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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/29/2025 has been entered.
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, 18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Himpens (US 5,397,331).
Regarding claim 17, Himpens discloses a laparoscopic device (Abstract, FIGs 5-9) for positioning and affixing reinforcing material (Net 13, FIG 3) to abdominal wall fascia (Abdominal wall 24, 25, 26 shown in FIGs 6-9) to reinforce and augment a fascial incision closure (The material reinforces a hernia in the tissue), comprising: a reinforcing material (13/14, col 4 line 66-col 5 line 34) configured to be affixed to abdominal wall fascia to reinforce and augment the fascial incision closure (As shown in its deployed state in FIG 9), a telescoping arm (20) configured to deliver the reinforcing material to an anterior surface of the abdominal wall fascia over the fascial incision closure (20 is attached to the material at the distal end of the arm, FIG 6, and is used to push the material through the opening in the abdominal wall to deliver to an anterior side), wherein the telescoping arm is further configured to position the reinforcing material over the fascial incision closure by releasing the reinforcing material therefrom (FIGs 6-9 show the use of 20 to deploy the material at the treatment site which includes releasing the material from the laparoscopic device, FIG 9, col 6 lines 17-26), wherein the reinforcing material is attachable to the telescoping arm (The material is able to be attached to the arm 20, FIG 6-8, col 5 line 46-col 6 line 27) before the reinforcing material reaches the fascia (During delivery to the target treatment site such as FIG 5-6); wherein the reinforcing material comprises a first portion (See annotated FIGS 3-4 below), the first portion configured to be attached to a first, top side of the fascia (FIG 6-9 show the device in use in relation to layers of the abdominal wall musculus obliquus externus and internus 24, musculus transversalis 25 and peritoneum 26. The device is at least configured such that the first portion half of the mesh can be attached to a top side of a fascia), and a second portion (See annotated FIGS 3-4 below), configured to be attached to a second, bottom side of the fascia opposite the first side (The device is at least configured such that the second portion half of the mesh can be attached to a bottom side of a fascia. While FIGS 8-9 show delivery of the mesh transverse to the plane of the abdominal wall, therefore attached both portions of the mesh to a top side of the wall, if the device were inserted at an acute angle relative to the wall, it is at least configured to be positioned such that the second portion of the mesh can be attached to a bottom side of a fascia); wherein the first portion is spaced from the second portion by a coupling (16) extending therebetween (FIGs 3-4).
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Regarding claim 18, Himpens discloses a guide (22) configured to cause the telescoping arm to move to deliver the reinforcing material to the fascia (FIGs 6-9, col 6 lines 17-26 disclose how 22 is configured to manipulate the detachment of telescoping arm 20 and the material), wherein the guide is coupled to the telescoping arm (FIGs 6-8) and wherein the guide can be controlled by an external user (22 is at least configured to be controlled by an external user by grasping 21 to apply the telescoping force).
Regarding claim 21, Himpens discloses the telescoping arm is configured to affix the reinforcing material to the fascia by applying a force, wherein the force applied to the reinforcing material can be controlled by the guide (Guide 22 is move inwardly to case a release of material form telescoping arm 20, col 6 lines 17-27. FIGs 6-8 show the axial movement of 20 and 22 which result in the release of the material from the laparoscopic device).
Claim(s) 22, 26, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rousseau et al. (US 2003/0004579).
Regarding claim 22, Rousseau et al. discloses a laparoscopic device for performing minimally invasive surgery to reinforce a fascia ([0002, 0007, 0022-0023, 0028]), comprising: a first reinforcing material portion (14a, FIG 1-4) configured to be attached to a first side of the fascia (FIG 4 shows attachment on a first side of fascia 42 at posterior side 47); a second reinforcing material portion (26, [0024-0025, 0028-0029, 0031]) configured to be attached to a second side of the fascia opposite the first side (FIG 4 shows attachment on a opposite side of fascia 42 at the anterior side 48); and a guide portion (looped suture 22 with knot 24, FIGs 1-4, [0024-0025 and 0028-0029]) configured to deploy (22 is used to deploy the materials to the expanded state by being tightened, [0028]) the first reinforcing material portion from a folded position (Folded configuration FIGs 1-2) to a deployed configuration (Deployed configuration FIG 4) and the second reinforcing material portion from a folded configuration (Although not shown in a folded position, sheet 26 is sufficiently flexible to be folded so as to reduce its profile while being delivered to the treatment site) to a deployed configuration (Deployed configuration FIG 4) once the laparoscopic device is at a target site for reinforcing the hernia fascia (Wherein the target site is the placement on both sides of the fascia and within the defect 43, FIGs 1-4, [0028-0029]), wherein the first reinforcing material portion is spaced from the second reinforcing material portion by a coupling member extending therebetween (14b and 28 are interpreted as the coupling extending between 14a and 26, FIG 1-4).
Regarding claim 26, Rousseau et al. discloses the first reinforcing material portion is in a folded configuration to pass through an incision in the fascia without widening the incision (See folded shape of FIG 3 which is folded while passing through 43), and wherein the first reinforcing material portion is configured to be deployed after it has passed through the incision (FIG 4, after passing through the incision, first reinforcing material 12/14 is deployed by pulling 22, [0028]).
Regarding claim 27, Rousseau et al. discloses the second reinforcing material portion (26) is configured to be deployed after the first reinforcing material portion has been deployed ([0028] discloses “Prosthesis 10 is inserted until overlay sheet 26 is flush with anterior side 48 of fascia 42”. This position is interpreted as being the deployed position of 26 and occurs after 14a in inserted and expanded to anchor in place on the opposing side of the fascia).
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) 23-25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Rousseau et al. (US 2003/0004579) in view of Himpens (US 5,397,331).
Regarding claim 23, Rousseau et al. discloses the invention substantially as claimed, as set forth above for claim 22.
Rousseau et al. is silent regarding an introducer portion configured to store the first reinforcing material portion and the second reinforcing material portion while the laparoscopic device is being delivered to the target site, wherein the guide portion is further configured to deploy the first reinforcing material portion and the second reinforcing material portion by removing the first reinforcing material portion and the second reinforcing material portion from the introducer portion.
However, Himpens teaches in the same field of endeavor of devices for reinforcing an abdominal fascia (Abdominal wall 24, 25, 26 shown in FIGs 6-9) , a laparoscopic device (Abstract, FIGs 5-9) for positioning and affixing reinforcing material (Net 13, FIG 3) to the fascia comprising: a reinforcing material (13/14, col 4 line 66-col 5 line 34) attached to the laparoscopic device (Wherein 20, 21, 22, 23 are interpreted as elements of the laparoscopic device, col 5 line 46-col 6 line 27) and an introducer portion (23) configured to store the reinforcing material while the laparoscopic device is being delivered to the target site (See stored position of FIG 6 wherein material 13 is folded be inserted within 23) and a guide portion (19, which is equivalent to 22 Rousseau in terms of its function regarding deployment of the material, col 6 lines 17-27).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Rousseau such that it is delivered to the treatment site within an introducer portion, as taught by Himpens, for the purpose of providing a structure to radially collapse the first and second reinforcement materials in their reduced profile until they have been delivered to the target treatment site and ready for expansion. In the device as modified, the guide portion is further configured to deploy the first reinforcing material portion and the second reinforcing material portion by removing the first reinforcing material portion and the second reinforcing material portion from the introducer portion (Suture 22 is at least configured such that it could be manipulated to pull the reinforcing material portions out of the introducer portion and thereby deploy them).
Regarding claim 24-25, Rousseau et al./Himpens disclose the invention substantially as claimed, as set forth above for claim 23. Rousseau et al further discloses the coupling member (14b and 28, FIG 1) configured to couple the first reinforcing material portion to the second reinforcing material portion (when assembled as shown in FIG 2-3, tubular structure 28 and 14b form a connection through at least mechanical contact between the first and second materials, [00247-0025]), wherein the guide portion is configured to be located at least in part within the coupling member (22 is fed longitudinally through a lumen of 28, [0025]), and wherein the coupling member is configured to be coupled to the introducer portion through a first opening in the first reinforcing material portion (Open base 20 forming the entrance to cavity 30, FIG 1, forms the first opening. 28 is at least configured to be coupled through mechanical contact and constrained to the introducer portion of the device as modified because the entire structure is housed and radially confined within the lumen of the introducer), and the first reinforcing material portion and the second reinforcing material portion can be folded around the coupling member in the folded configuration (FIGs 1-2 shows the first material portion being folded around the coupling member in the folded configuration. Second reinforcing portion 26 “can be” folded around the coupling member because 26 is flexible enough and large enough to be folded around the coupling member in the collapsed delivery profile).
Regarding claim 28, Rousseau et al./Himpens disclose the invention substantially as claimed, as set forth above for claim 24. Rousseau et al further discloses first reinforcing material portion, the second reinforcing material portion, and the coupling member are configured to be part of a continuous reinforcing material ([0026-0027] discloses all of the elements that form 10 can be fabricated of the same woven polypropylene mesh and therefore are understood the be part of a continuous reinforcing material), wherein the first reinforcing material portion and the second portion are configured to be deployed in a single action performed by the guide portion (Because the first and second reinforcing material portions are part of a unitary mesh device 10, deployment via suture 22 is considered to be achieved as a “single action” because it occurs as one continuous step of deployment).
Response to Arguments
Applicant argues on pages 6-7 regarding claim 17 that Himpens fails to disclose the reinforcing material configured to be attached to a top side of the fascia at the first portion and a bottom side of the fascia at the second portion. Applicant notes that Himpens shows the reinforcing material being attached to left and right sides of the same side of the fascia. It is the examiners position that the device of Himpens is still at least configured to be positioned in the claimed arrangement and that the limitations in question are functional language reciting an intended use of the device, therefore they do not need to be explicitly shown or taught by the prior art. The reinforcing material is at least configured such that the second portion half of the mesh can be attached to a bottom side of a fascia. While FIGS 8-9 show delivery of the mesh transverse to the plane of the abdominal wall, therefore attached both portions of the mesh to a top side of the wall, if the device were inserted at an acute angle relative to the wall, it is at least configured to be positioned such that the second portion of the mesh can be attached to a bottom side of a fascia while a first portion is positioned on the top side of the fascia. Therefore, applicants’ argument is not persuasive.
Applicant argues on pages 7-8 regarding claim 22 that Rousseau fails to disclose the second reinforcing material being configured to deploy from a folded position to a deployed configuration because flat overlay sheet 26 is only shown in the deployed configuration. It is the examiners position that although not shown in a folded position, sheet 26 is sufficiently flexible to be folded so as to reduce its profile while being delivered to the treatment site, therefore it is at least configured to achieve a folded position as claimed. Therefore, applicants’ argument is not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771