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 election of Indole-3-carbinole for claim 27 and Tamoxifen for claim 31 in the reply filed on February 10, 2026 is acknowledged. In addition, the election of species for claims 27 and 31 will be applied to claims 45-62 in the reply filed on March 12, 2026. 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)).
Claims 45-62 are examined on the merits.
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(s) 45-62 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 45 is indefinite because it is directed to a “use” type claim. “Use” type claims are not a statutory category of invention. Thus, it is unclear if the claims are a method or a composition. Thus, the metes and bounds of the claim are unclear. For the sake of examination, this claim is examined as a composition with an intended use because this is the broadest reasonable interpretation of the claim.
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.
Claim(s) 45-47, 51-52, 54-62 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A composition comprising a selective estrogen receptor modulator (e.g. licorice root extracts) and a second estrogen modulator encompasses naturally occurring substances.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant's claims are directed to a product; thus, the answer to Step 1 is Yes. The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant's claims recite a combination of a selective estrogen receptor modulator (SERM) and the estrogen modulator Indole-3-carbinole. Indole-3-carbinole is a naturally occurring substance and SERM can be naturally occurring substances such as isoflavones from soy. The claims also state that the Indole-3-carbinole is administered as a vegetable ingredient. Vegetables are also natural products. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that "When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A."
MPEP § 2106.04(c)(I) states that "if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is " a product of nature exception To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product's structure, function, and/or other properties…”.
In this case, the closest naturally occurring counterpart for each ingredient is the ingredient itself because each is naturally occurring.
There is no indication that the specified ingredients as commensurate in scope with the stated claim changes the structure, function, or other properties of the ingredients in any marked way in comparison with the closest naturally occurring counterpart. Each ingredient in the composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of preventing or treating gynecomastia. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by "Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself."
However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. The presence of a cruciferous vegetable supplement (e.g. a licorice root extract) within claim 47 of the present invention does not amount to significantly more than a combination of judicial exception because mixing ingredients is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
In addition, applicant’s intended use of preventing or treating gynecomastia is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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.
Claim(s) 45-46, 48-54 and 61-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kun (U.S. Pub. No. 2007/0015837 A1).
Kun teaches a composition that can contain chemopreventative agents such as tamoxifen and indole-3-carbinol (paragraph 0164). Kun teaches [that the] combinations may include, but are not limited to, the use of one or more various chemopreventative agents (paragraph 0148). Kun teaches the compounds of the present invention are used for the treatment of breast cancer (paragraph 0038) ([in page 12 and 18 of the specification of the current invention, applicant discusses that both I3C and tamoxifen can work to suppress the growth of human breast cancer cells and that tamoxifen and I3C combined has shown promising results in the treatment of gynecomastia and mastalgia (page 4, paragraphs 0017-0018, paragraphs 0022-0025 and page 12, paragraphs 0019-0024)]). Kun teaches the compounds may be formulated together [within a] tablet or capsule (paragraph 0169). Kun teaches oral administration of the composition (paragraph 0172). Kun teaches pharmaceutical compositions useful in the prevention and treatment of cancer in humans (paragraph 0006).
The Kun reference does not specifically teach that administering the composition would have an effect on gynecomastia and does not teach that the SERM, Tamoxifen is a triphenylethylene-type selective estrogen receptor modulator as claimed by the applicant within claims 45-62 and 48, respectively. However, the ingestion of a composition that comprises Indole-3-carbinole and Tamoxifen would inherently affect gynecomastia (also based on the provided information regarding I3C and Tamoxifen within the specification of the current invention) and that it is also inherent that Tamoxifen is a triphenylethylene-type SERM.
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.
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.
Claim(s) 45-47 and 55-60 are rejected under 35 U.S.C. 103 as being unpatentable over Kun (U.S. Pub. No. 2007/0015837 A1) and Boonmuen et al (Steroids, (Year: 2016), vol. 105, pp. 42-49).
The teachings of Kun are above.
Kun does not teach a selective estrogen receptor modulator that is a cruciferous vegetable supplement and Kun does not teach the administration of the selective estrogen receptor modulator (SERM) with or without the estrogen modulator (EM) in the specified dosages as claimed by the applicant in claims 55-60 of the present invention.
Regarding claim 47, Boonmuen et al teaches that licorice root extracts have selective estrogen receptor modulator or SERM-like activity (page 7).
The composition as taught by Kun can be modified to include the licorice root extract as a SERM as taught by Boonmuen, that can be used within the supplement to prevent or treat gynecomastia. The combination of the two references show that it was well known in the art prior to the effective filing date of the invention to use the ingredient (e.g. a licorice root extract) as a SERM and that in addition, licorice is derived from a plant which in turn means that the plant is a legume, therefore, one would reasonably expect that a legume, like licorice can be an example of a cruciferous vegetable supplement that can be used within a composition to help treat gynecomastia.
Regarding claim(s) 55-60, the references do not explicitly teach the dosages of the SERM and the EM administered, either separately or in conjunction with one another as a composition to treat gynecomastia. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Conclusion
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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