DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application claims benefit of priority to People’s Republic of China Application No. CN202010110327.X filed on February 24, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, a translation of the certified copy of the Chinese patent document was not provided. As such, the priority date of the instant application is January 08, 2021, the PCT filing date.
Drawings
The Drawings filed 08/03/2025 are accepted by the Examiner.
Amendments and Claim Status
In the reply filed 06/20/2026, Applicant canceled all of the previously pending claims and added new claims 21-34.
Claims 21-34 are currently pending and under examination.
Claim Objections
Claim 1, 22, 28 and 32 are objected to because of the following informalities: Claim 1 recites ‘Blautia’ in lines 5 and 20 without being italicized. Additionally, the specific strain designation, being B2132, is italicized. Strain designators are not usually italicized, just the genus and species. Claims 22, 28 and 32 further recite Blautia without being italicized. Appropriate correction is required.
Claims 24-25, 28 and 32 are objected to because of the following informalities: Claims 24-25, 28 and 32 are missing a space after “wherein,” at the end of the preamble. Additionally, the comma after ‘wherein’ is unnecessary. Appropriate correction is required.
Claims 21 is objected to for the following informalities: Claim 1 recites “the Blautia sp. B2132 strain, which is being deposited at …” in lines 2-3. It appears the strain has already been deposited as the strain has an associated deposit number. Therefore, the phrase “which is being” should be removed from the claim, leaving the claim to read “the Blautia sp. B2132 strain deposited at …” Appropriate correction is required.
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 28-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a product of nature.
Claim 28-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a microorganism comprising a Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296. This judicial exception is not integrated into a practical application because only an isolated strain of a Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296 is claimed. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only an isolated strain of a Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296 is claimed.
With regard to Step 1, the composition as claimed in claims 28-34 is a composition of matter.
With regard to Step 2A, prong one, claims 28-34 encompass a microorganism comprising a Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296. Thus, claims 28-34 are generally directed to a microorganism. It is indicated in the Specification that Blautia sp. B2132 strain was separated and identified from feces. Thus, it appears that the Blautia sp. B2132 strain is a natural strain that has been isolated. It is noted that isolating a natural microorganism, and then placing the isolated microorganism in a non-natural environment does not alter the structure of the microorganism. As such, the microorganism of claims 28-34 which only includes a Blautia sp. B2132 strain is deemed a natural product.
With regard to Step 2A, prong two, claims 28-34 do not recite any additional elements in addition to Blautia sp. B2132 strain. As such, there is no additional element in claims 28-34 that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the natural microorganism Blautia sp. B2132 strain such that the claims as a whole are more than a drafting effort designed to monopolize the exception.
With regard to Step 2B, claims 28-34 do not recite any additional elements in addition to Blautia sp. B2132 strain. As such, the claims do not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
Regarding the limitations present within claim 29, the recitation of the number of microorganisms present in the composition does not render the composition non-natural because the structure of the organism, meaning the sequence, is the same. Additionally, reciting an intended use of the composition does not render the composition non-natural.
For the forgoing reasons, the microorganism as claimed is not deemed to encompass patent eligible subject matter under 35 USC § 101.
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 21-27 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.
Claims 21-27 are indefinite because it is unclear exactly what Applicant is intending to claim. For example, claim 21 is directed to an application of Blautia in the preparation of a medicine and recites method steps for preparing the medication while also reciting treating ulcerative colitis or Crohn’s disease. Thus, the scope of claim 21 is unclear because it is unclear if the application is directed to preparing the deposited strain, making the composition or treating ulcerative colitis or Crohn’s disease. See MPEP 2173.05(p). Claim 22 recites “the medicine comprises a pharmaceutically effective dose of Blautia sp. B2132 strain and a pharmaceutically acceptable carrier” which is not a method step in preparing the medication, rather, it seems to be directed to a product type claim. Then, claim 23 is directed to providing the medication to a subject and reciting the pharmaceutically effective dose which is a method of using the medicine. Thus, it is generally unclear whether the claims are intended to be directed to a method of preparing the deposited strain, a method of making the composition or a method of treating. Therefore, claim 21 and all claims dependent upon claim 21 are rendered indefinite.
Claim 21 recites “the Blautia strain, which is being deposited at … under deposit number 1.5296” in lines 2-3. It is unclear if the claim is limited to the specific strain because the claim recites the strain “which is being deposited” instead of reciting “which is deposited.” Thus, it is unclear is if the specific strain has already been deposited and is a required limitation due to the narrative language.
Claim 21 recites “(containing 5% bovine serum and 0.1% cysteine)” line 8 and “(containing 5% bovine serum, 0.1% cysteine and 1 mg/L aztreonam) in line 13 of the claim. The use of parentheses leaves it unclear if the limitations within the parentheses are required limitations. Thus, the scope of claim 21 is unclear as it is unclear if the limitations recited within the parentheses are required or optional limitations.
Claims 23 and 29 are objected to for the following informalities: Claims 23 and 29 reciterecite “wherein providing the medicine to a subject and the pharmaceutically effective dose is 106 -1010 CFU/ml” in lines 1-2. The claims are grammatically incorrect leaving it generally unclear what claims 23 and 29 are intended to encompass. For example, it is unclear if this limitation means the medication is provided, meaning administered, to a subject and the dosage is 106 -1010 CFU/ml or if this limitation is simply stating the effective dosage when it is provided to a patient is 106 -1010 CFU/ml. Appropriate correction is required. Thus, claims 23 and 29 are indefinite.
Claim Rejections - 35 USC § 102
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 21-34 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Martinez et al. (WO 2019227085 A1, 11/28/2019).
Regarding claim 21, see 112b above. Claims 21-27 are being interpreted as a method of treating ulcerative colitis or Crohn’s disease with the Blautia sp. B2132 strain that has a 16S rRNA gene sequence as shown in instant SEQ ID NO: 7. As such, Martinez et al. disclose bacterial compositions useful for preventing and/or treating diseases and disorders associated with dysbiosis of the gastrointestinal microbiome (Paragraph [0002]). More specifically, Martinez et al. disclose a method of treating an inflammatory disease in a subject in need thereof, comprising administering to the subject an effective amount of the composition of claim 1 (Claim 61 of Martinez et al.) wherein the inflammatory disease is an inflammatory bowel disease (Claim 63 of Martinez et al.) and wherein the inflammatory bowel disease comprises Crohn’s disease or ulcerative colitis (Claim 64 of Martinez et al.). The composition of claim 1 comprises a purified bacterial population of one or more bacteria having a 16S rDNA sequence that is at least 97% identical, up to 100% identical, to SEQ ID NO: 187 (Claim 1 of Martinez et al.). SEQ ID NO: 187 of Martinez et al. shares 99.7% sequence identity to instant SEQ ID NO: 7. A sequence alignment is provided below wherein Qy is instant SEQ ID NO: 7 and Db is SEQ ID NO: 187 as disclosed by Martinez et al.
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Thus, SEQ ID NO: 5 of Martinez et al. disclose a 16S rRNA gene sequence as shown in instant SEQ ID NO: 7 because the sequence of Martinez et al. comprises a sequence as shown in instant SEQ ID NO: 7. Meaning, the sequence of Martinez et al. comprises a sequence of nucleotides as shown in instant SEQ ID NO: 7.
Therefore, Martinez et al. anticipate instant claim 21 insofar as disclosing a bacterial composition comprising SEQ ID NO: 187 which reads on a 16S rRNA gene sequence as shown in instant SEQ ID NO: 7, for the treatment of ulcerative colitis and/or Crohn’s disease.
Regarding claim 22, Martinez et al. disclose the composition can comprise conventionally acceptable carriers (Paragraph [0229]). Martinez et al. further disclose administering an effective amount of the bacterial composition to a subject in need thereof (Paragraph [0033]).
Regarding claims 23 and 29, Martinez et al. disclose administering an effective amount of the bacterial composition to a subject in need thereof (Paragraph [0033]). Martinez et al. further disclose the composition is formulated in a unit dosage form from about 102 to about 109 spores (Paragraph [0208]).
Regarding claims 24-25, Martinez et al. disclose the excipient, reading on carrier, is methylcellulose (Paragraph [0219]).
Regarding claims 26-27, as stated above, claims 21-27 are being interpreted as a method of treating ulcerative colitis or Crohn’s disease with the Blautia sp. B2132 strain that has a 16S rRNA gene sequence as shown in instant SEQ ID NO: 7.
Regarding claims 28-34, it noted these claims are product-by-process claims. In product-by-process claims, patentability is based on the product itself, not its method of production. See MPEP 2113. The product of claims 32-34 is a Blautia strain with a 16S rRNA gene sequence as shown in SEQ ID NO: 7. It is further noted the deposit number of CGMCC No. 1.5296 is nothing more than an identifier, a strain being deposited with a specific number does not make the strain novel. Regarding the product of a Blautia strain with a 16S rRNA gene sequence as shown in SEQ ID NO: 7, Martinez et al. disclose SEQ ID NO: 187 which shares 99.7% sequence identity to instant SEQ ID NO: 7.
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Thus, Martinez et al. anticipate instant claims 28-34 insofar as disclosing a bacterial strain that is not patentably distinct from the bacterial strain being produced by the product-by-process steps recited in instant claims 28-34.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12611433 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are identical except for the specific bacterial strain claimed.
Claim 1 of ‘433 recites:
A method of preparing an Anaerostipes sp. B2131 strain in the preparation of a medicine for treating ulcerative colitis or Crohn's disease, the Anaerostipes sp. B2131 strain, which is deposited at Common Microorganism Center of China Committee for Culture Collection of Microorganisms (CGMCC) under deposit number 1.5295, and has a 16S rRNA gene sequence as shown in SEQ ID NO: 7, wherein the Anaerostipes sp. B2131 strain is prepared through the following steps:
(1) collecting fresh feces from a healthy mouse and adding the feces to a pre-deoxygenated liquid BHI medium which containing 5% bovine serum and 0.1% cysteine, followed by agitation to obtain a bacterial suspension;
(2) serially diluting the bacterial suspension with the pre-deoxygenated liquid BHI medium at a 1:10 gradient for five times to obtain a diluted suspension, plating 100 μL of the diluted suspension onto a pre-deoxygenated solid BHI plate including a pre-deoxygenated solid BHI medium which containing 5% bovine serum, 0.1% cysteine and 1 mg/L aztreonam, and placing the pre-deoxygenated solid BHI plate in an anaerobic chamber for incubation at 37° C. for 72 hours;
(3) picking a single colony from the pre-deoxygenated solid BHI medium and inoculating the single colony onto another pre-deoxygenated solid BHI medium for subculturing; and
(4) transferring one colony into 20 μL of double-distilled water to form a mixture, boiling the mixture in a water bath for 5 minutes, and performing colony PCR using 16S rDNA universal primers to obtain a Anaerostipes species strain, with the 16S rDNA universal primers is as shown in SEQ ID NO: 1 and SEQ ID NO:2.
Claim 1 of ‘433 is identical to instant claim 21 except for the specific bacterial strain, including the specific primers utilized which share 100% sequence identity to instant SEQ ID NO: 1 and instant SEQ ID NO: 2, respectively. Regarding the specific strain claimed, it is noted ‘433 is directed to Anaerostipes sp. B2131 while the instant claims are directed to Blautia sp. B2132. However, SEQ ID NO: 7 of ‘433 and instant SEQ ID NO: 7 (the sequence of the claimed bacteria in the instant application) share 86% sequence identity, reading on a 16S rRNA gene sequence as shown in SEQ ID NO: 7. That is, instant SEQ ID NO: 7 and SEQ ID NO: 7 of ‘433 share a sequence of nucleotides which represent a 16S rRNA gene sequence as shown in SEQ ID NO: 7. Claim 2 of ‘433 is drawn to the specific strain and a carrier, corresponding to instant claim 21. Claim 3 of ‘433 is drawn to providing the medicine to a subject and the specific dosage, which is identical to instant claim 23. Claim 4 of ‘433 is drawn to specific pharmaceutically acceptable carriers, identical to instant claim 24. Claim 5 of ‘433 is drawn to a method of preparing liquid BHI medium, identical to instant claims 26-27. Claims 7-10 of ‘433 are product-by-process claims drawn to a pharmaceutical composition comprising the specific bacteria and a carrier made by specific process steps, identical to instant claims 28-31 except for the specific strain. Claims 11-13 of ‘433 are also product-by-process claims drawn to a food/health care product/food additive comprising the specific bacteria, identical to instant claims 32-34 expect for the specific strain.
Thus, claims 1-13 of ‘433 read on and anticipate instant claims 21-34 as the claims of ’443 and the instant claims recite the exact same method claims and product-by-process claims.
Conclusion
Claims 21-34 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
