DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The status of the claims stands as follows:
Pending claims: 1-11, 13-20
Withdrawn claims: None
Cancelled claims: 12
Claims currently under consideration: 1-11, 13-20
Currently rejected claims: 1-11, 13-20
Allowed claims: None
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/497,072, filed on 03/21/2018.
Claim Objections
Claim 9 is objected to because “A composition according to claim 1” should be read as “The composition according to claim 1”.
Appropriate correction is required.
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.
Claims 4-5 and 15-16 are rejected under 35 U.S.C. 112(b) 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 4, 5, 15, and 16 recite percentages for B-milk and sucrose. However, the claims do not recite a unit of measurement with the percentages (e.g., wt.%, vol.%). Therefore, the claims are indefinite.
For the purpose of this examination, percentages will be interpreted as being weight percentages.
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.
Claims 1-3, 6-11, 13-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Garrigues (WO 2015/193459).
Regarding claims 1, 6, and 7, Garrigues teaches a composition (corresponding to starter culture) for producing a fermented milk product (page 1, paragraph 1), comprising: (i) a mutated Streptococcus thermophilus (St) strain, wherein the St strain is galactose-fermenting (page 22, paragraph 3) and carries a mutation in the DNA sequence of the glcK gene encoding a glucokinase protein, wherein the mutation inactivates the glucokinase protein or has a negative effect on expression of the gene (page 21, paragraph 4); and (ii) a Lactobacillus delbrueckii subsp. bulgaricus (Lb) strain, wherein the Lb strain is lactose-deficient (page 14, paragraph 2 and part (c)) and capable of metabolizing the non-lactose carbohydrate glucose (page 13, paragraph 7).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the composition of Garrigues by combining the St and Lb strains from different embodiments since combining the alternative embodiments into a single embodiment as claimed must be held prima facie obvious absent any showing to the contrary. MPEP §2143.I.A. In this case, a fermented milk product comprising an St strain having the features recited in present claim 1 (page 22, paragraph 3; page 21, paragraph 4), and an Lb strain having the features recited in present claims 1, 6, and 7 (page 14, paragraph 2; page 13, paragraph 7) are all taught by Garrigues in separate embodiments as being capable of achieving its objective of fermenting milk products and improving control of post acidification in fermented milk products (page 1, paragraphs 1-2; page 8, paragraphs 1-2). As such, a skilled practitioner could have combined these elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Also, “[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 re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. MPEP 2144.06.I. At this time, there does not appear to be any evidence that the claimed composition possesses any unexpected property based on the combination of elements as compared to the function of each element alone; therefore, the claims 1, 6, and 7 are rendered obvious.
Regarding claim 2, Garrigues teaches the invention as disclosed above in claim 1, including the St strain is 2-deoxyglucose resistant (page 43, paragraph 7).
Regarding claim 3, Garrigues teaches the invention as disclosed above in claim 1, including the St strain carries a mutation that reduces the transport of glucose into the cell (page 21, paragraph 4).
Regarding claim 8, Garrigues teaches the invention as disclosed above in claim 1, including the Lb strain is selected from the group consisting of the strain deposited with the Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, Inhoffenstr. 7B, D-38124 Braunschweigh (DSMZ) under accession number DSM 28910, and mutant strains derived from DSM 28910 having the ability to generate white colonies on a medium containing lactose and X-Gal (page 14, paragraph 2, part (c)).
Regarding claim 9, Garrigues teaches the invention as disclosed above in claim 1, including the St strain is selected from the group consisting of the Streptococcus thermophilus strain CHCC16731 deposited with DSMZ under accession number DSM 28889 (page 47, paragraph 4), Streptococcus thermophilus strain CHCC15757 deposited with DSMZ under accession number DSM 25850 (page 37, paragraph 3), and Streptococcus thermophilus strain CHCC16404 deposited with DSMZ under accession number DSM 26722 (page 37, paragraph 4).
Regarding claim 10, Garrigues teaches a method for producing a fermented milk product, comprising inoculating and fermenting a milk substrate with the composition according to claim 1 (page 1, paragraph 1).
Regarding claim 11, Garrigues teaches a fermented milk product comprising the composition according to claim 1 (page 10, paragraph 2).
Regarding claim 13, Garrigues teaches the invention as disclosed above in claim 10, including the St strain is 2-deoxygucose resistant (page 43, paragraph 7).
Regarding claim 14, Garrigues teaches the invention as disclosed above in claim 10, including the St strain carries a mutation that reduces the transport of glucose into the cell (page 21, paragraph 4).
Regarding claims 17 and 18, Garrigues teaches the invention as disclosed above in claim 10, including the Lb strain is capable of metabolizing the non-lactose carbohydrate glucose (page 13, paragraph 7) as recited in present claims 17 and 18.
Regarding claim 19, Garrigues teaches the invention as disclosed above in claim 10, including the Lb strain is selected from the group consisting of the strain depositing with the (DSMZ) under accession number DSM 28910, and mutant strains derived from DSM 28910 having the ability to generate white colonies on a medium containing lactose and X-Gal (page 14, paragraph 2, part (c)).
Regarding claim 20, Garrigues teaches the invention as disclosed above in claim 10, including the St strain is selected from the group consisting of the Streptococcus thermophilus strain CHCC16731 deposited with DSMZ under accession number DSM 28889 (page 47, paragraph 4), Streptococcus thermophilus strain CHCC15757 deposited with DSMZ under accession number DSM 25850 (page 37, paragraph 3), and Streptococcus thermophilus strain CHCC16404 deposited with DSMZ under accession number DSM 26722 (page 37, paragraph 4).
Claims 4-5 and 15-16 are rejected over 35 U.S.C. 103 as being unpatentable over Garrigues (WO 2015/193459) as disclosed in claims 1 and 10 above, as evidenced by Johansen (US 2015/0086675).
Regarding claim 4, Garrigues teaches the invention as disclosed in claim 1 above, including the Streptococcus thermophilus strain CHCC15757 deposited with DSMZ under accession number DSM 25850 (page 37, paragraph 3) and Streptococcus thermophilus strain CHCC16404 deposited with DSMZ under accession number DSM 26722 (page 37, paragraph 4), which increase the amount of glucose in 9.5% B-milk to at least 5 mg/mL when inoculated into the 9.5% B-milk at a concentration of 106-107 CFU/mL and grown at 40°C for 20 hours as evidenced by Johansen [0049].
Regarding claim 5, Garrigues teaches the invention as disclosed in claim 1 above, including the Streptococcus thermophilus strain CHCC15757 deposited with DSMZ under accession number DSM 25850 (page 37, paragraph 3) and Streptococcus thermophilus strain CHCC16404 deposited with DSMZ under accession number DSM 26722 (page 37, paragraph 4), which increase the amount of glucose in 9.5% B-milk with 0.05% sucrose to at least 5 mg/mL when inoculated into the 9.5% B-milk with 0.05% sucrose at a concentration of 106-107 CFU/mL and grown at 40°C for 20 hours as evidenced by Johansen [0049].
Regarding claim 15, Garrigues teaches the invention as disclosed in claim 10 above, including the Streptococcus thermophilus strain CHCC15757 deposited with DSMZ under accession number DSM 25850 (page 37, paragraph 3) and Streptococcus thermophilus strain CHCC16404 deposited with DSMZ under accession number DSM 26722 (page 37, paragraph 4), which increase the amount of glucose in 9.5% B-milk to at least 5 mg/mL when inoculated into the 9.5% B-milk at a concentration of 106-107 CFU/mL and grown at 40°C for 20 hours as evidenced by Johansen [0049].
Regarding claim 16, Garrigues teaches the invention as disclosed in claim 10 above, including the Streptococcus thermophilus strain CHCC15757 deposited with DSMZ under accession number DSM 25850 (page 37, paragraph 3) and Streptococcus thermophilus strain CHCC16404 deposited with DSMZ under accession number DSM 26722 (page 37, paragraph 4), which increase the amount of glucose in 9.5% B-milk with 0.05% sucrose to at least 5 mg/mL when inoculated into the 9.5% B-milk with 0.05% sucrose at a concentration of 106-107 CFU/mL and grown at 40°C for 20 hours as evidenced by Johansen ([0049]).
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, 10, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 12 of U.S. Patent No. 11,540,527.
Although the claims at issue are not identical, they are not patentably distinct from each other. Patented claims 1, 9, and 12 recite a galactose-fermenting Streptococcus thermophilus strain that carries a glcK gene mutation that inactivates the glucokinase protein or has a negative effect on the expression of the gene and a Lactobacillus delbrueckii subsp. bulgaricus strain, which is also recited by instant claims 1, 10, and 11. Although co-pending claim 12 does not require the Lactobacillus strain to have the features of the strain recited in instant claim 1, its broad disclosure of a Lactobacillus strain does not exclude the strain recited by instant claim 1. Therefore, the selection of a strain having the features as recited by instant claim 1 renders the claim obvious.
Conclusion
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/KELLY P KERSHAW/Examiner, Art Unit 1791
