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 .
Claims 1-10 are pending and examined on the merits.
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.
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 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 microorganism Pediococcus acidilactici deposited under CGMCC No.28631 (i.e., Pediococcus acidilactici GOLDGUT-PA0755 in claims 3 and 10) 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 deposit information for the microorganism is in paragraphs [0006] and [0048] of the originally filed specification, but there is no indication in the specification as to public availability of the strain.
If the deposit is 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.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. §1.807); and
(e) the deposit will be replaced if it should ever become inviable.
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 2-4 and 10 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 2 recites “An application of the Pediococcus acidilactici in claim 1,” claim 3 recites “The application of claim 2,” and claim 4 recitation to “The application of claim 3.” The phrase “An application of” is interpreted as synonymous with “Use of.” Therefore, claims 2-4 are indefinite because they are “use” claims that attempt to claim a process without setting forth any steps involved in the process. MPEP 2173.05(q) states, “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.”
Claim 3 recites the limitation "the Pediococcus acidilactici GOLDGUT-PA0755" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claims 1 and 2 do not recite “Pediococcus acidilactici GOLDGUT-PA0755.” Instead, claim 1 recites a strain of Pediococcus acidilactici deposited with a deposit number of CGMCC No.28631. Since claim 3 is indefinite, then its dependent claim, claim 4, is rendered indefinite. Therefore, claims 3 and 4 are rejected under 35 U.S.C. 112(b). For examination purposes, “the Pediococcus acidilactici GOLDGUT-PA0755” is being interpreted as the P. acidilactici strain with deposit number CGMCC No.28631 - this is according to paragraph [0006] of the specification.
Claim 10 recites the limitation "the aforementioned Pediococcus acidilactici GOLDGUT-PA0755" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claims 1, 5, and 6 do not recite “Pediococcus acidilactici GOLDGUT-PA0755.” Instead, claim 1 recites a strain of Pediococcus acidilactici deposited with a deposit number of CGMCC No.28631. For examination purposes, “the aforementioned Pediococcus acidilactici GOLDGUT-PA0755” is being interpreted as the P. acidilactici strain with a deposit number CGMCC No.28631 - this is according to paragraph [0006] of the specification.
Also, claim 10 is rendered indefinite by the recitation “not less than 1×106 CFU/mL or 1×106 CFU/g.” It is unclear whether the viable count is (a) (i) not less than 1×106 CFU/mL; or (ii) 1×106 CFU/g; or (b) (i) not less than 1×106 CFU/mL; or (ii) not less than 1×106 CFU/g. For examination purposes, claim 10 is being interpreted as
Therefore, for the purpose of applying prior art, claim 10 is being interpreted as:
The drug of claim 6, wherein a viable count of the Pediococcus acidilactici deposited with a deposit number of CGMCC No.28631 in the drug is not less than 1×106 CFU/mL or not less than 1×106 CFU/g.
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 2-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
In particular, claim 2 recites “An application of the Pediococcus acidilactici in claim 1,” claim 3 recites “The application of claim 2,” and claim 4 recites “The application of claim 3.” The phrase “An application of” is being interpreted as synonymous with “Use of.” As indicated in MPEP 2173.05(q), “‘use’ claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101” The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter.
Claims 1 and 5-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims has been analyzed for eligibility in accordance with their broadest reasonable interpretation. The claims are directed to a statutory category, i.e. a composition of matter (Step 1: YES).
Claim 1: Claim 1 recites a strain of Pediococcus acidilactici deposited with a deposit number of CGMCC No.28631. According to the specification, the strain was derived from fresh fecal samples of healthy people in Shenzhen region (paragraph [0007]). Therefore, the CGMCC No.28631 strain is a naturally occurring product. As such, claim 1 recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because no ‘additional element’ other than the product of nature is recited in the claim. Thus, claim 1 does not recite any ‘additional element’ other than the judicial exception that integrates the judicial exception into a practical application (Step 2A, Prong Two: NO). As such, claim 1 is directed to a judicial exception (Step 2A: YES).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 1 does not recite any ‘additional element’ other than the judicial exception (Step 2B: NO). Accordingly, claim 1 is not eligible subject matter under 35 U.S.C. 101.
Claim 5: Claim 5 recites a product, wherein components of the product comprise the Pediococcus acidilactici of claim 1. As pointed out above, according to the specification, the strain of claim 1 was derived from fresh fecal samples of healthy people in Shenzhen region (paragraph [0007]). A fecal sample comprising the Pediococcus acidilactici of claim 1 is a naturally occurring product, and the fecal sample is directed to claim 5 since it is a product, wherein components of the product comprise the P. acidilactici of claim 1. Therefore, claim 5 recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because no ‘additional element’ other than the product of nature is recited in the claim. Thus, claim 5 does not recite any ‘additional element’ other than the judicial exception that integrates the judicial exception into a practical application (Step 2A, Prong Two: NO). As such, claim 5 is directed to a judicial exception (Step 2A: YES).
Claim 5 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 5 does not recite any ‘additional element’ other than the judicial exception (Step 2B: NO). Accordingly, claim 5 is not eligible subject matter under 35 U.S.C. 101.
Claims 6 and 7: Claim 6 recites a product wherein components of the product comprise the P. acidilactici of claim 1, wherein the product is a food or a drug. Furthermore, claim 6 recites that components of the food further comprise a functional food or a food additive, and components of the drug further comprise a drug carrier and/or a drug adjuvant. Claim 7 depends from claim 6 and further limits the food additive, the drug carrier, and the drug adjuvant. Since the claimed P. acidilactici CGMCC No.28631 strain has the therapeutic effect of treating ulcerative colitis (abstract), then a composition comprising the claimed strain is directed to a drug. As discussed above with respect to claim 1, the claimed P. acidilactici is a naturally occurring product. Additionally, water, which is a naturally occurring product, is directed to a drug adjuvant, specifically an excipient which is an embodiment of claim 7. According to the specification, the CGMCC No.28631 strain was derived from fresh fecal samples of healthy people in Shenzhen region (paragraph [0007]). Water is inherently present in fecal matter. Therefore, the combination of the CGMCC No.28631 strain and water (directed to a drug adjuvant which is an excipient) naturally occurs together in a fecal sample, and thus is a product of nature. Accordingly, claims 6 and 7 recite a product of nature exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because no ‘additional element’ other than the product of nature is recited in the claim. Thus, claims 6 and 7 do not recite any ‘additional element’ other than the judicial exception that integrates the judicial exception into a practical application (Step 2A, Prong Two: NO). As such, claims 6 and 7 are directed to a judicial exception (Step 2A: YES).
Claims 6 and 7 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims 6 and 7 do not recite any ‘additional element’ other than the judicial exception (Step 2B: NO). Accordingly, claims 6 and 7 are not eligible subject matter under 35 U.S.C. 101.
Claim 8: Claim 8 further limits the product of claim 6 by reciting the function(s) of the drug. For the same reasons as set forth above with respect to claims 6 and 7, claim 8 recites a product of nature exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application. As pointed out above with respect to claims 6 and 7, since the claimed P. acidilactici CGMCC No.28631 strain has the therapeutic effect of treating ulcerative colitis (abstract), then a composition comprising the claimed strain is directed to a drug. The function(s) of the drug recited in claim 8 are properties inherently possessed by the CGMCC No.28631 strain. The recited function(s) of the drug do not integrate the judicial exception (the combination of the CGMCC No.28631 strain and the drug adjuvant, specifically water, that is a product of nature) into a practical application because the recited function(s) set forth an intended use of the product. Accordingly, claim 8 does not recite any ‘additional element’ other than the judicial exception into a practical application (Step 2A, Prong Two: NO). As such, claim 8 is directed to a judicial exception (Step 2A: YES).
Claim 8 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The function(s) of the drug recited in claim 8 are properties inherently possessed by the CGMCC No.28631 strain, and thus do not amount to significantly more than the judicial exception. As such, claim 8 does not recite any ‘additional element’ that amounts to significantly more than the judicial exception (Step 2B: NO). Accordingly, claim 8 is not eligible subject matter under 35 U.S.C. 101.
Claim 9: Claim 9 further limits the drug of claim 6 by limiting the dosage form of the drug. The water (directed to a drug adjuvant) is directed to an ‘oral liquid’ recited as an embodiment comprised by the dosage form of the drug in claim 9. Therefore, claim 9 is not eligible subject matter under 35 U.S.C. 101 under the same basis as claim 6.
Claim 10: Claim 10 further limits the drug of claim 6 by limiting the viable count of Pediococcus acidilactici GOLDGUT-PA077 in the drug. According to the specification, P. acidilactici GOLDGUT-PA077 is P. acidilactici deposited with deposit number CGMCC No.28631 (paragraph [0006]). Therefore, claim 10 limits the viable count of the CGMCC No.28631 strain in the drug. The viable count of the CGMCC No. 28631 strain does not confer any markedly different characteristic on the product of nature (the combination of the CGMCC No.28631 strain and the drug adjuvant, water), thus claim 10 recites a ‘product of nature’ exception (Step 2A, Prong One: YES). Additionally, the viable count of the CGMCC No.28631 strain, which is an additional element other than the judicial exception, does not set forth a practical application of the judicial exception (Step 2A, Prong Two: NO). The inclusion of various amounts of the CGMCC No.28631 strain is well-understood, routine, and conventional activity prior to Applicant's invention because the selection of dosage of a probiotic strain (in this case, the CGMCC No.28631 strain) in a composition administered to a subject is well-understood, routine, and conventional activity. As such, the 'additional element' (viable count of the CGMCC No.28631 strain) of claim 10 does not amount to significantly more than the judicial exception (Step 2B: NO). Thus claim 10 is not eligible subject matter under 35 U.S.C. 101.
Notice Re: Prior Art Available Under Pre-AIA and AIA
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.
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.
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 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wolfenden (US 2019/0029230), as evidenced by Result 2 of SEQ ID NO: 3 search in the Published_Applications_NA_Main Database (Search performed on August 2, 2026).
Wolfenden discloses Pediococcus acidilactici FM18, wherein the 16S rDNA of the strain is SEQ ID NO: 1 paragraph [0003]). Additionally, Wolfenden discloses one or more probiotic(s) comprising a 16S rDNA sequence having at least 98% sequence identity to SEQ ID NO: 1, including a 16S rDNA sequence having at least 99.9% sequence identity to SEQ ID NO: 1 (paragraphs [0085]-[0086]). See also paragraphs [0135]-[0136] disclosing one or more lactic acid bacteria strain comprising a 16S rDNA sequence having at least 99.9% sequence identity to their SEQ ID NO: 1. Given that the probiotic having 100% sequence identity to SEQ ID NO: 1 of Wolfenden is the P. acidilactici FM18 strain, then it is obvious that the probiotic having at least 99.9% sequence identity to SEQ ID NO: 1 of Wolfenden is related to the FM18 strain and thus is a strain of Pediococcus acidilactici.
According to the instant specification, Pediococcus acidilactici deposited under CGMCC No.28631 is Pediococcus acidilactici GOLDGUT-PA0755 (paragraph [0006]). The instant specification further states that the 16S rDNA sequence of Pediococcus acidilactici GOLDGUT-PA0755 is shown in SEQ ID NO. 3 (paragraph [0007]). As evidenced by Result 2 of SEQ ID NO: 3 search in the Published_Applications_NA_Main Database, SEQ ID NO: 1 of Wolfenden has 99.9% sequence similarity to SEQ ID NO: 3 of the instant application, wherein there is a match of 1422 residues and a mismatch with 1 residue. Since Wolfenden discloses a P. acidilactici strain having at least 99.9% sequence identity to their SEQ ID NO: 1, then Wolfenden renders obvious a P. acidilactici strain having the 16S rDNA sequence of the claimed CGMCC No.28631 strain (i.e., the GOLDGUT-PA0755 strain). Therefore, Wolfenden renders obvious the claimed CGMCC No.28631 strain. As such, Wolfenden renders obvious instant claim 1.
Regarding instant claim 5, Wolfenden discloses a composition comprising one or more lactic acid bacteria strains comprising a 16S rDNA sequence having at least 99.9% sequence identity to their SEQ ID NO: 1 (paragraphs [0135]-[0136]). Therefore, Wolfenden renders obvious a product, wherein components of the product comprise the P. acidilactici CGMCC No.28631 strain. Thus, instant claim 5 is rendered obvious.
Regarding instant claims 6-8, Wolfenden discloses that the term “probiotic” is used for live microorganisms for administration to humans or animals for obtaining associated benefits for humans and animals (paragraph [0049]). Because of the therapeutic effect of the probiotic, then a composition comprising the probiotic (e.g., probiotic having at least 99.9% sequence identity to SEQ ID NO: 1 of Wolfenden, rendering obvious the claimed CGMCC No.28631 strain) is a drug. Additionally, Wolfenden teaches that the one or more lactic acid bacteria strains is administered in a wet formulation such as an aqueous formulation (paragraph [0434]). An aqueous formulation is directed to a product comprising a drug adjuvant, specifically water, which is directed to an excipient, meeting limitations of instant claims 6 and 7. Water is also directed to an excipient comprising a diluent, meeting an additional limitation of instant claim 7. Therefore, Wolfenden renders obvious instant claim 6 (drug; drug adjuvant) and 7 (excipient; diluent). Further regarding instant claim 8, the claimed functions are directed to properties inherently possessed by the P. acidilactici CGMCC No.28631 strain. Though Wolfenden does not recognize that the probiotic having 99.9% sequence identity to their SEQ ID NO: 1 (which renders obvious the claimed CGMCC No.28631 strain) has any of the functions recited in instant claim 8 (preventing and/or treating ulcerative colitis; inhibiting inflammation; and/or repairing intestinal barrier), the probiotic inherently possesses the claimed functions. As pointed out in MPEP 2112(I), “"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer."” Therefore, instant claim 8 is rendered obvious.
Regarding instant claim 9, as discussed in the preceding paragraph, Wolfenden renders obvious the drug of instant claim 6. Additionally, Wolfenden teaches that the one or more lactic acid bacteria strains is administered in a wet formulation such as an aqueous formulation (paragraph [0434]). An aqueous formulation is directed to an oral liquid. Therefore, instant claim 9 (oral liquid) is rendered obvious.
Regarding instant claim 10, Wolfenden differs from the claimed invention in that Wolfenden does not expressly disclose that the viable count of the probiotic having 99.9% sequence identify to their SEQ ID NO: 1 (rendering obvious the claimed CGMCC No.28631 strain, i.e. P. acidilactici GOLDGUT-PA0755) in their composition (directed to a drug because of the therapeutic effect of the probiotic) is not less than 1×106 CFU/mL or not less than 1×106 CFU/g. However, Wolfenden discloses that the one or more lactic acid bacteria strains is administered in a dose selected from a group that includes 1x104 to 1x105 CFU lactic acid bacteria per bird, and 1x1011 to 1x1012 CFU lactic acid bacteria per bird (paragraph [0198]). Before the effective filing date of the claimed invention, it would have been a matter of routine optimization to have varied the concentration of the probiotic having 99.9% sequence identity to SEQ ID NO: 1 of Wolfenden in the Wolfenden composition, including to a concentration of not less than 1×106 CFU/mL or not less than 1×106 CFU/g, in order to deliver the probiotic (lactic acid bacteria) in the dosages taught by Wolfenden for administration to a bird. Therefore, instant claim 10 is rendered obvious.
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.
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, Melenie Gordon can be reached at 571-272-8037. 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.
Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
Prosecution Insights