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 with traverse of Species B directed in the reply filed on July 21, 2025 is acknowledged. The traversal is on the ground(s) that Applicant submits that there exists no serious burden on the . This is not found persuasive because according to MPEP §809, even if there is a linking claim, a species restriction between two claimed species is still proper, and whether or not the species claims have a linking claim is irrelevant regarding search burden. According to MPEP §808.02, to establish a search burden there is only a need to show one of the following: (A) Separate classification thereof (B) A separate status in the art when they are classifiable together (C) A different field of search. Given that the two species are mutually exclusive, they have obtained a separate status in the art and would require a separate field of search which will likely require two separate pieces of art to be applied.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5 & 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species directed to an endoscope with a dissection tip, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 21, 2025.
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: a manipulation device including a surface configured to engage a vein in claims 7, 15, 19. The broadest reasonable interpretation of a manipulation device including a surface, based on the specification, is any device capable of engaging a vein and having some sort of holding capability.
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 § 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.
Claim(s) 1-4, 6-12, 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bayer (US 7645289 B2) in view of Skarbnik et al. (US 20140074134 A1, hereinafter Skarbnik).
Regarding Claim 1, Bayer discloses
An endoscopic vein harvesting system (endoscopic vessel harvesting instrument 10 ) comprising:
an endoscope (endoscope 162 of instrument 10 - FIG. 2A) including a proximal end (proximal end 15) having one or more of a collar or a handle (Base housing 18) and including a distal end (distal end 17);
a component (dissection tip 100) formed from a transparent material (Col. 8, Ln. 59-60 discloses transparent component) and configured to couple to the distal end of the endoscope (depicted in FIG. 1A);
However, Bayer does not disclose one or more visual indicators formed on or within a selected portion of the component.
Skarbnik teaches (FIG. 4D) an analogous component (tool 40) of an endoscopic vein harvesting system (automated tool tracking system 10). The system (10) has an endoscope (endoscope 32) which images the distal end of the component (40) which includes visual indicators (labels 234) which enable the tool distal end to be distinguished from elements of the body cavity [0024].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope system of Bayer with the component of Skarbnik in order to produce endoscope images with easily identifiable indicators to accurately locate the tool distal end in the images [Skarbnik - 0027 & 0057].
Regarding Claim 2, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 1, Skarbnik further teaches wherein the one or more visual indicators comprise a color selected to have a high contrast relative to biological material corresponding to a vein to be harvested (par. 57 discloses labels are colored or dyed to be easily distinguished from biological matter).
Regarding Claim 3, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 1, Skarbnik further teaches the color comprises a fluorescent green color (par. 44 discloses green illumination color; par. 68 discloses combinations and modification of features).
Regarding Claim 4, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 1, Skarbnik further teaches the one or more visual indicators comprise one or more of a line, a crosshair, a triangle, an arrow, or a dot (par. 57 discloses circular shape i.e. a dot; FIG. 2B depicts arrow indicators, par. 68 discloses combinations and modification of features).
Regarding Claim 6, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 1, Skarbnik further teaches the component comprises a bisector (FIG. 4D depicts tool as bisector) including a first tip and a second tip on either side of an opening (depicted in FIG. 4D); and the one or more visual indicators are formed on the first tip and the second tip (depicted in FIG. 4D).
Regarding Claim 7, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 1, Skarbnik further teaches the component comprises a manipulation device including a surface configured to engage a vein; and the one or more visual indicators are formed on the surface to provide a visible guide to facilitate alignment of the manipulation device to the vein (FIG. 4D discloses tool with labels on its surface; FIG. 1 discloses tool engaging vein).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope system of Bayer with the manipulation device of Skarbnik in order to produce endoscope images with easily identifiable indicators to accurately locate the tool distal end in the images [Skarbnik - 0027 & 0057].
Regarding Claim 8, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 1, Skarbnik further teaches
a display (screen/ display 24); and
a computing device (processor 16) coupled to the endoscope and the display, the computing device configured to receive optical data from the endoscope that includes image data captured through a distal end of the endoscope (par. 25 discloses processor analyzes endoscope image of tool distal end), the optical data including images of one or more of a vein (par. 40 discloses endoscope images veins), a carbon dioxide tunnel around the vein, or the surrounding biological material and the one or more visual indicators on the component (par. 57 discloses endoscope imaging of label), the computing device configured to provide at least a portion of the optical data that includes the one or more visual indicators to the display (par. 66-67 disclose processor outputs indicators as image on display).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope system of Bayer with the computing system of Skarbnik in order to produce and display endoscope images with easily identifiable indicators which can be used to accurately locate the tool distal end in the images [Skarbnik - 0027 & 0057].
Regarding Claim 9, Bayer discloses
An endoscopic vein harvesting system (endoscopic vessel harvesting instrument 10) comprising:
an endoscope (endoscope 162 of instrument 10 - FIG. 2A) including a proximal end (proximal end 15) including one or more of a collar or a handle (Base housing 18) and including a distal end (distal end 17) to be inserted through an incision into a patient (Col. 9, Ln. 5-6 disclose incision by surgeon);
a component (dissection tip 100) formed from a transparent material (Col. 8, Ln. 59-60 discloses transparent component) and configured to couple to the distal end of the endoscope prior to insertion (depicted in FIG. 1A),
However, Bayer does not disclose the component including one or more visual indicators formed on or within a selected portion of the component to facilitate positioning of the component relative to a vein to be harvested; and a computing system coupled to the endoscope and configured to receive optical data corresponding to a view through the distal end of the endoscope, the optical data including images of the vein, surrounding biological material, and the one or more visual indicators, the computing system including a display and configured to present at least a portion of the optical data including the one or more visual indicators to the display.
Skarbnik teaches (FIG. 4D) an analogous component (tool 40) of an endoscopic vein harvesting system (automated tool tracking system 10). The system (10) has an endoscope (32) which images the distal end of the component which includes visual indicators (labels 234) which enable the tool distal end to be distinguished from elements of the body cavity [0024], and a computing system (processor 16) which analyzes endoscope images of the tool distal end [0025], the images including that of the vein (par. 40 discloses endoscope images veins), surrounding biological material (par. 40 discloses endoscope images tissue, arteries, and other biological matter), and visual indicators (par. 57 discloses endoscope imaging of labels), moreover, the processor outputs indicators as images on a display (display/ screen 24) [0066-0067].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope system of Bayer with the component and computing system of Skarbnik in order to produce endoscope images with easily identifiable indicators which the processor can use to accurately locate the tool distal end in the images [Skarbnik - 0027 & 0057].
Regarding Claim 10, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 9, Skarbnik further teaches the one or more visual indicators comprise a color selected to have a high contrast relative to the biological material and the vein to be harvested (par. 57 discloses labels are colored or dyed to be easily distinguished from biological matter).
Regarding Claim 11, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 9, Skarbnik further teaches the color comprises a fluorescent green color (par. 44 discloses green illumination color; par. 68 discloses combinations and modification of features).
Regarding Claim 12, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 9, Skarbnik further teaches the one or more visual indicators comprise one or more of a line, a crosshair, a triangle, an arrow, or a dot (par. 57 discloses circular shape i.e. a dot; FIG. 2B depicts arrow indicators, par. 68 discloses combinations and modification of features).
Regarding Claim 14, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 9, Skarbnik further teaches the component comprises a bisector (FIG. 4D depicts tool as bisector) including a first tip and a second tip on either side of an opening (depicted in FIG. 4D); and the one or more visual indicators are formed on the first tip and the second tip (depicted in FIG. 4D).
Regarding Claim 15, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 9, Skarbnik further teaches a manipulation device including a surface to engage the vein; and the one or more visual indicators are formed on the surface to provide a visible guide to align the component to the vein (FIG. 4D discloses tool with labels on its surface; FIG. 1 discloses tool engaging vein).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope system of Bayer with the manipulation device of Skarbnik in order to produce endoscope images with easily identifiable indicators to accurately locate the tool distal end in the images [Skarbnik - 0027 & 0057].
Regarding Claim 16, Bayer discloses
An endoscopic vein harvesting system (endoscopic vessel harvesting instrument 10) comprising:
an endoscope (endoscope 162 of instrument 10 - FIG. 2A) including a proximal end (proximal end 15) having one or more of a collar or a handle (Base housing 18) and including a distal end (distal end 17);
a component (dissection tip 100) formed from a transparent material (Col. 8, Ln. 59-60 discloses transparent component) and configured to couple to the distal end of the endoscope (depicted in FIG. 1);
However, Bayer does not disclose one or more visual indicators formed on or within a selected portion of the component and comprising a color selected to have a high contrast relative to biological material corresponding to a vein to be harvested.
Skarbnik teaches (FIG. 4D) an analogous component (tool 40) of an endoscopic vein harvesting system (automated tool tracking system 10). The system (10) has an endoscope (32) which images the distal end of the component (40) which includes visual indicators (labels 234), that are colored or dyed to be easily distinguished from biological matter [0057], which enable the tool distal end to be distinguished from elements of the body cavity [0024].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope system of Bayer with the component of Skarbnik in order to produce endoscope images with easily identifiable indicators to accurately locate the tool distal end in the images [Skarbnik - 0027 & 0057].
Regarding Claim 17, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 16, Skarbnik further teaches the color comprises a fluorescent green color (par. 44 discloses green illumination color; par. 68 discloses combinations and modification of features).
Regarding Claim 18, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 16, Skarbnik further teaches the one or more visual indicators comprise one or more of a line, a crosshair, a triangle, an arrow, or a dot (par. 57 discloses circular shape i.e. a dot; FIG. 2B depicts arrow indicators, par. 68 discloses combinations and modification of features).
Regarding Claim 19, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 16, Skarbnik further teaches the component comprises one or more of:
a dissection cap including a tip;
a bisector including a first tip and a second tip on either side of an opening (depicted in FIG. 4D);
or a manipulation device including a surface configured to engage a vein; and
wherein the one or more visual indicators are formed on one or more of the dissection cap, the tip, the first tip, the second tip, or the surface to provide a visible guide to facilitate alignment of the manipulation device to the vein (FIG. 4D discloses bisector with labels on first and second tip).
Regarding Claim 20, Bayer, as previously modified by Skarbnik, discloses all of the elements of the current invention disclosed in claim 16, Skarbnik further teaches
a display (screen/ display 24); and
a computing device (processor 17) coupled to the endoscope and the display (depicted in FIG. 1A), the computing device configured to receive optical data from the endoscope that includes image data captured through a distal end of the endoscope (par. 25 discloses processor analyzes endoscope image of tool distal end), the optical data including images of one or more of a vein (par. 40 discloses endoscope images veins), a carbon dioxide tunnel around the vein, or the surrounding biological material and the one or more visual indicators on the component (par. 57 discloses endoscope imaging of label), the computing device configured to provide at least a portion of the optical data that includes the one or more visual indicators to the display (par. 66-67 disclose processor outputs indicators as image on display).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope system of Bayer with the computing system of Skarbnik in order to produce and display endoscope images with easily identifiable indicators which can be used to accurately locate the tool distal end in the images [Skarbnik - 0027 & 0057].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL HADI ABBASI/
Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
08/13/2025