DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 1-20 are currently pending. Claims 16-20 remain withdrawn as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-15 are directed to the elected invention and have been examined on their merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/22/2025 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in this IDS have been fully considered.
Claim Objections
Claim 12 is objected to because it erroneously contains a symbol image instead of an apostrophe in the word “Fuller’s”.
Appropriate correction is required.
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.
Previous rejections under 35 U.S.C. § 101
RE: Rejection of claims 1-15 under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
Applicant traverses the rejection of record by arguing that the examiner has improperly applied the § 101 analysis with respect to the individual components, rather than the composition as a whole. Additionally, applicant asserts that the analysis “appears to mix between considering the individual components and the composition” (Remarks, p. 8, par. 2) by stating that the components do no more than their naturally-occurring counterparts do individually and this analysis allegedly “skips over the fact that the naturally-occurring counterparts of the individual components do not exist together in a composition” (Id.) and thus, the composition structure is how the individual claimed components are markedly different from their naturally-occurring counterparts. Finally, applicant argues that if the Examiner contends that the claimed components do exist together, then the claimed composition is markedly different because it does not contain 2-butenal, 2-methyl-,(e); hexane, 2,3-dimethyl-; formamide, N-(1-methylpropyl)-; cyclohexane, 1,2-dimethyl-3,5-bis(1-methylethenyl-“, which are all present in the volatile emissions of M. crispans.
Applicant’s arguments have been fully considered but are not sufficient to overcome the rejection of record.
As discussed throughout prosecution, the claim is not to M. crispans (or even volatile by-products derived from M. crispans). Rather, the generic claim is broadly directed to any composition comprising “a plurality of esters of C2-C5 acids”, “a plurality of C2-C5 alcohols”, “at least one C2-C5 acid”, and “at least one C2-C5 aldehyde”, which is absent the recited components. Thus, although the products of M. crispans may be relevant to an analysis for a much narrower claim construction (e.g., a claim limited to only the components recited in Table 1 (p. 11) of the specification), M. crispans is largely irrelevant when determining subject-matter eligibility over the entire breadth of the claimed invention. And even if the claims were limited to only comprise compounds produced by M. crispans, the composition still fails the Markedly Different Characteristic Analysis.
Although applicant’s argument with respect to the differences between analyzing the composition for its individual components versus the composition as a whole are well taken, the rejection of record does not assess the individual components alone. Rather, the analysis is whether the resultant composition is markedly different in structure, property, or function and the functions of the individual components were assessed in order to determine if the resulting composition gained a new function as a result of the combination of the natural compounds. For example, by virtue of combination of each of the components into the recited composition, did the composition as a whole gain a new structure, property, or function? The answer is no. Each of the components were previously known to possess antimicrobial activity. For example, Strobel et al. (Microbiology, 2001, Vol. 147, pages 2943-2950; Cited in IDS; hereinafter Strobel) teaches the isolation and characterization of volatile organic compounds (VOCs) from Muscodor albus. Strobel tested the VOCs and found that alcohols, esters, ketones, acids, and lipids derived from this Muscodor sp. were capable of controlling growth of fungi (p. 2949, Table 3). Moreover, Strobel teaches that aldehydes such as benzaldehyde were previously suggested to do the same (p. 2943, right col., par. 1). Accordingly, applicant has merely claimed a composition comprising naturally occurring compounds performing their natural function and there is no evidence that the combination of these compounds elicits a markedly different change in structure, property, or function when compared to the natural counterparts.
And an absence of evidence that “a plurality of esters of C2-C5 acids; a plurality of C2-C5 alcohols; at least one C2-C5 acid; and at least one C2-C5 aldehyde” exist together in nature is not sufficient to obviate a rejection under § 101. For example, in the Lactobacillus and milk example, the composition is not subject matter eligible merely because Lactobacillus and milk did not occur together in nature. Rather, as discussed in MPEP § 2106.04(c)(I)(A), the resulting composition is what is assessed for markedly different characteristics.
Additionally, although the examiner acknowledges that applicant has characterized compositions derived from Muscodor species, that does not mean that the volatile extracts from Muscodor as a whole are the appropriate counterpart. Indeed, the claims have nothing to do with Muscodor and make no reference to Muscodor. Rather, they are far broader in scope and encompass any plurality of esters of C2-C5 acids, plurality of C2-C5 alcohols, at least one C2-C5 acid, and at least one C2-C5 aldehyde. Therefore, the examiner disagrees with applicant’s assertion that the analysis must be performed by comparing volatile extracts from Muscodor.
Assuming arguendo that Muscodor extracts were the appropriate counterpart, merely excluding other components does not render the composition subject matter eligible unless this change markedly changes the structure, properties, or functions of the resulting composition.
For at least these reasons, the examiner maintains that the rejection of record properly applied the markedly different characteristics analysis and the rejection has therefore been maintained.
Maintained rejection under 35 U.S.C. § 101
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
The instant claims recites laws of nature and natural phenomena. These judicial exceptions (JEs) are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1). Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A). Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
The Markedly Different Characteristics Analysis
The first step in the analysis is to select the appropriate counterpart to the nature-based product. When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. See MPEP § 2106.04(c)(II)(A).
The second step in the analysis is to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673. See MPEP § 2106.04(c)(II)(B).
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. See MPEP § 2106.04(c)(II)(C).
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a);
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d);
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e).
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1)(direction to a process, machine, manufacture, or composition of matter):
Claims 1-15 are directed to a composition of matter, which is a statutory category.
Therefore, the answer to this step for claims 1-15 is yes.
Step (2A) Prong 1 (recitation of a law of nature, natural phenomenon, or an abstract idea):
Claims 1-15 are directed to compositions comprising “a plurality of esters of C2-C5 acids”, “a plurality of C2-C5 alcohols”, “at least one C2-C5 acid”, and “at least one C2-C5 aldehyde”. Exemplary compounds include various compounds which have been derived from an isolated culture of Muscodor crispans ([0018] and [0045]). The appropriate naturally occurring counterpart for these components are the corresponding compounds found in nature (e.g., naturally occurring esters of C2-C5 acids, C2-C5 alcohols, C2-C5 acids, C2-C5 aldehydes, and C3-C5 ketones). There is no indication that isolation and co-formulation of these compounds causes them to be markedly different from their naturally occurring counterparts.
Although the claims require that the composition is “an antimicrobial composition”, these compounds have been previously demonstrated to possess the “antimicrobial” characteristic. For example, Strobel et al. (Microbiology, 2001, Vol. 147, pages 2943-2950; Cited in IDS; hereinafter Strobel) teaches the isolation and characterization of volatile organic compounds (VOCs) from Muscodor albus. Strobel tested the VOCs and found that alcohols, esters, ketones, acids, and lipids derived from this Muscodor sp. were capable of controlling growth of fungi (p. 2949, Table 3). Moreover, Strobel teaches that aldehydes such as benzaldehyde were previously suggested to do the same (p. 2943, right col., par. 1). Accordingly, applicant has merely claimed a composition comprising naturally occurring compounds, performing their natural function and there is no evidence that the combination of these compounds elicits a markedly different change in structure, property, or function when compared to the natural counterparts.
In addition, claims 11-15 are directed to articles comprising the antimicrobial composition. These claims encompass naturally occurring carriers such as water, ethanol, polyols, vegetable oils, organic esters, kaolin, bentonite, kieselguhr, dolomite, calcium carbonate, talc, powdered magnesia, Fuller’s earth, gypsum, diatomaceous earth, and China clay. There is no indication that combination of these components with the antimicrobial composition causes these JEs to be markedly different from their naturally occurring counterparts.
Therefore, the answer to this prong for claims 1-15 is yes.
Step 2A Prong 2 (recitation of additional elements that integrate the JE into a practical application):
Claim 1 limits the composition comprising the JEs to one which is absent naphthalene and azulene derivative compounds and absent 2-butenal, 2-methyl- (E)-; hexane, 2,3-dimethyl-; formamide, N-(1-methylpropyl)-; and cyclohexane, 1,2-dimethyl-3,5-bis(1-methylethenyl)-. There is no indication that excluding these components from the composition would cause the JEs to be transformed or reduced to a different state or thing.
Claims 2-7, 9-10, and 13 merely recite JEs and therefore do not integrate the JEs into a practical application.
Claim 8 merely recites a property of the compositions (i.e., being Generally Recognized as Safe under 21 CFR). This limitation is inherent to the properties of the JEs and therefore does not integrate the JEs into a practical application by transforming or reducing the JEs to a different state or thing.
Claims 11-12 and 15 incorporate the antimicrobial composition into “carrier” components. As discussed above, these carriers may be JEs themselves. For example, the carrier may be “water” (see claim 15). There is no indication that combination of the antimicrobial composition and a carrier such as water causes any of the naturally occurring components to be transformed or reduced to a different state or thing.
Claim 14 limits the “carrier” to a “food wrapper or film”. Although these components are not naturally occurring, there is no evidence that incorporating the JEs into these components transforms or reduces the JEs to a different state or thing. In addition, these limitations do not apply or use the JE to effect a particular treatment or prophylaxis for a disease or medical condition.
Therefore, the answer to this prong for claims 1-15 is yes.
Step (2B)(recitation of additional elements that amount to significantly different than the JE such that they provide an inventive concept):
Claim 1 limits the composition comprising the JEs to one which is absent naphthalene and azulene derivative compounds or 2-butenal, 2-methyl- (E)-; hexane, 2,3-dimethyl-; formamide, N-(1-methylpropyl)-; and cyclohexane, 1,2-dimethyl-3,5-bis(1-methylethenyl)-. Merely omitting certain naturally occurring components such as naphthalene and azulene derivative compounds does not cause the JE to be significantly different such that it provides an inventive concept. Moreover, as discussed above, volatile organic compounds were previously known to be antimicrobial and it therefore would be well-understood or routine to integrate them into an antimicrobial composition (see e.g., Strobel’s mixture of VOCs, discussed above).
Claims 2-7, 9-10, and 13 merely recite JEs and therefore do not amount to significantly more.
Claim 8 merely recites a property of the compositions (i.e., being Generally Recognized as Safe under 21 CFR). This limitation is inherent to the properties of the JEs and therefore does not amount to significantly more.
Claims 11 and 15 incorporate the antimicrobial composition into “carrier” components. As discussed above, the carrier may be one of the JEs. For example, the carrier may be “ethanol” which is a C2 alcohol. Ethanol is a VOC produced by M. albus (Strobel, p. 2947, Table 2). Accordingly, these claims do not provide an inventive concept because they are merely descriptive of well-understood compositions found in nature (e.g., found within an M. albus fungus).
Claim 12 limits the carrier to one of a variety of different carrier components. Although these components are not necessarily found together in nature with the VOCs recited in claim 1, incorporation of these components is not significantly different such that it provides an inventive concept. For example, Jenkins et al. (US 2006/0243212 A1; cited previously; hereinafter Jenkins) teaches animal litters having improved clumping and odor-inhibiting properties ([0001]). Jenkins teaches that the animal litter may further comprise active ingredients such as antimicrobials ([0052]; claim 14). Finally, Jenkins teaches that the animal litter may be kaolinite (i.e., kaolin), bentonite, dolomite, Fuller’s earth, gypsum, and diatomaceous earth ([0042]-[0043]). Thus, because it was previously known that the recited JEs were antimicrobial, and because Jenkins previously taught that carriers such as animal litter, kaolin, bentonite, dolomite, Fuller’s earth, gypsum, and diatomaceous earth could be incorporated with antimicrobials, this is merely considered to be a well-understood, routine, and conventional activity previously known to the industry.
Claim 14 limits the “carrier” to a “food wrapper or film”. Although these components are not necessarily found together in nature with the VOCs recited in claim 1, incorporation of these components is not significantly different such that it provides an inventive concept. For example, Quintavalla et al. (Meat Science, 2002, Vol. 62, pages 373-380; Cited in IDS; hereinafter Quintavalla) teaches that microbial contamination reduces the shelf-life of food and increases the risk of foodborne illness (p. 373, left col., par. 3). Quintavalla teaches that antimicrobial packaging is a promising form of active food packaging in particular for meat products and using packaging films containing antimicrobial agents could slow the migration of agents from the packaging material to the surface of the product and can control microbial contamination by reducing growth rate of microorganisms (p. 373, right col., par. 2 through p. 374, left col., par. 1). Thus, because it was previously known that the recited JEs were antimicrobial, and because Quintavalla teaches that incorporation of antimicrobials into packaging such as food wrappers or films is a “promising form of active food packaging”, this is merely considered to be a well-understood, routine, and conventional activity previously known to the industry.
Therefore, the answer to this prong for claims 1-15 is yes.
Conclusion
Claims 1-15 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. § 101.
Conclusion
No claim is allowed.
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 GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Weidner can be reached on (571)272-3045. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651