DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 14 September 2025. Claims 1-20 are now pending. The Examiner acknowledges the amendments to claims 1, 2, 3, 4, 5, 6, 7, 11, 14, 17.
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, 6, 7, 10, 13, 14, 17 are objected to because of the following informalities:
-Claim 1 recites “portion of the second layer wherein” in lines 13-14. Examiner recommends amending to –portion of the second layer, wherein—
-Claim 4 recites “wherein the top surface” in lines 6. Examiner recommends amending to –and wherein the top surface—
-Claim 6 recites “wherein outer portion” in line 1. Examiner recommends amending to –wherein the outer portion—
-Claim 7 recites “plane parallel” in line 6-7. Examiner recommends amending to –plane that is parallel—
-Claim 10 recites “the connection between the first layer and the second layer” in line 4. Examiner recommends amending to –the connection between the bottom surface of the first layer and the top surface of the second layer—as originally presented in claim 3.
-Claim 13 recites “wherein an area” in line 4. Examiner recommends amending to –and wherein an area—
-Claim 14 recites “wherein the top surface” in line 4. Examiner recommends amending to –and wherein the top surface—
-Claim 17 recites “position the edge” in line 4. Examiner recommends amending to –position, the edge—
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 12 reference “an unconnected annular region” in lines 22-23 and 23-24, respectively.
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 1-10 and 11-20 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 1 recites “the inner portion of the top surface” in lines 15-16. There is insufficient antecedent basis for this limitation in the claim.
-Claim 1 recites “the top layer” in line 16. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether this is referring to the first layer or the top surface.
-Claim 1 recites “the outer portions of the first and second layers surrounding the inner portions” in line 21. There is insufficient antecedent basis for this limitation in the claim. Preceding claim language does not introduce any aspect of the first and second layer outer portions surround the inner portions.
-Claim 9 recites “the body” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 11 recites “the top layer” in line 17. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether this is referring to the first layer or the top surface.
-Claim 11 recites “the outer “the outer portions of the first and second layers surrounding the inner portions” in line 22. There is insufficient antecedent basis for this limitation in the claim. Preceding claim language does not introduce any aspect of the first and second layer outer portions surround this inner layers.
-Claim 13 recites “the connection” in line 4. There is insufficient antecedent basis for this limitation in the claim.
-Claim 19 recites “the body” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 4-9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 4 recites “the outer portion thereof is adjacent to an outer surface of the dura mater” in lines 3-4, and “the outer portion thereof is adjacent to an inner surface of the dura mater” in lines 6-7 which is directed towards human subject matter. Examiner recommends amending this to:
–the outer portion thereof is configured to be positioned adjacent to an outer surface of the dura mater— and,
–the outer portion thereof is configured to be positioned adjacent to an inner surface of the dura mater—
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, 2, 3, 10, 11, 12, 13, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gingras (U.S. 20060141012).
Regarding Claim 1, Gingras teaches a surgical implant for repairing a defect in a dura mater [0123]—reference to repairing a defect with the dura listed as one of the potential anatomical areas of application, the implant comprising: a first layer having a top surface and a bottom surface [See annotated Fig. 1E below], the first layer being flexible and planar [0112]—reference to pliability of the scaffold, and Fig. 1E showing flat superficial shape of the layers, the first layer having an edge extending between the top surface of the first layer and the bottom surface of the first layer about a periphery of the first layer, the first layer having an inner portion remote from the periphery of the first layer [See annotated Fig. 1E below], the first layer having an outer portion between the periphery of the first layer and the inner portion of the first layer [Fig. 1F, element 10]—where interstices interconnecting the pores of the scaffold are interpreted to be the outer portion between the periphery (edge) of the first layer and inner portion (pores) making up the structure of the first layer;
a second layer having a top surface and a bottom surface [See annotated Fig. 1E below], the second layer being flexible and planar [0112]—reference to pliability of the scaffold, and Fig. 1E showing flat superficial shape of the layers, the second layer having an edge extending between the top surface of the second layer and the bottom surface of the second layer about a periphery of the second layer, the second layer having an inner portion remote from the periphery of the second layer [See annotated Fig. 1E below], the second layer having an outer portion between the periphery of the second layer and the inner portion of the second layer [Fig. 1F, element 18]—where interstices interconnecting the pores of the scaffold are interpreted to be the outer portion between the periphery (edge) of the second layer and inner portion (pores) making up the structure of the second layer;
wherein the bottom surface of the first layer proximate to the inner portion of the first layer thereof is connected to the top surface of the second layer proximate to the inner portion of the top surface thereof [Fig. 1G] so that the inner portion of the top layer is fixed relative to the inner portion of the second layer [0120]—reference to alignment of pores, and the outer portion of the first layer is moveable relative to the outer portion of the second layer so that the inner portion of the first layer is fixed relative to the inner portion of the second layer [0019]—describes first and second layers attaching so cell openings interconnect to define pathways, and the outer portion of the first layer is moveable relative to the outer portion of the second layer [Fig. 3L, element 90 (outer portion of first layer)] and [0127]—reference to outer section containing holes, 90, being removed from the scaffold;
wherein the outer portions of the first and second layers surrounding the inner portions are not connected to one another and are separated from one another to define an unconnected annular region between the outer portions [See annotated Fig. 1J], the unconnected annular region being configured to abut tissue surrounding the defect when the surgical implant is positioned in the defect in the dura mater [0013]—references surfaces of the scaffold contacting tissue and [0123]—for specific reference to contacting the dura.
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Regarding Claim 2, Gingras teaches wherein the first layer comprises a collagen-based graft material, and wherein the second layer comprises a collagen-based graft material [0114]—reference to the scaffold and layers of the scaffold including collagen.
Regarding Claim 3, Gingras teaches wherein an area of a connection between the bottom surface of the first layer and the top surface of the second layer is less than or equal to an area of the defect [0100; “the scaffold provides… microstructural variations in the structure across one or more dimensions that may mimic the anatomical features of the tissue. The cross sectional area… the regions with an increased cross sectional area would degrade at a slower rate.”]
Regarding Claim 10, Gingras teaches further comprising: a third layer having a top surface and a bottom surface, the third layer being flexible and planar [0112]—reference to pliability of the scaffold, and Fig. 1H showing flat superficial shape of the layers, the third layer being disposed between the first layer and the second layer, the third layer forming at least in part the connection between the first layer and the second layer [See annotated Fig. 1H below].
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Regarding Claim 11, Gingras teaches a method for repairing a defect in a dura mater in a mammal [0123]—reference to repairing a defect with the dura listed as one of the potential anatomical areas of application and [0016]—reference to application in mammals, the method comprising: applying a surgical implant to the defect [0123], wherein the surgical implant comprises: a first layer having a top surface and a bottom surface [See annotated Fig. 1E below], the first layer being flexible and planar [0112]—reference to pliability of the scaffold, and Fig. 1E showing flat superficial shape of the layers, the first layer having an edge extending between the top surface of the first layer and the bottom surface of the first layer about a periphery of the first layer, the first layer having an inner portion remote from the periphery of the first layer [See annotated Fig. 1E below], the first layer having an outer portion between the periphery of the first layer and the inner portion of the first layer [Fig. 1F, element 10]—where interstices interconnecting the pores of the scaffold are interpreted to be the outer portion between the periphery (edge) of the first layer and inner portion (pores) making up the structure of the first layer;
a second layer having a top surface and a bottom surface [See annotated Fig. 1E below], the second layer being flexible and planar [0112]—reference to pliability of the scaffold, and Fig. 1E showing flat superficial shape of the layers, the second layer having an edge extending between the top surface of the second layer and the bottom surface of the second layer about a periphery of the second layer, the second layer having an inner portion remote from the periphery of the second layer [See annotated Fig. 1E below], the second layer having an outer portion between the periphery of the second layer and the inner portion of the second layer [Fig. 1F, element 18]—where interstices interconnecting the pores of the scaffold are interpreted to be the outer portion between the periphery (edge) of the second layer and inner portion (pores) making up the structure of the second layer;
wherein the bottom surface of the first layer proximate to the inner portion thereof is connected to the top surface of the second layer proximate to the inner portion thereof [Fig. 1G] so that the inner portion of the top layer is fixed relative to the inner portion of the second layer [0120]—reference to alignment of pores, and the outer portion of the first layer is moveable relative to the outer portion of the second layer so that the inner portion of the first layer is fixed relative to the inner portion of the second layer [0019]—describes first and second layers attaching so cell openings interconnect to define pathways, and the outer portion of the first layer is moveable relative to the outer portion of the second layer [Fig. 3L, element 90 (outer portion of first layer)] and [0127]—reference to outer section containing holes, 90, being removed from the scaffold;
and wherein the outer portions of the first and second layers surrounding the inner portions are not connected to one another and are separated from one another to define an unconnected annular region between the outer portions [See annotated Fig. 1J], the unconnected annular region being configured to abut tissue surrounding the defect when the surgical implant is positioned in the defect in the dura mater [0013]—references surfaces of the scaffold contacting tissue and [0123]—for specific reference to contacting the dura.
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Regarding Claim 12, Gingras teaches wherein the first layer comprises a collagen-based graft material, and wherein the second layer comprises a collagen-based graft material [0114]—reference to the scaffold and layers of the scaffold including collagen.
Regarding Claim 13, Gingras teaches wherein the defect is in a spinal dura mater of the mammal [0016];
wherein the defect in the spinal dura mater has a defect area [0123],
wherein an area of the connection between the bottom surface of the first layer and the top surface of the second layer is less than or equal to the defect area [0100; “the scaffold provides… microstructural variations in the structure across one or more dimensions that may mimic the anatomical features of the tissue. The cross sectional area… the regions with an increased cross sectional area would degrade at a slower rate.”]
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) 4, 5, 6, 14, 15, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gingras (U.S. 20060141012) in view of Papanna (U.S. 20200016296).
Regarding Claim 4, Gingras teaches wherein the defect is in a dura mater [0123];
Gingras is silent on wherein the bottom surface of the first layer proximate to the outer portion thereof is adjacent to an outer surface of the spinal dura mater proximate to the defect therein when the surgical implant is received in the defect, wherein the top surface of the second layer proximate to the outer portion thereof is adjacent to an inner surface of the spinal dura mater proximate to the defect therein when the surgical implant is received in the defect. Papanna teaches wherein the bottom surface of the first layer proximate to the outer portion thereof is adjacent to an outer surface of the dura mater proximate to the defect therein when the surgical implant is received in the defect, [Fig. 1, element 10 (patch), 14 (inner surface), 16 (outer surface)], DM (dura), SK (skin)]
wherein the top surface of the second layer proximate to the outer portion thereof is adjacent to an inner surface of the dura mater proximate to the defect therein when the surgical implant is received in the defect [0019]—describes patch surface, 14 facing inward towards the spinal cord, with further reference to the reverse configuration with element 16 facing the spinal cord and 14 facing the skin.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the configuration of the implant in reference to the dura mater as taught by Papanna to repair a defect in the dura mater as suggested by Gingras, as Gingras discusses the promotion of tissue ingrowth [0098] and Papanna teaches cells associate with the anatomical area of interest attaching to the surfaces of the patch [0019].
Regarding Claim 5, Gingras is silent on wherein the edge of the second layer extends at least to the edge of the first layer when the surgical implant is received in the defect in the spinal dura mater so that the outer portion of the second layer inhibits a damage to arachnoid mater below the dura mater resulting from a suturing of the outer portion of the first layer and the dura mater. Papanna teaches wherein the edge of the second layer extends at least to the edge of the first layer when the surgical implant is received in the defect in the spinal dura mater so that the outer portion of the second layer inhibits a damage to arachnoid mater below the dura mater resulting from a suturing of the outer portion of the first layer and the dura mater [See annotated Fig. 1 below] and [0018]—reference to suturing the patch to the arachnoid layer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to secure the implant to the dura mater as taught by Papanna to repair a defect in the dura mater as suggested by Gingras, as Gingras includes attachment regions to receive sutures [0120] and Papanna teaches resulting tethering injury that can result from improper tethering procedures [0003-0004].
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Regarding Claim 6, Gingras further teaches wherein outer portion of the first layer of the implant is fixed relative to the dura mater with a suture between the outer portion of the first layer and the dura mater proximate to the defect [0014]—reference to attachment regions and [0120].
Regarding Claim 14, Gingras is silent on wherein the bottom surface of the first layer proximate to the outer portion thereof is adjacent to an outer surface of the spinal dura mater proximate to the defect therein when the surgical implant is received in the defect, wherein the top surface of the second layer proximate to the outer portion thereof is adjacent to an inner surface of the spinal dura mater proximate to the defect therein when the implant is received in the defect. Papanna teaches wherein the bottom surface of the first layer proximate to the outer portion thereof is adjacent to an outer surface of the spinal dura mater proximate to the defect therein when the surgical implant is received in the defect, [Fig. 1, element 10 (patch), 14 (inner surface), 16 (outer surface)], DM (dura), SK (skin)]
wherein the top surface of the second layer proximate to the outer portion thereof is adjacent to an inner surface of the spinal dura mater proximate to the defect therein when the implant is received in the defect [0019]—describes patch surface, 14 facing inward towards the spinal cord, with further reference to the reverse configuration with element 16 facing the spinal cord and 14 facing the skin.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the configuration of the implant in reference to the dura mater as taught by Papanna to repair a defect in the dura mater as suggested by Gingras, as Gingras discusses the promotion of tissue ingrowth [0098] and Papanna teaches cells associate with the anatomical area of interest attaching to the surfaces of the patch [0019].
Regarding Claim 15, Gingras further teaches further comprising the step of: suturing the outer portion of the first layer of the implant to the spinal dura mater proximate to the defect [0014]—reference to attachment regions and [0120].
Regarding Claim 16, Gingras is silent on wherein the edge of the second layer extends at least to the edge of the first layer when the surgical implant is received in the defect in the spinal dura mater so that the outer portion of the second layer inhibits a damage to an arachnoid mater below the dura mater resulting from a suturing of the outer portion of the first layer and the dura mater. Papanna teaches wherein the edge of the second layer extends at least to the edge of the first layer when the surgical implant is received in the defect in the spinal dura mater so that the outer portion of the second layer inhibits a damage to an arachnoid mater below the dura mater resulting from a suturing of the outer portion of the first layer and the dura mater [See annotated Fig. 1 below] and [0018]—reference to suturing the patch to the arachnoid layer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to secure the implant to the dura mater as taught by Papanna to repair a defect in the dura mater as suggested by Gingras, as Gingras includes attachment regions to receive sutures [0120] and Papanna teaches resulting tethering injury that can result from improper tethering procedures [0003-0004].
Claim(s) 7, 8, 9, 17, 18, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gingras (U.S. 20060141012) in view of Papanna (U.S. 20200016296) in further view of Ringeisen (U.S. 20100278891).
Regarding Claim 7, Gingras and Papanna are silent on wherein the second layer is biasable between a retracted position and an extended position, wherein in the retracted position the edge of the second layer about the periphery thereof is drawn together under the inner portion of the second layer thereby facilitating receipt of the second layer through the defect, wherein in the extended position the second layer extends in a plane parallel to the defect. Ringeisen teaches wherein the second layer is biasable between a retracted position and an extended position, [0029]—reference to contraction and stretching of the structure.
wherein in the retracted position the edge of the second layer about the periphery thereof is drawn together under the inner portion of the second layer thereby facilitating receipt of the second layer through the defect [0127]—reference to compression of the pores to lengthen overall structure of the cylinder and [0034]—reference to repair of dura defects,
wherein in the extended position the second layer extends in a plane parallel to the defect [Figs. 2A-2D, elements 200, 240, 260 and 290 (second layer)]-shows the layer extending in a parallel plane.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an adjustment means to adjust the implant as taught by Ringeisen to prepare the implant in reference to the repair a defect in the dura mater as suggested by Gingras, as Gingras discusses axially orienting the layers of film to one another [0006]; Papanna discloses orienting the patch in reference to the anatomy of the patient [0033] and Ringeisen teaches arranging the structure and orientation to be suitable for use as a spinal implant [0142].
Regarding Claim 8, Gingras teaches further comprising: a surgical thread received in the outer portion of the second layer about the periphery thereof [0120]—reference to attachment regions.
Gingras and Papanna are silent on wherein when the second layer is in the retracted position, the surgical thread is tensioned to maintain the second layer in the retracted state; wherein the second layer is biasable to the extended position when the tension is released from the surgical thread. Ringeisen teaches wherein when the second layer is in the retracted position, the surgical thread is tensioned to maintain the second layer in the retracted state; [0040]—discusses “suturability” of the layers of the implant in relation of mechanical integrity. The embodiment of draped and folded is interpreted to mean the retracted state of the apparatus with consideration of the tension considerations that are applied to the suture.
wherein the second layer is biasable to the extended position when the tension is released from the surgical thread [0128]—discusses forces applied in transverse direction releasing and allowing the structure to bias back to an elongated or extended form.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for varying mechanical properties of the structure by Ringeisen to incorporate into pliable material selection as well and other design considerations as suggested by Gingras, as Gingras discusses pliability of the structure [0112]; Papanna discloses tensioning considerations when tethering the structure to the spinal cord [0003] and Ringeisen teaches a pseudo-elastic memory design to allow for alignment, narrowing and lengthening of the structure [0128-0129].
Regarding Claim 9, Gingras and Papanna are silent on wherein the surgical thread is dissolvable in the body after implantation thereof. Ringeisen teaches wherein the surgical thread is dissolvable in the body after implantation thereof [0165]-reference to the microstructure being dissolved and removed. With the sutures attached to the microstructure this is interpreted as the sutures also being dissolved along with the microstructure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for solubility of the structure as taught by Ringeisen to impart an open structure during implantation as suggested by Gingras, as Gingras discusses the use of an open structure to permit tissue ingrowth [0111]; Papanna discloses closing the meningeal opening using the patch [0025] and Ringeisen teaches the creation of a more open structure of compressed porous plates [0165].
Regarding Claim 17, Gingras and Papanna are silent on wherein the second layer is biasable between a retracted position and an extended position, wherein in the retracted position the edge of the second layer about the periphery thereof is drawn together under the inner portion of the second layer thereby facilitating receipt of the second layer through the defect in the spinal dura mater, wherein in the extended position the second layer extends in a plane. Ringeisen teaches wherein the second layer is biasable between a retracted position and an extended position, [0029]—reference to contraction and stretching of the structure.
wherein in the retracted position the edge of the second layer about the periphery thereof is drawn together under the inner portion of the second layer thereby facilitating receipt of the second layer through the defect in the spinal dura mater, [0127]—reference to compression of the pores to lengthen overall structure of the cylinder and [0034]—reference to repair of dura defects,
wherein in the extended position the second layer extends in a plane [Figs. 2A-2D, elements 200, 240, 260 and 290 (second layer)]-shows the layer extending in a parallel plane.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an adjustment means to adjust the implant as taught by Ringeisen to prepare the implant in reference to the repair a defect in the dura mater as suggested by Gingras, as Gingras discusses axially orienting the layers of film to one another [0006]; Papanna wdiscloses orienting the patch in reference to the anatomy of the patient [0033] and Ringeisen teaches arranging the structure and orientation to be suitable for use as a spinal implant [0142].
Regarding Claim 18, Gingras and Papanna are silent on further comprising the step of releasing a surgical thread received in the outer portion of the second layer about the periphery thereof; wherein the releasing of the surgical thread causes the second layer to bias from the retracted position to the extended position. Ringeisen teaches further comprising the step of releasing a surgical thread received in the outer portion of the second layer about the periphery thereof; [0040]—discusses “suturability” of the layers of the implant in relation of mechanical integrity. The embodiment of draped and folded is interpreted to mean the retracted state of the apparatus with consideration of the tension considerations that are applied to the suture.
wherein the releasing of the surgical thread causes the second layer to bias from the retracted position to the extended position [0128]—discusses forces applied in transverse direction releasing and allowing the structure to bias back to an elongated or extended form.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for varying mechanical properties of the structure by Ringeisen to incorporate into pliable material selection as well and other design considerations as suggested by Gingras, as Gingras discusses pliability of the structure [0112]; Papanna discloses tensioning considerations when tethering the structure to the spinal cord [0003] and Ringeisen teaches a pseudo-elastic memory design to allow for alignment, narrowing and lengthening of the structure [0128-0129].
Regarding Claim 19, Gingras and Papanna are silent on wherein the surgical thread is dissolvable in the body after implantation thereof. Ringeisen teaches wherein the surgical thread is dissolvable in the body after implantation thereof [0165]-reference to the microstructure being dissolved and removed. With the sutures attached to the microstructure this is interpreted as the sutures also being dissolved along with the microstructure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for solubility of the structure as taught by Ringeisen to impart an open structure during implantation as suggested by Gingras, as Gingras discusses the use of an open structure to permit tissue ingrowth [0111]; Papanna discloses closing the meningeal opening using the patch [0025] and Ringeisen teaches the creation of a more open structure of compressed porous plates [0165].
Regarding Claim 20, Gingras further teaches wherein the implant further comprises: a third layer having a top surface and a bottom surface, the third layer being flexible and planar [0112]—reference to pliability of the scaffold, and Fig. 1H showing flat superficial shape of the layers, the third layer being disposed between the first layer and the second layer, the third layer forming at least in part the connection between the first layer and the second layer [See annotated Fig. 1H below].
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Response to Arguments
Applicant's arguments filed 14 September 2025 with respect to the drawings and specification objections have been fully considered and are persuasive in light of the
amendments.
Applicant's arguments filed 14 September 2025 with respect to the claim objections have been fully considered and are persuasive however, new objections in light of the amendments are presented.
Applicant's arguments filed 14 September 2025 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive however, new rejections are
presented in light of the amendments.
Applicant’s arguments filed 14 September 2025 with respect to the rejection of
claims 1-20 under 35 U.S.C.103 have been fully considered and are persuasive,
however, new rejections under 35 U.S.C. 102 and 103 are presented above in light of the amendments for claims 1-20.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791