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 22-41 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 22-27 and 41, in the reply filed on 03/24/2026 is acknowledged. Claims 28-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 22-27 and 41 are examined.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 01/19/2024 is acknowledged and has been considered.
Drawings
The drawings are objected to because “Figure” should be replaced with “FIG.”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: “Figure” on pages 6-7, 13-14, 21-22, 24-26 should be replaced with “FIG.”.
Appropriate correction is required.
Claim Objections
Claims 22-23 and 25 are objected to because of the following informalities:
In claim 22, the acronym “P. freudenreichii” should be replaced by the full name “Propionibacterium freudenreichii” the first time it appears.
Claims 23 and 25 recite “viable bacteria of the strain P. freudenreichii” which is incoherent. Applicant may consider amending the claim to recite “viable cells of Propionibacterium freudenreichii JS27”
Claims 22-23 and 25 recite an ungrammatical phrase: “the bacteria…is a bacterium”. Applicant may consider amending the claim to recite “wherein P. freudenreichii JS27 comprises”.
Appropriate correction is required.
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 24 and 27 are rejected under 35 U.S.C. 112(a), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel biological material, specifically, Bifidobacterium longum subsp. infantis TPY12-1. Since the biological material is essential to the claimed invention, they must be obtainable by a reproducible method set forth in the specification or otherwise readily available to the public. If the biological material is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological material.
The specification does not disclose a repeatable process to obtain the biological material and it is not apparent if the biological material is readily available to the public. It is noted that Applicant discloses Bifidobacterium longum subsp. infantis TPY12-1 is deposited at Laboratory of Food Biotechnology (LFB; ETH-Zurich) (Specification Table 1), but there is no indication in the specification as to public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
For clarity of record, P. freudenreichii JS27 was known before the filing of the instant application, and is made available to the public by the publication of its entire genome defined as SEQ ID NO:7. However, Bifidobacterium longum subsp. infantis TPY12-1 is not publicly available.
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 22-27 and 41 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.
Claim 22 recites the limitations "the strain P. freudenreichii JS27” and “the species Bifidobacterium longum subsp. infantis” in line 2, and “the bacterium” is line 7. There is insufficient antecedent basis for these limitations in the claim. Applicant may consider deleting “the strain” and “the species” to obviate the rejection
Claims 22 and 25 recite “16S rDNA sequence as defined by SEQ ID NO: 7”. The claims are indefinite because SEQ ID NO:7 is not the 16S rDNA of the strain but the whole genome sequence of the strain with a size of ~2.66 Mb as disclosed by applicant in the sequence listing.
Claims 22 and 25 recite “wherein post-stress survival is improved by co-culture of
the bacterium of the species Bifidobacterium longum subsp. infantis”. The claim is indefinite because it is not clear which bacteria are co-cultured. It is not clear if the claim requires co-culture of species Bifidobacterium longum subsp. infantis or co-culture of P. freudenreichii JS27 and Bifidobacterium longum subsp. infantis.
Claim 24 recites the limitation “the strain B. longum subsp. infantis TPY12-1” in line 2. There is insufficient antecedent basis for this limitation in the claim. This wherein clause can be amended to: wherein the bacteria of the species B. longum subsp. infantis are of TPY12-1 strain.
Claim 25 recites the limitations "the strain P. freudenreichii JS27” and “the species Bifidobacterium longum subsp. infantis” in lines 1-2, and “the bacterium” in line 7. There is insufficient antecedent basis for these limitation in the claim. Applicant may consider deleting “the strain” in line 1, “the species” in line 2, and “the bacteria of” in lines 2-3, to obviate the rejection
Claims 23, 26-27, and 41 which depend from claim 22 do not cure the indefiniteness and are also rejected.
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 22-27 and 41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Claims 22 and 25 recite a composition (Step 1: YES) comprising viable bacteria of the strain P. freudenreichii JS27 and of the species Bifidobacterium longum subsp. infantis. Claims 24 and 27 limit B. longum subsp. infantis to B. longum subsp. infantis TPY12-1. Claim 41 recites a food comprising viable bacteria of the strain P. freudenreichii JS27 and of the species Bifidobacterium longum subsp. infantis. Applicant discloses P. freudenreichii and B. longum subsp. infantis TPY12-1 are naturally found in cheese and feces, respectively (specification Table 1). 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. 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 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 § 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 22-23, 25-26, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Masri (WO 2007140621, published 2007, of record in Office Correspondence mailed on 01/26/2026) in view of Miescher (Antimicrobial and autolytic systems of dairy propionibacteria. Diss. ETH Zurich, 1999, of record in IDS) and as evidenced by LPSN (Species Bifidobacterium infantis, 2026, of record in Office Correspondence mailed on 01/26/2026).
Regarding claims 22-23, 25-26, and 41, Masri teaches a probiotic composition comprising a mixture of living bacteria comprising Propionibacterium freudenreichii and Bifidobacterium infantis (claim 11, [0011]). Bifidobacterium infantis is also known as Bifidobacterium longum subsp. infantis, as evidenced by LPSN (page 1 “Correct name”). Masri teaches the composition is mixed with food ([0081]). Masri teaches the strain are grown together (i.e., co-culture) (Fig. 7). Masri teaches propionibacteria are resistant to digestive stress and provide growth stimulation to bifidogenic bacteria ([0050]-[0051]). Masri does not teach Propionibacterium freudenreichii JS27.
However, Miescher teaches Propionibacterium sp. JS27 (Table 2-1 page 14). Applicant discloses that the instant P. freudenreichii JS27 comprising SEQ ID NO: 7 is Miescher’s Propionibacterium sp JS27 (specification Table 1). Miescher teaches the strain has low autolytic activity (Figure 3-18 page 53) and has antimicrobial activity (Table 6-3 pages 122-125). Miescher teaches co-culturing P. freudenreichii with lactic acid bacteria (page V third para., page 8 para. 1.5)
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 Masri by substituting Propionibacterium sp JS27 as suggested by Miescher for Masri’s Propionibacterium freudenreichii. One of ordinary skill in the art would be motivated to do so in order to form a safe probiotic composition comprising a Propionibacterium freudenreichii strain with low autolysis activity. MPEP 2144.06 II states it is obvious to substitute equivalents know for the same purpose. Since Masri teaches a desire to form a composition comprising Propionibacterium freudenreichii and since Miescher teaches Propionibacterium sp JS27 has low autolytic activity and has antimicrobial activity, there is a reasonable expectation of success. The limitations “wherein the P. freudenreichii JS27 maintains being capable of growing in a colon and wherein post-stress survival is improved by co-culture of the bacterium of the species Bifidobacterium longum subsp. infantis” are characteristics of the composition (See instant Figure 4). Since the prior art teaches the composition, the properties applicant discloses and/or claims are necessarily present (See MPEP 2112.01 (I) and (II)). Thus, the composition taught by Masri in view of Miescher is understood to have the recited limitations.
Claims 24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Masri and Miescher as applied to claims 22 and 26 above, and further in view of Bunesova (BMC microbiology 16.1 (2016): 248, of record in IDS).
Regarding claims 24 and 27, Masri and Miescher do not teach B. longum subsp. infantis TPY12-1.
However, Bunesova teaches B. longum subsp. infantis TPY12-1 can degrade L-fucose to form 1,2-PD, which is a precursor for intestinal propionate formation (Abstract, Table 2).
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 further modify the composition taught by Masri by substituting B. longum subsp. infantis TPY12-1 as suggested by Bunesova for Masri’s B. infantis. One of ordinary skill in the art would be motivated to do so in order to form a safe probiotic composition capable of increasing propionate formation in the intestine. MPEP 2144.06 II states it is obvious to substitute equivalents know for the same purpose. Since Masri teaches a desire to form a probiotic composition comprising bacteria capable of producing propionic acid and since Bunesova teaches B. longum subsp. infantis TPY12-1 can form 1,2-PD, a precursor for intestinal propionate formation, there is a reasonable expectation of success.
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 22-27 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 6 of U.S. Patent No. 11,179,427 in view of Xie (Frontiers in microbiology 10 (2019): 1541), Miescher, and Bunesova.
Regarding instant claims 22-27 and 41, patent claim 1 recites a method of treating infantile colic in a subject in need thereof, the method comprising administering to the subject an infant nutritional product comprising: (a) viable lactic acid-producing bacteria from one or more live bacteria strains; (b) viable, lactate utilizing, propionic acid producing bacteria from one or more live Cutibacteria strains; and (c) optionally prebiotics. Patent claim 3 recites wherein said viable lactic acid-producing bacteria (a) are selected from the group consisting of Bifidobacterium spp., Lactobacillus spp., Lactococcus spp., Streptococcus spp., Enterococcus spp., Leuconostoc spp., and Weissella spp.. Patent claim 6 recites wherein the infant nutritional product further comprises baby milk or baby milk powder. Patent claims 1, 3, and 6 do not recite P. freudenreichii and Bifidobacterium longum subsp. infantis TPY12-1.
However, Xie teaches co-culturing Propionibacterium freudenreichii and lactic acid bacteria (Title) and teaches that Propionibacterium freudenreichii prefers lactic acid as a carbon source and produces propionic acid (i.e., lactate utilizing, propionic acid producing bacteria) (page 8 left column third para.). Xie does not teach Propionibacterium sp. JS27.
However, Miescher teaches Propionibacterium sp. JS27 (Table 2-1 page 14). Applicant discloses instant P. freudenreichii JS27 comprising SEQ ID NO: 7 is Miescher’s Propionibacterium sp JS27 (specification Table 1). Miescher teaches the strain has low autolytic activity (Figure 3-18 page 53) and has antimicrobial activity (Table 6-3 pages 122-125). Miescher teaches co-culturing P. freudenreichii with lactic acid bacteria (page V third para., page 8 para. 1.5). Xie and Miescher do not teach Bifidobacterium longum subsp. infantis TPY12-1.
However, Bunesova teaches Bifidobacterium longum subsp. infantis TPY12-1 can degrade L-fucose to form 1,2-PD, which is a precursor for intestinal propionate formation (Abstract, Table 2).
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 method recited in patent claims 1, 3 and 6 by adding Propionibacterium sp. JS27 and B. longum subsp. infantis TPY12-1 as suggested by Xie, Miescher, and Bunesova. One of ordinary skill in the art would be motivated to do so in order to form a safe probiotic composition capable of increasing propionate formation in the intestine.
Conclusion
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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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/MARY A CRUM/Examiner, Art Unit 1657
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