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 .
Status of claims
Claims 24-43 as amended and new claims 44 and 45 as filed on 4/24/2025 are pending.
Claims 34-43 were been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions. Election was made without traverse in the reply filed on 10/04/2024.
Claims 24-33 as amended and new claims 44 and 45 as filed on 4/24/2025 are under examination in the instant office action.
Specification
In response to applicants request (4/24/2025) specification section “Brief description of drawings” has been revised. Description of Figure 8 indicates A and B, but the actual drawing 8 indicates only A, although contains 2 graphs.
Claim Rejections - 35 USC § 112
Claim 31 remains rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 31 recites incorporation of “one” probiotic of the genus Lactobacillus. This probiotic bacteria is already present and limited to a particular species in the preceding claim 24. Thus, claim 31 further extends rather than further limits the claimed scope.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 24-27, 29-33 as amended and new claims 44 and 45 remain/are rejected under 35 U.S.C. 103 as being unpatentable over the IDS reference “Products: Glutamine Forte Powder” and WO 2018/220429 (Mitchell et al).
The cited reference “Products: Glutamine Forte Powder” discloses a pharmaceutical or nutraceutical composition suitable for improving metal fatigue and low mood, wherein the composition comprises glutamine and extract from Curcuma longa in amounts 5g and 100 mg respectively, or about 98% and 1.9% respectively, that are the same as recited in claim 32 and, thus, similar and/or fall within acceptable percentage ranges as encompassed claim 1.
The cited reference “Products: Glutamine Forte Powder” is silent about incorporation of probiotic bacteria Lactobacillus rhamnosus into the composition.
However, the cited WO 2018/220429 teaches the use or incorporation of probiotic bacteria Lactobacillus rhamnosus into a pharmaceutical or nutraceutical composition for preventing and/or treating depression (abstract, 0075-0080), wherein the Lactobacillus rhamnosus preparation present in amount about 0.001-2% or 0.001-5% (par. 0079-0080) or in amounts 1-500mg (par. 00111, line 2) or as to provide at least 6x109 CFU per day and more (0099, 00104). The cited WO 2018/220429 teaches that Lactobacillus rhamnosus strain GG is suitable (par. 00121).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add Lactobacillus rhamnosus preparation to the product “Glutamine Forte” with glutamine and Curcuma extract with a reasonable expectation of success in providing a pharmaceutical or nutraceutical composition suitable for improving metal fatigue, low mood and/or depression because all ingredients including glutamine, Curcuma extract and Lactobacillus rhamnosus have been taught, suggested and used in compositions for improving metal fatigue, low mood and/or depression.
Moreover, the cited prior art discloses the use of glutamine, Curcuma extract and Lactobacillus rhamnosus in the compositions as intended for improving metal fatigue, low mood and/or depression as about same or similar amounts as encompassed by the claims 24-26, 32 and 33.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
As applied to claim 27: curcuminoids are main compounds of Curcuma extract.
As applied to claims 28-29: The cited WO 2018/220429 teaches that Lactobacillus rhamnosus strain GG is suitable (par. 00121). The cited WO 2018/220429 teaches that Lactobacillus rhamnosus is probiotic and it is provided in CFU (colony forming units), thereby, in live form.
As applied to claim 31: the cited WO 2018/220429 teaches incorporation of additional probiotics bacteria (00124), prebiotics, and/or vitamins (00116-00117).
As applied to claim 45: the composition 8.1 oz dose unit is provided in the form of powder.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claim 24-33, 44 and 45 remain/are rejected under 35 U.S.C. 103 as being unpatentable over the reference “Products: Glutamine Forte Powder” and WO 2018/220429 (Mitchell et al) as applied to claims 24-27 and 29-33 above, and further in view of Yadav et al (“Effect of Cyclodextrin Complexation of Curcumin on its Solubility and Antiangiogenic and Anti-inflammatory Activity in Rat Colitis Mode” AAPS PharmSciTech., 2009, Vol.10, No. 3, pages 752-762).
The cited references “Products: Glutamine Forte Powder” and WO 2018/220429 (Mitchell et al) are relied upon as explained above for the disclosure of pharmaceutical or nutraceutical compositions suitable for improving metal fatigue and low mood, wherein the compositions comprise glutamine and extract from Curcuma longa (Product Glutamine Forte) and Lactobacillus rhamnosus (WO 2018/220429 (Mitchell et al).
The cited WO 2018/220429 also teaches incorporation of additional ingredients including probiotics bacteria (00124), prebiotics, vitamins (00116-00117) as well as excipients or solubilizing agents such as cyclodextrin (page 16, last line). But it does not recognize role of cyclodextrin in compositions with curcumin.
However, Yadav teaches that incorporation of cyclodextrin into compositions with curcumin promotes solubility of curcumin and increases its oral bioavailability (abstract and conclusion).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to incorporate cyclodextrin into pharmaceutical or nutraceutical compositions comprising curcumin extract with a reasonable expectation of success in improving curcumin solubility and availability as intended for oral administration of curcumin-containing preparations as taught by Yadav. Moreover, cyclodextrin is also used as a common excipient in pharmaceutical or nutraceutical compositions with probiotics (WO 2018/220429).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 4/24/2025 have been fully considered but they are not persuasive.
With regard to claim rejection under 35 U.S.C. 103 as being unpatentable over the IDS reference “Products: Glutamine Forte Powder” and WO 2018/220429 (Mitchell et al) Applicants argue that glutamine amount in the “Products: Glutamine Forte Powder” is less than in the claimed product and that one of skill in the art would not add Lactobacillus to Curcuma-containing composition since curcumin is antibacterial agent as evidenced by the reference by Dai.
These arguments are not found persuasive.
First, glutamine amount in the dose form of “Products: Glutamine Forte Powder” is 5 g which fall in the range as recited in claim 32, thereby, within same/similar percentage range.
Secondly, the reference by Dao teaches antibacterial effect (grow inhibiting effect) of curcumin towards mostly gut pathogenic bacteria that do not include probiotic gut beneficial bacteria Lactobacillus. It is known that turmeric extract (plant Curcuma extract) does not have inhibitor effect on grow of Lactobacillus as evidenced by Azhari et al (Earth and Environmental Science, 2018, 205, 012048, pages 1-8); for example: see abstract.
Some of the Applicants’ arguments are drawn to unexpected effect of the claimed composition comprising all 3 ingredients (glutamine, curcumin and Lactobacillus) with regard to restoration of normal level of emotional reactivity versus each ingredient alone or in a combination of 2.
However, it is well knonw that the scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claim.
The particular contents, amounts and doses per bogy kg are not clear as argued for unexpected effects as intended. However, it is also well recognized that synergism is a highly unpredictable result that is very dependent on the ingredients used and the amounts of each. Thus any combination for which synergism is not clearly established would be properly rejected because non-obviousness would not have been established.
Further, the superior effects of 3 components together versus alone or combinations in pair do not appear to be so clear as argued and as shown in the as-filed specification. For example: the specification discloses that stressed animals spend a significantly longer time immobile (par. 0277 of published instant application US 2022/0249591). But model animals treated with 3 component product remain immobile for 148.1 seconds versus 143.9 and 145.5 seconds when treated with 2 (glutamine plus Lactobacillus) and 1 (glutamine only) component products respectively.
Thus, arguments have been fully considered, however they are not persuasive because the results are confusing as to the significance of the differences in effects as argued, as claimed and as disclosed.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Vera Afremova
July 29, 2025
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653