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
Claims 18-40 are pending in the instant application. Applicant’s election without traverse of Group I, Claims 18-26, in the reply filed on 12 June 2025 is acknowledged. Claims 38-40 are new. Claims 22, 24, and 28-34 are amended. Claims 27 and 35-37 are cancelled. Claims 18-26, 28-34, and 38-40 are being examined on the merits.
Information Disclosure Statement
The listing of references in the specification (e.g., page 2, line 13) 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 disclosure is objected to because of the following informalities: on page 40, line 33, “zinc bisglycinate (20 mg eq.,” should instead read ---zinc bisglycinate (20 mg eq.),---. Additionally, all instances of the variant name “boulardii” should be italicized as ---boulardii---.
Appropriate correction is required.
Claim Objections
Claims 18, 19, 21, 22, 31, 32, 34, and 40 are objected to because of the following informalities:
In Claim 18, “susceptible of suffering from” should instead read ---susceptible to suffering from---.
In Claim 18, “endometriosis” should instead read ---endometriosis,---.
In Claims 19 and 21, “claim 18, said method” should instead read ---claim 18, wherein said method---.
In Claim 21, “method normalizing” should instead read ---method for normalizing---.
In Claims 22, 31, 32, 34, and 40, “boulardii” should instead read ---boulardii---.
In Claim 40, “daily of 5 to 100 mg” should instead read ---daily dose of 5 to 100 mg---.
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 25, 26, 34, and 40 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.
Regarding Claims 25 and 34, the phrase "optionally" 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 26 recites the limitation "said one or more ingredients with a physiological or nutritional purpose,” however this limitation is optional. There is therefore insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "the zinc,” however this limitation is optional according to Claim 34. There is therefore insufficient antecedent basis for this limitation in the claim.
Claim 40 recites the limitation "yeast.” There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claims 18-21, 23, 25, and 28-30 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Capello (US 2013/0115195 A1) as evidenced by Ultrus (Lynside® Pro SCB, 2025, 2 pages), Dull et al. (Molecules, 2019, 21 pages), and Arablou & Kolahdouz-Mohammadi (Biomed Pharmacol, 2018, 91-97).
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
The instant claims are as of record, drawn to a method for treating a subject suffering from, or susceptible of suffering from, endometriosis, comprising the administration of an effective dose of resveratrol, a curcuma extract, and a Saccharomyces cerevisiae species to said subject.
Capello teaches a composition comprising 150-250 mg or more of Saccharomyces cervisiae ([0045]), 5-150 mg of 98% trans-resveratrol ([0030], [0040]), and 5-150 mg of 95% standardized curcumin extract (at least 15% curcuminoid content by weight; effective dose; [0028], [0040]; as required for instant Claims 18, 22, 31, 32, 34, and 40). The specification (page 17, lines 21-23) indicates that Lynside® Pro SCB may be used as the Saccharomyces cervisiae strain, which according to the product page provided by Ultrus, comprises 20 x 109 CFU/g, which converts to 200,000,000 CFU/mg, and thus the composition of the prior art would contain between 3 x 1010 and 5 x 1010 CFU of Saccharomyces cervisiae (as required for instant Claims 31, 33, and 34). If the maximum amount of each ingredient was used, the total mass of the composition would be 550 mg, comprising 45.5% Saccharomyces cervisiae and 27.3% of each of trans-resveratrol and curcumin extract (as required for instant Claim 28). Additionally, since the curcumin extract comprises 95% curcuminoids, the curcuminoids are therefore present in a range of 4.75-142.5 mg (as required for instant Claims 34 and 40). The composition is a nutritional supplement (nutraceutical; food supplement; [0020]) administered daily to a human ([0018]; as required for instant Claims 18 and 40) as an oral capsule wherein the ingredients can be provided in a single capsule (dosage form; [0058]; as required for instant Claims 23, 25, 28, 31, 32, 38, and 40). The composition additionally comprises vitamin D3 and vitamin C (Claims 12 and 13, page 6; as required for instant Claim 29). The composition comprises a probiotic, Saccharomyces cervisiae, and does not comprise Lactobacillus (as required for instant Claim 30).
Although Capello teaches each of the active steps in the claimed method, they are
silent regarding the intended use of the method recited in the preamble i.e. treating a subject suffering from, or susceptible of suffering from, endometriosis. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the composition of the prior art and the composition of the invention are capable of treating the same disease states. The single-step method of administration of a composition comprising overlapping, and therefore effective, amounts of resveratrol, a curcuma extract, and a Saccharomyces cerevisiae are the same, and thus the properties of treating a subject suffering from, or susceptible of suffering from, endometriosis are inherent, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the method of Capello is either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
The cited reference discloses a composition comprising 150-250 mg or more of Saccharomyces cervisiae, 5-150 mg of 98% trans-resveratrol, and 5-150 mg of 95% standardized curcumin extract which appears to be identical to the presently claimed method since it is formulated and/or obtained from the same component materials and is administered/administrable to a subject. Consequently, the claimed process (and compositions provided therein) appears to be anticipated by the reference. In the alternative, even if the process (and compositions therein (with respect to an intended therapeutic effect against endometriosis) is not identical to the referenced process, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of in the claimed process, particularly in view of the similar characteristics which they have been shown to share (e.g. the similar component materials/formulations and the same broad administration).
Additionally, Dull et al. teach that resveratrol is known to have anti-inflammatory properties that can inhibit endometriotic lesions (Dull et al., page 2; as required for instant Claim 19), decrease pain (e.g., pelvic pain) associated with endometriosis (Dull et al., page 10; as required for instant Claim 20), and induce antioxidant enzymes (decrease oxidative stress; Dull et al., page 11; as required for instant Claim 21). Arablou & Kolahdouz-Mohammadi further teach that curcumin inhibits endometrial lesions and reduces inflammation and thus is a useful dietary and pharmaceutical agent for prevention and treatment of endometriosis (Arablou & Kolahdouz-Mohammadi, Conclusion, page 96; as required for instant Claims 19-21).
Thus, the claimed process (and administered-composition effects intrinsic thereto) would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Claims 18-23, 25, 28-32, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Capello (US 2013/0115195 A1) as evidenced by Dull et al. (Molecules, 2019, 21 pages) and Arablou & Kolahdouz-Mohammadi (Biomed Pharmacol, 2018, 91-97) as applied to Claims 18-21, 23, 25, and 28-30 above and further in view of McFarland (World J Gastroenterol, 2010, 2202-2222).
The claims and teachings of Capello as evidenced by Dull et al. and Arablou & Kolahdouz-Mohammadi are as of record.
Capello does not teach wherein the Saccharomyces cerevisiae is of the variety boulardii.
McFarland teaches that S. boulardii is a safe and effective probiotic with clinical evidence for various diseases to back up its use, particularly in comparison to other strains of Saccharomyces (McFarland, Conclusion, 2216).
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 combine the teachings of Capello and McFarland to arrive at the instantly claimed invention. Due to its use for various diseases and safety profile, a skilled artisan could provide S. cerevisiae v. boulardii as the probiotic in the instant method with a reasonable expectation of success.
Capello and McFarland are relied upon for the reasons discussed above. Based upon the overall beneficial teaching provided by this reference with respect to S. boulardii, the selection of a particular variety of yeast from among those well-known in the art would have been a manner of judicial selection and routine optimization well within the purview of the skilled artisan, absent any specific evidence to the contrary regarding the nonobviousness of this variant.
Claims 18-21, 23-25, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Capello (US 2013/0115195 A1) as evidenced by Dull et al. (Molecules, 2019, 21 pages) and Arablou & Kolahdouz-Mohammadi (Biomed Pharmacol, 2018, 91-97) as applied to Claims 18-21, 23, 25, and 28-30 above, and further in view of Maia et al. (Int J Women Health, 2012, 543-549).
The claims and teachings of Capello as evidenced by Dull et al. and Arablou & Kolahdouz-Mohammadi are as of record.
Capello does not teach wherein the subject suffering from endometriosis has undergone or is to undergo a surgical treatment of resection of the endometriotic lesions, medically assisted reproduction, and/or contraceptive treatment.
Maia et al. teach that endometriosis patients taking a combination of oral contraceptives (under contraceptive treatment; as required for instant Claim 24) and resveratrol experience less endometriotic pain (Maia et al., Table 2, page 545). Additionally, patients having undergone laparascopy or hysteroscopy to treat endometriotic lesions taking resveratrol also experienced less pain (Maia et al., Results, page 545).
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 composition of Capello to the patient population of Maia et al. in order to reduce endometriosis-associated pain in patients undergoing contraceptive treatment and/or surgical intervention. A skilled artisan could do so with a reasonable expectation of success due to the positive teaching of resveratrol as a compound for pain reduction in a subject suffering from endometriosis.
Claims 18-23, 25, 28-32, 34, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Capello (US 2013/0115195 A1) as evidenced by Dull et al. (Molecules, 2019, 21 pages) and Arablou & Kolahdouz-Mohammadi (Biomed Pharmacol, 2018, 91-97) in view of McFarland (World J Gastroenterol, 2010, 2202-2222) as applied to Claims 18-23, 25, 28-32, 38, and 40 above and in further view of Yadav et al. (AAPS Pharm Sci Tech, 2009, 752-762).
The claims and teachings of Capello as evidenced by Dull et al. and Arablou & Kolahdouz-Mohammadi in view of McFarland are as of record.
Capello and McFarland do not teach wherein the curcuma extract is associated with a cyclodextrin.
Yadav et al. teach that inclusion complexes of cyclodextrin and curcumin (curcuma extract) protect the guest molecule from the environment while increasing solubility and stabilization for pharmaceutical purposes (Yadav et al., Introduction, page 753; as required for instant Claim 34).
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 combine the teachings of Capello and McFarland to arrive at the instantly claimed invention. Providing the curcuma extract in association with cyclodextrin would increase solubility and stability of the composition, thereby allowing a skilled artisan to include it in the instant invention with a reasonable expectation of success.
Claims 18-23, 25, 26, 28-34, and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Capello (US 2013/0115195 A1) as evidenced by Dull et al. (Molecules, 2019, 21 pages) and Arablou & Kolahdouz-Mohammadi (Biomed Pharmacol, 2018, 91-97) in view of McFarland (World J Gastroenterol, 2010, 2202-2222) and Yadav et al. (AAPS Pharm Sci Tech, 2009, 752-762) as applied to Claims 18-23, 25, 28-32, 34, 38, and 40 above and in further view of Gandia et al. (Int J Vitam Nutr Res, 2007, 243-248) and Staff (US Pharmacist, 2006, 13 pages).
The claims and teachings of Capello as evidenced by Dull et al. and Arablou & Kolahdouz-Mohammadi in view of McFarland and Yadav et al. are as of record.
Capello, McFarland, and Yadav et al. do not teach wherein each dosage unit comprises zinc and inulin or that the zinc is in the form of bisglycinate.
Gandia et al. teach that zinc is an essential trace mineral and that zinc bisglycinate is a safe, well-tolerated, and has higher oral availability than zinc gluconate (Gandia et al., Abstract, page 243; as required for instant Claims 26, 33, and 39).
Capello, McFarland, Yadav et al., and Gandia et al., do not teach wherein each dosage unit comprises inulin.
Staff teaches that inulin is a natural food fiber that is highly soluble, act as a prebiotic, and improve immune function (Staff, pages 1-2; as required for instant Claim 33).
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 combine the teachings of Capello, McFarland, Yadav et al., Gandia et al., and xxxxx to arrive at the instantly claimed invention. Providing zinc in the bisglycinate form provides a more readily available form of an essential trace mineral and inulin to improve immune function as a prebiotic. A skilled artisan could therefore include both in the composition of the claimed method with a reasonable expectation of success.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the processes thereof), 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