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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/3/2026 has been entered.
Response to Arguments
Applicant's arguments filed 2/3/2026 have been fully considered but they are not persuasive. Regarding the rejection of claims 1-4, 6, 7, and 19-24 under 35 U.S.C. 103 as being unpatentable over Iflah in view of Dasnurkar, applicant argues in all of Dasnurkar’s implementations of using an energy-activated adhesive, the adhesive is light-activated and the adhesive is in direct contact with the light source/energy transmitting means. The examiner does not find support for this argument in Dasnurkar. The light is what cures the adhesive and light is transmitted from the source. There is no disclosure in Dasnurkar that the light source must be in direct contact with the adhesive.
Applicant argues it would not have been obvious to use a light applicator on one side of a fabric to cure an adhesive on the other side of the fabric and the cited art does not provide any suggestion that Dasnurkar’s light might be capable of penetrating through Iflah’s sleeve 26 or any other material sufficiently to cure an adhesive on the other side. This is not persuasive because, as applicant points out, the sleeve of Iflah comprises a braided fabric mesh comprising polyethylene terephthalate. This mesh material is the same exact material disclosed in the instant application. A mesh by definition has openings and therefore allows for the transmission of light.
Applicant argues although Dasnurkar does describe an embodiment in which an adhesive is allowed to weep out of plug 222, there is no teaching or suggestion of curing the adhesive through the material of the plug. Applicant further argues that the adhesive that weeps out is not intended to be light-curable and points to par.104 of Dasnurkar. This argument ignores that par.104 specifically goes on to state “However, light-activated adhesives could also be used where the delivery system would include a curing light, similar to the delivery systems described above”. Therefore, it is clear that Dasnurkar discloses that embodiments wherein adhesive is transmitted through openings of a device (see openings 204A in balloon 204 in fig.19 and adhesive weeping out of openings in plug 222 in fig.29) may use light-activated adhesives and a light source for curing the adhesive.
Applicant argues even if a person of ordinary skill in the art were to modify Dasnurkar’s weeping plug embodiment in view of Dasnurkar’s light-curable embodiments, the resulting system would utilize the direct-exposure approach taught by Dasnurkar – e.g. positioning the light source either (i) within the catheter to cure the adhesive as it is being introduced into the plug or (ii) between the exterior of the plug and the tissue in order to cure the adhesive that has wept out of the plug. This is not persuasive because Dasnurkar does not disclose either of (i) or (ii). Applicant did not cite any portion of Dasnurkar to support these findings and the examiner finds no support in Dasnurkar for either of these scenarios. Instead, regarding (i), Dasnurkar discloses first applying adhesive and then activating the light source. See at least par.82 which discloses “The light-activated adhesive is then delivered via syringe, through the catheter, and to the target treatment location. The light-activated adhesive is then exposed to light and cures or hardens”, and par.98 which discloses the light 180 is “subsequently” delivered to cure the adhesive. Regarding (ii), Dasnurkar does not discuss positioning a light source between the exterior of the plug and the tissue, therefore a person of ordinary skill in the art would not include such as step based on Dasnurkar.
Applicant argues a person of ordinary skill in the art would not have learned from Dasnurkar that a system can be configured to allow for adhesive-curing light to penetrate fabric sufficiently to cure an adhesive located on the other side of the fabric and would not have a reasonable expectation that combining Iflah with Dasnurkar would result in successful curing of adhesive through the braided fabric mesh. This is not persuasive because the sleeve of Iflah is a braided fabric mesh identical to the material of the instant application. A person of ordinary skill in the art would understand that mesh by definition has openings which allow for light transmission. Dasnurkar teaches a material 204 with openings 204A for the adhesive to pass through (figs.19 and 25; par.109 also discloses an embodiment where the balloon has pores and the adhesive migrates through the pores of the balloon) and teaches in par.104 that light-activated adhesives could also be used with the embodiment of fig.19, where the delivery system would include a curing light. Based on these teachings in Dasnurkar, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to deliver a light-activated adhesive through the openings in the mesh of the sleeve of Iflah, since Dasnurkar teaches delivering an adhesive through openings to adhere to the vessel wall (par.109) as well as subsequently curing the adhesive by applying energy to the adhesive from a curing device disposed at the nozzle of the adhesive-applicator (figs. 4 and 12-15 discloses a curing device at the nozzle of the adhesive-applicator for applying energy to the adhesive). Dasnurkar also generally discloses the light should be radiant enough to cure the light-activated adhesive (par.95) which would have been obvious to a person of ordinary skill in the art. As such, while applicant argues that a person of ordinary skill in the art would not have learned from Dasnurkar that a system can be configured to allow for adhesive-curing light to penetrate fabric sufficiently to cure an adhesive located on the other side of the fabric and would not have a reasonable expectation that combining Iflah with Dasnurkar would result in successful curing of adhesive through the braided fabric mesh, the examiner disagrees based on the fact that the fabric of Iflah is a mesh which allows for light transmission and a person of ordinary skill in the art would understand that the light would need to be radiant enough to cure the adhesive. MPEP 2141.03 I states “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton" and “Office personnel may also take into account the inferences and creative steps that a person of ordinary skill in the art would employ”. Since Dasnurkar teaches light-curing adhesives can be used in the embodiments wherein adhesive is passed through a material and in such a case the delivery system would include a curing light, similar to the delivery systems described elsewhere in the specification, a person of ordinary skill in the art would understand that the light would need to pass through the material, like the adhesive, in order to cure the light-curing adhesive.
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.
Claims 1-4, 6, 7, and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Iflah et al. US 2018/0049875 (hereafter referred to as Iflah) in view of Dasnurkar et al. US 2018/0338767 (hereafter referred to as Dasnurkar).
Regarding claim 1, Iflah discloses a method, comprising transcatheterally advancing, to a heart of a subject, an implant 222 and an anchor applicator 61 (figs.3A-3C), the applicator comprising an anchor 32 (fig.2), and the implant including a wall formed from a porous fabric (par.395 discloses sleeve 26 is a braided fabric mesh), the wall having an external surface, and shaped to define an interior (considered the lumen of the sleeve 222), and while a tip 38, considered a nozzle, of the anchor applicator is disposed within the interior, adhering the external surface of the wall to tissue of the heart by using the anchor applicator to apply the anchor via the tip/nozzle to the interior, such that a portion of the anchor passes through the porous fabric of the wall to the external surface (figs.3C-3G). Iflah discloses the invention substantially as claimed, but Iflah uses anchors instead of adhesive to secure the implant to tissue of the heart and does not disclose an adhesive applicator containing an adhesive or the step of adhering the external surface of the wall to tissue of the heart by using the adhesive applicator to apply the adhesive via a nozzle to the interior such that a portion of the adhesive passes through the porous fabric of the wall to the external surface and subsequently curing the adhesive by applying energy to the adhesive from a curing device disposed at the nozzle of the adhesive applicator.
Dasnurkar teaches a method of repairing a heart, in the same field of endeavor, wherein an adhesive-applicator 110 includes a lumen 116 for light-activated adhesive and a lumen 118 for a curing device at the tip/nozzle of the adhesive applicator (fig. 4), and an adhesive-applicator comprising a lumen 160 for a light-curable adhesive and a curing device/light 164 at the tip/nozzle of the adhesive applicator (fig.13), as well as an adhesive-applicator 170, 171 comprising a lumen 176 for a light-curable adhesive and a curing device/light 180 at the tip/nozzle of the adhesive applicator (figs. 14-15), each applicator provided for the purpose of both delivering an adhesive and rapidly curing the adhesive upon delivery (pars.69, 96, and 98). Dasnurkar further teaches the steps of using an adhesive applicator 208 having a curing device disposed at the nozzle (par.112 says the device 208 has a passage for adhesive and a passage for light as described for other catheters) to deliver an adhesive 222A to an interior of a porous implant 222 and allowing the adhesive to weep out of the implant to anchor the implant to the tissue (par.127). Dasnurkar also teaches using an adhesive applicator 208 having a curing device disposed at the nozzle (par.112 says the device 208 has a passage for adhesive and a passage for light as described for other catheters) to deliver an adhesive through openings 204A of an implant 204 to anchor the implant to the tissue (figs. 19 and 25). Finally, Dasnurkar teaches an embodiment including the steps of passing an adhesive through pores linking the inner and outer surface of an implant to adhere to tissue (par.109).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Iflah to include an adhesive-applicator containing an adhesive and a curing device disposed at a nozzle of the adhesive-applicator and using the adhesive applicator to apply the adhesive via the nozzle to an interior of the implant and allow the adhesive to pass through the implant, and subsequently cure the adhesive by applying energy (light) to the adhesive from the curing device at the nozzle of the adhesive-applicator as taught by Dasnurkar in order to allow for the use of a single tool to both apply adhesive and rapidly cure the adhesive during anchoring of an implant to tissue (Dasnurkar par.69). It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an adhesive applicator and adhesive as taught by Dasnurkar rather than the anchor applicator and anchors of Iflah since such a modification amounts to simple substitution of one known fixing mechanism for attaching an implant to tissue of the heart for another to obtain predictable results (see MPEP 2143B).
Regarding claim 2-4, see Iflah fig. 3D for the external surface of implant 222 being pressed against tissue by the applicator tip/nozzle prior to applying the anchor. It would follow that the method of Iflah as modified by Dasnurkar applies the same pressure using the applicator to apply the adhesive instead of the anchor.
Regarding claim 6, Dasnurkar teaches PGSA is a suitable light curable adhesive in par.68.
Regarding claim 7, Iflah discloses a contracting portion (considered the portions of the sleeve able to be contracted) and a contraction member 226 extending along the contraction portion and after securing the wall to the tissue, contracting the contracting portion by tensioning the contraction member (par.467; fig.3G).
Regarding claim 19, see Iflah figs. 3A-3F which show sequential application of the anchors. Iflah as modified by Dasnurkar to replace the anchors of Iflah with adhesive as taught by Dasnurkar results in a sequential application of adhesive using the adhesive applicator instead of the anchors and anchor applicator.
Regarding claim 20, see par.466 and fig.3F of Iflah for adhering the external surface to both the left and right fibrous trigones 242, 244 of the heart.
Regarding claim 21, see Iflah figs. 3A-3D for guide-catheter 14, considered a guide, and sliding the anchor applicator along the guide and up to (and beyond) a tip of the guide. Iflah as modified by Dasnurkar to have the adhesive-applicator having a curing device instead of the anchor applicator would include the step of sliding the adhesive-applicator and curing device along the guide 14 and up to a tip of the guide.
Regarding claims 22 and 23, see Iflah figs. 3A-3F which show moving the applicator progressively along the implant to apply the anchors to successive locations along the implant. Therefore, it would follow that Iflah as modified by Dasnurkar to replace the anchors of Iflah with adhesive as taught by Dasnurkar results in moving the adhesive applicator progressively along the implant to apply the adhesive to successive locations along the implant and curing the adhesive at each location.
Regarding claim 24, see the rejection of claim 1 above. Iflah further discloses transcatheterally advancing, to a heart of a subject, an implant 222 and an anchor-applicator 36, 61 coupled to the implant (fig.3C). Therefore, it would follow that in the method of Iflah in view of Dasnurkar, wherein the anchor applicator and anchors are substituted by the adhesive-applicator and adhesive of Dasnurkar, the implant is coupled to the adhesive-applicator during the transcatheterally advancing step.
Claim 5, 8, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Iflah in view of Dasnurkar as applied to claim 1 above, and further in view of Ogle et al. US 2012/0197284 (hereafter referred to as Ogle).
Regarding claim 5, Iflah in view of Dasnurkar discloses the method of claim 1 as discussed above, but does not disclose that the adhesive is a polyethylene hydrogel.
Ogle teaches an adhesive for use in the body, in the same field of endeavor, wherein the adhesive is a polyethylene hydrogel (par.63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select polyethylene hydrogel as taught by Ogle as an adhesive in the method of Iflah in view of Dasnurkar since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07). Because polyethylene hydrogel was a known material for use as an adhesive as taught by Ogle, it would have been obvious to select polyethylene hydrogel.
Regarding claims 8, 11, and 13, Iflah in view of Dasnurkar discloses the method of claim 1 as discussed above, but does not disclose that the adhesive includes a first adhesive-component, and using the adhesive-applicator to apply the adhesive via the nozzle into the interior comprises using the adhesive-applicator to apply the first adhesive-component via the nozzle into the interior such that the first adhesive-component contacts a second adhesive-component and forms a hardened adhesive therewith, the adhesive applicator is a first adhesive applicator and wherein the method further comprises using a second adhesive applicator to apply the second-adhesive component into the interior via a second nozzle of the second adhesive applicator, wherein the first and second adhesives are albumin and glutaraldehyde.
Ogle teaches an adhesive applicator and adhesive for use in the body, in the same field of endeavor, wherein the adhesive applicator comprises two chambers (considered first or second applicators with respective nozzles/ends) with one comprising albumin and the other comprising glutaraldehyde for the purpose of applying adhesive to tissue (par.63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use first and second adhesive applicators comprising albumin and glutaraldehyde as taught by Ogle in the method of Iflah in view of Dasnurkar since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07). Because the combination of albumin and glutaraldehyde was a known material for use as an adhesive as taught by Ogle, it would have been obvious to select albumin and glutaraldehyde.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Iflah in view of Dasnurkar as applied to claim 1 above, and further in view of in view of Wei US 2019/0151089 (hereafter referred to as Wei). Iflah in view of Dasnurkar discloses the method of claim 1 as discussed above, but Iflah in view of Dasnurkar does not disclose that the adhesive includes a first adhesive-component, and using the adhesive-applicator to apply the adhesive via the nozzle into the interior comprises using the adhesive-applicator to apply the first adhesive-component via the nozzle into the interior such that the first adhesive-component contacts a second adhesive-component and forms a hardened adhesive therewith, wherein the second adhesive-component is attached to the porous fabric, and wherein using the adhesive-applicator to apply the first adhesive-component via the nozzle into the interior comprises using the adhesive-applicator to apply the first adhesive-component via the nozzle into the interior such that the first adhesive-component contacts the second adhesive-component attached to the porous fabric and forms the hardened adhesive therewith.
Wei teaches a method of adhering an implant to tissue with adhesive, in the same field of endeavor, wherein a first liquid adhesive component is delivered by an applicator and mixes with a second dry adhesive component located in the implant for the purpose of forming a hardened adhesive therewith (par.35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Iflah in view of Dasnurkar and include the steps of using the adhesive applicator to deliver a first adhesive into the interior such that the first adhesive-component contacts a second adhesive-component attached to the porous fabric in order to form a hardened adhesive therewith. Selection of the two adhesives taught by Wei in the method of Iflah in view of Dasnurkar would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Iflah in view of Dasnurkar in view of Ogle as applied to claim 11 above, and further in view of Duggirala US 2012/0116285 (hereafter referred to as Duggirala). Iflah in view of Dasnurkar in view of Ogle discloses the method of claim 11 as discussed above, including two adhesive applicators for applying two adhesive components to be mixed, which is common in the art. However, Iflah in view of Dasnurkar in view of Ogle does not disclose applying thrombin and fibrinogen or applying gelatin-resorcinol and formaldehyde-glutaraldehyde.
Duggirala teaches an adhesive for use in the body, in the same field of endeavor, wherein the adhesive can be a mixture of thrombin and fibrinogen or can be a mixture of gelatin-resorcinol and formaldehyde-glutaraldehyde (par.116).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use first and second adhesive applicators comprising thrombin and fibrinogen or gelatin-resorcinol and formaldehyde-glutaraldehyde as taught by Duggirala in the method of Iflah in view of Dasnurkar in view of Ogle since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07). Because the combinations of the claimed materials were known materials for use as an adhesive as taught by Duggirala, it would have been obvious to select thrombin and fibrinogen or gelatin-resorcinol and formaldehyde-glutaraldehyde.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Iflah in view of Dasnurkar in view of Ogle as applied to claim 11 above, and further in view of Malinin US 2015/0037432 (hereafter referred to as Malinin). Iflah in view of Dasnurkar in view of Ogle discloses the method of claim 11 as discussed above, including two adhesive applicators for applying two adhesive components, which is common in the art. However, Iflah in view of Dasnurkar in view of Ogle does not disclose applying gelatin-resorcinol and pentanedial-ethanedial.
Malinin teaches an adhesive for use in the body, in the same field of endeavor, wherein the adhesive can be a mixture of gelatin-resorcinol and pentanedial-ethanedial (par.101).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use gelatin-resorcinol and pentanedial-ethanedial as taught by Malinin in the method of Iflah in view of Dasnurkar in view of Ogle since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07). Because the combination of the claimed materials was a known material for use as an adhesive as taught by Malinin, it would have been obvious to select gelatin-resorcinol and pentanedial-ethanedial.
Conclusion
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774