Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-20 are pending. Claims 11-14 and 19-20 are examined on the merits. Claims 1-10 and 15-18 are withdrawn.
Election/Restrictions
Claims 1-10 and 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/30/2025.
Applicant's election with traverse of Group II (Claims 11-20), the species bloating, triterpenoid saponin, Aesculus, in the reply filed on 9/30/2025 is acknowledged. The traversal is on the ground(s) that there is no undue burden. This is not found persuasive because a search of one group is not coextensive with the search of the other groups. Thus, it would be burdensome to search the entire claims.
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 11-14 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. Claim(s) 11-14 are directed to a composition comprising natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims recite a herbal supplement comprising a condensed tannins and a triterpenoid saponin, which can be found in a plant, such as Aesculus extract and soybeans, respectively. 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 ingredients mixed together would still be a product of nature because as long as there are nature-based molecules found in the composition, the composition contains a mixture of products that are found in nature (the individual natural molecules) and thus must be evaluated as per the described analysis. Mixing together various natural molecules does not change those molecules per se; they are simply mixed together and thus would have the same characteristics as the same molecules prior to being mixed together.
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, the homogenized composition of the different plants together are non-natural. However, a composition can be used in many different ways and thus not integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then 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.” In this case, the amounts of Claim 12 are amounts that can be derived from plants. The mixing of plant compounds are well understood, routine, and conventional method of making a product for supplementing nutrition such as a fruit juice or powder (see Liu, 2013, J American Society for Nutrition Adv Nutr, 4: 3845-3925). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter. The claims are rejected under 35 U.S.C. 101 as drawn to a judicial exception.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 11, 13 and 19 are rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by Jiang et al. (CN 1119067 A).
Jiang et al. teaches an herbal tea preparation comprising condensed tannin and triterpenoid saponins for strengthening stomach (Description, paragraph 5) as a health drink for people (Abstract).
Claim(s) 20 is rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by Yves et al. (FR 2770228 A1).
Yves et al. teaches a concentrated extract of red quebracho for encapsulation as a capsule preferably containing 0.01-15% (Abstract) for use in cosmetics, demopharmarcy, pharmacy, food industry and chemistry (Description). A capsule includes a nutraceutically acceptable carrier such as additives (Claim 18).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11-14 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10940176 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed amounts are not the same range for condensed tannins. Applicant seeks to broaden the range.
US 10940176 B2 teaches:
1. An herbal supplement, comprising: (1) a red quebracho extract in an amount between about 0.5% to about 75% by weight of the total supplement; and (2) an anti-spasmodic agent in an amount between about 2% to about 70% by weight of the total supplement, or an herbal composition comprising a triterpenoid saponin in an amount between about 10% to about 90% by weight of the total supplement.
2. The herbal supplement of claim 1, wherein the red quebracho extract comprises condensed tannins in an amount between about 50% and 80%.
3. The herbal supplement of claim 1, wherein the triterpenoid saponin is provided in the form of an Aesculus or Satindus species plant extract.
4. The herbal supplement of claim 1, wherein the herbal supplement comprises an anti-spasmodic agent.
5. The herbal supplement of claim 4, wherein the anti-spasmodic agent is provided in the form of a peppermint oil.
6. The herbal supplement of claim 1, wherein the herbal supplement is formulated in a dosage form that comprises: (1) between about 20 to 500 mg of red quebracho extract; and (2) between about 100 to about 2000 mg of Aesculus hippocastanum plant extract or between about 0.05 to about 1 ml of peppermint oil.
7. The herbal supplement of claim 1, further comprising a nutraceutically acceptable carrier, wherein the herbal supplement is in the form of a tablet or capsule.
8. The herbal supplement of claim 1, wherein the supplement is formulated to reduce bloating or constipation in a human subject.
9. The herbal supplement of claim 1, wherein the supplement is formulated to reduce weight gain in a human subject.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising condensed tannins and triterpenoid saponin of the active agent combination for the following reasons. The reference does teach the composition for treating bloating. US 10940176 B2 teaches condensed tannins in an amount between about 50% and 80% and a triterpenoid saponin in an amount between about 10% to about 90% by weight of the total supplement. Thus, it would have been obvious to make a concentrated composition containing both comprising condensed tannins and triterpenoid saponin for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Claims 11-14 and19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11931394 B2 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed amounts are not the same range for condensed tannins. Applicant seeks to broaden the range.
US 11931394 B2 teaches:
1. An herbal supplement, comprising: (1) a red quebracho extract in an amount between about 0.5% to about 75% by weight the total supplement; and (2) an herbal composition comprising a triterpenoid saponin in an amount between about 10% to about 90% by weight of the total supplement.
2. The herbal supplement of claim 1, wherein the red quebracho extract comprises condensed tannins in an amount between 50% to about 80%.
3. The herbal supplement of claim 1, wherein the triterpenoid saponin is provided in the form of a plant extract.
4. The herbal supplement of claim 1, wherein the triterpenoid saponin is provided in the form of a plant extract in an amount between about 40% and about 65% by weight of the total supplement.
5. The herbal supplement of claim 1, wherein the triterpenoid saponin is provided in the form of an Aesulus species plant extract.
6. The supplement of claim 1, wherein the triterpenoid saponin is provided in the form of an Aesculus hippocustamum plant extract.
7. The herbal supplement of claim 1, wherein the triterpenoid saponin is provided in the form of an Satindus species plant extract.
8. The herbal supplement of claim 1, wherein the triterpenoid saponin is provided in the form of an Satindus trifoliatus plant extract.
9. The herbal supplement of claim 1, wherein the herbal supplement is formulated in a dosage form that comprises between about 100 to about 2000 mg of the triterpenoid saponin.
10. The herbal supplement of claim 9, wherein the herbal supplement is formulated in a dosage form that comprises between 300 to about 600 mg of the triterpenoid saponin.
11. An herbal supplement of claim 1, wherein the herbal supplement is formulated in a dosage form that comprises: (1) between about 20 to 500 mg of red quebracho extract; and (2) between about 100 to about 2000 mg of Aesculus hippocastanum plant extract.
12. The herbal supplement of claim 1, further comprising a nutraceutically acceptable carrier, wherein the herbal supplement is in the form of a tablet or capsule.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising condensed tannins and triterpenoid saponin of the active agent combination for the following reasons. The reference does teach the composition for treating bloating. US 11931394 B2 teaches condensed tannins in an amount between about 50% and 80% and a triterpenoid saponin in an amount between about 10% to about 90% by weight of the total supplement. Thus, it would have been obvious to make a concentrated composition containing both comprising condensed tannins and triterpenoid saponin for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice .
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached on 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655