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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/23/2025 has been entered. It is noted that within the amendment filed on 9/23/205 claims 3 and 17 should not have any text present since those claims have been canceled, see MPEP 714.Claims 1-2, 4, 6-16, 19-20 and 29-32 are currently pending and under examination.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 9/23/2025 clarifying the language of claims 1,7,16,19,10 and 32 the 112 rejections made against the claims 1-4,6-11, 16-17,19-20, 29 and 31-32 in the office action of 7/22/2025 have been withdrawn.
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 1-2, 4, 6-16, 19-20 and 29-32 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 “wherein the portion of the second cuff is configured to receive two or more sutures..”, however it is unclear what portion of the second cuff applicant is referring to since the previously recited portion relates to “a portion of the first cuff that is sized to fit in the opening”, clarification is required. Claim 1 recites “wherein the sutures allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”, is this the same inlet that is “a cannula defining an inlet” clarification is required. Further claim 1 recites that “the sutures allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”, it is unclear what structural features of the suture applicant is intending to encompass when reciting “allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”. The specification discloses sutures which appear to be ordinary sutures used within surgical procedures. The specification does not disclose any special sutures or special features of the sutures which allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end, therefore it is unclear what structural features of the suture applicant is intending to encompass, clarification is required. Further within claim 1, when reciting “wherein the sutures allow the endocardium..” it is unclear which sutures applicant is referring back to since the claim previously recites “first and second cuff are configured to receive sutures” and “the second cuff is configured to receive two or more sutures”, clarification is required. Claim 9 recites “wherein the first cuff defines a first diameter and the second cuff defines a second diameter smaller than the first diameter”, however claim 1 has been amended to recite that the first cuff covers an exterior surface of the cannula itself and the second cuff is distal from the first cuff. It appears from the original disclosure which includes the drawings a cuff 130 is present on the cannula and covers an exterior surface of the cannula between the flange 136 and the inlet 118 and another cuff 132 below cuff 130 is around a flange 136, however cuff 132 which is around flange 136 has a greater diameter, therefore the arrangement of the first cuff and second cuff is unclear since it is unclear how the second cuff has a smaller diameter than the first cuff as claimed, clarification is required. Claim 10 recites “wherein the cannula includes a first end that defines a groove extending around the cannula adjacent the inlet, and wherein the second cuff includes a fastener received in the groove.”, however claim 1 has been amended to recite that the first cuff covers an exterior surface of the cannula itself and the second cuff is distal from the first cuff. It appears from the original disclosure which includes the drawings a cuff 130 is present on the cannula and covers an exterior surface of the cannula between the flange 136 and the inlet 118 and another cuff 132 below cuff 130 is around a flange 136, however cuff 132 which is around flange 136 does not include a fastener received in a groove extending around the cannula adjacent the inlet, therefore the arrangement of the first cuff and second cuff is unclear since it is unclear how the second cuff includes a fastener received in a groove extending around the cannula adjacent the inlet, clarification is required. Claim 12 recites “a first cuff extending directly around a flange and contacting a proximal end of the cannula adjacent the inlet…sized to be situated in the opening,” and “a second cuff extending directly around the cannula adjacent a distal end of the first cuff and anchored to a flange”. The claim contradicts itself regarding the placement of the “first cuff”, “flange” and the “second cuff” since the “second cuff” is adjacent a distal end of the first cuff which is “directly around a flange” which is “contacting a proximal end of the cannula adjacent the inlet” therefore the “second cuff” is adjacent a distal end of the first cuff which directly extends around a flange so the “second cuff” is distal of the “flange” as well? Claim 13 provides further confusion as it states that the diameter of the second cuff is greater than the diameter of the first cuff. The arrangement of the first cuff, flange and second cuff included in the cannula system is unclear, clarification is required. It appears from the original disclosure which includes the drawings a cuff 130 is present on the cannula and covers an exterior surface of the cannula between the flange 136 and the inlet 118 and another cuff 132 below cuff 130 is around a flange 136, however cuff 132 which is around flange 136 and has a greater diameter and does not contact a proximal end of the cannula adjacent an inlet as now claimed. Clarification is required. Claim 12 recites “wherein the sutures allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”, is this the same inlet that is “a cannula defining an inlet” clarification is required. Further claim 12 recites that “the sutures allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”, it is unclear what structural features of the suture applicant is intending to encompass when reciting “allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”, clarification is required. The specification discloses sutures which appear to be ordinary sutures used within surgical procedures. The specification does not disclose any special sutures or special features of the sutures which allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end, therefore it is unclear what structural features of the suture applicant is intending to encompass, clarification is required. Further within claim 12, when reciting “wherein the sutures allow the endocardium..” it is unclear which sutures applicant is referring back to since the claim previously recites “the first cuff…receive two or more sutures” and “wherein the first cuff is configured to receive sutures”, clarification is required. Claim 16 recites “wherein the sutures allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”, is this the same inlet that is “a cylindrical cannula having a first end defining an inlet” clarification is required. Further claim 16 recites that “the sutures allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”, it is unclear what structural features of the suture applicant is intending to encompass when reciting “allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”, clarification is required. The specification discloses sutures which appear to be ordinary sutures used within surgical procedures. The specification does not disclose any special sutures or special features of the sutures which allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end, therefore it is unclear what structural features of the suture applicant is intending to encompass, clarification is required. Further within claim 16, when reciting “wherein the sutures allow the endocardium..” it is unclear which sutures applicant is referring back to since the claim previously recites “first configured to receive sutures”, “a second cuff configured to receive the sutures” and “wherein the first cuff is configured to receive two or more sutures”, clarification is required. Claims 2, 4, 6-11, 13-15, 19-20 and 29-32 directly or indirectly depend from claims 1,12 and 16 and are also rejected to for the reasons stated above regarding claims 1,12 and 16. For the purposes of examination, as best understood, “first cuff” within claims 1,12 and 16 has been interpreted to be cuff 130 while “second cuff” has been interpreted to be cuff 132 and any sutures which go through a first cuff and/or second cuff have been interpreted as sutures that “allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”.
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.
Claim(s) 1-2, 6-8,11-14,16,19-20 and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281840 to Larose et al. (Larose) in view of US 2018/0050143 to Nguyen et al. (Nguyen) and JP 2012213517 to Hideo et al. (Hideo) ( all previously cited).
In reference to at least claim 1
Larose teaches a flanged heart tissue blocker which disclose a cannula system (e.g. Figs. 1-7), comprising: a cannula defining an inlet, wherein the cannula is configured to extend through an opening formed in a myocardium of a heart such that the inlet is received in a chamber of the heart (e.g. inflow cannula 400 is placed within opening of the retaining element which extends through an opening formed in a myocardium of a heart, Figs. 1-7, para. [0044]-[0045]); a flange extending around the cannula and configured to be positioned proximate an exterior of the myocardium with the flange engaging a first cuff (e.g. flange element that is part of clamp 210 which is positioned proximate an exterior of the myocardium, Figs. 1-7); a first cuff (e.g. apparatus 100 includes member 10 and retaining element 12 that includes tubular body 14 which together define the “first cuff”, Figs. 1-7, para. [0037]-[0039]) that covers at least half of an exterior surface of the cannula in an axial direction of the cannula between the flange and the inlet (e.g. covers at least half of an exterior surface in an axial direction of the cannula between the flange element of clamp and the inlet of inflow cannula 400, Figs. 6-7; includes a height greater than the thickness of the heart wall, para. [0038]) a second cuff extending around the cannula distal from the first cuff and having a portion of the first cuff that is sized to fit in the opening (e.g. mounting ring 200 “second cuff” extends around the cannula adjacent the flange of the clamp 210 and is fixed to the cannula the flange of clamp 210, Figs. 3,5-6, para. [0040], [0044], [0046]), wherein the portion of the second cuff is configured to receive two or more sutures through a pledget such that the sutures extend through the second cuff and the first cuff (e.g. mounting ring receives sutures in which strips from the retaining element 12 can be sutured to the fabric ring of the mounting ring, para. [0040]-[0041]).
Larose further discloses the first cuff “being composed of a flexible material such as composed of one or more layers of a biocompatible fabric, plastic, or metal, e.g., tubular body 14 may be composed of one or more composite layers of knitted polymers, such as polyethylene terephthalate (“PET”)” (e.g. para. [0037]) but does not explicitly teach the portion of the first cuff situated in the opening being configured to receive sutures that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium and allow the endocardium to the pulled flush or substantially flush with the inlet around the connection end and the connection end extending no more than 5mm beyond the endocardium.
Nguyen discloses a cannula attachment system (e.g. Figs. 9-12,16) comprising: a first cuff (e.g. flexible layer “first cuff” 68 or 80, Fig. 12,16), having a portion configured to be situated in an opening formed in a myocardium of a heart (e.g. flexible layer “first cuff” 68/80, coupled with outside surface of the inflow cannula in a close fitting arrangement and extending through an opening formed in the heart, Figs. 12,16, para. [0075]-[0076]), wherein the first cuff is configured to receive sutures (e.g. suture may extend distally…into the outer surface of the flexible layer 68/80, para. [0078], [0082]), the first cuff defining a first central opening (e.g. central opening within flexible layer 68/80, Figs. 12,16, para. [0075]), wherein the portion of the first cuff situated in the opening being configured to receive sutures that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium allowing the endocardium to the pulled flush or substantially flush with the inlet around the connection end (e.g. sutures extending through the first cuff situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium, Fig. 16, para. [0082], the structure of the “first cuff” 68 or 80 of Nguyen is configured to receive sutures through the entire portion of the first cuff configured to be situated in the opening since there are no structural differences between a cuff that receives sutures through a portion of the first cuff and through an entire portion of the first cuff configured to be situated in the opening, the structure of the first cuff 68 or 80 of Nguyen would be capable of receiving sutures through the entire portion of the first cuff configured to be situated in the opening). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular body of Larose to include the portion of the first cuff situated in the opening being configured to receive sutures that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium allowing the endocardium to be pulled substantially flush with the inlet, as taught by Nguyen, to securely attach the cuff to the heart wall.
Hideo teaches an inflow conduit and auxiliary artificial heart which discloses a cannula system (e.g. Figs. 2-3,6-7 and 9), comprising: a cannula defining an inlet (e.g. tube main body “cannula” 21, Figs. 2-3,6-7 and 9); a flange extending around the cannula (e.g. a flange portion 22, Figs. 2-3,6-7 and 9) ; and a first cuff extending around the cannula (e.g. joint portion “first cuff” 24, Figs. 2-3,6-7 and 9), wherein the first cuff covers at least half of an exterior surface of the cannula between the flange and the inlet (e.g. joint portion “first cuff” 24 covers at least half of an exterior surface of the tube main body, Figs. 2-3,6-7 and 9, para. [0030]). Hideo further discloses that the tip portion 25 protrudes by a predetermined amount from the surface of the wall portion H4. The range of the predetermined amount of protrusion is preferably about 0.2 times to about 1.5 times the thickness of the wall portion H4 of the heart H1 as a reference. When the longitudinal dimension of the tip 25 is longer than the above range, as shown in FIG. 7, a stasis region R in which the blood flow is stagnant is formed around the tip 25. On the other hand, when the longitudinal dimension of the tip 25 is shorter than the above range, as shown in FIG. 8, the wall H4 of the heart H1 grows and overcomes the tip 25, and the insertion portion 23 invades inside (e.g. Figs. 6-8, para. [0032]-[0033]). Therefore, it would have been well within the level of ordinary skill in the art to select the length that the cannula extends beyond the endocardium including modifying the system of Larose modified by Nguyen to include the cannula being configured to extend into a chamber of a heart not more than 5mm beyond an endocardium of the heart to provide a length that reduces the likelihood of the heart wall growing into the main tube while also reducing blood stagnation as taught by Hideo.
In reference to at least claim 2
Larose modified by Nguyen and Hideo renders obvious a device according to claim 1. Larose further discloses wherein the first cuff covers a majority of the exterior surface of the cannula between the flange and the inlet (e.g. covers at least half of an exterior surface in an axial direction of the cannula between the flange element of clamp and the inlet of inflow cannula 400, Figs. 6-7).
In reference to at least claim 6
Larose modified by Nguyen and Hideo renders obvious a device according to claim 1. Larose discloses wherein the first cuff is configured to receive the sutures such that sutures extend through the second cuff and the first cuff (e.g. mounting ring receives sutures in which strips from the retaining element 12 can be sutured to the fabric ring of the mounting ring, Figs. 3, 5-7, para. [0040]-[0046]), and wherein the second cuff is configured to abut the exterior of the myocardium (e.g. flange element that is part of clamp 210 which is positioned proximate an exterior of the myocardium, Figs. 1-7)
In reference to at least claim 7
Larose modified by Nguyen and Hideo renders obvious a device according to claim 1 but does not explicitly teach the second cuff being integrally formed with the first cuff. It would have been obvious to one having ordinary skill in the art before the effective filing date to make the second cuff being integrally formed with the first cuff, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art, see MPEP 2144.04.
In reference to at least claim 8
Larose modified by Nguyen and Hideo renders obvious a device according to claim 1. Larose further discloses the flange is located between the first and second cuffs (e.g. flange element of clamp 210 is between the first and second cuffs, Figs. 6-7).
In reference to at least claim 11
Larose modified by Nguyen and Hideo renders obvious a device according to claim 1. Larose further discloses the first cuff “being composed of a flexible material such as composed of one or more layers of a biocompatible fabric, plastic, or metal. For example, tubular body 14 may be composed of one or more composite layers of knitted polymers, such as polyethylene terephthalate (“PET”)” (e.g. para. [0037]).
Nguyen further discloses the flexible layer 68 including a felt medium (e.g. para. [0065]-[0066], [0074]-[0075]). Nguyen further discloses additional embodiments in which the flexible layers can include multiple layers of material that comprise a felt material or textile material and may comprise PTFE, elastomer component, polyester, silicone, rubber, or other textile or any combination thereof and additionally may be a velour, woven fabric/textile, or other configuration (e.g. para. [0060], [0065]-[0066]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the mounting ring 200 “second cuff” of Larose to include a plurality of layers of mesh with a felt core, as taught by Nguyen, to provide the appropriate material for promoting tissue ingrowth, the desired rigidity, control for infection, or other desired properties. Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the mounting ring 200 “second cuff” from a material that includes a felt core with a plurality of layers of mesh, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 12
Larose teaches a flanged heart tissue blocker which disclose a cannula system (e.g. Figs. 1-7), comprising: a cannula defining an inlet configured to extend through an opening formed in a myocardium of a heart into a chamber of the heart (e.g. inflow cannula 400 is placed within opening of the retaining element which extends through an opening of the heart, Figs. 1-7, para. [0044]-[0045]); a first cuff (e.g. apparatus 100 includes member 10 and retaining element 12 that includes tubular body 14 which together define the “first cuff”, Figs. 1-7, para. [0037]-[0039]) extending directly around a flange (e.g. flange element “flange” that is part of clamp 210 contacts member 10 and retaining element 12 that includes tubular body 14 which together define the “first cuff” and has “a portion” situated in the opening of the heart, Figs. 1-7) and adjacent a proximal end of the cannula adjacent the inlet (e.g. apparatus 100 includes member 10 and retaining element 12 that includes tubular body 14 which together define the “first cuff” and extends into an opening formed through the myocardium, Figs. 1-7, para. [0037]-[0039]), the first cuff is sized to be situated in the opening and receive two or more sutures through a pledget (e.g. apparatus 100 includes member 10 and retaining element 12 that includes tubular body 14 which together define the “first cuff” and is situated in the opening of the heart, Figs. 1-7, para. [0037]-[0039]; proximal portion of the retaining element are configured to receive sutures, para. [0043]) and a second cuff extending directly around the cannula adjacent a distal end of the first cuff anchored to a flange (e.g. mounting ring 200 “second cuff” extends around the cannula adjacent the flange of the clamp 210 and is fixed to the cannula the flange of clamp 210, Figs. 3,5-6, para. [0040], [0044], [0046]), the second cuff configured to receive the sutures such that the sutures extend through the second cuff and the first cuff (e.g. mounting ring receives sutures in which strips from the retaining element 12 can be sutured to the fabric ring of the mounting ring, para. [0040]-[0041]).
Larose further discloses the first cuff “being composed of a flexible material such as composed of one or more layers of a biocompatible fabric, plastic, or metal, e.g., tubular body 14 may be composed of one or more composite layers of knitted polymers, such as polyethylene terephthalate (“PET”)” (e.g. para. [0037]) but does not explicitly teach the portion of the first cuff situated in the opening being configured to receive sutures that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium and allow the endocardium to the pulled flush or substantially flush with the inlet around the connection end and the connection end extending no more than 5mm beyond the endocardium.
Nguyen discloses a cannula attachment system (e.g. Figs. 9-12,16) comprising: a first cuff (e.g. flexible layer “first cuff” 68 or 80, Fig. 12,16), having a portion configured to be situated in an opening formed in a myocardium of a heart (e.g. flexible layer “first cuff” 68/80, coupled with outside surface of the inflow cannula in a close fitting arrangement and extending through an opening formed in the heart, Figs. 12,16, para. [0075]-[0076]), wherein the first cuff is configured to receive sutures (e.g. suture may extend distally…into the outer surface of the flexible layer 68/80, para. [0078], [0082]), the first cuff defining a first central opening (e.g. central opening within flexible layer 68/80, Figs. 12,16, para. [0075]), wherein the portion of the first cuff situated in the opening being configured to receive sutures that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium allowing the endocardium to the pulled flush or substantially flush with the inlet around the connection end (e.g. sutures extending through the first cuff situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium, Fig. 16, para. [0082], the structure of the “first cuff” 68 or 80 of Nguyen is configured to receive sutures through the entire portion of the first cuff configured to be situated in the opening since there are no structural differences between a cuff that receives sutures through a portion of the first cuff and through an entire portion of the first cuff configured to be situated in the opening, the structure of the first cuff 68 or 80 of Nguyen would be capable of receiving sutures through the entire portion of the first cuff configured to be situated in the opening). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular body of Larose to include the portion of the first cuff situated in the opening being configured to receive sutures that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium allowing the endocardium to be pulled substantially flush with the inlet, as taught by Nguyen, to securely attach the cuff to the heart wall.
Hideo teaches an inflow conduit and auxiliary artificial heart which discloses a cannula system (e.g. Figs. 2-3,6-7 and 9), comprising: a cannula defining an inlet (e.g. tube main body “cannula” 21, Figs. 2-3,6-7 and 9); a flange extending around the cannula (e.g. a flange portion 22, Figs. 2-3,6-7 and 9) ; and a first cuff extending around the cannula (e.g. joint portion “first cuff” 24, Figs. 2-3,6-7 and 9), wherein the first cuff covers at least half of an exterior surface of the cannula between the flange and the inlet (e.g. joint portion “first cuff” 24 covers at least half of an exterior surface of the tube main body, Figs. 2-3,6-7 and 9, para. [0030]). Hideo further discloses that the tip portion 25 protrudes by a predetermined amount from the surface of the wall portion H4. The range of the predetermined amount of protrusion is preferably about 0.2 times to about 1.5 times the thickness of the wall portion H4 of the heart H1 as a reference. When the longitudinal dimension of the tip 25 is longer than the above range, as shown in FIG. 7, a stasis region R in which the blood flow is stagnant is formed around the tip 25. On the other hand, when the longitudinal dimension of the tip 25 is shorter than the above range, as shown in FIG. 8, the wall H4 of the heart H1 grows and overcomes the tip 25, and the insertion portion 23 invades inside (e.g. Figs. 6-8, para. [0032]-[0033]). Therefore, it would have been well within the level of ordinary skill in the art to select the length that the cannula extends beyond the endocardium including modifying the system of Larose modified by Nguyen to include the cannula being configured to extend into a chamber of a heart not more than 5 mm beyond an endocardium of the heart to provide a length that reduces the likelihood of the heart wall growing into the main tube while also reducing blood stagnation as taught by Hideo.
In reference to at least claim 13
Larose modified by Nguyen and Hideo renders obvious a device according to claim 12. Larose further discloses wherein the second cuff defines a diameter greater than a diameter of the first cuff (e.g. Figs. 6-7).
In reference to at least claim 14
Larose modified by Nguyen and Hideo renders obvious a device according to claim 12 but does not explicitly teach the second cuff being integrally formed with the first cuff. It would have been obvious to one having ordinary skill in the art before the effective filing date to make the second cuff being integrally formed with the first cuff, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art, see MPEP 2144.04.
In reference to at least claim 16
Larose teaches a flanged heart tissue blocker which disclose a cannula system for connecting a pump to a heart (e.g. Figs. 1-7), comprising: a cylindrical cannula having a first end defining an inlet, the cannula configured for connection to a myocardium of a heart such that the first end extends through a myocardium of the heart and the inlet is in fluid communication with a chamber of the heart (e.g. inflow cannula 400 is placed within opening of the retaining element, Figs. 1-7, para. [0044]-[0045]); a first cuff configured to receive sutures (e.g. apparatus 100 includes member 10 and retaining element 12 that includes tubular body 14 which together define the “first cuff, Figs. 1-7, para. [0037]-[0039]; proximal portion of the retaining element are configured to receive sutures, para. [0043]) and directly fixed to the cannula adjacent the inlet (e.g. flange element “flange” that is part of clamp 210 contacts member 10 and retaining element 12 that includes tubular body 14 which together define the “first cuff” and has “a portion” situated in the opening of the heart, Figs. 1-7), the first cuff sized to be received in an opening through the myocardium of the heart (e.g. apparatus 100 includes member 10 and retaining element 12 that includes tubular body 14 which together define the “first cuff” and extends into an opening formed through the myocardium, Figs. 1-7, para. [0037]-[0039]); a second cuff configured to receive the sutures such that the sutures extend through the second cuff and the first cuff, the second cuff having a first side configured to connect an exterior of the myocardium of the heart (e.g. mounting ring 200 “second cuff” extends around the cannula adjacent the flange of the clamp 210 and is fixed to the cannula using the flange of clamp 210 and contacts an exterior of the myocardium, Figs. 3,5-6, para. [0040], [0044], [0046]; mounting ring received sutures including in which strips from the retaining element 12 can be sutured to the fabric ring of the mounting ring, Figs. 3, 5-7, para. [0040]-[0046]), a connector extending around the cannula, the connector having a first side configured to contact an exterior of the myocardium of the heart and a second side that contacts the first side of the second cuff to fix the second cuff to the cannula (e.g. mounting ring 200 “second cuff” extends around the cannula adjacent the flange of the clamp 210 and is fixed to the cannula the flange of clamp 210, Figs. 3,5-6, para. [0040], [0044], [0046]). Larose further discloses the first cuff “being composed of a flexible material such as composed of one or more layers of a biocompatible fabric, plastic, or metal, e.g., tubular body 14 may be composed of one or more composite layers of knitted polymers, such as polyethylene terephthalate (“PET”)” (e.g. para. [0037]) but does not explicitly teach a distance extending in an axial direction of the cannula from the first side of the connector to the inlet is less than 10 mm, the portion of the first cuff situated in the opening being configured to receive two or more sutures through a pledget that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium allowing the endocardium to be pulled flush or substantially flush with an inlet around a connection end and the connection end extending no more than 5mm beyond the endocardium into the heart chamber.
Hideo teaches an inflow conduit and auxiliary artificial heart which discloses a cannula system (e.g. Figs. 2-3,6-7 and 9), comprising: a cannula defining an inlet (e.g. tube main body “cannula” 21, Figs. 2-3,6-7 and 9); a flange extending around the cannula (e.g. a flange portion 22, Figs. 2-3,6-7 and 9) ; and a first cuff extending around the cannula (e.g. joint portion “first cuff” 24, Figs. 2-3,6-7 and 9), wherein the first cuff covers at least half of an exterior surface of the cannula between the flange and the inlet (e.g. joint portion “first cuff” 24 covers at least half of an exterior surface of the tube main body, Figs. 2-3,6-7 and 9, para. [0030]). Hideo further discloses that the tip portion 25 protrudes by a predetermined amount from the surface of the wall portion H4. The range of the predetermined amount of protrusion is preferably about 0.2 times to about 1.5 times the thickness of the wall portion H4 of the heart H1 as a reference. When the longitudinal dimension of the tip 25 is longer than the above range, as shown in FIG. 7, a stasis region R in which the blood flow is stagnant is formed around the tip 25. On the other hand, when the longitudinal dimension of the tip 25 is shorter than the above range, as shown in FIG. 8, the wall H4 of the heart H1 grows and overcomes the tip 25, and the insertion portion 23 invades inside (e.g. Figs. 6-8, para. [0032]-[0033]). Hideo further discloses that the tip portion 25 protrudes by a predetermined amount from the surface of the wall portion H4. The range of the predetermined amount of protrusion is preferably about 0.2 times to about 1.5 times the thickness of the wall portion H4 of the heart H1 as a reference. When the longitudinal dimension of the tip 25 is longer than the above range, as shown in FIG. 7, a stasis region R in which the blood flow is stagnant is formed around the tip 25. On the other hand, when the longitudinal dimension of the tip 25 is shorter than the above range, as shown in FIG. 8, the wall H4 of the heart H1 grows and overcomes the tip 25, and the insertion portion 23 invades inside (e.g. Figs. 6-8, para. [0032]-[0033]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Larose to include a distance extending in an axial direction of the cannula from the first side of the connector to the inlet is less than 10 mm as taught by Hideo to provide an exterior surface to the cannula that reduces the risk of inflammation and infection. Additionally, it would have been well within the level of ordinary skill in the art to select the length that the cannula extends beyond the endocardium including modifying the system of Larose to include the cannula being configured to extend into a chamber of a heart not more than 5 mm beyond an endocardium of the heart to provide a length that reduces the likelihood of the heart wall growing into the main tube while also reducing blood stagnation as taught by Hideo.
Nguyen discloses a cannula attachment system (e.g. Figs. 9-12,16) comprising: a first cuff (e.g. flexible layer “first cuff” 68 or 80, Fig. 12,16), having a portion configured to be situated in an opening formed in a myocardium of a heart (e.g. flexible layer “first cuff” 68/80, coupled with outside surface of the inflow cannula in a close fitting arrangement and extending through an opening formed in the heart, Figs. 12,16, para. [0075]-[0076]), wherein the first cuff is configured to receive sutures (e.g. suture may extend distally…into the outer surface of the flexible layer 68/80, para. [0078], [0082]), the first cuff defining a first central opening (e.g. central opening within flexible layer 68/80, Figs. 12,16, para. [0075]), wherein the portion of the first cuff situated in the opening being configured to receive sutures that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium (e.g. sutures extending through the first cuff situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium, Fig. 16, para. [0082], the structure of the “first cuff” 68 or 80 of Nguyen is configured to receive sutures through the entire portion of the first cuff configured to be situated in the opening since there are no structural differences between a cuff that receives sutures through a portion of the first cuff and through an entire portion of the first cuff configured to be situated in the opening, the structure of the first cuff 68 or 80 of Nguyen would be capable of receiving sutures through the entire portion of the first cuff configured to be situated in the opening). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the tubular body of Larose modified by Hideo to include the portion of the first cuff situated in the opening being configured to receive sutures that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium allowing the endocardium to be pulled substantially flush with the inlet, as taught by Nguyen, to securely attach the cuff to the heart wall.
In reference to at least claim 19
Larose modified by Nguyen and Hideo renders obvious a system according to claim 16. Larose further discloses wherein the connector includes the flange extending around the cannula and wherein the second cuff and the flange are configured to contact the exterior of the myocardium of the heart (e.g. mounting ring 200 “second cuff” extends around the cannula adjacent the flange of the clamp 210 and is fixed to the cannula by the flange of clamp 210 which both contact an exterior of the myocardium of the heart, Figs. 3,5-6, para. [0040]-[0041], [0044], [0046]).
In reference to at least claim 20
Larose modified by Nguyen and Hideo renders obvious a system according to claim 16. Hideo further discloses that the tip portion 25 protrudes by a predetermined amount from the surface of the wall portion H4. The range of the predetermined amount of protrusion is preferably about 0.2 times to about 1.5 times the thickness of the wall portion H4 of the heart H1 as a reference. When the longitudinal dimension of the tip 25 is longer than the above range, as shown in FIG. 7, a stasis region R in which the blood flow is stagnant is formed around the tip 25. On the other hand, when the longitudinal dimension of the tip 25 is shorter than the above range, as shown in FIG. 8, the wall H4 of the heart H1 grows and overcomes the tip 25, and the insertion portion 23 invades inside (e.g. Figs. 6-8, para. [0032]-[0033]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Larose to include a distance extending in an axial direction of the cannula from the first side of the connector to the inlet is less than 8 mm to provide a length that reduces the likelihood of the heart wall growing into the main tube while also reducing blood stagnation as taught by Hideo.
In reference to at least claim 29
Larose modified by Nguyen and Hideo renders obvious a device according to claim 1. Larose further discloses a flange extending around the cannula (e.g. flange element that is part of clamp 210, Figs. 1-7) but does not explicitly teach the flange is integrally formed with the cannula. It would have been obvious to one having ordinary skill in the art before the effective filing date to make the flange integrally formed with the cannula, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art, see MPEP 2144.04.
In reference to at least claim 30
Larose modified by Nguyen and Hideo renders obvious a device according to claim 12. Larose further discloses the flange extending around the cannula adjacent the second cuff (e.g. flange element that is part of clamp 210, Figs. 1-7).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281840 to Larose et al. (Larose) in view of US 2018/0050143 to Nguyen et al. (Nguyen) and JP 2012213517 to Hideo et al. (Hideo) as applied to claim 12 further in view of US 2011/0118766 to Reichenbach et al. (Reichenbach) (previously cited).
In reference to at least claim 15
Larose modified by Nguyen and Hideo renders obvious a system according to claim 12 but does not explicitly teach the first end defines a groove extending around the cannula adjacent the inlet, and wherein the first cuff includes a fastener received in the groove to fasten the first cuff directly to the cannula.
Reichenbach teaches an attachment system, device and method which discloses a cannula system that includes an attachment ring that includes a cuff (e.g. 35, Figs. 4a-4b) that is placed within a groove extending around a cannula (e.g. groove between band 32 and 33, Figs. 4a-4b) in which the cuff is attached to or pressure fitted between the bands (e.g. para. [0125]-[0127]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Larose modified by Nguyen to include the first end defines a groove extending around the cannula adjacent the inlet, and wherein the first cuff includes a fastener received in the groove to fasten the first cuff directly to the cannula as taught by Reichenbach to provide further securement between the cannula and the cuff to reduce any potential disconnect between the cuff and cannula.
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281840 to Larose et al. (Larose) in view of US 2018/0050143 to Nguyen et al. (Nguyen) and JP 2012213517 to Hideo et al. (Hideo) as applied to claims 16 and 30 further in view of US 2012/0143141 to Verkaik et al. (Verkaik) (previously cited).
In reference to at least claim 31
Larose modified by Nguyen and Hideo renders obvious a system according to claim 30. Larose further discloses a flange on a clamping device for fixing the second cuff to the cannula (e.g. Figs. 5-7, para. [0040], [0044]- [0046]) but does not explicitly teach the clamping device including a nut threaded on the cannula wherein the flange and the nut sandwich the second cuff to directly fix the second cuff to the cannula. It was well known in the art before the effective filing date of the claimed invention to use threaded nuts or screws as components within cannula connecting devices for providing securement between the components as evidence by Verkaik (e.g. Figs. 8A-8BC, 13-15, para. [0076], [0088]) allowing variable distance between the components able to conform to variable geometries (e.g. para. [0011], [0038], [0092]). Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the clamping device of Larose modified by Nguyen and Hideo to include a nut threaded on the cannula wherein the flange and the nut sandwich the second cuff to directly fix the second cuff to the cannula to provide an alternative technique for providing the second cuff on the clamping device for securement to the cannula allowing variable distance between the components able to conform to variable geometries.
In reference to at least claim 32
Larose modified by Nguyen and Hideo renders obvious a system according to claim 16. Larose further discloses the connector includes a flange extending around the cannula and wherein the second cuff and the flange are configured to contact the exterior of the myocardium of the heart (e.g. mounting ring 200 “second cuff” extends around the cannula adjacent the flange of the clamp 210 and is fixed to the cannula the flange of clamp 210 which both contact an exterior of the myocardium of the heart, Figs. 3,5-6, para. [0040]-[0041], [0044], [0046]) but does not explicitly teach the clamping device including a nut threaded on the cannula wherein the flange and the nut sandwich the second cuff to directly fix the second cuff to the cannula. It was well known in the art before the effective filing date of the claimed invention to use threaded nuts or screws as components within cannula connecting devices for providing securement between the components as evidence by Verkaik (e.g. Figs. 8A-8BC, 13-15, para. [0076], [0088]) allowing variable distance between the components able to conform to variable geometries (e.g. para. [0011], [0038], [0092]). Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the clamping device of Larose modified by Nguyen and Hideo to include a nut threaded on the cannula wherein the flange and the nut sandwich the second cuff to directly fix the second cuff to the cannula to provide an alternative technique for providing the second cuff on the clamping device for securement to the cannula allowing variable distance between the components able to conform to variable geometries.
Response to Arguments
Rejections under 103
Applicant’s arguments, see pgs. 8-9, filed 9/23/2025, with respect to the rejection(s) of claim(s) 12-14 and 30 under 35 USC 103 using Larose and Nguyen have been fully considered and are persuasive in view of the claim amendments now reciting the connection not extending more than 5mm beyond the endocardium into the heart. Therefore, the USC 103 using Larose and Nguyen against claim(s) 12-14 and 30 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hideo, see rejection above. It is noted that there are still numerous 112 issues with the claims, see claim rejection above, the claims have been reviewed and search as best understood, see claim rejection above. Additionally, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant argues various features not being disclosed by a particular reference which was not indicated as teaching that particular feature within the rejection, e.g. applicant argues Larose does not teach the first cuff situated in the opening being configured to receive sutures that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium, however within the rejection such teachings have not been indicated as being taught by Larose. It is the combination of Larose, Nguyen and Hideo which render obvious the claimed invention, see claim rejections above. Regarding the sutures as stated within the 112 rejection above, it is unclear what structural features of the suture applicant is intending to encompass when reciting “allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”. It does not appear from the specification that there are any particular or special features of the sutures or any particular or special sutures that are utilized within cannula system. Instead it appears that the cannula system utilizes ordinary sutures which are often used for surgical procedures that require attachment which is how the claims have been interpreted.
Applicant’s arguments, see pgs. 9, filed 9/23/2025, with respect to the rejection(s) of claim(s) 16-17 and 19-20 under 35 USC 103 using Larose, Nguyen and Hideo have been fully considered but are not persuasive. It is noted that there are still numerous 112 issues with the claims, see claim rejection above, the claims have been reviewed and search as best understood, see claim rejection above. Additionally, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant argues various features not being disclosed by a particular reference which was not indicated as teaching that particular feature within the rejection, e.g. applicant argues Larose does not teach the first cuff situated in the opening being configured to receive sutures that extend from the exterior of the myocardium, through the entire portion of the first cuff configured to be situated in the opening, through an endocardium of the heart, and through a full thickness of the myocardium to the exterior of the myocardium, however within the rejection such teachings have not been indicated as being taught by Larose. It is the combination of Larose, Nguyen and Hideo which render obvious the claimed invention, see claim rejections above. Hideo discloses that the tip portion 25 protrudes by a predetermined amount from the surface of the wall portion H4. The range of the predetermined amount of protrusion is preferably about 0.2 times to about 1.5 times the thickness of the wall portion H4 of the heart H1 as a reference. When the longitudinal dimension of the tip 25 is longer than the above range, as shown in FIG. 7, a stasis region R in which the blood flow is stagnant is formed around the tip 25. On the other hand, when the longitudinal dimension of the tip 25 is shorter than the above range, as shown in FIG. 8, the wall H4 of the heart H1 grows and overcomes the tip 25, and the insertion portion 23 invades inside (e.g. Figs. 6-8, para. [0032]-[0033]). Therefore, it would have been well within the level of one having ordinary skill in the art before the effective filing date of the claimed invention to select the length that the cannula extends beyond the endocardium including modifying the system of Larose modified by Nguyen and Hideo to include the cannula being configured to extend into a chamber of a heart not more than 5 mm beyond an endocardium of the heart, as taught by Hideo, to provide a length that reduces the likelihood of the heart wall growing into the main tube while also reducing blood stagnation. It appears as evidence by applicant’s declaration that Larose and Nguyen would provide a tipless cannula in certain circumstances. As stated above, it is unclear what structural features of the suture applicant is intending to encompass when reciting “allow the endocardium to be pulled flush or substantially flush with an inlet around a connection end”. It does not appear from the specification that there are any particular or special features of the sutures or any particular or special sutures that are utilized within cannula system. Instead it appears that the cannula system utilizes ordinary sutures which is often used for surgical procedures that require attachment which is how the claims have been interpreted.
Regarding secondary considerations, see pg. 11-12 of response filed 9/23/2025, MPEP 716.01(b) states “to be of probative value, any secondary evidence must be related to the claimed invention”. Throughout the declaration under 37 CFR 1.132 applicant makes reference to a “tipless cannula” but fails to show how a “tipless cannula” relates to the claimed invention which recites “no more than 5mm beyond the endocardium into the heart chamber”. Further, MPEP 716.01(c) states “Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference,” Applicant shows the Evaheart cannula system and a conventional heart assist device but does not provide any further details regarding the Evaheart cannula system or the conventional heart assist device which are shown and how it relates to the claimed invention and to the prior art that has been used against the claims. MPEP 716.02(e) states “An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness.” Applicant makes general statements on why the prior art references would not have been obvious but does not compare the claimed subject matter with the closest prior art. Instead applicant states the benefits of the invention in regards to a conventional heart assist device but fails to provide details regarding the conventional heart assist device applicant is referring to and how it relates to the prior art that has been used within the rejection. Further, there is no disclosure within the declaration regarding the length of the cannula system that was used with the Evaheart cannula system or the length of the cannula system used in the conventional heart assist device that is shown. The declaration provides several arguments regarding potential benefits of the invention but fails to provide how these benefits relate to the claimed invention and how the benefits show unexpected results, commercial success, solution of a long-felt need and/or inoperability of the prior art. It is noted that reference to the teachings of Hideo which has been used within the rejection for the limitations related to 5mm beyond the endocardium have not been discussed within the 1.132 declaration. For these reasons the declaration under 1.132 is insufficient to overcome the obviousness rejections.
Conclusion
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