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 .
Response to Arguments
New drawings objection necessitated by amendment.
Regarding claim interpretation
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive. For example, applicant argues “applicant submits that the terms do not constitute ‘means’ language and, in the context of the claims and specification, connote known medical-imaging and detection structure to a person of ordinary skill in the art. The specification identifies detection equipment including a cross-section detection device that performs real-time imaging and capture multiple cross-section images, and further explains that the detection equipment may be implemented using ultrasound, X-ray, tomography, or other medical imaging technology…. The specification also discloses associated image-analysis workflow for identifying an injury image, selecting healthy images, defining outlines, defining strong sites, and determining the strong center zone” and “submits that the claim language recites sufficiently definite structure, and 112(f) should not apply” (REMARKS pg. 5-6). Examiner respectfully disagrees in that the imaging device and detection device as currently claimed include language (i.e. a device) that constitutes a generic placeholder for means. Such use of the word “device” is specifically listed in 2181 as an example of a generic placeholder (see MPEP 2181(I)(A)), where imaging and detection are merely functional modifiers of the term device and do not provide sufficient structure to the claimed devices. Applicant’s arguments that the imaging device and detection device connote known medical-imaging and detection structure are merely conclusory without providing any evidence and it is noted that applicant’s arguments do not replace evidence where evidence is necessary (MPEP 2145(I)). For the reasons listed above, the 112(f) claim interpretations are maintained.
Regarding 35 U.S.C. 112(a)
Applicant’s arguments, see REMARKs filed 04/29/2026, with respect to the 112(a) rejection of “imaging device” have been fully considered and are persuasive. The 112(a) rejection of claims 1 and 20 with respect to the “imaging device” and has been withdrawn as a person having ordinary skill in the art would have recognized the structure of detection equipment utilizing ultrasound technology, X-ray technology, tomography technology, or other medical imaging technology.
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive. For example, applicant argues “the specification also discloses image-analysis functionality of the detection equipment, including identifying the injury site, defining the injury image as a reference plane, and selecting healthy images on two sides of the reference plane, defining outlines and centroid points, defining strong sites, and forming the strong center zone” and points to paragraphs [0025], [0027], and [0029] for support. (REMARKS pg. 6-7). Examiner notes that the cited paragraphs are directed to steps of an assessment method (see [0023]) and do not implicitly nor explicitly refer to any sufficient structure for performing such a method other than. While [0022] discloses “an assessment method of the repairing assist system” such disclosure does not a) define specific structure of the repairing assist system that would perform such an assessment method b) explicitly nor implicitly set forth that the assessment method is performed by the repairing assist system. In other words, the specification and cited paragraphs are written in a way which does not provide sufficient support for structure of detection equipment, let alone structure of detection equipment which performs any sort of image-analysis functionality such as determining/identifying as recited by the claims. For these reasons, applicant’s arguments regarding the detection device are not found persuasive and the 112(a) rejection of claim 1 regarding the detection device is maintained.
Applicant further argues “the specification also supports the claimed functional significance of the strong portions. The specification explains that the strong center zone provides sufficient strength to support a pulling force generated by a surgical suture during suturing. See spec [0034]. The specification further discloses marking the strong center zone, providing a coordinate corresponding to the strong center zone, and guiding the surgical needle through an injury area while confirming through real-time imaging that the surgical needle has entered the strong center zone” and points to [0031], [0032], [0041], and [0047] for support (REMARKS pg. 7). Examiner notes that applicant’s arguments appear to be directed towards the 112(a) rejection regarding the center zone comprising a linear path across the plurality of cross-sectional images. Examiner notes that while [0031], [0032], [0034], [0041], and [0047] disclose aspects related to marking a center zone and guiding the surgical needle through an injury area, such disclosure does not provide any support for previously recited that the center zone comprises a linear path across the plurality of cross sections. Furthermore, regarding amendments to the claims, there is no support for determining a linear path across the plurality of cross-section images through the strong portions of the plurality of healthy images and through the injured image. Let alone guiding the needle along such a path. Specifically, it is noted that [0018] discloses the image group 22 comprise at least one injury image corresponding to the injury site A’ and at least two healthy images corresponding to the two healthy part A” respectively, [0031] discloses the detection equipment can further mark the strong center zone 50 on each healthy image, [0034] discloses the strong center zone 50 can be used as an optimal suture point and be considered a candidate site for needle insertion during a repairing surgery. the strong center zone 50 of the healthy part A" is applied to ensure that the healthy part A" can provide a sufficient range to allow a surgical needle B2 to pass through and guiding a surgical suture S to be inserted. In addition, the strong center zone 50 also provides a sufficient strength to support a pulling force generated by a surgical suture S for closing the gap formed the injury site A' during suturing and [0048] discloses With reference to Fig. 5 and 6, when performing repairing surgery, both strong center zones 50 at the two side of the injury site A' are penetrated the surgical sutures S, and a surgical wound is opened on the surface injury area A between the two surgical sutures S. It is noted that in fig. 5 which depicts the “injured site A’” and the “healthy site A”” and the sutures (thus needles) are inserted only into the “strong portions” of the healthy tissue. In other words, while there appears to be support for guiding, via needle guide module, a surgical needle through portions of the plurality of healthy images, there is no actual support for determining a center zone along a plurality of sites in the plurality of cross-section images, determining a linear path across the plurality of cross-section images, and guiding, a surgical needle along the linear path. For at least these reasons, applicant’s arguments are not found persuasive and the 112(a) rejection of claim 1 has been maintained/updated.
Applicant further argues “that the pending ‘target depth’ limitation is support by the specifications’ coordinate-based guidance disclosure and points to [0031]-[0032] and [0035] for such support (REMARKS pg. 7). Examiner respectfully disagrees in that none of the cited paragraphs refer to a “depth”, let alone a target depth. Examiner notes that providing a coordinate corresponding to the strong center zone which may be an up/down distance from a centroid point 41 of the reference plane as disclosed in [0031]-[0032] is not understood to be a “target depth” where depth in the field of ultrasound/medical imaging is generally understood to be a depth from a surface/face of the imaging device. Examiner notes that if applicant intends for the depth to mean a distance from a centroid point or similar the claims should be amended in a similar manner as the disclosure. For at least these reasons, applicant’s arguments are not found persuasive.
Applicant further argues “the specification provides adequate written-description support for these limitation and points to the disclosure of [0036] with further arguments that “these disclosures reasonably convey possession of the claimed use of a deep-learning program based on a learning database containing surgical records to determine the center zone along the plurality of sites” (REMARKS pg. 7-8). Examiner respectfully disagrees the specification does not describe in sufficient detail the nature of the deep-learning program. For example, the specification fails to provide the type of deep learning program and/or architecture thereof in sufficient detail to inform one of ordinary skill in the art of how the inventor intends the function to be performed. Although, [0036] of the applicant’s originally filed specification describes that the detection equipment performs deep learning based on the learning databased and generates an interpretation module… the detection equipment can interpret the cross-section images of the image group 22 according to the interpretation module, and can identify the injury site A’, a level of damage, and can provide a surgical advice. Said surgical advice may be 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 is vague and does not describe the specific inputs/outputs of the deep learning, how it is analyzed/manipulated, what elements of the data are considered, what weighting considerations are applied or what parameters are being used in the algorithm. Therefore, the written description does not provide sufficient support for what the deep learning program is, how it is utilized, and how it functions with the information fed into it such that it is used in determining the center zone along the plurality of sites. For at least these reasons, applicant’s arguments are not found persuasive and the 112(a) rejection of claim 9 is maintained.
Regarding 112(b)
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive. For example, applicant argues “that the amendments clarify the ‘linear path’ terminology. The amended claims not specify that the linear path extends through the strong portions of the plurality of health images and through the injured image. This language clarifies that the claimed linear path is determined from the identified strong portions and the injured image for guiding the surgical needle” (REMARKS pg. 9). Examiner respectfully disagrees in that although amendments to the claims are made, the language does not make clear the metes and bounds of the linear path and how it is included in the center zone as recited. As noted in the previous office action the specification appears to describe that the needle is guided through the strong portion, but it is not clear what is meant by or how the linear path is through the strong portions of the healthy images and through the injured image and further how this is included in the center zone as the center zone which is determined is disclosed in applicant’s originally filed specification as the centroid 41 or strong center zone 50 which connects the site found in a healthy image.
Applicant further argues that the terms ‘tendon’, ‘target depth’, and ‘sites of the healthy portion’ are clear as amended and that in view of amended claims 1 and 20, the use of deep learning for center zone determination is clear” (REMARKS pg. 9). Examiner respectfully disagrees in that applicant’s arguments are merely conclusory and do not provide evidence of such “clarity” resolved by the amendments to the claims.
For at least the reasons listed above, the 112(b) rejections are maintained/updated in view of the amendments.
Regarding prior art
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive. For example, applicant argues that Cross “describes manual confirmation during a surgical procedure, which differs from image analysis by a detection device to identify portions in healthy images with sufficient strength and determining a path for a needle based on those portions and the injured image (REMARKS pg. 10). Examiner notes that Cross is not relied upon to teach the features regarding the detection device configured to perform the functions as recited, therefore, applicant’s arguments regarding the teachings of Cross are found to be moot in view of the rejection below which does not rely upon teachings of Cross for the functions of the detection device.
Applicant further argues “Applicant submits that Kamiyama’s image-processing regions are not based on portions of healthy tendon images having sufficient strength to support a pulling force generated by a surgical suture during suturing. Further applicant submits that Kamiyama does not teach determining a surgical needle path through strong portions of healthy images and through an injured image. Thus, even if Kamiyama were combined with Cross, the combination would not yield the claimed invention as amended” (REMARKS pg. 11). Examiner respectfully disagrees in that Kamiyama is relied upon for teaching identification of a center/centroid of a target (i.e. tendon) where it is evidenced that such a center of the target is considered to have sufficient strength to support a pulling force generated by a surgical suture during suturing. This is evidenced by at least Cross. Furthermore, Kaniyama teaches determination of a linear path via length in the horizontal direction in fig. 10A, where it is noted that Cross desires to insert the needle through the tendon along a central line. Where the linear path along the tendon through which the needle is guided is consistent with applicant’s specification (see at least fig. 7D and fig. 5)
Applicant further argues “Applicant submits that the motivation to improve tracking or image correction does not explain why a person of ordinary skill in the art would have modified Cross to identify strong portions of healthy images based on their ability to support suture pulling force and then determine a linear path through those strong portions and the injured image. The amended claims are directed to a particular arrangement, not merely to displaying ultrasound images, identifying a tendon center, or stabilizing an ultrasound image” (REMARKS pg. 11). Examiner respectfully disagrees in that a person having ordinary skill in the art would have recognized the benefits of the center identification (i.e. strong portions) and linear path determination of Kamiyama to improve visibility of an observation target on the ultrasound image as disclosed in [0046] of Kamiyama. The claims at this time do not require any specific arrangement other than the needle being guided through the linear path which is already taught by Cross, therefore, the displaying of ultrasound images, identifying the tendon center, or stabilizing the ultrasound image features of Kamiyama would benefit the system of Cross to enhance the overall procedure which relies on displayed images to ensure that the needle is inserted along the central portion of the Tendon. Furthermore, an additional/alternative motivation for determining the strong portions and linear path as taught by Kaniyama are to provide automated determinations of the center portion thereby enhancing the overall procedure of Cross to ensure that the needle takes a good bite. Applicant’s arguments against are not found persuasive for the reasons listed above.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the linear path across the plurality of cross-section images through the strong portions of the plurality of healthy images and through the injured image” and “the center zone comprises the linear path” of claims 1 and 20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 ultrasound, x-ray, tomography, or other medical imaging technology structure ([0017]) 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.
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 1-5, 8-10, 20-24, and 27-29 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 “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 by: identifying an injured image of the plurality of cross-section images; identifying a plurality of healthy images of the plurality of cross-section images; identifying strong portions of the plurality of healthy images, the strong portions, having sufficient strength to support a pulling force generated by a surgical suture during suturing; and determining a linear path across the plurality of cross-section images through the strong portions of the plurality of health images and through the injured tissue”. 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 by: identifying an injured image of the plurality of cross-section images; identifying a plurality of healthy images of the plurality of cross-section images; identifying strong portions of the plurality of healthy images, the strong portions having sufficient strength to support a pulling force generated by a surgical needle during suturing; and determining a linear path across the plurality of cross-section images through the strong portions of the plurality of healthy images and through the injured tissue, wherein the center zone comprises the linear path across the plurality of cross-section images” and “guide/guiding the surgical needle along the linear path”.
First examiner notes that regarding “identifying an injured image of the plurality of cross-section images” and “identifying a plurality of healthy images 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 an injured image and a plurality of healthy 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.
Second examiner notes that the limitation “identifying strong portions of the plurality of healthy images, the strong portions having sufficient strength to support a pulling force generated by a surgical needle during suturing” lacks sufficient written description. Specifically, it is noted that while there is literal textual support for the limitation in the originally filed specification (see for example, [0007] and [0039]), there is not sufficient written description for the algorithms/steps for identifying strong portions of the plurality of healthy images. The algorithm or steps/procedure taken to perform the function of identifying strong portions of the plurality of healthy images 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(I)). In this instance, the claim merely recites defining a centroid and multiple strong sites are defined on each connecting line from the centroid to the outline, and although there is disclosure that a distance between each strong site 43 and the centroid is less than 30 to 50 percent of a length of each connecting lines H, this appears to be merely a result of the identified strong portions and does not provide any steps/algorithm for actualy identifying strong portions (e.g. is it merely any point which is less than 30 to 50 percent of a length between the centroid and an outline of the tendon, is there some other analysis (e.g. image analysis) which determines points that are strong compared to other points, or is there some other way that the strong portions are identified such that they have sufficient strength to support a pulling force generated by a surgical suture during suturing).
Finally, examiner notes that the written description fails to disclose, implicitly nor explicitly, determining a linear path across the plurality of cross-section images through the strong portions of the plurality of healthy images and through the injured image, the center zone comprising the linear path, and guiding the surgical needle along the linear path. Examiner notes that [0018] discloses the image group 22 comprise at least one injury image corresponding to the injury site A’ and at least two healthy images corresponding to the two healthy part A” respectively, [0031] discloses the detection equipment can further mark the strong center zone 50 on each healthy image, [0034] discloses the strong center zone 50 can be used as an optimal suture point and be considered a candidate site for needle insertion during a repairing surgery. the strong center zone 50 of the healthy part A" is applied to ensure that the healthy part A" can provide a sufficient range to allow a surgical needle B2 to pass through and guiding a surgical suture S to be inserted. In addition, the strong center zone 50 also provides a sufficient strength to support a pulling force generated by a surgical suture S for closing the gap formed the injury site A' during suturing and [0048] discloses With reference to Fig. 5 and 6, when performing repairing surgery, both strong center zones 50 at the two side of the injury site A' are penetrated the surgical sutures S, and a surgical wound is opened on the surface injury area A between the two surgical sutures S. It is noted that in fig. 5 which depicts the “injured site A’” and the “healthy site A”” and the sutures (thus needles) are inserted only into the “strong portions” of the healthy tissue. Furthermore, it is noted that 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, there is insufficient written description regarding determining a linear path as currently amended and guiding the surgical needle along the linear path and 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 “determining a linear path across the plurality of cross-section images through the strong portions of the plurality of healthy images and through the injured image”, “the center zone comprises the 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 the linear path is a linear path through a center zone of the healthy tissue (consistent with applicant’s specification), however, clarification is required.
Claims 1 and 20 recite the limitation “a surgical needle”. It is unclear if this is the same surgical needle recited with respect to the pulling force generated by a surgical needle or a different surgical needle. For examination purposes, it has been interpreted to mean any surgical needle, however, clarification is required.
Claims 1 and 20 recite the limitation “identifying strong portions”. It is unclear if the strong portions are the same as, correspond with, or are different from the plurality of sites or if these are different portions. This is further made unclear as the linear path is recited as being across the plurality of cross-section images through the strong portions and the center zone comprises the linear path. It is therefore unclear what the relationship between the sites and the strong portions in the claim are. For examination purposes, it has been interpreted that they may be the same or different, 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 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 1-5, 8-10, 20-24, and 27-29 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 (US 20110245673 A1), hereinafter Kaniyama and WIPO LI (WO 2024145750 A1), hereinafter Li.
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)
Determining, a center zone along a plurality of sites in the plurality of cross-section images by:
Identifying an injured image of the plurality of cross-section images (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 an injured image of the tendon);
Identifying a plurality of healthy images of the plurality of cross-section images (evidenced by pg. e174 referring to the detailed description of the ultrasound technique provided in video 1 (see above) between 1:25-1:50 where the user identifies healthy images of the tendon);
Identifying strong portions of the plurality of healthy images (pg. e176 which discloses identifying the midportion, which is marked with a marking pen as a referent point when placing the jig, the Achilles tendon is then identified proximally and distally, as in both short and long axis. And evidenced by pg. e174 referring to the detailed description of the ultrasound technique provided in video 1. See Technique Video (video 1) cited above between 2:24 and 2:50 describing ensuring that the needle passes through the bulk of the achilles tendon and the needle passing through the central portion of the achilles tendon to see that the needles are “taking a good bite”), the strong portions having sufficient strength to support a pulling force generated by a surgical suture during suturing (examiner notes that the central portions are considered to have sufficient strength to support a pulling force generated by the surgical suture during suturing see 2:40-2:50 of video 1 above “unlikely that the sutures are going to cut through”);
Determining a linear path across the plurality of cross-section images through the strong portions of the plurality of healthy images and through the injured image (See video 1 above where the user visualizes the needle passing through the central portion of the Achilles tendon. Examiner notes that the insertion of the needle through the central portion of the healthy tissue is consistent with applicant’s specification see at least fig. 5 and 7D),
Wherein the center zone comprises the linear path (see video 1 and fig. 3 of pg. e176)
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 the 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 fig. 3 of page e 176 depicting a needle guided along the linear path of a center zone)
Since Cross teaches the PARS needle is guided along the 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, however, this feature is not explicitly taught by Cross. Cross, therefore, fails to explicitly teach the detection device configured to determine the center zone along the plurality of sites in the plurality of cross-section images by: Identifying the injured image of the plurality of cross-section images; Identifying the plurality of healthy images of the plurality of cross-section images; Identifying the strong portions of the plurality of healthy images; and determining the linear path across the plurality of cross-section images through the strong portions of the plurality of healthy images and through the injured image.
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 (20 and/or 21) and corresponding disclosure in at least [0081] and [0088]) 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), by identifying strong portions of the plurality of healthy images, the strong portions having sufficient strength to support a pulling force generated by a surgical suture during suturing (examiner notes that the center of 21) in each of the images constitutes strong portions of the plurality of healthy images, determining a linear path across the plurality of cross-section images through the strong portions of the plurality of healthy images (see at least fig. 10A depicting a linear path regarding the length of the long side of observation ROI 20 as disclosed in [0098]) the center zone comprises the 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 by identifying strong portions and determining the linear path 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 and would allow for improved visibility of an observation target on the ultrasound image (Kaniyama [0046]). Furthermore, a person having ordinary skill in the art would have recognized the benefit of determining a center zone with the detection device 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.
Cross, as currently modified, fails to explicitly teach the detection device configured to identify an injured image of the plurality of cross-section images and identifying the plurality of healthy images of the plurality of cross-section images.
Nonetheless, Li, in a similar field of endeavor involving ultrasound evaluation of tendons, teaches a detection device configured to identify an injured image of a plurality of cross-section images; and identify a plurality of healthy images 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 and Specifically, the ultrasonic images of multiple cross sections of the first rehabilitation stage can be processed to obtain the area of the normal area of the Achilles tendon and the area of the damaged area of each cross section)
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 identifying healthy and injured images 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.
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 claims 3 and 22,
Cross, as modified, teaches the elements of claims 1 and 20 as previously stated. Cross and Li further teaches wherein the injured image comprises at least one image of injured portions of a tendon (see video 1 of Cross and 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)
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, wherein identifying the strong portions of the plurality of healthy images comprises determining sites of healthy portions (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 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 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)
Regarding claims 9 and 28,
Cross, as modified, teaches the elements of claim 1 and 20 as previously stated. Cross, as currently 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.
Nonetheless, Li, in a similar field of endeavor involving ultrasound evaluation of tendons, teaches wherein a detection device is configured use a deep learning program based on a learning database containing surgical records for determining the inured and healthy 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 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Roh (US 20240252266 A1) teaches in a robotic system configured to repair an injured tendon by suturing lacerated ends of the tendons with one or more end effectors in (see [0036]) including identifying the lacerated tendon in images (see [0035]), Image processing can be applied to patient images (e.g., scans, video, or the like) to determine elasticity, strength, and other properties of soft tissue, such as cartilage, tendons, synovial fluid, or the like (see [0179]) [0104] using deep learning for differentiating features of interest from background features (see [0104]) and to analyze real-time data (e.g., video, images, etc.) of a surgery site to determine one or more candidate surgical steps, generate predicted outcomes for candidate surgical steps, and/or generate simulations for physician review and (see [0241])
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Primary Examiner, Art Unit 3797
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