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 24-33 are new. Claim 23 is withdrawn. Claims 16-21 and 23-33 are pending.
Response to Amendment
The objections to the specification and drawings are withdrawn in view of the amendment.
The rejection of claims 16-21 under 35 U.S.C. 112(b) is withdrawn in view of the amendment.
The rejection of claims 16-21 under 35 U.S.C. 103 is withdrawn in view of the amendment.
The rejections of claims 16-21 on the ground of nonstatutory double patenting are withdrawn in view of the amendment.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/22/2025 is acknowledged and has been considered.
Claim Objections
Claim 33 is objected to because of the following informalities:
In claim 33, the acronym “COVID-19” should be replaced by the full name the first time it appears. Applicant may consider amending the claim to recite “coronavirus disease 2019”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 33 is 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 33 recites wherein the pathogen infection is COVID-19. The claim does not further limit the structure recited in claim 16. MPEP 2111.04 states “Claim scope is not limited by…claim language that does not limit a claim to a particular structure. 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 16-21 remain rejected, and new claims 24-33 are rejected, under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite a dietary composition, comprising a probiotic composition comprising Bifidobacterium bifidum, Bifidobacterium adolescentis, Bifidobacterium longum, xylooligosaccharide, galactooligosaccharide and corn dietary fiber. Bifidobacterium adolescentis, Bifidobacterium bifidum and Bifidobacterium longum are naturally occurring in the gut (specification page 18 first para.). Global Prebiotic Association reports xylooligosaccharide is a product of nature found naturally in fruits and vegetables (page 3 para. “Sources”). Webmd reports galactooligosaccharide is naturally found in dairy products, beans, and certain root vegetables (page 2 para. “Overview”). Villines reports corn dietary fiber is naturally occurring in corn (page 1 first para). There is no change in any characteristic of the recited products compared to their naturally occurring counterparts and combining them into the recited composition does not change any of their natural characteristics individually or in combination. This judicial exception is not integrated into a practical application because merely combining these natural products does not add a meaningful limitation. Claim 19 recites the composition is formulated into a powder or a granule, which is also a product of nature. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because formulating probiotics and prebiotics into composition is well-understood, routine, and conventional activity in the field.
Applicant may consider amending claim 16 and limit the composition to the formulation of a tablet or capsule in order to obviate the rejection.
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 16-21, 26-29, 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Mogna (WO 2018078599) in view of Hang (CN111000247, published 04/14/2020, of record in Office Correspondence mailed on 07/23/2025) and Liu (CN111035014, published 04/21/2020, of record in Office Correspondence mailed on 05/06/2025).
Regarding claims 16-18, 20-21 and 33, Mogna teaches composition C1 comprising a mixture of bacteria which consists of the bacterial strains Bifidobacterium adolescentis, Bifidobacterium bifidum and Bifidobacterium longum in a ratio by weight of 1: 1: 1, and a suitable pharmaceutical and/or food grade excipients (page 4 second para.). Mogna teaches oral administration of the composition. Mogna does not teach xylooligosaccharide, galactooligosaccharide, and corn dietary fiber.
However, Hang teaches a composition comprising a probiotic powder and a prebiotic (page 4 “Technical issues”). Hang teaches the probiotic comprises Bifidobacterium bifidum, Bifidobacterium longum and Bifidobacterium adolescentis (page 4 “Technical solution”). Hang teaches the prebiotic comprises oligogalactose (i.e., galactooligosaccharide) and oligoxylose (i.e., xylooligosaccharide) (page 4 second para., page 16 Table 1). Hang teaches the probiotic concentration is in the range of 2.7x1011 cfu/mL to 5.0x1011 cfu/mL (page 5 para. 9).
Liu teaches a composition comprising a probiotic and a prebiotic: the probiotic comprises one or more of bifidobacterium longum and bifidobacterium bifidum; and the prebiotic comprises one or more of xylooligosaccharide, galactooligosaccharide, and corn fiber powder (claims 1, 5 and 7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Mogna by adding xylooligosaccharide, galactooligosaccharide and corn dietary fiber as suggested by Hang and Liu. One of ordinary skill in the art would be motivated to do so in order form a composition with healthy prebiotics. MPEP §2144.06(I) states that it 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. The idea of combining them flows logically from their having been individually taught in the prior art.”
Since Mogna, Hang and Liu are in the same field of endeavor to form a probiotic composition of Bifidobacterium with health benefits, there is a reasonable expectation of success.
The limitations of “facilitates recovery from a pathogen infection when administered to a subject” and “wherein the pathogen infection is COVID-19” are recitations of intended result. MPEP 2111.04 state that claim scope is not limited by claim language that does not limit a claim to a particular structure.
Regarding claim 19, Hang teaches the product is formulated into powder and granular product (Title, page 5 para. 8). Liu teaches the composition is formulated into tablet, capsule, or powder (page 4 para. 6). One of ordinary skill in the art would be motivated to formulate the composition into a tablet or capsule to ease the administration of the composition.
Regarding claim 26, Hang teaches forming the composition in single bags of 2g of the composition and teaches consuming one bag each time (i.e., single unit dose) (page 6 para. 5, page 9 second para.).
Regarding claims 27-29, Hang teaches the probiotic concentration is in the range of 2.7x1011 cfu/mL to 5.0x1011 cfu/mL (page 5 para. 9).
Regarding claim 31, Hang teaches using 0.154g or 0.1 g of galactooligosaccharide and 0.078g or 0.12g of xylooligosaccharide in 1g of composition (15.4g or 10g of galactooligosaccharide and 7.8g or 12g of xylooligosaccharide in 100g composition) (page 16 Table 1).
Claims 24, 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Mogna, Hang and Liu as applied to claim 16 above, and further in view of Costabile (PloS one 11.1 (2016): e0144457).
Regarding claim 24, Hang teaches a ratio of xylooligosaccharide and galactooligosaccharide of 0.5:1 and 0.8:1 and teaches using 7.8g of xylooligosaccharide and 15.4g of galactooligosaccharide (i.e., ratio of ~1:2) (page 16 Table 1).
Mogna, Hang and Liu do not teach weight ratio of xylooligosaccharide, galactooligosaccharide, and corn dietary fiber.
However, Costabile teaches that soluble corn fiber is a prebiotic and that 6 g/day of soluble corn fiber increased the amount of Bifidobacterium in the gut (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition taught by Mogna by adding 7.8g xylooligosaccharide, 15.4g galactooligosaccharide and 6g of corn dietary fiber (i.e., ratio of 1.3:2.5:1) or 12g of xylooligosaccharide, 15.4g galactooligosaccharide and 6g of corn dietary fiber (i.e., ratio of 1:1.3:0.5) in order to form a safe probiotic and prebiotic composition with no discomfort to the digestive system of the subject.
Regarding claim 30, Hang teaches a total amount of xylooligosaccharide and galactooligosaccharide of ~0.27g per gram of composition (7.8g or 12g of xylooligosaccharide and 15.4g or 10g of galactooligosaccharide in 100g composition) (page 16 Table 1). Costabile teaches 6 g/day of soluble corn fiber (Abstract) (i.e., total amount of xylooligosaccharide, galactooligosaccharide, and corn dietary fiber by weight is 6.27g).
Regarding claim 32, Mogna teaches ratio by weight of 1: 1: 1 of Bifidobacterium adolescentis, Bifidobacterium bifidum and Bifidobacterium longum (page 4 second para.). Hang teaches the probiotic concentration is in the range of 2.7x1011 cfu/mL to 5.0x1011 cfu/mL (page 5 para. 9). While Mogna, Hang, Liu and Costabile do not teach the claimed total amount and weight ratio of xylooligosaccharide, galactooligosaccharide, and corn dietary fiber, it would be obvious to one of ordinary skill in the art to optimize the total amount and weight ratio of xylooligosaccharide, galactooligosaccharide, and corn dietary fiber. Differences in concentrations do not support the patentability of subject matter encompassed by the prior art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. One of ordinary skill in the art would be motivated to further modify the composition taught by Mogna by optimizing the total amount and weight ratio of xylooligosaccharide, galactooligosaccharide, and corn dietary fiber in order to form a healthy composition and minimize side effects such as flatulence.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Mogna, Hang, Liu and Costabile as applied to claim 24 above, and further in view of Finegold (Food & Function 5.3 (2014): 436-445).
Regarding claim 25, Mogna, Hang, Liu and Costabile do not teach that the weight ratio of xylooligosaccharide, galactooligosaccharide, and corn dietary fiber is 0.25-0.5: 2-4: 0.5-0.75.
However, Finegold teaches that a 2.8g dose of xylooligosaccharide was tolerated without significant gastrointestinal side effects and increased counts of Bifidobacterium in the subject (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition taught by Mogna by adding 2.8g xylooligosaccharide, 15.4g galactooligosaccharide, and 6g of corn dietary fiber (i.e., ratio of 0.3: 2: 0.77) as suggested by Hang, Liu, Costabile and Finegold. One of ordinary skill in the art would be motivated to optimize the ratio of xylooligosaccharide, galactooligosaccharide, and corn dietary fiber in order to form a safe composition capable of increasing the counts of Bifidobacterium in the guts with no discomfort or gastrointestinal side effects in the subject.
Response to Arguments
Applicant's arguments filed 10/22/202 have been fully considered but they are not persuasive.
Applicant argues the recited specific probiotics and prebiotics are not found together in nature; and that the demonstrated therapeutic property of the claimed composition with these specific probiotics and prebiotics together is not a property possessed by these probiotics and prebiotics individually.
In response to the argument, Applicant discloses the recited probiotics are naturally found together in the guts (Specification page 22 first para). Xylooligosaccharide, galactooligosaccharide, and corn dietary fiber are found in natural foods as explained above. Applicant discloses that, in the synbiotic composition group, the abundance of Bifidobacterium adolescentis, Bifidobacterium bifidum and Bifidobacterium longum at weeks 2 and 5 increased (Specification page 28 first para., FIG 3D). However, there is no indication of a change in any characteristic of the recited products compared to their naturally occurring counterparts (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. The therapeutic efficacy of the composition is related to an increase in abundance of Bifidobacterium adolescentis, Bifidobacterium bifidum and Bifidobacterium longum in the gut of patients and not because of a change in the characteristics of the probiotics and prebiotics.
Applicant argues Hang and Liu do not exclude other probiotic and cannot support a prima facie case of obviousness.
In response to the argument, new reference Mogna teaches composition C1 comprising a mixture of bacteria which consists of the bacterial strains Bifidobacterium adolescentis, Bifidobacterium bifidum and Bifidobacterium longum and a suitable pharmaceutical and/or food grade excipients (page 4 second para.). Hang, Liu and new reference Costabile teach xylooligosaccharide, galactooligosaccharide, and corn dietary fiber are suitable prebiotic in a probiotic composition of Bifidobacterium. One of ordinary skill in the art would be motivated to add xylooligosaccharide, galactooligosaccharide, and corn dietary fiber to Mogna’s composition in order to form a healthy probiotic and prebiotic composition.
Conclusion
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 MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699