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 .
DETAILED ACTION
Claims 1-4, 11, 15, 17-20, 22-27, 30, 32, 35, and 37 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, 11, 15, 17-20, 22, 35, and 37, and species SEQ ID NOs: 2754, 2108 and 2067, livestock feed, solid, powder, and food in the reply filed on 05/19/2026 is acknowledged. Claims 23-27, 30, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 03/12/2024, 10/21/2024, and 05/19/2026 are acknowledged and have been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. The size of the XML file should be in bytes and not megabyte (MB)
Required response - Applicant must: Amend the disclosure to state the size of the file in bytes, 2181476 bytes.
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 11, 15, 17-20, 22-27, 30, 32, 35, and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-4, 35, and 37 recite bacteria comprises a 16S nucleic acid sequence selected from the recites SEQ ID NOs. Elected species SEQ ID NOs 2754 and 2067 consist of 225 nucleotides. A complete sequence of 16S rDNA is naturally about 1,500 nucleotides long across all known bacteria as reported by Clarridge (Clinical microbiology reviews 17.4 (2004): 840-862) (page 842 left column para.2). It is unclear if SEQ ID NOs 2754 and 2067 represent the whole 16S nucleic acid sequence of the claimed bacterium or a part of the whole 16S rDNA sequence. It is unclear if the claim requires the 16S rDNA sequence be to limited to the recited SEQ ID NOs.
Claims 11, 15, 17-19, and 22 do not cure the indefiniteness and are also rejected.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 37 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 is not a proper dependent claim because it fails to further limit the subject matter of the base claim from which it depends. Claim 1 already requires one or more bacteria comprising a 16S nucleic acid sequence with at least 97%, at least 98%, or at least 99% sequence identity to SEQ ID NOs 4104, 4116, 4364, 4620, 4814, 4828, 4921, 4943, 4944, and 4945.
Claim 37 is not a proper dependent claim because it fails to include all the limitations of claim 35 from which it depends. Claim 35 recites SEQ ID NOs which are not required in claim 35. Applicant may consider amending the claim to recite “further comprises” and to delete the SEQ ID NOs already recited in claim 35.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 11, 15, 17-20, 22, 35, and 37 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception of laws of nature, natural phenomena, and products of nature (a nature-based product) without significantly more.
Claims 1-4, 11, 15, 17-20, 22, 35, and 37 recite a composition (Step 1: YES) comprising one or more bacteria comprising a 16S nucleic acid sequence with at least 97%, at least 98%, or at least 99% sequence identity to any one of SEQ ID NOs: 2125-4945. Applicant discloses the bacteria are obtained from the gastrointestinal tract of cows ([0155]) (i.e., natural product) and a carrier suitable for ruminant administration. Applicant discloses that water is a suitable carrier (natural product). Claim 15 recites the composition is combined with cereal, starch, oilseed cake, vegetable waste, hay, haylage, silage, livestock feed, forage, fodder, beans, grains, micro-ingredients, fermentation compositions, or mixed ration (natural products). Claim 18 recites the composition is formulated as pellet, capsule, granulate, or powder (natural product). Claim 19 recites the composition is combined with food, water, medicine, vaccine, vitamin, mineral, amino acid, or enzyme (natural products). There is no markedly different characteristic of the recited products compared to their naturally occurring counterpart in their natural state (same structure or form, same biological and chemical properties), and combining them into the recited composition does not change any of their natural characteristics individually or in combination. Solid, liquid, pellet, capsule, powder and granule forms are all natural physical states of bacteria and do not impart any markedly different characteristics from any counterpart found in nature. The claimed product lacks markedly different characteristics and is a product of nature (Step 2A prong 1: YES). This judicial exception is not integrated into a practical application because formulating these natural products into a food or feed additive by simply mixing multiple naturally-occurring components is nothing more than an attempt to generally link the product of nature to a particular technological environment (Step 2A prong 2: NO). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B: NO).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 11, 15, 17-20, 22, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Embree (US 2018/0310592 A1, of record in IDS filed on 03/12/2024).
Regarding claims 1-4, 11, 15, 17-20, 22, and 35, Embree teaches a composition used for increased milk yield, improved milk compositional characteristics, improved rumen health, and/or modulation of the rumen microbiome and administered orally (Abstract, [0037], [0207]). Embree teaches the composition comprising a carrier suitable for ruminant administration and one or more bacteria comprising a 16S nucleic acid sequence at least 97% identical to SEQ ID NO: 1082 (claim 1). Alignment of SEQ ID NO 1082 and instant SEQ ID NO 2754 shows a 99.3% sequence identity (See Appendix A page 1). Embree teaches that the composition is encapsulated to minimizing the oxidative stresses and external stressors prior to entering the gastrointestinal tract of beef cattle ([0289]), that it is mixed with animal feed and is present in various forms such as pellets, capsules, granulated, powdered, mash, liquid, semiliquid ([0340]). Embree teaches that the bacteria are present in the composition in an amount of at least 102 cells ([0354]). Embree teaches that the composition comprises bacteria comprising a 16S nucleic acid sequence that is at least about 97% identical to any one of SEQ ID NO:1-5993 (claim 1). SEQ ID NO: 2510 is 100% identical to instant SEQ ID NO: 4943.
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.
Claims 1, 3-4, 11, 15, 17-20, 22, 35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Mallory (US 2023/0139325 A1) in view of Embree (US 2018/0310592 A1, of record in IDS filed on 03/12/2024).
For clarity of record, US 2023/0139325 A1 is a prior art because it has an earlier
effective filing date than instant application (US provisional filed on 03/31/2020) and names other inventors “Jordan EMBREE” and “Sean GILMORE” (i.e., a different inventive entity).
Regarding claims 1, 3-4, 11, 15, 17-20, 22, 35, and 37, Mallory teaches a composition comprising microorganisms used for modulating the production and yield of milk and milk components in ruminants (Abstract). Mallory teaches the composition comprises Ruminococcus bovis comprising a 16S nucleic acid sequence of SEQ ID NO: 2108, a Butyrivibrio sp. comprising a 16S nucleic acid sequence sharing at least about 97% sequence identity to SEQ ID NO: 2067, and a carrier suitable for oral ruminant administration ([0009]). Mallory teaches that the composition is formulated to protect the bacteria from oxidative stress, from external stressors prior to entering the gastrointestinal tract of the ruminant, and from moisture ([0018]). Mallory teaches that the composition is combined with livestock feed ([0019]), is formulated as a solid, liquid, or mixture thereof, and is formulated as a pellet, capsule, granulate, or powder ([0020]). Mallory teaches the bacteria are present in the composition in an amount of at least 102 cells ([0022]). Mallory does not teach composition comprises bacterium comprising a 16S nucleic acid sequence with at least 97% sequence identity to SEQ ID NO: 2754.
However, Embree teaches a composition used for increased milk yield, improved milk compositional characteristics, improved rumen health, and/or modulation of the rumen microbiome and administered orally (Abstract, [0037], [0207]). Embree teaches the composition comprising a carrier suitable for ruminant administration and one or more bacteria comprising a 16S nucleic acid sequence at least 97% identical to SEQ ID NO 1082 (claim 1). Alignment of SEQ ID NO 1082 and instant SEQ ID NO 2754 shows a 99.3% sequence identity (See Appendix A page 1). Embree teaches that the composition is encapsulated to minimizing the oxidative stresses and external stressors prior to entering the gastrointestinal tract of beef cattle ([0289]), that it is mixed with animal feed and is present in various forms such as pellets, capsules, granulated, powdered, mash, liquid, semiliquid ([0340]). Embree teaches that bacteria are present in the composition in an amount of at least 102 cells ([0354]).
MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In the instant case, the Examiner submits that one of ordinary skill in the art would be motivated to do so in order to form a composition used to increase milk yield, improve milk compositional characteristics, improve rumen health, and/or modulate the rumen microbiome, as suggested by Mallory and Embree.
Claims 1, 3, 11, 15, 17-20, 22, 35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Embree (US 2018/0310592 A1, of record in IDS filed on 03/12/2024) in view of MK761171 (of record in IDS), as evidenced by Appendix A.
Regarding claims 1, 3, 11, 15, 17-20, 22, 35, and 37, Embree teaches a composition used for increased milk yield, improved milk compositional characteristics, improved rumen health, and/or modulation of the rumen microbiome and administered orally (Abstract, [0037], [0207]). Embree teaches the composition comprising a carrier suitable for ruminant administration and one or more bacteria comprising a 16S nucleic acid sequence at least 97% identical to SEQ ID NO 1082 (claim 1). Alignment of SEQ ID NO 1082 and instant SEQ ID NO 2754 shows a 99.3% sequence identity (See Appendix A page 1). Embree teaches that the composition is encapsulated to minimizing the oxidative stresses and external stressors prior to entering the gastrointestinal tract of beef cattle ([0289]), that it is mixed with animal feed and is present in various forms such as pellets, capsules, granulated, powdered, mash, liquid, semiliquid ([0340]). Embree teaches that bacteria are present in the composition in an amount of at least 102 cells ([0354]). Embree teaches that the composition comprises bacteria genus Ruminococcus and that these bacteria are fiber-degrading ([0143], [0468]). Embree does not teach SEQ ID NO: 2108.
However, MK761171 teaches a Ruminococcus bovis strain isolated from rumen content and has a 16S rDNA sequence 100% identical to instant SEQ ID NO 2108 (whole document, See alignment in Appendix A pages 2-3).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Embree by adding the strain taught by MK761171. One of ordinary skill in the art would be motivated to do so in order to form a composition with probiotics native to rumen and are capable of degrading fiber. MPEP 2144.06 II states it is obvious to substitute equivalents know for the same purpose. Since Embree teaches a desire to form a composition comprising fiber-degrading bacteria of the genus Ruminococcus and since MK761171 teaches an isolated and sequenced strain of Ruminococcus bovis strain isolated from rumen, there is a reasonable expectation of success.
Claims 1, 4, 11, 15, 17-20, 22, 35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Embree (US 2018/0310592 A1, of record in IDS filed on 03/12/2024) in view of USPN 9,993,507 (of record in IDS).
Regarding claims 1, 4, 11, 15, 17-20, 22, 35, and 37, Embree teaches a composition used for increased milk yield, improved milk compositional characteristics, improved rumen health, and/or modulation of the rumen microbiome and administered orally (Abstract, [0037], [0207]). Embree teaches the composition comprising a carrier suitable for ruminant administration and one or more bacteria comprising a 16S nucleic acid sequence at least 97% identical to SEQ ID NO 1082 (claim 1). Alignment of SEQ ID NO 1082 and instant SEQ ID NO 2754 shows a 99.3% sequence identity (See Appendix A page 1). Embree teaches that the composition is encapsulated to minimizing the oxidative stresses and external stressors prior to entering the gastrointestinal tract of beef cattle ([0289]), that it is mixed with animal feed and is present in various forms such as pellets, capsules, granulated, powdered, mash, liquid, semiliquid ([0340]). Embree teaches that bacteria are present in the composition in an amount of at least 102 cells ([0354]). Embree does not teach bacteria comprising a 16S nucleic acid sequence of SEQ ID NO: 2067.
However, USPN 9,993,507 teaches a composition comprising bacteria used for modulating the production and yield of milk and milk components in ruminants and teaches the composition comprises bacteria with SEQ ID NO: 2067 (Abstract, column 84 line 34).
MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In the instant case, the Examiner submits that one of ordinary skill in the art would be motivated to do so in order to form a composition used for modulating the production and yield of milk and milk components in ruminants.
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, 3-4, 11, 15, 17-22, 35 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 6 of U.S. Patent No. 9,993,507 in view of Embree (US 2018/0310592 A1) as evidenced by Appendix A.
Regarding instant claims 1, 3-4, 11, 15, 17-22, 35 and 37, patent claim 1 recites orally administering to a ruminant an effective amount of a ruminant supplement comprising: a purified microbial population that comprises a bacteria with a 16S nucleic acid sequence and/or a fungi with an ITS nucleic acid sequence, which is selected from the group consisting of: SEQ ID NOs: 1-60 and 2045-2107; and a carrier suitable for ruminant administration (i.e., comprising instant SEQ ID NOs 1-30 and 2045-2103). Patent claim 3 recites the ruminant supplement is formulated as an: encapsulation, tablet, capsule, pill, feed additive, food ingredient, food additive, food preparation, food supplement, consumable solution, consumable spray additive, consumable solid. Patent claim 6 recites the purified microbial population is present in the ruminant supplement in an amount of at least 102 cell. Patent claim 1 does not recite 16S nucleic acid sequence with at least 97% sequence identity to SEQ ID NO: 2754.
However, Embree teaches a composition used for increased milk yield, improved milk compositional characteristics, improved rumen health, and/or modulation of the rumen microbiome and administered orally (Abstract, [0037], [0207]). Embree teaches the composition comprising a carrier suitable for ruminant administration and one or more bacteria comprising a 16S nucleic acid sequence at least 97% identical to SEQ ID NO 1082 (claim 1). Alignment of SEQ ID NO 1082 and instant SEQ ID NO 2754 shows a 99.3% sequence identity (See Appendix A page 1). Embree teaches that the composition is encapsulated to minimizing the oxidative stresses and external stressors prior to entering the gastrointestinal tract of beef cattle ([0289]), that it is mixed with animal feed and is present in various forms such as pellets, capsules, granulated, powdered, mash, liquid, semiliquid ([0340]). Embree teaches that the bacteria are present in the composition in an amount of at least 102 cells ([0354]).
MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In the instant case, the Examiner submits that one of ordinary skill in the art would be motivated to do modify the composition recited in patent claims 1, 3, and 6 in order to form a composition used to increase milk yield, improve milk compositional characteristics, improve rumen health, and/or modulate the rumen microbiome, as suggested by Embree.
Claims 1, 11, 15, 17-22, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16-17, and 19 of U.S. Patent No. 11,871,767 in view of Embree (US 2018/0310592 A1) as evidenced by Appendix A.
Regarding instant claims 1, 11, 15, 17-22, and 35, patent claim 1 recites a method for improving one or more desirable traits in a ruminant, the method comprising administering to the ruminant an effective amount of a microbial composition comprising: a purified population of bacteria comprising a 16S nucleic acid sequence that shares at least 97% sequence identity to SEQ ID NO: 75; and a carrier suitable for ruminant administration. Patent claim 16 recites the microbial composition is a tablet, a capsule, a pill, a feed additive, a powder, a food ingredient, a food preparation, a food supplement, a water additive, a thermostable-additive, a moisture resistant additive, a pre-pelleted feed additive, a pelleted feed additive, a post-pelleting-applied feed additive, a solution. Patent claim 17 recites bacteria are encapsulated. Patent claim 19 recites the bacteria comprise at least 102 cells. Patent claim 1 does not recite 16S nucleic acid sequence with at least 97% sequence identity to SEQ ID NO: 2754.
However, Embree teaches a composition used for increased milk yield, improved milk compositional characteristics, improved rumen health, and/or modulation of the rumen microbiome and administered orally (Abstract, [0037], [0207]). Embree teaches the composition comprising a carrier suitable for ruminant administration and one or more bacteria comprising a 16S nucleic acid sequence at least 97% identical to SEQ ID NO 1082 (claim 1). Alignment of SEQ ID NO 1082 and instant SEQ ID NO 2754 shows a 99.3% sequence identity (See Appendix A page 1). Embree teaches that the composition is encapsulated to minimizing the oxidative stresses and external stressors prior to entering the gastrointestinal tract of beef cattle ([0289]), that it is mixed with animal feed and is present in various forms such as pellets, capsules, granulated, powdered, mash, liquid, semiliquid ([0340]). Embree teaches that the bacteria are present in the composition in an amount of at least 102 cells ([0354]).
MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In the instant case, the Examiner submits that one of ordinary skill in the art would be motivated to do modify the composition recited in patent claims 1, 3, and 6 in order to form a composition used to increase milk yield, improve milk compositional characteristics, improve rumen health, and/or modulate the rumen microbiome, as suggested by Embree.
Claims 1, 11, 15, 17-22, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,398,154 in view of Embree (US 2018/0310592 A1) as evidenced by Appendix A.
Regarding instant claims 1, 11, 15, 17-22, and 35, patent claim 1 recites a method for increasing milk production or improving milk compositional characteristics in a ruminant, the method comprising: feeding a ruminant a feed composition comprising: a ruminant feed, a Pichia kudriavzevii, and a Clostridium butyricum. Patent claim 1 does not recite 16S nucleic acid sequence with at least 97% sequence identity to SEQ ID NO: 2754.
However, Embree teaches a composition used for increased milk yield, improved milk compositional characteristics, improved rumen health, and/or modulation of the rumen microbiome and administered orally (Abstract, [0037], [0207]). Embree teaches the composition comprising a carrier suitable for ruminant administration and one or more bacteria comprising a 16S nucleic acid sequence at least 97% identical to SEQ ID NO 1082 (claim 1). Alignment of SEQ ID NO 1082 and instant SEQ ID NO 2754 shows a 99.3% sequence identity (See Appendix A page 1). Embree teaches that the composition is encapsulated to minimizing the oxidative stresses and external stressors prior to entering the gastrointestinal tract of beef cattle ([0289]), that it is mixed with animal feed and is present in various forms such as pellets, capsules, granulated, powdered, mash, liquid, semiliquid ([0340]). Embree teaches that the bacteria are present in the composition in an amount of at least 102 cells ([0354]).
MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In the instant case, the Examiner submits that one of ordinary skill in the art would be motivated to do modify the composition recited in patent claims 1, 3, and 6 in order to form a composition used to increase milk yield, improve milk compositional characteristics, improve rumen health, and/or modulate the rumen microbiome, as suggested by Embree.
Claims 1, 3-4, 11, 15, 17-22, 35 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 10,293,006 in view of Embree (US 2018/0310592 A1) as evidenced by Appendix A.
Regarding instant claims 1, 3-4, 11, 15, 17-22, 35, and 37, patent claim 1 recites a ruminant supplement capable of increasing milk production or improving milk compositional characteristics in a ruminant, comprising: a purified population of vitrified Pichia fungi comprising fungi with an ITS nucleic acid sequence comprising SEQ ID NO: 32 (i.e., 100% identical to instant SEQ ID NO: 32) and a carrier suitable for ruminant administration. Patent claim 3 recites the ruminant supplement further comprising: a purified population of bacteria that comprises bacteria with a 16S nucleic acid sequence selected from the group consisting of: SEQ ID NOs: 1-30 and 2045-2103 (i.e., 100% identical to instant SEQ ID NOs 1-30 and 2045-2103). Patent claim 1 does not recite 16S nucleic acid sequence with at least 97% sequence identity to SEQ ID NO: 2754.
However, Embree teaches a composition used for increased milk yield, improved milk compositional characteristics, improved rumen health, and/or modulation of the rumen microbiome and administered orally (Abstract, [0037], [0207]). Embree teaches the composition comprising a carrier suitable for ruminant administration and one or more bacteria comprising a 16S nucleic acid sequence at least 97% identical to SEQ ID NO 1082 (claim 1). Alignment of SEQ ID NO 1082 and instant SEQ ID NO 2754 shows a 99.3% sequence identity (See Appendix A page 1). Embree teaches that the composition is encapsulated to minimizing the oxidative stresses and external stressors prior to entering the gastrointestinal tract of beef cattle ([0289]), that it is mixed with animal feed and is present in various forms such as pellets, capsules, granulated, powdered, mash, liquid, semiliquid ([0340]). Embree teaches that the bacteria are present in the composition in an amount of at least 102 cells ([0354]).
MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In the instant case, the Examiner submits that one of ordinary skill in the art would be motivated to do modify the composition recited in patent claims 1, 3, and 6 in order to form a composition used to increase milk yield, improve milk compositional characteristics, improve rumen health, and/or modulate the rumen microbiome, as suggested by Embree.
Conclusion
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/MARY A CRUM/ Examiner, Art Unit 1657
/THANE UNDERDAHL/ Primary Examiner, Art Unit 1699
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