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 amendment filed June 6, 2026, has been received and entered.
Claims 2 and 17 are cancelled.
Claims 1 and 3-16 are pending.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1 and 3-12, in the reply filed on June 2, 2026, is acknowledged. The traversal is on the ground(s) that there would not be a serious burden on the examiner if restriction were not required. Applicant points out that claim 1 links inventions I, II, and II, so upon allowance of the linking claim, the restriction requirement as to the linked inventions should be withdrawn and all claims within the linked inventions should be examined in the instant application. This is not found persuasive because serious burden is not a criteria for determination of unity of invention for a national stage application submitted under 35 U.S.C. 371, as in the case of the instant application. With respect to Applicant’s argument regarding claim 1 linking inventions I, II, and III, as pointed on page 8, last paragraph through page 9, first full paragraph of the restriction requirement, when all product claims (as in invention I) are found allowable, withdrawn process claims that include all the limitations of the allowable product should be considered for rejoinder.
The requirement is still deemed proper and is therefore made FINAL.
During a telephone conversation with Yoshimi D. Barron on July 6, 2026, a provisional election was made to prosecute the invention of the elected species of claim 1 of ‘a mutation in the branched chain amino acid transport ATP-binding protein LivG (TC 3.A.1.4.1) gene’ and a mutation that is nucleotide T at a position corresponding to position 506 of SEQ ID NO: 11. Affirmation of this election must be made by applicant in replying to this Office action.
As set forth in MPEP 803.02(III)(C)(2), “If the elected species or group of patentably indistinct species is not anticipated by or obvious over the prior art, the examiner should extend the search and examination to a non-elected species or group of species that falls within the scope of a proper Markush grouping that includes the elected species. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made.” No prior art was found that anticipates or renders obvious the elected species, so the Examiner extended the search to a non-elected species. The search and consideration had to be extended to all species since no prior art was found that anticipates or renders obvious any of the species recited in claim 1. Since the full scope of claim 1 has been searched and determined to be allowable over the prior art, then the provisional election of species requirement has been withdrawn.
Claims 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1 and 3-12 are examined on the merits.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
In particular, an embedded hyperlink is recited on page 17, lines 4 and 20 of the specification.
Claim Objections
Claims 1 and 3-12 are objected to because of the following informalities:
Claim 1 is objected to because the format for the sequence identifier is not consistent. In particular, the sequences are recited with either “SEQ ID NO:” (e.g., “SEQ ID NO: 12” in line 4) or “SEQ ID NO.:” (e.g., “SEQ ID NO.: 11” in lines 4-5) as the sequence identifier. A single format for the sequence identifier should be recited in claim 1. Since claim 1 is objected to, then the claims that incorporate it, claims 3-12, are objected to.
Claim 6 is objected to because the species name Streptococcus thermophilus should be recited for the strain DSM22587, as set forth in Table 7 on page 43 of the specification. For instance, “Streptococcus thermophilus strain DSM22587.”
Claim 7 is objected to because of the recitation “phage DSM24022.” This objection can be overcome by inserting the word “strain” with the term “DSM24022” (e.g., “strain DSM24022”). Alternatively, this objection can be overcome by substituting the recitation with “phage deposited under Accession No. DSM24022” (according to Table 7 on page 43 of the specification).
Claim 8 is objected to because the word “strain” should be inserted with the term “DSM22933” (e.g., “strain DSM22933”).
Claim 9 is objected to because it should recite “the strain DSM22933” or “the DSM22933 strain.”
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.
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 1 and 3-12 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 1 is rendered indefinite by every recitation of a mutation that is “at a position corresponding to position…of SEQ ID NO…” The specification explains that it means that, “in the mutated amino acid or nucleotide sequence, there may be further mutations (e.g., deletions, insertions, substitutions, etc.) besides the specific substitution or mutation at the specified position (or at a position corresponding to that specific position, in case, e.g., where there are deletions or insertions in the mutated sequence)” (page 18, lines 19-25). However, it is unclear what is defined by a position corresponding to a particular position of a particular sequence, e.g., a position corresponding to position 506 of SEQ ID NO.: 11. It is unclear that any sequence of the claimed genes (e.g., the branched chain amino acid transport ATP-binding protein LivG (TC 3.A.1.4.1)) in Streptococcus thermophilus strains have positions corresponding to the particular positions of the particular sequences recited in claim 1. The specification explains that, “The skilled person is able to identify a ‘position corresponding to a certain position in a certain sequence’, e.g., by aligning the sequences and finding the position which would correspond to a certain position in the original sequence” (page 19, lines 11-14). However, no original sequences are defined in the claims for any of the claimed genes. Therefore, the metes and bounds of the claimed mutations are unclear. Since claim 1 is indefinite, then the claims that incorporate it, claims 3-12, are rendered indefinite.
Claims 3-6 recite the limitation "mutations (i), (ii) and/or (iii)". See line 3 of claim 3, and lines 2-3 of each of claims 4-6. There is insufficient antecedent basis for this limitation in the claim. Mutations are not recited as mutation (i), mutation (ii), or mutation (iii). Instead, the mutations are set forth in parts (i), (ii), and (iii) of claim 1. This rejection can be overcome by inserting the word “of” between the recitations “mutations” and “(i), (ii) and/or (iii)” (i.e., “mutations of (i), (ii) and/or (iii)”).
Regarding claim 12, the word "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear whether the starter culture is in a frozen, spray-dried, freeze-dried, vacuum-dried, air dried, tray dried, or liquid form.
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 8 and 9 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 enablement requirement. The claim(s) contains 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 organism, Streptococcus thermophilus strain DSM22933, is recited in the claims, and thus is essential to the claimed invention. Since the microorganism is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the microorganism 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 microorganism, and it is not apparent if the biological material is readily available to the public. It noted that the strain has been deposited under the Budapest Treaty (Table 6 on page 43 of the specification), but there is no indication in the specification as to public availability of the strain.
Since the deposit was made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the specific strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
Claims 1 and 3-12 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 a Streptococcus thermophilus strain having a mutation in one or more of three specific genes, wherein the mutations are not clearly defined (see rejection under 35 U.S.C. 112(b) of claim 1).
MPEP 2163(II)(A)(3)(a)(ii) recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice…, reduction to drawings…, or by disclosure of relevant, identifying characteristics, sufficient to show the inventor was in possession of the claimed genus.”
Regarding representative number of species, MPEP 2163(II)(A)(3)(a)(ii) states, “A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.”
Regarding the identifying species, MPEP 2163(II)(A)(3)(a) states, “An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that inventor was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.” Further still, MPEP 2163(II)(A)(3)(a)(ii) states, “For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.”
In the instant case, Applicant has not described the genus of the claimed S. thermophilus strain such that the specification might reasonably convey to the skilled artisan that Applicant had possession of the full scope of the claimed invention at the time the application was filed. Because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus.
The broadest reasonable interpretation of claim 1 is towards a mutation in the branched chain amino acid transport ATP-binding protein LivG (TC 3.A.1.4.1) gene, a mutation in the ABC transporter permease protein gene, and/or a mutation in the peptide deformylase protein gene in a Streptococcus thermophilus strain according to (i), (ii), and/or (iii) as recited in claim 1. In claim 1, (i), (ii), and (iii) recite mutation(s) “at a position corresponding to” a specific position of a specific sequence. The specification explains that it means that, “in the mutated amino acid or nucleotide sequence, there may be further mutations (e.g., deletions, insertions, substitutions, etc.) besides the specific substitution or mutation at the specified position (or at a position corresponding to that specific position, in case, e.g., where there are deletions or insertions in the mutated sequence)” (page 18, lines 19-25). This encompasses numerous mutations and numerous amino acid and nucleic acid sequences. Therefore, the genus is highly variant in the claims because a significant number of structural differences between genus members is permitted.
The specification only describes the species of a Streptococcus thermophilus strain DSM22933 (an embodiment of claim 8), wherein the DSM22933 strain comprises the following mutations: (i) a mutation in the branched amino acid transport ATP-binding protein LivG (TC 3.A.1.4.1) gene, wherein the amino acid sequence of the mutated protein comprises SEQ ID NO: 12 and the nucleic acid sequence of the mutated gene comprises SEQ ID NO: 11; (ii) a mutation in the ABC transporter permease protein gene, wherein the amino acid sequence of the mutated protein comprises SEQ ID NO: 4 and the nucleic acid sequence of the mutated gene comprises SEQ ID NO: 3; and (iii) a mutation in the peptide deformylase protein gene, wherein the amino acid sequence of the mutated protein comprises SEQ ID NO: 8 and the nucleic acid sequence of the mutated gene comprises SEQ ID NO: 7. The specification does not describe all other members of the claimed genus by complete structure. Therefore, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. As such, the Applicant was not in possession of the claimed genus. The claimed subject matter is not fully supported by an adequate written description because a representative number of species has not been described.
Claim 3 recites that the strain generates higher shear stress and/or higher efflux time in a viscosity pipette test than a strain which does not have mutations of (i), (ii), and/or (iii) as defined in claim 1, when used for fermenting milk. However, the specification only describes the specific sequences set forth in Table 1 of mutations in the mother strain S. thermophilus DSM22587 to produce the mutant S. thermophilus strain which is the DSM22933 strain. There are no drawings or structural formulas disclosing any S. thermophilus strain, besides the DSM22933 strain, which generates higher shear stress and/or higher efflux time in a viscosity pipette test than a strain which does not have mutations of (i), (ii), and/or (iii) as defined in claim 1, when used for fermenting milk. Moreover, the claimed limitation of a “strain which does not have mutations (i), (ii) and/or (iii) as defined in claim 1” is very broad as it is directed to any strain that does not have any of those mutations, including strains of microorganisms of species, genera, families, etc., other than S. thermophilus. Even with respect to S. thermophilus strain DSM22933 as being the claimed S. thermophilus strain, there is only written description of it possessing higher shear stress and efflux time in a viscosity pipette as compared to S. thermophilus strain DSM22587 of claim 6, when used for fermenting milk. Furthermore, there is insufficient written description to show that only one or fewer than all of the mutations in the mother strain DSM22587 would have the specific functional claimed property of generating higher shear stress and/or higher efflux time in a viscosity pipette test when used for fermenting milk.
Claim 8 recites the S. thermophilus strain DSM22933 “or a mutant or variant thereof.” Furthermore, claim 9 recites that the mutant or variant shows “the same or similar texturing properties as DSM22933.” A “mutant” is described in the specification as “a strain derived from another strain (or the “mother strain”) by means of, e.g., genetic engineering, radiation and/or chemical treatment, and/or selection, adaptation, screening, etc.” (page 16, lines 4-7). However, the specification does not sufficiently describe any member of the claimed genus of a “mutant” by complete structure. Additionally, the term “variant” is defined in the specification as “a strain which is functionally equivalent to a strain of the invention” (page 16, lines 25-26). However, the specification does not describe the mutations that are suitable to result in a strain functionally equivalent to the DSM22933 strain since all functions of the DSM22933 strain are not fully described. There is no known or disclosed correlation between the functions of the DSM22933 strain and structure to demonstrate possession of the claimed genus of “variant” of the DSM22933 strain.
Regarding claim 9, the specification defines “same or similar shear stress” as being understood as “a range spanning from 10% below the shear stress characteristics of DSM22933 to 10% above the shear stress characteristics of DSM22933” (page 25, lines 30-32). However, the specification does not describe any mutation of the DSM22933 strain that is associated with conferring the claimed shear stress characteristics of the DSM22933 strain. There is no known or disclosed correlation between the shear stress characteristics of the DSM22933 strain and structure to demonstrate possession of the claimed genus of the “mutant or variant” of the DSM22933 strain of claim 9.
In sum, while there is written description for the Streptococcus thermophilus strain DSM22933, adequate written description is lacking to demonstrate possession of the full scope of a S. thermophilus strain as recited in the claims.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Folkenberg (US 2012/0107451) discloses Streptococcus thermophilus DSM22587, and mutants and variants thereof (claim 18 of Folkenberg). The DSM22587 strain of Folkenberg is relevant to the claimed invention in that one embodiment of the claimed S. thermophilus strain, specifically the DSM22933 strain recited in instant claim 8, is a phage resistant mutant resistant mutant of the DSM22587 strain, wherein the mutations identified in the claimed DSM22933 strain as compared to the DSM22587 strain are described in Table 1 (page 39, line 13 through page 40, line 5). Therefore, the DSM22587 strain of Folkenberg meets limitations of the claimed Streptococcus thermophilus strain in that there is a high level of sequence identity between their amino acid and nucleic acid sequences. However, the DSM22587 strain of Folkenberg differs from the claimed S. thermophilus strain in that the DSM22587 strain does not have any of the mutations recited in claim 1; the DSM 22587 strain does not comprise SEQ ID NOs: 3, 4, 7, 8, 11, or 12 of instant claim 1. See Table 1 of the specification for the differences between the two strains.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN EMILY FERNANDEZ whose telephone number is (571)272-3444. The examiner can normally be reached 10:30am - 7pm.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
Prosecution Insights