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 .
The Amendments and Remarks filed 2/19/26 in response to the Office Action of 8/20/25 are acknowledged and have been entered.
Claims 29-40 have been added by Applicant.
Claims 1, 3-5, 7-11, and 16-40 are pending.
Claims 1, 3-5, 7-11, and 16-28 have been amended by Applicant.
Claims 1, 3-5, 7-11, and 16-40 are currently under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The following Office Action contains NEW GROUNDS of rejections Necessitated by Amendments.
Objections Withdrawn
All objections are withdrawn.
Rejections Withdrawn
The rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
The rejection of claims under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 103 are withdrawn.
The rejection of claims under 35 U.S.C. 101 is withdrawn.
Rejection of claims on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 18-25 of copending Application No. 17/637518 in view of Bergmann (EP 2 594 588 B1; 5/21/14; “Bergmann2”) is withdrawn.
Rejection of claims on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 17/802817 (reference application) in view of Bergmann (WO 2017/182561 A1; 10/26/17) is withdrawn.
Rejection of claims on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/998052 (reference application) is withdrawn.
Rejections Maintained
Double Patenting
Claims 1, 3, 4, 7-11, 19, and 24-28 remain provisionally rejected and claims 5 and 16-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, 10, 16, 18-20, 22-26, 28-30, and 32 of copending Application No. 17/801108 (reference application). Copending claims and the instant claims are both drawn to methods of administering an anti-ADM antibody to a patient in shock that has been determined to have a level of ADM-HN2 above a threshold level and/or a level of DPP3 in a bodily fluid sample below a threshold. Copending claims do not recite an ADM-HN2 threshold level that is between 40-100 pg/mL or a DPP3 threshold that is between 30 and 80 ng/mL or that the capture binder used to measure level of ADM-HN2 or DPP3 is an “antibody”, an antibody that binds full-length DPP3, or an antibody that is immobilized on a surface. Copending claims further do not recite determining level of DPP3 involves a separation step that is a washing step to remove ingredients not bound to the capture binder. Copending claims further do not recite levels of ADM-HN2 and DPP3 are measured using a microfluidic device. Copending claims do not specifically recite DPP3 “activity” levels as the DPP3 levels.
Although the claims at issue are not identical, they are not patentably distinct from each other because one have been motivated to perform methods of copending claims wherein DPP3 level is determined in a bodily fluid sample of a patient with shock using steps of determining DPP3 levels disclosed by the copending specification (including using a microfluidic point-of-care device that detects levels of DPP3 and/or ADM-HN2; and including using an antibody that specifically binds full-length DPP3 that is immobilized on a surface, contacting the sample with the immobilized antibody, and a separation step that is a washing step that removes ingredients of the sample that are not bound to the antibody and separates bound DPP3 from the sample, and quantifying DPP3 levels; including wherein DPP3 the levels are DPP3 “activity” levels measured using recited substrates) and wherein the DPP3 threshold is 50 mg/mL and ADM-HN2 threshold is 70 pg/mL because the copending specification discloses that is how levels of DPP3 and/or ADM-HN2 are measured (paragraph spanning pages 22-23, lines 8-10 on page 23, lines 30-32 on page 14, lines 4-5 on page 24, lines 9-11 on page 26) and the copending specification teaches such thresholds 50 mg/mL DPP3 and 70 pg/mL ADM-HN2 as the “most preferred” thresholds to be used in the claimed method (lines 30-35 on page 6 and lines 16-20 on page 7, in particular).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In the Reply of 2/19/26, Applicant argues this rejection should be withdrawn because claim 1 incorporates some language previously found in claim 5.
The amendments to the claims and the arguments found in the Reply of 2/19/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that this rejection should be withdrawn because claim 1 incorporates some language previously found in claim 5, the examiner disagrees. Previously pending claims have all been amended. Previous claim 5 was not part of any prior art or NSDP rejection because the claim was too unclear to determine what was being claimed.
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112
Claim 11 is 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 11 recites “…not bound to a capture-binding from the captured DPP3.” There is insufficient antecedent basis for “the captured DPP3” in the claim. In an effort to expedite prosecution, the following amendment is suggested to obviate this rejection: “…not bound to a capture-binding from captured DPP3.”
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.
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/SEAN E AEDER/Primary Examiner, Art Unit 1642