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 .
Status of the Claims
Claims 1-15 are pending (claim set as filed on 5/7/2026). Claims 6-15 were withdrawn after restriction/election requirement. Claims 1-5 are under examination.
Election/Restrictions
Claims 6-15 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected culture, kit of parts, product and a method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/7/2026.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
This application claims benefit to foreign application no. CN 2021/129546 on 11/9/2021. As the conditions for foreign priority benefits have been met, the effective filing date of the application is 11/9/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/7/2024 is considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim ObjectionsClaims 3-5 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to the other claims in the alternative form only and/or cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Claim 3 is objected to because it improper depends on claims 1-2 instead of 1 and/or 2. Claim 4 is objected to because it depends on improperly dependent claim 3. Claim 5 is objected to because it improperly depends on claims 1-4 instead of and/or any combination of those claims. Accordingly, the claims have been further treated on the merits, however the examiner has interpreted the claim dependency to mean claim 3 depends on claim 1, claim 4 depends on claim 3 which in turns depends on claim 1, and claim 5 depends on claim 1.
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.
Claims 2-5 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.
The term “at least about” in claim 2 is a relative term which renders the claim indefinite. The term “at least about” is not defined by the claim and the specification does not provide a standard for ascertaining the requisite degree. The claims recite “at least“ which limit the claims to the specified numerical value, but also recite “about” which includes the lower range of this value as well. The scope of the numerical range of the inventions is then unclear as to when one would infringe on them. For examination purposes, it has been interpreted to mean at least 70%.
Claim 2 further recites 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). One could not ascertain if the claimed range of sequence identity percentages are limiting or merely exemplary.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “the beta-galactosidase gene lacL/M”, and the claim also recites “PlacLM” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Claim 3 further recites “which promoter region is defined by any one of SEQ ID NO: 10 or SEQ ID NO: 11”. The meaning of the claim is indefinite as it is unclear as to what is being limited. The claim recites limitations for the promoter region as it must be defined by the SEQ ID NO: 10 or 11, however it also limits that the promoter region must comprise one or more mutations. One could not ascertain if the promoter region in SEQ ID NO: 10 or 11 is inherently defined by the mutation(s), or if promoter must have SEQ ID NO: 10 or 11 and one or more mutations in the nucleotide sequence. For examination purposes, it has been interpreted to mean the promoter region in SEQ ID NO: 10 is inherently defined by the mutation(s). As SEQ ID NO: 10 has the claimed GG to AA mutation as described in the instant application, it has been interpreted that SEQ ID NO: 10 is the mutated promoter sequence and SEQ ID NO: 11 the wild type promoter sequence.
Claims 4 is rejected for depending on claim 3.
Claim 4 recites the phrase “in the -10 region of the promoter”. However, the language renders the scope of the promoter region unclear as one cannot determine if the “-10” limitation is referring to a specific point within the sequence or if it relative to the position of the end or beginning of the promoter sequence. The specification does not provide a definition for the term and thus it is unclear where the mutation is located within the promoter sequence. For examination purposes, the claim language is interpreted to mean a mutation within the promoter region sequence.
Claim 4 further recites 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). It is unclear if the specified mutation is a recitation of a limitation or if it is merely exemplary language.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Christensen (Patent No. US 11,160,288 B2 – date of patent 11/2/2021).
Christensen’s general disclosure relates to the use of Streptococcus thermophilus in producing a fermented milk product (see abstract).
Regarding claim 1, Christensen anticipates a method for producing a fermented dairy product comprising inoculating a fermented dairy milk product with a glucose-deficient bacteria (see Christensen col. 22, claim 1). As lactose is a disaccharide requiring both glucose and galactose, if the bacteria is glucose-deficient, logically the bacteria is also lactose-deficient. Christensen also defines the fermented product as containing 2% galactose (see Christensen col. 3, ¶ 3), which reads on “about” 0-1% galactose. This anticipates the claimed limitation as the instant specification defines the term “about” as +/- 10% of the claimed numerical value (see specification pg. 7, ¶ 2)..
Regarding claim 5, Christensen anticipates the lactose-deficient bacteria strain comprises Lactobacillus plantarum in particular embodiments(see col. 8, ¶ 8).
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bloc (Pre-Grant Publication No. US 2021/0153517 A1 – date of publication 5/27/2021).
Bloc’s general disclosure relates to the process of producing a fermented milk product (see abstract).
Regarding claim 1, Bloc anticipates a method for producing a fermented dairy product comprising inoculating a fermented dairy milk product with two strains of lactose-deficient bacteria (see pg. 12, claim 1). Bloc also anticipates in particular embodiments that the fermented product comprises galactose, defined as a non-lactose carbohydrate (see [0089]), at 0.5-1.2% (see [0100]) which is “about” 0-1%. This anticipates the claimed limitation as the instant specification defines the term “about” as +/- 10% of the claimed numerical value (see specification pg. 7, ¶ 2). ,
Claim Rejections - 35 USC § 103
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 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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Bloc (Pre-Grant Publication No. US 2021/0153517 A1 – date of publication 5/27/2021) and further in view of Donohue (Pre-Grant Publication No. US 2020/0017891 A1 – date of publication 1/16/2020).
Bloc’s general disclosure has been set forth above.
Regarding claim 2, Bloc teaches the lactose-deficient bacterial strains (see pg. 12, claim 1).
Regarding claim 3, Bloc teaches the lactose-deficient bacterial strains (see pg. 12, claim 1).
Regarding claim 4, Bloc teaches the lactose-deficient bacterial strains (see pg. 12, claim 1).
Regarding claim 5, Bloc teaches the lactose-deficient bacterial strain comprises a Lactobacillus strain (see [0125]).
Regarding claim 2, Bloc does not teach the beta-galactosidase protein amino acid sequence.
Regarding claim 3, Bloc does not teach the mutation in the promoter region of the beta-galactosidase protein gene.
Regarding claim 4, Bloc does not teach the mutation is in the -10 region of the promoter.
Regarding claim 5, Bloc does not explicitly teach the Lactobacillus plantarum species.
Donohue’s general disclosure relates to a microbiome composition comprising Lactobacillaceae members (see abstract).
Regarding claim 2, Donohue teaches a beta-galactosidase protein having an amino acid sequence with 99.4% percent sequence match set forth in SEQ ID NO: 1 (see pg. 27, claim 12, SEQ ID NO: 724), which is at least 70% identity match as claimed. As noted in the 112b rejections above, the sequence identity match was interpreted to mean at least 70% as the claim recited indefinite and exemplary language; thus the 99.4% referenced identity match reads on the claim.
It would be obvious to one of ordinary skill in the arts at the time of the effective filing date to add the beta-galactosidase protein taught in Donohue to the lactose-deficient bacteria as taught in Bloc. One would be motivated to do so because Donohue teaches that beta-galactosidase can hydrolyze bacterial oligosaccharides (see Donohue [0226]). This would be an advantageous addition to Bloc’s disclosure which claims a process of using lactose-deficient strains to metabolize non-lactose carbohydrates (see Bloc pg. 12, claim 2).
Regarding claim 3, Donohue teaches a mutation in the promoter region of the beta-galactosidase gene lacL/M gene, defined by SEQ ID NOs 10-11, with a percent identity match of 99.4% to SEQ ID NO: 10 (see pg. 27, claim 12 SEQ ID NO: 724). Donahue discloses a mutation in the promoter region of the beta-galactosidase gene sequence where there is an insertion of thymine at bp 110891 (see pg. 27, claim 12 SEQ ID NO: 724).
It would be obvious to one of ordinary skill in the arts at the time of the effective filing date to try the mutated promoter of the beta-galactosidase gene lacL/M as taught in Donohue in view of the lactose-deficient bacteria as taught in Bloc. One would be motivated to do so because there are a finite number of nucleotides in the 282 base pair promoter sequence. Therefore, the ordinary artisan would only have to change one nucleotide in order to enact a mutation in the promoter and would have had a reasonable expectation of success in doing so. See MPEP 2143, rationale (E).
Regarding claim 4, Donohue teaches a mutation in the promoter region of the beta-galactosidase gene sequence where there is an insertion of thymine at bp 110891 (see pg. 27, claim 12 SEQ ID NO: 724). As noted in the 112b rejections above, the recitation of the phrase “in the -10 region of the promoter” renders the claim indefinite as it is unclear as to where in the promoter sequence the mutation is occurring. Further, the recitation of exemplary language “such as” renders the limitations following the usage indefinite as well.
Regarding claim 5, Donohue teaches the strain Lactobacillus plantarum (see [0124]).
It would have been obvious to one of ordinary skill in the arts to add the strain Lactobacillus plantarum as taught in Donohue to the Lactobacillus species as taught in Bloc. One would be motivated to do so because Donohue teaches that Lactobacillus plantarum is successful for use in fermentation (see Donohue [0124]). This addition would be an advantage to Bloc which discloses a need for a Lactobacillus strain that can ferment sugars (see Bloc [0125]).
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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/E.R.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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