DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed October 24, 2025 has been received and entered.
3. Claims 1-15 are currently pending.
Election/Restrictions
4. Applicant's election with traverse of Group I, claims 1-9 and 12-15, in the reply filed on October 24, 2025 is acknowledged. In view of the prior art, the restriction requirement is withdrawn.
Claim Objections
5. Claims 10 and 11 are objected to because of the following informalities: in line 2 of each claim, it appears that “comparing” should read “comprising”. 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 1-15 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.
6. Claim 1 is indefinite because it is unclear if the “/” between “pharmaceutical” and “nutraceutical” is intended to mean “and” or “or”. In addition, it is unclear if the “gastro-resistant” limitation is intended to apply to the nutraceutical formulation as well as the pharmaceutical formulation.
7. Claim 4 is indefinite because the multiple uses of “and/or” make it unclear which elements can be selected as alternatives.
8. Claim 6 is indefinite because there is a lack of antecedent basis for “the griffona”. This claim currently depends from claim 1; however, it appears that it should depend from claim 2.
9. Claim 8 is indefinite because there is a lack of antecedent basis for “the three components,” “when griffona is present” and “the four components.”
10. Claim 11 is indefinite because the multiple uses of “and/or” make it unclear which elements can be selected as alternatives.
11. Claim 13 is indefinite because there is a lack of antecedent basis for “the four components.”
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.
12. Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cettour-Rose (BMC Physiology (2013), col. 13, no. 5, 11 pages), Luenemann (US 5,006,338), Wang (Cells (January 2020), vol. 9, no. 331, 15 pages), de Kraker (Plant Physiol. (1998), vol. 117, pp. 1381-1392), Lee (KR 20190087149 (July 24, 2019) – English translation), Park (KR 20190125804 (November 7, 2019) – English translation), Jain (US 2009/0258896), and McHugh (“Freeze-Drying Fundamentals.” Food Technology Magazine (2018), 13 pages, accessed at https://www.ift.org/news-and-publications/food-technology-magazine/issues/2018/february/columns/processing-freeze-drying-foods).
Cettour-Rose teaches that quinine is a component from the bark (cortex) of the cinchona tree. The reference teaches that quinine reduces food intake and body weight (see page 1). The reference does not teach that the cinchona tree is Cinchona succiruba. However, Luenemann teaches that C. succiruba is a known type of cinchona tree which contains quinine (see column 6, lines 55-63). Thus, an artisan would expect that C. succiruba could be used as the source of the quinine ingredient.
Wang teaches that lactucin is a component from endive (synonymous with chicory) useful for treating obesity, lowering body weight, and treating obesity related metabolic diseases (see page 2, second paragraph and Discussion section on pages 12-13). The reference does not teach that the endive is Cichorium intybus. However, de Kraker teaches that C. intybus is known as French endive and that the leaves and roots of this plant are a source of lactucin (see page 1381). Thus, an artisan would expect that C. intybus roots and leaves could be used as the source of the lactucin ingredient.
Lee teaches that gentiopicroside (gentiopicrin) is useful for treating obesity and obesity related diseases (see page 1 and claims of the translation). The reference does not teach that the gentiopicroside is from Gentiana lutea roots. However, Park teaches that Gentiana lutea roots are a known source of gentiopicroside (see page 2 of the translation). Thus, an artisan would expect that G. lutea roots could be used as the source of the gentiopicroside ingredient.
Jain teaches using a Griffonia simplicifolia seed extract containing 5-HTP to treat obesity and obesity related disorders, promote weight loss, and suppress appetite. The reference teaches that the composition can be formulated into a gastro-resistant formulations such as tablets (see paragraphs 3, 26, 79, and 83 and Example 11).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that treat obesity and obesity related disorders, promote weight loss, and suppress appetite. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to treat obesity and obesity related disorders, promote weight loss, and suppress appetite, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to treat obesity and obesity related disorders, promote weight loss, and suppress appetite. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The references do not teach that the cinchona, chicory, and gentian ingredients are freeze-dried. However, McHugh teaches that freeze-drying is a useful process for preserving bioactive materials and is advantegous to other preservation methods because it produces a product with superior quality in terms of flavor, color, appearance, texture, shelf-life, and preservation of the bioactivity of the active ingredients (see pages 4 and 5). Thus, an artisan of oridnary skill would reasonably expect that the product suggested by the combination of the references would be improved if the ingredients were freeze-dried. This reasonable expectation of improvement would have motivated the artisan to modify the references to include the use of freeze-dried ingredients.
The references do not specifically teach adding the ingredients together in the concentrations claimed by applicant. 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 pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical 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.
13. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655