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
The claims filed on July 8, 2023, have been acknowledged. Claims 1-6 are pending and examined on the merits.
Claim Objections
Claim 4 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claim has not been further treated on the merits.
Claim 1 id objected to because of the following informalities:
Claim 1 lacks a period at the end of the claim.
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 1-3 and 5-6 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 uses parentheses to define in-situ as being in the gut system and claim 5 use parentheses to identify examples of short-chain fatty acids, weight loss beneficial compounds, and anti-inflammatory compounds. However, this renders the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention.
Claims 2-3 and 5-6 are also rejected because of their dependency on claim 1.
Claims 2-3 and 5-6 are considered indefinite because they are recited as method claims while being dependent on a composition claim (claim 1). It is unclear whether claims 2-3 and 5-6 are supposed to be method or composition claims.
As claims 2-3 and 5-6 are dependent on a composition claim and do not recite any active method steps, these claims are interpreted as composition claims and not method claims.
Appropriate correction is required.
The term “key functional ingredients” in claim 2 is a relative term which renders the claim indefinite. The term “key functional ingredients” is not defined by the claim, the specification does not provide a standard for ascertaining the meaning, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term key functional ingredients is a subjective term and does not provide certainty to one of skill in the art as what is a “key functional ingredient” is dependent on an individual’s subjective opinion of what is of interest. As such, the “key functional ingredient” could change depending on the person. Therefore, the claim is considered indefinite.
Claims 3 and 5 are also rejected because of their dependency on claim 2.
Regarding claim 5, the phrases “i.e.”, “e.g.”, and "such as" render the claim indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 recites the limitation "the target functional ingredients" in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of “a target functional ingredients”. Instead there is a prior recitation of “key functional ingredients”.
Claim 6 is rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The claim(s) are narrative in form. The claim(s) must be in one sentence form only. Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See MPEP 608.01(m). Note the format of the claims in published patents. Only the first sentence of claim 6 is considered to be the claim.
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 1-2 and 5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. As claims 2 and 5 are dependent on a composition claim and do not recite any active method steps, these claims are interpreted as composition claims and not method claims. Claims 1-2 and 5 have a broadest reasonable interpretation that encompasses naturally occurring probiotic bacteria which is not markedly different from its naturally occurring counterpart. As an initial matter, engineered probiotic is considered to encompass naturally occurring bacteria as Applicant has not provided a definition for engineered and natural selection and evolution are considered forms of engineering. Furthermore, the claim language “including but not limited to” is considered optional language and is not considered to require the engineered probiotic have each of the identified species of claim 1. Instead, any probiotic is considered to be encompassed by claim 1. This judicial exception is not integrated into a practical application because the natural product is not linked to a particular technology. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are understood to occur in naturally occurring prebiotic cells.
Applicant is directed to the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on 1/07/2019, which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf; and the October 2019 Update: Subject Matter Eligibility, which is found at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf.
Briefly summarized here, the new guidance cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
In regard to Step 1, Claims 1-2 and 5 is drawn to a composition of matter-a cell.
In regard to Step 2A prong one, Claims 1-2 and 5 is drawn to a nature-based product which is not markedly different from its naturally occurring counterpart. Specifically, claim 1 is directed to an engineered probiotic. Thus, naturally occurring probiotic cells would fall within the limitations of claim 1. Because instant claims are directed to a nature-based product, i.e., probiotic cells such as bacterial cells, the nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. Markowiak-Kopec et al. (Nutrients 12: 1-23. 2020) evidences that naturally occurring probiotic bacterial species are capable of converting simple sugars into short chain fatty acids. Markowiak-Kopec evidences that Lactobacillus rhamnosus GG (LGG), Lactobacillus gasseri PA 16/8, Bifidobacterium longum SP 07/3, Bifidobacterium bifidum MF 20/5, Lactobacillus salivarius spp salcinius JCM 1230, Lactobacillus agilis JCM 1048, and Lactobacillus acidophilus CRL 1014 produce propionic acid (a short chain fatty acid) through fermentation of glucose and lactate (page 4, paragraph 1-page 6, paragraph 3 and Table 2). Furthermore, as stated supra, the fact that instant claim 1 recites “engineered probiotic” does not differentiate it from naturally occurring bacterial cells because naturally occurring bacterial cells are also engineered through natural selection and evolution. Thus, instant claims 1-2 and 5 encompass host cells that are identical (no difference in structural or functional characteristics) to naturally occurring bacterial cells. Because there is no difference between the claimed and naturally occurring cells, the claimed cells do not have markedly different characteristics, and thus are a “product of nature” exception. Accordingly, instant claims are directed to a judicial exception.
In regard to Step 2A prong two, the judicial exception is not integrated into a practical application. In particular, Claims 1-2 and 5 recite no additional elements to integrate the claimed probiotic into a practical application.
In regard to Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As stated supra, Claims 1-2 and 5 recite no additional elements to the probiotic that are different to what is found in naturally occurring probiotic cells.
Therefore, Claims 1-2 and 5 are directed to a natural cell product, that is not markedly different from its natural counterpart, is not integrated into a practical application, and does not include elements that amount to significantly more than the natural product itself and do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Markowiak-Kopec et al. (Nutrients 12: 1-23. 2020).
As an initial matter, as claims 2 and 5 are dependent on a composition claim and do not recite any active method steps, these claims are interpreted as composition claims and not method claims. Additionally, engineered probiotic is considered to encompass naturally occurring bacteria as Applicant has not provided a definition for engineered and natural selection and evolution are considered forms of engineering. Furthermore, the claim language “including but not limited to” is considered optional language and is not considered to require the engineered probiotic have each of the identified species of claim 1. Instead, any probiotic is considered to be encompassed by claim 1.
Markowiak-Kopec teaches that naturally occurring probiotic bacterial species are capable of converting simple sugars into short chain fatty acids. Markowiak-Kopec teaches that Lactobacillus rhamnosus GG (LGG), Lactobacillus gasseri PA 16/8, Bifidobacterium longum SP 07/3, Bifidobacterium bifidum MF 20/5, Lactobacillus salivarius spp salcinius JCM 1230, Lactobacillus agilis JCM 1048, and Lactobacillus acidophilus CRL 1014 produce propionic acid (a short chain fatty acid) through fermentation of glucose and lactate (page 4, paragraph 1-page 6, paragraph 3 and Table 2).
Claims 1-2 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al. (Metabolic Engineering 11: 335-346. 2009), as evidenced by Valle et al. (Aquaculture 569: 1-17. 2023) and Salman et al. (Nutr Hosp 39: 803-813. 2022).
As an initial matter, as claims 2-3 and 5-6 are dependent on a composition claim and do not recite any active method steps, these claims are interpreted as composition claims and not method claims.
Regarding claims 1-3, Nguyen teaches that they engineered a Saccharomyces cerevisiae to produce DHA (an omega 3 fatty acid) from sugars. Firstly, three glycerol dehydrogenase (GDH) genes from different microbial sources were expressed in yeast. Among them, the NAD+-dependent GDH of Hansenula polymorpha showed the highest glycerol oxidizing activity. DHA concentration in shake-flask experiments was roughly 100mg/l DHA from 20 g/l glucose, i.e. five times the wild-type level. Secondly, DHA kinase activity was abolished to prevent conversion of DHA to dihydroxyacetone phosphate (DHAP). The dak1Ddak2D double-deletion mutant overexpressing H. polymorpha gdh produced 700 mg/l DHA under the same conditions (abstract, page 336, column 2, paragraph 4-page 343, column 1, paragraph 1 and Figures 4 and 7).
Valle evidences that Saccharomyces cerevisiae can be a probiotic (page 2, column 1, paragraph 4-page 5, column 1, paragraph 2).
Regarding claim 5, Salman evidences that DHA supplementation led to reductions in weight, waist, BMI, and abdominal fat mass and percentage (abstract). Therefore, DHA is considered to fall within the limitations of a weight loss beneficial compound.
Regarding claim 6, Nguyen teaches that they measured DHA in the supernatant after complete fermentation of the glucose (page 340, column 1, paragraph 3). As can be seen in Figure 4, DHA concentrations in the supernatant are similar to what is found in the empty vector S. cervisiae controls when there is no stress or oxygen-limited conditions. Therefore, as the biosynthesis pathways, GDH enzymes, and glucose are present (as shown in Figure 1) in the engineered S. cervisiae, but the produced DHA is not being secreted into the supernatant, it is considered that glucose is being converted into DHA within the cell, but is not being excreted into the supernatant, fulfilling the requirements of claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Doug Schultz can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEENAN A BATES/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631