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 .
Claim Objections
Claims 1, 4, 10-11, 20, and 22-23 are objected to because of the following informalities: in lines 5, 6, 7, 8, and 10 of claim 1, “the pocket” should read “the subcutaneous pocket” for consistency with the rest of claim 1 and with the dependent claims 10-11; in line 2 of claim 4, “one or more introduction tools” should be “the one or more introduction tools” for clarity; in claim 10, the sentence should end with a period; in line 1 of claim 11, “the method of any one of claim 1” should be amended to “the method of claim 1” to remove a typo; and in line 2 of claim 20, line 2 of claim 22, and line 2 of claim 23, “the suture” should read “the at least one suture” for consistency with claim 17. 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.
Claims 4, 17, and 20-21 are 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 4 recites the limitation "a first incision" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, upon which claim 4 depends, already introduced a first incision, and the claim is unclear on if these are the same limitation or different limitations. Applicant should amend claim 4 to “the first incision” or distinguish the limitations. For the purposes of examination, they will be considered the same limitation.
Claim 17 recites the limitation "an implant" in line 6. There is insufficient antecedent basis for this limitation in the claim. Claim 17 already introduced an implant in line 1, and the claim is unclear on if these are the same implant or different implants. Applicant should amend claim 17 to “the implant” or otherwise correct the antecedent basis. For the purposes of examination, the implants will be considered the same.
Claim 20 recites the limitation "one of the introduction tools" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 20 has not previously introduced introduction tools. Applicant should amend to “one of a plurality of introduction tools” or otherwise correct the antecedent basis.
Claim 21 recites the limitation "the suture passer" in line 2. There is insufficient antecedent basis for this limitation in the claim. Neither claim 17, upon which claim 21 depends, nor claim 21 have previously introduced a suture passer. Applicant should amend claim 21 to “a suture passer” to correct the antecedent basis.
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) 1-4, 6-8, 10-18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yaari (Pub. No. 2019/0247033).
Regarding claim 1, Yaari discloses a method of inserting and affixing an implant ([0274] and FIGs. 11-21), the method comprising the steps of:
making a first incision ([0275] 220 is inserted through an incision made in the abdominal wall) in an abdominal wall (124);
forming a subcutaneous pocket (abdominal cavity C, also labeled 124; [0439]; FIGs. 13-14) between a first layer of the abdominal wall (W) and a second layer of the abdominal wall ([0269] subcutaneous fat layers; shown by the rough half-circle at the bottom of FIG. 13), such that the pocket is at least 2 centimeters from the costal margin ([0271] the procedures done are for lower abdomen, such as uterus or GI tract, and are therefore at least 2 cm from the costal margin), and such that the first incision defines an opening into the pocket (FIG. 2: the cut in 124 is the opening 226 into 234);
inserting an implant through the opening and into the pocket ([0275] and FIG. 2: 220 is inserted through 226 and placed within abdominal cavity 124);
positioning the implant into the pocket ([0275] 220 is positioned within abdominal cavity 124);
affixing the implant within the subcutaneous pocket ([0290] 220 can be sealed to the inside of the cavity); and
closing the opening such that the implant is secured within the pocket ([0290] at least part of 220 remains behind while [0334] 230 is sutured close).
Regarding claim 2, Yaari further discloses creating a second incision for a first introduction tool ([0244] additional incisions can be made to create different ports introduce other tools).
Regarding claim 3, Yaari further discloses creating additional incisions for one or more introduction tools ([0244] additional incisions can be made to create different ports introduce other tools).
Regarding claim 4, Yaari further discloses forming the first incision and four additional incisions for one or more introduction tools ([0334] at least four additional incisions can be made for each of the additional tools that can be provided for the procedure, such as a grasper, a suturing tool, an electro-cutting tool, and a suction tool, as [0244] discloses making additional ports for other tools).
Regarding claim 6, Yaari further discloses each of the incisions for the one or more introduction tools accommodates at least a 10 mm trocar ([0439] and FIGs. 13-14: T1 is a conventional trocar, whose dimensions are between 10 and 110 mm in [0348], and which is used to introduce the tools from [0334]).
Regarding claim 7, Yaari further discloses the one or more introduction tools comprises an umbilical introduction tool, wherein the umbilical introduction tool is a 15-millimeter trocar ([0439] and FIGs. 13-14: T1 is a conventional trocar, which the present Spec in [0020] discloses is an umbilical introduction tool, whose dimensions are between 10 and 110 mm in [0348]).
Regarding claim 8, Yaari further discloses an introduction tool in the one or more introduction tools creates a port to accommodate a lead ([0334] some of the additional tools include electrical components that would include leads, and [0438] a trocar can be used to create the opening).
Regarding claim 10, Yaari further discloses the subcutaneous pocket is between subcutaneous tissue and the rectus sheath ([0269] the cavity is between subcutaneous fat layers and the rectus sheath).
Regarding claim 11, Yaari further discloses the subcutaneous pocket is 7.5 centimeters to 8.5 centimeters in length ([0348] the length of the pocket is determined by the device going into the pocket, and the length is between 0.75 and 3 times the diameter of the device, which is between 1 and 11 cm, which gives 0.75-33 cm in length and includes the claimed range).
Regarding claim 12, Yaari discloses a method of creating a pocket for securing a surgical implant between subcutaneous tissue and rectus abdominus muscle ([0274] and FIGs. 11-21), the method comprising the steps of:
making a first incision ([0275] 220 is inserted through an incision made in the abdominal wall) in an abdominal wall (124);
inserting a surgical instrument into the first incision ([0439] conventional trocar T1 is inserted into the incision); and
using the surgical instrument to extend the pocket from the first incision ([0439] T1 helps to expand the pocket to be a larger size), wherein the pocket is at least 2 centimeters from the costal margin ([0271] the procedures done are for lower abdomen, such as uterus or GI tract, and are therefore at least 2 cm from the costal margin).
Regarding claim 13, Yaari further discloses inserting the surgical instrument further comprises developing the pocket using blunt dissection ([0334] the pocket tissue can be further developed by use of a grasper which can bluntly manipulate tissue to the point of tearing, or a welder which can cut tissue without a shape edge).
Regarding claim 14, Yaari further discloses the pocket is 7.5 centimeters to 8.5 centimeters in length ([0348] the length of the pocket is determined by the device going into the pocket, and the length is between 0.75 and 3 times the diameter of the device, which is between 1 and 11 cm, which gives 0.75-33 cm in length and includes the claimed range).
Regarding claim 15, Yaari further discloses the pocket is 2.5 centimeters to 3.5 centimeters in width ([0348] the width of the pocket is determined by the diameter of device going into the pocket, which is between 1 and 11 cm and includes the claimed range).
Regarding claim 16, Yaari further discloses inserting and affixing an implant in the pocket ([0275] and FIG. 2: 220 is inserted through 226 and placed within the abdominal cavity 124; [0290] 220 can be sealed to the inside of the cavity).
Regarding claim 17, Yaari discloses a method of inserting an implant ([0274] and FIGs. 11-21), the method comprising the steps of:
making a first incision ([0275] 220 is inserted through an incision made in the abdominal wall) in an abdominal wall (124);
forming a subcutaneous pocket (234) between a first layer of the abdominal wall (124) and a second layer of the abdominal wall ([0269] subcutaneous fat layers), such that the first incision defines an opening into the pocket (FIG. 2: the cut in 124 is the opening 226 into 234);
inserting an implant through the opening and into the pocket ([0275] and FIG. 2: 220 is inserted through 226 and placed within 124);
positioning the implant into the pocket ([0275] 220 is positioned within 124);
closing the opening such that the implant is secured by at least one suture within the pocket ([0290] at least part of 220 remains behind while [0334] 230 is sutured close).
Regarding claim 18, Yaari further discloses the pocket is at least 2 centimeters from the costal margin ([0271] the procedures done are for lower abdomen, such as uterus or GI tract, and are therefore at least 2 cm from the costal margin).
Regarding claim 20, Yaari further discloses grasping the suture with a suture passer through one of the introduction tools ([0334] a suturing tool may be placed through the opening), wherein the suture passer is visualized under laparoscopic visualization ([0300] an inserted imager can provide internal visualization to tools inserted into the openings, including the suturing tool).
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.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yaari in view of Chin (Pub. No. 2013/0165955).
Regarding claim 21, Yaari discloses the invention as claimed in claim 17, as discussed above. Yaari is silent regarding advancing a suture passer through the fascia in an upper distal corner of the pocket.
Chin teaches in the same field of endeavor of inserting an implant ([0082] a method of inserting a trocar; FIGs. 8A-8C), and discloses advancing a suture passer (106) through the fascia in an upper distal corner of the pocket ([0091] 106 is advanced through facial tissue 110 in the upper distal corner of the cavity) for the purpose of allowing the suture passer to be drawn across the inside of the opening to suture the internal side of the opening ([0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Yaari to include advancing a suture passer through the fascia in an upper distal corner of the pocket, as taught by Chin, for the purpose of allowing the suture passer to be drawn across the inside of the opening to suture the internal side of the opening.
Regarding claim 22, Yaari discloses the invention as claimed in claim 17, as discussed above. Yaari is silent regarding clamping the suture to maintain proper cranial to caudal alignment.
Chin teaches in the same field of endeavor of inserting an implant ([0082] a method of inserting a trocar; FIGs. 8A-8C), and discloses clamping the suture to maintain proper cranial to caudal alignment ([0054] the suture is grasped by clamping to ensure proper alignment) for the purpose of grabbing and securing the suture at the delivery site ([0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Yaari to include clamping the suture to maintain proper cranial to caudal alignment, as taught by Chin, for the purpose of grabbing and securing the suture at the delivery site.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yaari in view of Irwin et al. (Pub. No. 2023/0149724)
Regarding claim 22, Yaari discloses the invention as claimed in claim 17, as discussed above. Yaari is silent regarding the suture is selected from the group of: a U-stitch and a staple.
Irwin et al. teaches in the same field of endeavor of laparoscopic procedures ([0033]), and discloses using a suture or other fixation means such a staple ([0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the suture of Yaari for the staple of Irwin et al., because both fixation means are disclosed as functional equivalents for closing tissue, and the substitution of one for the other would have had the predictable result of closing the tissue opening.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771