DETAILED ACTION
This action is in response to papers filed on 10/07/2025. Claims 1, 30, 32-35, and 38-43, 45-46, 48-50, and 52-56 are pending examination on the merits: no amendments have been made. Claims 1, 30, 32-35, and 38-43, 45-46, 48-50, and 52-56 are rejected.
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 .
Priority
Applicant’s claim to benefit of provisional application 63/226,668 filed on 07/28/2021 is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 05/27/2025, 11/04/2025, and 01/08/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Withdrawn Claim Rejections
The following rejections are withdrawn in view of Applicant’s arguments (c.f., Applicant’s Remarks at pp. 9-12):
The rejection of claims 1, 30, 33-34, and 43, 45-46, 49-50, 52-53, and 55- under 35 U.S.C. 102(a)(1) as being anticipated by Hassanen et al., International Journal of Nutrition and Food Sciences. 2015; 4(4): 465-476, and as evidenced by Wu et al., Molecules. 2016 Jan 22;21(2):134 (“Wu”) is withdrawn in view of Applicant’s arguments. Applicant’s arguments that the water distillation extraction technique used by Hassanen to obtain their extracts, relative to the solubility of the claimed compounds, would not have resulted in Hassanen’s extract comprising the claimed lignans, and therefore could not be attributed to the nutritional success disclosed by Hassanen. Applicant’s arguments were persuasive and the rejection is withdrawn.
The rejection of claims 32, 35, 38-42, and 48 under 35 U.S.C. 103 as being obvious over Hassanen et al., International Journal of Nutrition and Food Sciences. 2015; 4(4): 465-476, as applied above to claims 1, 30-31, 33-34, and 43, 45-47, 49-50, 52-53, and 55-56, in view of Ahmad et al., (1989) Planta Medica 55 (1989), 307-308 (“Ahmad”); and Maneechai et al., Pharmacogn. J. 2017; 9(6): 929-931 (“Maneechai”) is withdrawn in view of Applicant’s arguments. Applicant’s arguments that the water distillation extraction technique used by Hassanen to obtain their extracts, relative to the solubility of the claimed compounds, would not have resulted in Hassanen’s extract comprising the claimed lignans, and therefore could not be attributed to the nutritional success disclosed by Hassanen. Applicant’s arguments were persuasive and the rejection is withdrawn.
The rejection of claim 54 under 35 U.S.C. 103 as being unpatentable over Hassanen, as applied to claims 49 and 53 above, and further in view of Schlemper et al. (Ciência Rural, Santa Maria, v.51:12, e20200855, 2021, publication date July 26,2021) (“Schlemper”) is withdrawn in view of Applicant’s arguments. Applicant’s arguments that the water distillation extraction technique used by Hassanen to obtain their extracts, relative to the solubility of the claimed compounds, would not have resulted in Hassanen’s extract comprising the claimed lignans, and therefore could not be attributed to the nutritional success disclosed by Hassanen. Applicant’s arguments were persuasive and the rejection is withdrawn.
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, 30, 32-35, and 38-43, 45-46, and 48are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature, specifically, naturally-occurring botanical compounds which are extracted and resolved with routine methods, without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception – i.e., as drafted, the claims read upon a product of nature (i.e., a law of nature/a natural phenomenon) for the following reasons:
Claims 1, 30, 32-35, and 38-43, 45-46, 48-50, and 52-56 are drawn to a composition (for the intended use as a animal feed composition) formed entirely from natural ingredients (as disclosed on page 3, paragraph [0007] of the instant specification). The claimed composition is not markedly different from its/their naturally-occurring counterpart(s) because there is no indication that the composition has any characteristics or properties that are different from the naturally-occurring counterpart(s) (including the natural compounds found therein). The cited claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Furthermore, the claims, such as independent claim 1, do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) and the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials.
Regarding claim 1, the claim is directed to an ingredient composition (i.e., “an animal feed composition”), comprising naturally-occurring plant extracts of Guaiacum sanctum or Guaiacum officinale, to be added to an “animal feed”, wherein the claimed intended use of these naturally-occurring plant extracts is as an ingredient. This is not considered limiting as does it not integrate the judicially-excepted naturally-occurring compounds into a practical application. “A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional element(s) demonstrating that the claim as a whole integrates the exception into a practical application.” MPEP 2106.04(d)(2). There are no additional elements recited in the claim beyond the judicial exceptions, as the limitation, “wherein the animal feed is chicken feed, pig feed, dairy cow feed, or beef cattle feed” is also not considered to be further limiting of the composition itself.
Regarding claim 30, the amended claim recites, “The composition of claim 1, wherein the at least one animal feed component is selected from the group consisting of a vitamin, mineral, probiotic, enzyme, flavoring, amino acid, and preservative”. The claim is directed to the addition of routine animal feed ingredients, e.g., vitamins, minerals, etc. to the ingredient of claim 1, and thus does not integrate the judicially-excepted naturally-occurring compounds into a practical application.
Regarding claims 31-33:
Claim 33 recites:
The composition of claim 1, wherein the furoguaiacin or furoguaiacin-like compound or guaiacin or guaiacin-like compound is obtained from an extract from a Guaiacum sanctum or Guaiacum officinale plant or part thereof.
Claim 32 recites:
The composition of claim 1, wherein the furoguaiacin or furoguaiacin-like compound or guaiacin compound is obtained from an extract of heartwood or branches of a Guaiacum sanctum or Guaiacum officinale plant.
Claim 33 specifies that the claimed compound(s)/ingredient(s) of claim 1 is of plant origin; claim 32 essentially narrows the part of the plant from where the naturally-occurring plant extract is obtained: “compound is obtained from heartwood or branches of a Guaiacum sanctum or Guaiacum officinale plant”. Neither claims 32 or 33 integrate the judicially-excepted naturally-occurring compounds into a practical application.
Regarding claim 34, the claim recites:
The composition of claim 33, wherein the extract is produced from heartwood, whole trunk, bark, stems, leaf, flowers, branches, roots or fruits of a Guaiacum sanctum or Guaiacum officinale plant or part thereof, or any combination thereof.
Claim 34 limits the parts of the plant from which the extract is obtained and does not integrate the judicially-excepted naturally-occurring compounds into a practical application.
Regarding claim 35, the claim recites:
The composition of claim 33, wherein the extract is an aqueous,
ethanolic, methanolic, isopropanolic, ethyl acetate, acetonic, hexane, or a mixture thereof, or a supercritical CO2 extract.
Claim 35 recites a typical extraction process that is routine in the art, especially when attempting to isolate organic compounds. As applied to the claim, this does not integrate the judicially-excepted naturally-occurring compounds into a practical application.
Regarding claims 38-42, the claims recite:
Claim 38: “The composition of claim 1, wherein lignans comprise between about 5% and about 30% of the composition.”
Claim 39: “The composition of claim 38, wherein lignans comprise at least 9%
of the composition.”
Claim 40: “The composition of claim 1, wherein total lignans in the
composition comprise at least 20% furoguaiacin or furoguaiacin-like compounds and guaiacin compounds.”
Claim 41: “The composition of claim 1, further wherein the guaiacin compound makes up from about 20% to about 60% of total lignans comprised in said composition by weight.”
Claim 42: “The composition of claim 1, further wherein the furoguaiacin or
furoguaiacin-like compound makes up from about 20% to about 60% of total lignans comprised in the composition by weight.”
Claims 40-42 are directed to total lignan concentrations of the composition of claim 1. This does not integrate the judicially-excepted naturally-occurring compounds into a practical application. Similarly, claim 39 recites an additional limitation of lignan content of claim 38, and does not integrate the judicial exception into a practical application.
Regarding claim 43, the claim recites:
An animal feed comprising the animal feed ingredient composition
of claim 1 in an amount effective to improve zootechnical performance in an animal fed the animal feed relative to a control feed lacking the animal feed ingredient composition.
Claim 43 is directed to an animal feed comprising the ingredient composition of claim 1, with an intended use of improving zootechnical performance. This intended use is not a limitation (see, MPEP §2111.02 (II)) and does not integrate the judicial exception into a practical application.
Regarding claim 45, the claim recites:
Claim 45: “The animal feed of claim 43, wherein the improved zootechnical
performance is altered feed intake, increased average daily weight gain, increased feed efficiency, decreased feed conversion ratio or increased milk yield.”
Claim 45 is directed to intended uses of the animal feed of claim 43, and neither adds an integration of the judicially-excepted natural products.
Regarding claims 46 and 48, the claims recite:
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Claim 46 is directed to a broad and generic range of the claimed compounds in the animal feed of claim 43, without any integrative element. Claims 48 limit the origins of the claimed compounds of claim 43 by plant genus and species, and also contains no integrative element.
Regarding claims 49-50, and 53-55, claim 49, for example, recites:
“A method of improving the performance of an animal feed, comprising adding an effective amount of the composition of claim 1 to the animal feed.”
This is a statement of intended use of the composition of claim 1, and does not present an integrative element. Claims 50, 53, 54 and 55 are similar statements of intended use and none present an integrative element.
Regarding claim 52 and 56, the claims recite:
Claim 52: “The method of claim 49, wherein the furoguaiacin or furoguaiacin-like
compound or guaiacin compound, or biologically acceptable salt thereof, is present in an amount of from about 0.01 mg to about 2000 mg per kg of animal feed.”
Claim 56: “The method of claim 53, wherein the animal feed comprises the
furoguaiacin or furoguaiacin-like compound or guaiacin compound, or biologically acceptable salt thereof, in an amount of from about 0.01 mg to about 2000 mg per kg of animal feed.
Claims 52 and 56, as is claim 46, is directed to a broadly claimed generic range of the claimed compounds in the animal feed of claim 49, and adds no integrative element. The claims do not recite any parameters that distinguish the claimed amounts from naturally occurring levels of the compound, nor do they demonstrate that the claimed range achieves a result that is markedly different from the compounds natural behavior.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims are individually addressed to:
a) formulations involving unaltered botanical extracts (claims 1 and 30);
b) the sources of the claimed compounds used in claim 1 (plants: claim 33);
c) the botanical sources of the claimed compounds used in claim 43 (plants: 48);
d) total lignan limitations of the composition of claim 1 (claims 38, 40, 41 and 42) and claim 38 (claim 39);
e) an animal feed comprising the ingredient of claim 1 (claim 43) and its use (claim 45);
f) the amount of claimed compounds in the animal feed of claim 43 (claim 46);
g) the method of feeding the animals (claim 49);
h) the amount of claimed compounds in the animal feed of claim 49 (claim 52);
i) the amount of claimed compounds in the animal feed of claim 43 (claim 56); and
j) claims directed to intended use (50, 53, 54 and 55).
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart(s) (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please note that combining natural extracts (such as from two or more plants) does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. – 333 U.S. 127 (1948)) because again there is no evidence of a marked difference brought about by combining the instantly claimed herbal extracts. Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter. No combination of claim elements amount to significantly more than the judicial exception.
Applicant’s Arguments
Applicant contends that the Office has not provided sufficient reasons to support a rejection under 35 USC § 101. Applicant argues that the animal feed composition, for example as recited in claim 1, comprises an added extract of Guaiacum sanctum or Guaiacum officinale, and argues that the extract itself is markedly different from its naturally occurring form, as the extraction process removes many inert components, leaving solely the extract. Applicant’s Remarks at pages 7-9. Applicant highlights that the intended purpose of the composition is one that is “An animal feed composition”, comprising an extract of Guaiacum sanctum or Guaiacum officinale, and further comprising at least one animal feed component; wherein the added amount is sufficient to improve zootechnical performance of an animal feed to which the composition is added. Applicant argues that the extract is only one component of the composition, and also argues that animals fed only the plant material would not show improvement in zootechnical performance. Applicant also refers Example 2 of the specification for support. Applicant’s Remarks at page 9.
Examiner’s Response to Arguments
Applicant’s arguments are fully acknowledged, but are not found to be persuasive in view of the above rejections.
MPEP §2106.04(b) states that:
Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. The courts have often described these exceptions using other terms, including "physical phenomena," "scientific principles", "natural laws," and "products of nature."
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state and can be expressed as the product’s structure, function, and/or other properties. MPEP 2106.04 (c)(II).
Applicant contends that the claimed extract of Guaiacum sanctum or Guaiacum officinale is markedly different from its naturally occurring form because the extraction process removes inert components is not persuasive. The claims do not recite any structural, functional, or chemical modification for furoguaiacin, furoguaiacin-like compounds, or guaiacin that results in characteristics markedly different from those found in nature. Merely isolating, purifying, or concentrating a naturally occurring compounds without a demonstrated change in structure or function does not confer patent eligibility.
As disclosed in MPEP 2106.04 (c)(I)(A), “Where the claim is to a nature-based product by itself (e.g., a claim to "a Lactobacillus bacterium"), the markedly different characteristics analysis should be applied to the entire product. The claimed composition, along with the added feed component such as vitamins and minerals (instant claim 30), is found in the plants, or plant parts, and also their extracts.
Nutmegs (Myristica fragrans as recited in the claim), for example, is a naturally occurring counterpart to the claimed composition, as it contains both the claimed compounds, along with several vitamins including vitamins A, C, and E (as required by claim 30). Both nutmeg and the claimed composition have the same or similar biological or pharmacological functions or activities because of the components found inside the plant part, and their extracts. The characteristics of the furoguaiacin-like, furoguaiacin, and guaiacin compounds present in the claimed composition does not change as compared to the nutmeg itself, and is thus an inherent or innate characteristic of the naturally occurring nutmeg counterpart.
The instant claims recite naturally occurring lignans, and lignan-like compounds derived from Guaiacum species. The extraction process, as described above, does not impart any new structural features, nor does the claim require properties different from the compound’s natural behavior. Removal of inert plant material alone is insufficient to establish markedly different characteristics. Accordingly, the claimed compounds remain judicial exceptions under 35 USC § 101.
Applicant further argues that the claims are integrated into a practical application because the extract is included in an animal feed composition in an amount effective to improve zootechnical performance. This argument also is not persuasive. When considered as a whole, the claims merely recite: a naturally occurring compound or extract thereof, and its inclusion in animal feed at an amount alleged to be effective. The claims do not recite, for example, a specific mechanism by which zootechnical performance is improved, a defined physiological pathway or technical improvement, any particular feeding regimen, duration, or operational constraint, nor any limitation that meaningfully restricts the use of the compound beyond its natural properties.
The recitation of an intended result (i.e., “effective to improve zootechnical performance”) does not integrate the judicial exception into a practical application, as it amounts to a result-oriented limitation without additional technical features. Placement of a natural product into a conventional environment such as animal feed, without more, does not impose a meaningful limitation on the exception. That is, the claims do not recite any parameters demonstrating that the claimed amounts or composition produce effects that are different in kind, rather than degree, from the naturally occurring compounds.
Applicant cites Example 2 of the specification as evidence that the claimed extract produces improved zootechnical performance and argues that animals fed only plant material would not show such improvement. This reliance is misplaced as Example 2 describes a comparative feeding study involving:
Diet 1: a basal diet without any compound,
Diet 2: a basal diet supplemented with a known alternative antibiotic growth promoter (XTRACT® Evolution-B),
Diet 3: Diet 1 supplemented with 8 g per metric ton of total lignans, composed of 50% furoguaiacin-like compounds and 40% guaiacin-like compounds.
More notably, Example 2:
Does not isolate the effects of furoguaiacin or guaiacin alone,
Does not establish that the claimed compounds themselves are responsible for the observed results,
Does not demonstrate a mechanism or technical improvement attributable specifically to the claimed compounds,
Does not establish that the claimed compounds function differently from their naturally occurring counterparts.
Rather, the example compares a basal diet, a known antibiotic growth promoter, and a mixed lignan supplement, and thus does not support Applicant’s assertion that the claimed extract, as claimed, constitutes a practical application sufficient to overcome the judicial exception. Furthermore, reliance on disclosure in the specification cannot cure a §101 deficiency where the claims themselves do not recite the features alleged to confer eligibility.
In sum, the use of naturally occurring lignans in animal feed at broadly effective amounts is considered routine and conventional in the field of animal nutrition. The claims do not include unconventional processing steps, non-routine formulations, or specific technical implementations that would transform the nature of the claims. The “furoguaiacin or a furoguaiacin-like compound or guaiacin compound…”, are considered a nature-based product that are naturally occurring and do not have markedly different characteristics compared to what occurs in nature. More specifically, as disclosed in instant claim 3, “the furoguaiacin or furoguaiacin-like compound or guaiacin compound is obtained from an extract from a plant or part thereof”. The pharmacological functions or activities, chemical and physical properties of the compounds, and chemical structures remain the same, even in combination with “… at least one animal feed component…”. Claims 1, 30-36, and 38-43, 45-50, and 52-56, in view of the specification, do not appear “to possess markedly different characteristics from any naturally occurring counterpart” as required.
For at least the reasons set forth above, Applicant’s arguments are not persuasive. The claims remain directed to a judicial exception without integration into a practical application and without reciting significantly more. The rejection under 35 U.S.C. § 101 is maintained.
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.
Claims 1, 30, 32-35, and 38-43, 45-46, 48-50, and 52-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-9, and 10-14 of U.S. Patent No. 12193457 (‘457; previous copending Application No. 17/955,268 (‘268)).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to an animal feed ingredient composition comprising an effective amount of furoguaiacin, or guaiacin. While claim 1 of U.S. Patent ‘457 discloses (in part) an animal feed composition, “… wherein the composition is further defined as comprising an added amount of an extract of Guaiacum sanctum comprising furoguaiacin or guaiacin wherein the added amount of the extract of Marrubium vulgare and the extract of Guaiacum sanctum is effective to improve the performance of an animal feed to which the extract of Marrubium vulgare and the extract of Guaiacum sanctum is added compared to when the extract of Marrubium vulgare and the extract of Guaiacum sanctum is not present in the animal feed…”, the claim does not specifically teach an animal composition comprising only an extract of Guaiacum sanctum comprising furoguaiacin or guaiacin.
However, considering that the composition of ‘457 contains two extracts effective to improve the performance of an animal feed to which the extracts are added to, one of ordinary skill in the art would have several recognized motivations to use the two extracts separately rather than combined in an animal feed, and arrive at the instant claims. One of ordinary skill in the art would have been motivated to retain formulation flexibility, particularly in the absence of any teaching or reasonable expectation of synergistic benefit from their combination. It would have therefore been prima facie obvious, to one of ordinary skill in the art, to explore the effectiveness of each individual extracts separately, and arrive at the claimed invention, with reasonable expectation of success. Furthermore, the open-ended transitional phrase “comprising” in the instant claims, do not preclude the presence of marrubiin and other components.
Claims 1, 30, 32-35, and 38-43, 45-46, 48-50, and 52-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/423,936 (‘936).
Claim 1 of co-pending application ‘936 recites the following:
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Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to an animal feed ingredient composition comprising an effective amount of furoguaiacin, or guaiacin.
However, while the composition of ‘936 contains three different compounds/extracts effective to improve the performance of an animal feed to which the extracts are added to, one of ordinary skill in the art would have several recognized motivations to use the three extracts separately rather than combined in an animal feed, and arrive at the instant claims. One of skill in the art would have been motivated to retain formulation flexibility, particularly in the absence of any teaching or reasonable expectation of synergistic benefit from their combination. It would have therefore been prima facie obvious, to one of ordinary skill in the art, to explore the effectiveness of each individual extracts separately, and arrive at the claimed invention, with reasonable expectation of success. Furthermore, the open-ended transitional phrase “comprising” in the instant claims do not preclude the presence of marrubiin and other components. This is a provisional nonstatutory double patenting rejection.
Claims 1, 30, 32-35, and 38-43, 45-46, 48-50, and 52-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 59-78 of copending Application No. 18964225 (‘225).
Claim 59 of co-pending application ‘225 recites the following:
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Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to an animal feed ingredient composition comprising an effective amount of furoguaiacin, or guaiacin.
The claims of ‘225 are directed to a method of preparing the instantly claim composition method and are related to the instant invention by way of a process of making and a product. The composition of ‘225 contains two different extracts; one of ordinary skill in the art would have several recognized motivations to use the two extracts separately rather than combined in an animal feed, and arrive at the instant claims. One of skill in the art would have been motivated to retain formulation flexibility, particularly in the absence of any teaching or reasonable expectation of synergistic benefit from their combination. It would have therefore been prima facie obvious, to one of ordinary skill in the art, to explore the effectiveness of each individual extracts separately, and arrive at the claimed invention, with reasonable expectation of success. Furthermore, the open-ended transitional phrase “comprising” in the instant claims do not preclude the presence of marrubiin and other components.
Consistent with this reasoning, claims 1, 30, 32-35, and 38-43, 45-46, 48-50, and 52-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 59-78 of copending Application No. 18964225 (‘225). This is a provisional nonstatutory double patenting rejection.
Applicant’s Arguments
Applicant argues for the rejections to be held in abeyance until allowable subject matter is identified. Applicant’s Remarks at pp. 13-14.
Examiner’s Response
Applicant’s arguments are acknowledged, but are not found to be persuasive. The rejection will not be held in abeyance, and is maintained.
Conclusion
No claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 04/04/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
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.
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/C A/Examiner, Art Unit 1622 January 8, 2026
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622