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 .
Election/Restrictions
Applicant’s election of Group 1, Claims 17-27 in the reply filed on 07/10/2026 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)).
Claims 28-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of treating dysbiosis in a cancer patient and method for treating dysbiosis in an individual who is a high risk heavy smoker having a cardiovascular event, there being no allowable generic or linking claim.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms "Biomerieux [pg 19, line 26)", “eBioscience [pg 22, line 35]”, and “Cytoflex [pg 23, line 8]” etc., which are trade names or marks used in commerce, have been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1is objected to because of the following informalities:
the term "MAdCAM-1" in step (i) should be written as "Mucosal Addressin Cellular Adhesion Molecule-1 (MAdCAM-1) when referenced the first time. It is proper to use the acronym thereafter.
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 17-27 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.
Claim 17 recites the limitation "the level of serum soluble MAdCAM-1" in step (i). That limitation is not defined in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 18-27 are dependent on claim 17, thus also rejected.
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 17-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 17 recites “ comparing the level of serum soluble MAdCAM-1 in the sample to a predetermined threshold value”. The limitation stated above, as drafted, are processes that, under their broadest reasonable interpretation, cover performance of the limitations in the mind.
Step 1: Claim 17 recites at least one step or act. Thus, the claim is to a method, which is one of the statutory categories of invention. Claim 18-27 are dependent on Claim 17.
Step 2A Prong One: Claim 17 recites a judicial exception ad identify that abstract idea/law of nature/natural phenomenon. Claim 17 recites comparing the difference between the sample and predetermined threshold value. This would be considered an evaluation (mental step) as well as can be done with pen and paper and therefore is an abstract idea.
Step 2A Prong Two: The judicial exception is not integrated into a practical application because the claim does not impose any meaningful limits on practicing the abstract idea. Claim 17 generally describes comparing the difference between the sample and the predetermined threshold of level of serum soluble MAdCAM-1. Once the abstract idea is complete, there is a broad step of treating the patient after the comparison described with a high-level of generality. The general step of treating the patient does not appear to be enough to integrate the abstract idea into a practical application.
Step 2B: Claim 17 recite highly general steps which are well known and conventional in the art and taught by the references below. Claim 18-27 define parameters of the method to be performed which are well known in the art and taught by the references below. Claimed 18- 27 do not appear to have ‘significantly’ more and all steps in the method in claim 17 are well understood routine and conventional. Claim 18 recites a further measuring step which is recited in a high level of generality. Claims 19-24 recites specific embodiment of I-O therapy and MCI which does not add significantly more. Claims 25-27 recite administering step which appear to be highly general and non-specific. Claims 18-27 are ineligible because the step of comparing the difference is claimed at a high-level generality, there is no meaningful limitation claimed.
Thus, claim 17 is ineligible. Claims 18-27 are dependent on claim 17, do not include anything more than the abstract idea, thus also ineligible.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 17, 18, 19, 20, 23, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (WO 2020150208 A1) and further in view of Shaked (US 20190113513 A1).
Regarding claim 17, Zhang teaches a method of treating cancer patient comprising:
measuring the level of Duoxa2 in a sample from the patient (pg 2, para 0008),
comparing the level of Duoxa2 in the sample to a predetermined threshold value that is a median of the levels of Duoxa2 in a cohort of individuals suffering from the same cancer as the patient (pg 3, para 0008-0009),
if the level of serum soluble MAdCAM-1 in the sample is less than the threshold value (pg 2, para 0008) , treating the patient with a compensatory microbiota-centered intervention (MCI) (‘retinoic acid’, para 0093) before administration of an immune-oncology (I-0) therapy (‘anti-PDI therapy’, para 0012, and para 0085).
Zhang does not teach measuring the level of serum soluble MAdCAM-1 in a sample from the patient, and comparing the level of serum soluble MAdCAM-1 in the sample to a predetermined threshold value that is a median of the levels of soluble MAdCAM-1 in a cohort of individuals suffering from the same cancer as the patient.
However, Shaked teaches a method of predicting response of a cancer patient to treatment with immune checkpoints inhibitors by determining changes in the levels of factors/biomarkers (Abstract). Shaked further teaches the factor being MadCAM-1 (para 0082). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Duoax2 as taught by Zhang with MAdCAM-1 as taught by Shaked for the benefit of improving therapeutic outcomes (para 0007).
Regarding claim 18, Zhang in view of Shaked teaches the invention of claim 17.
Zhang does not teach measuring the level of serum soluble MAdCAM-1 in a sample from the patient after MCI.
Shaked teach measuring the level of serum soluble MAdCAM-1 in a sample from the patient after MCI (para 0042 ). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Zhang with measuring the level of serum soluble MAdCAM-1 in a sample from the patient after MCI as taught by Shaked for the benefit of determining how well the treatment is working (para 0076).
Regarding claim 19, Zhang in view of Shaked teaches the invention of claim 17. Zhang teaches immune-oncology therapy is a treatment with anti-PD1 antibodies (para 0012).
Regarding claim 20, Zhang in view of Shaked teaches the invention of claim 17. Zhang teaches immune-oncology therapy is a treatment with anti-PDL-1 antibodies (para 0012).
Regarding claim 23, Zhang in view of Shaked teaches the invention of claim 17. Zhang further teaches the MCI is retinoic acid (para 0093).
Regarding claim 25, Zhang in view of Shaked teaches the invention of claim 17. Zhang further teaches the immune-oncology therapy is administered in combination with an anti-IL17A (para 00127 and 0080).
Regarding claim 26, Zhang in view of Shaked teaches the invention of claim 17. Zhang further teaches the immune-oncology therapy is administered in combination with an anti-IL1RA (para 00127 and 0080).
Claims 21, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (WO 2020150208 A1) in view of Shaked (US 20190113513 A1) as applied to claim 17 above, and further in view of non-patent literature "Gut microbiota modulation: a novel strategy for prevention and treatment of colorectal cancer" by Fong et al.
Regarding claim 21, Zhang in view of Shaked teaches the invention of claim 17.
Zhang in view of Shaked does not teach the MCI is oral vancomycin antibiotics.
However, Fong teaches the role of gut microbiome for treatment of colorectal cancer (pg 4925, Section: Abstract). Fong further teaches vancomycin as an MCI (pg 4932, Section: Comprise of Immunotherapy efficacy). Thus, it would be obvious to modify the MCl taught in Zhang in view of Shaked with vancomycin as taught by Fong to yield predictable result of augmenting the therapeutic efficacy of anticancer drugs (pg 4936, Section: Potentiate efficacy of anticancer therapy).
Regarding claim 22, Zhang in view of Shaked teaches the invention of claim 17.
Zhang in view of Shaked does not teach the MCI is Akkermansia muciniphila.
However, Fong teaches the role of gut microbiome for treatment of colorectal cancer (pg 4925, Section: Abstract). Fong teaches Akkermansia muciniphila as an MCI (pg 4938, Section: Potentiate efficacy of anticancer therapy). Thus, it would be obvious to modify the MCl taught in Zhang in view of Shaked with Akkermansia muciniphila as taught by Fong to yield predictable result of enhanced PD1-based immunotherapy (pg 4938, Section: Potentiate efficacy of anticancer therapy).
Regarding claim 24, Zhang in view of Shaked teaches the invention of claim 17.
Zhang in view of Shaked does not teach the MCI is fecal microbial transplantation.
However, Fong further teaches fecal microbial transplantation as an MCI (pg 4932, Section: Fecal microbiota transplantation). Thus, it would be obvious to modify the MCl taught in Zhang in view of Shaked with fecal microbial transplantation as taught by Fong to yield predictable result of restoring microbial homeostasis (pg 4932, Section: Fecal microbiota transplantation).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (WO 2020150208 A1) in view of Shaked (US 20190113513 A1) as applied to claim 17 above, and further in view of non-patent literature "Interleukin-7 and immune reconstitution in cancer patients: a new paradigm for dramatically increasing overall survival" by Morre et al.
Regarding claim 27, Zhang in view of Shaked teaches the invention of claim 17.
Zhang in view of Shaked does not teach the immune-oncology therapy is administered in combination with a recombinant IL-7.
However, Morre teaches immunotherapy treatment for cancer patients using interleukin-7 (pg 55, Section: Abstract). Morre further teaches using key biomarkers for immune status of patients and to see the effects of drug therapy (pg 56, Section: The various aspects of lymphopenia: a multi-dimensional problem). Morre further teaches recombinant IL-7 used for immunotherapy (pg 55, Section: Introduction). Thus, it would be obvious to one of ordinary skill in the art before the effective filling date to modify the teachings of Zhang in view of Shaked with recombinant IL-7 in combination with other therapies as taught by Morre for the benefit of creating condition favorable for the emergence of an immune response (pg 61, Section: IL-7 for immune reconstitution: clinical data).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENA BERA whose telephone number is (571)272-9964. The examiner can normally be reached Mon-Fri 8:00-5:00pm EST.
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, Charles Capozzi can be reached at (571) 270-3638. 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.
/H.R.B./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
Prosecution Insights