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 .
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Receipt is acknowledged of IDS filed on 09/05/2025.
Claims 20 and 21 have been added.
Claims 1, 3-13 and 15-21 are pending.
Claims 2, 14, 15 are cancelled.
Claims 5, 7-13, 16-19 and 21 are withdrawn.
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 20 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 20 recites the limitation "the B-cell". There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is in reference to B-cell immune tolerance and it is unclear how this limits claim 1.
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.
Claims 1, 3 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JONES (Folate and Inflammation – links between folate and features of inflammatory conditions. Journal of Nutrition and Intermediary Metabolism. 2019.).
Regarding claim 1, JONES teaches that low folate levels are commonly observed with chronic inflammatory diseases, indicating that inadequate folate may be involved in the pathogenesis of inflammatory conditions (abstract). Folate supplementation can be a treatment for these inflammatory conditions (abstract). Folate may prevent endothelium dysfunction by maintaining levels of homocysteine (Hcy) (Page 1, paragraph 2). At elevated levels, Hcy can cause endothelial dysfunction, resulting in a shift towards a pro-inflammatory state (page 2, paragraph 3). 5-10 mg/day of folic acid over 6-8 weeks improved endothelial function in subjects with elevated Hcy (Page 4, paragraph 2). This reads on a method for treatment of hypersensitivity comprising administering an effective amount of folic acid to a subject.
Regarding claim 3, note: claim 1 only requires B-cell immune tolerance for transplant rejection not hypersensitivity, therefor claim 3 does not apply.
Regarding claim 4, note: the art is towards treating a hypersensitivity not the production against an immunogenic substance, therefor claim 4 does not apply.
Claims 1, 3, 6 and 20 is rejected under 35 U.S.C. 102(a)(1) as anticipated by SANDHAUS (Organ Transplantation. Life Extension. 2010.).
Regarding claims 1 and 6, SANDHAUS teaches that immunosuppressive drugs must be taken in order to avoid organ transplant rejection (Section 8, paragraph 2). Immunosuppressive drugs can cause an increase in homocysteine levels, which damages endothelial cells (Section 7, paragraph 3). A method of administering folic acid significantly reduced the levels of homocysteine (Hcy) to assist in organ transplant patients (Section 7, paragraph 7).
Regarding claim 1, 3 and 20, although the reference is silent about inducing B-cell immune tolerance, where the B-cell is a spleen or lymph node B-cell expressing mIgm, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. /n re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the subject is being administered the same active agent, folic acid, by the same mode of administration in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, the references teaches, either expressly or inherently, each and every limitation of the instant claims.
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 1, 3, 4, 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over SANDHAUS (Organ Transplantation. Life Extension. 2010.) in view of CHOWDHURY (Post-transplant diabetes mellitus. Royal College of Physicians. 2019).
SANDHAUS teaches Applicant’s invention as discussed above.
SANDHAUS does not teach administering insulin with the folic acid.
CHOWDHURY teaches that post-transplant diabetes mellitus (PTDM) is common following organ transplantation (abstract). Administering insulin after transplantation has been found to reduce risk of post-transplant diabetes mellitus (page 394, paragraph 6).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate administering insulin with the folic acid. The person of ordinary skill in the art would have been motivated to make those modifications, because it prevents PTDM in patients, and reasonably would have expected success because the references are in the same field of endeavor, such as medicines for organ transplants.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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