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
Acknowledgement is made of applicant’s amendment which was received by the office on 6/27/2025. Claims 1-20 are currently pending and under examination.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 6/27/2025 clarifying the language of claims 10 and 12 the 112 rejections made against the claims in the office action of 3/27/2025 have been withdrawn.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 12-17 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 12 recites “wherein one or more of the at least one filter membrane” it is unclear how many filter membranes applicant is attempting to encompass when reciting “wherein one or more” and then “at least one filter membrane”. Is applicant stating at least one filter membrane or multiple filter membranes? Clarification is required. Claims 13-17 directly or indirectly depend from claim 12 and are also rejected to for the reasons stated above regarding claim 12.
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) 1-5, 10 and 18-20 are is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0256797 to Schenck et al. (Schenck) in view of US 2019/0105437 to Siess et al. (Siess).
In reference to claim 1
Schenck discloses a catheter pump system (e.g. catheter system 100A and 1300, Figs. 2,7) comprising: a catheter pump having a proximal end, a distal end, and an elongate body extending therebetween (e.g. catheter pump includes impeller assembly 116A/116 and catheter body including a proximal end and a distal end with elongate body 120A/120 and 174A/174 extending therebetween, Figs. 2,7), the elongate body defining at least an inner lumen (e.g. “catheter body can include one or more lumens”, para. [0087]); a fluid system located within the catheter pump (e.g. the “fluid system located within the catheter pump” includes the lumen(s) within the elongate body 120A/120 and 174A/174 used to “deliver fluids to and/or remove fluids from the catheter assembly 100A” from “the fluid handling system 350”, para. [0087]), the fluid system configured to pressurize the catheter pump with fluid (e.g. “the fluid handling system 350 can be configured to deliver fluids to and/or remove fluids from the catheter assembly 100A”, para. [0087]).
Schenck discloses at least one filter membrane (e.g. filter 1311, para. [0126]) configured to reduce an amount of particles within the fluid of the fluid system (e.g. “a filter 1311 can be employed to remove debris and other undesirable particles from the infusate or priming fluid before the catheter body 120 is infused or primed with liquid”, para. [0126]) but does not explicitly teach the at least one filter membrane being positioned within the catheter pump.
Siess teaches a blood pump with filter which discloses a catheter pump (e.g. 1, Figs. 11a, 12C) that includes a filter membrane (e.g. 50) that is positioned within the catheter pump (e.g. “has a filter 40 that is integrated directly in the blood flow inlet 3. “, para. [0055]; “In the final position as shown in FIG. 12c, the filter 50 covers the blood flow inlet 3 of the blood pump 1 “, para. [0056]) that prevents clots from entering the pump section (e.g. “In the final position as shown in FIG. 12c, the filter 50 covers the blood flow inlet 3 of the blood pump 1 to prevent clots from entering the pump section 2, which helps to avoid failure of the blood pump by clogging.”, para. [0056]).
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 system of Schenck to include the at least one filter membrane being positioned within the catheter pump near an inlet, as disclosed by Siess, in order to prevent clots from entering the pump aiding in avoiding failure of the pump by clogging (‘437, para. [0056]).
In reference to claim 2
Schenck modified by Siess renders obvious a system according to claim 1. Schenck further discloses wherein the fluid system comprises a fluid lumen located within the fluid system (e.g. “configured to deliver fluids to and/or remove fluids from the catheter assembly 100A”, therefore the “fluid system” inherently includes a lumen to deliver fluids to and/or remove fluids from the catheter assembly 100A, para. [0087]).
In reference to claim 3
Schenck modified by Siess renders obvious a system according to claim 1. Schenck further discloses wherein the at least one filter membrane is located within or proximate to the fluid lumen (e.g. “a filter 1311” located proximate before the catheter body is infused or primed with fluid, Fig. 7, para. [0126]). Siess also discloses wherein the at least one filter membrane is located within or proximate to the fluid lumen (e.g. “has a filter 40 that is integrated directly in the blood flow inlet 3. “, para. [0055]; “In the final position as shown in FIG. 12c, the filter 50 covers the blood flow inlet 3 of the blood pump 1 “, para. [0056]).
In reference to claim 4
Schenck modified by Siess renders obvious a system according to claim 3. Schenck further discloses wherein the at least one filter membrane is located proximate to the fluid lumen (e.g. “a filter 1311” located proximate before the catheter body is infused or primed with fluid, Fig. 7, para. [0126]) configured to capture debris within the fluid lumen while preserving flow of the fluid within the fluid system (e.g. “can be employed to remove debris and other undesirable particles from the infusate or priming fluid before the catheter body 120 is infused or primed with liquid”, para. [0126]). Siess also discloses wherein the at least one filter membrane is located proximate to the fluid lumen (e.g. “has a filter 40 that is integrated directly in the blood flow inlet 3. “, para. [0055]; “In the final position as shown in FIG. 12c, the filter 50 covers the blood flow inlet 3 of the blood pump 1 “, para. [0056]) and being a mesh membrane (e.g. “The filter 50 may have any suitable mesh structure and aperture configuration as described above.”, para. [0056]).
In reference to claim 5
Schenck modified by Siess renders obvious a system according to claim 4 except the mesh membrane being formed of a polyvinylpyrrolidone (PVP) coated nylon material. It would have been obvious to one having ordinary skill in the art at the time of the invention to make the mesh membrane is formed of a polyvinylpyrrolidone (PVP) coated nylon material, 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 claim 10
Schenck modified by Siess renders obvious a system according to claim 1. Schenck further discloses wherein the at least one filter membrane is located proximate the distal end of the catheter pump (e.g. “a filter 1311” located proximate before the catheter body is infused or primed with fluid, Fig. 7, para. [0126]). Siess also discloses wherein the at least one filter membrane is located proximate the distal end of the catheter pump (e.g. “has a filter 40 that is integrated directly in the blood flow inlet 3. “, para. [0055]; “In the final position as shown in FIG. 12c, the filter 50 covers the blood flow inlet 3 of the blood pump 1 “, para. [0056]).
In reference to claim 18
Schenck discloses a catheter pump system (e.g. catheter system 100A and 1300, Figs. 2,7) comprising: a catheter pump having a proximal end, a distal end, and an elongate body extending therebetween (e.g. catheter pump includes impeller assembly 116A/116 and catheter body including a proximal end and a distal end with elongate body 120A/120 and 174A/174 extending therebetween, Figs. 2,7), the elongate body defining at least an inner lumen (e.g. “catheter body can include one or more lumens”, para. [0087]); a fluid system located within the catheter pump (e.g. “the fluid handling system 350 can be configured to deliver fluids to and/or remove fluids from the catheter assembly 100A”, para. [0087]), the fluid system configured to pressurize the catheter pump with fluid (e.g. “the fluid handling system 350 can be configured to deliver fluids to and/or remove fluids from the catheter assembly 100A”, para. [0087]); and a first filter membrane (e.g. filter 1311, para. [0126]) configured to provide fluid path protection for fluid within the system (e.g. “a filter 1311 can be employed to remove debris and other undesirable particles from the infusate or priming fluid before the catheter body 120 is infused or primed with liquid”, para. [0126]).
Schenck discloses at least one filter membrane (e.g. filter 1311, para. [0126]) configured to reduce an amount of particles within the fluid of the fluid system (e.g. “a filter 1311 can be employed to remove debris and other undesirable particles from the infusate or priming fluid before the catheter body 120 is infused or primed with liquid”, para. [0126]) but does not explicitly teach a second filter membrane disposed within the catheter pump, the second membrane configured to reduce an amount of particles within the fluid of the fluid system.
Siess teaches a blood pump with filter which discloses a catheter pump (e.g. 1, Figs. 11a, 12C) that includes a filter membrane (e.g. 50) that is positioned within the catheter pump (e.g. “has a filter 40 that is integrated directly in the blood flow inlet 3. “, para. [0055]; “In the final position as shown in FIG. 12c, the filter 50 covers the blood flow inlet 3 of the blood pump 1 “, para. [0056]) that prevents clots from entering the pump section (e.g. “In the final position as shown in FIG. 12c, the filter 50 covers the blood flow inlet 3 of the blood pump 1 to prevent clots from entering the pump section 2, which helps to avoid failure of the blood pump by clogging.”, para. [0056]).
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 system of Schenck to include a second filter membrane being positioned within the catheter pump near an inlet, as disclosed by Siess, in order to prevent clots from entering the pump aiding in avoiding failure of the pump by clogging (‘437, para. [0056]).
In reference to claim 19
Schenck modified by Siess renders obvious a system according to claim 1. Schenck further discloses wherein the first filter membrane is located proximate the distal end of the catheter pump (e.g. “a filter 1311” located proximate before the catheter body is infused or primed with fluid, Fig. 7, para. [0126]).
In reference to claim 20
Schenck modified by Siess renders obvious a system according to claim 18. Schenck further discloses wherein the filter membrane is located proximate to the fluid system (e.g. “a filter 1311” located proximate before the catheter body is infused or primed with fluid, Fig. 7, para. [0126]) configured to capture debris within the fluid lumen while preserving flow of the fluid within the fluid system (e.g. “can be employed to remove debris and other undesirable particles from the infusate or priming fluid before the catheter body 120 is infused or primed with liquid”, para. [0126]). Siess also discloses wherein the second filter membrane includes a mesh membrane located proximate the fluid system (e.g. “The filter 50 may have any suitable mesh structure and aperture configuration as described above.”, para. [0056]) and wherein the mesh membrane is configured to capture debris within the fluid system while preserving flow of fluid within the fluid system (e.g. “In the final position as shown in FIG. 12c, the filter 50 covers the blood flow inlet 3 of the blood pump 1 to prevent clots from entering the pump section 2, which helps to avoid failure of the blood pump by clogging.”, para. [0056]).
Claim(s) 6 and 11 is is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0256797 to Schenck et al. (Schenck) in view of US 2019/0105437 to Siess et al. (Siess) as applied to claim 1 further in view of US 2020/0023110 to Jahangir (Jahangir) (previously cited).
In reference to claim 6
Schenck modified by Siess renders obvious a system according to claim 1. However, Schenck does not explicitly teach wherein the elongate body comprises a sheath, wherein at least part of the sheath is formed of at least one of a fluorinated ethylene propylene (FEP), hydrogels, polyurethane (PE), PE blends, poly(vinyl pyrrolidone) (PVP), polyethylene glycol (PEG), and polyvinyl alcohol (PVA).
Jahangir, in the same field of endeavor of blood pump systems, discloses a catheter that includes an elongate body (e.g. 110 and pump 140) that includes a sheath (e.g. 416) that includes a hydrogel (e.g. hydrogel, para. [0023]) which “permits gas flow between the two portions to allow sterilization inside one of the portions, and may prevent liquid contamination if an aqueous solution attempts to flow between the two portions.” (e.g. para. [0023], [0053]) aiding in providing leak protection to the pump (e.g. para. [0060]).
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 system of Schenck modified by Siess to include on the elongate body a sheath with parts formed of hydrogels, as taught by Jahangir, in order to provide leak protection to the pump (e.g. ‘110, para. [0060]).
In reference to claim 11
Schenck modified by Siess renders obvious a system according to claim 10. However, Schenck does not explicitly teach wherein the inner lumen includes a guidewire guide. It was well-known in the art before the effective filing date to insert a blood pump system as disclosed in Schenck within the vasculature of a patient using a guide catheter that is threaded over a guidewires as evidence by Jahangir (e.g. para. [0034]). 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 system of Schenck modified by Siess to include the inner lumen providing a guidewire guide, as such technique for threading the pump over the guidewire was known in the art and would have yielded the predictable result of easily backloading the pump with a guide wire passing through the free space of the impeller without damaging the impeller (e.g. ‘110, para. [0034]).
Claim(s) 7-9 is is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0256797 to Schenck et al. (Schenck) in view of US 2019/0105437 to Siess et al. (Siess) as applied to claim 1 further in view of US 2020/0345979 to Loh et al. (Loh) (previously cited).
In reference to claim 7
Schenck modified by Siess renders obvious a system according to claim 1. Schenck further discloses wherein the elongate body comprises an aortic arch transition area (e.g. catheter positioned with aortic arch, therefore it includes “an aortic arch transition area”, Fig. 1, para. [0075]).
However, Schenck does not explicitly teach wherein the aortic arch transition area comprises a coating within the elongate body.
Loh discloses a catheter that is inserted into a patient’s aortic arch (e.g. “at least part of the catheter is inserted into the patient’s aortic arch”, para. [0040], [0163]) in which the catheter contains a lubricious coating including an anti-vasospasm drug that reduces the frequency or intensity of spasm of the blood vessels (e.g. “using a catheter with a lubricious coating, where the catheter releases agents that prevent vasospasms”, para. [0160], claim 11).
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 system of Schenck modified by Siess to include on the catheter including the “aortic arch transition area” a lubricious coating including an anti-vasospasm drug, as taught by Loh, in order to allow smoother interaction with blood vessels reducing the frequency or intensity of spasms of blood vessels when the catheter is inserted into a patients vasculator or the patient’s aortic arch (e.g. ‘979, para. [0040], [0160]).
In reference to claim 8
Schenck modified by Siess and Loh renders obvious a system according to claim 7. Loh further discloses wherein the coating is formed of at least one of a bioabsorbable layer and a lubricious layer (e.g. “using a catheter with a lubricious coating”, para. [0160]).
In reference to claim 9
Schenck modified by Siess and Loh renders obvious a system according to claim 7. Loh further discloses a re-flowed finishing layer within the elongate body (e.g. “using a catheter with a lubricious coating” with release agents “finishing layer” that prevent vasospasms, para. [0160], claim 11).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In particular the arguments regarding a filter membrane disposed within the pump. Siess has been included within the rejection for teaching a filter membrane positioned within the catheter pump and configured to reduce an amount of particles within the fluid of the fluid system, see 103 rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JG/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796