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 .
Election/Restrictions
Applicant’s election without traverse of Species v (Fig. 33a-34c) in the reply filed on 7/17/26 is acknowledged.
Claim Objections
Claim 20 is objected to because of the following informalities: on line 2, “an inner abdominal wall” should be –the inner abdominal wall--. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: on line 3, “a body cavity” should be –the body cavity--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 24 recites “without the distal tip axially shortening”, this limitation is viewed as a negative limitation. As stated in MPEP 2173.05(i), any negative limitation or exclusionary provision must have bases in the original disclosure. The mere absence of a positive recitation is not basis for an exclusion.
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 26 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 26 recites the limitation "the first opening" in line 2 and “the second opening” in line 5. There is insufficient antecedent basis for this limitation in the claim.
The first and second openings are introduced in claim 25 not in claim 24.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 17-24 and 27-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sherts et al. (2013/0165956).
Sherts discloses the following claimed limitations:
Claim 17: A method of controlling a fascial bite of tissue when closing a trocar wound site (Fig. 9a-h, [0175], [0177-178]), comprising: inserting a surgical guide device (108) (Fig. 1-2 and 8-9h) into the trocar site (Fig. 9a-h and [0255-268]), the surgical guide device comprising a barrel (114) (Fig. 1-2 and [0248]) defining a first channel (136, 140) (Fig. 2 and [0231]) and a second channel (138, 142) (Fig. 2 and [0231]), the first channel comprising a first exit (126, 134) (Fig. 2 and [0233]) for directing a needle (110) (Fig. 9e-f and [0261]) into a body cavity (Fig. 9a-h and [0255-268]), the second channel comprising a second exit (124, 132) (Fig. 2 and [0231]) for directing the needle into the body cavity (Fig. 9f-h and [0265-267]); visualizing a plurality of numerical markings (179) (Fig. 7 and 9a-h and [0249]) disposed along an exterior surface of the barrel (Fig. 7 and 9a-h and [0249]); aligning a selected one of the plurality of numerical markings with an inner abdominal wall (Fig. 9a-h and [0255-268]);inserting the needle through the first channel of the barrel to guide a suture (Fig. 9a-h and [0255-268]); inserting the needle through the second channel (Fig. 9a-h and [0255-268]), opposite the first channel of the barrel (Fig. 9a-h and [0255-268]), to guide the suture (Fig. 9a-h and [0255-268]); and utilizing a distal tip (156) of the barrel (Fig. 9a-h and [0255-268]), when positioned into the body cavity, to direct the suture to create a stitch (Fig. 9a-h and [0255-268]), wherein the fascial bite of tissue is set based on the selected one of the plurality of numerical markings that are aligned with the inner abdominal wall (Fig. 9a-h and [0255-268]).
Claim 18: wherein the fascial bite of tissue is selected based on a clinical need of a patient ([0060], [0175], [0177-178]), [0249]).
Claim 19: wherein the selected one of the plurality of numerical markings is selected to prevent excess tissue within a suture loop stitch ([0248]).
Claim 20: wherein the selected one of the plurality of numerical markings is aligned with an inner abdominal wall to predictably pass the needle through the first channel or the second channel and through tissue at a determined distance from an edge of a fascial defect (Fig. 9a-h, [0248], and [0255-268]).
Claim 21: wherein the plurality of numerical markings include a logo ([0283]).
Claim 22: wherein the plurality of numerical markings include a plurality of lines (Fig. 1 and 8 and [0283]).
Claim 23: further comprising: moving first and second self-supporting suture catchers (arms 154, 198) (Fig. 9a-10 and [0289]) in unison to the retracted configuration by moving an actuator proximally with respect to the barrel (Fig. 9a-10, [0255-268], [0289]); and moving the first and second self-supporting suture catchers in unison to the radially extended configuration by moving the actuator distally with respect to the barrel (Fig. 9a-10, [0255-268], [0289]).
Claim 24: further comprising extending the first self-supporting suture catcher and the second self-supporting suture catcher radially outward and in opposite directions from the distal tip without the distal tip axially shortening with respect to the barrel when changing between the retracted configuration and the radially extended configuration (Fig. 9a-10, [0255-268], [0287-289]).
Claim 27: A method of controlling a fascial bite of tissue when closing a trocar site (Fig. 9a-h, [0175], [0177-178]), comprising: inserting a surgical guide device (108) (Fig. 1-2 and 8-9h) into the trocar site (Fig. 9a-h and [0255-268]), the surgical guide device comprising a barrel (114) (Fig. 1-2 and [0248]) defining a first channel (136, 140) (Fig. 2 and [0231]) and a second channel (138, 142) (Fig. 2 and [0231]), the first channel comprising a first exit (126, 134) (Fig. 2 and [0233]) for directing a needle (110) (Fig. 9e-f and [0261]) into a body cavity (Fig. 9a-h and [0255-268]), the second channel comprising a second exit (124, 132) (Fig. 2 and [0231]) for directing the needle into the body cavity (Fig. 9f-h and [0265-267]), the barrel having a plurality of numerical markings (179) (Fig. 7 and 9a-h and [0249]) disposed along an exterior surface thereof (Fig. 7 and 9a-h and [0249]); aligning a selected one of the plurality of numerical markings with an inner surface of tissue through which the surgical guide is inserted (Fig. 9a-h and [0255-268]); inserting the needle through the first channel of the barrel to guide a suture (Fig. 9a-h and [0255-268]); inserting the needle through the second channel, opposite the first channel of the barrel, to guide the suture (Fig. 9a-h and [0255-268]); and directing the suture with a distal member (156) of the surgical guide that is within the abdominal cavity to create a stitch (Fig. 9a-h and [0255-268]), wherein the fascial bite of the tissue is set based on the selected one of the plurality of numerical markings that are aligned with the inner surface of tissue (Fig. 9a-h and [0255-268]).
Claim 28: wherein the selected one of the plurality of numerical markings are aligned with the inner surface of tissue through visualization of the selected one of the plurality of the numerical markings within a body cavity (Fig. 7 and 9a-h and [0249]).
Claim 29: wherein the inner surface of tissue is a peritoneum of an abdominal cavity (abstract and [0255]).
Claim 30: wherein the plurality of numerical markings include a logo ([0283]).
Claim 31: wherein the plurality of numerical markings include a plurality of lines (Fig. 1 and 8 and [0283]).
Claim 32: wherein the fascial bite of tissue is selected based on a clinical need of a patient ([0060], [0175], [0177-178]), [0249]).
Claim 33: wherein the selected one of the plurality of numerical markings is selected to prevent excess tissue within a suture loop stitch ([0248]).
Claim 34: wherein the selected one of the plurality of numerical markings is aligned with the inner tissue surface to predictably pass the needle through the first channel or the second channel and through tissue at a determined distance from an edge of a fascial defect (Fig. 9a-h, [0248], and [0255-268]).
Claim 35: Sherts discloses all the claimed limitations discussed above.
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) 17-35 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Heneveld (2015/0313583) in view of Sherts et al. (2013/0165956).
Heneveld discloses a method of controlling a fascial bite of tissue when closing a trocar wound site (Fig. 11-15), comprising: inserting a surgical guide device (130) (Fig. 6a-c and [0093]) into the trocar site (Fig. 11-15 and [0104-112]), the surgical guide device comprising a barrel (131) (Fig. 6a-c and [0093]) defining a first channel (132) (Fig. 6a-c and [0093]) and a second channel (136) (Fig. 6a-c and [0093), the first channel comprising a first exit (134) ([0099]) for directing a needle (100) (Fig. 11-15 and [0104-112]) into a body cavity (Fig. 11-15 and [0104-112]), the second channel comprising a second exit (138) ([0099]) for directing the needle into the body cavity (Fig. 11-15 and [0104-112]); inserting the needle through the first channel of the barrel to guide a suture (Fig. 11-15 and [0104-112]); inserting the needle through the second channel (Fig. 11-15 and [0104-112]), opposite the first channel of the barrel (Fig. 11-15 and [0104-112]), to guide the suture (Fig. 11-15 and [0104-112]); and utilizing a distal tip (140) of the barrel (Fig. 11-15 and [0104-112]), when positioned into the body cavity, to direct the suture to create a stitch (Fig. 11-15 and [0104-112]).
Heneveld further discloses comprising: moving first and second self-supporting suture catchers (arms 147, snares 146) in unison to the retracted configuration by moving an actuator proximally with respect to the barrel (Fig. 11-15 and [0104-112]); and moving the first and second self-supporting suture catchers in unison to the radially extended configuration by moving the actuator distally with respect to the barrel (Fig. 11-15 and [0104-112]); further comprising extending the first self-supporting suture catcher and the second self-supporting suture catcher radially outward and in opposite directions from the distal tip without the distal tip axially shortening with respect to the barrel when changing between the retracted configuration and the radially extended configuration (Fig. 11-15 and [0104-112]); further comprising retracting the first self-supporting suture catcher and the second self-supporting suture catcher in unison to close a first opening (149, snare opening) and a second opening (149, snare opening) while simultaneously capturing a first suture portion and a second suture portion (Fig. 11-15 and [0104-112]); passing and dropping the first suture portion into the first opening formed by the first self-supporting suture catcher (Fig. 11-15 and [0104-112]), such that the first suture portion resides loosely within the first opening (Fig. 11-15 and [0104-112]); and passing and dropping the second suture portion into the second opening formed by the second self-supporting suture catcher, such that the second suture portion resides loosely (Fig. 11-15 and [0104-112]).
Heneveld teaches all the claimed limitations discussed above however; Heneveld does not disclose the numerical markings as claimed.
Sherts discloses all the limitations discussed in the 102 rejection above including visualizing a plurality of numerical markings (179) (Fig. 7 and 9a-h and [0249]) disposed along an exterior surface of the barrel (Fig. 7 and 9a-h and [0249]); aligning a selected one of the plurality of numerical markings with an inner abdominal wall (Fig. 9a-h and [0255-268]); wherein the fascial bite of tissue is set based on the selected one of the plurality of numerical markings that are aligned with the inner abdominal wall (Fig. 9a-h and [0255-268]).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Heneveld with numerical markings in view of the teachings of Sherts, in order to indicate a thickness of the surgical cavity wall ([0182]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/ Primary Examiner, Art Unit 3771
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