948)) because, again, there is no evidence of a marked difference brought about by combining the instantly claimed herbal extracts. Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter.
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 (i.e., changing from AIA to pre-AIA ) 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.
(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 1-4, 8, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Newmark et al. (US 6387416 B1).
The instant claims are as of record, drawn to a combination preparation comprising resveratrol, at least one gingerol, and pharmaceutically or nutraceutically acceptable adjuvants and additives.
Newmark et al., however, anticipate the claims by teaching a topically or orally administered composition (combination preparation) capable of reducing inflammation in animals comprising supercritical carbon dioxide extracts of ginger (gingerols), turmeric (curcumin) and huzhang (resveratrol, e.g., col. 6, ln. 33-36; Newmark et al., Abstract and Claim 4; as required for instant Claims 1- 4, 8, 14, 15, and 17). The composition additionally comprises adjuvants and additives such as excipients, carriers, diluents, and lubricants (Newmark et al., col. 6, ln. 46-64; as required for instant Claim 1). The compositions can be in various forms including lotions and creams (homogenous mixture; Newmark et al., col. 7, ln. 21; as required for instant Claims 11-13).
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 (i.e., changing from AIA to pre-AIA ) 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 1-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Newmark et al. (US 6387416 B1) as applied to 1-4, 8, and 14 above, and further in view of Krutmann et al. (US 10857089 B2).
The instant claims and teachings of Newmark et al. are as of record.
Newmark et al. do not teach specific gingerols, shogaols, or amounts thereof.
Krutmann et al., however, teaches cosmetic compositions comprising a commercially available CO2 (supercritical carbon dioxide) extract of ginger root (rhizome) which contains, by weight: 25-30% 6-gingerol, 5-10% 8-gingerol, 5-10% 10-gingerol, 6-shogaol, 8-shogaol, and 10-shogaol wherein the total amount of gingerols sums up to 35-50% by weight (Krutmann et al., col. 5, ln. 61-67, col. 6, ln. 1-8; as required for instant Claims 5 and 7). Based upon these values, the amount of 6:8:10-gingerol could therefore be 25:5:10 (sum of 40%), which reduces to 5:1:2 and falls within the ratio of instant Claim 6. It is also disclosed that extracts of ginger root have been described as antioxidants (Krutmann et al., col. 5, ln. 15-17) and have anti-inflammatory activity (Krutmann et al., col. 5, ln. 48; as required for instant Claims 15 and 17). The compositions can be in various forms, including lotions and creams (homogenous mixture; Krutmann et al., col. 7, ln. 45; as required for instant Claims 11-13).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the supercritical carbon dioxide extract as taught by Krutmann et al. in the composition of Newmark et al. because it is a commercially available extract readily accessible to a skilled artisan. An artisan would be motivated to select this extract because it has been shown to inhibit expression of POMC and IL-6, which protect against excessive melanin formation and inflammation, respectively (Krutmann et al., col. 1, ln. 46-65; col. 36, Example 4). A skilled artisan could therefore incorporate this supercritical carbon dioxide extract of ginger rhizome with a reasonable expectation of success.
Newmark et al. and Krutmann et al. are relied upon for the reasons discussed above. If not expressly taught by the prior art, based upon the overall beneficial teaching provided by this reference with respect to supercritical carbon dioxide extracts of ginger root and extracts comprising resveratrol utilized in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable total gingerol ranges and dilutions thereof (instant Claim 9)), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1-4, 8, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Newmark et al. (US 6387416 B1) as applied to 1-4, 8, and 14 above, and further in view of Ye et al. (Trend Food Sci Tech, 2018, 167-179).
The instant claims and teachings of Newmark et al. are as of record.
Newmark et al. do not teach wherein the combination preparation is in the form of a microencapsulated product.
Ye et al. teach that microencapsulation of functional ingredients enhances nutrition, masks off-flavors, facilitates storage, and extends shelf life without adverse effects on the physical, chemical, or functional properties of the functional (active) ingredients (Ye et al., Introduction, page 168; as required for instant Claims 11-13).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the product of Newmark et al. in the form of a microencapsulated product as taught by Ye et al. due to the benefits of enhanced nutrition, masked off-flavors, storage facilitation, and extension of shelf life. A skilled artisan would therefore be motivated to provide a microencapsulated dosage form and could do so with a reasonable expectation of success due to the lack of adverse effects on the physical, chemical, or functional properties of the functional (active) ingredients.
With respect to the USC 103 rejections above, please note that the intended use of the claimed composition (e.g., Claims 15 and 17) does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
From the 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 was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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