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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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) 1-3, 8-14, 16-23, 25-29, 31, 33-45 and 47-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile (US PGPub 2009/0156997) in view of Cook (US PGPub 2024/0108325) and in further view of Kim (US PGPub 2007/0250020).
Regarding Claim 1, Trenhaile teaches a system for surgically augmenting tissue of a patient (Abstract; Figure 2), the system comprising:
a patch (labeled “patch” in Figure 2) configured to integrate with the tissue being repaired, the patch comprising patch material configured to progressively integrate with tissue of the patient (Paragraphs 0002-0003, 0005, 0025, and 0043 state that the patch is an allograft patch);
an expandable member (122/124; Figure 2; Paragraph 0030) defining a longitudinal axis (122/124; where the longitudinal axis is parallel with the fluid inlet/influx tube (126) in Figure 2);
While Trenhaile discloses the use of sutures (sutures Figure 2 to attach the patch (patch; Figure 2) and expandable member (122/124; Figure 2; see also Figures 5-7; Paragraph 0031-0032, 0034-0035), Trenhaile fails to explicitly teach:
a suture channel extending through the expandable member in a direction generally parallel to the longitudinal axis of the expandable member,
the suture channel having a first end and a second end sized and configured to receive and pass a suture therethrough.
Cook teaches a system for surgically augmenting tissue of a patient (abstract) comprising a patch (50; Figure 1; Paragraph 0025), a pad portion (30) having a border (45), a suture channel (105) extending through the border (45; Figures 1B-1C; Paragraph 0025) in a direction generally parallel to the longitudinal axis (55; Figure 1B), the suture channel (105) having a first end (near reference number 105a in Figure 1B) and a second end (opposite reference number 105a in Figure 1B) sized and configured to receive and pass a suture (75) therethrough (Paragraph 0025).
It would have been obvious to one of ordinary skill in the art to modify the teachings of Trenhaile such that the expandable portions comprise a suture channel extending in a direction generally parallel to the longitudinal axis of the expandable member, as taught by Cook, for the advantage of providing a passageway to protect the sutures from being caught on tissue and such that the sutures can transmit anchoring forces throughout the entire length of the medical implant.
The combination of references further fail to explicitly teach wherein the suture channel extends through the expandable member.
Kim teaches an implantable medical device (abstract; Figure 38) in which an expandable member (10; Figure 38) having an inflation valve (12; Figure 38) for inflating the expandable member (10; Paragraph 0220; Figure 38), and further comprising a suture channel (12a) that extends through the expandable device (10) to allow a suture (59) to be passed through for the purposes to anchoring the expandable member to tissue (Paragraph 0220), the suture channel (12a) extending from a first end (58a; Figure 38) to a second end (58b; Figure 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references disclosed above such that the suture channel extends through the expandable member, as taught by Kim, since it known that expandable/inflatable structures can have suture channels for the purpose of anchoring, which the same purpose of both Trenhaile and Cook.
Regarding Claim 2, the combination of references disclosed above teaches the system of claim 1 where Trenhaile teaches the expandable member has a first edge (top edge away from influx tube 126) and a second edge (bottom edge which is attached to influx tube 126), and wherein Cook teaches the first end of the suture channel being at the first edge, the second end of the suture channel being at the second edge (as shown in Figures 1B, the suture channels extend all the way from a top edge to a bottom edge).
Regarding Claim 3, the combination of references disclosed above teaches the system of claim 1 wherein Trenhaile teaches the expandable member (122/124) comprises an inflatable balloon (124) having an expandable interior (Paragraphs 0030-0033).
Regarding Claim 8, the combination of references disclosed above teaches the system of claim 1 wherein Trenhaile teaches the patch forms a first footprint, and the expandable member forms a second footprint, the first footprint being greater than the second footprint.
Regarding Claim 9, the combination of references disclosed above teaches the system of claim 1 wherein Trenhaile the patch material is an allograft (Paragraph) which is native tissue, and thus is known to often comprise collagen but Trenhaile fails to explicitly teach the patch material comprises collagen.
Cook teaches wherein the patch material comprises collagen (Paragraph 0037 and Paragraph 0041).
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patch material of Trenhaile using the materials as taught by Cook, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07). In this case, the collagen is a known material, as evidence by Cook, to be suited to be used as a patch material.
Regarding Claim 10, the combination of references disclosed above teaches the system of claim 1 wherein Trenhaile teaches the expandable member (122/124) is configured to urge the patch toward the tissue after placement in or on the patient (Paragraph 0032-0033).
Regarding Claim 11, the combination of references disclosed above teaches the system of claim 1 wherein the expandable member (122/124) is formed to progressively degrade within the patient (Paragraph 0035).
Regarding Claim 12, the combination of references disclosed above teaches the system of claim 11 wherein Trenhaile teaches the patch is configured to integrate with the tissue faster than the expandable member degrades within the patient (Paragraph 0025 states the patch is an allograft and Paragraph 0035 states that the expandable member is cornstarch and thus it’s the Examiner’s position that the patch is configured to integrate with tissue and the expandable member degrades within the patient over time, however the patch integration with tissue will occur upon delivery to the tissue in the absence of any immune response).
Regarding Claim 13, the combination of references disclosed above teaches the system of claim 1 wherein Trenhaile teaches the patch forms a patch longitudinal axis (Figure 2) and Cook teaches the patch forms a patch longitudinal axis and the expandable member forms a second suture channel (105b) generally parallel to the patch longitudinal axis (Figure 1B).
Regarding Claim 14, the combination of references disclosed above teaches the system of claim 1 wherein Trenhaile the expandable member (122/124) has an interior volume (124) configured to receive a drug for elution into the patient (Paragraph 0033; the Examiner notes that the drug is not positively recited in the claims and the inflatable chamber does have an interior volume configured to receive a drug that is in liquid form).
Regarding Claim 16, the combination of references disclosed above teaches the system of claim 1 wherein Trenhaile teaches the expandable member (122/124) is at least partly encapsulated within the patch (as shown in Figure 3 in the delivery state).
Regarding Claim 17, the combination of references disclosed above teaches the system of claim 1 wherein Trenhaile teaches the expandable member (122/124) is integrated with the patch (Paragraph 0031; wherein the patch is integrated into the expandable member via sutures).
Should Applicant disagree with the interpretation of “integrated”, the Examiner notes that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the expandable member and patch of Trenhaile to be integrated since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding Claim 18, the combination of references disclosed above teaches the system of claim 1 wherein Trenhaile teaches the expandable member (122/124) is separate and mechanically connected to the patch (Paragraph 0031; the patch is attached to the expandable member via sutures).
Regarding Claim 19, Trenhaile teaches a system for surgically augmenting tissue of a patient, the system comprising:
a scaffold portion (patch and pad 122; Figure 2) comprising scaffold material (allopathic patch; Paragraph 0025) that progressively integrates with tissue of the patient (Paragraphs 0002-0003, 0005, 0025, and 0043 state that the patch is an allograft patch), the scaffold portion (patch) defining a first longitudinal axis (Figure 2; longitudinal axis is parallel element 126); and
an expandable portion (124) configured to urge the scaffold portion (patch) toward the tissue after placement in or on the patient (Paragraph 0033), the expandable portion (124) defining a second longitudinal axis (longitudinal axis is parallel with element 126; Figure 2),
the scaffold portion (patch and pad 122) and expandable portion (124) being associated to form a repair matrix having an interior (Paragraph 0030, wherein the interior is the inflatable chamber); and
While Trenhaile discloses the use of sutures (sutures Figure 2 to attach the patch (patch; Figure 2) and expandable member (124; Figure 2; see also Figures 5-7; Paragraph 0031-0032, 0034-0035), Trenhaile fails to explicitly teach:
at least one suture channel extending through the interior of the repair matrix in a direction generally parallel to one or both the first and second longitudinal axes,
each at least one suture channel having two open ends sized and configured to receive and pass a suture.
Cook teaches a system for surgically augmenting tissue of a patient (abstract) comprising a patch (50; Figure 1; Paragraph 0025), a pad portion (30) having a border (45), at least one suture channel (105a and 105b) extending through the border/interior of the repair matrix (45; Figures 1B-1C; Paragraph 0025) in a direction generally parallel to the longitudinal axis (55; Figure 1B), each at least one suture channel (105a and 105b) having a first end (near reference number 105a in Figure 1B) and a second end (opposite reference number 105a in Figure 1B) sized and configured to receive and pass a suture (75) therethrough (Paragraph 0025).
It would have been obvious to one of ordinary skill in the art to modify the teachings of Trenhaile such that the expandable portions comprise a suture channel extending in a direction generally parallel to the longitudinal axis of the expandable member, as taught by Cook, for the advantage of providing a passageway to protect the sutures from being caught on tissue and such that the sutures can transmit anchoring forces throughout the entire length of the medical implant.
The combination of references further fail to explicitly teach wherein the suture channel extends through the expandable member.
Kim teaches an implantable medical device (abstract; Figure 38) in which an expandable member (10; Figure 38) having an inflation valve (12; Figure 38) for inflating the expandable member (10; Paragraph 0220; Figure 38), and further comprising a suture channel (12a) that extends through the expandable device (10) to allow a suture (59) to be passed through for the purposes to anchoring the expandable member to tissue (Paragraph 0220), the suture channel (12a) extending from a first end (58a; Figure 38) to a second end (58b; Figure 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references disclosed above such that the suture channel extends through the expandable member, as taught by Kim, since it known that expandable/inflatable structures can have suture channels for the purpose of anchoring, which the same purpose of both Trenhaile and Cook.
Regarding Claim 20, the combination of references disclosed above teaches the system of claim 19 wherein the combination of references would result in the at least one suture channel (105a and 105b; as taught by Cook in Figure 1B) extends through the expandable portion (124; Figure 2 of Trenhaile).
Regarding Claim 21, the combination of references disclosed above teaches the system of claim 19 wherein Cook teaches the at least one suture channel extends through the scaffold portion (as seen in Figure 5 and 6 of Cook in which the sutures extend through the pad portion; 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the placement of the suture channel along any portion of the repair matrix for the advantage of providing optimal suturing of the patch to tissue and since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950).
Regarding Claim 22, the combination of references disclosed above teaches the system of claim 19 where Cook teaches the repair matrix has a first edge and a second edge, the at least one suture channel (105a and 105B) extending between and through the first edge and the second edge (as shown in Figures 1B-1C).
Regarding Claim 23, the combination of references disclosed above teaches the system of claim 19 wherein Cook teaches the at least one suture channel (105) is configured to completely encapsulate a suture (75) across the repair matrix (as shown in Figure 1C).
Regarding Claim 25, the combination of references disclose teaches the system of claim 19 wherein Cook teaches the at least one suture channel (105a and 105b) extends at least halfway across the repair matrix (30; Figure 1B; Paragraph 0025).
Regarding Claim 26, the combination of references disclosed above teaches the system of claim 19 wherein Trenhaile the scaffold portion (122 and the patch) forms a first footprint and the expandable portion (124) forms a second footprint, the first footprint being greater than the second footprint (the area encompassed by 122 and the patch is a greater area than that formed by expandable portion 124; Figure 2).
Regarding Claim 27, the combination of references disclosed above teaches the system of claim 19 wherein Trenhaile teaches the expandable portion (124) comprises a balloon having an interior for receiving an inflating fluid (Paragraph 0033).
Regarding Claim 28, the combination of references disclosed above teaches the system of claim 19 wherein Trenhaile the expandable portion (124) is formed to progressively degrade within the patient (Paragraph 0035).
Regarding Claim 29, the combination teaches the system of claim 28 wherein Trenhaile teaches the scaffold portion (122 and patch) is configured to integrate with the tissue faster than the expandable portion (124) degrades within the patient (Paragraph 0025 states the patch is an allograft and Paragraph 0035 states that the expandable member is cornstarch and thus it’s the Examiner’s position that the patch is configured to integrate with tissue and the expandable member degrades within the patient over time, however the patch integration with tissue will occur upon delivery to the tissue in the absence of any immune response).
Regarding Claim 31, the combination of references disclosed above teaches the system of claim 19 wherein Trenhaile the expandable member (122/124) has an interior volume (124) configured to receive a drug for elution into the patient (Paragraph 0033; the Examiner notes that the drug is not positively recited in the claims and the inflatable chamber does have an interior volume configured to receive a drug that is in liquid form).
Regarding Claim 33, the combination of references disclosed above teaches the system of claim 19 wherein Trenhaile teaches the scaffold portion (122 and Patch) comprises a patch forming a first layer (Paragraph 0031; Figure 2), further wherein the expandable portion (124) comprises a balloon forming a second layer (Paragraph 0031; Figure 2), the first and second layers being mechanically coupled (Paragraph 0031), but Trenhaile fails to explicitly teach the patch material comprises collagen.
Cook teaches wherein the patch material comprises collagen (Paragraph 0037 and Paragraph 0041).
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patch material of Trenhaile using the materials as taught by Cook, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07). In this case, the collagen is a known material, as evidence by Cook, to be suited to be used as a patch material.
Regarding Claim 34, the combination of references disclosed above teaches the system of claim 19 wherein Trenhaile teaches the scaffold portion (122 and Patch) comprises a patch forming a first layer (Paragraph 0031; Figure 2), further wherein the expandable portion (124) comprises a balloon forming a second layer (Paragraph 0031; Figure 2), the first and second layers being mechanically coupled and thus integrated (Paragraph 0031), but Trenhaile fails to explicitly teach the patch material comprises collagen.
Cook teaches wherein the patch material comprises collagen (Paragraph 0037 and Paragraph 0041).
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patch material of Trenhaile using the materials as taught by Cook, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07). In this case, the collagen is a known material, as evidence by Cook, to be suited to be used as a patch material.
Should Applicant disagree with the interpretation of “integrated”, the Examiner notes that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the expandable member and patch of Trenhaile to be integrated since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding Claim 35, the combination of references disclosed above teaches the system of claim 19 wherein Trenhaile teaches the expandable portion (124) is at least partly encapsulated within the scaffold portion (patch; Figure 3; during delivery in the cannula).
Regarding Claim 36, the combination of references disclosed above teaches the system of claim 19 further wherein Trenhaile teaches the expandable portion (124) comprises means (126) for receiving a fluid (Figure 2; Paragraph 0033).
Regarding Claim 37, Trenhaile teaches a system for surgically augmenting tissue of a patient, the system comprising:
a scaffold portion (122 and patch; Figure 2) comprising scaffold material that progressively integrates with tissue of the patient (Paragraph 0035);
an expandable portion (124) configured to urge the scaffold portion (122 and patch) toward the tissue after placement in or on the patient (Paragraph 0033), the expandable portion (124) defining a top surface, a bottom surface, and at least one side surface, the top and bottom surfaces defining a thickness of the expandable portion (124), the expandable portion also having two edges (as seen in Figure 2 which is the top view);
While Trenhaile discloses the use of sutures (sutures Figure 2 to attach the patch (patch; Figure 2) and expandable member (124; Figure 2; see also Figures 5-7; Paragraph 0031-0032, 0034-0035) and to tissue (as seen in Figure 1), Trenhaile fails to explicitly teach:
at least one suture channel extending at least in part through the thickness of the expandable portion between the top and bottom surfaces of the expandable portion, the
at least one suture channel being at least in part within the thickness of the expandable portion, the at least one suture channel terminating approximately at or between a) two edges or b) one of the edges and no more than one of the surfaces of the expandable portion, the at least one suture channel being generally straight, each at least one suture channel having two open ends sized and configured to receive and pass a suture.
Cook teaches a system for surgically augmenting tissue of a patient (abstract) comprising a patch (50; Figure 1; Paragraph 0025), a pad portion (30) having a border (45), at least one suture channel (105a and 105b) extending through the thickness of border of the repair matrix (45; Figures 1B-1C; Paragraph 0025; which is comparable to the expandable portion taught by Trenhaile) between a top surface and a bottom surface of the border (Figure 1C), at least one suture channel (105a and 105b) being at least in part within the thickness of the border portion (Figure 1C), the at least one suture channel (105a and 105b) terminating approximately at or between a) two edges or b) one of the edges and no more than one of the surfaces of the border portion (Figure 1B), the at least one suture channel (105a and 105b) being generally straight (Figure 1B), each at least one suture channel (105a and 105b) having two open ends sized and configured to receive and pass a suture (Figure 1B; Paragraph 0025).
It would have been obvious to one of ordinary skill in the art to modify the teachings of Trenhaile such that the expandable portions comprise a suture channel extending in a direction generally parallel to the longitudinal axis of the expandable member, as taught by Cook, for the advantage of providing a passageway to protect the sutures from being caught on tissue and such that the sutures can transmit anchoring forces throughout the entire length of the medical implant.
The combination of references further fail to explicitly teach wherein the suture channel extends through the expandable member.
Kim teaches an implantable medical device (abstract; Figure 38) in which an expandable member (10; Figure 38) having an inflation valve (12; Figure 38) for inflating the expandable member (10; Paragraph 0220; Figure 38), and further comprising a suture channel (12a) that extends through the expandable device (10) to allow a suture (59) to be passed through for the purposes to anchoring the expandable member to tissue (Paragraph 0220), the suture channel (12a) extending from a first end (58a; Figure 38) to a second end (58b; Figure 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references disclosed above such that the suture channel extends through the expandable member, as taught by Kim, since it known that expandable/inflatable structures can have suture channels for the purpose of anchoring, which the same purpose of both Trenhaile and Cook.
Regarding Claim 38, the combination of references disclosed above teaches the system of claim 37 wherein Trenhaile teaches the expandable portion (124) defines a longitudinal axis between medial and lateral edges of the expandable portion (as shown in Figure 2, wherein the longitudinal axis is parallel with element 126)), and Cook teaches the at least one suture channel (105a and 105b) being substantially parallel with the longitudinal axis (55; as shown in Figure 1A).
Regarding Claim 39, the combination of references disclosed above teaches the system of claim 37 wherein Cook teaches the scaffold portion comprises a collagen patch.
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patch material of Trenhaile using the materials as taught by Cook, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 40, the combination of references disclosed above teaches the system of claim 37 wherein Trenhaile teaches the expandable portion (124) comprises a balloon (Paragraph 0030).
Regarding Claim 41, the combination of references disclosed above teaches the system of claim 37 wherein Trenhaile teaches the expandable portion (124) is formed to progressively degrade within the patient (Paragraph 0035).
Regarding Claim 42, the combination of references disclosed above teaches the system of claim 41 wherein Trenhaile teaches the scaffold portion (patch portion) is configured to integrate with the tissue faster than the expandable portion (124) degrades within the patient (Paragraph 0025 states the patch is an allograft and Paragraph 0035 states that the expandable member is cornstarch and thus it’s the Examiner’s position that the patch is configured to integrate with tissue and the expandable member degrades within the patient over time, however the patch integration with tissue will occur upon delivery to the tissue in the absence of any immune response)
Regarding Claim 43, the combination of references disclosed above teaches the system of claim 37 wherein Trenhaile teaches the expandable portion (124) defines a longitudinal axis (parallel with element 126), and Cook teaches the at least one suture channel (105a and 105b) not being normal (are parallel) to the longitudinal axis (55). Thus the combination of references teach the claim limitations as presented.
Regarding Claim 44, Trenhaile teaches a surgical expandable member comprising:
an expandable portion (122/124) defining a top surface, a bottom surface, and at least one side surface, the top and bottom surfaces defining a thickness of the expandable portion, the expandable portion (122/124) also having two edges (as seen in Figure 2 in a top view, where one is seeing the top surface, the side surface is the two short sides, the two edges are the two long sides in Figure 2);
Trenhaile fails to disclose:
at least one suture channel extending through the interior of the expandable portion between the top and bottom surfaces of the expandable portion, the at least one suture channel being at least in part within the thickness of the expandable portion, the at least one suture channel terminating approximately at or between a) two edges or b) one of the edges and no more than one of the surfaces of the expandable portion,
each at least one suture channel having two open ends sized and configured to receive and pass a suture.
Cook teaches a system for surgically augmenting tissue of a patient (abstract) comprising a patch (50; Figure 1; Paragraph 0025), a pad portion (30) having a border (45), a suture channel (105) extending through the border (45; Figures 1B-1C; Paragraph 0025) in a direction generally parallel to the longitudinal axis (55; Figure 1B), the suture channel (105) having a first end (near reference number 105a in Figure 1B) and a second end (opposite reference number 105a in Figure 1B) sized and configured to receive and pass a suture (75) therethrough (Paragraph 0025).
It would have been obvious to one of ordinary skill in the art to modify the teachings of Trenhaile such that the expandable portions comprise a suture channel sized and configured to pass a suture, as taught by Cook, for the advantage of providing a passageway that creates a tight-fit or friction fit with the sutures to prevent excessive movement of strands relative to the body of the patch (Paragraph 0025).
Regarding Claim 45, the combination of references disclosed above teaches the surgical expandable member of claim 44 wherein Trenhaile teaches an allograft patch (Patch; Figure 2; Paragraph 0025) but fails to disclose the patch comprises collagen.
Cook teaches wherein the patch material comprises collagen (Paragraph 0037 and Paragraph 0041).
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patch material of Trenhaile using the materials as taught by Cook, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 47, the combination of references disclosed above teaches the surgical expandable member of claim 44 wherein Cook teaches the at least one suture channel (105a and 105b) is generally straight (Figure 1B; Paragraph 0025).
Regarding Claim 48, the combination of references disclosed above teaches the surgical expandable member of claim 44 wherein Cook teaches the at least one suture channel (105a and 105b) traverses across one or both the top and bottom surfaces (as seen in Figure 1B and 1C the suture channel transverses across the top surface).
Claim(s) 4, 5, 30 and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile (US PGPub 2009/0156997) in view of Cook (US PGPub 2024/0108325) and Kim (US PGPub 2007/0250020) as applied to claims 1, 4, 19, and 44 above, and further in view of Gallagher (GB 2,293,975).
Regarding Claim 4, 5, 30, and 46, the combination of references disclosed above teaches the system of claim 1, 19, and 44 but fails to explicitly state wherein the expandable member comprises pillow valve.
Gallagher teaches a self-sealing pillow valve for use in inflatable and implantable devices (see abstract) comprising an inflatable cavity (8/9) and a pillow valve (11 and 12) (Figures 1-2) for inflating the cavity (9).
Therefore, it is the Examiner' s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute valve taught by Trenhaile with self-sealing pillow valve as taught by Gallagher since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the valve of Gallagher would be sufficient to provide selective inflation to the expandable member of Trenhaile.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile (US PGPub 2009/0156997) in view of Cook (US PGPub 2024/0108325) and Kim (US PGPub 2007/0250020) as applied to claim 1 above, and further in view of Myers (US PGPub 2021/0338886)
Regarding Claim 6, the combination of references disclosed above teaches the system of claim 1 but fails to disclose wherein the suture channel extends at least halfway across a longest dimension of the expandable member.
Myers teaches a collagen device for tissue repair which has a plurality of suture channels (102) that extend fully along the longest dimension of the patch (100; as seen in Figures 10-11).
It would have been obvious to one of ordinary skill in the art to modify the combination of references such that the suture channels extend along the longest dimension of the patch, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950). In this case, the suture channels would be on the longest dimension rather than the shorter dimension which would be advantageous in treating tissue that has a longer repair site, rather than a wider repair site.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile (US PGPub 2009/0156997) in view of Cook (US PGPub 2024/0108325) and Kim (US PGPub 2007/0250020) as applied to claim 1 above, and further in view of Adams (US PGPub 2008/0065229).
Regarding Claim 7, the combination of references disclosed above teaches the system of claim 1 wherein the expandable member is tufted in at least one location.
Adams teaches an inflatable patch for repairing an intra-abdominal defect (abstract) comprising an patch (12) and an expandable member (16/18) (Paragraph 0041-0042; Figures 1 and Figure 4), wherein the expandable member is tufted (see Figures 8-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the expandable member of Trenhaile, to include the tufted teachings of Adams for the advantage of providing rigidity to the patch (Paragraph 0054-0056)
Claim(s) 15 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile (US PGPub 2009/0156997) in view of Cook (US PGPub 2024/0108325) and Kim (US PGPub 2007/0250020) as applied to claims 1 and 13 above, and further in view of Keane (US PGPub 2025/0205032; which has Foreign Application Priority to 03/21/2022 (WO 2023/180259).
Regarding Claim 15 and 32,the combination of references disclosed above teaches the system of claim 1 and 19, but fails to disclose further comprising a sensor associated with the patch/repair matrix, the sensor configured to collect patient data.
Keane teaches an anatomical defect repair matrix mesh (abstract) comprising sensors to monitor one or more parameters such monitoring pressure at the anatomical site, monitoring for biomarkers or other signs of disease or infection, or any other useful parameter or bio sign (Paragraph 0085).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mesh/patch/repair matrix taught by Trenhaile, to include a sensor for collecting patient data, as taught by Keane, for the advantage of monitoring the patient to make sure the procedure is successful (Paragraph 0085; Keane).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile (US PGPub 2009/0156997) in view of Cook (US PGPub 2024/0108325) and Kim (US PGPub 2007/0250020) as applied to claim 19 above, and further in view of Whittaker (US PGPub 2020/0000573)
Regarding Claim 24, the combination of references disclosed above teaches the system of claim 19 wherein Trenhaile and Cook, each, teach the repair matrix forms a generally planar surface (120; Figure 2; Trenhaile) (5; Figure 1B; Cook), but fails to disclose the at least one suture channel having one or more open portions to the generally planar surface.
Whittaker teaches an soft tissue repair implant (abstract) comprising an a patch/repair matrix (2410a; Figure 34A-34B; Paragraph 0376) having a plurality of suture channels (2470a and 2470b; Figures 34A-34B; Paragraph 0376) wherein the at least one suture channel having one or more open portions (ends) to the generally planar surface (the top surface of the patch/repair matrix). (see also Figures 35A-35B, elements 2570A-2570B; see Figures 36A-36B, elements 2612a and 2616a).
It would have been obvious to one of ordinary skill in the art to modify the suture channels taught by Cook, such that they were segmented and/or shorter than the generally planar surface, as taught by Whittaker for the advantage that the break in the suture channel allows the suture to be deployed through the patch/repair matrix in a central location and to be attached to the underlying tissue (Paragraph 0376; Whittaker)
Conclusion
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771