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 .
Priority
This application filed 07/01/2024 Claims Priority from Provisional Application 63524302 , filed 06/30/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/24/2024 complies with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 8 been renumbered 5.
Misnumbered claim 9 been renumbered 6.
Misnumbered claim 10 been renumbered 7.
Drawings
Figure 1, 3A, 3B, 4A, 4B should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental processes) and law of nature without significantly more. The claim(s) recite(s) the judicial exception of measuring plasma renin, measuring angiotensin I and II levels in the sample, calculating ratio, and baseline plasma renin at least about three-fold higher than normal. The claim also recites a relationship between the baseline renin and the patient with angiotensin II-responsive vasodilatory shock, that is a law of nature. This judicial exception is not integrated into a practical application because the claims are drafted such that the steps are recited at best mere instructions with no integration into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. See the following analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a process.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or
abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes,
the claim recites an abstract idea (mental process) and law of nature. Under the broadest reasonable interpretation, the claimed process requires an arithmetic operation (division) that can be performed in the mind. It thus falls within the “mathematical calculations” and “mental processes” groupings of abstract ideas in MPEP 2106.04(a). This step also describes the relationship between renin levels and the patient, that is a law of nature.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The claim is directed only to the steps of diagnosis that are mere instructions to apply the exception.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental processes) and law of nature without significantly more. The claim(s) recite(s) the judicial exception of treating vasodilatory shock.
Step 1 and Step 2A prong one, are the same as for claim 1.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The additional element of ‘administration’ step is recited at such high level of generality that it is best mere instructions to apply the exception.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental processes) and law of nature without significantly more. The claim(s) recite(s) the judicial exception of diagnosing vasodilatory shock.
Step 1 and Step 2A prong one, are the same as for claim 1.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The claim is directed only to the steps of diagnosis that are mere instructions to apply the exception.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental processes) and law of nature without significantly more. The claim(s) recite(s) the judicial exception of treating vasodilatory shock.
Step 1 and Step 2A prong one, are the same as for claim 1.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The additional element of ‘administration’ step is recited at such high level of generality that it is best mere instructions to apply the exception.
Claim 5 (misnumbered claim 8) is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental processes) and law of nature without significantly more. The claim(s) recite(s) the judicial exception of treating vasodilatory shock.
Step 1 and Step 2A prong one, are the same as for claim 1.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The claim is directed only to the steps of diagnosis that are mere instructions to apply the exception.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Rinaldo Bellomo et al., hereinafter Bellomo (Rinaldo Bellomo et al., Am J Respir Crit Care Med, Vol 202, Iss9,pp1253–1261,Nov1,2020).
Regarding claim 1, Bellomo teaches treatment of catecholamine-resistant vasodilatory shock. Bellomo teaches that serum samples are analyzed from patients enrolled in the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) trial for renin, angiotensin I and angiotensin II concentrations before the start of administration of angiotensin II (see Abstract -Methods section) (i.e. obtaining sample; measuring). Specifically, Bellomo teaches that baseline serum renin concentration is above the upper limits of normal, approximately threefold higher than the upper limit of normal (see Abstract -Measurements and main results). Bellomo teaches that renin concentrations correlated positively with Angiotensin I/II ratios (i.e. calculating ratio), prior to initiation of angiotensin II therapy (see Abstract -Measurements and main results). See Fig 1.
Regarding claim 2, Bellomo teaches administration of angiotensin II (see Abstract -Measurements and main results).
Regarding claim 3, Bellomo teaches that baseline serum renin concentration is above the upper limits of normal, approximately threefold higher than the upper limit of normal (see Abstract -Measurements and main results). Bellomo teaches that renin concentrations correlated positively with Angiotensin I/II ratios (i.e. calculating ratio), prior to initiation of angiotensin II therapy (see Abstract -Measurements and main results).
Regarding claim 4, the rejected has been noted above in claim 2.
Regarding claim 5 (misnumbered claim 8), Bellomo teaches catecholamine-resistant vasodilatory shock (see Results, line 1).
Regarding claim 6 (misnumbered claim 9), Bellomo teaches intravenous angiotensin II therapy (see page 1254, last two lines of introduction).
Regarding claim 7 (misnumbered claim 10), Bellomo teaches intravenous angiotensin II therapy (see page 1254, last two lines of introduction).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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