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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/10/2025 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 10 regarding the amended limitations of wherein the shaft is “cylindrical” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Carranza is not relied upon to disclose a “cylindrical shaft”. Additionally, in regards to Applicant’s contention that the claimed “shaft” of Carranza, as defined in the office action, is “just an arbitrarily-defined portion of the measurement tool”, the Examiner notes that the portion of the elongate body from which the walls 6 protrude radially outward from (as shown in Fig. 4) is reasonably interpretable as a “shaft” since this is the elongate component extending along the length of the device to which all of the protruding walls extend from and are connected to. Until further limitations are read into the claims further defining the “shaft”, the interpretation of the “shaft” limitation remains upheld.
Applicant's arguments filed 9/10/2025 with regards to the amended limitation(s) of “the first distance along the shaft axis separates the corresponding tab axis of the second of the plurality of reference tabs and a corresponding tab axis of a third of the plurality of reference tabs, and the first distance along the shaft axis separates the corresponding tab axis of the third of the plurality of reference tabs and a corresponding tab axis of a fourth of the plurality of reference tabs” have been fully considered but they are not persuasive.
In the updated rejection below pertaining to the above-reference amended limitations, the examiner respectfully contends that the “first distance” that separates the first and second of the plurality of reference tabs can be interpreted to separate all four of the reference tabs from one-another. As shown in Examiner’s Diagram of Fig. 4_Distances in the rejection below, a common distance can be shown to separate the four cited plurality of reference tabs from one-another. The examiner notes that each “plurality of walls” does not need to include the same amount of walls (since this limitation is not recited in the claims) and as the claimed “plurality” is not defined within the claims, so long as each of the plurality of walls comprises at least one wall, the limitation is thereby met; therefore, so long as the “first distance” is constant and separates the defined walls making up a “plurality of reference tabs”, each of the “plurality of walls” may comprise a differing amount of walls in said grouping.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites, “wherein a third distance along the shaft axis separates the corresponding tab axis of the third of the plurality of reference tabs and a corresponding tab axis of a fourth of the plurality of reference tabs, the third distance is equal to the first distance and the second distance” and it is unclear to the examiner if the claimed “third distance” is the same as the “first distance” that is also claimed to separate the third and fourth plurality of reference tabs as recited in claim 10, or whether this “third distance” is a separate and distinct distance from the “first distance” performing the same function. Further, the recitation of “the second distance” lacks proper antecedent basis as no “second distance” is present or previously defined in claim 10, as amended.
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, 5, 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carranza (US 2004/0097835 A1)(previously of record) in view of Hatcher (US 2020/0163713 A1)(previously of record), further in view of Harari (US 2004/0133129 A1)(previously of record), further in view of Mooreville (US 2022/0039830 A1).
Regarding claim 1, Carranza discloses:
A length indicator (measurement tool 2, see Fig. 4) for use with a minimally invasive surgical device for vessel harvesting (see Para. [0022]), the length indicator comprising:
a shaft that extends along a shaft axis from a first end to a second end (see Fig. 4 showing wherein the measurement tool comprises a central shaft extending along the terminal ends of the device);
a plurality of reference tabs (walls 6, see Fig. 4; the examiner notes that the amount of reference tabs is not bound by those displayed in Fig. 4, see Para. [0016]) extending from the shaft (see Fig. 4 showing wherein the walls 6 extend radially from the central shaft), each of the plurality of reference tabs extending from a first end (portion of each wall furthest radially outward from the longitudinal axis of the device, see Examiner’s Diagram of Fig. 4 below) to a second end (portion of each wall that is directly attached to the elongate body of the device, see Examiner’s Diagram of Fig. 4 below) along a tab axis (see Examiner’s Diagram of Fig. 4 below illustrating a “tab axis” from which each wall extends radially outward from), and each of the tab axes are normal to the shaft axis (see Examiner’s Diagram of Fig. 4 below showing wherein the “tab axis” is parallel (normal) to the “shaft axis”);
PNG
media_image1.png
400
727
media_image1.png
Greyscale
Examiner’s Diagram of Fig. 4
wherein each of the plurality of reference tabs extends from a first end to a second end along each corresponding tab axis (see Examiner’s Diagram of Fig. 4 above showing where each wall comprises thickness that extends longitudinally along the tab axis); and
wherein the second end of each of the plurality of reference tabs is coupled to a corresponding portion of the shaft (see Examiner’s Diagram of Fig. 4 above showing wherein both ends of each wall are coupled to the elongate body of the device);
a marker portion extending from a point at or adjacent to the first end of each of the plurality of reference tabs to a portion of the shaft (see Examiner’s Diagram of Fig. 4 above showing a flat portion of each wall facing radially outward from shaft axis and comprising numerical indicia thereon); and
wherein a marker comprising indicia uniquely identifying each of the plurality of reference tabs is provided on each corresponding marker portion (see Examiner’s Diagram of Fig. 4 above);
wherein a first distance along the shaft axis separates a corresponding tab axis of a first of the plurality of reference tabs and a corresponding tab axis of a second of the plurality of reference tabs (see Examiner’s Diagram of Fig. 4_Distances below showing wherein a defined “first distance” separates a “first plurality” of walls from an adjacent “second plurality” of walls by a spacing along the shaft axis from which each wall extends radially outward from), the first distance along the shaft axis separates the corresponding tab axis of the second of the plurality of reference tabs and a corresponding tab axis of a third of the plurality of reference tabs (see Examiner’s Diagram of Fig. 4_Distances below showing wherein the defined “first distance” separates the “second plurality” of walls from an adjacent “third plurality” of walls by the same spacing along the shaft axis from which each wall extends radially outward from; the examiner notes that each “plurality of walls” does not need to include the same amount of walls and as the claimed “plurality” is not defined within the claims, so long as each of the plurality of walls comprises at least one wall, the limitation is thereby met; therefore, so long as the “first distance” is constant, each of the “plurality of walls” may comprise a differing amount of walls in said grouping), and the first distance along the shaft axis separates the corresponding tab axis of the third of the plurality of reference tabs and a corresponding tab axis of a fourth of the plurality of reference tabs (see Examiner’s Diagram of Fig. 4_Distances below showing wherein the defined “first distance” separates the “third plurality” of walls from an adjacent “fourth plurality” of walls by the same spacing along the shaft axis from which each wall extends radially outward from).
PNG
media_image2.png
392
741
media_image2.png
Greyscale
Examiner’s Diagram of Fig. 4_Distances
However, while Carranza discloses wherein the measurement tool may comprise “any other shape” (see Para. [0015]), wherein the measurement tool may be used to measure tubular structures within a patient (see Para. [0020]), wherein the measurement tool may be formed from any biocompatible material (see Para. [0015]), in addition to wherein the measurement tool is formed as a unitary body (see Para. [0016] and [0018] mentioning wherein the components (i.e., walls, recesses, and distal indent) are formed within the measurement tool body) Carranza does not expressly disclose:
Wherein the measurement tool comprises a cylindrical shaft;
wherein the measurement tool is flexible;
a tether disposed at the first end of the shaft, the tether configured to be removably coupled to the minimally invasive surgical device for vessel harvesting; and
wherein the shaft, the tether, and the plurality of reference tabs are formed as a single, unitary component, and wherein the shaft is flexible such that the shaft axis is configured to be movable between a first linear position and a second non-linear position.
However, in the same field of endeavor, namely surgical measurement devices, Hatcher teaches a measurement device (gauge 24, see Figs. 5-6, see also Para. [0104]) that is connectable to a surgical instrument (see Para. [0109] and Figs. 5-6) via a loop fastener at one end of the measurement device (see Figs. 5-6).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the measurement tool of Carranza to comprise a looped connector at the proximal end thereof, as taught and suggested by Hatcher to, in this case, allow the measurement device to be connectable to other surgical devices for a wider range of procedures (see Hatcher Para. [0109]). The examiner notes that, since the loop of Hatcher is an integral part of the gauge (see Figs. 5-6), upon incorporation into the device of Carranza, the connection loop would be formed integrally with the measurement tool.
In the same field of endeavor, namely measurement devices configured to measure body lumens, Harari teaches wherein measurement devices made from biocompatible may be formed from any of: Stainless steel, titanium, or any other biocompatible metal. Alternatively, guidewires may be constructed of memory shaped alloys, such as Nitinol (see Para. [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known material for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the measurement device of Carranza be formed from the flexible, biocompatible material of nitinol. Since Carranza expressly discloses wherein the measurement device may be formed from any biocompatible material (see Para. [0015]), one of ordinary skill in the art would have been able to select from a list of known biocompatible materials, such as those disclosed by Harari (including the disclosure of Nitinol as a known alternative biocompatible material). Therefore, forming the measurement device of Carranza from nitinol (a flexible, shape memory material), would have yielded predictable results to one of ordinary skill in the art since such a disclosure by Harari is within the scope of the acceptable materials as disclosed by Carranza. As the device of Carranza is formed as a single, unitary component (i.e., the device in its final form is a single piece as opposed to several different pieces), the nitinol material used to form said device would allow a user to bend the measurement tool between a first linear position and a second non-linear position (i.e., any degree of bending away from 0 degrees).
In the same field of endeavor, namely measurement devices for use in a surgical setting, Mooreville teaches a surgical measurement device (see Fig. 1 and Para. [0017]-[0019] having a cylindrical body (see Fig. 1) with measuring indicia located along the length thereof (see Fig. 1).
Since Carranza discloses wherein the measurement tool may comprise “any shape” (see Para. [0015]), one of ordinary skill in the art would have found it obvious, as a matter of simple substitution of one known shape for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having formed the body of the measurement tool of Carranza as a cylindrical tubular structure as disclosed as an alternative surgical measurement tool shape by Mooreville. Since Carranza expressly discloses wherein “any other shape” may be used to form the measurement tool interchangeably with the rectangular solid shown in the figures, one of ordinary skill in the art would have had a reasonable expectation of success that the device of Carranza would function appropriately with either a rectangular solid or cylindrical body since both shapes are used in surgical measurement procedures/devices. Further, Applicant does not provide any express disclosure within the specification in regards to the “cylindrical shape” of the device, instead appearing to rely solely on the disclosed drawings to show the claimed feature. Therefore, the claimed “cylindrical shape” is not seen to be critical to the functional of the device or solves any stated problem and one of ordinary skill in the art would have therefore been able to modify the structure of Carranza as an obvious matter of design choice within the skill of the art given the lack of criticality in both the disclosure of Carranza and the specification of the claimed invention.
Regarding claim 5, the combination of Carranza, Hatcher, Harari and Mooreville disclose the invention of claim 1, Carranza, as modified by Hatcher, further discloses wherein the tether is a ring formed at the first end of the shaft (loop of Hatcher, as incorporated into the device of Carranza is in for form of a loop as shown in Hatcher Figs. 5-6).
Regarding claim 7, the combination of Carranza, Hatcher, Harari and Mooreville disclose the invention of claim 1, Carranza further discloses wherein the first end of each of the plurality of reference tabs is aligned along an axis that is parallel to and offset from the shaft axis (see Examiner’s Diagram of Fig. 4 above showing wherein each wall is positioned along an axis parallel and laterally offset from the “shaft axis”).
Regarding claim 9, the combination of Carranza, Hatcher, Harari and Mooreville disclose all of the limitations of the invention of claim 1.
However, while Carranza discloses wherein each indented recess (between adjacent walls) is “substantially parallel” and wherein the bottom surfaces of the walls connecting to the elongate body are curved such that they are “substantially perpendicular” to both sides of the first recess (see Para. [0016]), Carranza does not expressly disclose wherein a lower edge defining each of the marker portions extends obliquely from the point at or adjacent to the first end of each of the plurality of reference tabs to the corresponding portion of the shaft.
However, it would have been obvious to one of ordinary skill in the art, as a matter of being obvious to try (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the walls of each protruding measurement element be at angles not “completely parallel” to one another. Since Carranza discloses wherein each adjacent wall may be “substantially parallel”, this is seen to mean that angles other than “completely parallel” are within the scope of the present disclosure. Since there are a finite amount of non-parallel angles within the scope of the term “substantially”, one of ordinary skill in the art would have had a reasonable expectation of success that, in choosing from a finite number of alternative, near parallel angles for each opposing wall, the device of Carranza would operate as expected without suffering a loss of functionality. Therefore, in having angles slightly off-parallel, the walls of the measurement device would extend and connect from the radially-outward surface to the shaft axis at an angle that is oblique. The examiner notes that as this limitation is not expressly disclose in the specification of the present disclosure, Applicant appears to be relying on the disclosed drawings to show this feature and is thus not seen to be a critical feature to the functioning of the device.
Claim(s) 10-11, 14, 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knodel (US 2013/0282009 A1)(previously of record) in view of Carranza (US 2004/0097835 A1)(previously of record) in view of Hatcher (US 2020/0163713 A1)(previously of record), further in view of Harari (US 2004/0133129 A1)(previously of record), further in view of Mooreville (US 2022/0039830 A1).
Regarding claim 10, Knodel discloses:
An assembly comprising:
a minimally invasive surgical device (vein harvesting device 100, see Fig. 1), comprising:
a device shaft (shaft assembly 104, see Fig. 1) extending from a proximal end to a distal end (see Fig. 1);
a distal housing (vein harvesting system 110, see Figs. 2A-2B) coupled to the distal end of the device shaft (see Figs. 1-2A), the distal housing defining a rotatable dissector (cutting element 404, see Figs. 4A-4B, see Para. [0018]);
a drive element (drive shafts within shaft assembly 104, see Para. [0016]) coupled to rotatable dissector (see Para. [0094], see also Figs. 1-3A and 10), at least a portion of the drive element being disposed in an interior portion of the shaft device (drive shafts extend through shaft assembly 104 to connect the rotatable cutting elements 404 to the handle assembly 102, see Para. [0015]); and
an actuator coupled to the drive element (operation and control mechanisms within the handle assembly, see Para. [0015]).
However, Knodel does not expressly disclose:
a length indicator comprising:
a cylindrical shaft that extends along a shaft axis from a first end to a second end;
a tether disposed at the first end of the shaft, the tether configured to be removably coupled to the rotatable dissector of the minimally invasive surgical device; and
a plurality of reference tabs extending from the shaft, each of the plurality of reference tabs extending from a first end to a second end along a tab axis, and each of the tab axes are normal to the shaft axis;
wherein each of the plurality of reference tabs extends from a first end to a second end along each corresponding tab axis, and wherein the second end of each of the plurality of reference tabs is coupled to a corresponding portion of the shaft;
a marker portion extending from a point at or adjacent to the first end of each of the plurality of reference tabs to a portion of the shaft, and wherein a marker comprising indicia uniquely identifying each of the plurality of reference tabs is provided on each corresponding marker portion;
wherein a first distance along the shaft axis separates a corresponding tab axis of a first of the plurality of reference tabs and a corresponding tab axis of a second of the plurality of reference tabs, and the first distance along the shaft axis separates the corresponding tab axis of the second of the plurality of reference tabs and a corresponding tab axis of a third of the plurality of reference tabs, and the first distance along the shaft axis separates the corresponding tab axis of the third of the plurality of reference tabs and a corresponding tab axis of a fourth of the plurality of reference tabs;
wherein the shaft, the tether, and the plurality of reference tabs are formed as a single, unitary component; and
wherein the shaft is flexible such that the shaft axis is configured to be movable between a first linear position and a second non-linear position.
However, in the field of endeavor of surgical measurement devices configured for use in measuring vascular grafts, Carranza teaches:
A length indicator (measurement tool 2, see Fig. 4) for use with a minimally invasive surgical device for vessel harvesting (see Para. [0022]), the length indicator comprising:
a shaft that extends along a shaft axis from a first end to a second end (see Fig. 4 showing wherein the measurement tool comprises a central shaft extending along the terminal ends of the device);
a plurality of reference tabs (walls 6, see Fig. 4; the examiner notes that the amount of reference tabs is not bound by those displayed in Fig. 4, see Para. [0016]) extending from the shaft (see Fig. 4 showing wherein the walls 6 extend radially from the central shaft), each of the plurality of reference tabs extending from a first end (portion of each wall furthest radially outward from the longitudinal axis of the device, see Examiner’s Diagram of Fig. 4 below) to a second end (portion of each wall that is directly attached to the elongate body of the device, see Examiner’s Diagram of Fig. 4 below) along a tab axis (see Examiner’s Diagram of Fig. 4 below illustrating a “tab axis” from which each wall extends radially outward from), and each of the tab axes are normal to the shaft axis (see Examiner’s Diagram of Fig. 4 below showing wherein the “tab axis” is parallel (normal) to the “shaft axis”);
PNG
media_image1.png
400
727
media_image1.png
Greyscale
Examiner’s Diagram of Fig. 4
wherein each of the plurality of reference tabs extends from a first end to a second end along each corresponding tab axis (see Examiner’s Diagram of Fig. 4 above showing where each wall comprises thickness that extends longitudinally along the tab axis); and
wherein the second end of each of the plurality of reference tabs is coupled to a corresponding portion of the shaft (see Examiner’s Diagram of Fig. 4 above showing wherein both ends of each wall are coupled to the elongate body of the device);
a marker portion extending from a point at or adjacent to the first end of each of the plurality of reference tabs to a portion of the shaft (see Examiner’s Diagram of Fig. 4 above showing a flat portion of each wall facing radially outward from shaft axis and comprising numerical indicia thereon); and
wherein a marker comprising indicia uniquely identifying each of the plurality of reference tabs is provided on each corresponding marker portion (see Examiner’s Diagram of Fig. 4 above);
wherein a first distance along the shaft axis separates a corresponding tab axis of a first of the plurality of reference tabs and a corresponding tab axis of a second of the plurality of reference tabs (see Examiner’s Diagram of Fig. 4_Distances below showing wherein a defined “first distance” separates a “first plurality” of walls from an adjacent “second plurality” of walls by a spacing along the shaft axis from which each wall extends radially outward from), the first distance along the shaft axis separates the corresponding tab axis of the second of the plurality of reference tabs and a corresponding tab axis of a third of the plurality of reference tabs (see Examiner’s Diagram of Fig. 4_Distances below showing wherein the defined “first distance” separates the “second plurality” of walls from an adjacent “third plurality” of walls by the same spacing along the shaft axis from which each wall extends radially outward from; the examiner notes that each “plurality of walls” does not need to include the same amount of walls and as the claimed “plurality” is not defined within the claims, so long as each of the plurality of walls comprises at least one wall, the limitation is thereby met; therefore, so long as the “first distance” is constant, each of the “plurality of walls” may comprise a differing amount of walls in said grouping), and the first distance along the shaft axis separates the corresponding tab axis of the third of the plurality of reference tabs and a corresponding tab axis of a fourth of the plurality of reference tabs (see Examiner’s Diagram of Fig. 4_Distances below showing wherein the defined “first distance” separates the “third plurality” of walls from an adjacent “fourth plurality” of walls by the same spacing along the shaft axis from which each wall extends radially outward from).
PNG
media_image2.png
392
741
media_image2.png
Greyscale
Examiner’s Diagram of Fig. 4_Distances
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the vessel harvesting device of Knodel to include the sizing device of Carranza to allow a user to determine the measurement metrics of a desired vessel (see Carranza Para. [0016] and [0020]).
However, while Carranza discloses wherein the measurement tool may comprise “any other shape” (see Para. [0015]), wherein the measurement tool may be used to measure tubular structures within a patient (see Para. [0020]), wherein the measurement tool may be formed from any biocompatible material (see Para. [0015]), in addition to wherein the measurement tool is formed as a unitary body (see Para. [0016] and [0018] mentioning wherein the components (i.e., walls, recesses, and distal indent) are formed within the measurement tool body) Carranza does not expressly disclose:
Wherein the measurement tool comprises a cylindrical shaft;
wherein the measurement tool is flexible;
a tether disposed at the first end of the shaft, the tether configured to be removably coupled to the minimally invasive surgical device for vessel harvesting; and
wherein the shaft, the tether, and the plurality of reference tabs are formed as a single, unitary component, and wherein the shaft is flexible such that the shaft axis is configured to be movable between a first linear position and a second non-linear position.
However, in the same field of endeavor, namely surgical measurement devices, Hatcher teaches a measurement device (gauge 24, see Figs. 5-6, see also Para. [0104]) that is connectable to a surgical instrument (see Para. [0109] and Figs. 5-6) via a loop fastener at one end of the measurement device (see Figs. 5-6).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the measurement tool of Carranza to comprise a looped connector at the proximal end thereof, as taught and suggested by Hatcher to, in this case, allow the measurement device to be connectable to other surgical devices for a wider range of procedures (see Hatcher Para. [0109]). The examiner notes that, since the loop of Hatcher is an integral part of the gauge (see Figs. 5-6), upon incorporation into the device of Carranza, the connection loop would be formed integrally with the measurement tool.
In the same field of endeavor, namely measurement devices configured to measure body lumens, Harari teaches wherein measurement devices made from biocompatible may be formed from any of: Stainless steel, titanium, or any other biocompatible metal. Alternatively, guidewires may be constructed of memory shaped alloys, such as Nitinol (see Para. [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known material for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the measurement device of Carranza be formed from the flexible, biocompatible material of nitinol. Since Carranza expressly discloses wherein the measurement device may be formed from any biocompatible material (see Para. [0015]), one of ordinary skill in the art would have been able to select from a list of known biocompatible materials, such as those disclosed by Harari (including the disclosure of Nitinol as a known alternative biocompatible material). Therefore, forming the measurement device of Carranza from nitinol (a flexible, shape memory material), would have yielded predictable results to one of ordinary skill in the art since such a disclosure by Harari is within the scope of the acceptable materials as disclosed by Carranza. As the device of Carranza is formed as a single, unitary component (i.e., the device in its final form is a single piece as opposed to several different pieces), the nitinol material used to form said device would allow a user to bend the measurement tool between a first linear position and a second non-linear position (i.e., any degree of bending away from 0 degrees).
In the same field of endeavor, namely measurement devices for use in a surgical setting, Mooreville teaches a surgical measurement device (see Fig. 1 and Para. [0017]-[0019] having a cylindrical body (see Fig. 1) with measuring indicia located along the length thereof (see Fig. 1).
Since Carranza discloses wherein the measurement tool may comprise “any shape” (see Para. [0015]), one of ordinary skill in the art would have found it obvious, as a matter of simple substitution of one known shape for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having formed the body of the measurement tool of Carranza as a cylindrical tubular structure as disclosed as an alternative surgical measurement tool shape by Mooreville. Since Carranza expressly discloses wherein “any other shape” may be used to form the measurement tool interchangeably with the rectangular solid shown in the figures, one of ordinary skill in the art would have had a reasonable expectation of success that the device of Carranza would function appropriately with either a rectangular solid or cylindrical body since both shapes are used in surgical measurement procedures/devices. Further, Applicant does not provide any express disclosure within the specification in regards to the “cylindrical shape” of the device, instead appearing to rely solely on the disclosed drawings to show the claimed feature. Therefore, the claimed “cylindrical shape” is not seen to be critical to the functional of the device or solves any stated problem and one of ordinary skill in the art would have therefore been able to modify the structure of Carranza as an obvious matter of design choice within the skill of the art given the lack of criticality in both the disclosure of Carranza and the specification of the claimed invention.
Regarding claim 11 (see 112b rejection above), the combination of Knodel, Carranza, Hatcher, Harari and Mooreville disclose the invention of claim 10, Carranza further discloses wherein a third distance along the shaft axis separates the corresponding tab axis of the third of the plurality of reference tabs and a corresponding tab axis of a fourth of the plurality of reference tabs (see Examiner’s Diagram of Fig. 4_Distances above showing wherein the defined “first distance” (taken to be identical to the “third distance” pending resolution to the outstanding 112(b) rejection above) separates the “third plurality” of walls from an adjacent “fourth plurality” of walls by the same spacing along the shaft axis from which each wall extends radially outward from; the examiner notes that each “plurality of walls” does not need to include the same amount of walls and as the claimed “plurality” is not defined within the claims, so long as each of the plurality of walls comprises at least one wall, the limitation is thereby met; therefore, so long as the “first distance” is constant, each of the “plurality of walls” may comprise a differing amount of walls in said grouping).
Regarding claim 14, the combination of Knodel, Carranza, Hatcher, Harari and Mooreville disclose the invention of claim 10, Carranza, as modified by Hatcher, further discloses wherein the tether is a ring formed at the first end of the shaft (loop of Hatcher, as incorporated into the device of Carranza is in for form of a loop as shown in Hatcher Figs. 5-6).
Regarding claim 16, the combination of Knodel, Carranza, Hatcher, Harari and Mooreville disclose the invention of claim 10, Carranza further discloses wherein the first end of each of the plurality of reference tabs is aligned along an axis that is parallel to and offset from the shaft axis (see Examiner’s Diagram of Fig. 4 above showing wherein each wall is positioned along an axis parallel and laterally offset from the “shaft axis”).
Regarding claim 18, the combination of Knodel, Carranza, Hatcher, Harari and Mooreville disclose all of the limitations of the invention of claim 10.
However, while Carranza discloses wherein each indented recess (between adjacent walls) is “substantially parallel” and wherein the bottom surfaces of the walls connecting to the elongate body are curved such that they are “substantially perpendicular” to both sides of the first recess (see Para. [0016]), Carranza does not expressly disclose wherein a lower edge defining each of the marker portions extends obliquely from the point at or adjacent to the first end of each of the plurality of reference tabs to the corresponding portion of the shaft.
However, it would have been obvious to one of ordinary skill in the art, as a matter of being obvious to try (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the walls of each protruding measurement element be at angles not “completely parallel” to one another. Since Carranza discloses wherein each adjacent wall may be “substantially parallel”, this is seen to mean that angles other than “completely parallel” are within the scope of the present disclosure. Since there are a finite amount of non-parallel angles within the scope of the term “substantially”, one of ordinary skill in the art would have had a reasonable expectation of success that, in choosing from a finite number of alternative, near parallel angles for each opposing wall, the device of Carranza would operate as expected without suffering a loss of functionality. Therefore, in having angles slightly off-parallel, the walls of the measurement device would extend and connect from the radially-outward surface to the shaft axis at an angle that is oblique. The examiner notes that as this limitation is not expressly disclose in the specification of the present disclosure, Applicant appears to be relying on the disclosed drawings to show this feature and is thus not seen to be a critical feature to the functioning of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2010/0217092 A1 to Paolitto, US 2019/0105123 A1 to Kunkov, US 2012/0053441 A1 to Kassab, US 2013/0184553 A1 to Kassab, US 2015/0150642 A1 to Lau and US 2023/0338022 A1 to Burnet all disclose surgical devices that are capable of being used as measurement devices comprising at least one protrusion or surgical cutting devices comprising a rotating cutter at the distal end thereof.
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.B.H./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771