DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I, claims 1-17, drawn to a method for assessing risk for colorectal adenoma recurrence in an individual after removal of colorectal cancer or adenoma, in the reply filed on 12/18/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of species is incomplete, in the reply filed on 12/18/2025. The claims are drawn to more than one generic invention as recited in claims 1 and 10. To expedite prosecution, the specie election requirement is withdrawn and claims 10-17 are objected below in the non-final office action.
Claims Status
Claims 1-17, 21, 27 and 33 are pending.
Claims 21, 27 and 33 are withdrawn.
Claims 1-17 are currently under examination.
Priority
This application is a 371 U.S. national phase application of PCT Application No. PCT/CN2021/131499, filed November 18, 2021, which claims priority to U.S. Provisional Patent Application No. 63/116,104, filed November 19, 2020, and U.S. Provisional Patent Application No. 63/196,582, filed June 3, 2021.Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date of claim set filed on November 27, 2023, is determined to be November 19, 2020.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency - This application contains a “Sequence Listing as a PDF file (37 CFR 1.821(c)(2)) or as physical sheets of paper (37 CFR 1.821(c)(3)), but fails to comply with the requirements of 37 CFR 1.821 - 1.825 because a copy of the "Sequence Listing" in computer readable form (CRF) has not been submitted as required by 37 CFR 1.821(e)(1)(i) or 1.821(e)(2)(i) as indicated in item 2) above.
Required response - Applicant must provide:
A new CRF of the “Sequence Listing” in accordance with 37 CFR 1.821(e)(1)(i) or 1.821(e)(2)(i) and
A statement that the content of the CRF is identical of the “Sequence Listing” part of the disclosure, submitted as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Specification
The listing of references in the specification is not a proper information disclosure
statement. The specification filed on 05/18/2023 includes a list of references on pages 43-44. 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 10 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 11 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 12 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 4. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 13 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 5. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 14 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 6. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 15 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 7. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 16 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 8. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 17 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 9. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim 2 is 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 “Table 1", it is unclear what “Table 1” is referring to as the claim should be complete and clear by limitations recited in the claims without referring to any tables or drawings disclosed in the specification. See MPEP § 2173.05(s).
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards abstract ideas of obtaining levels, calculating score, detecting the value higher than the control and determining increased risk for recurrence for colorectal adenoma recurrence and routine and conventional method of obtaining level of bacterial species in a stool sample, without significantly more. The claim(s) recite(s) abstract ideas and routine and conventional methods. This judicial exception is not integrated into a practical application because no additional elements integrate the judicial exceptions into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are considered significantly more than the judicial exceptions.
Claim analysis
The instant claim 1 is directed towards: A method for assessing risk for colorectal adenoma recurrence in an individual after removal of colorectal cancer or adenoma, comprising the steps of: (a) obtaining in a first stool sample taken from the individual prior to the removal of colorectal cancer or adenoma a baseline level of one or more of four bacterial species of a Lachnoclostridium species carrying genetic marker m3 (m3), Fusobacterium nucleatum (Fn), Clostridium hathewayi (Ch), and Bacteroides clarus (Bc); (b) obtaining in a second stool sample taken from the individual after the removal of colorectal cancer or adenoma a follow-up level of the one or more of the four bacterial species; (c) calculating a combined score from the baseline level and follow-up level of any one of more of the four bacterial species Fn, m3, Bc, and Ch; and (d) detecting the value to be higher than a standard control value and determining the individual as having increased risk for colorectal adenoma recurrence.
The obtaining levels, calculating score, detecting the value higher than the control and determining increased risk for recurrence are abstract ideas.
The method of obtaining level of bacterial species in a stool sample, detecting the value higher than the control and determining increased risk for recurrence is considered to be an active step requiring the analysis of a sample. The active step is routine and conventional as demonstrated by the 35 USC § 103 rejections stated below.
Dependent claims set forth further limitations about the calculation of combined score of baseline and follow-up levels, individual, type of level, measurement of level, and stool samples.
The instant claim 10 is directed towards: A method for assessing risk for colorectal adenoma recurrence in an individual after removal of colorectal cancer or adenoma, comprising the steps of: (a) obtaining in a stool sample taken from the individual after the removal of colorectal cancer or adenoma a value of (1) level of one or more of three bacterial species of a Lachnoclostridium species carrying genetic marker m3 (m3), Fusobacterium nucleatum (Fn), and Clostridium hathewayi (Ch); or (2) combined score of levels of two bacterial species m3 and Ch, which is calculated by I2+β5*m3+β6*Ch; or (3) combined score of levels of three bacterial species Fn, m3, and Ch, which is calculated by I3+β7*Fn+β8*m3+β9*Ch; or (4) combined score of levels of four bacterial species Fn, m3, Bc, and Ch, which is calculated by I1+β1*Fn+β2*m3+β3*Bc+β4*Ch; and (b) detecting the value to be higher than a standard control value and determining the individual as having increased risk for colorectal adenoma recurrence.
The obtaining levels, calculating score, detecting the value higher than the control and determining increased risk for recurrence are abstract ideas.
The method of obtaining level of bacterial species in a stool sample, detecting the value higher than the control and determining increased risk for recurrence is considered to be an active step requiring the analysis of a sample. The active step is routine and conventional as demonstrated by the 35 USC § 103 rejections stated below.
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case, the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, abstract ideas.
With regard to claim 1, the claim recites “A method for assessing risk for colorectal adenoma recurrence in an individual after removal of colorectal cancer or adenoma, comprising the steps of: (a) obtaining in a first stool sample taken from the individual prior to the removal of colorectal cancer or adenoma a baseline level of one or more of four bacterial species of a Lachnoclostridium species carrying genetic marker m3 (m3), Fusobacterium nucleatum (Fn), Clostridium hathewayi (Ch), and Bacteroides clarus (Bc); (b) obtaining in a second stool sample taken from the individual after the removal of colorectal cancer or adenoma a follow-up level of the one or more of the four bacterial species; (c) calculating a combined score from the baseline level and follow-up level of any one of more of the four bacterial species Fn, m3, Bc, and Ch; and (d) detecting the value to be higher than a standard control value and determining the individual as having increased risk for colorectal adenoma recurrence.” The obtaining levels, calculating score, detecting the value higher than the control value and determining increased risk for recurrence are abstract ideas.
With regard to claim 10, the claim recites, “A method for assessing risk for colorectal adenoma recurrence in an individual after removal of colorectal cancer or adenoma, comprising the steps of: (a) obtaining in a stool sample taken from the individual after the removal of colorectal cancer or adenoma a value of (1) level of one or more of three bacterial species of a Lachnoclostridium species carrying genetic marker m3 (m3), Fusobacterium nucleatum (Fn), and Clostridium hathewayi (Ch); or (2) combined score of levels of two bacterial species m3 and Ch, which is calculated by I2+β5*m3+β6*Ch; or (3) combined score of levels of three bacterial species Fn, m3, and Ch, which is calculated by I3+β7*Fn+β8*m3+β9*Ch; or (4) combined score of levels of four bacterial species Fn, m3, Bc, and Ch, which is calculated by I1+β1*Fn+β2*m3+β3*Bc+β4*Ch; and (b) detecting the value to be higher than a standard control value and determining the individual as having increased risk for colorectal adenoma recurrence.” The obtaining levels, calculating score, detecting the value higher than the control value and determining increased risk for recurrence are abstract ideas.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? No, there are no additional steps that integrate the claims into a practical application.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No, there are no additional elements that are significantly more than the judicial exceptions.
Regarding claims 1 and 10, the claims require the routine and conventional active steps of obtaining level of bacterial species in a stool sample, detecting the value higher than the control and determining increased risk for recurrence similar to that of Teh Muy, Teck, (“Teh”, WO 2012013931 A1, Feb. 2, 2012)
Teh discloses methods for diagnosing cancer in a patient or for identifying a patient at risk of developing cancer. The methods comprise determining the amount of five or more biomarkers selected from HOXA7, AURKA, NEK2, FOXMIB, CCNBI, CEP55, CENPA, DNMT3B, DNMTI, HELLS, MAPKS, BMII, ITGBl, IVL and CTNNBI in a sample obtained from a patient and comparing the amount of the determined biomarkers in the sample from the patient to the amount of the biomarkers in or of a normal control (Abstract). Thus, the claim does not provide additional steps which are significantly more.
Dependent claims require calculation of combined score levels, individual, type of level, measurement of level, and stool samples which are all routine and conventional based on Teh, Muy, Teck ("Teh", Patent App. Pub. No. WO 2012013931 A1, Feb. 2, 2012) in view of Spetzler et al.
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.
Claim(s) 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (“Yu”; Patent App. Pub. WO 2018036503 A1, Mar. 1, 2018, filed on Aug. 25, 2016).
Yu discloses “Provided is a non-invasive method for diagnosing colorectal cancer in a subject by detecting enrichment or reduction of certain bacterial species. A kit and device useful for such methods are also provided. In addition, a method for reducing the risk of colon cancer by regulating the pertinent bacterial species in human colon is also provided.” (Abstract).
Regarding claims 1 and 10, Yu teaches a method comprising “The present invention relates to measuring the level or amount of a signature DNA or RNA for one or more bacterial species found in a person's stool sample as a means to detect the presence, to assess the risk of developing, and/or to monitor the progression or treatment efficacy of colon cancer, including assessing the likelihood of disease recurrence.” (Para. 110; Para. 6). Yu teaches a method comprising “Stool samples were collected from individuals referred to colonoscopy due to symptoms associated with CRC or from patients who had been diagnosed with CRC and referred to large bowel resection for their primary cancer disease” (Para. 197). Yu teaches a method comprising “Such increased or decreased presence of these bacterial species results in higher or lower levels of signature DNA, RNA, and protein species unique to these species, which in turn can be used for detection, both qualitatively and quantitatively, the abnormally enriched/suppressed bacteria population in the samples, thus providing critical information relating to the presence of or a heightened risk of CRC in a human subject, including an increased risk of recurrence of CRC after initial treatment (e.g., surgical intervention, chemotherapy, and/or radiation therapy) in a patient who has been diagnosed of the disease” (Para. 5).
Regarding claims 1 and 10, Yu teaches a method comprising “steps of: (a) quantitatively determining level of at least one of the bacterial species of … Bacteroides clarus… Clostridium hathewayi in a stool sample taken from the subject; (b) comparing the level obtained in step (a) with a standard control; (c) determining the level obtained in step (a) as increased or decreased from the standard control; and (d) determining the subject as having an increased risk for colon cancer.” (Para. 7). Yu teaches a method comprising “determining the level of a DNA unique to each of Bacteroides clarus and Clostridium hathewayi, optionally further comprising determining the level of a DNA unique to Fusobacterium nucleatum.” (Para. 9) and Marker gene id “482585” (Pg. 86, Table S13). Yu also teaches a method comprising “Lachnospiraceae” Firmicutes. “Marker gene id 482585” reads on Lachnoclostridium species carrying genetic marker M3. “Lachnoclostridium species carrying genetic marker M3” reads on the Lachnospiraceae family. Thus, Yu teaches a method for assessing risk for colorectal adenoma recurrence in an individual after removal of colorectal cancer or adenoma, comprising the steps of: (a) obtaining in a first stool sample taken from the individual prior to the removal of colorectal cancer or adenoma a baseline level of one or more of four bacterial species of a Lachnoclostridium species carrying genetic marker m3 (m3), Fusobacterium nucleatum (Fn), Clostridium hathewayi (Ch), and Bacteroides clarus (Bc); (b) obtaining in a second stool sample taken from the individual after the removal of colorectal cancer or adenoma a follow-up level of the one or more of the four bacterial species; (c) calculating a combined score from the baseline level and follow-up level of any one of more of the four bacterial species Fn, m3, Bc, and Ch; and (d) detecting the value to be higher than a standard control value and determining the individual as having increased risk for colorectal adenoma recurrence; and a method for assessing risk for colorectal adenoma recurrence in an individual after removal of colorectal cancer or adenoma, comprising the steps of: (a) obtaining in a stool sample taken from the individual after the removal of colorectal cancer or adenoma a value of (1) level of one or more of three bacterial species of a Lachnoclostridium species carrying genetic marker m3 (m3), Fusobacterium nucleatum (Fn), and Clostridium hathewayi (Ch); or (2) combined score of levels of two bacterial species m3 and Ch, which is calculated by I2+β5*m3+β6*Ch; or (3) combined score of levels of three bacterial species Fn, m3, and Ch, which is calculated by I3+β7*Fn+β8*m3+β9*Ch; or (4) combined score of levels of four bacterial species Fn, m3, Bc, and Ch, which is calculated by I1+β1*Fn+β2*m3+β3*Bc+β4*Ch; and (b) detecting the value to be higher than a standard control value and determining the individual as having increased risk for colorectal adenoma recurrence.
The teachings of Yu are documented above in the rejection of claims 1 and 10 under 35 U.S.C. 103. Claims 2-9 depend on claim 1. Claim 7 depend on claim 6, which depend on claim 1. Claim 9 depend on Claim 8, which depend on claim 1. Claims 11-17 depend on claim 10. Claim 15 depends on claim 14, which depend on claim 10.
Regarding claim 2, Yu teaches a method wherein “A simple linear combination of four bacterial marker candidates (Fn, Bc, Ch, and …) improves the diagnostic ability of Fn alone for CRC.” (Para. 104). Thus, Yu teaches a method wherein the combined score of the baseline and follow-up levels of any one, two, three, or four of the four bacterial species is calculated by a method listed in Table 1.
Regarding claims 3 and 11, Yu teaches a method wherein “Marker gene id “482585” (Pg. 86, Table S13). “Marker gene id 482585” reads on genome of m3 and SEQ ID:19. Thus, Yu teaches a method wherein the genome of m3 comprises the nucleotide sequence of SEQ ID NO:19, or wherein the genome of Ch comprises the nucleotide sequence of SEQ ID NO:20, or wherein the genome of Fn comprises the nucleotide sequence of SEQ ID NO:21, or wherein the genome of Bc comprises the nucleotide sequence of SEQ ID NO:22.
Regarding claims 4 and 12, Yu teaches a method wherein “Patients were diagnosed by colonoscopic examination and histopathological review of any biopsies taken.” (Para. 251). “colonoscopic examination and biopsies” reads on adenoma removed by polypectomy. Thus, Yu teaches a method wherein the individual had colorectal adenoma removed by polypectomy.
Regarding claims 5 and 13, Yu teaches a method wherein “level of a DNA, RNA, or protein” and “determining the level of a DNA unique to each of Bacteroides clarus and Clostridium hathewayi, optionally further comprising determining the level of a DNA unique to Fusobacterium nucleatum.” (Para. 9). Furthermore, Yu teaches a method wherein “case-enriched …gene markers …their abundances were measured by qPCR…m482585” (Para. 184).” m482585” reads on m3. Thus, Yu teaches a method wherein steps (a) and (b) each comprises obtaining the level of a DNA, RNA, or protein unique to at least one of the bacterial species Fn, m3, Bc, and Ch.
Regarding claims 6-7 and 15-14, Yu teaches a method wherein “Once DNA or mRNA is extracted from a sample, the amount of a predetermined bacterial DNA or RNA (such as 16s rDNA or RNA encoded by a bacterial gene unique to the bacterial species) may be quantified. The preferred method for determining the DNA or RNA level is an amplification-based method, e.g., by polymerase chain reaction (PCR), including reverse transcription-polymerase chain reaction (RT-PCR) for RNA quantitative analysis.” (Para. 114). Thus, Yu teaches a method wherein steps (a) and (b) each comprises a polymerase chain reaction (PCR) for measuring the level or levels of the bacterial species; and wherein the PCR is a quantitative polymerase chain reaction (qPCR) or reverse transcription polymerase chain reaction (RT-PCR)
Regarding claims 8 and 16, Yu teaches a method wherein “when the subject is determined as having an increased risk for colon cancer, a repeat … is performed at a later time using another stool sample from the subject at the later time.” (Para. 11). Yu teaches a method wherein “increased or decreased presence of these bacterial species results in higher or lower levels of signature DNA, RNA, and protein species unique to these species, which in turn can be used for detection, both qualitatively and quantitatively, the abnormally enriched/suppressed bacteria population in the samples, thus providing critical information presence of or a heightened risk of CRC in a human subject, including an increased risk of recurrence of CRC after initial treatment (e.g., surgical intervention)” (Para. 5). Furthermore, Yu teaches a method wherein “In addition, upon detecting the enrichment of certain bacterial species in a patient's gut, which is shown by the present inventors as relevant to colon cancer, one may establish the presence of colon cancer in the patient or an increased risk of later developing the disease in the patient… undergo regularly scheduled screening/examination … every 5 years).” (Para. 133). “at a later time” reads on about one to five years. Thus, Yu teaches a method wherein the second stool sample is taken from the individual about one to five years after the removal of the colorectal cancer or adenoma.
Regarding claims 9 and 17 Yu teaches a method wherein “when the subject is determined as having an increased risk for colon cancer, a repeat … is performed at a later time using another stool sample from the subject at the later time.” (Para. 11). “at a later time” reads on about one year after. Thus, Yu teaches a method wherein the second stool sample is taken from the individual about one year after the removal of the colorectal cancer or adenoma.
Therefore, the invention as recited in claims 1-17 are prima facie obvious over the prior art Yu et al. One of ordinary skill in the art would have had a reasonable expectation of success given the lack of novelty. It would have been obvious to provide a method for assessing the risk for colorectal adenoma recurrence in an individual after removal of colorectal cancer or adenoma according to the limitations of the instant application claims 1-17 based on Yu et al. (Patent App. Pub. No. WO 2018036503 A1).
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. US 11603567 B2, Mar. 14, 2023, filed Aug. 23, 2017) in view of Yu et al. (“Yu”; Patent App. Pub. WO 2018036503 A1, Mar. 1, 2018, filed on Aug. 25, 2016). Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is made obvious over the claims 1-3 of U.S. Patent No. US 11603567 B2.
The claims of U.S. Patent No. US 11603567 B2 are drawn to:
“1. A method for assessing risk for colon cancer in a subject, comprising the steps of: (a) performing a polymerase chain reaction to amplify the nucleotide sequence set forth in SEQ ID NO:3, thereby quantitatively determining level of a bacterial species whose genome comprises the nucleotide sequence set forth in SEQ ID NO:3 in a stool sample taken from the subject; (b) comparing the level obtained in step (a) with a standard control; (c) determining the level obtained in step (a) as increased from the standard control; (d) determining the subject who has an increased level in step (c) as having an increased risk for colon cancer; and (e) administering colonoscopy to the subject who has been determined in step (d) as having an increased risk for colon cancer/examination.
2. The method of claim 1, further comprising quantitatively determining Parvimonas micra, Solobacterium moorei, Clostridium hathewayi, or Fusobacterium nucleatum level in the sample.
3. The method of claim 1, further comprising quantitatively determining Bacteroides clarus or Roseburia intestinalis level in the sample.”
The teachings of Yu are documented above in the rejection of claims 1-17 under 35 U.S.C. 103.
Claims 1-3 of U.S. Patent No. of U.S. Patent No. US 11603567 B2 in view of Yu make obvious the instantly claimed invention. One of ordinary skill in the art would have had a reasonable expectation of success given the lack of novelty. It would have been obvious to provide a method for assessing the risk for colorectal adenoma recurrence in an individual after removal of colorectal cancer or adenoma according to the limitations of the instant application claims 1-17 based on U.S. Patent No. US 11603567 B2 in view of Yu (Patent App. Pub. No. WO 2018036503 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Feng et al. (“Feng”; Patent No. US 10526659 B2, Jan. 7, 2020, filed on Feb. 5, 2016). (entire document; Claim 3 SEQ ID No:10, 17, 14 and 19 have 100% identity to SEQ ID No: 19-22, respectively)
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENDRA R VANN-OJUEKAIYE whose telephone number is (571)270-7529. The examiner can normally be reached M-F 9:00 AM- 5:00 PM.
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/KENDRA R VANN-OJUEKAIYE/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682