DETAILED ACTION
Comments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Claims 1, 6-8, 11-14, 19-22, and 27-33 are pending and examined in the instant Office action.
Even though the claims recite judicial exceptions, the claims are subject matter eligible because the claims recite the practical application of treating subjects with cardiovascular disease.
Terminal Disclaimer
The terminal disclaimer filed on 13 April 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 11,714,093 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Rejections
The rejections under 35 U.S.C. 103 (except for claim 22) are withdrawn in view of amendments filed to the instant set of claims on 13 April 2026.
The double patenting rejections are withdrawn in view of the Terminal Disclaimer filed on 13 April 2026.
Claim Rejections - 35 USC § 112(a) - Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 6-8, 11-14, 19-22, and 27-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims have been amended to only administer disease therapy to patients classified as responsive using a pre-treatment gene expression assay of a biomarker. This limitation does not have support in the specification or original claims. While the working examples describe a clinical trial, the subjects who received treatment versus a placebo were randomized. While pages 17-18 describe drug treatments, drug treatment were not given ONLY to patients with a favorable genetic profile as tested pre-treatment. Without possession of the amended limitation, this limitation comprises NEW MATTER.
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.
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.
The following rejection is reiterated:
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steinhoff et al. [EBioMedicine, volume 22, 29 July 2017, pages 208-224; on IDS] in view of Fortney et al. [PLoS Genetics, volume 11, volume 11, article e1005728, 23 pages; on attached 892 form].
Claim 22 is drawn to a biomarker of the mutant SH2B3 gene in combination with EPC.
The document of Steinhoff et al. studies cardiac function improvement and bone marrow response with outcome analysis of the randomized PERFECT Phase III clinical trial of intramyocardial CD 133 positive application after myocardial infarction [title]. Table 4 on page 218 of Steinhoff et al. compares VEGF and EPO (SH3B2 gene biomarkers) responders and non-responders at an initial time and 10 days after treatment. Section 2.10 on pages 214-215 of Steinhoff et al. teaches using machine learning to predict the response of the treatment using cross-validation. Figure 5 and the paragraph bridging columns 1 and 2 on page 221 teaches that a subset of the study has a prediction accuracy of greater than 90%. The Methods section of Steinhoff et al. teaches treating all of the diseased patients, which would include patients responsive to the disease therapy. Table 4 on page 218 of Steinhoff et al. teaches EPC, EPO, and VEGF.
While Table 4 of Steinhoff et al. teaches SH2B3 biomarkers, Table 4 of Steinhoff et al. does not teach SH2B3 biomarker variants that are associated with a positive response to disease therapy. Steinhoff does not teach applying machine learning to SH2B3 biomarker variants. However, the paragraph bridging the columns on page 222 of Steinhoff et al. suggests that SNPs in SH2B3 promoter regions relate to coronary heart disease, arteriosclerosis, and human longevity.
The paragraph bridging the columns on page 222 of Steinhoff et al. cites Fortney et al. for further analysis of mutations of SH2B3. The document of Fortney et al. studies that a genome-wide scan informed by age-related disease identifies loci for exceptional human longevity [title]. The first full paragraph on page 13 of Fortney et al. teaches that there are mutants of SH2B3 wherein some mutants of SH2B3 are associated with cardiovascular disease and other mutants are associated with protection against lung and pancreatic cancer, coronary heart disease, rheumatoid arthritis, diastolic blood pressure, bone mineral density and human longevity. The mutants of SH2B3 in the latter aforementioned list (i.e. detected after treatment) are associated with a positive response to disease therapy.
It would have been obvious to someone of ordinary skill in the art at the time of the effective filing date of the instant application to modify the SH2B3 gene biomarkers of Steinhoff et al. by use of the SH2B3 biomarker variants of Fortney et al. wherein the motivation would have been that Fortney et al. relates SH2B3 variants to outcomes associated with the treatment [first full paragraph, page 13 of Fortney et al.].
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/ Primary Examiner, Art Unit 1686 16 August 2026
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