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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 06/26/2024 has been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English.
Claim Status
The claim set filed June 26, 2024 has been entered.
Thus, claims 1-6 are examined on the merits herein.
Claim Interpretation
Claim 1, line 1 recites “A health functional food composition for improving exercise performance”, and
Claim 6, line 1 recites “A pharmaceutical composition for improving exercise performance”.
The Examiner notes MPEP 2111.02(II) states “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”.
Moreover, MPEP 2111.02(II) states “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art”.
Furthermore, the Examiner notes it is well-settled that “intended use” of a composition or product, e.g., “for improving exercise performance”, will not further limit claims drawn to a composition, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount, as the instantly claimed (See MPEP 2111.02(II).
Thus, the Examiner notes the limitation of “for improving exercise performance” as recited in claims 1 and 6 above has not been considered when applying the prior art or assessing double patenting as written below.
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 3- 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.
(I) Claim 5 recites the limitation "the administration dosage" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes claim 1, from which claim 5 depends, does not recite any dosage let alone “the administration dosage” as required within claim 5.
In the interest of compact prosecution, the Examiner will interpret the recitation of "the administrative dosage" to mean "an administrative dosage".
(II) Claim 3, recites “wherein the active ingredient is gypenoside L and gypenoside LI”; and Claim 5, line 2, recites “the active ingredients”.
The Examiner notes claim 1, from which both claim 3 and claim 5 depend, recites and requires a health functional food composition comprising a gypenoside represented by Chemical Formula 1, a stereoisomer thereof, or a sitologically acceptable salt thereof as an active ingredient.
Therefore, the recitation of “gypenoside L and gypenoside LI” in claim 3 and "the active ingredients" in claim 5 result in each claim being unclear and indefinite as to the number of active ingredients within the composition, for example, do claim 3 and claim 5 require only one active ingredient as recited in claim 1, or do claim 3 and claim 5 require more than one active ingredient as recited in these claims.
The Examiner notes Chemical Formula 1 which is recited in claim 1 is known as “gypenoside L” (see specification, pg. 7, lines 1-5).
Accordingly, in the interest of compact prosecution and to promote clarity for claim 3 and claim 5, the Examiner will interpret claim 3 recites “wherein the active ingredient further comprises gypenoside LI”, and is supported in the specification on pg. 9, lines 10-15.
The Examiner will also interpret claim 5 depends from claim 3 which recites the active ingredient is “gypenoside L and gypenoside LI”; and thus, the Examiner notes the total amount of gypenoside L and gypenoside LI within said dosage is 0.01 to 200 mg/kg/day as recited in claim 5.
Claim 4 is included in this rejection as it depends from claim 3.
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al., (Published 15 October 2019, nutrients, Vol. 11, Issue 10, Article Number 2475, pp. 1-15, PTO-892).
Regarding claims 1-6, Lee teaches Gynostemma pentaphyllum extract (GPE) ameliorates high-fat diet induced obesity in C57BL/6N mice (e.g. a health functional food composition, required in claim 1, line 1; and a pharmaceutical composition, required in claim 6, line 1), see pg. 1, title.
Lee teaches GPE contains gypenoside L (1.8%, w/w) (e.g. gypenoside L, required in claims 2-4; and the gypenoside compound represented by Chemical Formula 1, required in claim 6, line 4); gypenoside LI (1.4% w/w) (e.g. gypenoside L, required in claims 2-4; and the stereoisomer of the gypenoside compound, required in claim 6, line 2); and ginsenoside Rg3 (0.15% w/w), see pg. 2, 2.1. Preparation of GPE, paragraph 1.
Lee teaches the GPE produced in this study, enriched in gypenoside L, gypenoside LI and ginsenoside Rg3, has potent anti-obesity activity (e.g. as an active ingredient, see claim 1, line 3 and claim 6, line 3), see pg. 11, 5. Conclusions, paragraph 1.
The Examiner notes Lee teaches the GPE extract contains gypenoside L (1.8%, w/w) and gypenoside LI (1.4% w/w). Accordingly, the weight ratio of gypenoside L and gypenoside LI taught by Lee is approximately 1.29.
Therefore, the Examiner notes said weight ratio of Lee reads on the claimed weight ratio as recited in claim 4 as the Examiner notes the recited weight ratio of gypenoside L and gypenoside LI required in instant claim 4 is 100 : 20 to 80 which reads on a weight ratio range from 1.25 to 5.
Lee teaches in the experimental design and treatment that C57BL/6N mice were randomly divided into five groups and fed the following diets which include (3) a high-fat diet (HFD) + 100 mg/kg body weight (BW) / day GPE (GPE 100), see pg. 3, 2.3. Experimental Design and Treatment, paragraph 1.
The Examiner notes in view of the preceding paragraphs if 100 mg/kg body weight (BW) / day GPE were administered to said mice and said GPE contains gypenoside L at 1.8% (w/w) and gypenoside LI at 1.4% (w/w); then the combined amount of gypenoside L and gypenoside LI provided to said mice is 3.2 mg/kg/day and thus reads on the administrative dosage range recited in claim 5 as interpreted by the Examiner above.
Thus, in view of the teachings of Lee as discussed above, Lee anticipates instant claims 1-6.
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.
(I) Claims 1-4 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,653,856 (Common (Joint) Inventors: Joo Myung Moon and Tae Young Kim, PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions comprising a gypenoside compound.
Reference claim 1 recites a method for treating obesity by administering a composition comprising a Gynostemma pentaphyllum tea or tea extract, which comprises gypenoside L and gypenoside LI at a weight ratio of 100:20-80; implying possession of the composition as recited.
With respect to the recitation of “A pharmaceutical composition” recited in instant claim 6; the Examiner reasonably interprets the composition administered for treating obesity which comprises gypenoside L and gypenoside LI as recited by reference claim 1 of the ‘856 patent is a pharmaceutical composition.
Thus, in view of reference claim 1, the ‘856 patent anticipates instant claims 1-4 and 6.
(II) Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,653,856 (Common (Joint) Inventors: Joo Myung Moon and Tae Young Kim, PTO-892) in view of Lee et al., (Published 15 October 2019, nutrients, Vol. 11, Issue 10, Article Number 2475, pp. 1-15, PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions comprising a gypenoside compound.
The ‘856 patent recites as discussed above.
Although, the ‘856 patent does not recite where an administrative dosage of the active ingredients is 0.01 to 200 mg/kg/day as required in instant claim 5.
However, in the same field of endeavor of treating obesity, Lee teaches Gynostemma pentaphyllum extract (GPE) ameliorates high-fat diet induced obesity in C57BL/6N mice, see pg. 1, title.
Lee teaches GPE contains gypenoside L (1.8%, w/w); gypenoside LI (1.4% w/w); and ginsenoside Rg3 (0.15% w/w), see pg. 2, 2.1. Preparation of GPE, paragraph 1.
Lee teaches in the experimental design and treatment that C57BL/6N mice were randomly divided into five groups and fed the following diets which include (3) a high-fat diet (HFD) + 100 mg/kg body weight (BW) / day GPE (GPE 100), see pg. 3, 2.3. Experimental Design and Treatment, paragraph 1.
The Examiner notes in view of the preceding paragraphs if 100 mg/kg body weight (BW) / day GPE were administered to said mice and said GPE contains gypenoside L at 1.8% (w/w) and gypenoside LI at 1.4% (w/w); then the combined amount of gypenoside L and gypenoside LI provided to said mice is 3.2 mg/kg/day and thus corresponds to the administrative dosage range recited in instant claim 5 as interpreted by the Examiner above.
Furthermore, the Examiner notes Lee teaches the GPE extract contains gypenoside L (1.8%, w/w) and gypenoside LI (1.4% w/w). Accordingly, the weight ratio of gypenoside L and gypenoside LI taught by Lee is approximately 1.29.
Therefore, the Examiner notes said weight ratio of Lee corresponds to the weight ratio as recited in reference claim 1 of the ‘856 patent as the Examiner notes the recited weight ratio of gypenoside L and gypenoside LI recited in reference claim 1 is 100:20-80 which corresponds to a weight ratio range from 1.25 to 5.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated the teachings of Lee into the recitations of the ‘856 patent as within the scope of the artisan as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to provide a composition comprising Gynostemma pentaphyllum extract to treat obesity as recited in the ‘856 patent. One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated the teachings of Lee into the recitations of the ‘856 patent, because both the ‘856 patent and Lee are drawn to using compositions comprising gypenoside L and gypenoside LI for treating obesity as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined recitations of the ‘865 patent and the teachings of the prior art.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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, Renee Claytor can be reached at (571) 272-8394. 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.
/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
Prosecution Insights