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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/17/2025 is acknowledged.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The limitation “imaging device” in claims 1 and 20 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “device” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “device”) is modified by functional language (“capture/capturing”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “detection device” in claims 1 and 20 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “device” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “device”) is modified by functional language (“determine/determining”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “needle guide module” in claims 1 and 20 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “module” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “module”) is modified by functional language (“guide/guiding a surgical needle”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a jig (see at least fig. 3) which physically guides a needle appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 and 20-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 20 recite the limitation “an imaging device”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “capturing a plurality of cross-section images”. Examiner notes that although the specifically describes that the detection equipment may apply/implement ultrasound technology, X-ray technology, tomography technology, or other medical technology for example in at least [0009], [0020]-[0022], this appears to describe the detection equipment and does not provide any sufficient support for the corresponding structure of an imaging device. Furthermore, the drawings depict an imaging device 21, however, it appears to be a black box drawing and does not provide any sufficient support for the corresponding structure of the imaging device. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claims 1 and 20 recite the limitation “a detection device”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “determining a center zone along a plurality of sites in the plurality of cross-section images”. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claims 1 and 20 recite the limitation “determine/determining a center zone along a plurality of sites in the plurality of cross-section images, wherein the center zone comprises a linear path across the plurality of cross-section images” and “guide/guiding the surgical needle along the linear path”. Examiner notes that the written description fails to disclose that the center zone comprises a linear path across the plurality of cross-section images and further fails to disclose guiding the surgical needle along the linear path. Examiner notes that while fig. 7C depicts a center zone 50 formed by connecting a plurality of sites, such a connection appears to be a path/line across the plurality of sites, but is not across the plurality of cross-section images and further fig. 7D appears to depict guiding the needle through the center zone, but not along any linear path found as part of the center zone. For at least the reasons listed above, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 3 recites “identifying healthy portions of a tendon and injured portions of the tendon”, claim 22 recites “the detection device is configured to detect healthy portions of a tendon and injured portions of the tendon”, and claims 6 and 25 recite “identifying at least two healthy images of the plurality of cross-section images” and “identifying at least one injured image of the plurality of cross-section images”. Examiner notes that while there is literal textual support of the recited limitation in the specification, there is insufficient written description of the algorithm or steps/procedure for identifying healthy portions of a tendon and injured portions of tendon and identifying healthy images and injured images. Examiner notes that the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed (MPEP 2161.01). In other words, a person having ordinary skill in the art would not have recognized the steps/algorithm used to identify healthy portions of a tendon and injured portions of a tendon nor to identify healthy images or injured images of the plurality of cross-section images (e.g. comparison of images to ground truth/known healthy tendon images, pixel analysis, probability evaluation, etc.). For at least these reasons, the limitations lack sufficient written description such that a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 4 recites the limitation “determining a target depth on a proximal or distal side of the injured portions of the tendon to avoid injuring the tendon”. Examiner notes that there is insufficient written description for the cited limitation in the claim. In other words, while there is literal textual support in the claim itself, there is no disclosure of a target depth nor the steps/procedure for determining a target depth in the specification. Examiner notes that the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed (MPEP 2161.01). In other words, the specification fails to provide any detail let alone sufficient detail regarding how to determine a target depth and what is considered to be a target depth. For at least these reasons, the limitation lacks sufficient written description such that a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 9 recites the limitation “wherein determining the center zone along the plurality of sites comprises using a deep learning program based on a learning database containing surgical records” and claim 20 recites the limitation “wherein detection device is configured to detect the center zone along the plurality of sites by using a deep learning program based on a learning database containing surgical records”. Examiner notes that while [0036] of applicants specification appears to describe the detection equipment performs deep learning and can interpret the cross-section images of the image group and can identify the injury site A’, a level of damage, and can provide a surgical advice such as “to select the healthy images at two sides of the reference plane Y by directly confirm the expected distance or the expected range, and directly determine the strong center zone 50. Such disclosure does not A) provide any support for determining the center zone along the plurality of sites using the deep learning program and B) does not provide sufficient written description of the algorithm/steps included in/performed by such a deep learning program to identify the injury site, a level of damage or provide a surgical advice, let alone to be used to determine the center zone along the plurality of sites. Examiner notes that the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed (MPEP 2161.01). For at least these reasons, there is insufficient written description of the claimed limitation as a whole as well as the deep learning program recited in the limitation such that a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim Rejections - 35 USC § 112(b)
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 1-10 and 20-29 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.
Claims 1 and 20 recite the limitation “determine/determining a center zone along a plurality of sites in the plurality of cross-section images”. The limitation is unclear as to whether the plurality of sites are each in the plurality of cross-section images or if the claim is intending to refer to a plurality of sites, each site found in a respective cross-section image, or if the claim merely requires a plurality of sites found in at least one of the cross-section images. Specifically when looking at figs. 7C and 7D the center zone appears to merely be a centroid/single point found in a single image, therefore, it is not clear how the center zone is determined along a plurality of sites in the plurality of cross-section images. For examination purposes, it has been interpreted to mean determine a center zone along a plurality of sites based on the plurality of cross-section images or within at least one of the plurality of cross-section images, however, clarification is required.
Claims 1 and 20 recite the limitation “ the center zone comprises a linear path across the plurality of cross-section images” and “guide/guiding the surgical needle along a linear path”. It is unclear what is meant by the center zone comprising a linear path across the plurality of cross-section images. The metes and bounds of a linear path across a plurality of cross-sections is not made clear by the claim nor is it clear how this is included in the center zone. Examiner notes that while the figures appear to describe a center zone as a centroid (41) or strong center zone (50) which connects the “sites”, it is unclear what is considered the linear path and where/how the needle is guided along the linear path. As shown in fig. 7D the needle is guided through the strong center zone 50, however, this does not make clear the nature of the linear path through which the surgical needle is guided. For examination purposes, it has been interpreted that any center is considered a center zone comprising a linear path and that the needle is guided through the center zone, however, clarification is required.
Claims 3 and 22 recite the limitation “a tendon”. It is unclear if the tendon is same as the tissue being repaired, one of the plurality of sites or included in the plurality of sites or if this is a different/distinct element. For examination purposes, it has been interpreted to mean any tendon, however, clarification is required.
Claim 4 recites the limitation “a target depth”. It is unclear if the target depth is the same as or included in the center zone or if this is a different element. The claim further recites positioning the surgical needle at the target depth and claim 1 recites guiding the surgical needle along the linear path, thus there appears to require some sort of correspondence between at least the linear path included in the center zone and the target depth, however, such correspondence is not reflected by the claims rendering the claim unclear. For examination purposes, it has been interpreted to mean that the target depth is included in the center zone or is the same as the center zone/linear path, however, clarification is required.
Claims 5 and 24 recite the limitation “sites of the healthy portion of the tendon with sufficient range to allow the surgical needle to pass through the sites”. The limitation is first unclear as to whether the sites of the healthy portions are the same as or included in the plurality of sites or if these are different/distinct elements for determining the center zone. It is further unclear what is meant by “with sufficient range” as sufficient is a relative term and it is not clear what the extent of the range is to be considered sufficient and further unclear what is meant by the sites having a range (e.g. from each other, from a surface, or some other range). Finally, the limitation “the sites” recited at the end is unclear whether it is referring to the plurality of sites or the sites of the healthy portions. For examination purposes, it has been interpreted to mean determining any sites which would allow the surgical needle to pass through any of the previously recited sites, however, clarification is required.
Claims 7 and 26 recites the limitation “a zone with sufficient strength”. It is unclear if the zone is the same as the center zone or if this is a different zone. For examination purposes, it has been interpreted to mean any zone, however, clarification is required.
Claims 9 and 28 recite the limitation “detect/determining the center zone along the plurality of sites… using a deep learning program based on a learning database containing surgical records”. It is unclear how determining the center zone comprises or is done by using a deep learning program. For example, the specification appears to describe that the detection unit may perform deep learning and may then interpret the cross-section images and can identify the injury site, a level of damage and provide surgical advice, however, such disclosure does not make clear how such features tie to determining/detecting the center zone. For examination purposes, it has been interpreted that deep learning is used to analyze/interpret the images for any purpose including to identify injured/healthy tissue, however, clarification is required.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8, 10, 20-24, 26-27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Cross (“Percutaneous Achilles Tendon Repair Using Ultrasound Guidance: An Intraoperative Ultrasound Technique” published February 2023) in view of Kamiyama
Regarding claims 1 and 20,
Cross teaches a tissue repair system comprising:
An imaging device (pg. e175 which discloses ultrasound transducer. See at least fig. 2 depicting an ultrasound probe (i.e. imaging device)) configured to capture a plurality of cross-section images (See at least fig. 3 depicting a plurality of ultrasound images);
A detection device (Examiner notes that the ultrasound procedure depicting ultrasound images of fig. 3 require at least a processor to process the ultrasound images into ultrasound images, such a processor is considered a detection device in its broadest reasonable interpretation)
A surgical needle (pg. e175 which discloses the first free needle is then passed through # 1 hole in the jig system); and
A needle guide module (at least fig. 2 depicting a needle guide module (i.e. jig system disclosed in at least pg. e175)) configured to guide the surgical needle along a linear path across the plurality of cross-section images, the linear path being included in a center zone along a plurality of sites in the plurality of cross-section images (see at least 3 of page e 176 depicting a needle guided along a linear path of a center zone)
Since Cross teaches the PARS needle is guided along a center zone comprising a linear path in at least fig. 3 and this is disclosed as the appropriate position, it would appear that cross would determine, via the detection device, the center zone along a plurality of sites in the plurality of cross-section images. Cross further teaches identifying a midportion of the proximal stump this feature is not explicitly taught by Cross.
Nonetheless, Kaniyama, in a similar field of endeavor involving ultrasound imaging, teaches a detection device (at least fig. 7 (15) and corresponding disclosure in at least [0085]) configured to determine a center zone (at least fig. 9 (21) and corresponding disclosure in at least [0081]) along a plurality of sites (at least fig. 9 (22-25) and corresponding disclosure in at least [0088]) in a plurality of cross-section images (see at least fig. 9 and abstract which discloses The image creating unit creates a plurality of ultrasound images in time series; and the motion-vector calculating unit calculates a motion vector of a local region between two successive ultrasound images (at least a first image and a second image) in time series among the ultrasound images created by the image creating unit) the center zone comprises a linear path (see at least fig. 9 in which the center zone includes a path which is considered linear) and further teaches wherein the target for which the observation ROI 20 is set may be a tendon ([0122]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cross to include determining a center zone as taught by Kaniyama in order to provide motion tracking of the tendon which may occur due to inadvertent pressure applied by the imaging device. Such a modification would further allow for correcting images when movement exceeds a threshold amount. Furthermore, a person having ordinary skill in the art would have recognized the benefit of determining a center zone in order to guide the needle to the appropriate position enhancing the security of the suture and therefore would enhance needle guidance/suturing of Cross.
Examiner notes that in the modified system by guiding the needle through the center of the tendon, the surgical needle is guided along the linear path such that it passes through the center of the tendon.
Regarding claim 2,
Cross further teaches wherein capturing the plurality of cross-section images comprises capturing the plurality of cross-section images using ultrasound imaging (pg. e175 which discloses high resolution ultrasound is used throughout the case).
Regarding claim 3,
Cross further teaches further comprising identifying healthy portions of a tendon and injured portions of the tendon (evidenced by pg. e174 referring to the detailed description of the ultrasound technique provided in video 1 which can be found in the URL version (https://www.sciencedirect.com/science/article/pii/S2212628722002729?via%3Dihub#mmc3). See Technique Video (video 1) between :44 and :48 where the user identifies injured portion of the tendon and between 1:25-1:40 where the user identifies healthy portion of the tendon).
Examiner notes that the needle is inserted into the proximal stump of the tendon as disclosed in at least pg. e175-e176, thus needle insertion path is based at least in part on a position of the injured portions of the tendon. Therefore, in the modified method determining of the center zone is based at least in part on a position of the injured portions of the tendon.
Regarding claim 4,
Cross, as modified, teaches the elements of claim 3 as previously stated. Cross, as modified, further teaches wherein determining the center zone along the plurality of sites comprises determining a target depth (Examiner notes that the center determined by Kaniyama is considered a target depth) on a proximal or distal side (Pg. e175 which discloses The transducer is then turned to short axis to visualize the proximal stump of the Achilles tendon, identifying the midportion, which is marked with a marking pen as a reference point when placing the jig. The Achilles tendon is then identified proximally and distally, as well in both short and long axis and pg. e177 which discloses the PARS guide is then placed on the distal stump and in similar fashion, the distal tendon is captured with the sutures in the same fashion, as described for the proximal tendon stump) of the injured portions of the tendon to avoid injuring the tendon, wherein guiding the surgical needle comprises positioning the surgical needle at the target depth (See at least fig. 3 of Cross depicting positioning the surgical needle at the center of the tendon)
Regarding claims 5 and 24,
Cross, as modified, teaches the elements of claims 3 and 23 as previously stated. Cross, as modified, further teaches wherein the detection device is configured to detect the center zone along the plurality of sites comprises determining sites (Kaniyama center site and/or sites 21-25) of the healthy portions of the tendon with sufficient range to allow the surgical needle to pass through the sites such that a surgical suture attached to the surgical needle can close a gap formed at the injured portions of the tendon (evidenced by pg. e174 referring to the detailed description of the ultrasound technique provided in video 1 which can be found in the URL version (https://www.sciencedirect.com/science/article/pii/S2212628722002729?via%3Dihub#mmc3). See Technique Video (video 1) between 2:25-2:35 in which it is described that each of the needles I passed through the bulk of the tendon stump and central portion of the tendon is being pierced by the needle and the needles are taking a “good bite” and it’s unlikely that the sutures are going to cut through).
Regarding claim 6,
Cross further teaches wherein identifying the healthy portions of the tendon comprises identifying at least two healthy images of the plurality of cross-section images, wherein identifying the injured portion comprises identifying at least one injured image of the plurality of cross-section images, and wherein the at least one injured image is between the at least two healthy images (pg. e175 the transducer is then turned to short axis to visualize the proximal stump of the Achilles tendon, identifying the midportion, which is marked with a marking pen as a reference point when placing the jig and pg. e177 which discloses the PARS guide is then placed on the distal stump and in similar fashion, the distal tendon is captured with the sutures in the same fashion. Examiner thus notes that the method of identifying the healthy portions includes identifying at least two healthy images (i.e. images of the proximal and distal stump which are heathy) where it is noted that the at least one injured image identified is between the proximal and distal stump).
Regarding claims 7 and 26,
Cross, as modified, teaches the elements of claim 1 as previously stated. Cross, as modified, further teaches, wherein the detection device is configured to detect the center zone along the plurality of sites by identifying a zone (Kamiyama (21)) with sufficient strength to support a pulling force generated by a surgical suture during suturing (evidenced by pg. e174 referring to the detailed description of the ultrasound technique provided in video 1 which can be found in the URL version (https://www.sciencedirect.com/science/article/pii/S2212628722002729?via%3Dihub#mmc3). See Technique Video (video 1) between 2:25 and 2:35 in which it is described that each of the needles I passed through the bulk of the tendon stump and central portion of the tendon is being pierced by the needle and the needles are taking a “good bite”. Examiner notes that the 21 identified by Kaniyama is a zone with sufficient strength to support a pulling force generated by a surgical suture during suturing)
Regarding claims 8 and 27,
Cross further teaches further comprising simultaneously confirming that the surgical needle is positioned along the linear path while moving the surgical needle (evidenced by pg. e174 referring to the detailed description of the ultrasound technique provided in video 1 which can be found in the URL version (https://www.sciencedirect.com/science/article/pii/S2212628722002729?via%3Dihub#mmc3). See Technique Video (video 1) between 2:20 and 2:35 describing seeing in the ultrasound image that the central portion of the tendon is being pierced by the needle during the percutaneous tendon repair. See also pg. e175 During this process, easch needle is placed and visualized on ultrasound in both short (Fig 3, A and B) and long axis (Fig 4, A and B) to confirm mid-substance placement. The ultrasound is also used to identify the location of the sural nerve and ensure that the needle placement does not disrupt the nerve (Video 1). Examiner notes this is done using the needle guide module)
Regarding claims 10 and 29,
Cross further teaches further comprising a display configured to display the plurality of cross-section images, the plurality of sites and the center zone in real time (evidenced by pg. e174 referring to the detailed description of the ultrasound technique provided in video 1 which can be found in the URL version (https://www.sciencedirect.com/science/article/pii/S2212628722002729?via%3Dihub#mmc3) See Technique Video (video 1) between 1:00 and 2:00 depicting real time display of the cross-section images and a plurality of sites which are included in the ultrasound images and 3:00-3:15 depicting the center-zone and plurality of sites which are included in the ultrasound images displayed on a display)
Regarding claim 21,
Cross further teaches wherein the imaging device is an ultrasound imaging device (i.e. ultrasound transducer)
Regarding claim 22,
Cross further teaches wherein the detection device is configured to detect healthy portions of a tendon and injured portions of the tendon (evidenced by pg. e174 referring to the detailed description of the ultrasound technique provided in video 1 which can be found in the URL version (https://www.sciencedirect.com/science/article/pii/S2212628722002729?via%3Dihub#mmc3). See Technique Video (video 1) between :44 and :48 where the user identifies injured portion of the tendon and between 1:25-1:40 where the user identifies healthy portion of the tendon, thus the system is configured to detect such portions via ultrasound imaging such portions where detecting is broadly recited and merely includes that the signals/images from such portions are detected).
Examiner notes that the needle is inserted into the proximal stump of the tendon as disclosed in at least pg. e175-e176, thus needle insertion path is based at least in part on a position of the injured portions of the tendon. Therefore, in the modified method determining of the center zone is based at least in part on a position of the injured portions of the tendon.
Regarding claim 23,
Cross further teaches further comprising a surgical suture attached to the surgical needle (pg. e175 which discloses a looped suture is loaded onto the needle in hole #3, and the nonlooped end is passed through the jig system, and the needle is subsequently placed through hole #5. The looped sutures from holes #3 and #4 will be used to create a locking suture. Another looped suture is loaded onto the needle in hole #4)
Claims 9, 25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Cross and Kamiyama, as applied to claims 1, 20, and 22 above, and further in view of WIPO LI (WO 2024145750 A1), hereinafter Li. Examiner notes that citations to Li are with respect to the translated copy provided herein.
Regarding claims 9 and 28,
Cross, as modified, teaches the elements of claim 1 and 20 as previously stated. Cross, as modified, fails to explicitly teach wherein the detection device is configured to detect/determine the center zone along the plurality of sites by using a deep learning program based on a learning database containing surgical records.
Li, in a similar field of endeavor involving ultrasound evaluation of tendons, teaches wherein a detection device is configured to determine healthy/damaged regions in a plurality of cross-sectional ultrasound images by using a deep learning program based on a learning database containing surgical records (pg. 5-6 which disclose the processor 20 can input the acquired multiple cross-sectional images into a pre-trained deep learning model, and the model outputs the Achilles tendon region and the damaged region in each cross-sectional image The model can be trained by multiple training images, some of which are cross-sectional ultrasound images marked with the Achilles tendon region and the damaged region, and some of which are cross-sectional ultrasound images of the Achilles tendon without damage, marked with the Achilles tendon region)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cross, as currently modified to include using a deep learning program based on a learning database containing surgical records as taught by Li in order to provided an automated system for identifying healthy/damaged regions of the tendon. Such a modification would provide for enhanced surgical suturing in the system of cross by providing automated assurance that the needles will be inserted into the healthy portions for ensuring a “good bite” by the needles to suture.
Regarding claim 25,
Cross, as modified, teaches the elements of claim 22 as previously stated. Cross further teaches wherein the healthy portions of the tendon are detected in at least two heathy images of the plurality of cross-section images, and the injured portion are detected in at least one injured image of the plurality of cross-section images, and wherein the at least one injured image is between the at least two healthy images.
Cross, as currently modified, fails to explicitly teach wherein the detection device is configured to identify the healthy portions of the tendon by identifying the at least two healthy images of the plurality of cross-section images, wherein identifying the injured portions of the tendon comprises identifying at least one injured image of the plurality of cross-section images.
Li, in a similar field of endeavor involving ultrasound evaluation of tendons, teaches a detection device configured to identify healthy images of a plurality of cross-section images, and identifying at least one injured image of the plurality of cross-section images (pg. 5-6 which disclose the processor 20 can input the acquired multiple cross-sectional images into a pre-trained deep learning model, and the model outputs the Achilles tendon region and the damaged region in each cross-sectional image The model can be trained by multiple training images, some of which are cross-sectional ultrasound images marked with the Achilles tendon region and the damaged region, and some of which are cross-sectional ultrasound images of the Achilles tendon without damage, marked with the Achilles tendon region)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cross, as currently modified to include using a deep learning program based on a learning database containing surgical records as taught by Li in order to provide an automated system for identifying healthy/damaged regions of the tendon. Such a modification would provide for enhanced surgical suturing in the system of cross by providing automated assurance that the needles will be inserted into the healthy portions for ensuring a “good bite” by the needles to suture.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Examiner, Art Unit 3797