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 Amendment
This Office action is in response to the applicant’s communication filed 12/03/2025.
Status of the claims:
Claims 1 – 4 and 6 – 18 are pending in the application.
Claims 13 – 18 are withdrawn.
Claim 10 is amended.
Priority
The instant application, filed on 12/07/2022, which claims priority to PCT/US2021/036271 filed on 06/07/2021 which claims priority to Provisional Application 63/035,820 filed on 06/07/2020. Claims 6 and 7 of the instant application are directed to subject matter that was introduced for the first time in the PCT, filed on 06/07/2021. The earlier Provisional Application fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the “ratio of the suturing thread diameter to the helical needle inner diameter being in the range of 1:6 – 1:10 and/or greater than 1:8” as recited by dependent claims 6 and 7. Accordingly, claims 6 and 7 are not entitled to the benefit of the prior applications because the claimed ratio is considered to be unsupported within the disclosure of the Provisional Application listed above. The earliest disclosure for the subject matter of claims 7 and 8 and thus the effective filing date for the subject matter of claims 7 and 8 is 06/07/2021.
Drawings
The objections to the drawings in the previous action dated 06/03/2025 have been withdrawn in light of the Applicant’s amendments filed 12/03/2025. Specifically, the objection to the drawings for not showing the claimed “at least one cutter” in previous claim 5, has been withdrawn as the limitation has been cancelled.
Claim Objections
The objections to claim 10 in the previous action dated 06/03/2025 have been withdrawn in light of the Applicant’s amendments filed 12/03/2025. Specifically, the objection to claim 10, regarding the phrase “a shaft”, has been withdrawn as the appropriate corrections have been made.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 – 4, 6 – 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Dubrovsky (US 2010/0114122 A1) (previously cited) in view of Wingardner et al (US 2010/0274265 A1) (previously cited).
Regarding claims 1 – 4, 8 – 10, and 12, Dubrovsky discloses a device for automatic suturing (sewing device) (abstract, paragraphs [0011], [0096], [0159 – 0161], and Fig. 25) (Examiner’s note: as stated in paragraph [0159] the device of Fig. 25 is similar in structure as that of Fig. 1; therefore, although the Examiner is relying on the embodiment of Fig. 25, the Examiner is also relying on passages within Dubrovsky that discuss the functions of the structures of the device in Fig. 1) comprising:
a shaft (body 1) having a longitudinal axis (paragraph [0098] and Fig. 25);
a clamp (gripping jaws 6 and 7) at a distal end of the shaft (Fig. 25) and configured to be positioned over a length of tissue to be sutured (abstract, paragraphs [0034], and [0105]);
a driver (handle 14) configured to engage with a screw (internal screw threads) of the shaft (paragraph [0100]) so as to translate along a length of the shaft when rotated (paragraphs [0103] and [0159 – 0161]);
a helical needle (hollow needle 12) connected to the driver such that the helical needle is rotated while advancing or retracting over and [claim 9] wherein the helical needle is configured to be advanced over an exterior of the clamp a length of the clamp and the shaft (paragraphs [0103], [0159 – 0161], and Fig. 25); [claim 2] a tip (sharp end) of the helical needle (hollow needle 12) is at a radially exterior portion of the helical needle for movement over the shaft (Examiner’s note: as shown in Fig. 25, the tip is radially exterior on the needle and is mounted on the shaft);
[claim 3] a suturing thread (string) having a leading end near a tip (sharp end) of the helical needle (hollow needle 12) (Examiner’s note: as stated in paragraph [0057] only the distal end of the thread is fixed outside of the needle, thus in order to properly stitch the tissue, the proximal end (i.e., the leading end) must be near the tip of the needle);
[claim 4] the helical needle (hollow needle 12) is hollow and the suturing thread is disposed through the helical needle (paragraph [0160]);
[claim 8] a lock (rack mechanism 5) for reversibly locking the clamp in a closed position (paragraphs [0097 – 0098] and Fig. 25);
[claim 10] wherein the helical needle (hollow needle 12) is configured to be disposed over the shaft when in a retracted position (position shown in Fig. 25) (Fig. 25);
[claim 12] wherein the helical needle (hollow needle 12) further comprises one or more windows (paragraph [0160]) (Examiner’s note: the hollow needle 12 comprises the distal opening and the proximal opening from which the string / fluid enters and exits, therefore the hollow needle 12 has two windows).
However, Dubrovsky is silent regarding (i) the shaft having a joint rotatable about a joint axis which is at an angle > 0 degrees to the longitudinal axis, (ii) [claims 1 and 2] the needle being moveable over the joint of the shaft.
As to the above, Wingardner teaches an endoscopic stitching device comprising a shaft (neck assembly 310 – Fig. 17) and a clamp (jaws 332/330 / end effector 300; which equate(s) to the jaws 6 and 7 of Dubrovsky) for grasping tissue attached to the distal end of the shaft (abstract, paragraphs [0027], [0054], [0352], and Fig. 17), wherein the shaft (neck assembly 310) has a joint (joint at rotational axis “B”) which is rotatable about a joint axis (axis “B”) which is at an angle of 90o (i.e., > 0o) to the longitudinal axis of the shaft (Fig. 17).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the shaft of Dubrovsky to incorporate a joint rotatable about a rotatable axis, based on the teachings of Wingardner, for the purpose of allowing the user to articulate the clamp, without having to articulate the entire system, in order to grasp tissue at different angles. Additionally, it should be understood that the modified device would encompass wherein the hollow needle 12 of Dubrovsky is movable / moved over the joint when moved distally so that the needle sutures the tissue; therefore, the combination teaches the device as claimed above.
Regarding claims 6 and 7, as discussed above, the combination of Dubrovsky and Wingardner teaches the device of claim 3. Additionally, Dubrovsky discloses wherein the suturing thread has a diameter and the helical needle has an inside diameter (paragraphs [0159 – 0160]) (Examiner’s note: because the needle 12 is hollow, the needle 12 will have an inner diameter).
However, the combination of Dubrovsky and Wingardner is silent regarding (i) the specific dimensions of the outer diameter of the thread and the inner diameter of the hollow needle such that the ratio of the suturing thread diameter to the helical needle inside diameter is [claim 7] in the range of 1:6-1:10, inclusive and/or [claim 8] greater than 1:8. With respect to (i), it should be understood that because Dubrovsky discloses that the thread (string) is within the needle (hollow needle 12) (paragraph [0160]) then the outer diameter of the thread (string) must be smaller than the inner diameter of the needle (hollow needle 12).
As to the above, there is no evidence of record that establishes that changing ratio of the outer diameter of the thread to the inner diameter of the needle would result in a difference in function of the device of Dubrovsky. Further, a person having ordinary skill in the art, being faced with modifying the outer diameter of the thread and/or the inner diameter of the needle, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ratio of the outer diameter of the thread to the inner diameter of the needle. Lastly, Applicant has not disclosed that the claimed ratio range solves any stated problem, indicating that the ratio “may” be within the claimed range, and offering other acceptable ranges (e.g., specification at para. [0036]) and therefore there appears to be no criticality placed on the ratio range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the outer diameter of the thread and/or the inner diameter of the needle such that the ratio of the outer diameter of the thread to the inner diameter of the needle is within 1:6 – 1:10 and/or greater than 1:8 as an obvious matter of design choice within the skill of the art.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Dubrovsky (US 2010/0114122 A1) (previously cited) in view of Wingardner et al (US 2010/0274265 A1) (previously cited), as applied to claim 1 above, and further in view of Saadat et al (US 2006/0161185 A1) (previously cited).
Regarding claim 11, as discussed above, the combination of Dubrovsky and Wingardner teaches the device of claim 1.
However, the combination of Dubrovsky and Wingardner is silent regarding (i) a motor operably connected to the driver.
As to the above, Saadat teaches a tissue engagement device (helical tissue grasper 950; which equates to the helical needle 12 of Dubrovsky) attached to a rotatable driver with threads (drive shaft 972; which equates to the rotatable handle 14 with threads of Dubrovsky) wherein the driver (drive shaft 972) is operably connected to a motor (second motor 970) for the purpose of advancing and retracting the helical grasper 950 (which quates to the helical needle 12 of Dubrovsky) (paragraph [0160 – 0161]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Dubrovsky in view of Wingardner to incorporate a motor operably connected to the driver, based on the teachings of Saadat, for the purpose of being able to advance and retract the handle 14 (and ultimately the hollow needle 12) in a more controlled manner, as the motor operates at a constant rate and provides a smooth translation of the device.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s argument that “The Proposed Combination Is Technically Incompatible and Would Not Have Been Made”, “Grafting Wingardner 's rotatable joint into Dubrovsky 's device would destroy the fixed spatial relationship that Dubrovsky requires between the needle axis and the static deflection surfaces (ramp/slant or curved jaw). If the clamp and its deflection features are mounted on a joint whose orientation varies, those surfaces will regularly misalign with the rotating helical needle during advance, defeating Dubrovsky 's guidance and leading to binding, misplacement, or tissue trauma. Neither reference teaches the synchronization mechanisms needed to maintain correct orientation of the deflection surfaces through articulation while the helical needle is concurrently rotating and advancing”, and “Applicant's claim requires the helical needle to be rotated while it advances/retracts over the clamp and over the shaft joint. Dubrovsky confines the hollow spiral needle to straight paths along fixed guiding openings and employs static deflection surfaces only for flexible needles; Dubrovsky does not disclose traversing "over a joint." Wingardner, while teaching articulation, uses a non-helical suture needle transferred between jaws with blades; there is no teaching of a multi-turn helical needle advancing "over the joint" during rotation”, the Examiner acknowledges that the hollow needle of Dubrovski has to travel in a straight line, however, the claims require only that the needle be advancable and retractable over the joint and that the “joint axis” be angled relative to the longitudinal axis, and as stated in the rejection above, the “joint axis” is 90 degrees relative to the longitudinal axis. The claims as currently written do not require the joint to be rotated/bent at any specific angle when the needle is extended over the joint. Furthermore, there is nothing that prohibits the needle of Dobrovski from extending over the joint, when the joint is in the non-rotated state / is parallel with the shaft (i.e., forming a straight line), therefore, because the needle of Dobrovski is extendable over the length of the system, the needle of Dobrovski is extendable over the joint when the joint is the straightened state, and therefore, the combination meets the limitations of the claims. Thus, Applicant’s arguments are not persuasive.
With respect to Applicant’s argument that “Wingardner's Joints Are for End-Effector Positioning, Not for Guiding a Helical Needle "Over a Joint"”, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986);
In response to applicant's argument that “The Proposed Combination Is Technically Incompatible and Would Not Have Been Made”, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
With respect to Applicant’s argument that “Applicant's claim recites a driver-screw relationship (e.g., a lead screw) whose rotation causes the driver to linearly translate along the shaft. Neither reference discloses this, Dubrovsky describes rotation of the spiral needle via rollers or a rotating cylinder with internal thread, but does not teach a driver that engages a shaft's screw to translate along the shaft during rotation”, the Examiner notes that Dubrovsky teaches in paragraph [0100] that the proximal part of the body 1 (i.e., the shaft) there is an internal screw thread (i.e., the screw of the shaft) on which the screw 13, with handle 14 (i.e., the driver), with an external groove moves; and paragraph [0103] recites at rotation of the handle 14 the screw 13 is screwed in the body 1. Therefore, the driver (the handle 14) engages with a screw (internal threaded portion of the body 1) of the shaft (the body 1) and translates along the shaft (via the screw 13) when rotated. The claims as currently written do not require the drive to have any specific structure nor do the claims require the driver to be externally rotated along the shaft. Therefore, Applicant’s argument is not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771