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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3-13 and 16, and the species of capsule in the reply filed on 9/15/2025 is acknowledged.
Claims 7, 11, 16 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/15/2025.
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 1-5, 8-10 and 12-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural composition of matter without significantly more.
Claim 1 recites a composition comprising sodium butyrate. Claim 3 states a property of the composition. Claim 4 is directed to a composition comprising sodium butyrate and vitamin D. Claim requires the composition to comprise a coating such as sugar. Claim 9 requires the composition to be in a carrier (which embraces water). Claims 10 and 12 recite a dietary supplement comprising the sodium butyrate.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a natural product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites a product of nature. In this case, the compositions are directed to composition comprising sodium butyrate along with water, vitamins and sugar , which are also natural products.
Thus, the claims do recite products of nature (sodium butyrate and also the additional ingredients such as water, sugar and vitamins). MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”. MPEP section 2106.04 (c-I-B) states “the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart…”.
These instantly claimed invention is drawn to a product of nature, namely the naturally occurring compounds sodium butyrate and vitamin D. Thus, the instantly claimed composition does not amount to an exception of the judicial exception because there is no evidence that the resultant mixture is “markedly different” from the naturally occurring components.
This judicial exception is not integrated into a practical application because there is no indication that the sodium butyrate, water, sugar and vitamin D as mention above used are markedly different from those occurring in nature and the placement of said ingredient(s) into composition or dietary supplement does not add a meaningful limitations and simply links the product of nature to a particular technological environment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. There is also no evidence that mixing sodium butyrate with water, sugar and/or vitamins changes the structure, function, or other properties of the sodium butyrate in any marked way in comparison with the closest naturally occurring counterpart.
Regarding claim 5, this claim simply links the product to a particular technological environment.
Regarding the claimed treatment or prevention of viral infections and instant claim 3, the judicial exception is not integrated into a practical application because either method steps of a physical manifestation of the administration of the composition are needed to show a practical application. The claims are drawn to a composition rather than method claims and composition claims do not demonstrate a physical manifestation of the administration of the composition. Therefore, the judicial exception is not integrated into a practical application. Furthermore, there is no evidence that sodium butyrate as found in nature would not have the claimed function. Altering the concentration of a particular component found in nature does not change its structure or function and does not make it markedly different.
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.
Claim 8 is 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.
Regarding claim 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 3-4, 10 and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McDermott (WO 2018/227146).
McDermott teaches administering to subjects a composition comprising 2000 IU Vitamin D3 and 300mg of sodium butyrate (pg.13).
Regarding claim 1: This claim recites “for use in … Rhinovirus.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner.
Regarding claim 3: Claim 3 states that the “composition stimulated… its replication,” this is a property of the claimed composition. The prior art anticipates the claimed composition, therefore, the composition claimed and the composition of the prior art would inherently have the same properties. Furthermore, the instant specification teaches the composition to comprise 100-300mg of sodium butyrate and 400-4000 IU of vitamin D, the composition of McDermott anticipates these ranges.
Regarding claim 4: The composition of McDermott comprises vitamin D3.
Regarding claim 10: Claim 10 requires the composition be provided as a dietary supplement. This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner.
Regarding claim 12: While McDermott does not teach the composition to be a dietary supplement, per MPEP 2111.02: If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In the instant case, The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner. Claim 12 also recites “recites “for prevention in … Rhinovirus.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner.
Regarding claim 13: The composition of McDermott comprises vitamin D3.
Claim(s) 1, 3, 5-6, 9-10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Borycka (WO 2008/091170).
Borycka discloses an oral preparation containing sodium butyrate protected in a triglyceride matrix at a concentration of 200-400mg/g (Abs).
Regarding claim 1: This claim recites “for use in … Rhinovirus.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner.
Regarding claim 3: Claim 3 states that the “composition stimulated… its replication,” this is a property of the claimed composition. The prior art anticipates the claimed composition, therefore, the composition claimed and the composition of the prior art would inherently have the same properties.
Regarding claim 5: Claim 5 is a recitation of intended use. Borycka teaches an oral preparation (i.e. via the mouth) and as such is capable of being administered via the mouth.
Regarding claim 6: Borycka teaches the oral formula to be in the form of tablets, granules of capsules (Abs).
Regarding claim 9: Borycka teaches the composition to comprise a triglyceride matrix, reading on acceptable carrier.
Regarding claim 10: Claim 10 requires the composition be provided as a dietary supplement. This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner.
Regarding claim 12: While Borycka does not teach the composition to be a dietary supplement, per MPEP 2111.02: If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In the instant case, The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner. Claim 12 also recites “recites “for prevention in … Rhinovirus.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner.
Claim(s) 1, 3, 5-6, 8-10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gawronska (WO 2020/060426). This reference is cited on the 9/29/2022 IDS.
Gawronska discloses an oral preparation in the form of a capsule comprising sodium butyrate and an inner retarding coating on the capsule (Abs).
Regarding claim 1: This claim recites “for use in … Rhinovirus.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner.
Regarding claim 3: Claim 3 states that the “composition stimulated… its replication,” this is a property of the claimed composition. The prior art anticipates the claimed composition, therefore, the composition claimed and the composition of the prior art would inherently have the same properties.
Regarding claim 5: Claim 5 is a recitation of intended use. Gawronska teaches an oral preparation (i.e. via the mouth) and as such is capable of being administered via the mouth.
Regarding claim 6: Gawronska teaches the oral formula to be in the a capsule (Abs).
Regarding claim 8: Gawronska teaches the composition (i.e. capsule) to have a coating.
Regarding claim 9: Gawronska teaches the composition to be a capsule which comprises sodium butyrate as a granulate with other ingredients, which reads on acceptable carrier (Abs).
Regarding claim 10: Claim 10 requires the composition be provided as a dietary supplement. This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner.
Regarding claim 12: While Gawronska does not teach the composition to be a dietary supplement, per MPEP 2111.02: If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In the instant case, The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner. Claim 12 also recites “recites “for prevention in … Rhinovirus.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art anticipates the claimed composition, therefore, the composition claimed would inherently be capable of being used in the claimed manner.
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, 5-6, 8-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bacopoulos (WO 2005/023179).
Bacopoulos discloses a method of treating cancer by administration of SAHA and an anti-cancer agent, HDAC inhibitor, which can be sodium butyrate, selected from a finite number of options (Bacopoulos – claims 1, 3 and 7). Bacopoulos teaches the HDAC inhibitor to be used in amounts of up to 800mg, preferably orally (pg. 12).
Regarding claim 1: This claim recites “for use in … Rhinovirus.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art makes obvious the claimed composition, therefore, the composition claimed would be expected be capable of being used in the claimed manner.
Regarding claim 3: Claim 3 states that the “composition stimulated… its replication,” this is a property of the claimed composition. The prior art makes obvious the claimed composition, therefore, the composition claimed and the composition of the prior art would be expected have the same properties. Furthermore, the instant specification teaches the composition to comprise 100-300mg of sodium and the composition of Bacopoulos makes obvious these ranges.
Regarding claim 5: Claim 5 is a recitation of intended use. Bacopoulos teaches an oral preparation (i.e. via the mouth) and as such is capable of being administered via the mouth.
Regarding claim 6: Bacopoulos teaches the oral formula to be in the a capsule (pg. 12).
Regarding claim 8: Bacopoulos teaches that suitable carriers include liposomes, oils, solid carriers (pg. 76-77).
Regarding claim 9: Bacopoulos teaches that coating can be added to the composition (pg. 78).
Regarding claim 10: Claim 10 requires the composition be provided as a dietary supplement. This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art anticipates the claimed composition, therefore, the composition claimed would be expected to be capable of being used in the claimed manner.
Regarding claim 12: While Bacopoulos does not teach the composition to be a dietary supplement, per MPEP 2111.02: If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In the instant case, The prior art makes obvious the claimed composition, therefore, the composition claimed would be expected be capable of being used in the claimed manner.
Claim 12 also recites “recites “for prevention in … Rhinovirus.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The prior art makes obvious the claimed composition, therefore, the composition claimed would be expected be capable of being used in the claimed manner.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613