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 .
Election/Restrictions
Applicant’s election without traverse of Group III in the reply filed on 6/22/26 is acknowledged.
“In addition, to comply with the species election requirement, Applicant hereby elects, without traverse, the species corresponding to Presepsin as the first biomarker and GDF-15 as the second biomarker, as recited in claims 23(b) and 23(c). All elections above are commensurate with one another and directed to the same embodiment, namely a method for determining the amount of Presepsin and GDF-15 in a sample from a subject by contacting the sample with agents which specifically bind each of these biomarkers.”
Claims 23-27 are considered as they read on the elected species.
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.
Claims 23-27 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.
Claim 23, and subsequently its dependents, are rendered indefinite because it is confusing and unclear what the correlation and/or relationship between steps (b-d) and e is. The claim is drawn to “a method of determining the amount…” which seems to be represented in steps b-d via specific binding so it is unclear if step e is intended to define steps b-d or is an actual separate step. As a separate additional step, step e would seem repetitive to steps b-d but it is unclear what the step adds to the “a method of determining the amount…” As such the claims are rendered indefinite but the current claim language as the claims fail to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Please note that the language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its "metes and bounds". See, e.g., the following decisions: In re Hammack, 427 F 2d. 1378, 1382, 166 USPQ 204, 208 (CCPA 1970); In re Venezia 530 F 2d. 956, 958, 189 USPQ 149, 151 (CCPA 1976); In re Goffe, 526 F 2d. 1393, 1397, 188 USPQ 131, 135 (CCPA 1975); In re Watson, 517 F 2d. 465, 477, 186 USPQ 11, 20 (CCPA 1975); In re Knowlton 481 F 2d. 1357, 1366, 178 USPQ 486, 492 (CCPA 1973). The courts have also indicated that before claimed subject matter can properly be compared to the prior art, it is essential to know what the claims do in fact cover. See, e.g., the following decisions: In re Steele, 305 F 2d. 859, 134 USPQ 292 (CCPA 1962); In re Moore 439 F 2d. 1232, 169 USPQ 236 (CCPA 1969); In re Merat, 519 F 2d. 1390, 186 USPQ 471 (CCPA 1975).
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 23-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giron et al medRxiv,16 November 2020.
Giron (p. 6, li. 93-96) teaches that levels of soluble CD14 (sCD14) were significantly increased during severe versus mild infection of healthy controls. sCD14 is cleaved in plasma to sCD14-ST (presepsin) meaning that levels of presepsin are consequently the same as sCD14 levels. GironD6 (p. 7, li. 113-115) teaches measuring levels of GDF-15 (Figure 2f; indicative of oxidative stress), with the levels of GDF-15 higher in deceased hospitalized patients compared to survivors (Figure 2g). Fig. 2g shows levels of GDF-15 increase in severe (and moderate) infection versus and healthy controls (scoring the level of infection). Determination of said biomarkers was performed in plasma samples (see p. 16, li. 372 - p. 17, li. 390) by contacting the markers with specific agents including antigens/antibodies (p 4).
The reference anticipates the claim subject matter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
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