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
In the amendments filed 29 July 2026:
Claims 4 and 16 are cancelled
Claims 1, 3, 5, 8, 11-12, 15, 17, 20, 22 are amended
Claims 1-3,5-15,17-22 are pending
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 29 July 2026 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
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 1-3,5-15,17-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 12, and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method and non-transitory computer program product, which are within a statutory category.
Step 2A1
The limitations of:
Claims 1, 12, and 22 (Claim 1 being representative)
catalogue components of the surgical instrument;
receive data characterizing a geopolitical location of a healthcare site hosting the surgical procedure;
determine […a function is…] non-compliant with local rules of the geopolitical location;
in response to determining non-compliant with the local rules of the geopolitical
location, alter or de-activate capabilities compliant with the local rules of the geopolitical location;
and in response to determining that the manufacturer-sealed sterile surgical package has been opened:
determine a waste classification of a component of the surgical instrument;
determine a disposal procedure for the component of the surgical instrument based on the waste classification;
adjust the disposal procedure based on the received data characterizing the geopolitical location of the healthcare site hosting the surgical procedure;
and generate a control signal configured to cause a change in a color to indicate the adjusted disposal procedure at an end of the surgical procedure,
as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to properly classify and dispose of a surgical instrument in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “cataloguing, determining and generating” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a method implemented by a processor (computer), the claimed invention amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The Examiner notes that the limitation reciting “in response to determining that the component is non-compliant with the local rules of the geopolitical location, alter or de-activate capabilities of the component such that the component is compliant with the local rules of the geopolitical location” is described in the specification (Spec. Para. 0236) as encompassing a decision to not collecting certain data. This functionality is performed by the processor of the claim, i.e., a component of the manufacturer-sealed sterile surgical package. This feature represents choosing not to collect data and represents part of the rules or instructions of Certain Methods of Organizing Human Activity.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a processor and non-transitory computer program product that implements the identified abstract idea. The processor and non-transitory computer program product are not described by the applicant and is recited at a high-level of generality (i.e., a generic server performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claims further recite the additional elements of a manufacturer-sealed sterile surgical package containing a component, a surgical instrument and light emitting diode (LED). The manufacturer-sealed sterile surgical package containing a component, a surgical instrument and light emitting diode (LED) merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a processor and non-transitory computer program product to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a manufacturer-sealed sterile surgical package containing a component, a surgical instrument and light emitting diode (LED) were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. As such the claims are not patent eligible.
Claims 2-11, and 13-21 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 13 merely describe(s) measuring accuracy of the disposal, which further defines the abstract idea.
Claim(s) 3, 15 merely describe(s) characterizing available procedures, which further defines the abstract idea.
Claim(s) 5, 17 merely describe(s) characterizing a performance error, which further defines the abstract idea.
Claim(s) 6, 18 merely describe(s) a return address, which further defines the abstract idea.
Claim(s) 7, 19 merely describe(s) instructions, which further defines the abstract idea.
Claim(s) 8, 20 merely describe(s) a display, which further defines the abstract idea.
Claim(s) 2 also includes the additional element of “a display” which is analyzed the same as the “a manufacturer-sealed sterile surgical package” and does not provide a practical application or significantly more for the same reasons.
Claim(s) 9 merely describe(s) using e-ink label, which further defines the abstract idea.
Claim(s) 10, 21 merely describe(s) color matching to bins, which further defines the abstract idea.
Claim(s) 11 merely describe(s)…, which further defines the abstract idea.
Claim(s) 2 also includes the additional element of “a remote device” which is analyzed the same as the “a manufacturer-sealed sterile surgical package” and does not provide a practical application or significantly more for the same reasons.
Claim(s) 14 merely describe(s)…, which further defines the abstract idea.
Subject Matter Free of Prior Art
Claim(s) 1-3,5-15,17-22recite subject matter that is free of prior art. In particular, the cited prior art of record fails to teach or suggest the combination of:
Claim 1 describe(s) A manufacturer-sealed sterile surgical package containing a surgical instrument configured to be used in a surgical procedure, wherein the manufacturer-sealed sterile surgical package comprises a processor configured to: catalogue components of the surgical instrument;
receive data characterizing a geopolitical location of a healthcare site hosting the surgical procedure; determine that a component of the manufacturer-sealed sterile surgical package is non-compliant with local rules of the geopolitical location; in response to determining that the component is non-compliant with the local rules of the geopolitical location, alter or de-activate capabilities of the component such that the component is compliant with the local rules of the geopolitical location;
determine that the manufacturer-sealed sterile surgical package has been opened;
and in response to determining that the manufacturer-sealed sterile surgical package has been opened: determine a waste classification of a component of the surgical instrument; determine a disposal procedure for the component of the surgical instrument based on the waste classification; adjust the disposal procedure based on the received data characterizing the geopolitical location of the healthcare site hosting the surgical procedure; and generate a control signal configured to cause a change in a color of a light-emitting diode (LED) on the manufacturer-sealed sterile surgical package to indicate the adjusted disposal procedure at an end of the surgical procedure.
Claims 1-3,5-11 depend on Claim 1 and are therefore also subject matter free of prior art.
Claim 12 describe(s) a method, performed by a manufacturer-sealed sterile surgical package, the method comprising: cataloguing components of a surgical instrument contained within the manufacturer-sealed sterile surgical package and used in a surgical procedure; receiving data characterizing a geopolitical location of a healthcare site hosting the surgical procedure; determining that a component of the manufacturer-sealed sterile surgical package is non-compliant with local rules of the geopolitical location; in response to determining that the component is non-compliant with the local rules of the geopolitical location, altering or de-activating capabilities of the component such that the component is compliant with the local rules of the geopolitical location; determining that the manufacturer-sealed sterile surgical package has been opened; and in response to determining that the manufacturer-sealed sterile surgical package has been opened: determining a waste classification of a component of the surgical instrument; determining a disposal procedure for the component of the surgical instrument based on the waste classification; adjusting the disposal procedure based on the received data characterizing the geopolitical location of the healthcare site hosting the surgical procedure; and generating a control signal configured to cause a change in a color of a light-emitting diode (LED) on the manufacturer-sealed sterile surgical package to indicate the adjusted disposal procedure at an end of the surgical procedure.
Claims 13-15,17-21 depend on Claim 12 and are therefore also subject matter free of prior art.
Claim 22 describe(s) a non-transitory computer program product storing instructions which, when executed by a processor forming part of a manufacturer-sealed sterile surgical package, cause the processor to: catalogue components of a surgical instrument contained within the manufacturer-sealed sterile surgical package and used in a surgical procedure; receive data characterizing a geopolitical location of a healthcare site hosting the surgical procedure; determine that a component of the manufacturer-sealed sterile surgical package is non-compliant with local rules of the geopolitical location; in response to determining that the component is non-compliant with the local rules of the geopolitical location, alter or de-activate capabilities of the component such that the component is compliant with the local rules of the geopolitical location; determine that the manufacturer-sealed sterile surgical package has been opened; and in response to determining that the manufacturer-sealed sterile surgical package has been opened: determine a waste classification of a component of the surgical instrument; determine a disposal procedure for the component of the surgical instrument based on the waste classification; adjust the disposal procedure based on the received data characterizing the geopolitical location of the healthcare site hosting the surgical procedure; and generate a control signal configured to cause a change in a color of a light-emitting diode (LED) on the manufacturer-sealed sterile surgical package to indicate the disposal procedure at an end of the surgical procedure.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-3,5-15,17-22, the Examiner has considered the Applicant’s arguments; however the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
During the interview, it was suggested that the claims be amended to recite action(s) that occur outside of the processor and directly impact/alter the claimed packaging. With this in mind, the claims have been amended to recite "in response to determining that the component [of the surgical package] is non- compliant with the local rules of the geopolitical location, altering or de-activating capabilities of the component such that the component is compliant with the local rules of the geopolitical location." This feature recites a tangible action that directly impacts the surgical package disposed therein.
Regarding (a), the Examiner respectfully disagrees. Initially, as discussed in the basis of rejection, the broadest reasonable interpretation of this feature, in light of the specification, encompasses the processor (which is a component of the surgical package) choosing not to receive data. It thus represents part of the abstract idea; the rules or instructions for a person or persons to follow. The Examiner notes that this feature does not improve the functioning of the processor; the processor is performing its intended functions. This feature also does not improve another technology because, as indicated by the Specification, it is confined to the processor, which is a component of the surgical package. No other “capabilities” are described as being affected. And finally, there is no description of the collection of impermissible data as being a technological problem caused by the processor. As such, even if this feature were considered to be an additional element, it does not provide a practical application or significantly more.
Moreover, Applicant submits that this feature integrates the alleged judicial exception into a practical application. MPEP 2106.04(d) states, "Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:... an improvement to other technology or technical field." The present claims improve surgical packaging by automatically adjusting components thereof so that they comply with local regulations.
Regarding (b), the Examiner respectfully disagrees. As previously recited in (a), the adjustments are not made to “other technology or technical field” and therefore is instead part of the abstract idea.
Additionally, MPEP 2106.04(d) further states, "Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:... Effecting a transformation or reduction of a particular article to a different state or thing." The present claims recite transforming a component of the surgical package to a different state, i.e., by altering or de-activating capabilities of the component.
Regarding (c), the Examiner respectfully disagrees. Turning off the collection of data is not even remotely a transformation within the meaning of the word.
Rejection under 35 U.S.C. § 103
Regarding the rejection of Claims 1-3,5-15,17-22, the Examiner has considered the Applicant’s arguments; however, these arguments are moot given the new grounds of rejection as necessitated by amendment.
Conclusion
The prior art made of record and not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Waris et al (US Publication No. 20140279596) discloses a method, system and computer program product for managing transportation and storage of goods.
Hilsley et al (US Publication No. 20180240065) discloses systems and methods for package delivery tracking.
Gittings et al (US Publication No. 10019692) discloses systems, methods, and computer program products for dynamically monitoring transport of a plurality of packages potentially containing regulated goods so as to ensure compliance with one or more regulations within a plurality of jurisdictions.
THIS ACTION IS MADE FINAL, necessitated by amendment. 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN C EDOUARD whose telephone number is (571)270-0107. The examiner can normally be reached M-F 730 - 430.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (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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/JONATHAN C EDOUARD/Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
