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
Applicant’s election without traverse of Group I, a heat-resistant mold growth inhibitor comprising diethyl fumarate, 2-decenoic acid, or a combination of diethyl fumarate and 2-decenoic acid as an active component; and 2-decenoic acid as the elected species of heat-resistant mold growth inhibitor in the reply filed on May 27, 2026 is acknowledged.
Claims 5 and 7-10 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 27, 2026.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment filed on February 15,
2024, wherein claims 1-2, 5 and 8 are unchanged; and claims 3-4, 6-7 and 9-10 are amended.
Claims 1-10 are pending.
Claims 5 and 7-10 are withdrawn.
Claims 1-4 and 6 are under examination in accordance with the elected species.
Priority
The instant application 18/684,158 filed on February 15, 2024 is a 371 of PCT/JP2022/037389 filed on October 6, 2022, which claims priority to, and the benefits of Foreign Application No.
JP2021-186541 filed on November 16, 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 15, 2024 and July 12, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Please note that foreign references without an English translation but have an English translation of the abstract will only have the abstract considered by the Examiner.
Claim Interpretation
The claimed “heat-resistant mold growth inhibitor” is reasonably construed by the Examiner to be a property of the claimed compound, i.e., diethyl fumarate, 2-decenoic acid, or a combination of diethyl fumarate and 2-decenoic acid.
The claimed limitation “the heat-resistant mold survives under a heating condition at 70°C for 10 minutes” in claim 2, and the claimed limitation “the heat-resistant mold belongs to at least one of the genus Byssochlamys or the genus Neosartorya” in claim 3 are reasonably construed by the Examiner to be a property of the claimed compound, i.e., diethyl fumarate, 2-decenoic acid, or a combination of diethyl fumarate and 2-decenoic acid.
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature without significantly more.
Instant claims recite a heat-resistant mold growth inhibitor comprising diethyl fumarate, 2-decenoic acid, or a combination of diethyl fumarate and 2-decenoic acid as an active component; and a food or drink, comprising the heat-resistant mold growth inhibitor, wherein the diethyl fumarate, the 2-decenoic acid, or the combination of diethyl fumarate and 2-decenoic acid is at a concentration of 1 to 40000 ppm.
The claimed 2-decenoic acid is not markedly different from its naturally occurring counterpart, because there is no indication that the claimed 2-decenoic acid are markedly different from the 2-decenoic acid occurred in nature; and no indication that including 2-decenoic acid at the claimed concentration exhibits any characteristics that are markedly different from the 2-decenoic acid occurred in nature. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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, the instant claims are directed to a heat-resistant mold growth inhibitor comprising 2-decenoic acid as an active component, which can be found in nature. Specifically, according El-Guendouz (Natural Product Communications, 2020. Vol. 15, 2: 1-13), high content of 2-decenoic acid is present in the Royal jelly samples (see e.g., abstract; p. 11, right column, 1st paragraph); and royal jelly is a milk-white and strongly acidic fluid produced by the hypopharyngeal and mandibular glands of A. mellifera L. young worker honey bees, and it is the food given to all young larvae of workers and drones in their maturation process (see e.g., p. 1, left column, 1st paragraph). Therefore, the claims do recite a judicial exception, i.e., products of nature, which require further eligibility analysis.
MPEP § 2106.04(b) states that “[w]hen 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…”. Since there is no indication in the specification that the claimed heat-resistant mold growth inhibitor changes the structural, functional, or other properties of the active component(s), e.g., 2-decenoic acid, in any marked way in comparison with the 2-decenoic acid found in nature (Royal Jelly). Therefore, the answer to Step 2A, Prong One is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claims 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. Since the claims do not recite any additional elements that integrate anything beyond the judicial exception, the answer to Step 2A, Prong Two, is No.
The analysis must then 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.” Instant claims recite the active component, e.g., 2-decenoic acid at a specific concentration, e.g., “1 to 40000 ppm” or “1 to 20000 ppm” in food or drink (see claims 4 and 6), and that does not constitute additional elements that amounts significantly more than the judicial exception, because the claimed food or drink merely incorporate naturally occurring component(s), e.g., 2-decenoic acid, at a amount that retain their natural structural and functional characteristics. Therefore, instant claims do not provide any limitations beyond the judicial exception or provide anything that adds significantly more to the judicial exceptions. Thus, the answer to Step 2B is No.
Therefore, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112
Claims 1-4 and 6 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The Markush grouping of the active component is improper, because the alternatives defined by the Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
Instant claims recite heat-resistant mold growth inhibitor comprising alternated active component(s) that do not share a substantial structural feature in common, and they also do not share a common use that flows from the substantial structural feature.
Specifically, the Markush grouping of active component(s) includes diethyl fumarate and 2-decenoic acid. According to CAS Registry Number 623-91-6 (Entered on STN Registry on November 16, 1984), diethyl fumarate is a diester having a chemical structure of:
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91
192
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; and according to CAS Registry Number 3913-85-7 (Entered on STN Registry on November 16, 1984), 2-decenoic acid is a compound having the structure of:
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64
229
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. These two compounds do not share a substantial structural feature in common.
Each of these findings demonstrates that not all members recited in this Markush grouping of active components belong to the same recognized chemical class; i.e., the species fail to share a single structural similarity or any substantial structural feature in common.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
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.
(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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiruma et al. (JP-2008013486-A).
Please note Hiruma et al. is written in Japanese and a machine translation has been provided by the Examiner, any reference hereinafter to column and lines will be based upon the machine translation. Such reference should be interpreted as corresponding to the disclosure of the JP publication.
Hiruma et al. teaches 2-decenoic acid is an arachidonic acid metabolism inhibitor (see e.g., abstract); and a food or beverage containing the arachidonic acid metabolism inhibitor as an active ingredient is intended for blood flow improvement and/or anti-inflammation (see e.g., claim 6). Hiruma et al. further teaches when the arachidonic acid metabolism inhibitor is added to the food and drink, the addition amount is not particularly limited, but is preferably 0.001 to 5 mass % (see e.g., [0016]). Hiruma et al. further teaches formulation examples of the arachidonic acid metabolism inhibitor, including chocolate formulation example shown below (see e.g., [0038]):
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215
419
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.
Please note said chocolate formulation contains 0.01 weight% of the arachidonic acid metabolism inhibitor.
According to MPEP 2112.01, II, “’[p]roducts of identical chemical composition cannot have mutually exclusive properties.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”. In the instant case, Hiruma et al. is silent regarding “heat-resistant mold growth inhibitor”, the limitation of “the heat-resistant mold survives under a heating condition at 70°C for 10 minutes” in claim 2, and the limitation of “the heat-resistant mold belongs to at least one of the genus Byssochlamys or the genus Neosartorya” in claim 3; However, these limitations are properties of the claimed compound(s), and will inevitably flow from the 2-decenoic acid taught by Hiruma et al. because products of identical chemical structure cannot exert mutually exclusive properties.
Regarding “[a] food or drink, comprising the heat-resistant mold growth inhibitor…wherein the 2-decenoic acid… is at a concentration of 1 to 40000 ppm” in claim 4, and “the concentration of 2-decenoic acid is 1 to 20000 ppm” in claim 6, according to MPEP 2131.03, I, “’[w]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art.’ Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”. Applying the same logic to the instant claims, the chocolate formulation taught by Hiruma et al. comprising 0.01% of 2-decenoic acid as the arachidonic acid metabolism inhibitor. Because both weight percent (mass %) and parts per million (ppm) are unites expressing mass ratio, 0.01 mass % corresponds to 100 ppm (0.01 x 10,000 = 100). Therefore, Hiruna expressly teaches a food composition comprising 100 ppm 2-decenoic acid, which falls within the claimed concentration range. Said mass percentage can reasonably be converted to unit in parts per million (ppm) by multiplying the percentage value by 10,000, which when calculated by:
%
×
10,000
=
100
p
p
m
, which gives 100 ppm of 2-decenoic acid in the chocolate formulation; and that anticipated the claimed concentration.
Therefore, the claimed invention is being anticipated by Hiruma et al.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST.
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/CHIHYI LEE/Examiner, Art Unit 1628
/JEAN P CORNET/Primary Examiner, Art Unit 1628
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