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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/11/26 has been entered.
Claims 1, 3-5, 7-11, and 16-40 are pending and currently under consideration.
Rejections Maintained
Double Patenting
Claims 1, 3-5, 7-11, and 16-40 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 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 would 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 lines 1-3 on page 21) 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 9/11/26, Applicant request a Notice of Allowance for the instant application because the instant claims are allowable but for the provisional nonstatutory double patenting rejection, claims of the copending application are subject to further amendment, and the instant application is not commonly owned with the copending application. Applicant further correctly states no claim of the copending application recites the ”pre-determined threshold of DPP3 protein level is between 30 and 80 ng/mL” claimed in instant claim 1. Applicant further cites MPEP 2144.05(II)(D) and argues copending claim 1 does not overlap with instant claim 1 because (i) it does not specify a protein level, and (ii) even if an unrecited protein level could be read into the claim (which it should not be, because to do so requires hindsight based on the language of instant claim 1), such an unrecited protein level would be “so broad” as to “not invite optimization by one skilled in the art.” Applicant further cites MPEP 2144.05(I) and argues the value of 120 ng/mL of copending claim 4 is well outside of instant claim 1’s range of “between 30 and 80 ng/mL” and concludes copending claim 4 does not “overlap or lie inside the range” of instant claim 1, nor is “merely close” to the range in instant claim 1. Applicant further cites In re Kaplan and argues the instant claim 1 only could have been found to be an obvious variant of the copending application by impermissibly treating the copending application’s disclosure as though it were prior art. Applicant further correctly states that instant claim 33 recites “determining a level of DPP3 activity in a sample of bodily fluid of said patient, [and] comparing said level of determined DPP3 activity to a pre-determined threshold of DPP3 activity”, while claim 1 of the copending application recites a level of dipeptidyl peptidase (DPP3) without further specifying the level is “activity” level and does not recite the “determining” or “comparing” steps of instant claim 33. Applicant further correctly states the word “comparing” is not found in any claims of the copending application.
The arguments found in the Reply of 9/22/26 have been carefully considered, but are not deemed persuasive. In regards to the request a Notice of Allowance for the instant application because the instant claims are allowable but for the provisional nonstatutory double patenting rejection, claims of the copending application are subject to further amendment, and the instant application is not commonly owned with the copending application: the request is denied.
In regards to the citation of MPEP 2144.05(II)(D) and argument copending claim 1 does not overlap with instant claim 1 because (i) it does not specify a protein level, and (ii) even if an unrecited protein level could be read into the claim (which it should not be, because to do so requires hindsight based on the language of instant claim 1), such an unrecited protein level would be “so broad” as to “not invite optimization by one skilled in the art”, copending claim 1 is not read in a vacuum. Portions of the copending disclosure that provide support for copending claim 1 (including those that provide support for a recited protein level) are considered when addressing the issue of whether a claim in the instant application defines an obvious variation of the copeding claims and such portions specify a protein level encompassed by instant claim 1. This use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.
In regards to the citation of MPEP 2144.05(I) and argument the value of 120 ng/mL of copending claim 4 is well outside of instant claim 1’s range of “between 30 and 80 ng/mL” and concludes copending claim 4 does not “overlap or lie inside the range” of instant claim 1, nor is “merely close” to the range in instant claim 1, a threshold “between 30 and 80 ng/mL” for copneding claim 1 is found in portions of the copending disclosure that provide support for copending claim 1.
In regards to the citation of In re Kaplan and argument that instant claim 1 only could have been found to be an obvious variant of the copending application by impermissibly treating the copending application’s disclosure as though it were prior art, the examiner disagrees. With the claims at issue with In re Kaplan, Kaplan had been issued a patent on a process of making chemicals in the presence of an organic solvent. Among the organic solvents disclosed and claimed as being useful were tetraglyme and sulfolane. One unclaimed “example” in the patent was specifically directed to a mixture of these two solvents. The claims in the application to Kaplan and Walker, the application before the Office, were directed to essentially the same chemical process, but requiring the use of the solvent mixture of tetraglyme and sulfolane. In reversing the double patenting rejection, the court stated that the mere fact that the broad process claim of the patent requiring an organic solvent reads on or "dominates" the narrower claim directed to basically the same process using a specific solvent mixture does not, per se, justify a double patenting rejection. The court also pointed out that the double patenting rejection improperly "used the disclosure of the appellants’ joint invention [solvent mixture] in the Kaplan patent specification as though it were prior art." Kaplan, 789 F.2d at 1577, 229 USPQ at 681. See MPEP 804. Unlike claims at issue with in re Kaplan, the copending specification does not merely teach a threshold encompassed by instant claim 1 as just one of many examples. Rather, the copending specification discloses thresholds of 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).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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
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