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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11517737. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and the US Patent both claim an expandable anchoring apparatus, conical proximal portion and a distal annulus which is advanced over a cardiac pump in the aorta. The current application is a more general claim variant of the US Patent more narrower claim language.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12064613. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and the US Patent both claim an expandable anchoring apparatus, conical proximal portion and a distal annulus which is advanced over a cardiac pump in the aorta. The current application is a more general claim variant of the US Patent more narrower claim language.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The term petal is not described or found in the Specification. The figures show elements 216A-C, 316A-C, but it is only described as proximal portions forming a loop in paragraphs 0067, 0071 of the Specification. It is unclear what the petal for the anchoring device. Are the proximal portion loops the petals? Are the petals different from these proximal loops?
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5, 9-15, 17, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jarvik (US 20100249489) in view of Aboul-Hosn (US 20060100565), both cited previously.
Regarding claim 1, Jarvik discloses anchoring a cardiac pump 8 within a patient’s aorta (Fig. 1, section 0026, a prosthetic tissue valve 2, secured to the aorta at the annulus of the aortic valve 4, by an expandable metal stent), the method comprising: advancing a cannula 12, 16 of a cardiac pump 8 through the aorta into a heart 10 of the patient such that an inflow distal section 40 of the cannula of the cardiac pump is positioned on a first side of an aortic valve 14 (Fig. 1, section 0028, the inflow side of the pump, where the flow enters as indicated by the arrows, may include a cage 40 to prevent it from becoming blocked with myocardial tissue) and an outflow proximal section 18 of the cannula 16 of the cardiac pump 8 (Fig. 1, section 0026, The outflow of the pump is connected to a conduit 12 within the ventricle that channels blood flow across the aortic valve at 14 in the position of the non-coronary cusp of the natural aortic valve. A portion of the conduit 16 extends into the aorta distal to the valve and discharges blood as indicated by arrow 18); and radially expanding an expandable anchoring device 6, 66 coupled to the cardiac pump 8, 64 within the aorta 4 such that the expandable anchoring device 6, 66 engages 68, 70 an inner wall of the aorta (Figs. 1, 4, section 0026, 0030, secured to the aorta at the annulus of the aortic valve 4, by an expandable metal stent. The natural aortic valve 62 connects a blood pump 64 to an expandable stent 66 anchored in the aorta. To increase the strength of the grip of the stent to the aortic wall, hooks 68, 70, may be included), wherein the expandable anchoring device is disposed about the cannula of the cardiac pump such that the cannula extends through the expandable anchoring device (section 0004, The device includes a cannula and an expandable stent around the cannula used to enlarge the diameter of the cannula after insertion).
However, Jarvik does not specifically disclose a plurality of outflow windows is positioned on a second side of the aortic valve. Aboul-Hosn discloses a cardiac pump 50 that is placed within the aorta (Fig. 15, section 0018, The inner cannula may further be positioned through the aortic valve and disposed inside the left ventricle to transport blood deposited in the aorta thereby unloading the left ventricle), the pump has a plurality of outflow windows 64 is positioned on a second side of the aortic valve (Figs. 6A-B, 15, section 0052, The distal opening of the housing body 52 of the pump 50 may be covered with a housing cap 60. The housing cap 60 is preferably constructed of stainless steel or rigid polymer and may be formed with a plurality of outflow windows 64). This allows the proper direction of blood to flow out the pump by multiple windows and through the outer tube into the aorta. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the device of Jarvik by adding a plurality of outflow windows as taught by Aboul-Hosn in order to facilitate proper direction of blood to flow out the pump by multiple windows and through the outer tube into the aorta.
Regarding claim 2, Jarvik discloses the expandable anchoring device 32 is coupled to the cardiac pump 24 proximal of outflow window 12 (Fig. 2 shows two outflow arrows from at least two outflow windows from the pump 24 with the anchor 32 being proximal the outflow arrows, since the figures 1-2 also show plurality of inflow arrows for entering the pump via plurality of inflow windows). However, Jarvik does not specifically disclose a plurality of outflow windows is positioned on a second side of the aortic valve. Aboul-Hosn discloses a cardiac pump 50 that is placed within the aorta (Fig. 15, section 0018, The inner cannula may further be positioned through the aortic valve and disposed inside the left ventricle to transport blood deposited in the aorta thereby unloading the left ventricle), the pump has a plurality of outflow windows 64 is positioned on a second side of the aortic valve (Figs. 6A-B, 15, section 0052, The distal opening of the housing body 52 of the pump 50 may be covered with a housing cap 60. The housing cap 60 is preferably constructed of stainless steel or rigid polymer and may be formed with a plurality of outflow windows 64). This allows the proper direction of blood to flow out the pump by multiple windows and through the outer tube into the aorta.
Regarding claim 3, Jarvik discloses the anchoring device has a conical shape in which a distal portion of the expandable anchoring device is coupled to the cardiac pump and a proximal portion of the expandable anchoring device extends radially outward relative to the distal portion (Fig. 2, Broadest reasonable interpretation of Fig. 2 shows the stent 32 is wider when engaging the aorta and narrows into a conical shape from the filaments 26, 28 30 that attach to the pump in the left ventricle).
Regarding claim 4, Jarvik discloses the distal portion of the expandable anchoring device comprises portions that are overlapping when in a constrained configuration and are non-overlapping when in an unconstrained configuration (section 0026, The term "expandable metal stent" is intended to include fenestrated metallic structures, metallic structures fabricated from wire or sheet stock, and hinged folding structures that can be inserted into a blood vessel when folded to a first smaller diameter, and then unfolded to a second larger diameter. Broadest reasonable impetration of the metal sent is that when folded the wires of the stent will be overlapping until expanded).
Regarding claim 5, Jarvik discloses the proximal portion of the expandable anchoring device 6, 32 comprises a plurality of proximal portions that are configured to expand equidistant from a central axis of the cannula of the cardiac pump when unconstrained (Figs. 1-5, show the expandable stent is deployed outwardly to engage the aortic wall at an equidistant so as to hold the device in place).
Regarding claim 9, Jarvik discloses a constraining member 114 arranged over the expandable anchoring device 6, 32, 94, 98 to constrain the expandable anchoring device in a constrained configuration for delivery of the expandable anchoring apparatus within the aorta (Fig. 7-8, section 0033, Two spring struts are shown within the catheter. The catheter may be inserted across the aortic valve by a transapical approach and end of the catheter positioned in the aorta at the level where it is intended for the hooks to anchor the struts. Then, holding the pusher rod steady and pulling back on the catheter ejects the struts which spring outwardly and imbed the hooks and barbs into the aortic tissue).
Regarding claim 10, Jarvik discloses the constraining member 114 is a sheath arranged around the expandable anchoring device 6, 32, 94, 98 to constrain the expandable anchoring device in the constrained configuration (Fig. 7, section 0033, Two spring struts are shown within the catheter).
Regarding claim 11, Jarvik discloses actuating the sheath 114 to deploy the expandable anchoring device 6, 32, 94, 98 radially outward into engagement with the inner wall of the aorta (Fig. 8, section 0033, a pusher rod, 118 is illustrated. During insertion, the catheter may be inserted across the aortic valve by a transapical approach and end of the catheter positioned in the aorta at the level where it is intended for the hooks to anchor the struts. Then, holding the pusher rod steady and pulling back on the catheter ejects the struts which spring outwardly and imbed the hooks and barbs into the aortic tissue).
Regarding claim 12, Jarvik discloses a cardiac pump 8 comprising a cannula 12, 16 configured to draw blood from a left ventricle of a heart of a patient into an inflow distal section 40 of the cardiac pump (Figs. 1-2, 6, section 0019, 0026 0028, expandable stent is shown in the aorta distal to the valve and a miniature blood pump is within the left ventricle. a miniature rotary blood pump located in left ventricle and anchored to the aorta. the inflow side of the pump, where the flow enters as indicated by the arrows, may include a cage 40 to prevent it from becoming blocked with myocardial tissue), and the cardiac pump 8 configured to release the blood 18 into an aorta of the patient from an outflow window 12, 16 in an outflow proximal section of the cardiac pump (Fig. 1, section 0026, The outflow of the pump is connected to a conduit 12 within the ventricle that channels blood flow across the aortic valve at 14 in the position of the non-coronary cusp of the natural aortic valve. A portion of the conduit 16 extends into the aorta distal to the valve and discharges blood as indicated by arrow 18. Fig. 2 shows two outflow arrows from at least outflow window from the pump 24 with the anchor 32 being proximal the outflow arrows, since the figures 1-2 also show plurality of inflow arrows for entering the pump via plurality of inflow windows); and an expandable anchoring device 6, 66 including a distal portion coupled to the cardiac pump 8 (Figs. 1, 4) and a proximal portion configured to circumferentially expand to an unconstrained configuration (section 0026, The term "expandable metal stent" is intended to include fenestrated metallic structures, metallic structures fabricated from wire or sheet stock, and hinged folding structures that can be inserted into a blood vessel when folded to a first smaller diameter, and then unfolded to a second larger diameter), the proximal portion 26 having a conical shape that has an outer diameter greater 32 than a diameter of the patient’s aorta 38 to thereby engage an inner wall of the aorta when expanded (Fig. 2, Broadest reasonable interpretation of Fig. 2 shows the stent 32 is wider when engaging the aorta and narrows into a conical shape from the filaments 26, 28 30 that attach to the pump in the left ventricle); wherein the proximal portion 16 of the expandable anchoring device 6 extends proximal of the outflow window 12, 16 (Figs. 1, 2 shows two arrows where the blood outflow is leaving the pump. section 0026, The outflow of the pump is connected to a conduit 12 within the ventricle that channels blood flow across the aortic valve at 14 in the position of the non-coronary cusp of the natural aortic valve. A portion of the conduit 16 extends into the aorta distal to the valve and discharges blood as indicated by arrow 18), wherein the expandable anchoring device is disposed about the cannula of the cardiac pump such that the cannula extends through the expandable anchoring device (section 0004, The device includes a cannula and an expandable stent around the cannula used to enlarge the diameter of the cannula after insertion).
However, Jarvik does not specifically disclose a plurality of outflow windows is positioned on a second side of the aortic valve. Aboul-Hosn discloses a cardiac pump 50 that is placed within the aorta (Fig. 15, section 0018, The inner cannula may further be positioned through the aortic valve and disposed inside the left ventricle to transport blood deposited in the aorta thereby unloading the left ventricle), the pump has a plurality of outflow windows 64 is positioned on a second side of the aortic valve (Figs. 6A-B, 15, section 0052, The distal opening of the housing body 52 of the pump 50 may be covered with a housing cap 60. The housing cap 60 is preferably constructed of stainless steel or rigid polymer and may be formed with a plurality of outflow windows 64). This allows the proper direction of blood to flow out the pump by multiple windows and through the outer tube into the aorta. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the device of Jarvik by adding a plurality of outflow windows as taught by Aboul-Hosn in order to facilitate proper direction of blood to flow out the pump by multiple windows and through the outer tube into the aorta.
Regarding claim 13, Jarvik discloses the distal portion of the expandable anchoring device 32 is coupled to the cardiac pump 24 proximal of the plurality of outflow windows 12 (Fig. 2 shows two outflow arrows from outflow window from the pump 24 with the anchor 32 being proximal the outflow arrows, since the figures 1-2 also show plurality of inflow arrows for entering the pump via plurality of inflow windows). However, Jarvik does not specifically disclose a plurality of outflow windows is positioned on a second side of the aortic valve. Aboul-Hosn discloses a cardiac pump 50 that is placed within the aorta (Fig. 15, section 0018, The inner cannula may further be positioned through the aortic valve and disposed inside the left ventricle to transport blood deposited in the aorta thereby unloading the left ventricle), the pump has a plurality of outflow windows 64 is positioned on a second side of the aortic valve (Figs. 6A-B, 15, section 0052, The distal opening of the housing body 52 of the pump 50 may be covered with a housing cap 60. The housing cap 60 is preferably constructed of stainless steel or rigid polymer and may be formed with a plurality of outflow windows 64). This allows the proper direction of blood to flow out the pump by multiple windows and through the outer tube into the aorta.
Regarding claim 14, Jarvik discloses the expandable anchoring device includes a plurality of petals 26, 28, 30 , wherein each petal has a base coupled to the cardiac pump 24 and a proximal tip 34, 36 extending proximally and radially outward (Section 0027, FIG. 2 the blood pump 24 hangs and is attached by three filaments or cords 26, 28, 30 from a stent 32 affixed within the aorta 38).
Regarding claim 15, Jarvik discloses the proximal tip 34, 36 of each of the plurality of petals defines at least one barb for securing the expandable anchoring device to the aorta (Fig. 2, section 0027, to better anchor the stent in light of this force, hooks 34, 36 that penetrate the aortic wall are provided on stent).
Regarding claim 17, Jarvik discloses a cardiac pump 8 comprising a cannula 12 configured to draw blood from a left ventricle of a heart of a patient into an inflow distal section 40 of the cardiac pump (Fig. 1, section 0028, the inflow side of the pump, where the flow enters as indicated by the arrows, may include a cage 40 to prevent it from becoming blocked with myocardial tissue), and the cardiac pump 8 configured to release the blood into an aorta of the patient from outflow window 12, 16 in an outflow proximal section of the cardiac pump (Fig. 1, section 0026, The outflow of the pump is connected to a conduit 12 within the ventricle that channels blood flow across the aortic valve at 14 in the position of the non-coronary cusp of the natural aortic valve. A portion of the conduit 16 extends into the aorta distal to the valve and discharges blood as indicated by arrow 18. Fig. 2 shows two outflow arrows from outflow window from the pump 24 with the anchor 32 being proximal the outflow arrows, since the figures 1-2 also show plurality of inflow arrows for entering the pump via plurality of inflow windows); and an expandable anchoring device 6, 32 66, including a distal portion 26, 28, 30 coupled to the cardiac pump 8 and a proximal portion 34, 36 configured to circumferentially expand to an unconstrained configuration (Fig. 1, 2, 4, section 0026-0027, The term "expandable metal stent" is intended to include fenestrated metallic structures, metallic structures fabricated from wire or sheet stock, and hinged folding structures that can be inserted into a blood vessel when folded to a first smaller diameter, and then unfolded to a second larger diameter. the blood pump 24 hangs by three filaments or cords 26, 28, 30 from a stent 32 affixed within the aorta 38. The filaments or cords are in tension as a result of the forces created by the pump and blood as it is thrust across the aortic valve. To better anchor the stent in light of this force, hooks 34, 36 that penetrate the aortic wall are provided on stent), the proximal portion having a conical shape that has an outer diameter greater than a diameter of the patient’s aorta to thereby engage an inner wall of the aorta when expanded (Fig. 2, Broadest reasonable interpretation of Fig. 2 shows the stent 32 is wider when engaging the aorta and narrows into a conical shape from the filaments 26, 28 30 that attach to the pump in the left ventricle); wherein the expandable anchoring device 32 includes a plurality of petals 26, 28, 30, wherein each petal has a base coupled to the cardiac pump 24 and a proximal tip 32 extending proximally and radially outward (Section 0027, FIG. 2 the blood pump 24 hangs by three filaments or cords 26, 28, 30 from a stent 32 affixed within the aorta 38), wherein the expandable anchoring device is disposed about the cannula of the cardiac pump such that the cannula extends through the expandable anchoring device (section 0004, The device includes a cannula and an expandable stent around the cannula used to enlarge the diameter of the cannula after insertion).
However, Jarvik does not specifically disclose a plurality of outflow windows is positioned on a second side of the aortic valve. Aboul-Hosn discloses a cardiac pump 50 that is placed within the aorta (Fig. 15, section 0018, The inner cannula may further be positioned through the aortic valve and disposed inside the left ventricle to transport blood deposited in the aorta thereby unloading the left ventricle), the pump has a plurality of outflow windows 64 is positioned on a second side of the aortic valve (Figs. 6A-B, 15, section 0052, The distal opening of the housing body 52 of the pump 50 may be covered with a housing cap 60. The housing cap 60 is preferably constructed of stainless steel or rigid polymer and may be formed with a plurality of outflow windows 64). This allows the proper direction of blood to flow out the pump by multiple windows and through the outer tube into the aorta. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the device of Jarvik by adding a plurality of outflow windows as taught by Aboul-Hosn in order to facilitate proper direction of blood to flow out the pump by multiple windows and through the outer tube into the aorta.
Regarding claim 20, Jarvik discloses the proximal tips of the plurality of petals 26, 28, 30 are positioned proximal of the plurality of outflow windows (Fig. 2, shows the petals 26, 28, 30 proximal the outflow arrows. Broadest reasonable interpretation of Fig. 2 shows two outflow arrows from at least two outflow windows from the pump 24 with the anchor 32 being proximal the outflow arrows, since the figures 1-2 also show plurality of inflow arrows for entering the pump via plurality of inflow windows).
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jarvik (US 20100249489) in view of Aboul-Hosn (US 20060100565) and further in view of Agah (US 20210275795).
Regarding claim 6, Jarvik in view of Aboul-Hosn discloses the invention substantially as claimed however does not show the expandable anchoring device is releasably coupled to the cannula of the cardiac pump. Agah discloses the expandable anchoring device is releasably coupled to the cannula of the cardiac pump (section 0050, Each of the struts has a second end portion configured to be removably coupled to a corresponding attachment portion such that the blood pump can be removably coupled to the expandable member). This allow for ease of removal of the cardiac pump from the anchor device and from the implanted location. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Jarvik by adding the expandable anchoring device is releasably coupled to the cannula of the cardiac pump as taught by Agah in order to facilitate ease of removal of the cardiac pump from the anchor device and from the implanted location.
Regarding claim 7, Jarvik in view of Aboul-Hosn in view of Agah, specfically Jarvik discloses advancing the distal portion of the expandable anchoring apparatus 6, 32 over a proximal end 12, (portion of fig. 2 where outflow arrows are shown) of the cardiac pump 8, 24 to position the expandable anchoring device 32 within the aorta 38 (Fig. 1-2, section 0026, 0027, a prosthetic tissue valve 2, secured to the aorta at the annulus of the aortic valve 4, by an expandable metal stent 6. The blood pump 24 hangs by three filaments or cords 26, 28, 30 from a stent 32 affixed within the aorta 38).
Regarding claim 8, Jarvik in view of Aboul-Hosn in view of Agah, specfically Agah discloses the expandable anchoring apparatus is advanced over a proximal end of the cardiac pump after the cardiac pump has been advanced into the patient’s heart (section 0125-0126, The blood pump assembly is then advanced through the entry blood vessel and to a target blood vessel, at 44. As shown by the arrow II in FIG. 17, in some embodiments, the catheter assembly 671 can be advanced in a retrograde manner within the descending aorta, through the aortic arch and into the ascending aorta. The expandable member is then transitioned from the collapsed configuration to an expanded configuration such that the flexible segments contact an inner surface of the target blood vessel (e.g., the ascending aorta), at 46. In this manner, the blood pump is suspended within the target blood vessel by the struts). This allows for the placement of the pump to be implanted in the correct location before securing it to the cardiac wall.
Response to Arguments
Applicant's arguments filed 6/10/2026 have been fully considered but they are not persuasive. Examiner still finds that the term Petals lacks supports in the specification and is not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Examiner suggests amending the claims that pertain to the “petals” with language that is supported in the specification. Examiner also finds that Jarvick discloses wherein the expandable anchoring device is disposed about the cannula of the cardiac pump such that the cannula extends through the expandable anchoring device (section 0004, The device includes a cannula and an expandable stent around the cannula used to enlarge the diameter of the cannula after insertion).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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