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 .
Status of the Claims
Claims 1-20 are pending in the application.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claims 1-11 and 13 are rejected under 35 USC 103 as unpatentable over Fahey (WO 2020/257530 A1) in view of Osypka (US 2013/0331920 A1).
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As to claim 1, Fahey teaches an implantable medical device 300 (an interatrial shunting system 300, Fig.3; [0083]), comprising: a first anchoring portion 302/3a/306a (first portion of flow control system 302, Fig.3; [0084]-[0085]; ... the flow control system 302 is an annular and/or toroid-shaped structure including a first end surface 306a, [0085]) formed by one or more first materials ([0085]; see Fig.3), the first anchoring portion defining a first internal chamber 3a (Fig.3C;as interior portion of the flow control system 302/306a, [0089]); a second anchoring portion 302/3b/306b (second portion of a flow control system 302, Fig.3; [0085]; ... the flow control system 302 is an annular and/or toroid-shaped structure including ... a second end surface 306b opposite the first end surface 306a, [0085]) formed by one or more second materials ([0085; see Fig.31), the second anchoring portion defining a second internal chamber 3b ( interior portion 3b of the flow control system 302, [0089]; Fig.3C); an intermediate portion 312 (a circumferential groove or channel 312, Fig.3; [0085]) connecting the first anchoring portion and the second anchoring portion (In the illustrated embodiment, the flow control system 302 is an annular and/or toroid-shaped structure including a first end surface 306a, a second end surface 306b opposite the first end surface 306a, an outer surface 308 extending between the first and second end surfaces 306a-b ... the outer surface
308 can include a circumferential groove or channel 312, [0085]; see Fig.3A-C); and one or more canisters (one or more electronic components 320, Fig.3; [0094]) positioned within and retained by the first internal chamber and/or the second internal chamber (electronic component(s) 320 can be positioned at any suitable location of the system 300, such as within the interior portion of the flow control system 302, [0094]), wherein the one or more canisters include a fluidly sealed housing that carries one or more components of the medical device ([0094]).
Fahey fails to explicitly teach wherein the first anchoring portion is formed by one or more first filaments and the second anchoring portion is formed by one or more second filaments. However, Osypka, in the field of implantable medical devices (Abstract) and teaches a first and second anchoring portions (electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, [0031]; Figs. 1-5) formed by one or more first and second filaments, respectively (electrode pole 1 is braided from threads made from biocompatible metal, preferably memory metal threads like Nitinol wires, [0030]; see also Figs. 1-5 and 8). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the anchoring portions of Fahey to be formed by filaments as suggested by Osypka, and one of skill would have been motivated to do so, in order to provide an improved device having higher strength combined with superelasticity, thereby providing greater implantation adaptability and accommodation while maintaining optimum biocompatibility.
As to claim 2, Fahey further teaches wherein the one or more components carried in the housing comprises one or more energy storage components (one or more energy storage components (e.g., a battery), energy receiving components, controllers, sensors, etc; electronic components 320 include one or more energy storage components, such as a primary battery, a rechargeable battery, a capacitor, a supercapacitor, and/or other suitable elements that can retain energy, [0094]).
As to claim 3, Fahey teaches wherein the one or more components carried in the housing comprises one or more sensors (one or more energy storage components (e.g .. a battery), energy receiving components, controllers, sensors, etc ... ln some embodiments, the electronic components 320 include one or more energy storage components, such as a primary battery, a rechargeable battery, a capacitor, a supercapacitor, and/or other suitable elements that can retain energy, [0094]).
As to claim 4, Fahey teaches wherein the one or more components carried in the housing comprises electronics (such as one or more energy storage components (e.g., a battery), energy receiving components, controllers, sensors, etc ... ln some embodiments, the electronic components 320 include one or more energy storage components, such as a primary battery, a rechargeable battery, a capacitor, a supercapacitor, and/or other suitable elements that can retain energy, [0094]).
As to claim 5, Fahey teaches wherein the one or more canisters include at least a first canister positioned in the first internal chamber and a second canister positioned in the second internal chamber (the flow control system 302 can further include one or more electronic components 320 (shown schematically) for operating the flow control system 302; The electronic component(s) 320 can be positioned at any suitable location of the system 300, such as within the interior portion of the flow control system 302, [0094]).
As to claim 6, Fahey. teaches wherein the one or more canisters are connected to the one or more first materials and/or the one or more second materials (canisters are inherently indirectly connected to the material within which they reside, see Fig.3).
Fahey fails to explicitly teach wherein the one or more first materials are one or more filaments and the one or more second
materials are formed by one or more second filaments. However, Osypka teaches first and second anchoring portions (electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, [0031]; Figs. 1-5) formed by one or more first and second filaments, respectively (electrode pole 1 is braided from threads made from biocompatible metal, preferably memory metal threads like Nitinol wires, (0030]; see also Figs. 1-5 and 8).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the materials of Fahey to be formed by filaments as suggested by Osypka, and one of skill would have been motivated to do so, in order to provide an improved device having higher strength combined with superelasticity, thereby providing greater implantation adaptability and accommodation while maintaining optimum biocompatibility.
As to claim 7, Fahey teaches wherein the one or more canisters are not connected to the one or more first materials and/or the one or more second materials (as shown in Fig.3, there is a space separating the canisters from the outer material, therefore the canisters are not directly connected to the material). Fahey fails to explicitly teach wherein the one or more first materials are one or more filaments and the one or more second materials are formed ·by one or more second filaments. However, Osypka teaches first and second anchoring portions (electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, [0031]; Figs. 1-5) formed by one or more first and second filaments, respectively (electrode pole 1 is braided from threads made from biocompatible metal, preferably memory metal threads like Nitinol wires, [0030); see also Figs. 1-5 and 8). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the materials of Fahey to be formed by filaments as suggested by Osypka, and one of skill would have been motivated to do so, in order to provide an improved device having higher strength combined with superelasticity, thereby providing greater implantation adaptability and accommodation while maintaining optimum biocompatibility.
As to claim 8, Fahey teaches having the one or more first and second materials ([0085); see Fig.3). Fahey fails to explicitly teach wherein the one or more first materials are one or more first filaments that include one or more first braided wires, and wherein the one or more second materials are one or more second filaments that include one or more second braided wires. However, Osypka teaches first and second anchoring portions (electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, [0031]; Figs. 1-5) formed by one or more first and second filaments, respectively, that include one or more first and second braided wires, respectively (electrode pole 1 is braided from threads made from biocompatible metal, preferably memory metal threads like Nitinol wires, [0030]; see also Figs. 1-5 and 8). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the anchoring portions of Fahey to be formed by braided wires as suggested by Osypka, and one of skill would have been motivated to do so, in order to provide an improved device having higher strength combined with superelasticity, thereby providing greater implantation adaptability and accommodation while maintaining optimum biocompatibility.
As to claim 9, Fahey teaches wherein the one or more canisters include at least a first canister and a second canister positioned in the first internal chamber (flow control system 302 can further include one or more electronic components 320 (shown schematically) for operating the flow control system 302, such as one or more energy storage components (e.g ., a battery), energy receiving components, controllers, sensors, etc. The electronic component(s) 320 can be positioned at any suitable location of the system 300, such as within the interior portion of the flow control system 302, [0094]), wherein the first canister and the second canister are coupled (electronic components 320 can also include or be operably coupled to one or more sensors, [0096]).
As to claim 10, Fahey teaches wherein the first canister and the second canister are coupled via an electrical lead (electronic components 320 can also include or be operably coupled to one or more sensors, [0096]).
As to claim 11, Fahey teaches a lumen (a lumen 304, Fig.3; [0084]) extending through the first anchoring portion, the second anchoring portion, and the intermediate portion (see Fig.3; Paras. [00841), wherein, when the device is implanted in a patient, the lumen is configured to shunt fluid (flow control system 302 can be engaged with a lumen 304 of a shunting element (not shown), (00841).
As to claim 13, Fahey fails to explicitly teach wherein: the first internal chamber is configured to be connected to an environment external to the first anchoring portion, and the second internal chamber is configured to be connected to an environment external to the second anchoring portion.
However, Osypka teaches first and second internal chambers that are configured to be fluidly coupled to an environment external to first and second anchoring portions, respectively (electrode pole 1 is braided from threads made from biocompatible metal, preferably memory metal threads like Nitinol wires, [0030); see also Figs. 1-5 and 8; The electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, (0031]; Figs. 1-5). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the materials of Fahey to be formed by filaments as suggested by Osypka, and one of skill would have been motivated to do so, in order to provide an improved device having higher strength combined with superelasticity, thereby providing greater implantation adaptability and accommodation while maintaining optimum biocompatibility.
Claims 1 and 14-20 are rejected under 35 USC 103 as unpatentable over Osypka in view of Fahey.
As to claim 1, Osypka teaches an implantable medical device (an indifferent reference electrode pole 1, Fig.1; (0030]), comprising: a first anchoring portion (electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, (0031]; Figs. 1-5) formed by one or more first filaments (electrode pole 1 is braided from threads made from biocompatible metal, preferably memory metal threads like Nitinol wires, (0030]: see also Figs. 1-5 and 8), the first anchoring portion defining a first internal chamber (space formed between the braided threads of the left hand side of electrode pole 1, see Figs. 1-5 and 8); a second anchoring portion (electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, [0031]; Figs. 1-5) formed by one or more second filaments (electrode pole 1 is braided from threads made from biocompatible metal, preferably memory metal threads like Nitinol wires, [0030]; see also Figs. 1-5 and 8), the second anchoring portion defining a second internal chamber (space formed between the braided threads of the right hand side of electrode pole 1, see Figs. 1-5 and 8): and an intermediate portion (see Figs. 1-5) connecting the first anchoring portion and the second anchoring portion (electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, [0031]; Figs. 1-5). Osypka fails to explicitly teach one or more canisters positioned within and retained by the 'first internal chamber and/or the second internal chamber, wherein the one or more canisters include a fluidly sealed housing that carries one or more components of the medical device. However, Fahey teaches one or more canisters (one or more electronic components 320, Fig.3; (0094]) positioned within and retained by a first internal chamber and/or a second internal chamber (electronic component(s) 320 can be positioned at any suitable location of the system 300, such as within the interior portion of the flow control system 302, [0094]}, wherein the one or more canisters include a fluidly sealed housing that carries one or more components of a medical device ([0094]).
It would have been obvious to one of ordinary skill in the art al the time of the invention to modify the device of Osypka to include the features of Fahey , and one of skill would have been motivated to do so, in order to allow the clinician the ability to adjust...the therapy once the device is implanted ([0048] of Fahey), thereby providing an improved device for treating heart failure patients ([0005] of Fahey).
As to claim 14, Osypka teaches an implantable medical device (an indifferent reference electrode pole 1, Fig.1; [0030]), comprising: a first anchoring portion (electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, [0031]; Figs. 1-5) defining a first internal chamber (Figs. 1-5 and 8); a second anchoring portion (electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, (0031]; Figs. 1-5) defining a second internal chamber (see Figs. 1-5 and 8); an intermediate portion (see Figs. 1-5) connecting the first anchoring portion and the second anchoring portion (electrode pole 1 is preferably of umbrella shape forming a double disc which bridges the left and the right atrium, (0031]; Figs. 1-5); and wherein the first anchoring portion, the second anchoring portion, and the intermediate portion are formed at least partially by one or more filaments (electrode pole 1 is braided from threads made from biocompatible metal, preferably memory metal threads like Nitinol wires, (0030]; Figs. 1-5 and 8). Osypka fails to explicitly teach one or more canisters positioned within and retained by the first internal chamber and/or the second internal chamber, wherein the one or more canisters include a fluidly sealed housing that carries one or more components of the medical device. However, Fahey teaches one or more canisters (one or more electronic components 320, Fig.3; [0094]) positioned within and retained by a first internal chamber and/or a second internal chamber (electronic component(s) 320 can be positioned at any suitable location of the system 300, such as within the interior portion of the flow control system 302, [0094]), wherein the one or more canisters include a fluidly sealed housing that carries one or more components of a medical device ((0094]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Osypka to include the features of Fahey, and one of skill would have been motivated to do so, in order to allow the clinician the ability to adjust...the therapy once the device is implanted ([0048] of Fahey), thereby providing an improved device for treating heart failure patients ([0005] of Fahey).
As to claim 15, Osypka teaches wherein the first anchoring portion, the second anchoring portion, and the intermediate portion are formed by a single filament (electrode pole 1 is braided from threads made from biocompatib\e metal, preferably memory metal threads like Nitinol wires. The braiding may consist of one single wire braiding or a double or multi wire braiding, (0030]).
As to claim 16, Osypka teaches wherein the single filament is a braided wire (braiding may consist of one single wire braiding or a double or multi wire braiding, (0030])
As to claim 17, Osypka teaches wherein the first anchoring portion, the second anchoring portion, and the intermediate portion are formed by at least two filaments coupled together (braiding may consist of one single wire braiding or a double or multi wire braiding, (0030]).
As to claim 18, Osypka teaches wherein the one or more filaments are composed of Nitinol (electrode pole 1 is braided from threads made from biocompatible metal, preferably memory metal threads like Nilinol wires, [0030]).
As to claim 19, Osypka fails to explicitly teach wherein the one or more components include one or more energy storage components, one or more sensors, and/or electronics. However, Fahey teaches that the one or more components include one or more energy storage components, one or more sensors, and/or electronics (such as one or more energy storage components (e.g., a battery), energy receiving components, controllers, sensors, etc; electronic components 320 include one or more energy storage components, such as a primary battery, a rechargeable battery, a capacitor, a supercapacitor, and/or other suitable elements that can retain energy, (0094]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Osypka to include the features of Fahey, and one of skill would have been motivated to do so, in order to allow the clinician the ability to adjust...the therapy once the device is implanted ((0048] of Fahey), thereby providing an improved device for treating heart failure patients ([0005] of Fahey).
As to claim 20, Osypka teaches a lumen (a tube like opening 7, Figs.1-5; (0031]) extending through the first anchoring portion, the second anchoring portion, and the intermediate portion (centrally arranged tube like opening 7 has a proximal and a distal end, the proximal end near the right atrium and is attached to an elongated tube 18, [0043]; Figs. 1-5), and wherein, when the device is implanted in a patient, the lumen is configured to shunt fluid therethrough (tube like opening 7 may comprise a valve 5 in order to stop the shunting of blood between the atria, (0044]).
Claim 12 is rejected under 35 USC 103 as unpatentable over Osypka in view of Fahey and further in view of McHugo (US 2013/0060323 A1).
As to claim 12, Osypka fails to explicitly teach wherein: the first anchoring portion includes the one or more first filaments and at least partially enclosing the first internal chamber, and the second anchoring portion includes the one or more second filaments and at least partially enclosing the second internal chamber. However, McHugo, in the same field of medical devices ([0002]), teaches a membrane (covering 102, Figs. 1 and 2; [0029]) that is coupled (Indeed, in some embodiments, the covering membrane may cover over the entire stent framework from the proximal end to the distal end. In other embodiments, the stent may have a covering over a central portion of the structure and one or more uncovered ends or flanges. Moreover, a membrane covering may comprise any suitable biocompatible material, [0030]) to a filament (wire first portion 104 and wire second portion 106, Figs. 1 and 2; For example, wire first portion 104 and wire second portion 106 preferably comprises one or more elastically deformable materials such as shape memory alloys (e.g., stainless steel, nitinol, and the like), although other materials are contemplated, [0171]. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Osypka to include a first and second membrane as suggested by McHugo, and one of skill would have been motivated to do so, in order to provide an improved device having greater rigidity and preservation in addition to greater biocompatibility.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781