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 .
This office action is in response to the reply filed 5/19/2026.
Election/Restrictions
Claims 7, 11, 16 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim.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.
Response to Arguments
All of Applicant’s arguments filed 5/19/2026 have been fully considered.
101 Rejection
Applicant remarks that the claimed combination has markedly distinct characteristics from any naturally occurring counterparts and argues that the specification discloses that the claimed composition is advantageous to some individuals.
This is not persuasive as it is unsupported by factual data commensurate in scope with the instant claims.
Applicant remarks that tablets and capsules are examples of the “solid oral dosage form” as amended and should render the claim eligible for the same reasons as tablets and capsules.
This is not persuasive, as tablets and capsules tend to provide longer absorption time, however, solid dosage form also embraces powders and mixtures of sodium butyrate and vitamin D3 as powders would not be expected to result in a materially distinct characteristics unlike tablets and capsule which alter the absorption time of the naturally occurring counterpart.
112 Rejection
In view of the amendments to claim 8 removing the “such as” language, the rejection has been withdrawn.
102 and 103 Rejections
In view of the amendments to the claims, all 102 and 103 rejection presented in the office action mailed 11/20/2025 have been withdrawn and a new rejection is presented below.
Maintained 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, 3 and 8-10 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 and vitamin D. Claim 3 states a property of the composition. Claim 8 requires the composition to comprise a coating such as sugar. Claim 9 requires the composition to be in a carrier (which embraces water). Claim 10 recites 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 the claimed oral dosage form, this claim simply links the product to a particular technological environment and there is also no evidence that formulating the composition as a solid oral dosage form such as a powder amounts to significantly more than the judicial exception.
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.
New Claim Rejections - 35 USC § 112
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 1, 3 and 6-7 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. Claim 1 recites “therapeutically effective amounts of sodium butyrate” the specification as originally filed does not provide support for the generically claimed “therapeutically effective amounts”. There is sufficient support for a range of 100-300 or 2000mg sodium butyrate, but there is no support for amounts outside of those listed which maybe therapeutically effective for the claimed purpose.
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 6 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDermott (WO 2018/227146).
Regarding claim 1: McDermott teaches administering to subjects a composition comprising Vitamin D3 and 300mg of sodium butyrate (pg.13) and teaches varying and using quantities of Vitamin D3 (1000 IU, 2000 IU and 4000 IU) (pg. 12 and 2). McDermott teaches the composition can be formulated in solid dosage forms including tablets and capsules (pg. 11). It would have been prima facie obvious to formulate a tablet or capsule composition comprising 1000IU (i.e. 25 micrograms) of Vitamin D3 and 300 mg of sodium butyrate with a reasonable expectation of success.
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 instant specification teaches the composition to comprise 100-300mg of sodium butyrate and 400-4000 IU of vitamin D and the composition of McDermott makes obvious these ranges, therefore, the composition claimed would be expected to 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 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 makes obvious these ranges.
Regarding claims 6 and 9: McDermott teaches the composition can be formulated in solid dosage forms including tablets and capsules, these can include excipients such as starch, gelatin, sucrose, calcium carbonate (pg. 11), 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 makes obvious the claimed composition, therefore, the composition claimed would be expected to be capable of being used in the claimed manner.
Claim(s) 1, 3, 6, 8, and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDermott (WO 2018/227146), as applied to claims 1, 3, 6 and 9-10 above, and further in view of Clark (US 2005/0271724).
As discussed above, McDermott makes obvious the limitations of claims 1, 3, 6 and 9-10, but does not teach the dosage form to be coated with a sugar as recited by instant claim 8.
McDermott teaches that the composition can be formulated as controlled release, sustained release or immediate release formulations (pg. 11).
Clark teaches compositions useful as coatings for solid dosage forms of therapeutic agents and solid dosage forms comprising such coatings. The coating compositions generally provide excellent strength and resistance to cracking, even when applied to flexible/swellable tablet cores such as hydrogel-type cores. The compositions also exhibit excellent odor-blocking characteristics (Abs). The coating is taught to comprise a sugar (Clark – claim 1). Clark teaches that the sugar coating and tablet core can be designed to release their ingredients at different rates, the present invention may be utilized to provide, in a single dosage form, both a quick release and a sustained release formulation of the therapeutic agent(s) [0049].
It would have been prima facie obvious to modify the teachings of McDermott with those of Clark. One of skill in the art would have been motivated to add a sugar coating to the tablet of McDermott as Clark teaches that the coating provide excellent strength and resistance to cracking and can be used to control the control release properties of the tablet. One of skill in the art would have a reasonable expectation of success as both McDermott and Clark teaches tablets and McDermott teaches that the formulations can be formulated to have different types of controlled release profiles.
Conclusion
No claims are allowable.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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