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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/10/2026 has been entered.
Status of the Claims
This action is in response to papers filed 02/10/2026 in which claims 4-5, 7-8, 10-11, and 13-20 were canceled; claims 1, 9, 21, and 26-28 were amended; and claims 29-33 were newly added. All the amendments have been thoroughly reviewed and entered.
Claims 1-3, 6, 9, 12, 21-33 are under examination.
Withdrawn Rejections
The Examiner has re-weighted all the evidence of record. Any rejections and/or objections not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Maintained-Modified Rejections
Modification Necessitated by Applicant’s Claim Amendments
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.
Claim(s) 1-3, 6, 9, 12, 21-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hagen et al (US 2017/0095508 A1; cited in IDS filed 10/05/2022) in view of Huckaba (WO 2017/173393 A1), and as evidenced by the instant specification and Hoar et al (“Production Cycle of Swine.” Retrieved from internet on 28 July 2013; publicly accessible date: 10 January 2017).
Regarding claim 1, Hagen teaches a method of improving growth performance in an animal comprising orally administering a therapeutically effective amount of an antimicrobial clay to the animal. Hagen teaches the antimicrobial clay is a clay mined in the Crater Lake region of the Cascade Mountains of Oregon (Abstract; [0007]-[0008], [0012], [0014]-[0015], [0020], [0110]-[0111], [0117]-[0119], [0171], [0176], [0196]; claims 37-39 and 56-58). Hagen teaches the clay is formulated in a feed composition for oral adminstration to the animal ([0011], [0015], [0020], [0090], [0115], and [0181]-[0182], and claims 37-39 and 56-58). Hagen teaches the amount of clay in a feed composition ranges from about 0.05% to about 0.15% ([0011], [0015], [0020] and [0117]).
While Hagen teaches the animal is a weanling pig, it would have been obvious to use the method of improving growth performance of Hagen on an adult animal such as an adult pig per guidance from Huckaba.
Huckaba teaches a method for improving the growth and/or health of an animal, the method comprising orally administering a therapeutically effective amount of a bioactive clay to the animal (Abstract; pages 2-7, 11-12, 14-17, and 32; claims 1-3 and 5). Huckaba teaches the animal is a pig, wherein the pig is a grow-finish pig (pages 11-12 and 14-15; claims 1-3 and 5). Huckaba teaches the bioactive clay is a clay mined in the Crater Lake region of the Cascade Mountains of Oregon (pages 2 and 4-7). Huckaba teaches the clay is formulated in a feed composition for oral adminstration to the animal (pages 13-17; claims 15 and 16). Huckaba teaches improving growth and/or health an animal encompasses growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) (pages 11, 13-15 and 17).
It would have been obvious to one of ordinary skill in the art to use the method of improving growth performance of Hagen on an adult animal such as a grow-finish pig, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Huckaba provided the guidance to do so by teaching that the therapeutic clay of Hagen is useful in both weanling pigs and adult pigs such as grow-finish pig, and such oral administration of the clay to the grow-finish pig improves growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) (Huckaba: pages 2, 11-15, and 17; claims 1-3 and 5). One of ordinary skill in the art would have reasonable expectation of success in doing so because Hagen does permit the use of the antimicrobial clay for adult animals (Hagen: [0196]). Thus, an ordinary artisan seeking to improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) in an adult animal such as a grow-finish pig, would have looked to using the method of improving growth performance of Hagen on an adult animal such as a grow-finish pig with a reasonable expectation that the orally administration of the clay to the pig would effectively improve growth performance of the pig, and achieve Applicant’s claimed invention with reasonable success.
It would have been obvious that the improvement in growth performance using the antimicrobial (bioactive) clay of Hagen and Huckaba would include increasing volatile fatty acid production in the grow-finish pig, and vice versa, improving increasing volatile fatty acid production would have been a result from improvement in growth performance. This is because Hagen and Huckaba used the same therapeutic clay as the claimed invention, and as discussed above, Huckaba indicated that oral administration of the clay to the grow-finish pig improves growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) (Huckaba: pages 2, 11-15, and 17; claims 1-3 and 5). Furthermore, it is noted that Huckaba further indicated that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply (page 27). This is consistent with claim 9 of the instant application which further defines improving performance provides improving energy use from volatile fatty acids.
With respect to the clay is formulated in a feed composition for oral administration to the animal at an amount of less than about 1lbs/ton of the feed of claim 1, Huckaba teaches the bioactive clay inclusion rate in an animal feed is about 100 ppm to about 5000 ppm (0.01% to 0.5%) (pages 2 and 16). Huckaba teaches the therapeutically effective amount of the bioactive clay for a finishing pig is about 0.1 g/day to about 1.5 g/day (about 0.0002 lbs to about 0.003 lbs) or about 0.6 g/day to 0.8 g/day (about 0.001 lbs to about 0.002 lbs) (pages 11-12). Huckaba teaches bioactive clay is therapeutically effective dosage and/or amount is selected to effect the desired improved growth and/or improved health of the animal relative to a control animal that does not receive the bioactive clay (page 11). Thus, it would have been obvious to one of ordinary skill in the art to optimize the amount of clay formulated in the feed composition to an amount of less than about 1lbs/ton of the feed, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Huckaba teaches the bioactive clay inclusion rate in an animal feed is about 100 ppm to about 5000 ppm (0.01% to 0.5%) and that the therapeutically effective amount of the bioactive clay for a finishing pig is about 0.1 g/day to about 1.5 g/day (about 0.0002 lbs to about 0.003 lbs) or about 0.6 g/day to 0.8 g/day (about 0.001 lbs to about 0.002 lbs), which are low amounts that overlaps the claimed range of “less than about 1 lbs/ton.” It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Provided the guidance from Huckaba, it would have been customary for an artisan of ordinary skill to determine the optimum amounts of clay formulated in a feed composition for oral administration to a finishing pig to achieve the desired improved growth performance of the finishing pig. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of amount of clay in a feed composition for oral administration in an adult animal would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 2, Hagen and Huckaba teach the clay is a clay mined in the Crater Lake region of the Cascade Mountains of Oregon (Hagen:[0007], [0014]-[0020] and [0111]; Huckaba: pages 2 and 4-7).
Regarding claim 3, Hagen teaches the clay is naturally mined, and the level of reducing agent in the clay is adjusted to provide therapeutically effective amounts of the reducing agent ([0008], [0109]; claim 11).
Regarding claim 6, as discussed above, Huckaba teaches and provides the guidance for the adult animal to be a healthy grow-finish pig.
Regarding claim 9, as discussed above, Hagen teaches the clay improves growth performance in the animal by improving growth performance and weight gain ([0012], [0015], [0020], [0090], [0171], [0175], and [0181]). As discussed above Huckaba indicated that oral administration of the clay of Hagen to the grow-finish pig improves growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) (Huckaba: pages 2, 11-15, and 17; claims 1-3 and 5). Furthermore, Huckaba further established that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply (page 27).
Regarding claim 12, as discussed above, Huckaba teaches the bioactive clay inclusion rate in an animal feed is about 100 ppm to about 5000 ppm (0.01% to 0.5%) (pages 2 and 16). Huckaba teaches the therapeutically effective amount of the bioactive clay for a finishing pig is about 0.1 g/day to about 1.5 g/day (about 0.0002 lbs to about 0.003 lbs) or about 0.6 g/day to 0.8 g/day (about 0.001 lbs to about 0.002 lbs) (pages 11-12). Huckaba teaches bioactive clay is therapeutically effective dosage and/or amount is selected to effect the desired improved growth and/or improved health of the animal relative to a control animal that does not receive the bioactive clay (page 11). Thus, it would have been obvious to one of ordinary skill in the art to optimize the amount of clay formulated in the feed composition to an amount of less than about 1lbs/ton of the feed, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Huckaba teaches the bioactive clay inclusion rate in an animal feed is about 100 ppm to about 5000 ppm (0.01% to 0.5%) and that the therapeutically effective amount of the bioactive clay for a finishing pig is about 0.1 g/day to about 1.5 g/day (about 0.0002 lbs to about 0.003 lbs) or about 0.6 g/day to 0.8 g/day (about 0.001 lbs to about 0.002 lbs), which are low amounts that overlaps the claimed range recited in claim 12. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Provided the guidance from Huckaba, it would have been customary for an artisan of ordinary skill to determine the optimum amounts of clay formulated in a feed composition for oral administration to a finishing pig to achieve the desired improved growth performance of the finishing pig. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of amount of clay in a feed composition for oral administration in an adult animal would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 21, as discussed above, Hagen teaches the clay improves growth performance in the animal by improving growth performance and weight gain ([0012], [0015], [0020], [0090], [0171], [0175], and [0181]). Huckaba teaches the clay improves growth, weight gain, feed intake, feed conversion, and intestinal health of the animal (Huckaba: pages 2, 11-15, and 17; claims 1-3 and 5).
Regarding claims 22-25, as discussed above, Huckaba teaches the bioactive clay inclusion rate in an animal feed is about 100 ppm to about 5000 ppm (0.01% to 0.5%) (pages 2 and 16). Huckaba teaches the therapeutically effective amount of the bioactive clay for a finishing pig is about 0.1 g/day to about 1.5 g/day (about 0.0002 lbs to about 0.003 lbs) or about 0.6 g/day to 0.8 g/day (about 0.001 lbs to about 0.002 lbs) (pages 11-12). Huckaba teaches bioactive clay is therapeutically effective dosage and/or amount is selected to effect the desired improved growth and/or improved health of the animal relative to a control animal that does not receive the bioactive clay (page 11). Thus, it would have been obvious to one of ordinary skill in the art to optimize the amount of clay formulated in the feed composition to an amount of less than about 1lbs/ton of the feed, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Huckaba teaches the bioactive clay inclusion rate in an animal feed is about 100 ppm to about 5000 ppm (0.01% to 0.5%) and that the therapeutically effective amount of the bioactive clay for a finishing pig is about 0.1 g/day to about 1.5 g/day (about 0.0002 lbs to about 0.003 lbs) or about 0.6 g/day to 0.8 g/day (about 0.001 lbs to about 0.002 lbs), which are low amounts that overlaps the claimed ranges as recited in claims 22-25. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Provided the guidance from Huckaba, it would have been customary for an artisan of ordinary skill to determine the optimum amounts of clay formulated in a feed composition for oral administration to a finishing pig to achieve the desired improved growth performance of the finishing pig. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of amount of clay in a feed composition for oral administration in an adult animal would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claims 26-28, as discussed above the improvement in growth performance using the antimicrobial (bioactive) clay of Hagen and Huckaba would include increasing volatile fatty acid production in the grow-finish pig, and vice versa, improving increasing volatile fatty acid production would have been a result from improvement in growth performance. This is because Hagen and Huckaba used the same therapeutic clay as the claimed invention, and as discussed above, Huckaba indicated that oral administration of the clay to the grow-finish pig improves growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) (Huckaba: pages 2, 11-15, and 17; claims 1-3 and 5). Thus, the results of “the method further provides increasing fermentation of fiber in the grow-finish pig” as recited in claim 26, “the method further provides reducing maintenance nutrient requirements in the grow-finish pig” as recited in claim 27, and “the method further provides improving energy use from volatile fatty acids in the grow-finish pig” as recited in claim 28, are implicit results from the improvement in growth performance using the antimicrobial (bioactive) clay of Hagen and Huckaba, because Hagen and Huckaba used the same therapeutic clay as the claimed invention, and Huckaba establishes that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply and that the bioactive clay satisfy the nutrition requirements (page 27).
Regarding claims 29-31, as discussed above the improvement in growth performance using the antimicrobial (bioactive) clay of Hagen and Huckaba would include increasing volatile fatty acid production in the grow-finish pig, and vice versa, improving increasing volatile fatty acid production would have been a result from improvement in growth performance. This is because Hagen and Huckaba used the same therapeutic clay as the claimed invention, and as discussed above, Huckaba indicated that oral administration of the clay to the grow-finish pig improves growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) (Huckaba: pages 2, 11-15, and 17; claims 1-3 and 5). Furthermore, Huckaba further indicate that VFA includes acetate (acetic acid), butyrate (butyric acid), and isovalerate (isovaleric acid) (Huckaba: page 17, lines 1-9; page 21, lines 4-6; and pages 27-28). Thus, the results of “the increasing volatile fatty acid producing comprises an increase in acetate” as recited in claim 29, “the increasing volatile fatty acid producing comprises an increase in butyrate” as recited in claim 30, and “the increasing volatile fatty acid producing comprises an increase in isovalerate” as recited in claim 31, are implicit results from the improvement in growth performance and the increase in volatile fatty acid (VFA) production using the antimicrobial (bioactive) clay of Hagen and Huckaba, because Hagen and Huckaba used the same therapeutic clay as the claimed invention, and Huckaba establishes that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply and that the bioactive clay satisfy the nutrition requirements (page 27).
Regarding claim 32, as discussed above, Huckaba teaches and provides the guidance for the adult animal to be a healthy grow-finish pig. As defined by the specification, "growing and finishing pig" refers to a weened pig removed from the nursery, at about 6 weeks after birth (instant specification: [0041]). Thus, the administration of the clay to a grow-finish pig as guided by Huckaba would implicitly be an administration to the pig at about 6 weeks of growing and finishing as claimed because as evidenced by the instant specification, the "growing and finishing pig" of Huckaba is a weened pig removed from the nursery at about 6 weeks after birth.
Regarding claim 33, Huckaba teaches and provides the guidance for the adult animal to be a healthy grow-finish pig. As evidenced by Hoar, the grow-finish pig of Huckaba is defined to have a weight of about 120 to 150 lbs (Hoar: page 7, right column). Thus, it would have been reasonably obvious that the administration of the clay to a grow-finish pig as guided by Huckaba would implicitly be an administration to the pig when the weight of the pig is about 160 to about 200 lbs or about 190 to about 200 lbs as claimed, absence of evidence to the contrary.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 02/10/2026 have been fully considered but they are not persuasive.
Applicant argues that “[t]he antimicrobial clay of Hagen and Huckaba are explicitly taught to be antimicrobial. Antimicrobial clays release antimicrobial ions (Fe²⁺, Fe³⁺, Al) or produce a reducing environment to kill microbes in an animal. Antimicrobial clays that kill or inhibit microbes do not necessarily increase microbe fermentation and in fact they may reduce fermentative bacteria, or select for different metabolic pathways. In contrast, a therapeutic clay acts by physiochemical toxin adsorption, which may indirectly improve gut health and/or nutrient utilization.” Thus, Applicant alleges that “a clay additive that is antimicrobial does not inherently produce the same physicochemical or microbiome-mediated results as an adsorbent therapeutic clay.” Applicant goes on to allege that “[a]bsent any teaching that antimicrobial activity would enhance microbial fermentation or volatile fatty acid production, a person of ordinary skill in the art would have had no reasonable expectation that the antimicrobial clays of Hagan or Huckaba would improve nutrient utilization via fermentation-based mechanisms.” Applicant further alleges that “Huckaba provides no proposed mechanism to suggest that volatile fatty acid production would increase growth performance in an animal” and that “Huckaba provides no teaching, hypothesis, or suggestion that its disclosed compositions would increase volatile fatty acid production or improve nutrient utilization via volatile fatty acids.” Applicant further alleges that “Huckaba provides no reasonable expectation of success that its methods would increase volatile fatty acid production.” (Remarks, pages 8-11).
In response, the Examiner disagrees. While Hagen classified the clay as an “antimicrobial clay,” the clay of Hagen, as well as, the “bioactive clay” of Huckaba (both Hagen and Huckaba teach structurally the same clay) meets the generically claimed “therapeutic clay,” as recited in claim 1 because “antimicrobial clay” and “bioactive clay” as classified by Hagen and Huckaba are considered “therapeutic” clays. In fact, as previously discussed, the instant specification at paragraph [0020] discloses that “[a] clay having therapeutic properties suitable for a method of the instant disclosure can be as described in U.S. Patent Application No. 15/266,570, the disclosure of which is incorporated herein by reference in its entirety.” It is noted that U.S. Patent Application No. 15/266,570 is the patent application of the published Hagen reference (US 2017/0095508), the cited primary reference in the standing 103 rejection. Thus, the clay of Hagen is the same clay as the claimed “therapeutic clay.” As such, both Hagen and Huckaba used the same clay as the instantly claimed method for improving performance, particularly Huckaba provided the direct guidance for administering the same clay as the claimed invention to a grow-finish pig to growth and/or health an animal encompasses growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids). See 103 rejection, pages 4-5 of this office action.
To this end, as discussed above in the pending 103 rejection, it would have been obvious that the improvement in growth performance using the antimicrobial (bioactive) clay of Hagen and Huckaba would include increasing volatile fatty acid production in the grow-finish pig, and vice versa, improving increasing volatile fatty acid production would have been a result from improvement in growth performance. This is because Hagen and Huckaba used the same therapeutic clay as the claimed invention, and as discussed above, Huckaba indicated that oral administration of the clay to the grow-finish pig improves growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) (Huckaba: pages 2, 11-15, and 17; claims 1-3 and 5). Furthermore, it is noted that Huckaba further indicated that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply (page 27). This is consistent with claim 9 of the instant application which further defines improving performance provides improving energy use from volatile fatty acids.
Thus, it is maintained that it would have been reasonably obvious and with reasonable expectation and predictability that the administration of the clay of Hagen in the method of improving growth performance would also increase volatile fatty acid production in the grow-finish pig because as discussed above, both Hagen and Huckaba used the same clay as the instantly claimed invention, and Huckaba provided the direct guidance for administering the same clay as the claimed invention to a grow-finish pig to growth and/or health an animal encompasses growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids). Furthermore, as discussed in the 103 rejection, Huckaba further indicated that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply (page 27). As such, Huckaba provided the nexus and reasonable expectation that improving growth performance would also increase volatile fatty acid production in the grow-finish pig, as the same clay of the instant claimed invention was used.
Applicant is noted that MPEP §2143.02 (II) states “[o]bviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Some degree of predictability and reasonable expectation of success have been established by the combined teachings of Hagen and Huckaba, as discussed supra. Thus, absence objective evidence showing there was no reasonable expectation of success, the combined teachings of Hagen and Huckaba remain sufficient to render obvious Applicant’s claimed method of improving performance of a grow-finish pig.
Applicant argues:
“[a]s detailed in Example 4 of the specification as filed, finishing pigs fed a diet containing therapeutic clay showed a 8.6% increase in acetate production (P=0.11), a 30% increase in butyrate production (P=0.01), and a 30% increase in isovalerate production (P=0.04) in feces compared to pigs fed a control diet (FIG. 3). FIG. 3 and Example 4 clearly demonstrate that supplementation with the therapeutic clay produces a consistent increase across multiple volatile fatty acids, including butyrate and isovalerate, which are recognized as biologically important fermentation products. Furthermore, a person of ordinary skill in the art would understand that the p-values generated are indicative of the statistical significance of the generated data, and, small p-values are suggestive of results that are not due to random chance. Here, the experimental p-values shown in FIG. 3, i.e. P=0.11, P=0.01, and P=0.04, respectively, provide strong evidence that a diet containing the claimed therapeutic clay is providing an increase in volatile fatty acid production. The exhibited increases in volatile fatty acids therefore constitutes a surprising and advantageous property not taught by the combination of Hagen, Huckaba, and evidentiary references.” (Remarks, page 12).
In response, the Examiner disagrees. Applicant’s experimental data from Example 4 and FIG. 3 of the instant specification, are considered, but found insufficient to obviate the standing 103 rejection as set forth in this office action for the reasons discussed below.
As discussed above, the instant specification at paragraph [0020] discloses that “[a] clay having therapeutic properties suitable for a method of the instant disclosure can be as described in U.S. Patent Application No. 15/266,570, the disclosure of which is incorporated herein by reference in its entirety.” It is noted that U.S. Patent Application No. 15/266,570 is the patent application of the published Hagen reference (US 2017/0095508), the cited primary reference in the standing 103 rejection. Thus, the clay of Hagen is the same clay as the claimed “therapeutic clay.” As such, both Hagen and Huckaba used the same clay as the instantly claimed method for improving performance, particularly Huckaba provided the direct guidance for administering the same clay as the claimed invention to a grow-finish pig to growth and/or health an animal encompasses growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids). See 103 rejection, pages 4-5 of this office action.
To this end, as discussed above in the pending 103 rejection, it would have been obvious that the improvement in growth performance using the antimicrobial (bioactive) clay of Hagen and Huckaba would include increasing volatile fatty acid production in the grow-finish pig, and vice versa, improving increasing volatile fatty acid production would have been a result from improvement in growth performance. This is because Hagen and Huckaba used the same therapeutic clay as the claimed invention, and as discussed above, Huckaba indicated that oral administration of the clay to the grow-finish pig improves growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) (Huckaba: pages 2, 11-15, and 17; claims 1-3 and 5). Furthermore, it is noted that Huckaba further indicated that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply (page 27). This is consistent with claim 9 of the instant application which further defines improving performance provides improving energy use from volatile fatty acids.
Thus, it is maintained that it would have been reasonably obvious and with reasonable expectation and predictability that the administration of the clay of Hagen in the method of improving growth performance would also increase volatile fatty acid production in the grow-finish pig because as discussed above, both Hagen and Huckaba used the same clay as the instantly claimed invention, and Huckaba provided the direct guidance for administering the same clay as the claimed invention to a grow-finish pig to growth and/or health an animal encompasses growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids). Furthermore, as discussed in the 103 rejection, Huckaba further indicated that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply (page 27). As such, Huckaba provided the nexus and reasonable expectation that improving growth performance would also increase volatile fatty acid production in the grow-finish pig, as the same clay of the instant claimed invention is used.
Applicant is noted that MPEP §2143.02 (II) states “[o]bviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Some degree of predictability and reasonable expectation of success have been established by the combined teachings of Hagen and Huckaba, as discussed supra. Thus, absence objective evidence showing there was no reasonable expectation of success, the combined teachings of Hagen and Huckaba remain sufficient to render obvious Applicant’s claimed method of improving performance of a grow-finish pig.
Applicant is also noted that under Example 4 from the instant specification, at paragraph [00126], the specification disclosed “[t]he increased production of these short- chain fatty acids results in greater energy release that can be used for maintenance and growth, which reduce dietary energy requirements, improves energy for gain and ultimately improves feed efficiency.” This analytical results disclosed in the instant specification was also suggested in Huckaba. As discussed above, Huckaba used the same clay as the instantly claimed invention, and Huckaba provided the direct guidance for administering the same clay as the claimed invention to a grow-finish pig to growth and/or health an animal encompasses growth performance of the pig by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids). Furthermore, as discussed in the 103 rejection, Huckaba further indicated that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply (page 27). Thus, the above supports the Examiner’s obviousness analysis of Applicant’s claimed method because the increase in volatile fatty acid (VFA) production in a grow-finish pig using the claimed therapeutic clay is not an unexpected results, as the increase in volatile fatty acid (VFA) production using the same clay was also suggested in Huckaba supra.
Furthermore, Example 4 from the instant specification detailed that “finishing pigs fed a diet containing therapeutic clay showed a 8.6% increase in acetate production (P=0.11), a 30% increase in butyrate production (P=0.01), and a 30% increase in isovalerate production (P=0.04).” However, the results of 8.6% increase in acetate production (P=0.11), a 30% increase in butyrate production (P=0.01), and a 30% increase in isovalerate production (P=0.04), is not captured in claim 1. Claim 1 is drawn generically and broadly to “increasing volatile fatty acid production.” Thus, claim 1 is not commensurate in scope with the results shown in Example 4. Additionally, as previously discussed, claim 1 is also not commensurate in scope with the therapeutic clay used in the Examples of the instant specification. It is noted that paragraphs [00118] and [00127] of the instant specification disclose:
[00118] Four experiments were conducted following the same procedure shown in Example1 to evaluate the effect of feeding Therapeutic clay on growth performance of finishing pigs. In each experiment, finishing pigs (start BW = 200 lb) were housed in pens(27 pigs per pen) and randomly assigned to either a control diet (CON) or a diet containing Therapeutic clay at 0.4 lb/ton, resulting in 44 replicated pens for CON and 47 replicated pens for Therapeutic clay treatment over three experiments. Pigs were fed their respective experimental diets for an average of 44 d prior to harvest. Study1, 3 and 4 did not have TBCC in the basal diet, while Study2 had TBCC at 0.8 lb/ton to provide 150 ppm of Cu of the diet. Data from the three experiments were compiled for meta- analysis using the MIXED procedure of SAS.
[00127] Taken together the data in the Examples above illustrate that pigs fed diets containing Therapeutic clay, from 165 to 290 lbs BW, had reduced maintenance energy requirements, resulting in greater energy for body weight gain and improved feed conversion. Feeding diets containing bentonite therapeutic clay did not result in the same type of improvements as feeding diets containing Therapeutic clay to pigs from 165 to 290 lbs. The improved intestinal health results in less dietary energy required for maintenance, improved feed conversion, or both in the grow-finish pigs. The reduced dietary energy requirement for maintenance and can be attributed to increased abundance of beneficial bacteria that produce increased fecal volatile fatty acids concentrations that can be used as energy for maintenance in the intestine, decreasing the amount of energy needed from the diet. Further, the ability to ferment fiber in a finishing pig is greater than in a nursery pig. Therefore, the reduced dietary energy requirement for maintenance and gain in grow-finish pigs when compared to nursery pigs can also be attributed to the increase in the ability to ferment fiber with age and maturity in nonruminants.
It is noted that the method of claim 1 uses generically “a therapeutic clay” which also encompassed the bentonite therapeutic clay disclosed in paragraph [00127] of the instant specification that did not result in any improvements. Thus, the claimed method claiming generically “a therapeutic clay” encompassed therapeutic clays including bentonite that did not provide any improvements. Furthermore, the therapeutic clay was used at an amount of specifically 0.4 lb/ton, yet method claim 1 recites broadly a range of less than 1 lbs/ton, which encompassed 0.9 lb/ton and 0.01 lb/ton, amounts that were not shown or used in providing the alleged improvement results.
Thus, MPEP §716.02(d) states that [w]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support."
As a result, for at least reasons discussed above and preponderance of evidence, claims 1-3, 6, 9, 12, 21-33 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the standing 103 rejection as set forth in this office action.
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 1-3, 6, 9, 12, 21-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 37, 39, 56-57, 59-60, and 62-75 of copending Application No. 18212953 in view of Huckaba (WO 2017/173393 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the copending application ‘953 significant overlap with the subject matter of the instant claims i.e. methods of improving performance of an animal comprising orally administering to the animal a therapeutically effective amount of a clay mined in the Crater Lake region of the Cascade Mountains of Oregon, wherein the clay is incorporated in a feed composition.
While the instantly claimed methods are drawn to using the clay for improving performance that include increasing volatile fatty acid production, and the claims in the copending application ‘953 are drawn to improving growth performance, it would have been obvious to use the therapeutic clay of the copending application ‘953 to also increase volatile fatty acid production in the animal in view of the guidance from Huckaba, which teaches oral administration of the clay to an animal improves growth performance of the animal by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) (Huckaba: pages 2, 11-15, and 17; claims 1-3 and 5), as well as, Huckaba further establishes that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply and that the bioactive clay satisfy the nutrition requirements (Huckaba: page 27).
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending Application No. 18212953 in view of Huckaba.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 02/10/2026 have been fully considered but they are not persuasive.
Applicant argues “[t]he deficiencies of Hagen for upholding an obviousness rejection are described in Section II. above. Accordingly, the instant rejection that includes the teachings of Hagen can also not stand.” Thus, Applicant alleges “he Examiner has not established a prima facie case of obviousness over the claims of the '953 application in view of Hagen.” (Remarks, page 10).
In response, the Examiner disagrees. As discussed above in the pending double rejection, [w]hile the instantly claimed methods are drawn to using the clay for improving performance that include increasing volatile fatty acid production, and the claims in the copending application ‘953 are drawn to improving growth performance, it would have been obvious to use the therapeutic clay of the copending application ‘953 to also increase volatile fatty acid production in the animal in view of the guidance from Huckaba, which teaches oral administration of the clay to an animal improves growth performance of the animal by improving growth, weight gain, feed intake, feed conversion, feed efficiency, intestinal health, digesta pH, and one or more colon digesta organic acids (i.e., branched chain volatile fatty acids) (Huckaba: pages 2, 11-15, and 17; claims 1-3 and 5), as well as, Huckaba further establishes that increase in volatile fatty acid (VFA) production is a result from ruminal fermentation and such VFA provides for about 70% of a ruminant’s energy supply and that the bioactive clay satisfy the nutrition requirements (Huckaba: page 27).
Accordingly, for the at least the reason discussed above and in the absence of a terminal disclaimer, the provisional double patenting rejection of copending Application No. 18212953 is maintained because the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending Application No. 18212953 in view of Huckaba.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613