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
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12-4-2025 is acknowledged. Claims 1-25 are pending. Claims 11-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-10 are pending.
Information Disclosure Statement
The Information Disclosure Statements filed on 10-13-2023 and 4-22-2024 have been considered. Initialed copies are attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 7 is objected to for utilizing the abbreviation “mPa.s” without defining it upon its first recitation.
Claim 9 is objected to for utilizing the abbreviation “mPa.s” without defining it upon its first recitation.
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 1-3 and 6-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Laws of nature or natural phenomena include naturally occurring principles/ relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature (MPEP2106.04(b)).
“The law of nature and natural phenomenon exceptions reflect the Supreme Court's view that the basic tools of scientific and technological work are not patentable, because the "manifestations of laws of nature" are "part of the storehouse of knowledge," "free to all men and reserved exclusively to none." Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Thus, "a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter" under Section 101. Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980). "Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity." Id. Nor can one patent "a novel and useful mathematical formula," Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978); electromagnetism or steam power, O’Reilly v. Morse, 56 U.S. (15 How.) 62, 113-114 (1853); or "[t]he qualities of ... bacteria, ... the heat of the sun, electricity, or the qualities of metals," Funk, 333 U.S. at 130, 76 USPQ at 281; see also Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1853).”
Products of nature are analyzed under 35 USC 101 through the “markedly different characteristics analysis”. MPEP 2106.04(c) as a part of step 2A prong one of the analysis.
“If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible (Step 2A: NO) at Pathway B unless the claim recites another exception (such as a law of nature or abstract idea, or a different natural phenomenon). For claims where the entire claim is a single nature-based product (e.g., a claim to "a Streptococcus thermophilus strain"), once a markedly different characteristic in that product is shown, no further analysis would be necessary for eligibility because no product of nature exception is recited (i.e., Step 2B is not necessary because the answer to Step 2A is NO). For claims including limitations in addition to the nature-based product, further eligibility analysis is required.
If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application.
Claims 1-3 and 6-7 recite the following natural product:
An isolated Streptococcus thermophilus strain, wherein the activity of a native ABC transporter complex ATP binding protein or a component thereof, is reduced, impaired, or disabled.
MPEP2106.04(C) II sets forth:
Appropriate characteristics can be expressed as the nature-based product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include:
• Biological or pharmacological functions or activities;
• Chemical and physical properties;
• Phenotype, including functional and structural characteristics; and
• Structure and form, whether chemical, genetic or physical.
“To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.” (MPEP2106.04 (c)II. C).
Comparing the relevant characteristics between the product of claims 1-3 and 6-7 and its naturally occurring counterpart, the examiner finds no markedly difference characteristics between the characteristics. Naturally occurring the ABC transporter complex ATP binding proteins or (components thereof) are naturally affected by environmental factors.
If there are no markedly different characteristics between the product of the claim and the naturally occurring counterpart, the claim is probed for the presence of additional limitations. The claimed additional elements are analyzed alone or in combination to determine if the natural product is sufficiently different than is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the natural product, the claim fails to integrate the natural product into a practical application (MPEP 2106.04(d).III).
There are no additional limitations to the natural product in claim 1-3 and 6-7.
The recitation of the phrase “the activity of a native ABC transporter complex ATP binding protein or a component thereof, is reduced, impaired, or disabled” is not considered an additional limitation as it conveys no structural limitations and naturally occurring the ABC transporter complex ATP binding proteins or (components thereof) are affected by environmental factors.
Considering the additional limitations in addition to the natural product together as a whole, the additional elements do not rise to the level of significantly more than the natural product.
In combination, the lack of additional limitations, acted upon by the judicial exception (or natural law, or natural product), fail to rise to the level of significantly more. No additional limitation has clearly been identified.
The claims have all been examined to identify the presence of a naturally occurring product or natural phenomena. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. Individually, the limitations of the claims and the claims as a whole have been found lacking.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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.
Biological Deposit
Claims 4-5 and 8 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.
It is apparent that the Streptococcus thermophilus strains CBS129207, CBS14908, ASCC1275 and MN-ZLW-002 are required in order to practice the invention. The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)). The examiner acknowledges the deposit of the Streptococcus thermophilus strains CBS129207, CBS14908 strains in partial compliance with this requirement. However, said deposits are not in full compliance with 37 CFR 1.803-1.809.
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, 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 requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) 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; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements.
Written Description
Claims 1-10 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.
The rejected claims are drawn to Streptococcus thermophilus strains wherein the activity of a native ABC transporter complex ATP binding protein or a component thereof, is reduced, impaired, or disabled and optionally wherein:
the ABC transporter complex ATP binding protein is an ATPase (claim 2);
the ABC transporter complex ATP binding protein is a HrtA protein and/or a HrtA_2 protein and/or another hemin import ATP-binding protein (claim 3);
the Streptococcus thermophilus strain is Streptococcus thermophilus strain CBS149207 and mutants and variants thereof or an isolated Streptococcus thermophilus strain CBS149208 and mutants and variants thereof, and wherein said strains contain a combination of mutations set forth in Table 1 and Table 2 (claim 4);
wherein said strain has the same milk acidification characteristics as Streptococcus thermophilus strain CBS149207 or CBS149208 (claim 5);
said strain has milk acidification characteristics in the preparation of a fermented milk product comprise acidification of a milk substrate to a pH of about or exactly 4.6 in less than 5 hours and a pH variation of less than 0.2 unit during storage of the freshly prepared fermented milk product at 25° Celsius for 28 days (claim 6);
wherein the milk acidification characteristics further comprise viscosity of the fermented milk product of at least about 300mPa.s, optionally the viscosity is within the range of about or exactly 300mPa.s to about or exactly 1000mPa.s and optionally the viscosity is within the range of about or exactly 400mPa.s to about or exactly 550mPa.s (claim 7);
said strain has a genome with at least 80% sequence identity to the genome of Streptococcus thermophilus ASCC1275 or Streptococcus thermophilus MN-ZLW-002, and demonstrates the same or substantially the same milk acidification characteristics as Streptococcus thermophilus strain CBS149207 or CBS149208 in the preparation of a fermented milk product, wherein the milk acidification characteristics in the preparation of a fermented milk product comprise acidification of a milk substrate to a pH of about or exactly 4.6 in less than 5 hours and a pH variation of less than 0.2 unit during storage of the freshly prepared milk product at 25° Celsius for 28 days, and wherein the Streptococcus thermophilus strain comprises at least one mutation selected from the groups of mutations consisting of:- F1 to F43, optionally selected from the group consisting of F-1, F-10, F-18, F-22, F- 29, and F-42 and combinations thereof, each as depicted in Table 1; and- C1 to C35, optionally selected from the group consisting of C-2, C-19, C-20, C-22,C-28, C-29 and C-33 and combinations thereof, each as depicted in Table 2 (claim 8);
the milk acidification characteristics further comprise viscosity of the fermented milk product of at least about 300mPa.s, optionally the viscosity is within the range of about or exactly 300mPa.s to about or exactly 1000mPa.s (claim 9); and
the strain is a mutant or variant that is obtained by mutagenesis or by genome editing and subsequent selection for the milk acidification characteristics.
The Streptococcus thermophilus strain CBS149207 and Streptococcus thermophilus strain CBS149208 meet the written description requirement. However, the rejected claims encompass any mutant or variant strain having all of the aforementioned characteristics. None of the Veillonella atypica strains meet the written description requirements of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
To fulfill the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of variants and mutants of the Streptococcus thermophilus strain CBS149207 and Streptococcus thermophilus strain CBS149208, Applicant must not only adequately describe the mutations within the ABC transporter complex ATP binding protein (or component thereof) would result in the claimed biological characteristics but also describe which strains of Streptococcus thermophilus would be able to accommodate said mutations. Moreover, with the regard to claim 8, Applicant must describe which portions of the ASCC1275 and MN-ZWL-002 genomes must be present in a given Streptococcus thermophilus strain in order to have the claimed biological characteristics. With the exception of the Streptococcus thermophilus CBS149207 and CBS149208 strains, the specification does not disclose distinguishing and identifying features of a representative number of members of the genus of variant Streptococcus thermophilus strains to which the claims are drawn, as they fail to describe what constitutes “all the identifying features”. Consequently, the skilled artisan cannot immediately envision, or recognize at least a substantial number of members of the claimed genus of variant strains of the Streptococcus theromphilus.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, 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. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
And:
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. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Therefore, because the art is unpredictable, in accordance with the MPEP and currently case law, with the exception of the Streptococcus thermophilus strain CBS149207 and CBS149208, the description of the variant strains of the Streptococcus thermophilus encompassed by the rejected claims are not properly described.
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 4 and 8 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.
Applicants are directed to MPEP 2173.05(s) “Reference to Figures or Tables Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).” Since the sequences are easily presented by reference to a sequence identifier and nucleotide residues, the sequences do not fall under the category of "exceptional circumstance".
Claims 7 and 9 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.
Said claim are rendered vague for the use of the abbreviation “mPa.s”. It is unclear what units are meant to be engendered by said abbreviation. Consequently, it is impossible to determine the metes and bounds of the claimed invention.
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 1-2, 7 and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Janzen et al. (U.S. Patent Application Publication US 2025/0101372).
Janzen et al. disclose Streptococcus thermophilus strains having a mutation in the branched amino acid transport ATP-binding protein LivG (see abstract). Janzen et al. further disclose that said mutants have an improved acidification properties and viscosity (see paragraph [0062] and paragraph [00182] for example). Consequently, Janzen et al. anticipates all the limitations of the rejected claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached Monday thru Friday; 6:30 am - 3pm EST.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 March 30, 2026
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