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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 25 August 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 25 August 2025. As directed by the amendment: claims 1-2, 14, and 20 have been amended, claims 23 and 24 have been added. Thus claims 1-24 are presently pending in this application and claim 19 remains withdrawn.
Response to Arguments
Applicant argues on pages 7-8 of REMARKS there is no motivation to modify Thaxton in view of Casas because the method of Thaxton, which discloses mostly variations of a material-eluting stent, is silent to a patch or sleeve and Casas teaches that the patch or sleeve may be implanted upstream of a stent. Applicant argues the goal of any upstream delivery taught by Casas is to result in dosing local to the stent, providing drug to locations downstream of a stent is not contemplated by either Thaxton of Casas.
The examiner respectfully disagrees. While Thaxton does describe material eluting stents, it is clear that the structure of the device is not limited to only stents ([0062] “Examples of implantable devices include, but are not limited to, stents such as self-expandable stents, balloon-expandable stents, coronary stents, peripheral stents, stent-grafts, shunts, catheters, other expandable tubular devices for various bodily lumen or orifice”). Casas is also not limited to only drug delivery upstream of a stent. Using the structure of the patch or sleeve of Casas in the method of Thaxton would be obvious to one of ordinary skill in the art.
Applicant argues on page 9 that the cited art does not teach or suggest one or more agent delivery membranes or platforms comprising a calcineurin inhibitor or a steroid. The examiner agrees that the amended limitations are not taught in the art, further as outlined in the Allowable Subject Matter section below, Thaxton teaches away from this limitation. As such the previous rejection of claim 14 has been withdrawn.
Applicant argues on page 9 that the combination of cited art frustrates the purpose of the prior art invention because Thaxton describes reducing rejection risk is through preventing or treating ischemia-reperfusion injury and modifying Thaxton to provide a therapeutic agent to reduce an immune response would render the methods of Thaxton unsatisfactory for their intended purpose of treating injury. While the examiner disagrees that changing the specific drug to reduce rejection risk would render the methods of Thaxton unsatisfactory, Thaxton does teach away from the specific drugs claimed, a calcineurin inhibitor or a steroid, so the claimed therapeutic agents would not be obvious to include.
Applicant argues on page 10 that new claim 23 is not taught by the art of record. The examiner agrees. Accordingly, claim 23 is indicated as being allowable subject matter.
Applicant argues on page 11 that new claim 24 is not taught by the art of record because Rink teaches autograft techniques, which simply include transplanting a subject’s own tissue into the subject, nowhere do Thaxton, Casas, or Rink teach or suggest that a device of the invention may be attached to a fluid passageway of a subject upstream of a location designated for the placement of an organ in an organ transplant procedure.
The examiner respectfully disagrees. This argument suggests the device is attached to a fluid passageway of the recipient before the organ is transplanted, then upon transplantation, the organ is placed downstream of the fluid passageway with the device in the recipient. However, this specific method is not claimed, further this interpretation would not be possible in view of the limitations recited in claim 1. Claim 1 recites “surgically accessing an inner surface of at least one fluid passageway upstream from an extracted and isolated organ designated for transplantation […] attaching the one or more agent delivery membranes or platforms to the inner surface of the at least one fluid passageway”.
Attaching the device to a fluid passageway of a subject upstream of a location designated for the placement of an organ as argued would not include the fluid passageway with the attached device being upstream from an extracted and isolated organ. Instead, the fluid passageway would be upstream from the location of where the extracted and isolated organ would be placed. The limitations claimed only make sense if the upstream fluid passageway and the organ for transplant are both from the recipient subject, this is why a modification in view of Rink is included for claims 2 and 24.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5-12, 15-16, 18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Thaxton et al. (US 2020/0330655 A1) in view of Casas et al. (US 2010/0131043 A1).
Regarding claim 1, Thaxton et al. discloses a method of administering to a recipient subject downstream delivery of agents in a surgical procedure for transplanting an organ ([0018] “a method for transplanting a donor organ in a recipient subject”, the recipient subject would be administered the delivery of agents through the organ that is transplanted), comprising the steps of: surgically accessing an inner surface of at least one fluid passageway ([0062] “Examples of implantable devices include, but are not limited to, stents such as self-expandable stents, balloon-expandable stents, coronary stents, peripheral stents, stent-grafts, shunts, catheters, other expandable tubular devices for various bodily lumen or orifice”) of an extracted and isolated organ designated for transplantation ([0018] “a method for transplanting a donor organ in a recipient subject comprising: harvesting a donor organ”); selecting one or more agent delivery membranes or platforms comprising a therapeutic agent; attaching the one or more agent delivery membranes or platforms to the inner surface of the at least one fluid passageway ([0018] “contacting the donor organ with the implantable device described herein”); and transplanting the organ ([0018] “and transplanting the donor organ into a recipient subject”).
However, Thaxton et al. fails to disclose the inner surface of the at least one fluid passageway is upstream from an extracted and isolated organ, the organ is downstream from the one or more agent delivery membranes or platforms.
Casas et al. teaches a method of administering downstream delivery of agents in a surgical procedure, comprising the steps of: surgically accessing an inner surface of at least one fluid passageway upstream from an organ designated for treatment ([0006] “The present disclosure provides endoluminal implants that deliver bioactive materials […] regionally downstream, distal to the implant site.”); selecting one or more agent delivery membranes or platforms comprising a therapeutic agent ([0009] “The patch is selected from a variety of sizes and shapes depending on the target application”, [0006] “The present disclosure provides endoluminal implants that deliver bioactive materials”); attaching the one or more agent delivery membranes or platforms to the inner surface of the at least one fluid passageway ([0007] “the patch adheres to the internal side of the organ wall or lumen”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the method of Thaxton et al. to include the method of administering downstream delivery of agents in a surgical procedure as taught by Casas et al. to provide bioactive material delivery to a treatment site where downstream, regional therapy is needed [0033]. The modification of Thaxton et al. in view of Casas et al. would result in the organ designated for transplantation being the organ designated for treatment by the upstream agent delivery membranes or platforms, and the step of transplanting including transplanting the organ downstream from the one or more agent delivery membranes or platforms.
Regarding claim 3, modified Thaxton et al. teaches the method of claim 1. Modified Thaxton et al. further teaches wherein the at least one fluid passageway is attached to and forms part of the organ designated for transplantation (Thaxton et al. modified in view of Casas et al. would result in the fluid passageway the delivery membrane or platform being attached upstream of and part of the target [0009] “fixed to the intraluminal aspect of the target organ (i.e., artery, esophagous, vein, urether, urethra, respiratory conduits, Fallopian ductus, etc.) and […] proximal to the diseased/affected tissue (for regional downstream effects).”).
Regarding claim 5, modified Thaxton et al. teaches the method of claim 1. Modified Thaxton et al. further teaches wherein the organ is a lung ([0084] “Transplanted tissue may be […] entire organs (e.g., heart, lung […]”).
Regarding claim 6, modified Thaxton et al. teaches the method of claim 5. The rejection of claim 5 relies upon the alternative wherein the selected organ is a lung, selected from the Markush grouping of alternatives. As claim 6 is further limiting an alternative that was not relied upon for the rejection of claim 5, claim 6 is also rejected.
Regarding claim 7, modified Thaxton et al. teaches the method of claim 1. Modified Thaxton et al. further teaches wherein the agent delivery membrane or platform is in the shape of a substantially planar patch (Casas et al.- [0046] “The endoluminal implants can comprise flat, smooth or porous films”).
Regarding claim 8, modified Thaxton et al. teaches the method of claim 1. Modified Thaxton et al. further teaches wherein the agent delivery membrane or platform comprises a monolithic combination of a polymer carrier agent and a therapeutic agent (Casas et al.- the matrix layer as represented by 420 and shown in Fig 4B is a monolithic layer, [0041] “the sleeve's matrix layer components can be composed of […] bioactive agent-polymer blends”).
Regarding claim 9, modified Thaxton et al. teaches the method of claim 1. However, modified Thaxton et al. is silent to wherein the agent delivery membrane or platform is in the shape of a ring or tube spanning the inner circumference of the at least one fluid passageway.
Casas et al. teaches an embodiment wherein the agent delivery membrane or platform is in the shape of a ring or tube spanning the inner circumference of the at least one fluid passageway (the embodiment of the patch shown in Fig 3A and 3B includes “circumferential expandable rings 310” that are part of the platform and span the inner circumference of the fluid passageway). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the agent delivery membrane or platform of modified Thaxton et al. to be in the shape of a ring or tube spanning the inner circumference of the at least one fluid passageway as taught by the embodiment of Casas et al. as it is a passive fixation mechanism [0039] and Casas et al. teaches the patch can be adhered with various mechanisms ([0013] “the implant is a patch and the patch adheres to the lumen through a mechanism selected from the group consisting of an active mechanism, a passive mechanism, and combinations thereof.”).
Regarding claim 10, modified Thaxton et al. teaches the method of claim 1. However, modified Thaxton et al. fails to teach wherein the agent delivery membrane or platform is attached using sutures, adhesives, or hooks.
Casas et al. teaches an embodiment wherein the agent delivery membrane or platform is attached using sutures, adhesives, or hooks ([0036] “In one embodiment (FIG. 1), an endoluminal device is comprised of a therapeutic patch having an active fixation mechanism based on micro-hooks in peripheral needles (FIGS. 2A and 2B)”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the agent delivery membrane or platform of modified Thaxton et al. to be attached using sutures, adhesives, or hooks as taught by the embodiment of Casas et al. as it is an active fixation mechanism [0036] and Casas et al. teaches the patch can be adhered with various mechanisms ([0013] “the implant is a patch and the patch adheres to the lumen through a mechanism selected from the group consisting of an active mechanism, a passive mechanism, and combinations thereof.”).
Regarding claim 11, modified Thaxton et al. teaches the method of claim 1. However, modified Thaxton et al. fails to teach wherein an impermeable layer of material is positioned between the agent delivery membrane or platform and the inner surface of the at least one fluid passageway.
Casas et al. teaches an embodiment wherein an impermeable layer of material ([0042] “If bioactive material release is not desired from a portion of an endoluminal implant (e.g., device's parietal aspect), non-permeable layers can be included to prevent bioactive material release from that portion of the implant.”, 410 Fig 4B is shown as a non-permeable parietal layer) is positioned between the agent delivery membrane or platform (400 Fig 5A) and the inner surface of the at least one fluid passageway (See the inner surface shown in Fig 5A). It would have been obvious to one of ordinary skill in that art at the time of effective filing for the device of modified Thaxton et al. to include the layer with the limitations as taught by the embodiment of Casas et al. to prevent release of bioactive material at that portion of the lumen that does not require treatment and so that all of the bioactive material will be released downstream to the treatment site as shown in Fig 5A.
Regarding claim 12, modified Thaxton et al. teaches the method of claim 1. Modified Thaxton et al. further teaches wherein the agent delivery membrane or platform delivers the therapeutic agent into the fluid passageway (Casas et al.- As shown in the embodiment of Fig 5A, [0006] “The present disclosure provides endoluminal implants that deliver bioactive materials […] regionally downstream, distal to the implant site.”, Figs 1 and 2A [0036] “Patch body 20 includes passages 22 to allow passage of fluid and metabolic products to and from the patch therapeutic construct”).
Regarding claim 15, modified Thaxton et al. teaches the method of claim 1. Modified Thaxton et al. further teaches wherein the therapeutic agent is embedded within the agent delivery membrane or platform (Casas et al.- the matrix layer 420 is shown in Fig 4B as a monolithic layer, [0041] “the sleeve's matrix layer components can be composed of […] bioactive agent-polymer blends”).
Regarding claim 16, modified Thaxton et al. teaches the method of claim 1. Modified Thaxton et al. further teaches wherein the therapeutic agent is contained in a reservoir (Casas et al.- a matrix layer such as 420 shown in Fig 4B is a reservoir as described in [0041] “a matrix reservoir 420”) embedded within the agent delivery membrane or platform (See Fig 4B).
Regarding claim 18, modified Thaxton et al. teaches the method of claim 11. Modified Thaxton et al. further teaches wherein the therapeutic agent is delivered over a period of one or more minutes, one or more hours, one or more days, one or more months, or one or more years (Casas et al.- [0049] “Bioactive material release can be short term to long term (from about 1 hour to years) depending on the therapeutic approach.”).
Regarding claim 20, Thaxton et al. discloses a method of administering to a recipient subject downstream delivery of agents in a surgical procedure for transplanting an organ ([0018] “a method for transplanting a donor organ in a recipient subject”, the recipient subject would be administered the delivery of agents through the organ that is transplanted), comprising the steps of: surgically accessing an inner surface of at least one lumen ([0062] “Examples of implantable devices include, but are not limited to, stents such as self-expandable stents, balloon-expandable stents, coronary stents, peripheral stents, stent-grafts, shunts, catheters, other expandable tubular devices for various bodily lumen or orifice”) of an isolated tissue designated for transplantation ([0018] “a method for transplanting a donor organ in a recipient subject comprising: harvesting a donor organ”); selecting one or more agent delivery membranes or platforms comprising a therapeutic agent; attaching the one or more agent delivery membranes or platforms to the inner surface of the lumen ([0018] “contacting the donor organ with the implantable device described herein”); and transplanting the tissue ([0018] “and transplanting the donor organ into a recipient subject”).
However, Thaxton et al. fails to disclose the inner surface of the at least one lumen is upstream from the isolated tissue, the tissue is downstream from the one or more agent delivery membranes or platforms.
Casas et al. teaches a method of administering downstream delivery of agents in a surgical procedure, comprising the steps of: surgically accessing an inner surface of at least one lumen upstream from a tissue designated for treatment ([0006] “The present disclosure provides endoluminal implants that deliver bioactive materials […] regionally downstream, distal to the implant site.”); selecting one or more agent delivery membranes or platforms comprising a therapeutic agent ([0009] “The patch is selected from a variety of sizes and shapes depending on the target application”, [0006] “The present disclosure provides endoluminal implants that deliver bioactive materials”); attaching the one or more agent delivery membranes or platforms to the inner surface of the lumen ([0007] “the patch adheres to the internal side of the organ wall or lumen”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the method of Thaxton et al. to include the method of administering downstream delivery of agents in a surgical procedure as taught by Casas et al. to provide bioactive material delivery to a treatment site where downstream, regional therapy is needed [0033]. The modification of Thaxton et al. in view of Casas et al. would result in the tissue designated for transplantation being the tissue designated for treatment by the upstream agent delivery membranes or platforms, and the step of transplanting including transplanting the tissue downstream from the one or more agent delivery membranes or platforms.
Regarding claim 21, modified Thaxton et al. teaches the method of claim 20. Modified Thaxton et al. further teaches wherein the lumen supports a liquid fluid stream (Casas et al.- [0009] “(i.e., artery, esophagous, vein, urether, urethra, respiratory conduits, Fallopian ductus, etc.)” a urethra supports a liquid fluid stream).
Regarding claim 22, modified Thaxton et al. teaches the method of claim 20. Modified Thaxton et al. further teaches wherein the lumen is a urethra (Casas et al.- [0009] “(i.e., artery, esophagous, vein, urether, urethra, respiratory conduits, Fallopian ductus, etc.)”).
Claims 2 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Thaxton et al. (US
2020/0330655 A1) in view of Casas et al. (US 2010/0131043 A1) and Rink et al. (US 2020/0281961 A1).
Regarding claim 2, modified Thaxton et al. teaches the method of claim 1. Modified Thaxton et al. further teaches wherein the at least one fluid passageway includes an artery, a vein, an airway, or a gastrointestinal tract (Casas et al.- [0009] “(i.e., artery, esophagous, vein, urether, urethra, respiratory conduits, Fallopian ductus, etc.)”).
However, modified Thaxton et al. fails to teach wherein the at least one fluid passageway is of the recipient subject.
Rink et al. teaches a method wherein a treated organ is of a recipient subject ([0125] “Transplants may be the patient's own tissue (autografts”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the at least one fluid passageway to be of the recipient subject as autografts are a well-known and common form of transplant that have lower incidence of rejection.
Regarding claim 24, modified Thaxton et al. teaches the method of claim 20. Modified Thaxton et al. further teaches transplanting of the organ occurs subsequent to attaching the delivery membrane to the recipient subject's fluid passageway (Thaxton et al.- [0018] “contacting the donor organ with the implantable device described herein; and transplanting the donor organ into a recipient subject”).
However, modified Thaxton et al. fails to teach wherein the at least one fluid passageway comprises tissue of the recipient subject.
Rink et al. teaches a method wherein a treated organ is of a recipient subject ([0125] “Transplants may be the patient's own tissue (autografts”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the at least one fluid passageway to comprise tissue of the recipient subject as autografts are a well-known and common form of transplant that have lower incidence of rejection.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Thaxton et al. (US 2020/0330655 A1) in view of Casas et al. (US 2010/0131043 A1) and Kizhakkedathu et al. (US 2016/0295856 A1).
Regarding claim 4, modified Thaxton et al. teaches the method of claim 3. However, modified Thaxton et al. fails to teach further comprising a step of perfusing the organ with a preserving solution prior to the step of transplanting the organ.
Kizhakkedathu et al. teaches further comprising a step of perfusing the organ with a preserving solution ([0002] “Flushing and storage of donor organs with a cold preservation solution”) prior to the step of transplanting the organ ([0023] “The methods comprising procuring tissue and maintaining it in a transplant preservation solution, and transplanting said tissue to the patient.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the method of modified Thaxton et al. to include the limitations as taught by Kizhakkedathu et al. “for limiting donor tissue injury during tissue procurement and transplant” [0016].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Thaxton et al. (US 2020/0330655 A1) in view of Casas et al. (US 2010/0131043 A1) and Dai et al. (US 2002/0193419 A1).
Regarding claim 13, modified Thaxton et al. teaches the method of claim 12. Casas et al. teaches an embodiment wherein the therapeutic agent is delivered into distal airways ([0029] “the respiratory system (trachea, bronchi, and bronchioles)” and [0037] “to interact with the intraluminal components (e.g.,[…] air”).
However, modified Thaxton et al. is silent to wherein the therapeutic agent is delivered in the form of an aerosol into distal airways and alveoli.
Dai et al. teaches a therapeutic agent is delivered in the form of an aerosol into distal airways and alveoli ([0103] “The compound may also be administered by inhalation, in the form of aerosol particles, either solid or liquid, preferably of respirable size. Such particles are sufficiently small to pass through the mouth and larynx upon inhalation and into the bronchi and alveoli of the lungs.”). It would have been obvious to one of ordinary skill in the art to include the limitations as taught by Dai et al. to administer the therapeutic agent to the entire respiratory system to effectively treat the whole lung.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Thaxton et al. (US
2020/0330655 A1) in view of Casas et al. (US 2010/0131043 A1) and Hanson et al. (US 5985307 A).
Regarding claim 17, modified Thaxton et al. teaches the method of claim 1. However, modified Thaxton et al. fails to teach wherein the therapeutic agent is contained in a reservoir located external to the at least one fluid passageway and fluidly connected to the fluid passageway by one or more lumens having an opening in the agent delivery membrane or platform.
Hanson et al. teaches a therapeutic agent (Col 7 lines 18-19 “A substance, e.g., a fluid containing a drug or other therapeutic agent”) is contained in a reservoir located external (Col 8 line 39 “a remote fluid delivery source”) to the at least one fluid passageway and fluidly connected to the fluid passageway (60 Fig 3) by one or more lumens (16 Fig 3) having an opening in the agent delivery membrane or platform (18 Fig 3, Col 7 lines 1-2 “distal end 18 which is in fluid communication with inflation chamber 26”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the therapeutic agent of modified Thaxton et al. to be contained with the limitations as taught by Hanson et al. to allow dosages to be changed or different therapeutic agent to be introduced after placement of the agent delivery membrane or platform (Col 8 lines 17-61).
Allowable Subject Matter
Claims 14 and 23 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 14, the closest art of record is Thaxton et al. in view of Casas et al., however, it would not be obvious to modify the drug of modified Thaxton to include a calcineurin inhibitor or a steroid as required by the claim because Thaxton teaches away from their use ([0088] “Treatment regimens include corticosteroids, calcineurin inhibitors[…]”, “However, immunosuppressants suppress all immune responses and contribute to many posttransplantation complications, including development of cancer, acceleration of cardiovascular disease, and even death due to overwhelming infection.”).
Regarding claim 23, the closest art of record is Thaxton et al. in view of Casas et al., and Kizhakkedathu et al. However, because Kizhakkedathu et al. is silent to attaching a delivery membrane there is no teaching of when the attaching of the delivery membrane would be relative to the perfusing step.
Conclusion
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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