DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1, 3-21, 23, 26, and 28-33 are currently pending.
Election/Restrictions
3. Applicant's election with traverse of Group I, claims 1, 3-15, 18 and 19, gum arabic for species A, 6-gingerol for species B, and quillaja for species C in the reply filed on January 16, 2026 is acknowledged. The traversal is on the ground(s) that a finding of obviousness by the International Searching Authority is not applicable to the present claims because the International Searching Authority uses a distinct standard for obviousness than the USPTO. This is not found persuasive because as demonstrated below, the references cited by the International Searching Authority are also applicable under US practice and demonstrate a lack of unity between the claimed inventions because the teach the linking technical feature of a combination of gingeroids, gum arabic, and saponins (see paragraph 15 which utilizes reference Li (US 2008/0160116) cited by the ISA in the Written Opinion). Thus, applicant’s argument is not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
4. Claims 16, 17, 20, 21, 23, 26, and 28-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
5. Claims 1, 3-16, 18, and 19 are examined on the merits in regards to the elected species.
Specification
6. The disclosure is objected to because of the following informalities: “xanthan” is misspelled as “xantham” throughout the specification.
Appropriate correction is required.
Claim Objections
7. Claim 1 is objected to because of the following informalities: “xanthan” is misspelled as “xantham”. Appropriate correction is required.
8. Claim 4 is objected to because of the following informalities: a comma is missing between “6-gingerol” and “8-gingerol” in line 2. Appropriate correction is required.
9. Claim 9 is objected to because of the following informalities: “ginseng” is misspelled in line 3.
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 15, 18, and 19 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.
10. Claim 15 is indefinite because it is directed to a “use” type claim which is a non-statutory category of invention. Since this is a non-statutory category, it is unclear if applicant is intending to claim a composition with an intended use or a method claim. For the sake of examination, claim 15 is interpreted as a composition with an intended use because this is the broadest reasonable interpretation of the claim and because the claim does not contain any active method steps.
11. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 18 recites the broad recitation “comprising”, and the claim also recites “consisting of” and “consisting essentially of” which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
12. Regarding claim 19, the phrase "such as" in line 5 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In addition, the phrase “as appropriate” in claim 19 is indefinite because it is unclear how to determine when it is or is not “appropriate” to add the claimed ingredients.
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.
13. Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it is directed to a “use” type claim which is a non-statutory category of invention
14. Claims 1, 3-15, 18, and 19 rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products 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 claims recite gingeroids in the form of oleoresin from ginger, gums such as gum arabic, and saponins such as quillaja saponin. Gingeroids, gum arabic, and quillaja saponin are all naturally occurring substances. 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, extraction of ginger oleoresin/gingerols, arabic gum and quillaja saponin 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 the 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 the 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 extracted from the source material. Thus, while extraction of the compounds 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; 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 the 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. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. 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 claims are directed to a composition with an intended use as a nutraceutical, dietary product, food product, supplement, etc. 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.” 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 and the combination of the extracts with naturally occurring carriers such a silica and food ingredients (which can also be naturally occurring such as lactose). 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 and carriers 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 uses are 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
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.
15. Claim(s) 1, 3-8, 13-15, 18 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (US 2008/0160116).
This reference teaches a gingerol composition contained in oleoresin extracted from ginger (Zingiber officinale). The reference teaches that the oleoresin is combined with gum arabic. The reference teaches that the gingerol component contains 6-gingerol and saponins (see paragraphs 123, 172, 177, 179, 181, 198). In addition, the reference teaches that the oleoresin is extracted using CO2 extraction. Furthermore, the reference teaches that the gingerols are present in an amount of at least 5% or 10%. The reference also teaches that the composition can be mixed with carriers such as maltodextrin and formed into particles of various sizes including 150 to 700 microns. The reference teaches that the composition is formulated into oral and transdermal formulations suitable for humans and animals (see paragraphs 2, 7-13, 44, 114-116, 119-120, 132-137).
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.
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.
16. Claim(s) 1, 9, 10, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2008/0160116) in view of Schrader (US 2012/0322750).
The teachings of Li are discussed above. The reference does not specifically teach including quillaja saponin in the composition. However, Li does teach that the gingerol ingredients are insoluble in water (see paragraphs 61-67).
Schrader teaches using a combination of gum arabic and quillaja saponin to improve the water solubility of water insoluble ingredients in order to better formulate the insoluble ingredients for pharmaceutical, cosmetic, and food uses. Schrader teaches that the quillaja saponin is obtained from an extract from quillaja containing 50% saponins (see abstract, paragraphs 1, 20-23, and Example 1). Thus, it was well known in the art that gingerols are water insoluble and that a combination of gum arabic and quillaja saponin was highly effective at formulating insoluble ingredients to allow for their dispersion in water. Based on this known use of gum arabic and quillaja saponin, an artisan of ordinary skill would have reasonably expected that the gingerol composition taught by Li could be improved by the addition of gum arabic and quillaja saponin to achieve a water soluble product containing the gingerols. This reasonable expectation of success would have motivated the artisan to modify Li to include the addition of gum arabic and quillaja saponin to the gingerols. Thus, applicant’s claimed combination is considered to be an obvious modification of what was known in the art at the time of the invention.
The references do not specifically teach adding the ingredients together in the amounts claimed by applicant. However, 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).” Schrader teaches that the concentration of both the saponin ingredient and the gum arabic can be varied (see paragraph 29). Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
17. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655