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
In response to the preliminary amendment filed on 2/24/2025, claims 1-14 have been canceled, and newly added claims 15-34 are pending.
Claim Objections
Claim 32 is objected to because of the following informalities: “moving grasper” should recite - - moving the grasper - -. Appropriate correction is required.
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 29 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 29 recites “further comprising reengaging the actuation rod with the coupling element”. However, in order to reengage, a step of disengage would necessarily need to happen prior. No such disengagement step has been recited. It is therefore unclear if disengagement is first required by claim 29. The step of disengaging is not recited until dependent claim 28, from which claim 29 is not dependent upon.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 15-19, 21, 23-25, 27, 28, 30, 31 and 34 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rohaninejad et al (US 2014/0243586).
Rohaninejad et al discloses the following limitations:
Claim 15. A method for performing a surgical procedure (Figs. 11A-11I, 15A-15D), comprising:
introducing a grasper (shown as 14 in Figs. 11A-11I for the method, but specifically relying on the grasper 230 of Fig. 15A-15D for the rejection, wherein it is understood the various embodiments of the grasper disclosed in Rohaninejad et al are used by the method of Figs. 11A-11I) into a body of a patient (Fig. 11A; [0060], into the abdominal cavity) wherein the grasper comprises first (232) and second arms (234) connected by a linkage assembly (242, 244, 248), and wherein the linkage assembly is connected to a coupling element (236) [0068]);
engaging the coupling element (236) with an actuation rod (240) (Figs. 15B-15C; the actuation rod 240 is inserted through the lumen of coupling element 236 and thus is engaging); and
moving the grasper from a closed configuration (Fig. 16B) to an open configuration (Fig. 15C) by distally advancing the actuation rod (240) ([0068]-[0069]).
Claim 16. The method of claim 15, wherein moving the grasper to the open configuration (Fig. 15C) comprises increasing a separation distance between the first and second arms (232, 234) along a transverse axis of the grasper (see between Fig. 15B to Fig. 15C, wherein the separation distance is within the confines defined by the bounds of coupling element 236 in Fig. 15B when the grasper is closed, and the separation distance is increased beyond the confines in Fig. 15C in the open configuration).
Claim 17. The method of claim 16, wherein both of the first and second arms (232, 234) comprise a tissue-engaging surface (textured surface on inside face of arms 232, 234), and wherein the separation distance is increased between the tissue-engaging surfaces (distance increased between Fig. 15B to Fig. 15C).
Claim 18. The method of claim 15, wherein moving the grasper to the open configuration (Fig. 15C) comprises moving the linkage assembly (242, 244, 248) from a collapsed configuration (Fig. 15B) to an expanded configuration (Fig. 15C).
Claim 19. The method of claim 18, wherein the linkage assembly comprises a plurality of struts (242, 244), and wherein moving the linkage assembly from the collapsed configuration (Fig. 15B) to the expanded configuration (Fig. 15C) comprises rotating the plurality of struts such that a length of the linkage assembly increases along a transverse axis of the grasper (see between Fig. 15B to Fig. 15C, wherein the length is seen within the confines defined by the bounds of coupling element 236 in Fig. 15B when the grasper is closed, and the distance is increased beyond the confines in Fig. 15C in the open configuration).
Claim 21. The method of claim 15, wherein the linkage assembly comprises at least one pivot joint (248) ([0068]).
Claim 23. The method of claim 15, wherein the grasper (14, 230) is in the closed configuration when introduced into the body of the patient (Figs. 2A, 11A; [0060], [0060]; the arms are closed to carry magnetic element 16 as seen in Fig. 2A during introduction into the body).
Claim 24. The method of claim 15 further comprising positioning tissue between the first and second arms (242, 244) when the grasper is in the open configuration ([0061], [0069]).
Claim 25. The method of claim 15 further comprising moving the grasper (230) from the open configuration (Fig. 15C) to the closed configuration (Fig. 15D) to secure the tissue between the first and second arms (242, 244) (Fig. 11C; [0061], [0069]).
Claim 27. The method of claim 15 further comprising applying a magnetic field to manipulate the grasper (14, 230) within the body of the patient (Figs. 11E-11I; [0063]).
Claim 28. The method of claim 15 further comprising disengaging the actuation rod from the coupling element (from Figs. 11C to 11D; [0062]).
Claim 30. The method of claim 15 further comprising advancing the grasper through a laparoscopic port while the grasper is in the closed configuration ([0009], [0014], [0016], [0019], [0020], [0046]).
Claim 31. The method of claim 15, wherein the grasper further comprises a protective sheath (238) (Fig. 15C; [0068]).
Claim 34. The method of claim 15, wherein the coupling element (236) comprises a distal end (end further from user) connected to the linkage assembly (via pin 248) and a proximal end (end closer to user) configured to be releasably engaged by the actuation rod (via insertion of the rod 240 through the lumen of coupling element 236).
Claim(s) 15-21, 23-25, 31-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suzuki et al (US 2013/0289617).
Suzuki et al discloses the following limitations:
Claim 15. A method for performing a surgical procedure (Figs. 6-8), comprising:
introducing a grasper (2) into a body of a patient ([0059], [0062], [0088]), wherein the grasper comprises first (12) and second arms (13) connected by a linkage assembly (18, 19, 20, 21), and wherein the linkage assembly is connected to a coupling element (22) ([0034], [0035]);
engaging the coupling element with an actuation rod (52) (axis 22 is inserted through actuation rod 52 as is thus considered engaging); and
moving the grasper from a closed configuration (Fig. 6) to an open configuration (Figs. 7, 8) by distally advancing the actuation rod ([0088]-[0092]).
Claim 16. The method of claim 15, wherein moving the grasper to the open configuration comprises increasing a separation distance between the first and second arms (12, 13) along a transverse axis of the grasper (see between Fig. 6 to Figs. 7-8, wherein the separation distance is within the confines defined by the bounds of covers 16 in Fig. 6 when the grasper is closed, and the separation distance is increased beyond the confines in Figs. 7-8 in the open configuration).
Claim 17. The method of claim 16, wherein both of the first and second arms (12, 13) comprise a tissue-engaging surface (12a, 13a) ([0085]), and wherein the separation distance is increased between the tissue-engaging surfaces (from Fig. 6 to Figs. 7-8 distance is increased between surfaces 12a, 13a).
Claim 18. The method of claim 15, wherein moving the grasper to the open configuration (Figs. 7-8) comprises moving the linkage assembly from a collapsed configuration (Fig. 6) to an expanded configuration (Figs. 7-8).
Claim 19. The method of claim 18, wherein the linkage assembly comprises a plurality of struts (19, 21) ([0034], [0035]), and wherein moving the linkage assembly from the collapsed configuration (Fig. 6) to the expanded configuration (Figs. 7-8) comprises rotating the plurality of struts such that a length of the linkage assembly increases along a transverse axis of the grasper (see between Fig. 6 to Figs. 7-8, wherein the length is seen within the confines defined by the bounds of covers 16 in Fig. 6 when the grasper is closed, and the distance is increased beyond the confines in Figs. 7-8 in the open configuration).
Claim 20. The method of claim 19, wherein the plurality of struts is rotated about a plurality of pivot joints (18, 20) ([0034], [0035]).
Claim 21. The method of claim 15, wherein the linkage assembly comprises at least one pivot joint (18, 20) ([0034], [0035]).
Claim 31. The method of claim 15, wherein the grasper further comprises a protective sheath (11) ([0026]-[0029]).
Claim 32. The method of claim 31, wherein moving grasper to the open configuration (Fis. 7-8) comprises moving the linkage assembly out of a lumen of the protective sheath (the linkage moves beyond the confines of covers 16 which is considered the lumen of the sheath).
Claim 33. The method of claim 31 further comprising moving the linkage assembly into a lumen of the protective sheath to move the grasper from the open configuration to the closed configuration (Fig. 6; the linkage moves into and within the confines of covers 16 which is considered the lumen of the sheath).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 26 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rohaninejad et al in view of Rapacki et al (US 5569274).
Claim 26. Rohaninejad et al discloses the invention substantially as claimed above, but fails to disclose releasing tissue secured between the first and second arms by moving the grasper from the closed configuration to the open configuration.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely tissue graspers, Rapacki et al teaches a method of performing a surgical procedure, including the step of releasing tissue secured between the first and second arms by moving the grasper from the closed configuration to the open configuration (col. 3, ll. 46-64). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Rohaninejad et al to include the step of releasing tissue secured between the first and second arms by moving the grasper from the closed configuration to the open configuration as taught by Rapacki et al to allow the user to reposition the grasper if necessary.
Claim 29. Rohaninejad et al discloses the invention substantially as claimed above, but fails to disclose reengaging the actuation rod with the coupling element to reposition the grasper within the body of the patient.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely tissue graspers, Rapacki et al teaches a method of performing a surgical procedure, including the step of reengaging the clamp with its actuation mechanism (akin to reengaging the actuation rod with the coupling element in Rohaninejad et al) to reposition the grasper within the body of the patient (col. 3, ll. 46-64). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Rohaninejad et al to include the step of reengaging the actuation rod with the coupling element to reposition the grasper within the body of the patient based upon the teachings of Rapacki et al to allow the user to make adjustments as necessary for accurate positioning within the body.
Allowable Subject Matter
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior arts of record, Rohaninejad et al and Suzuki et al, each discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed method comprising, inter alia, the actuation rod engages the coupling element via a magnetic force. Instead, in each of Rohaninejad et al and Suzuki et al, the actuation rod is mechanically engaged with the coupling element. Specifically, in Rohaninejad et al, the actuation rod is engaged (advanced through) the coupling element when the surgeon wants to open the grasper. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Marucci et al (US 6582451) teaches a method of performing a surgical procedure using a tissue grasper comprising first and second arms connected by a linkage assembly of a plurality of struts and pivot joints. The grasper is moved from a closed configuration to an open configuration by distally advancing an actuation rod.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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 at (571)272-4695. 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.
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
Prosecution Insights