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 .
Prior Art Discussion
The closest prior art is Dhara et al. (US 2021/0324376) which discloses an assay for transposase-accessible chromatin and a method for calculating a prognostic score for predicting PDAC recurrence. See Example 1. Each of the genes identified in instant claim 119 parts (c)(i) and (c)(ii) are recited in Table 1 of the reference.
Dhara et al. fails to teach the contacting of step (c)(iii) and the normalizing set forth in the step (d). These combined steps are not suggested by Dhara et al. or the prior art as a whole. The instant specification teaches selection of these genes as internal control regions that are constantly accessible genomic locations in both pancreatic tumor cells and CD8+ T cells (¶00308) and using the values from these genes to normalize the values of the diagnostic genes (¶00306) and Figure 6.
Thus, the instant claims are free of the prior art.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 119-128 in the reply filed on 7/15/2026 is acknowledged. The election of species is withdrawn.
Claim 129-138, which required all the limitations of that are indicated to be free of the prior art, previously withdrawn from consideration as a result of the restriction requirement, were canceled by applicant in the reply filed on 7/15/2026.
The canceled, nonelected claim(s) may be reinstated by applicant if submitted in a timely filed amendment in reply to this action. Upon entry of the amendment, such amended claim(s) will be examined for patentability under 37 CFR 1.104.
In view of the withdrawal of the restriction requirement as set forth above, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Specification
The disclosure is objected to because of the following informalities: The specification refers to colors in drawings where the drawings are presented in black and white. See ¶ 00316.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 119-128 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.
This is a rejection for new matter.
The current claims were first filed 12/19/2025 in a preliminary amendment. The remarks filed with the amendment stated that support for the new claims can be found throughout the specification and claims as originally filed. However, basis could not be identified by the examiner for the following:
“an epigenetic drug treatment-sensitive pancreatic ductal adenocarcinoma (PDAC) tumor”
“(e) diagnosing the subject with an epigenetic drug treatment-sensitive PDAC tumor when the prognostic score is less than 0.6.”
The description ¶00235 and ¶00236 which state that “a subject having a prognostic score lower than 0.6, a poor prognostic report, indication or recurrence, or a low disease-free survival score may be advised to have no further treatment modalities…the one or more treatment modalities…an epigenetic drug.” Thus, the specification expressly teaches that if a prognostic score less than 0.6 is calculated no further treatment, including with epigenetic drugs” is advised. There is no written description of an “epigenetic drug treatment-sensitive pancreatic ductal adenocarcinoma” and is no written description that a prognostic score of less than 0.6 leads to diagnosing a subject with an epigenetic drug treatment-sensitive PDAC tumor.
Further, no basis could be identified for teaching the different drugs recited in the independent claim. The specification teaches that the “epigenetic drug is selected from DNMT inhibitor, an HDAC inhibitor, and EZH2 inhibitor, or combinations thereof….the DNMT inhibitor is azacytidine or decitabine…the HDAC in inhibitor is borinostat or romidepsin.” There is no basis identified for the specific drugs recited.
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 119-128 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.
In part (c)(ii) of the claim there is no antecedent basis of “the solid support comprising a second plurality of oligonucleotide probes bound thereto” because the claim does not previously refer to a solid support comprising a second plurality plurality of oligonucleotide probes bound thereto. It is unclear if the solid support referred to in part (ii) is the same support as the one in part (c)(i) or if it is a different solid support to with the second plurality. Part (c)(iii) is similarly indefinite when it recites “the solid support comprising a third plurality.”
The “wherein” clause of part (d) of claim 119 recites “determining a first normalized differential value of (d)(i)” and it is unclear what a “normalized differential value” is. Part d(i) is “detecting a first median hybridization intensity” and it is not clear form the claims what must occur to determine the “normalized differential value.” The term suggests normalizing but does not tell how the intensity is normalized and it suggests some sort of “differential” but is silent as to how this is determined. Thus, the metes and bounds of the requirement are unclear. The claim is similarly unclear when it recites “a second normalized differential value of (d)(ii).” There is no definition of this term in the specification and thus the metes and bounds are unclear.
Furthermore, the wherein clause states that “the prognostic score is calculated” by determining the differential values and “comparing” them. It is unclear how “comparing” accomplishes calculating the prognostic score since “comparing” is a logical operation and not an arithmetic operation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
