DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the communication filed 8/20/2024. Claims 1-20 are currently pending.
Claim Rejections - 35 USC § 112
3. 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.
3.1. Claims 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
3.2. The terms “minimal,” “intermittent,” and “full” in claims 1, 9, and 16 are a relative term which renders the claim indefinite. These terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the limitations “minimal interaction level,” “intermittent interaction level,” and “full interaction level” are indefinite.
Claim Rejections - 35 USC § 101
4. 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.
4.1. Claims 1-20 are rejected under 35 U.S.C. § 101 because while the claims (1) are to a statutory category (i.e., process, machine, manufacture or composition of matter, the claims (2A1) recite an abstract idea (i.e., a law of nature, a natural phenomenon); (2A2) do not recite additional elements that integrate the abstract idea into a practical application; and (2B) are not directed to significantly more than the abstract idea itself.
In regards to (1), the claims are to a statutory category (i.e., statutory categories including a process, machine, manufacture or composition of matter). In particular, independent claims 1, 9 and 16, and their respective dependent claims are directed, in part, to a method and system for an operating room to collect data on surgical procedures and equipment.
In regards to (2A1), the claims, as a whole, recite and are directed to an abstract idea because the claims include one or more limitations that correspond to an abstract idea including mental processes and/or certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. For example, independent claims 1, 9 and 16, as a whole, are directed to receiving data on surgical procedures and equipment by receiving data associated with a surgical procedure, identifying surgery equipment, receiving interaction levels for the equipment, and selecting an interaction level, etc. which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. The dependent claims include all of the limitations of their respective independent claims and thus are directed to the same abstract idea identified for the independent claims but further describe the elements and/or recite field of use limitations.
Furthermore, assuming arguendo, the claims are not directed to certain methods of organizing human activities, the claims, nevertheless, are directed to an abstract idea because the claims, except for certain limitations (* identified below in bold), under the broadest reasonable interpretation, can be reasonably and practically performed in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion. That is, other than reciting the certain additional elements, nothing in the claims precludes the limitations from being practically performed in the mind and/or with pen and paper.
CLAIM 1:
A method for operating a surgical smart system in an operating room, the method comprising:
receiving data associated with a surgical procedure, wherein the data comprises at least a surgical manifest of the surgical procedure and a lookup table of surgical devices;
identifying a piece of equipment during the surgical procedure;
receiving a plurality of interaction levels for the identified piece of equipment comprising any of a minimal interaction level, intermittent interaction level, or full interaction level; and
selecting an interaction level from the plurality of interaction levels based on the selected interaction level being associated with a surgical preference.
CLAIM 2:
The method of claim 1, wherein selecting the interaction level from the plurality of interaction levels based on the selected interaction level being associated with a surgical preference further comprises:
cross-referencing the identified piece of equipment with the surgical manifest;
determining a best use case of the identified piece of equipment based on the surgical manifest; and
selecting the interaction level from the plurality of interaction levels based on the best use case of the identified piece of equipment.
CLAIM 3:
The method of claim 1, wherein selecting the interaction level from the plurality of interaction levels based on the selected interaction level being associated with a surgical preference further comprises:
cross-referencing the identified piece of equipment with the surgical manifest;
determining a best use case of the identified piece of equipment based on the surgical manifest;
displaying the plurality of interaction levels on a display of the surgical smart system, wherein the interaction level that is associated with the best use case is distinctly displayed among the plurality of interaction levels; and
receiving, from the display of the surgical smart system, the selected interaction level.
CLAIM 4:
The method of claim 1, wherein the method further comprises:
monitoring operation of the identified piece of equipment during the surgical procedure;
generating operational data associated with the operation of the identified piece of equipment during the surgical procedure;
analyzing the operational data associated with the operation to detect a performance change in the identified piece of equipment;
displaying, on an interface of the surgical smart system, the analyzed operational data associated with the monitored operation; and
transmitting, to a database, the analyzed operational data associated with the monitored operation for further usage.
CLAIM 5:
The method of claim 4, wherein analyzing the operational data associated with the monitored operation comprises determining an impact of the operation of the identified piece of equipment on patient physiological parameters, and wherein the method further comprises: modifying the interaction level based on detecting the performance change in the identified piece of equipment.
CLAIM 6:
The method of claim 4, wherein analyzing the data associated with the monitored operation comprises predicting a future performance of the identified piece of equipment based on detected usage patterns of the identified piece of equipment, and wherein the method further comprises: modifying the interaction level based on the detected usage patterns of the identified piece of equipment.
CLAIM 7:
The method of claim 4, wherein displaying the analyzed operational data associated with the monitored operation comprises displaying an estimated time to failure of the identified piece of equipment.
CLAIM 8:
The method of claim 4, wherein transmitting the analyzed operational data associated with the monitored operation to a database comprises generating a comprehensive digital record of the operation of the identified piece of equipment during the surgical procedure.
CLAIM 9:
A surgical smart system in an operating room, the surgical smart system comprising:
a processor configured to:
receive data associated with a surgical procedure, wherein the data comprises at least a surgical manifest of the surgical procedure and a lookup table of surgical devices;
identify a piece of equipment during the surgical procedure;
receive a plurality of interaction levels for the identified piece of equipment comprising any of a minimal interaction level, intermittent interaction level, or full interaction level;
select an interaction level from the plurality of interaction levels based on the selected interaction level being associated with a surgical preference.
CLAIM 10:
The surgical smart system of claim 9, wherein the processor configured to select the interaction level from the plurality of interaction levels based on the selected interaction level being associated with a surgical preference comprises the processor being further configured to:
cross-reference the identified piece of equipment with the surgical manifest;
determine a best use case of the identified piece of equipment based on the surgical manifest; and
select the interaction level from the plurality of interaction levels based on the best use case of the
identified piece of equipment.
CLAIM 11:
The surgical smart system of claim 9, wherein the processor being configured to select the interaction level from the plurality of interaction levels based on the selected interaction level being associated with a surgical preference comprises the processor being further configured to:
cross-reference the identified piece of equipment with the surgical manifest;
determine a best use case of the identified piece of equipment based on the surgical manifest;
display the plurality of interaction levels on a display of the surgical smart system, wherein the interaction level that is associated with the best use case is distinctly displayed among the plurality of interaction levels; and
receive, from the display of the surgical smart system, the selected interaction level.
CLAIM 12:
The surgical smart system of claim 9, wherein the processor is further configured to:
monitor operation of the identified piece of equipment during the surgical procedure;
generate operational data associated with the operation of the identified piece of equipment during the surgical procedure;
analyze the operational data associated with the operation to detect a performance change in the identified piece of equipment;
display, on an interface of the surgical smart system, the analyzed operational data associated with the monitored operation; and
transmit, to a database, the analyzed operational data associated with the monitored operation for further usage.
CLAIM 13:
The surgical smart system of claim 12, wherein the processor configured to analyze the operational data associated with the monitored operation comprises the processor being configured to:
determine an impact of the operation of the identified piece of equipment on patient physiological parameters; and
modify the interaction level based on detecting the performance change in the identified piece of equipment.
CLAIM 14:
The surgical smart system of claim 12, wherein the processor configured to analyze the operational data associated with the monitored operation comprises the processor being configured to:
predict a future performance of the identified piece of equipment based on detected usage patterns of the identified piece of equipment; and
modify the interaction level based on the detected usage patterns of the identified piece of equipment.
CLAIM 15:
The surgical smart system of claim 12, wherein the processor configured to transmit the analyzed operational data associated with the monitored operation to a database comprises the processor being configured to generate a comprehensive digital record of the operation of the identified piece of equipment during the surgical procedure.
CLAIM 16:
A surgical smart system in an operating room, the surgical smart system comprising:
a processor configured to:
receive data associated with a surgical procedure, wherein the data comprises at least a surgical manifest of the surgical procedure;
identify a piece of equipment;
receive a plurality of interaction levels for the identified piece of equipment comprising any of a minimal interaction level, intermittent interaction level, or full interaction level;
select an interaction level from the plurality of interaction levels.
CLAIM 17:
The surgical smart system of claim 16, wherein the processor configured to select the interaction level from the plurality of interaction levels comprises the processor being further configured to:
cross-reference the identified piece of equipment with the surgical manifest;
determine a best use case of the identified piece of equipment based on the surgical manifest; and
select the interaction level from the plurality of interaction levels based on the best use case of the identified piece of equipment.
CLAIM 18:
The surgical smart system of claim 16, wherein the processor being configured to select the interaction level from the plurality of interaction levels comprises the processor being further configured to:
cross-reference the identified piece of equipment with the surgical manifest;
determine a best use case of the identified piece of equipment based on the surgical manifest;
display the plurality of interaction levels on a display of the surgical smart system, wherein the interaction level that is associated with the best use case is distinctly displayed among the plurality of interaction levels; and
receive, from the display of the surgical smart system, the selected interaction level.
CLAIM 19:
The surgical smart system of claim 16, wherein the processor is further configured to:
monitor operation of the identified piece of equipment during the surgical procedure;
generate operational data associated with the operation of the identified piece of equipment during the surgical procedure;
analyze the operational data associated with the operation to detect a performance change in the identified piece of equipment;
display, on an interface of the surgical smart system, the analyzed operational data associated with the monitored operation; and
transmit, to a database, the analyzed operational data associated with the monitored operation for further usage.
CLAIM 20:
The surgical smart system of claim 19, wherein the processor configured to analyze the operational data associated with the monitored operation comprises the processor being configured to:
determine an impact of the operation of the identified piece of equipment on patient physiological parameters; and
modify the interaction level based on detecting the performance change in the identified piece of equipment.
* The limitations that are in bold are considered “additional elements” that are further analyzed below in subsequent steps of the 101 analysis. The limitations that are not in bold are abstract and/or can be reasonably and practically performed in the human mind and/or with pen paper.
In regards to (2A2), the claims do not recite additional elements that integrate the abstract idea into a practical application. The additional elements in the claims (i.e., * identified above in bold) do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements (e.g., smart surgical system, processor, display, interface, database, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Moreover, the claims recite “a processor configured to”, etc. devoid of any meaningful technological improvement details and thus, further evidence the additional elements are merely being used to leverage generic technologies to automate what otherwise could be done manually. Accordingly, the 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.
Furthermore, the additional elements do not recite improvements to the functioning of a computer, or to any other technology or technical field—the additional elements merely recite general purpose computer technology; the additional elements do not recite applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition—there is no actual administration of a particular treatment; the additional elements do not recite applying the judicial exception with, or by use of, a particular machine—the additional elements merely recite general purpose computer technology; the additional elements do not recite limitations effecting a transformation or reduction of a particular article to a different state or thing—the additional elements do not recite transformation such as a rubber mold process; the additional elements do not recite applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment—the additional elements merely leverage general purpose computer technology to link the abstract idea to a technological environment.
In regards to (2B), the claims, individually, as a whole and in combination with one another, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of (A) a generic computer structure(s) that serves to perform computer functions that serve to merely link the abstract idea to a particular technological environment (i.e., computers); and/or (B) functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Here, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer technologies. Mere instructions to apply an exception using generic computer technologies cannot provide an inventive concept.
Moreover, paragraphs [0034]-[0036] of applicant's specification (US 2025/0166817) recites that the system/method may be implemented using a computer-implemented, a cloud computing system, a cloud server, a cloud server, etc. system which are well-known general purpose or generic-type computers and/or technologies. The use of generic computer components recited at a high level of generality to process information through an unspecified processor/computer does not impose any meaningful limit on the computer implementation of the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Furthermore, the additional elements are merely well-known general purpose computers, components and/or technologies that receive, transmit, store, display, generate and otherwise process information which are akin to functions that courts consider well-understood, routine, and conventional activities previously known to the pertinent industry, such as, performing repetitive calculations; receiving or transmitting data over a network; electronic recordkeeping; retrieving and storing information in memory; and sorting information (See, for example, MPEP § 2106).
Therefore, the claims are not patent-eligible under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
5.1. 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.
5.2. `Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Codd et al. (US 2020/0395118).
CLAIM 1
Codd teaches a method for operating a surgical smart system in an operating room (Codd: abstract), the method comprising:
receiving data associated with a surgical procedure, wherein the data comprises at least a surgical manifest of the surgical procedure and a lookup table of surgical devices (Codd: abstract; ¶¶ [0006], [0036], [0041]; FIGS. 1-6B);
identifying a piece of equipment during the surgical procedure (Codd: abstract; ¶¶ [0041], [0044] “computing device 146 may include an object use analyzer 148 configured to receive, from the RFID readers 140, information indicating presence of RFID tags 142 within areas near the respective RFID readers”, [0070] “the object use analyzer 148 may receive information about one or more surgical procedures and usage of surgical instruments during the procedure(s)”; FIGS. 1-6B);
receiving a plurality of interaction levels for the identified piece of equipment comprising any of a minimal interaction level, intermittent interaction level, or full interaction level (Codd: abstract; ¶¶ [0063]-[0067]; FIGS. 1-6B); and
selecting an interaction level from the plurality of interaction levels based on the selected interaction level being associated with a surgical preference (Codd: abstract; ¶¶ [0063]-[0067]; FIGS. 1-6B).
CLAIM 2
Codd teaches the method of claim 1, wherein selecting the interaction level from the plurality of
interaction levels based on the selected interaction level being associated with a surgical preference further comprises: cross-referencing the identified piece of equipment with the surgical manifest (Codd: abstract; ¶¶ [0006] “preference card… a listing of instruments or sets of instruments that are to be supplied to the surgeon for a particular surgery”, [0096] “cross referencing the surgical preference card with the census of the instrument tables”; FIGS. 1-6B); determining a best use case of the identified piece of equipment based on the surgical manifest (Codd: abstract; ¶¶ [0026] “Surgical instrument usage data collected by the system may be analyzed by the system to make recommendations as to which instruments should be supplied during specific surgeries for particular surgeons”; FIGS. 1-6B); and selecting the interaction level from the plurality of interaction levels based on the best use case of the identified piece of equipment (Codd: abstract; ¶¶ [0063]-[0064]; FIGS. 1-6B).
CLAIM 3
Codd teaches the method of claim 1, wherein selecting the interaction level from the plurality of interaction levels based on the selected interaction level being associated with a surgical preference further comprises: cross-referencing the identified piece of equipment with the surgical manifest (Codd: abstract; ¶¶ [0006] “preference card… a listing of instruments or sets of instruments that are to be supplied to the surgeon for a particular surgery”, [0096] “cross referencing the surgical preference card with the census of the instrument tables”; FIGS. 1-6B); determining a best use case of the identified piece of equipment based on the surgical manifest (Codd: abstract; ¶¶ [0026] “Surgical instrument usage data collected by the system may be analyzed by the system to make recommendations as to which instruments should be supplied during specific surgeries for particular surgeons”; FIGS. 1-6B); displaying the plurality of interaction levels on a display of the surgical smart system, wherein the interaction level that is associated with the best use case is distinctly displayed among the plurality of interaction levels (Codd: abstract; ¶¶ [0063]-[0067]; FIGS. 1-6B); and receiving, from the display of the surgical smart system, the selected interaction level (Codd: abstract; ¶¶ [0063]-[0067]; FIGS. 1-6B).
CLAIM 4
Codd teaches the method of claim 1, wherein the method further comprises: monitoring operation of the identified piece of equipment during the surgical procedure (Codd: abstract; ¶¶ [0069]-[0081]; FIGS. 1-6B); generating operational data associated with the operation of the identified piece of equipment during the surgical procedure (Codd: abstract; ¶¶ [0069]-[0081]; FIGS. 1-6B); analyzing the operational data associated with the operation to detect a performance change in the identified piece of equipment (Codd: abstract; ¶¶ [0069]-[0081]; FIGS. 1-6B); displaying, on an interface of the surgical smart system, the analyzed operational data associated with the monitored operation (Codd: abstract; ¶¶ [0069]-[0081]; FIGS. 1-6B); and transmitting, to a database, the analyzed operational data associated with the monitored operation for further usage (Codd: abstract; ¶¶ [0069]-[0081]; FIGS. 1-6B).
CLAIM 5
Codd teaches the method of claim 4, wherein analyzing the operational data associated with the monitored operation comprises determining an impact of the operation of the identified piece of equipment on patient physiological parameters, and wherein the method further comprises: modifying the interaction level based on detecting the performance change in the identified piece of equipment (Codd: abstract; ¶¶ [0063]-[0067], [0091]-[0095]; FIGS. 1-6B).
CLAIM 6
Codd teaches the method of claim 4, wherein analyzing the data associated with the monitored operation comprises predicting a future performance of the identified piece of equipment based on detected usage patterns of the identified piece of equipment, and wherein the method further comprises: modifying the interaction level based on the detected usage patterns of the identified piece of equipment (Codd: abstract; ¶¶ [0063]-[0067]; FIGS. 1-6B).
CLAIM 7
Codd teaches the method of claim 4, wherein displaying the analyzed operational data associated with the monitored operation comprises displaying an estimated time to failure of the identified piece of equipment (Codd: abstract; ¶¶ [0090]-[0095]; FIGS. 1-6B).
CLAIM 8
Codd teaches the method of claim 4, wherein transmitting the analyzed operational data associated with the monitored operation to a database comprises generating a comprehensive digital record of the operation of the identified piece of equipment during the surgical procedure (Codd: abstract; ¶¶ [0036], [0088]; FIGS. 1-6B).
CLAIM 9
Codd teaches a surgical smart system in an operating room, the surgical system comprising: a processor configured to: (Codd: abstract; ¶¶ [0016], [0025]; FIGS. 1-6B).
The remainder of claim 9 repeats substantially the same limitations as those in claim 1. As such, the remainder of claim 9 is rejected for substantially the same reasons given for claim 1 and are incorporated herein.
CLAIMS 10-15
Claims 10-15 repeat substantially the same limitations as those in claims 2-6 and 8. As such, claims 10-15 are rejected for substantially the same reasons given for claims 2-6 and 8 and are incorporated herein.
CLAIM 16
Codd teaches a surgical smart system in an operating room, the surgical smart system comprising: a processor configured to: (Codd: abstract; ¶¶ [0016], [0025]; FIGS. 1-6B).
The remainder of claim 16 repeats substantially the same limitations as those in claim 1. As such, the remainder of claim 16 is rejected for substantially the same reasons given for claim 1 and are incorporated herein.
CLAIMS 17-20
Claims 17-20 repeat substantially the same limitations as those in claims 2-5. As such, claims 17-20 are rejected for substantially the same reasons given for claims 2-5 and are incorporated herein.
Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
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, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681