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 .
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.
Election/Restrictions
Applicant’s election of Group I (claims 13-20), in the reply filed on 3 October 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of “dysbiosis” in the reply filed on 3 October 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
A prior art search of the formulation of claim 13 for use in treating Applicants’ elected “dysbiosis” retrieved no prior art. Said search only retrieved the instant application/pre-grant publication.
An extended Markush search of the formulation of claim 13 for use in treating “microbiome” also only retrieved the instant pre-grant publication and no other prior art reference.
An extended Markush search of the formulation of claim 13 for use in treating “intestinal health” and / or immunity retrieved a prior art reference. Therefore, the Markush search will not be extended unnecessarily to additional species in this Office Action.
The Markush search extension reads on claims 13-20.
Claims 1-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention of Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3 October 2025.
Current Status of 18/194,867
This Office Action is responsive to the amended claims of 3 October 2025.
Claims 13-20 have been examined on the merits. Claim 13 is currently amended. Claims 14-20 are original.
Priority
The effective filing date is 1 April 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9 April 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 14-15 are objected to as these claims contain “a subject”. While “a subject” is technically not a lack of antecedent basis/112b indefiniteness issue, it nevertheless is awkward as claims 14-15, which depend on claim 13, really intend the subject to be “the avian” of claim 13. Therefore, why can’t Applicants just reference -- the avian -- instead of “a subject” within claims 14-15? So, please revise claims 14-15, as relevant to: -- the avian [[a subject]] -- .
Claims 17-18 are objected to as they are missing -- of -- within the statement: “The formulation claim 13”. So, please revise each claim to: -- The formulation of claim 13 -- to render moot this objection.
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 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomena without significantly more. The claim(s) recite(s) soybean-derived genistein (claims 13 and 17) which is naturally occurring/a judicial exception (JE). This judicial exception is not integrated into a practical application because the claims 13-20 do not impose meaningful limits on the JE genistein, such that these claims 13-20 are more than mere drafting efforts designed to monopolize the exception. Furthermore, claims 13-20 all amount to “insignificant extra-solution activities to the judicial exceptions”. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim 13 intended use/inherent properties/functions (see, below); the weight percentages of claims 14-15; and the dietary supplements of claim 16 all constitute well-understood, routine, and conventional (“WURC”) aspects which are known to the artisans in the veterinarian science/agricultural arts.
The broadest reasonable interpretation of the instant claims 13-20 are drawn to a formulation/composition comprising any amount of genistein. The limitations “optionally effective, in an avian” and limitations (a)-(i) are each interpreted as being intended use (nothing precludes the use(s) as claimed) and/or inherent property/function. Thus, the broadest reasonable interpretation of claim 13 is drawn to a composition comprising naturally occurring genistein, which comes from soybeans (according to instant claim 17).
Step 1: Is the claim drawn to a process, machine, manufacture, or composition of matter?
Yes, the broadest reasonable interpretation (BRI) of claims 13-20 are drawn to formulations/compositions of matter comprising naturally occurring (soybean-derived-claim 17) genistein.
Revised Step 2A:
Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes: The BRI of claims 13-20 are drawn to natural phenomena: the BRI of claims 13-20 are drawn to a formulation comprising genistein, which comes from naturally occurring soybeans (instant claim 17), and hence is interpreted as “natural phenomenon”. Thus, these claims are drawn to naturally occurring genistein (which is the judicial exception (JE)).
Moreover, there is no “markedly different” characteristics involved with the intended uses/inherent properties of claim 13 and the “formulation” of claim 13 (and claims 14-20) could be the plant, or even just a genistein extract; the weight percentages of claims 14-15; the dietary supplements and source plants (soybeans) of claims 16-17, respectively; the avian subjects (claims 18-19); and the routes of administration (claim 20). The limitations of claim 13 that are intended use and/or inherent properties/functions (see, above) and the limitations of claims 14-20 are drawn to natural phenomena hence they recite a judicial exception (JE). The BRI of limitations from claims 14-20 do not recite any markedly different characteristics that would serve to distinguish these dependent claims from naturally occurring phenomena recited in parent claim 13. Hence, the BRI of claims 13-20 do not recite any markedly different characteristics that would serve to distinguish these claims from naturally occurring phenomena. See MPEP 2106.04(c).
Prong 2: Does the claim recite additional elements that integrate the JE into a practical application?
No, the BRI of claims 13-20 do not recite additional elements that integrate the JE into a practical application. Prong 2 requires an additional element or combination of additional elements to use the JE in a manner that imposes a meaningful limit on the JE, such that the claims are more than mere drafting efforts designed to monopolize the exceptions.
The claim 13 limitations “optionally effective in an avian” AND the limitations (a)-(i) are interpreted as either intended use (nothing precludes the use as claimed) and/or inherent properties/function of naturally occurring genistein (the JE). Thus, there are no limitations within claim 13 that “recite additional elements that integrate the JE genistein into a practical application” (the “formulation” of claim 13 (and claims 14-20) could be the plant, or even just a genistein extract).
The claims 14-15, which merely recite weight percentages of naturally occurring genistein, do not recite additional elements that integrate the JE genistein into a practical application. The claim 16 recites “wherein the formulation is a feed formulation or dietary supplement”. This does not recite additional elements that integrate the JE genistein into a practical application as there is nothing additional about adding a naturally occurring substance (genistein) into feed additives or as dietary supplements. In fact, claim 17 says the genistein is sourced from soybeans. There is nothing “additional” about adding naturally occurring soybeans with naturally occurring genistein into avian feed or as dietary supplements.
Claims 18-20, drawn to the age of the avian subject (claim 18), the genus (claim 19), and the route of administration (claim 20) also do not add additional elements integrating the JE into practical applications.
In fact, claims 14-20 do not impose meaningful limits on the JE genistein, such that these claims 13-20 are more than mere drafting efforts designed to monopolize the exception: naturally occurring genistein. The weight percentages of claims 14-15; the soybean-derived genistein (claim 17) being added to dietary supplements (claim 16); and the subjects who received the genistein (claim 18), the genus of said subjects (claim 19), and the routes of administration (claim 20) all amount to “insignificant extra-solution activities to the judicial exception”.
Step 2B: Does the claim recite additional elements that amount to significantly more than the JE?
No, the BRI of claims 13-20 do not recite additional elements that amount to significantly more than the JE.
The limitations that are intended use/inherent property/function (see, above) from claim 13; the weight percentages of claims 14-15; the dietary supplements of claim 16 all constitute well-understood, routine, and conventional (“WURC”) aspects of the veterinarian uses of naturally occurring genistein (from soybeans-claim 17) in avian feed (claim 16) to be given via any of the routes of administration of claim 20 to avians, such as genus Gallus chickens (claims 18-19). Put another way, the weight percentages (claims 14-15), and integration of a naturally occurring soybean-derived (claim 17) genistein into animal feed (claim 16) certainly constitute WURC in the veterinarian arts. Orally administering and/or administration by any of the routes of claim 20 of said feed to avians, such as chickens (claims 18-19) of genus Gallus or other avians (claim 19) also constitute WURC activities in the veterinarian/agricultural arts.
Thus, claims 13-20 are NOT patent eligible subject matter under 35 USC 101.
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 13-20 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.
The phrase “optionally effective, in an avian” renders the metes and bounds of claim 13 undefined (hence rendering claim 13 indefinite under 35 USC 112(b)) since confusion arises from “optionally” as used in the claim 13: the artisan is not certain if Applicants are claiming that “optionally effective” means that one could infringe on the claim if one administers “ineffective” amounts of genistein? The claims 13-20 are drawn to a composition, and claim 13 is drawn to “any amount” of genistein. Therefore, the artisan, upon seeing limitations (a)-(i), would believe that a composition comprising any amount of genistein could do any or all of the limitations (a)-(i), but, “optionally effective” leaves open the possibility/interpretation that it does not have to be enough (or too much) to be effective in avians to do any of the limitations (a)-(i).
Claims 14-20 are similarly rejected as indefinite since these claims refer back to claim 13 but do not remedy the rationale underpinning the basis for rejecting claim 13.
Please strike “optionally” from claim 13 to render moot this rejection.
Claim 18 recites the limitation "non-avian". There is insufficient antecedent basis for this limitation in the claim.
As drafted, claim 18’s limitation “non-avian” renders the metes and bounds of claim 18 undefined (hence rendering claim 18 indefinite under 35 USC 112(b)) since the artisan does not know where antecedent basis for “non-avian” is found within “avian” requirements of claim 13. Put another way, how can something be both “avian” (required by parent 13) and “non avian”? Please strike “a young non-avian” from the claim to render moot this rejection.
Claim 19 recites the limitation "the subject". There is insufficient antecedent basis for this limitation in the claim.
As drafted, “the subject” renders the metes and bounds of claim 19 undefined (hence rendering claim 19 indefinite under 35 USC 112(b)) since the artisan does not know where antecedent basis can be found for “subject” within claim 13. Claim 13 is silent as to “a subject” or “subject”; although claim 13 does contain “avian”. Could Applicants really intend -- the avian -- instead of “the subject” within claim 19?
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 18-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 18, drawn to the embodiment “non-avian”, improperly further limits parent claim 13, which just permits “avian” and is silent as to “non-avian”. Thus, claim 18 is rejected under 35 USC 112(d).
Dependent claim 19, which references “the subject”, improperly further limits parent claim 13, which is silent as to “a subject” or “subject”. Hence dependent claim 19 is rejected under 35 USC 112(d). Might Applicants really intend claim 19 to say: -- wherein the avian [[subject]] is selected from the group consisting of -- ?
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claims 13 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
KAMBOH (Kamboh, A.A., et. al. “Individual and combined effects of genistein and hesperidin on immunity and intestinal morphometry in lipopolysaccharide-challenged broiler chickens.” Poultry Science. (2014), 93(9), pp. 2175-2183, provided by Applicants and referenced in IDS of 9 April 2024),
as evidenced by:
GALLUS (“History of the Chicken.” Penn State College of Agricultural Sciences. Published: Jan 31, 2001. Accessed on 2 Feb 2026. Available from: < https:// extension.psu.edu/programs/4-h/opportunities/projects/animal-science/poultry/raising-rearing/viii-other-online-resources/the-chicken/history-of-the-chicken / ).
Claim 13 is interpreted as being drawn to a composition (“formulation”) comprising genistein. If a prior art reference teaches any amount of genistein it would anticipate the composition of instant claim 13 comprising genistein since the limitations (a)-(i) are interpreted as intended use and/or inherent property/function. Moreover, “optionally effective in an avian” could either be interpreted as inherent property/function or intended use.
The prior art reference KAMBOH teaches compounds of genistein being used as an alternative feed additive in the poultry industry to promote gut health and improve immunity against infections (see last sentence of “Abstract” on page 2175). A review of the KAMBOH prior art reference and particularly, its “Abstract” shows that chickens were fed genistein. Thus, KAMBOH teaches that chickens (“avians”) were fed a composition comprising genistein. Since no one compound of genistein exists in isolation (it is impossible to “feed” an animal one compound only) but rather in a collection/composition/formulation of genistein, at a minimum, KAMBOH anticipates “a formulation comprising an [any] amount of genistein” of instant claim 13.
The limitations “optionally effective, in an avian” and the individual limitations (a)-(i) all individually (or in any combination) comprise intended use limitations. Nothing precludes the use(s) as claimed. Alternatively, one could also reasonably interpret “optionally effective, in an avian” AND any of the alternative limitations (a)-(i) as inherent properties/functions. Since the compound genistein (and compositions thereof) recited in the prior art reference are substantially the same as that of the claims, claimed properties/functions are presumed inherent. See MPEP 2112.01(I) and (II). Thus, KAMBOH anticipates the instant claim 13 with the claim interpretation, above.
Examiner also interprets the prior art reference KAMBOH’s use of genistein as feed additives (hence “oral administration” thereby anticipating instant claim 20) in the poultry industry to promote gut health and improve immunity against infections (see last sentence of “Abstract” on page 2175) as anticipating the limitations “an amount of genistein”, “optionally effective, in an avian” and at least one of the following limitations: (e), (h) (if one “improves/promotes gut health and improve immunity”, then one necessarily “prevents intestinal abnormality and infection and/or disease”), and/or (i). Thus, under this explicit interpretation KAMBOH anticipates instant claim 13, 16, and 18 as explicitly written.
KAMBOH teaches that soybean based diets were administered to the chickens (and that’s how at least some of the genistein was introduced as a feed additive) (see right column on page 2176), which anticipates instant claim 17.
The reference GALLUS is relied upon for the beneficial teaching that the chickens (used in the KAMBOH prior art reference) are classified in the genus Gallus, (see first paragraph under “History of the Chicken” title) thereby anticipating instant claim 19.
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.
Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over:
KAMBOH (Kamboh, A.A., et. al. “Individual and combined effects of genistein and hesperidin on immunity and intestinal morphometry in lipopolysaccharide-challenged broiler chickens.” Poultry Science. (2014), 93(9), pp. 2175-2183, provided by Applicants and referenced in IDS of 9 April 2024),
as evidenced by:
GALLUS (“History of the Chicken.” Penn State College of Agricultural Sciences. Published: Jan 31, 2001. Accessed on 2 Feb 2026. Available from: < https:// extension.psu.edu/programs/4-h/opportunities/projects/animal-science/poultry/raising-rearing/viii-other-online-resources/the-chicken/history-of-the-chicken / ),
in view of:
ANSEL (Ansel, Howard C., et al. “Pharmaceutical Dosage Forms and Drug Delivery Systems.” (1999), 7th ed. Lippincott Williams & Wilkins, pp. 48-53).
Determining the scope and contents of the prior art:
The prior art reference KAMBOH as evidenced by GALLUS teaches instant claims 13 and 16-20, supra.
Furthermore, KAMBOH teaches that the chickens were fed 5 mg of genistein/kg and varying doses of genistein in combination with hesperidin (see “Abstract”). This teaching helps to show that the artisan can envision varying the dose of genistein to the avian subjects.
Ascertaining the differences between the prior art and the claims at issue:
While KAMBOH teaches the formulation of instant claim 13 and also teaches that the chickens were fed 5 mg of genistein/kg and varying doses of genistein in combination with hesperidin (see “Abstract”), the reference KAMBOH does not teach the specific weight percentage ranges of instant claims 14-15.
While ANSEL teaches that physicians routinely change (increase or decrease) the dosage to meet particular treatment requirements of their patients (see right column of page 48). However, ANSEL does not teach the specific weight percentages of claims 14-15 or the formulation of claim 13.
Resolving the level of ordinary skill in the pertinent art:
The artisan is knowledgeable in formulating compositions/formulations of genistein for animal/agricultural use. The artisan possesses the skills to vary the dosage of genistein to increase veterinarian medicinal/therapeutic outcomes, such as improving intestinal health, improving immunity, and fighting infection within the veterinary subject.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
The artisan, seeing the varying doses and ratios of genistein within the Abstract of KAMBOH (see KAMBOH “Abstract”) would view as prima facie obvious the varying ranges of weight percentages (interpreted as concentrations) of genistein per instant claims 14-15. The artisan would view these varying ranges as variables that the artisan routinely optimizes to maximize anti-microbial/gut health/immunity treatment efficacy (KAMBOH “Abstract”).
The artisan would be expected to vary the weight percentages of genistein in order to maximize treatment efficacy. The artisan would be motivated to vary the concentration of genistein (concentration/weight percentage is a variable that is routinely optimized in the agricultural veterinarian art) according to instant claims 14-15 to optimize the treatment efficacy and health of the chickens that are fed genistein in their chicken feed. This is especially true since neither the claims nor the Specification indicate how the concentrations (weight percentages) within dependent (emphasis) claims 14-15 are critical. Moreover, the artisan would look to what is known in the pharmaceutical arts which shows that the veterinarian (“physician”) routinely increases or decreases dosage (concentrations/weight percentages) to meet the particular requirements of the patient (herein, the chickens) (see ANSEL, page 48).
Moreover, patent law views differences in concentration (herein, the varying ranges of weight percentages of genistein) as not supporting 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); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). See MPEP 2144.05(II)(A).
Thus, prior art reference KAMBOH, as evidenced by GALLUS, in view of ANSEL teaches instant claims 13-20.
Conclusion
No claims are presently allowable as written.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625