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 .
Election/Restrictions
Claims 1-5, 7-10, 12-16, and 20-25 are currently pending. Claims 6, 11 and 17-19 were cancelled in the preliminary amendment filed October 11, 2022.
Applicant's election without traverse of Group I and a single formulation species extracted from Ipomoea batatas comprising resin glycoside of Formula (I) or resin glycoside of Formula (II); the formulation species further comprises Batatoside F; the formulation species optionally further comprises Batatoside I (claims 1-5 and 7-10) in the reply filed on July 30, 2025 is acknowledged.
Claim(s) 12-16 and 20-25 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group/species, there being no allowable generic or linking claim.
Claim(s) 1-5 and 7-10 are currently under examination.
Information Disclosure Statement (IDS)
The information disclosure statements (IDS) submitted on March 4, 2025; January 27, 2025 and October 13, 2023, respectively, have been considered by the Examiner; however, the IDS contains references that are in part in a foreign language. The relevant portions of 37 CFR § 1.98 (a) and (b) state:
(a) Any information disclosure statement filed under § 1.97 shall include the items
listed in paragraphs (a)(1), (a)(2) and (a)(3) of this section...
(2) A legible copy of:
(i) Each foreign patent;
(ii) Each publication or that portion which caused it to be listed, other than U.S. patents and U.S. patent application publications unless required by the Office;
(iv) All other information or that portion which caused it to be listed.
(3)(i) A concise explanation of the relevance, as it is presently understood by the individual designated in § 1.56(c) most knowledgeable about the content of the information, of each patent, publication, or other information listed that is not in the English language. The concise explanation may be either separate from applicant’s specification or incorporated therein.
(ii) A copy of the translation if a written English-language translation of a non-English-language document, or portion thereof, is within the possession, custody, or control of, or is readily available to any individual designated in § 1.56(c).
(b)(4) Each foreign patent or published foreign patent application listed in an
information disclosure statement must be identified by the country or patent office which issued the patent or published the application, an appropriate document number, and the publication date indicated on the patent or published application.
(5) Each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication.
Accordingly, the references have been considered to the extent presented in the English language; as presented and accompanied by reference document which is an English language equivalent or translation, to the extent cited in the instant Application’s disclosure, or as cited by the Examiner in a PTO-892.
In the instant case, references submitted with an English Abstract only (e.g. March 4, 2025 IDS, Foreign Patent Documents, Cite No. 1; January 27, 2025 IDS, Other Documents, Cite Nos. 2 and 3; October 13, 2023 IDS, Foreign Patent Documents, Cite No. 1) lack an accompanying reference document which is a full English language equivalent or translation, and therefore have not been fully considered and only the English translations provided have been considered.
Please note, Applicant is required to provide page numbers and/or a page sheet count in the citation.
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.
Claim(s) 1-5 and 7-10 is/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.
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.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claim recites an extract from Ipomoea batatas comprising resin glycoside of Formula (I) or resin glycoside of Formula (II); the formulation species further comprises Batatoside F; the formulation species optionally further comprises Batatoside I; in some embodiments further comprising a component selected from protein, fiber, polyphenolic compound, lipid or a combination thereof. Thus, the claim does recite a product 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, extraction of plants (i.e. Ipomoea batatas and/or Ipomoea aquatica) only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material(s); i.e., the compound is not inventive or “man-made.” Thus, each of the extracts in turn is a mixture of the naturally occurring compounds found in the particular plants. Combining extracts from the individual plants leads to a combination of the naturally occurring compounds from each of the plants. Thus, the claims are drawn to mixtures of naturally occurring products.
There is no indication that mixing the specified extracts together as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, each plant extract is only a mixture of the naturally occurring compounds found in the plant. Each extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination.
Moreover, in the instant case, an extract from Ipomoea batatas comprising resin glycoside of Formula (I) or resin glycoside of Formula (II); the formulation species further comprises Batatoside F; the formulation species optionally further comprises Batatoside I; and in some embodiments, further comprising protein, fiber, polyphenolic compound and/or lipid, or combination thereof, comprises naturally occurring products which is/are known in the art to be biologically sourced from a natural source (see Yin, et al., “Pentasaccharide Glycosides from the Tubers of Sweet Potato (Ipomoea batatas)” J Agric Food Chem. 2008 Apr 9;56(7):2363-8.). There is no evidence or reason to expect that any new compounds are formed from the extraction process. The extract itself is a mixture of the naturally occurring components sourced from Ipomoea batatas, i.e., the components are not inventive or “man-made.” Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. 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, Applicant’s claim is directed broadly to an extract from Ipomoea batatas comprising resin glycoside(s) with an intended use of weight loss or weight management. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Moreover, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) and/or the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials.
The capsule as claimed in claim 9 is recited with such a high degree of generality that it encompasses merely containing the natural product and does not require of the capsule any process (e.g. versus materially distinguishing encapsulations disclosed in the instant specification but not recited in the claims: “means for encapsulation (e.g. spray-drying, coating, extrusion, coacervation and molecular inclusion)”, using sodium alginate encapsulation, “particles or droplets are surrounded by a coating”, etc.; see instant Specification pgs 45-46). Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must 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 additional element in the claims is the combination of extracts. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s intended use of weight loss and/or weight management is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102/103
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claim(s) 1, 3-5, 7-8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yin, et al., “Pentasaccharide Glycosides from the Tubers of Sweet Potato (Ipomoea batatas)” J Agric Food Chem. 2008 Apr 9;56(7):2363-8.
The instant claim(s) is/are of record, drawn to the following: an extract from Ipomoea batatas comprising resin glycoside of Formula (I) or resin glycoside of Formula (II); the formulation species further comprises Batatoside F; the formulation species optionally further comprises Batatoside I; in some embodiments further comprising a component selected from protein, fiber, polyphenolic compound, lipid or a combination thereof.
Yin, et al. teaches pentasaccharide glycosides from tubers of Ipomoea batatas (sweet potato), suitable as an edible food/herb and/or pharmaceutical composition. Yin, et al. teaches 95% EtOH extraction/isolation/purification of several active constituents of sweet potato including resin glycosides, batatosides A-G (including batatoside F (i.e. compound 6)), batatinoside I and simonin IV (see Abstract; “Materials and Methods”, pages 2363-65).
Consequently, the claim(s) appear to be anticipated by the reference. In the alternative, even if the method(s) and composition(s) are not identical to the referenced method(s) and/or composition, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced method(s) and/or composition is likely to inherently possess the same characteristics as of in the claimed composition and/or process (e.g. resin glycoside compound(s) (as required in claims 1, 3-5, 7-8 and 10), IC50 activity (as required in claim 5)) particularly in view of the similar characteristics which they have been show to share (e.g. similar and/or identical source plant, component materials/compounds, formulations, and/or steps and broad administration). Thus, the claimed method(s) and composition(s) would have at least been obvious to those of ordinary skill in the art within the meaning of 35 U.S.C. §103(a).
Claims 2 and 9 is/are rejected under 35 U.S.C. 103 as obvious Yin, et al., “Pentasaccharide Glycosides from the Tubers of Sweet Potato (Ipomoea batatas)” J Agric Food Chem. 2008 Apr 9;56(7):2363-8., as applied to claim 1, 3-5, 7-8 and 10 above, and in view of Meira, et al., “Review of the genus Ipomoea: Traditional uses, chemistry and biological activities.”, Revista Brasileira de Farmacognosia. 22. 682-713. 10.1590/S0102-695X2012005000025, (2012).
The instant claim(s) and teachings of Yin, et al., is/are of record (see above).
Yin, et al., is silent as to the percent by weight of each ingredient in the claimed composition(s) (instant claim 2) and/or broad dosage form (i.e. capsule) (instant claim 9).
However, Meira, et al., teaches broad uses of Ipomoea (including species batatas and aquatica) including as ornamental plants, food, medicines or in religious rituals (see Abstract; Charter 1, page 683; pages 697-99). Meira, et al., teaches Ipomoea contains resin glycosides and has been used for the treatment of several diseases including diabetes with evidence of hypoglycemic effects (see Abstract).
It would have been obvious to one of person of ordinary skill in the art at
the time of the instant invention effective filing to have combined the extract from Ipomoea batatas comprising resin glycoside as taught by Yin et al., for weight loss and/or weight management as taught by Meira, et al. A person of ordinary skill in the art would have been motivated to use an extract of Ipomoea batatas comprising resin glycosides for weight loss and/or management, particularly where it was well-known in the art that Ipomoea is used as a food/medicine for treating diabetes with hypoglycemic effects.
A person of ordinary skill in the art would have had a reasonable expectation of success for using an extract of Ipomoea batatas comprising resin glycosides, as instantly claimed. Thus, it would have been obvious to a person of ordinary skill in the art to combine the teachings of the references to arrive at the instantly claimed invention(s) with a reasonable expectation of success.
The references is/are relied upon for the reasons discussed above. If not expressly taught by the references, based on the overall beneficial teaching provided by the references with respect to the ingredients of the composition(s) and/or method(s) of making and/or using disclosed therein, the adjustments of particular conventional working conditions (E.g. the percent by weight of each ingredient in the claimed composition(s) and/or broad dosage form (i.e. capsule) (claims 2 and 9, respectively)) in which to perform such method is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. 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).” Thus, absent some demonstration of unexpected results or criticality from the claimed parameters, this optimization would have been obvious before the effective filing date of applicant’s claimed invention.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within recited processes), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vani G. Verkhovsky whose telephone number is (571)272-3777. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm EST.
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/V.G.V./Examiner, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655