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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New grounds of rejection under 35 U.S.C. 101 are presented. Since the new grounds are not entirely necessitated by Applicant’s amendment to the claims, this action is made non-final.
Applicant’s arguments, see remarks, filed 8/5/2025, with respect to the rejection of claims 1-12 and 17-20 have been fully considered and are persuasive. The rejection of claims 17-20 under 35 U.S.C. 101 has been withdrawn. Specifically, applicant amendments to the claims are interpreted to integrate the judicial exception into a practical application by providing a specific improvement in the technological field of access disconnection detection. Although the claims only require the limited action of generating an alarm, or stopping the pump, these are limitations which are necessary for the device to prevent loss of blood or life following making a determination on access disconnection.
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.
Claims 1-12 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites,
“an extracorporeal circuit extending from a patient blood withdrawal site through an extracorporeal blood treatment device and back to a patient blood delivery site, wherein the extracorporeal circuit comprises a blood withdrawal line extending from the [[a]] patient blood withdrawal site to the [[a]] blood treatment device, a blood delivery line extending from the blood treatment device to the [[a]] patient blood delivery site”
These limitations effectively require the device be directly connected to the patient and therefore are interpreted to encompass the human organism. Examiner recommends applicant consider rewriting the claim language as functional language related to the extracorporeal circuit. For example, “an extracorporeal circuit configured to extend
Claims 2-12 are rejected based on their dependency from, and therefor incorporation of the limitations of, claim 1.
Allowable Subject Matter
Claims 17-20 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN JACOB KLEIN whose telephone number is (571)270-5213. The examiner can normally be reached 8:00am - 5:00pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
