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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/22/2025 has been entered.
Priority
This application claims priority from provisional application 62/137,759 filed on 03/24/2015.
Status of Claims
Claims 147, 149-156, 159, 160, 163, 164, and 167-171 are pending.
Claims 1-146, 148, 157, 158, 161, 162, 165, and 166 have been cancelled.
Election/Restrictions
Applicant elected Species 9 (Figures 9A-B) without traverse on 07/02/2024.
In view of the applicant’s amendments claim 152 has been rejoined.
Claim Rejections - 35 USC § 112
In regards to claim 159, the function of enabling tailoring without unraveling is being interpreted to require that some sort of cut or trimming can be done that doesn’t cause they entire device to unravel.
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 149 and 164 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.
Claims 149 and 164 lack antecedent basis for the recitations “the medial surface area” and “the lateral surface area”. The applicant is advised to change both recitations of “the” to “a”.
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) 147, 149-154, 156, 159, 160, 163, 164, and 167-171 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Debbas USPN 5,716,409.
147. Debbas discloses an implantable mesh for a sublay inguinal hernia repair in a subject (Figure 4, See modified Figure 4 below to demonstrate all references in this rejection), the implantable mesh comprising:
(a) a fabric layer 40 having a superior surface area (upper half) and an inferior surface area (Lower half) separated by a horizontally-oriented center line (Horizontal line) extending from a lateral edge (lower right diagonal edge) of the implantable mesh to a medial edge (upper left diagonal edge) of the implantable mesh, the implantable mesh comprising a plurality of pores configured to enable tissue in-growth to the mesh upon implantation of the mesh in the subject (5:59-6:13 discloses the mesh which is capable of the intended in-growth), and
b) an anti-adhesive barrier (46) comprising a shape (it is noted that the claims do not require the shape to be the entire barrier portion, but permit the shape to be an identifiable portion of the barrier) configured to prevent direct contact between the fabric layer and at least a portion of a spermatic cord or at least a portion of a genital nerve of a patient upon implantation (barrier 46 is inherently capable of preventing contact from at least a small portion of the cord or nerve after implantation), wherein the shape covers a part of the inferior surface area on an anterior side of the fabric layer (see Figure 4 below), the shape being less than 25% of a combined inferior and superior surface area on the anterior side of the fabric layer, wherein the shape is inferior to the horizontally-oriented centerline and medial to a vertically-oriented centerline (vertical line) (Figure below show barrier 46 both below and to the left of the center lines), wherein at least a portion of the combined inferior and superior surface area of the anterior side of the fabric layer does not include the anti-adhesive barrier (the majority of the entire surface is uncovered), the at least a portion being greater than 75% of the combined inferior and superior surface area (Debbas does not disclose a percentage but the barrier covers far less than 25% of the surface), and wherein the anti-adhesive barrier is limited to be within a predetermined distance to an inferior edge of the fabric layer (the barrier does not move so it inherently is limited to a predetermined position with respect to all edges of the implant), wherein the implantable mesh at its maximum width from the lateral edge to the medial edge defines a line that is substantially parallel to the horizontally-oriented centerline and is inferior to the horizontally-oriented centerline (as seen below the mesh of Debbas is a rotatable rectangle that can be rotated to have its horizontal centerline positioned to intersect the two longer edges, this provides for two maximum widths defining lines that are parallel to the horizontal centerline, one line shown dashed below is also inferior to the centerline).
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149. and 164. Debbas discloses a horizontal length of the superior surface area and a horizontal length of the inferior surface area are each greater than i) a vertical length of the medial surface area and ii) a vertical length of the lateral surface area (All three areas have a variety of lengths allowing for one to identify the longest lengths of the superior and inferior surface areas and compare them to the shortest lengths of the vertical lengths of the medial and lateral areas).
150. Debbas discloses the implantable mesh has a height along the vertically-oriented centerline of about 1 inch to about 5 inches and a width along the horizontally-oriented centerline of about 3 inches to about 15 inches (Debbas discloses the unrotated dimensions are about 3” by 5”, even rotated the centerlines will both inherently fall within these ranges especially given the broad range language “about”).
151. Debbas discloses a width of the fabric layer at the intersection of the horizontally-oriented centerline and the vertically-oriented centerline is greater than a height of the fabric layer (See modified Figure 4 above).
152. Debbas discloses a portion of one or more edge of the implantable mesh is flat (See modified Figure 4 above).
153. and 163. Debbas discloses a portion of one or more edges of the implantable mesh are curved (the slot and through hole define inner edges with curved portions).
154. Debbas discloses the implantable mesh has a three-dimensional shape (every possible implant is inherently 3D because it inherently has a thickness).
156. Debbas discloses the implantable mesh comprises a synthetic material comprising polypropylene (Debbas discloses Marlex with comprises polypropylene 3:8-9).
159. Debbas discloses at least a portion of the fabric layer comprises a weave, a braid, an interlaced structure, or any combination thereof that define the plurality of pores and that enable tailoring of the implantable mesh without unravelling of a portion of the implantable mesh (Debbas discloses an interlaced mesh).
160. Debbas discloses an implantable mesh (See modified Figure 4 above) for a sublay inguinal hernia repair in a subject, the implantable mesh comprising:
(a) a fabric layer (40) having a superior surface area and an inferior surface area (upper and lower portions) separated by a horizontally-oriented center line extending from a lateral edge (lower right diagonal edge) of the implantable mesh to a medial edge (upper left diagonal edge) of the implantable mesh, the implantable mesh comprising a plurality of pores configured to enable tissue in-growth to the implantable mesh upon implantation of the implantable mesh in the subject (5:59-6:13 discloses the mesh which is capable of the intended in-growth), wherein the fabric layer has an inferomedial quarter that is inferior to the horizontally-oriented centerline and medial to a vertically-oriented centerline (bottom left section of modified Figure 4 above),
(b) an anti-adhesive barrier (46) comprising a shape (it is noted that the claims do not require the shape to be the entire barrier portion, but permit the shape to be an identifiable portion of the barrier) configured to prevent direct contact between the fabric layer and a tissue of a patient upon implantation (barrier 46 is inherently capable of preventing contact from at least a small portion of the patient’s tissue implantation), wherein the shape covers a part of the inferior surface area on an anterior side of the fabric layer (the modified figure above shows barrier 46 both below and to the left of the center lines), the shape being less than 25% of a combined inferior and superior surface area on the anterior side of the fabric layer (Debbas does not disclose a percentage but the barrier covers far less than 25% of the surface), wherein the shape is located on the inferomedial quarter of the anterior side of the fabric layer (see modified figure above), wherein at least a portion of the combined inferior and superior surface area on the anterior side of the fabric layer does not include the anti-adhesive barrier, the at least a portion being greater than 75% of the combined inferior and superior surface area (Debbas does not disclose a percentage but the barrier covers far less than 25% of the surface resulting in more than 75% uncovered), and wherein the anti-adhesive barrier is limited to be within a predetermined distance to an inferior edge of the fabric layer (the barrier does not move so it inherently is limited to a predetermined position with respect to all edges of the implant),
wherein the implantable mesh at its maximum width from the lateral edge to the medial edge defines a line that is substantially parallel to the horizontally-oriented centerline and is inferior to the horizontally-oriented centerline (as seen above the mesh of Debbas is a rotatable rectangle that can be rotated to have its horizontal centerline positioned to intersect the two longer edges, this provides for two maximum widths defining lines that are parallel to the horizontal centerline, one line shown dashed below is also inferior to the centerline).
167. and 168. Debbas discloses the predetermined distance is about 1 cm from the inferior edge so as to allow the inferior edge to adhere to surrounding tissues (the claims require the barrier to be within the predetermined distance, meaning spaced less than the predetermined distance. Debbas discloses the width of the barrier in Figure 4 is 3/4 of an inch (about 2 cm) , therefore the small distance between the barrier and the adjacent inferior edge (bottom left and right edges) is inherently less than 1 cm).
169. Debbas discloses the implantable mesh is configured to fold from the anterior side toward a posterior side, from the edge toward the horizontally oriented centerline, or from the edge toward the vertically-oriented centerline (the flexible mesh of Debbas is fully capable of folding in any direction because of its flexible open mesh framework).
170. and 171. Debbas discloses the shape of the anti- adhesive barrier extends outward and inferiorly such that the width of the anti-adhesive barrier increases gradually from a superior portion of the anti-adhesive barrier towards an inferior portion of the anti-adhesive barrier (Debbas discloses a tapered barrier in Figure 6, which if rotated and aligned in the same manner as modified Figure 4 above would meet this claimed limitation).
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) 155 is/are rejected under 35 U.S.C. 103 as being unpatentable over Debbas in view of Mathisen et al (Mathisen) US 2007/0299542 A1.
Debbas discloses the invention substantially as claimed being described above. However, Debbas does not disclose the fabric layer has a density of no greater than about 40 grams per square meter (g/m2).
Mathisen teaches the use of a hernia prosthesis comprising a fabric layer the fabric layer has a density of 20 grams per square meter (g/m2) [0046] in the same field of endeavor for the purpose of for the purpose of providing a sturdy mesh that promotes ingrowth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the fabric layer of Debbas to have a density of 20 g/m2 as disclosed by Mathisen in order to provide a sturdy mesh that promotes ingrowth.
Response to Arguments
Applicant's arguments filed 10/23/2025 have been fully considered but they are not persuasive.
The applicant has not presented any arguments with respect to the new claims filed on 10/23/2025. However it is noted that several limitations are extremely broad, see examples below.
With respect to the shape of the an anti-adhesive barrier, the applicant is reminded that the claims do not require the shape to be the entire barrier portion, but permit the shape to be an identifiable portion of the barrier.
With respect to the curved edges, the applicant is reminded that the implant of Debbas is flexible allowing the edges to also be curved in the direction of their thickness
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774