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 .
Claims 1-18 are pending. Claims 1-18 are rejected herein.
Priority
This application claims sufficient priority to provisional application 63/525,572 and has an effective fling date of 07 July 2023.
Subject Matter Free of Prior Art
In particular, the Examiner found “…storing parameters corresponding to the surgical instrument, the stored parameters comprising operational information of the surgical instrument, the operational information comprising operational instructions,” in combination with the later limitation “wherein the plurality of historical data points are recorded during respective portions of a plurality of cycles within a period of time and at a frequency that varies based on a type of the events;…” in combination with the later recited limitation: “…determining, based on the plurality of recorded historical data points, a degradation level of the surgical instrument;…” to distinguish the material over the prior art at large. For example, the integration of the instrument degradation level, the fact that the surgical instrument operational information was loaded on the packaging storage, and the alteration of the recording frequencies on the basis of type of events was not taught.
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 1-18 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 1,10 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: The Statutory Categories
The claim recites a system, a method and a non-transitory computer program product storing instructions, which are all within a statutory category (or are interpreted to be within a statutory category for subject matter eligibility analysis purposes).
Step 2A Prong One: The Abstract Idea
The limitations of (claim 1 being representative) […] storing parameters corresponding to the surgical instrument, the stored parameters comprising operational information of the surgical instrument, the operational information comprising operational instructions; recording […] a plurality of historical data points characterizing events experienced by the surgical instrument, wherein the plurality of data points characterizing events experienced by the surgical instrument, wherein the plurality of historical data points are recorded during respective portions of a plurality of cycles within a period of time and at a frequency that varies based on a type of the events; [receiving a data set characterizing parameters associated with the surgical instrument;] determining, based on the plurality of recorded historical data points, a degradation level of the surgical instrument; adjusting, based on the received data set and the determined degradation level, the stored parameters, wherein the stored parameters are adjusted by adjusting the operational instructions; determining a graphic depiction characterizing the adjusted parameters; generating a control signal configured to display the graphical depiction of the adjusted parameters […] as drafted, is a process that, under the broadest reasonable interpretation, covers performance of the limitation in the mind but for recitation of generic computer components.
Other than the additional elements analyzed below, this claim encompasses a person thinking about: storing parameters, recoding a plurality of historical data points characterizing certain events, receiving a data set characterizing certain parameters, determining, based on the plurality of recorded historical data points, a degradation level, adjusting the stored parameters and determining a certain graphical depiction characterizing the adjusted parameters in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. The Examiner notes that a claim that requires a computer may still recite a mental process (see MPEP 2106.04(a)(2)). Accordingly, the claim recites an abstract idea.
Step 2A Prong Two: Practical Application
Claim 1, 10 and/or 18 recites the following additional elements, which will be dealt with in turn: a manufacturer-sealed sterile surgical packaging containing a surgical instrument, a graphical display, a sensor comprising a circuit disposed on a portion of the manufacturer-sealed sterile surgical packaging, at least one data processor, a memory storing instructions configured to cause the at least one processor to perform operations, and a non-transitory computer program product for storing instructions, graphical display.
These judicial exceptions are not integrated into a practical application. In particular, the independent claims recite the additional elements of an graphical display, at least one data processor, a memory storing instructions configured to cause the at least one processor to perform operations, and a non-transitory computer program product for storing instructions that implements the identified abstract idea. These are not described by the applicant and are recited at a high-level of generality such that they amount to 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 they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim further recites the additional element of an “a manufacturer-sealed sterile surgical packaging containing a surgical instrument, a sensor comprising a circuit disposed on a first portion of the manufacturer-sealed sterile surgical packaging” and “a sensor comprising a circuit disposed on a portion of the manufacturer-sealed sterile surgical packaging,….” These merely generally link 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.
The claim further recites the additional element of “receiving a data set characterizing parameters associated with the surgical instrument,” which was left in brackets in the highlighted abstract idea above to indicate it is an additional element. This bracketed additional element was put in the abstract idea outlined above to maintain conceptual continuity only. It was analyzed as an additional element. MPEP 2106.05(g) Insignificant Extra Solution Activity indicates that when determining whether an additional element is insignificant extra-solution activity at Step 2A Prong Two, the examiner may consider the following: whether the limitation is significant (i.e., it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention) and whether the limitation amounts to necessary data gathering or output (i.e., all uses of the recited judicial exception require such data gathering or data output). The recited limitation does not impose meaningful limits on the claim such that it is not nominally or tangentially related to the invention and the limitation amounts to necessary data gathering. This same section of the MPEP indicates that mere data gathering is an activity that the courts have found to be insignificant extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
The claim does 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 a graphical display, at least one data processor, a memory storing instructions configured to cause the at least one processor to perform operations, and a non-transitory computer program product for storing instructions 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 element of “a manufacturer-sealed sterile surgical packaging containing a surgical instrument,” and “a sensor comprising a circuit disposed on a first portion of the manufacturer-sealed sterile surgical packaging,” which 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. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
The claim further recites the additional element of “receiving a data set characterizing parameters associated with the surgical instrument.” MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. MPEP 2106.05(g) Insignificant Extra Solution Activity indicates that when determining whether an additional element is insignificant extra-solution activity at Step 2B the examiner may consider the following: whether the extra-solution limitation is well known, whether the limitation is significant (i.e., it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention) and whether the limitation amounts to necessary data gathering and output (i.e., all uses of the recited judicial exception require such data gathering or data output). After reevaluation of the extra-solution activity at Step 2B, the recited limitation was determined to be well understood routine and conventional activity because it amounts to receiving or transmitting data over a network, the recited limitation does not impose meaningful limits on the claim such that it is not nominally or tangentially related to the invention and the limitation amounts to necessary data gathering. MPEP 2106.05(d) Well-Understood Routine, Conventional Activity indicates that the courts have recognized receiving or transmitting data over a network as well‐understood, routine, and conventional functions when they claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Dependent Claims and Dependent Additional Elements
Claims 2-5, 8-10, and 12 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 and 11 merely describe(s) details concerning the stored parameters and the adjusted parameters. Claim 3 and 12 merely describes historic states include certain information experienced by the surgical packaging. Claim 4 and 13 merely describes the future states include at least one of certain types of information. Claim 5 and 14 merely describes the operational information includes certain information including operational instructions. Claim 6 and 15 merely describes providing, based on an on-demand user request, at least a portion of certain parameters. Claim 7 merely describes the on-demand user request requires an authentication to access the stored parameters. Claim 8 and 17 merely describes the graphical display comprises at least one e-ink label. Claim 9 merely describes the adjusted parameters are transmitted and displayed on a certain device. Claim 16 merely describes the on-demand user request is authenticated prior to providing the at least a portion of certain parameters.
The dependent claims also includes the additional element of “e-ink label,” and a remote device in electronic communication with the manufacturer-sealed sterile surgical packaging. The additional elements of an “e-ink label,” and a “remote device in electronic communication with the manufacturer-sealed sterile surgical packaging” generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Response to Arguments
35 U.S.C. 101 Argument Responses
As stated in the interview summary record provided by the Examiner no agreement was reached. Examiner Gilligan’s comments, which were paraphrased in the interview summary, reflect that a technical solution to a technical problem might be developed out of the material based in the Specification at para. [0128], in particular, from the material related to the duty cycle timer, reflecting the fact that an improvement defined at step 2A prong two and step 2B that also resulted in energy savings to the battery via improved function of the sensor might be eligible. The amendment reflected material introduced in the Specification and this material was used to modulate the frequency at which the sensors record a plurality of historical data points characterizing events experienced by the surgical instrument. The Examiner considered, “…recording, via the sensor, a plurality of historical data points characterizing events experienced by the surgical instrument, wherein the plurality of historical data points are recorded during respective portions of a plurality of cycles within a period of time and at a frequency that varies based on a type of the events…,” alone and in combination with the other additional elements at step 2A prong 2 and step 2B. As the claim is specifically recited, energy savings here are brought about by reduced sampling (i.e. reduced use of the sensor) not because the sensor itself is using less energy over the same or more time and saving battery to do the same task and/or gaining a new function. The function of the sensor is unchanged: to measure x state/characteristic y number of times with z amount of battery. For example, the frequency of sensor sampling is arbitrary (for example, it is explained at para. [0128] that to measure semi-stable states, such as temperature, the sensor sampling rate can be reduced to save battery because the temperature isn’t changing that rapidly). The recited limitation, even as an additional element in tandem with the other elements, is not an improvement to any other technology and/or technical process at Step 2A prong two or Step 2B of the Alice/May Subject Matter Eligibility Analysis framework and the limitation, devoid of additional elements, was incorporated into the abstract idea and analyzed as part of the judicial exception. As for the request to contact the undersigned, the Examiner is available to interview upon filing of an RCE.
35 U.S.C. 103 Argument Responses
The 35 U.S.C. 103 rejection has been withdrawn in response to the amendment and the argument is moot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2020/0297429 A1 (hereafter Montane) teaches trackable protecting packaging for tools and methods for calibrating tool installation using the same that is tangentially related to the subject matter herein.
Mendes et al. Ethylene oxide sterilization of medical devices: A review, American Journal of Infection Control, Volume 35, Issue 9, 2007, Pages 574-581, ISSN 0196-6553. Mendes teaches on the sterilization technique used for medical devices, which is tangentially relevant to the subject matter herein.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/T.I.E./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683
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