DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114), the Response, and Amendment filed 05/11/2026 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims: (1) the objection to claim 40 has been withdrawn; (2) the 35 U.S.C. §101 rejections of claims 29, 31, and 42 have been withdrawn; (3) the 35 U.S.C. §112(b) rejections of claims 31 and 40 have been withdrawn; and (4) the 35 U.S.C. §102(a)(1) rejections of claims 31 and 40 over Zemel have been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 2-5, 7-30, 33, 35-36, 38, 41-44
Withdrawn claims: None
Previously cancelled claims: 1, 6, 32, 34, 37, 39
Newly cancelled claims: 31, 40
Amended claims: 29-30, 36, 41-42
New claims: 43-44
Claims currently under consideration: 2-5, 7-30, 33, 35-36, 38, 41-44
Currently rejected claims: 2-5, 7-30, 33, 35-36, 38, 41-44
Allowed claims: None
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/11/2026 has been entered.
Priority
The Examiner notes that due to (A) claims 41 and 42 including amounts of ingredients that were not disclosed in the provisional application filed 04/18/2023 (e.g., resveratrol in a daily dose of 50-500 g); and (B) claim 30 reciting yohimbine HCl which was not disclosed in the provisional application filed 04/18/2023, the present claims have the effective filing date of 04/10/2024, which is the date when the present application was filed.
Claim Objections
Claims 36, 41, and 42 are objected to because of the following informalities:
In claim 36, “GLP-1 RA” should be read as “GLP-1 receptor agonist (GLP-1 RA)”.
In claim 41, “10-20 billion cfu, and allulose in a daily dose of 4-25 g, rebaudioside a in a daily dose of range 0.4-1.5 g; and” should be read as “10-20 billion cfu, allulose in a daily dose of 4-25 g, and rebaudioside A in a daily dose of range 0.4-1.5 g; and”.
In claim 42, “10-20 billion cfu, and allulose in a daily dose of 5-25 g, rebaudioside a in a daily dose of range 0.4-1.5 g;” should be read as “10-20 billion cfu, allulose in a daily dose of 5-25 g, and rebaudioside A in a daily dose of range 0.4-1.5 g;”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2, 4, 12-14, 16-17, 21-27, 29-31, and 41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 2, 4, 12-14, 16-17, 21-27, and 41 are directed to a composition comprising a nature-based product (i.e., a composition containing myricetin). This composition is not markedly different from their closest naturally-occurring counterparts because there is no indication that the preparation has caused the nature-based products to have any characteristics that are markedly different from the closest naturally-occurring products and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The ingredient recited in the claims is a natural product that would occur naturally; thus, the claims fall within judicial exceptions. There is no indication in the record of any markedly different characteristics (either structural or functional) of the composition as broadly claimed. For example, there is no evidence of record of a structural difference between the myricetin in the claimed composition and that of its nature-based counterpart. Also, there is no evidence of record of a structural difference the myricetin in the claimed composition and that of its nature-based counterparts. Consequently, the claimed composition is structurally the same as its closest naturally-occurring counterpart.
Nor is there any difference in functional characteristics. To show a marked difference, the characteristic(s) must be changed as compared to its closest naturally-occurring counterpart. For example, an assertion of changed functionality must be accompanied with evidence of a comparison of the claimed composition with its closest naturally-occurring counterpart and should apply to the full scope of the claim. Furthermore, inherent or innate characteristics of the naturally-occurring counterpart cannot show a marked difference. Likewise, differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference.
Thus, there is no evidence of record to indicate that the claimed products are markedly different, structurally, chemically, functionally, than their closest naturally-occurring counterparts and are not eligible subject matter under current 35 U.S.C. 101 standards.
Claim Rejections - 35 USC § 112
Claims 2-5, 7-30, 33, 35-36, 38, and 41-44 are rejected under 35 U.S.C. 112(b) 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 29 recites a “green coffee bean extract in a daily dose range of”. The claim does not provide a numerical range for the green coffee bean extract. Also, it is unclear as to whether the “daily dose” amount is the amount of ingredient in the composition; or if the phrase “daily dose” is the amount of the ingredient that a consumer is administered each day. Therefore, the claim is indefinite.
For the purpose of this examination, the claim will be interpreted as meaning that the composition comprises the recited ingredient in any amount greater than 0 mg.
Claims 30, 41, 42, 43, and 44 recite a daily dose for the listed ingredients. However, it is unclear as to whether the “daily dose” amount is the amount of ingredient in the composition; or if the phrase “daily dose” is the amount of the ingredient that a consumer is administered each day. Therefore, the claims are indefinite.
For the purpose of this examination, the claims will be interpreted as meaning that the composition comprises the recited ingredient in any amount greater than 0 mg.
Regarding claims 41 and 42, the phrases written in parentheses (i.e., green tea extract ) render the claims indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
For the purpose of this examination, the phrases written in parentheses will not be considered as part of the claim.
Claims 2-5, 7-28, 33-36, and 38 are rejected by reason of dependency from claim 41.
Claim Rejections - 35 USC § 102
Claims 2-5, 7-10, 12-17, 20-22, 26-30, 36, 38, and 41-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zemel (US 2018/0105498; previously cited).
Regarding claims 41, 42, 43, and 44, Zemel teaches a composition for oral administration (corresponding to dietary supplement or a food stuff) [0495] for weight loss and glucose management (corresponding to reducing and treating obesity and diabetes) [0007] in humans and animals [0184]. Zemel teaches that the composition may comprise probiotics, chlorogenic acid, resveratrol, R-lipoic acid (corresponding to lipoic acid), and caffeine [0364], [0379], [0381], [0423], [0453]. Therefore, Zemel teaches a composition comprising a GLP-1 releasing agent, a GIP releasing agent, a DPP-4 inhibitor, an insulin-resistance improver, and a thermogenic activator as recited in present claims 41, 42, 43, and 44. Due to the inclusion of the claimed GLP-1 releasing agent, the claimed GIP releasing agent, the claimed DPP-4 inhibitor, the claimed insulin-resistance improver, and the claimed thermogenic activator, the composition of Zemel enhances endogenous secretion of GLP-1 and inhibits DPP-4 activity to assist in weight loss and glycemic control without significant undesirable side effects as recited in present claims 41 and 42.
Regarding claim 2, Zemel teaches the invention as described above in claim 41, including the composition further comprises a compound to improve insulin resistance (corresponding to a supplement that has beneficial effects on insulin sensitivity) [0422].
Regarding claim 3, Zemel teaches the invention as described above in claim 41, including the composition is in a powder form [0503] and is combined with a solubilizer [0517]. Therefore, the composition is configured to be dissolved in water or another liquid prior to oral administration. It is noted that the phrase “configured to be formulated for dissolution in water or another liquid before oral administration” in claim 3 does not actually require the composition to be dissolved in water or another liquid.
Regarding claim 4, Zemel taches the invention as described above in claim 41, including the composition is for oral administration in a form of a powder, granule, tablet, capsule, liquid, gel [0503], or a food item [0495].
Regarding claim 5, Zemel taches the invention as described above in claim 41, including the composition is an emulsion [0503].
Regarding claim 7, Zemel taches the invention as described above in claim 41, including the composition is a liquid, fluid, solution, or emulsion [0503].
Regarding claim 8, Zemel taches the invention as described above in claim 41, including the composition is a gel [0503].
Regarding claim 9, Zemel taches the invention as described above in claim 41, including the composition is a nano-dimensional structure (corresponding to nanoparticle), nanoparticle, liposome, or micelle [0554].
Regarding claim 10, Zemel taches the invention as described above in claim 41, including the composition is in the form of a powder for oral administration [0503] and contains protein (corresponding to gelatin) [0518]. Therefore, the composition is a protein powder blend for oral administration as presently claimed.
Regarding claim 12, Zemel taches the invention as described above in claim 41, including the composition is administered in food form [0495].
Regarding claim 13, Zemel taches the invention as described above in claim 41, including the composition is a food additive (corresponding to the composition being combined with other substances for oral administration) [0503].
Regarding claim 14, Zemel teaches a composition as described above in claim 41, including the composition is a medicinal food (corresponding to pharmaceutical composition) [0075].
Regarding claim 15, Zemel taches the invention as described above in claim 41, including the composition is a powder for oral administration [0503].
Regarding claim 16, Zemel teaches a composition as described above in claim 41, including the composition comprises the claimed GLP-1 releasing agent and is administered to humans [0426], [0471]. Therefore, the composition is configured to enhance endogenous GLP-1 secretion in humans as presently claimed.
Regarding claim 17, Zemel teaches a composition as described above in claim 41, including the composition comprises the claimed GLP-1 releasing agent and the claimed DPP-4 inhibitor [0426], [0471]. Therefore, the composition is configured to increase plasma GLP-1 levels as presently claimed.
Regarding claim 20, Zemel teaches a composition as described above in claim 41, including the composition reduces body weight [0487].
Regarding claim 21, Zemel teaches a composition as described above in claim 41, including the composition decreases body fat content [0283].
Regarding claim 22, Zemel teaches a composition as described above in claim 41, including the composition reduces body weight [0487] within four weeks of use [0292].
Regarding claim 26, Zemel teaches a composition as described above in claim 41, including the composition lowers the body mass index (BMI) (corresponding to treating hyperlipidemia) [0007], [0274].
Regarding claim 27, Zemel teaches a composition as described above in claim 2, including the composition reduces blood glucose levels [0272].
Regarding claims 28 and 29, Zemel teaches a composition as described above in claim 41, including the composition further comprises chlorogenic acid [0356], [0361]. Present claim 29 recites that chlorogenic acid is an agonist of glucose-dependent insulinotropic polypeptide (GIP); therefore, Zemel teaches that the composition comprises a natural GIP agonist in the form of chlorogenic acid as recited in present claims 28 and 29.
Regarding claim 30, Zemel teaches a composition as described above in claim 41, including the composition may further comprise caffeine and/or cocoa bean extracts (corresponding to cocoa and chocolate) [0356], [0361], [0363]. The disclosed compounds are members of the group recited in present claim 30 and are thus considered to be thermogenesis activator compounds which enhance thermogenesis in brown adipose tissue (BAT) or white adipose tissue (WAT) as presently claimed.
Regarding claim 36, Zemel teaches a composition as described above in claim 41, including the composition contains the claimed GLP-1 releasing agent [0422], [0471]; therefore, the prevents weight regain after discontinuing another medication containing GLP-1 receptor releasing agent.
Regarding claim 38, Zemel teaches a composition as described above in claim 41, including the composition reduces weight (corresponding to increasing weight loss) [0272] in dogs, cats, and animals [0184].
Claim 11 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zemel (US 2018/0105498; previously cited) as applied to claim 41 above, as evidenced by Cervoni (Cervoni, B., “How You Can Incorporate Alfalfa Into Your Diet”, 2024, Very Well Health, https://www.verywellhealth.com/health-benefits-of-alfalfa-4584280?print; previously cited).
Regarding claim 11, Zemel teaches the invention as described above in claim 41, including the composition comprises alfalfa [0423]. Alfalfa contains fiber as evidenced by Cervoni (page 1, first paragraph under “May Control Blood Sugar”). Therefore, Zemel teaches that the composition is a fiber blend as presently claimed.
Claims 18-19 and 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zemel (US 2018/0105498; previously cited) as applied to claim 41 above, as evidenced by New (“Why Do I Need Probiotics on GLP-1 Medication?”, 2024, New You, https://newyoulongview.com/blog/f/why-do-i-need-probiotics-on-glp-1-medication; previously cited).
Regarding claim 18, Zemel teaches the invention as described above in claim 41, including the composition comprises probiotics [0423]. Probiotics prevent adverse gastrointestinal effects associated with the use of GLP-1 releasing agents as evidenced by New (page 3, 1st paragraph). Therefore, the composition of Zemel is formulated to prevent adverse gastrointestinal effects associated with the use of GLP-1 releasing agents as presently claimed.
Regarding claim 19, Zemel teaches the invention as described above in claim 41, including the composition comprises probiotics [0423]. Probiotics prevent nausea, vomiting, and diarrhea associated with the use of GLP-1 releasing agents as evidenced by New (page 3, 1st paragraph). Therefore, the composition of Zemel is formulated to prevent nausea, vomiting, and diarrhea associated with the use of GLP-1 releasing agents as presently claimed.
Regarding claim 23, Zemel teaches the invention as described above in claim 41, including the composition comprises the claimed GLP-1 releasing agent [0471]. The activation of GLP-1 receptors by the GLP-1 releasing agents reduces hunger and increases the feeling of satiety as evidenced by New (page 2, bullet points under paragraph beginning “GLP-1 medications work by mimicking”). Therefore, the composition of Zemel is configured to reduce hunger and increase the feeling of satiety as presently claimed.
Regarding claim 24, Zemel teaches the invention as described above in claim 41, including the composition comprises the claimed GLP-1 releasing agent [0471]. The activation of GLP-1 receptors by the GLP-1 releasing agents enhances the feeling of satiety as evidenced by New (page 2, bullet points under paragraph beginning “GLP-1 medications work by mimicking”). Therefore, the composition of Zemel is configured to enhances the feeling of satiety as presently claimed.
Regarding claim 25, Zemel teaches the invention as described above in claim 41, including the composition comprises the claimed GLP-1 releasing agents [0422], [0423], [0453], [0363]. The activation of GLP-1 receptors by the GLP-1 releasing agents delay gastric emptying as evidenced by New (page 2, bullet points under paragraph beginning “GLP-1 medications work by mimicking”). Therefore, the composition of Zemel is configured to delay gastric emptying as presently claimed.
Claim 33 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zemel (US 2018/0105498; previously cited) as applied to claim 41 above, as evidenced by Martins (Martins et al., “Hypothalamic anorexigenic signaling pathways (leptin, amylin, and proopiomelanocortin) are semaglutide (GLP-1 analog) targets in obesity control in mice”, 2023, Life Sciences, 313, 121268; previously cited).
Regarding claim 33, Zemel teaches the invention as described above in claim 41, including the composition comprises semaglutide [0117]. Semaglutide improves leptin sensitivity as evidenced by Martins (page 3, column 2, third paragraph under “4. Discussion”). Therefore, Zemel teaches a composition comprising a compound that decreases leptin resistance as presently claimed.
Claims 35 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zemel (US 2018/0105498; previously cited) as applied to claim 41 above, as evidenced by Haus (“Semaglutide Weight Loss: Everything You Need to Know”, 2022, Haus of Aesthetics, https://hausofaestheticsslc.com/semaglutide-weight-loss-treatment/#:~:text=Semaglutide%20is%20a%20peptide%20that,less%20hungry%20throughout%20the%20day.; previously cited).
Regarding claim 35, Zemel teaches the invention as described above in claim 41, including the composition comprises semaglutide [0117]. Semaglutide suppresses ghrelin levels as evidenced by Haus (page 2, paragraph under “How Does Semaglutide Work?”). Therefore, Zemel teaches that the composition further comprises a compound that suppresses ghrelin levels.
Response to Arguments
Claim Objections: Applicant canceled claim 40. Applicant amended claim 36 to address the objection written in the previous Office Action. However, claim 36 remains rejected for the reason provided above.
Claim Rejections – 35 U.S.C. §101 of claims 2, 4, 12-14, 16-17, 21-27, 29-31, and 41-42: Applicant canceled claim 31. Applicant argued that claim 41 recites daily dose ranges of specific natural GLP-1 agonists and DDP-4 inhibitors that result in weight loss and glycemic control in humans, without needing to resort to pharmaceuticals. Applicant argued that claim 42 further comprises daily dose ranges of specific natural GLP-1 agonists, DDP-4 inhibitors, insulin-resistance improvers, and thermogenic activators that result in weight loss and glycemic control in humans, without needing to resort to pharmaceuticals (Applicant’s Remarks, page 15, 3rd paragraph – page 16, 1st paragraph).
The cancelation of claim 31 moots the rejection. The amendment of claims 29 and 42 overcomes the rejection. Therefore, the rejections of these claims are withdrawn.
In regard to the rejections of claims 2, 4, 12-14, 16-17, 21-27, 29-31, and 41, the Examiner points out that claim 41 is directed to products, not methods. Therefore, the recitations of a “daily dose” of each ingredient are not considered to be part of the claim as described in the 35 U.S.C. §112(b) rejections above. Therefore, the product of claim 41 (and the dependent claims identified in the 35 U.S.C. §101 rejections) are considered to merely require any amount of the recited ingredient greater than 0 mg. As such, claim 41 (and the identified dependent claims) remain rejected for being nature-based products.
Claim Rejections – 35 U.S.C. §112(b) of claims 2-5, 7-36, 38, and 40-42: Applicant canceled claims 31 and 40. Therefore, the rejections of these claims are moot. Applicant amended claims 29, 30, 41, and 42. However, these claims (and their identified dependents) remain rejected for the reasons provided above.
Claim Rejections – 35 U.S.C. §102(a)(1) of claims 2-5, 7-10, 12-17, 20-22, 26-31, 36, 38, and 40-42; over Zemel; claim 11 over Zemel as evidenced by Cervoni; claims 18-19 and 23-25 over Zemel as evidenced by New; claim 33 over Zemel as evidenced by Martins; claim 35 over Zemel as evidenced by Haus: Applicant’s amendments and arguments have been fully considered and are not considered to overcome the rejections.
Applicant canceled claims 31 and 40. Applicant argued that Zemel does not teach using a composition containing GLP-1 agonists and DPP-4 inhibitors in the claimed dosages without the use of the new sirtuins disclosed in Zemel. Applicant argued that, even though Zemel discloses the claimed GLP-1 agonists and DPP-4 inhibitors, there is no mention of a specific dose of the claimed GLP-1 agonists and DPP-4 inhibitors in Zemel. Applicant argued that Zemel does not teach that the claimed ingredients can be used as GLP-1 agonists, DPP-4 inhibitors, and/or GIP releasing agents. Applicant argued that the laundry list of possible ingredients in [0423] of Zemel at most suggests to try using the claimed ingredients but does not anticipate the claimed invention recited in present claims 41 and 42. Applicant argued that claim 40 recites a method of using the composition of claim 41 and, thus claim 40 is patentable (Applicant’s Remarks, page 16, 3rd paragraph – page 18, 3rd paragraph).
However, in response to Applicant’s assertion that Zemel does not teach using a composition containing GLP-1 agonists and DPP-4 inhibitors without the use of the new sirtuins disclosed in Zemel, the Examiner points out that the present claims do not exclude any ingredient from the composition as the claims use an open-ended transitional term (i.e., claim 41 recites “the composition comprising”; claim 42 recites “the composition comprising”). Therefore, the claims do not require a GLP-1 releasing agent and a DPP-4 inhibitor alone and do not exclude sirtuins.
In response to Applicant’s assertion that, even though Zemel discloses the claimed GLP-1 agonists and DPP-4 inhibitors, there is no mention of a specific dose of the claimed GLP-1 agonists and DPP-4 inhibitors in Zemel, as stated in the 35 U.S.C. §112(b) rejections provided above and in the 35 U.S.C. §112(b) rejections provided in the Final Action filed 02/10/2026, it is unclear as to whether the “daily dose” ranges recited in present claims 41 and 42 are the amounts of ingredient in the composition; or if the phrase “daily dose” is the amount of the ingredient that a consumer is administered each day as these claims are product claims, not method claims. As such, these claims are indefinite and are being interpreted as meaning that the composition comprises the recited ingredient in any amount greater than 0 mg. Since Zemel mentions the inclusion of the claimed ingredients in its composition, the amount of the claimed ingredient in the composition of Zemel is necessarily greater than 0 mg, thereby meeting the limitations of the present claims.
In response to Applicant’s assertion that Zemel does not teach that the claimed ingredients can be used as GLP-1 agonists, DPP-4 inhibitors, and/or GIP releasing agents, since Zemel teaches the same ingredients in its composition as claimed and instantly disclosed, the ingredients of Zemel would have the claimed GLP-1 releasing ability, the claimed DPP-4 inhibiting ability, and/or the claimed GIP releasing ability as presently claimed. Regarding product claims, when the ingredient recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be present in the ingredient of the prior art. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s function, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F .3d 1342, 1347, 51 USPQ2d 1943. 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function, or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). MPEP §2112.I.
In response to Applicant’s assertion that the laundry list of possible ingredients in [0423] of Zemel at most suggests to try using the claimed ingredients but does not anticipate the claimed invention recited in present claims 41 and 42, “A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) MPEP 2131.02.II. Since Zemel specifically names the claimed ingredients, Zemel is considered to anticipate the claims, even though Zemel recites other ingredients in addition to the claimed ingredients.
In regard to Applicant’s assertion that claim 40 is patentable, Applicant canceled claim 40. Therefore, claim 40 is not patentable.
Since the prior art has been shown to anticipate the features of the present claims and Applicant’s arguments have been shown to be unpersuasive, the rejections of claims 2-5, 7-30, 33, 35-36, 38, and 41-42 are maintained as written herein. The rejections of claims 31 and 40 are moot due to the cancelation of the claims.
Conclusion
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/KELLY P KERSHAW/Examiner, Art Unit 1791
