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 .
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 1-20 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.
Claim 1 recites the limitation “in real-time during an operation” in lines 11-12. The limitation “real-time” is a broad, vague, and unclear term. Everything we do is in “real-time”, we cannot operate in a state different that “real-time”. Examiner believes this term adds no value to the limitation amended and suggests moving forward with only “during an operation” as it means the same thing.
Claims 2-16 are rejected because of their dependency on claim 1.
Claim 17 recites the limitation “in real-time during an operation” in lines 11-12. The limitation “real-time” is a broad, vague, and unclear term. Everything we do is in “real-time”, we cannot operate in a state different that “real-time”. Examiner believes this term adds no value to the limitation amended and suggests moving forward with only “during an operation” as it means the same thing.
Claims 18-20 are rejected because of their dependency on claim 17.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1 and 17 recite implants, instruments, a microscope, a compatibility checking apparatus and the method of checking compatibility between the different instruments and implants by automatically checking compatibility when an implant and an instrument are in a microscopic field of view.
To start off, step 1 is covered as the claims recite a machine and process respectively.
Moving on to step 2A, this is a two-prong analysis. Under prong one, examiner is required to show the abstract idea, law of nature, or natural phenomenon. In this case, examiner points out that the steps of “automatic checking of a compatibility of one of the at least two mutually different instruments and one of the at least two mutually different implants that are positioned together in the microscope field of view in real-time during an operation under a live microscopic view” and “automatically checking compatibility of said one of the at least two mutually different instruments with said one of the at least two mutually different implants when said one of the at least two mutually different instruments and said one of the at least two mutually different implants are positioned together in a microscope field of view of a microscope in real-time during an operation under a live microscopic view” are the abstract idea directed to a mental process. These limitations, under broadest reasonable interpretation, can be done in the mind other than the recitation of the generic computer component. That is, other than reciting “a compatibility checking apparatus” nothing in the claim precludes the step from practically being performed in the mind. The step of checking compatibility can simply mean the surgeon looking through the microscope and comparing an implant size/code to an instrument size/code. 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. Accordingly, the claim recites an abstract idea.
Under prong two, examiner is required to show that the judicial exception is not integrated into a practical application. In particular, the claims recites the additional elements including: “at least two mutually different implants”, “at least two mutually different instruments”, and “a microscope”. In this case, all of the additional elements recited appear to be mere filed of use because they a merely just elements that a person looks at to make the “checking compatibility” decision. The claims don’t really do anything with these additional elements except look at them. Accordingly, these additional element do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea (MPEP 2106.05F). The claim is directed to an abstract idea.
Lastly for 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 “at least two mutually different implants”, “at least two mutually different instruments”, and “a microscope” amount to no more than mere filed of use. The claim is not patent eligible.
Examiner states that the claim recites a judicial exception but is not integrated into a practical application (Step 2b of 2019 PEG). In particular the steps of the claim do not recite any additional element that is required for the claim to be performed, moreover the steps of the claim add insignificant extra-solution activity to the abstract idea. (See MPEP 2106.05 (g)). Therefore, the claim does not integrate the abstract idea into a practical application, because it does not impose any meaningful limits on practicing the abstract idea. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements recited. Dependent claims 2-16 and 18-20 do not integrate the abstract idea into a practical application.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 2021/0192759 Lang, hereinafter, “Lang” (cited previously).
Regarding claim 1, Lang discloses a medical system (Abstract) comprising:
at least two mutually different implants (Para 96; Para 392; the implantable markers; Para 1369-1375 show the use of multiple implants);
at least two mutually different instruments (Para 96; Para 1369-1375 show the use of multiple instruments, see also Para 1324-1325);
a microscope (Para 308 and 965); and
a compatibility checking apparatus (Para 1324 and 1325; the imaging tool and the software act as this apparatus),
each of the at least two mutually different instruments being configured to cooperate with one of the at least two mutually different implants that is compatible (Para 1324 and 1325 and Para 1369-1375 also describes fitting shapes and sizes),
the microscope defining a microscope field of view (Para 965),
the compatibility checking apparatus being configured for automatic checking of a compatibility of one of the at least two mutually different instruments and one of the at least two mutually different implants that are positioned together in the microscope field of view (Para 1324-1325), in real-time during an operation under a live microscopic view (First examiner would like to state the interpretation of this limitation, under BRI the claim seems to require automatic checking of compatibility for two instruments that are positioned together in the microscope of view, but does not require that “checking” to be performed within the microscope field of view, this specific newly amended limitation is worded in a way that makes it seem that the checking is happening during an operation, and that the operation is being performed under a live microscopic view and not necessarily that the checking is happening in the microscopic view. Having said that refer first to Para 412 that discloses “As the optical marker enters the surgeon's field of view, an image and/or video capture system integrated into or attached to the OHMD on the surgeon's head can detect the optical marker and display the next virtual surgical step”, which shows the automatic checking during an operation under a live microscopic view. Also refer to Para 498 that discloses “When a pin or a screw is placed in a surgical site including a joint and/or a bone, (…), with an integrated or attached optical marker with a QR code or when an instrument, (…) with an integrated or attached optical marker with a QR code enters the field of view of a bar code and/or QR code reader and/or an image and/or video capture system integrated or attached to the OHMD, or enters the proximity of the surgical field or surgically altered tissue, the information on the bar code or QR code on the physical pin or screw, the physical instrument, the physical trial implant, and/or the physical implant component can be read and compared against the intended surgical site information and/or the intended laterality information and/or the virtual surgical plan and/or the intended sizing information and/or the intended templating information.” This discloses the automatic compatibility checking to make sure the right instrument and implant are being used. Examiner suggests amending to disclose that the checking is also happening under live microscopic view).
Regarding claim 2, Lang discloses the microscope is an optical microscope or a digital microscope (Para 145 and 965; the imaging system is an optical imaging system that can be a microscope that detects optical markers).
Regarding claim 3, Lang discloses the microscope comprises an optical microscope image sensor (Para 965 an image sensor is known in the art to be an imager that detects and conveys information used to form an image; therefore, detecting a virtual instrument by means of scanning a code (Para 386) is image sensing).
Regarding claim 4, Lang discloses the compatibility checking apparatus comprises an optical detection device for detecting an optical code (Para 1324-1325 and 1375 disclose mismatching of a tool and implantable, Para 392 shows that the implantable can carry a code for optical detection),
the optical detection device defines a detection field of view, and
the microscope field of view and the detection field of view at least partially overlap (Para 965).
Regarding claim 5, Lang discloses an overlap of the microscope field of view and the detection field of view is in a range of approximately 50% to approximately 100% (Para 965; a 100% is within the field of view of the microscope when the optical marker is in a field of view of the microscope and therefore the detection code is fully viewed by the microscopic image).
Regarding claim 6, Lang discloses the optical detection device comprises at least one optical image sensor (Para 145 and 965; the detection is an optical imaging system that detects optical markers; an image sensor is known in the art to be an imager that detects and conveys information used to form an image; therefore, detecting a virtual instrument by means of scanning a code (Para 386) is image sensing).
Regarding claim 7, Lang discloses the optical microscope image sensor defines or forms the at least one optical image sensor (Para 145 and 965; the detection is an optical imaging system that detects optical markers; an image sensor is known in the art to be an imager that detects and conveys information used to form an image; therefore, detecting a virtual instrument by means of scanning a code (Para 386) is image sensing).
Regarding claim 8, Lang discloses the at least two mutually different implants and the at least two mutually different instruments each comprise at least one optical code, each optical code of the at least two mutually different implants being different, and each optical code of the at least two mutually different instruments being different (Para 392 and 1324-1325; a code can be a size or shape code or a variety of pattern codes; this system is capable of scanning codes and determining a different shape code and indicating a mismatch; also a color code is possible Para 1369-1375 “Any instrument or implant can be color coded”).
Regarding claim 9, Lang discloses respective optical codes of implants and instruments that are compatible with one another are identical (Para 1369-1375).
Regarding claim 10, Lang discloses the at least two mutually different instruments comprise an instrument end that is engageable with one of the at least two mutually different implants, and wherein the respective optical code is arranged or configured on or in a region of the instrument end (Para 392 and 1369-1375; screws and screwdriver heads would be color coded at their ends).
Regarding claim 11, Lang discloses each of the respective optical codes is a bar code, a data matrix code, a QR code, a shape code or a color code (Para 392-393 and 1372).
Regarding claim 12, Lang discloses the compatibility checking apparatus comprises an optical detection device for detecting an optical code (Para 1324-1325 and 1375 disclose mismatching of a tool and implantable, Para 392 shows that the implantable can carry a code for optical detection);
the optical detection device defines a detection field of view (See Para 498; “enters the proximity of the surgical field or surgically altered tissue”, “attached optical marker and bar code or QR code”; the detection field is the surgical field);
the microscope field of view and the detection field of view at least partially overlap (See Para 498; “enters the proximity of the surgical field or surgically altered tissue”, “attached optical marker and bar code or QR code”; the detection field is the surgical field, see also Para 965);
the compatibility checking apparatus comprises an image processing device (Para 76);
the image processing device is configured for reading out the respective optical codes of the at least two mutually different implants and the at least two mutually different instruments from an image of the detection field of view and/or the microscope field of view (Para 76 and 392).
Regarding claim 13, Lang discloses the compatibility checking apparatus comprises an image processing device for automatically determining instruments and/or implants in the microscope field of view (Para 1324-1325).
Regarding claim 14, Lang discloses the compatibility checking apparatus comprises a display device for displaying a result of the automatic checking of the compatibility (Para 1324 discloses an OHMD display; Para 1325 and 1375 indicate visual warnings of mismatch on the OHMD).
Regarding claim 15, Lang discloses the microscope comprises a microscope display device for displaying an image of the microscope field of view, and
the microscope display device comprises the display device (Para 308 the microscope magnified image is displayed on the OHMD).
Regarding claim 16, Lang discloses the at least two mutually different implants are medical clips, and wherein the at least two mutually different instruments are clip application instruments (Para 136 and 142-143).
Regarding claim 17, Lang discloses a method (Abstract) for checking compatibility of implants and instruments of a medical system that has at least two mutually different implants (Para 1324-1325) (Para 96; Para 392; the implantable markers; Para 1369-1375 show the use of multiple implants) and at least two mutually different instruments (Para 96; Para 1369-1375 show the use of multiple instruments, see also Para 1324-1325), with each of the at least two mutually different instruments configured to cooperate and be compatible with one of the at least two mutually different implants (Para 1324 and 1325 and Para 1369-1375 also describes fitting shapes and sizes), the method comprising the steps of:
positioning one of the at least two mutually different instruments adjacent to said one of the at least two mutually different implants (Para 1324 and 1325); and
automatically checking compatibility of said one of the at least two mutually different instruments with said one of the at least two mutually different implants (Para 1324 and 1325) when said one of the at least two mutually different instruments and said one of the at least two mutually different implants are positioned together in a microscope field of view of a microscope (Para 965), in real-time during an operation under a live microscopic view (First examiner would like to state the interpretation of this limitation, under BRI the claim seems to require automatic checking of compatibility for two instruments that are positioned together in the microscope of view, but does not require that “checking” to be performed within the microscope field of view, this specific newly amended limitation is worded in a way that makes it seem that the checking is happening during an operation, and that the operation is being performed under a live microscopic view and not necessarily that the checking is happening in the microscopic view. Having said that refer first to Para 412 that discloses “As the optical marker enters the surgeon's field of view, an image and/or video capture system integrated into or attached to the OHMD on the surgeon's head can detect the optical marker and display the next virtual surgical step”, which shows the automatic checking during an operation under a live microscopic view. Also refer to Para 498 that discloses “When a pin or a screw is placed in a surgical site including a joint and/or a bone, (…), with an integrated or attached optical marker with a QR code or when an instrument, (…) with an integrated or attached optical marker with a QR code enters the field of view of a bar code and/or QR code reader and/or an image and/or video capture system integrated or attached to the OHMD, or enters the proximity of the surgical field or surgically altered tissue, the information on the bar code or QR code on the physical pin or screw, the physical instrument, the physical trial implant, and/or the physical implant component can be read and compared against the intended surgical site information and/or the intended laterality information and/or the virtual surgical plan and/or the intended sizing information and/or the intended templating information.” This discloses the automatic compatibility checking to make sure the right instrument and implant are being used. Examiner suggests amending to disclose that the checking is also happening under live microscopic view).
Regarding claim 18, Lang discloses the step of automatically checking compatibility comprises a comparison step in which a first optical code on said one the at least two mutually different implants is compared with a second optical code on said one of the at least two mutually different instruments (Para 392 and 1324-1325; a code can be a size or shape code or a variety of pattern codes; this system is capable of scanning codes and determining a different shape code and indicating a mismatch; also a color code is possible Para 1369-1375 “Any instrument or implant can be color coded”).
Regarding claim 19, Lang discloses the step of outputting a result of the comparison step (Para 1324 discloses an OHMD display; Para 1325 and 1375 indicate visual warnings of mismatch on the OHMD).
Regarding claim 20, Lang discloses the result of the comparison step is output optically and/or acoustically (Para 1324 discloses an OHMD display; Para 1325 and 1375 indicate visual warnings of mismatch of the OHMD; Optical or acoustic is disclosed).
Response to Arguments
Applicants’ arguments filed 08/04/2026 have been fully considered but they are moot because of the new grounds of rejection.
Refer to the U.S.C. 101 and the U.S.C. 112(b) rejections above.
Refer to the newly rejected amended claims above.
Regarding applicants’ arguments, examiner respectfully disagrees.
First, applicant discloses “it is Applicant's understanding that the Office considers Lang to teach checking the compatibility of two mutually different instruments with two mutually different implants by virtue of the surgeon selecting a compatible instrument/implant combination during preoperative planning, thus making the compatibility inherent at the time of the surgical procedure.” Examiner respectfully disagrees. Yes, the surgeon performs preoperative planning of the virtual instruments and implants as mentioned in Para 1324-1325, however, this does not make the compatibility inherent at the time of the surgical procedure. Para 1324-1325, 412, and 498 disclose that the comparison of all the tools are happening during the surgery against the virtual pre-selected instruments. So even though the surgeon plans the surgery pre-operatively, the compatibility is still being checked during the surgery when a QR code/color code ents the proximity of the surgical field.
In terms of the limitation “in real-time during an operation under a live microscopic view”, examiner takes this stand: First examiner would like to state the interpretation of this limitation under BRI seems to require automatic checking of compatibility for two instruments that are positioned together in the microscope of view, but does not require that “checking” to be performed within the microscope field of view, this specific newly amended limitation is worded in a way that makes it seem like the checking is happening during an operation, and that the operation is being performed under a live microscopic view and not necessarily that the checking is happening in the microscopic view. Having said that refer first to Para 412 that discloses “As the optical marker enters the surgeon's field of view, an image and/or video capture system integrated into or attached to the OHMD on the surgeon's head can detect the optical marker and display the next virtual surgical step”, which shows the automatic checking during an operation under a live microscopic view. Also refer to Para 498 that discloses “When a pin or a screw is placed in a surgical site including a joint and/or a bone, (…), with an integrated or attached optical marker with a QR code or when an instrument, (…) with an integrated or attached optical marker with a QR code enters the field of view of a bar code and/or QR code reader and/or an image and/or video capture system integrated or attached to the OHMD, or enters the proximity of the surgical field or surgically altered tissue, the information on the bar code or QR code on the physical pin or screw, the physical instrument, the physical trial implant, and/or the physical implant component can be read and compared against the intended surgical site information and/or the intended laterality information and/or the virtual surgical plan and/or the intended sizing information and/or the intended templating information.” This discloses the automatic compatibility checking to make sure the right instrument and implant are being used. Examiner suggests amending to disclose that the checking is also happening under live microscopic view.
Lastly, regarding “the claimed invention provides significant benefits over Lang” examiner also respectfully disagrees. When a surgeon plans a surgery, it is assumed that a surgeon lacks mistakes as they are a skilled person in their profession and in most cases, there is a lot on the line, so mistakes are null. A surgeon himself typically validates his own work multiple times, including a review from the surgical team to ensure no mistakes are being made, so it would be safe to assume that the virtual plans put together by the surgeon are free of errors. Also, Lang does disclose the updating or adjusting of a virtual plan during surgery if circumstances call for it. See for example Para 473 that states “the resultant information can, for example, be used to update or adjust or modify a virtual surgical plan […] moving or adjusting one or more aspects or components of the virtual surgical plan including one or more of […] virtual surgical instrument […] virtual implant or virtual device” or Para 713 that states “The surgeon can then assess the actual changes induced in the live patient 81. The surgeon can compare the actual changes induced in the live patient with the predetermined changes in the virtual data of the patient, e.g. in a virtual surgical plan or in a virtual 3D display 82. The magnitude of the difference(s) between the actual and the predetermined changes can be determined 83.[…] If the difference(s) between the actual and the predetermined changes are not acceptable 86, the surgeon has several means of addressing the difference(s), modify the last surgical step 87, modify the next surgical step 88, modify the virtual surgical plan 89”. Therefore, examiner believes the system of Lang can account for intraoperative changes that therefore offers the same benefits as the current invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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