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 .
CONTINUING DATA
This application is a 371 of PCT/JP2022/038130 10/12/2022
FOREIGN APPLICATIONS
JAPAN 2021-204572 12/16/2021
Claims 1-19 are pending.
Drawings
The drawings are objected to because Figures 2a-2c, 3a-3b, 5c, 5f, 5g, 6h, 6i, 7f, 7i, 9b, 9c, 9d, 10a, 10b, 11c, 12b, 13a, and 13b are pixelated or contain text which is pixelated and difficult to read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Table 4 in the specification is pixelated and difficult to read.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-14 and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yvin (WO03045414A2, cited on IDS).
Yvin teaches treatment of colon cancer using soluble laminarin. See abstract. The laminarin is extracted from brown algae, has a molecular weight of 2500-6000, the average degree of polymerization is close to 25, and it is essentially beta-(1,3) linked with a low proportion of beta-(1,6) branches. Page 2. Soluble laminarin is extracted from Laminaria saccharina. Page 4. Laminarin treated mice experienced significant inhibition of cancer growth. End of page 11. The subject to be treated is also one having a disease of the immune system. Page 12, first paragraph.
Yvin is silent about whether the laminarin has Dectin-1 inhibitory activity or inhibits PGE2 production or promotes IL-22BP production. The basis in fact or technical reasoning to conclude that Yvin’s laminarin inherently has these properties is that it is beta-(1,3) linked, has a small molecular weight, is isolated from seaweed, and is soluble. The current specification that beta-glucans having a small molecular weight inhibit Dectin-1 and suppress PGE2 production and promote IL-22BP production. See paragraph [0131] of the published application. Paragraph [0137] of the current specification states that for suppressing intestinal tumors, suppressing PGE2 production, or promoting IL-22BP production, the beta-glucan is preferably a soluble beta-glucan, preferably one containing beta-1,3 linkages, and preferably derived from a seaweed, and is preferably laminarin.
A subject having colon cancer inherently in need of inhibition of PGE2 production because PGE2 induces the growth of colon cancer cells and promotes tumor angiogenesis. See Dufour.
A subject having colon cancer is inherently in need of promoting ILL-22BP production because ILL-22BP acts an IL-22 antagonist, blocking IL-22 from fueling cancer progression. See Giannou.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (US 2018/0044422 A1, February 2018, cited on IDS).
Miller teaches methods for treating tumors using Dectin-1 inhibitors. See abstract. The tumor is colorectal cancer [0007]. The Dectin-1 inhibitor can be a small molecule compound that binds Dectin-1 and inhibits its activity [0008]. The Dectin-1 antagonist can be an inhibitor of a Dectin-1 ligand [0009]. The Dectin-1 antagonist can be an antibody [0044].
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.
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.
Claim(s) 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yvin (WO03045414A2, cited on IDS) in view of Dufour (Biochemical and Biophysical Research Communications 451 (2014) 587-591).
Yvin teaches as set forth above, but Yvin does not teach treatment of a tumor which is accompanied by an increase in expression level of PEG2.
Dufour teaches that PGE2 directly induces the growth of colon cancer cells and promotes tumor angiogenesis. See abstract. High PGE2 levels were found in human samples of CRC. See Introduction.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out Yvin’s method wherein the tumor is accompanied by an increase in expression level of PGE2 because PGE2 drives colon cancer and high levels are found in human samples. A subject having a tumor accompanied by an increase in expression level of PGE2 is particularly in need of treatment because PGE2 drives colon cancer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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