FINAL 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted 04/02/2026 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to papers filed 06/24/2026 in which claims 2, 4-8, 10-11, 13-20, and 29-31 were canceled; claims 1 and 9 were amended; and claims 34-39 were newly added. All the amendments have been thoroughly reviewed and entered.
Claims 1, 3, 9, 12, 21-28 and 32-39 are under examination.
New Rejection
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 34-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 34-38 introduce new matter as the claims recite the following limitations:
“the increase in relative abundance of Bifidobacterium in the grow-finish pig is at least 10%” (claim 34)
“the increase in relative abundance of Bifidobacterium in the grow-finish pig is at least 50%” (claim 35)
“the increase in relative abundance of Bifidobacterium in the grow-finish pig is at least 100%” (claim 36)
“the increase in relative abundance of Bifidobacterium in the grow-finish pig is at least 200%” (claim 37)
“the increase in relative abundance of Bifidobacterium in the grow-finish pig is at least 300%” (claim 38)
There is no support in the specification for the aforementioned limitations.
Applicant asserted that the support for the amendments can be found in “FIG.2 of the specification as filed, which shows the changes of microflora abundance in finishing pigs fed a control or a clay. The pigs fed the clay exhibited an increase of 362% of Bifidobacterium compared to pigs fed to control.” (Remarks filed 06/24/2026, page 7, 2nd paragraph).
However, after a thorough review of FIG.2, as well as, throughout the specification, there appears to be no support or disclosure for the increase in relative abundance relative abundance of Bifidobacterium in the grow-finish pig to be in the broad ranges of “at least 10,” “at least 50,” “at least 100,” “at least 200,” and “at least 300,” respectively, of claims 34-38. While Applicant has possession of an increase of 362% of Bifidobacterium, as shown in FIG.2, Applicant does not have possession for the increase in relative abundance relative abundance of Bifidobacterium in the grow-finish pig to be in the broad ranges of “at least 10,” “at least 50,” “at least 100,” “at least 200,” and “at least 300,” respectively, of claims 34-38. There is no support for any said ranges in FIG.2 or anywhere in the specification.
As such, the disclosure does not reasonably convey that the inventor had possession of the subject matter of claims 34-38 as amended at the time of filing of the instant application.
Modified Rejections
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, 9, 12, 21-28 and 32-39 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 Subramaniam et al (Journal of Animal Science and Biotechnology, 2015, 6(38): 1-9), 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 a pig comprising orally administering a therapeutically effective amount of an antimicrobial clay to the pig. 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 pig ([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 pig 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.
With respect to “the method provides an increased relative abundance of Bifidobacterium in the intestine of the grow-finish pig” as recited in claim 1, it would have been obvious that the improvement in performance using the antimicrobial (bioactive) clay of Hagen and Huckaba would also provide an increased relative abundance of Bifidobacterium in the intestine of the pig. 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 well-established in the art in view of Subramaniam, the antimicrobial (bioactive) clay of Hagen and Huckaba when fed to pigs not only improve in the performance of the pigs including improving weigh gain, feed conversion, and increase in nutrient digestibility, but also reducing the incidence, severity and duration of diarrhea in pigs due to increases in the numbers of Bifidobacteria and Lactobacillus and decreases in the numbers of Clostridium and E. Coli in the small intestine of the pigs (Subramaniam: Abstract; Introduction; pages 1-9).
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 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 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 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.
Regarding claims 34-38, as discussed above, it would have been obvious that the improvement in performance using the antimicrobial (bioactive) clay of Hagen and Huckaba would also provide an increased relative abundance of Bifidobacterium in the intestine of the pig. This is because Hagen and Huckaba used the structurally 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 well-established in the art in view of Subramaniam, the antimicrobial (bioactive) clay of Hagen and Huckaba when fed to pigs not only improve in the performance of the pigs including improving weigh gain, feed conversion, and increase in nutrient digestibility, but also reducing the incidence, severity and duration of diarrhea in pigs due to increases in the numbers of Bifidobacteria and Lactobacillus and decreases in the numbers of Clostridium and E. Coli in the small intestine of the pigs (Subramaniam: Abstract; Introduction; pages 1-9). Thus, the increase in relative abundance relative abundance of Bifidobacterium in the grow-finish pig of “at least 10,” “at least 50,” “at least 100,” “at least 200,” and “at least 300,” as respectively recited in claims 34-38 would have been implicit results from administration of the structurally same therapeutic clay of Hagen and Huckaba to grow-finish pig, as Subramaniam had established supra that the clay of Hagen, Huckaba, and the claimed invention reduces the incidence, severity and duration of diarrhea in pigs due to increase in the numbers of Bifidobacteria and Lactobacillus and decrease in the numbers of Clostridium and E. Coli in the small intestine of the pigs.
Regarding claim 39, Hagen and Huckaba teach that vitamin, mineral, amino acid, antioxidant, probiotic, essential fatty acid or a combination there of as a dietary supplement can be further administered to the pig (Hagen: [0118]-[0151]; Huckaba: pages 15-17 and 23).
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 06/24/2026 have been fully considered but they are not persuasive.
Applicant argues that “[t]he combined teachings of Hagen and Huckaba do not teach or suggest administration of an antimicrobial clay whereby the antimicrobial clay provides an increased relative abundance of Bifidobacterium in the intestines of the grow-finish pig.” Thus, Applicant alleges that “there is no suggestion or motivation from the combined teachings of Hagen and Huckaba that would lead a person of ordinary skill with the requisite reasonable expectation of success to believe that administering a therapeutic clay would provide an increased abundance of Bifidobacterium in a grow-finish pig.” (Remarks, pages 8-12).
In response, the Examiner disagrees. As discussed in the standing 103 rejection, it would have been obvious that the improvement in performance using the antimicrobial (bioactive) clay of Hagen and Huckaba would also provide an increased relative abundance of Bifidobacterium in the intestine of the pig. 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 well-established in the art in view of Subramaniam, the antimicrobial (bioactive) clay of Hagen and Huckaba when fed to pigs not only improve in the performance of the pigs including improving weigh gain, feed conversion, and increase in nutrient digestibility, but also reducing the incidence, severity and duration of diarrhea in pigs due to increases in the numbers of Bifidobacteria and Lactobacillus and decreases in the numbers of Clostridium and E. Coli in the small intestine of the pigs (Subramaniam: Abstract; Introduction; pages 1-9). Thus, the combined teachings of Hagen, Huckaba, and Subramaniam would indeed lead a person of ordinary skill with the requisite reasonable expectation of success that the administration a therapeutic clay would provide an increased abundance of Bifidobacterium in a grow-finish pig, as it is established above by Subramaniam, the antimicrobial (bioactive) clay of Hagen and Huckaba, which is structurally the same as the therapeutic clay of the claimed invention, when fed to pigs reduces the incidence, severity and duration of diarrhea in pigs due to increase in the numbers of Bifidobacteria and Lactobacillus and decrease in the numbers of Clostridium and E. Coli in the small intestine of the pigs. Accordingly, obviousness of the claimed method have been adequately established by the combined teachings of combined teachings of Hagen, Huckaba, and Subramaniam.
Applicant argues that FIG. 2 from the specification demonstrated significant data demonstrating an increase in beneficial microflora in finishing pigs. Applicant alleged that “the Bifidobacterium enrichment observed in FIG. 2 cannot be attributed to a reduction in competing pathogenic bacteria as it represents an independent, beneficial effect on the intestinal microbiome absent from the teachings of Hagen and Huckaba.” Thus, Applicant alleges that “evidence in the specification as filed indicates that the therapeutic clay is acting in a significant, unanticipated manner to modulate the fecal microflora and increase the abundance of Bifidobacteria.” (Remarks, pages 12-13).
In response, the examiner disagrees. Applicant’s alleged unexpected results shown in FIG.2 of the specification are considered but found insufficient to obviate the standing 103 rejection over the combined teachings of Hagen, Huckaba, and Subramaniam for the reasons set forth below.
As discussed above, it would have been obvious that the improvement in performance using the antimicrobial (bioactive) clay of Hagen and Huckaba would also provide an increased relative abundance of Bifidobacterium in the intestine of the pig. 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 well-established in the art in view of Subramaniam, the antimicrobial (bioactive) clay of Hagen and Huckaba when fed to pigs not only improve in the performance of the pigs including improving weigh gain, feed conversion, and increase in nutrient digestibility, but also reducing the incidence, severity and duration of diarrhea in pigs due to increases in the numbers of Bifidobacteria and Lactobacillus and decreases in the numbers of Clostridium and E. Coli in the small intestine of the pigs (Subramaniam: Abstract; Introduction; pages 1-9). Thus, the combined teachings of Hagen, Huckaba, and Subramaniam would indeed lead a person of ordinary skill with the requisite reasonable expectation of success that the administration a therapeutic clay would provide an increased abundance of Bifidobacterium in a grow-finish pig, as it is established above by Subramaniam, the antimicrobial (bioactive) clay of Hagen and Huckaba, which is structurally the same as the therapeutic clay of the claimed invention, when fed to pigs reduces the incidence, severity and duration of diarrhea in pigs due to increase in the numbers of Bifidobacteria and Lactobacillus and decrease in the numbers of Clostridium and E. Coli in the small intestine of the pigs. Furthermore, it is noted that Hagen also disclosed that the antimicrobial clay significantly reduced the frequency of diarrhea when fed to the pigs (Subramaniam: Abstract; Introduction; pages 1-9). This is preponderance of evidence to support the Examiner’s obviousness analysis based on the combined teachings of Hagen, Huckaba, and Subramaniam. Thus, Applicant’s alleged unexpected results drawn to increase in the abundance of Bifidobacteria appeared to be not unexpected, but rather reasonably expected results when the structurally same clay of Hagen and Huckaba to that of the claimed invention is administered to the grow-finish, as established by Subramaniam supra. It is noted that [e]xpected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).
Furthermore, claim 1 is not commensurate in scope with the results shown in Example 4 and FIG.2 drawn to increase in relative abundance of Bifidobacterium of 362% in the grow-finish pig. 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, 9, 12, 21-28 and 32-39 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, 9, 12, 21-28 and 32-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 37, 39, 56, 59-60, 62-65, 69-72 and 76-71 of copending Application No. 18212953 in view of Subramaniam et al (Journal of Animal Science and Biotechnology, 2015, 6(38): 1-9).
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 also providing an increased relative abundance of Bifidobacterium in the intestines, 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 provide an increased relative abundance of Bifidobacterium in the intestines of the animal in view of the guidance from Subramaniam, which Subramaniam establishes that the clay used in the instant claims and that of copending application ‘953 when fed to pigs not only improve in the performance of the pigs including improving weigh gain, feed conversion, and increase in nutrient digestibility, but also reducing the incidence, severity and duration of diarrhea in pigs due to increases in the numbers of Bifidobacteria and Lactobacillus and decreases in the numbers of Clostridium and E. Coli in the small intestine of the pigs (Subramaniam: Abstract; Introduction; pages 1-9).
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 Subramaniam.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 06/24/2026 have been fully considered but they are not persuasive.
Applicant argues that “the Examiner has not established a prima facie case of obviousness over the claims of the '953 Application in view of Huckaba.” (Remarks, page 14).
In response, the Examiner disagrees. As discussed above in the standing double patenting rejection, a prima facie case of obviousness over the claims of the '953 Application has been adequately established by the Examiner in view of Subramaniam. See double patenting rejection, pages 22-23 of this office action, said pages being incorporated herein in its entirety. Thus, pending filing of a terminal disclaimer, it is maintained that the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending Application No. 18212953 in view of Subramaniam.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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