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 Group II, method for closing a tissue defect, in the reply filed on 1/2/26 is acknowledged.
Double Patenting
Claims 34-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23 of U.S. Patent No. 12,004,730 (“patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are narrower than the claims of the instant application and thus read on the above claims of the instant application. Claim 34 recites “positioning” the strap while the patent recites the specific steps involved in the positioning in greater detail (such as that of claims 36 and 38 in the application).
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 38 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 38 refers to pushing a distal end of the strap through a third incision, and pulling a second strap through the fourth puncture site and out of the body through a second incision. However, a second incision was already recited and it is unclear if this refers to the same incision or not. The specification appears to refer only to a first and second incision. Further clarification is required.
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.
Claim(s) 34-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schiebler [US 7582089 B2].
Re. claim 34, Schiebler discloses a method for closing a tissue defect [long fascial wound, Fig. 20] of a patient, the method comprising:
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positioning a first self-locking [“The hub 14 has a plunger device 129, or devices so that when the strip 12 has engaged the hub 14, the plunger devices 129 are positioned in a locked position, engaging the forward facing protrusions 117,” Col 5 lines 60-64] strap [first strap 10, see Annotated Fig. 20, with strap shown in Fig. 1]; through a first puncture site and a second puncture site [penetration point on either side of wound; see annotated Fig. 20], wherein the first puncture site and the second puncture site are located within soft tissue on either side of a soft tissue defect [fascial wound, Fig. 20];
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positioning a second self-locking strap [second strap 10, Fig. 20] through a third puncture site and a fourth puncture site [penetration point on either side of wound through which second strap extends; see annotated Fig. 20],, wherein the third puncture site and the fourth puncture site are located in the soft tissue on either side of the soft tissue defect [Fig. 20]; and
sequentially tightening the first strap and the second strap [“each needle is subsequently threaded through said closure hub [14] of said at least one linkage device [10],” Claim 13, i.e. the straps are sequentially tightened and “The apparatus is unclamped, and then each needle 23 is pulled through the intercostal space, such as with forceps. Each needle is then threaded through the hub 14 of the linkage device 10 to secure the invention around the wound, split sternum or any other defect requiring closure,” Col. 13 lines 5-11.] to incrementally close the soft tissue defect [the intended result of the claimed method, this is the result achieved by the above method of Schiebler as well].
Re. claim 35, Schiebler discloses the third puncture site is spaced along the soft tissue defect apart from the first puncture site and the fourth puncture site is spaced along the soft tissue defect apart from the second puncture site [see Annotated Fig. 20 above].
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.
Claim(s) 36, 38, 39, 41, 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schiebler in view of Chin [US 2013/0165955 A1].
Re. claims 36 and 38 (as best understood), Schiebler discloses wherein positioning the first [second] strap comprises:
pushing a distal end of the first [second] self-locking strap and through the first [third] puncture site and into a body cavity on a first side of the soft tissue defect, while leaving a proximal end of the first [second] strap outside of the body [Fig. 20];
pulling the distal end of the first [second] strap, through the second [fourth] puncture site in the soft tissue on the opposite side of the soft tissue defect, and out of the body [Fig. 20]; and pulling the distal end of the first [second] strap, until the distal end of the first [second] strap exits such that the first [second] strap encircles the defect [“Each needle is then threaded through the hub 14 of the linkage device 10 to secure the invention around the wound, split sternum or any other defect requiring closure,” Col. 13 lines 7-11].
Schiebler is silent regarding specifically the pushing the strap through a first [third] incision in skin, pulling the strap from within the body cavity and out through a second incision, and pulling the strap subcutaneously until its distal end exits through the first [third] incision.
However, Chin teaches, in a method of repairing fascial tissue, pushing the strap through a first [third] incision in skin [Fig. 4 and Par. 0061],
pulling the strap from within the body cavity [Fig. 4] and out through a second incision [Fig. 4 Par. 0061], and pulling the strap subcutaneously until its distal end exits through the first [third] incision [Par. 0061 and Fig. 4]. 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 Schiebler by using incisions (for claim 38, see 112(b)) and pulling the strap from within the body cavity and pulling the strap subcutaneously through a second incision because, in the case where the tissue to be repaired is located beneath the skin, this allows for the devices to penetrate through the skin to the desired tissue.
Re. claim 39, Schiebler discloses the apparatus set forth including the strap having a lock-head [14] for tightening the strap but fails to teach the support tube. However, Chin teaches wherein tightening a strap comprises: placing a support tube [202, Figs. 2A, Par. 0039] over the strap [Fig. 2A]; and pulling a proximal end of the first self-locking strap [Par. 0046]. 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 Schiebler by adding the step of placing a support tube over the strap as taught by Chin in order to “direct [the] suture…to the site of fascial opening” and “protect [the] suture” [Chin Par. 0039].
Regarding pushing the support tube against a lock-head of the first self-locking strap to tighten the first self-locking strap, given the above teachings, where Scheibler teaches the self-locking strap lock-head and Chin teaches, the tube, one of ordinary skill would reasonably be apprised of the benefits of pushing the support tube against the lock-head of the first self-locking strap to tighten the first self-locking strap as claimed.
Re. claim 41, Schiebler fails to teach cutting excess material. Chin teaches cutting excess material from a suture length ]Par. 0093]. 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 Schiebler to add the step of cutting excess strap material from the first self-locking strap in order to remove excess material.
Re. claim 42, given the above teachings of Schiebler and Chin, the step of cutting would necessarily occur adjacent a lock-head (this is where the excess strap material would be located). Furthermore, Chin teaches the cutting occurring within the patient’s body [Figs. 9D-F] and having the step of cutting occur within the patient's body would have been obvious in cases where this is where the excess length is located.
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schiebler in view of Chin, as applied to claim 36 above, and further in view of Rosenberg [US 2012/0330356 A1].
Re. claim 37, Schiebler discloses placing the distal end of the first strap through a lock-head on the proximal end of the first strap [see e.g. Fig. 4, and citations of claim 1 above], but fails to specifically teach pulling the distal end of the first strap until the lock-head passes under the skin of the patient. However, Rosenberg teaches pulling a first strap until the lock-head passes under the skin of the patient [Par. 0043]. 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 Schiebler as taught by Rosenberg in order to ensure that the protruding parts are located under the skin, reducing risk of injury by pulling. Furthermore, doing this by pulling a distal end of the first strap would have been obvious as this in one of a limited number of ways of ensuring this placement.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schiebler in view of Harper [US 20160242890 A1].
Re. claim 40, Schiebler discloses the soft tissue is part of the abdomen of the patient, but fails to disclose the soft tissue is the rectus abdominus. However, Harper teaches a method of repairing tissue, wherein the soft tissue is the rectus abdominus of the patient [Fig. 5]. 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 Schiebler by configuring the soft tissue to be rectus abdominus as taught by Harper because this allows Schiebler’s method to be used to fix defects in this tissue.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schiebler in view of Gerber et al. [US Pat. 9816884].
Re. claim 43, Schiebler discloses the method above but fails to teach a tension gauge. However, Gerber teaches the step of tightening comprises using a tension gauge [22] to measure the tension. 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 Schiebler by using a tension gauge to measure tension in the first self-locking strap or the second self- locking strap as taught by Gerber in order to enable high measuring accuracy [Gerber, Abstract] and ensure that the proper amount of tension is used [e.g., too much would damage the tissue].
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schiebler in view of Wilk [US Pat. 5217003].
Re. claim 44, Schiebler discloses the method set forth above but fails to teach the robotic arm. However, Wilk teaches a method wherein the step of positioning comprises using a robotic arm to manipulate [30, Col. 2 line 36-Col. 3 line 34]. 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 Schiebler such that the step of positioning the first self-locking strap comprises using a robotic arm to manipulate the first self-locking strap because this amounts to automating a manual activity, allowing for improved speed and ease of use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771