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 .
DETAILED ACTION
Response to Submission
The present Office Action is in response to the Request for Continued Examination dated 14 April 2026.
In the submission dated 14 April 2026, the Following occurred: Claims 8 and 18 were amended.
Claims 1-18 are pending.
Priority
This application claims priority to U.S. Provisional Patent Application No. 63/525,572 dated 07 July 2023.
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 14 April 2026 has been entered.
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 14 April 2026 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Subject Matter Free of Prior Art / Subject Matter Eligible
The claimed invention is free of prior art and is subject matter eligible for the reasons presented in the Notice of Allowance dated 14 January 2026.
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 1-18 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 pre-AIA the applicant regards as the invention.
Claims 1, 9, and 18 recite (Claim 1 being representative) “a manufacturer-sealed sterile surgical package, a surgical instrument, and an environmental sensor; at least one data processor disposed in the surgical package; a killswitch operatively coupled to the at least one data processor and the surgical instrument; and memory disposed in the surgical package and storing instructions configured to cause the at least one data processor to perform operations comprising….” The claim is indefinite because it is unclear whether the surgical instrument and environmental sensor are contained within the manufacturer-sealed sterile surgical package. The claim implies that the environmental sensor is within the package, but does not explicitly state this. In the event that the environments sensor is outside of the package, it is unclear how the environmental sensor can sense humidity (and possibly temperature) inside the package. Similarly, the claim implies that that the surgical instrument is within the surgical package, but never explicitly states this. Because the claim can be read two ways with regard to the surgical instrument and environmental sensor being within the surgical container, the claim is indefinite. A review of the Specification (Para. 0028, 0080, 0227) and Drawings (Fig. 2, 5, 8-10, 20, 21,) indicate that both of these items are within the package and the Examiner suggests explicitly claiming this.
By virtue of their dependence from Claim 1 or 9, this basis of rejection also applies to dependent Claims 2-8 and 10-17.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Bunza et al. (U.S. Patent No. 7,812,731) which discloses a system for detecting predetermined environment conditions via various sensors disposed around a shield that mitigates incontinence (a diaper).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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