DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/31/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-23 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 8/31/26 have been fully considered but they are not persuasive. The Applicant argues that Washburn fails to disclose that the hypotube and the cannula have a ratio of 1:5 >R1 > 1:25. The Examiner respectfully disagrees. Paras. 77, 137: “In certain embodiments, the outer diameter of the hypotube 1204 may range from approximately 0.1 mm to 0.3 mm … In some embodiments, the inner diameter of the outer tubular body 1208 ranges from approximately 0.1 mm to 10 mm, specifically 1.6mm”; 0.1mm outer diameter of the hypotube to 1.6mm diameter of inner diameter of outer cannula is a 1:16 ratio and 0.3mm outer diameter of the hypotube to 1.6mm inner diameter of the cannula is a ratio of 1.5333 both which fit exactly within the ratios provided. Washburn discloses the claimed invention except for explicitly stating the ratios of the outer and inner diameters. However, Washburn discloses that the outer diameter of the hypotube may range from 0.1mm to 0.3mm and the outer cannula can have an inner diameter of 0.1-10mm, specifically 1.6mm as clearly disclosed in paragraphs 77 and 137. Since Washburn clearly discloses that the outer diameter of the hypotube can be 0.1mm to 0.3mm, it would be obvious to use the diameters with the stated inner diameter of the outer cannula. Therefore, It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Washburn, to use a hypotube using the stated outer diameter range of 0.1-0.3mm to have a ratio between 1:5 and 1:25 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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.
Claims 2-3 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. Claim 2 has been amended to state that the optical fiber is arranged to freely move within the second lumen of the hypotube, and further the optical fiber is attached to the hypotube. However, paragraph 63 of the specification state that the optical fiber may be attached to hypotube (i.e. adhered to the hypotube, or otherwise restricted from moving axially independently of the hypotube) at or near a proximal end. The specification states that when the fiber is attached to the hypotube, the optical fiber does not move freely within the lumen. Since the specification states that when the fiber is attached to the hypotube the fiber does not freely move, the claims fail to comply with the written description requirement.
Claim 3 is rejected for inheriting the same deficiencies as claim 2.
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 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Washburn (US PGPUB 2017/0265879).
Regarding claim 1, Washburn (US2017/0265879) discloses a system comprising:
a cannula having an inner surface and an outer surface (Fig. 2B: tubular body 1126), the inner and outer surface defining a cannula wall having a thickness, the inner surface of the cannula defining a first lumen therethrough (Fig. 3A: lumen 1138);
a flexible hypotube attached to the cannula (Fig. 3A: hypotube 1128), the flexible hypotube having an outer surface and an inner surface, the inner surface of the flexible hypotube defining a second lumen therethrough, wherein the second lumen is arranged to 0hypotube 1204 may comprise an image guide 1202 (which may be enclosed in one or more layers of tubing), at least one illumination fiber or fiber bundle 1210, an infusion lumen 1206, and outer tubular body 1208.”);
wherein a ratio R1 of a diameter of the outer surface of the hypotube to a diameter of the inner surface of the cannula is 1:5 > R1> 1:25 (Paras. 77, 137: “In certain embodiments, the outer diameter of the hypotube 1204 may range from approximately 0.1 mm to 0.3 mm … In some embodiments, the inner diameter of the outer tubular body 1208 ranges from approximately 0.1 mm to 10 mm, specifically 1.6mm”; 0.1mm outer diameter of the hypotube to 1.6mm diameter of inner diameter of outer cannula is a 1:16 ratio and 0.3mm outer diameter of the hypotube to 1.6mm inner diameter of the cannula is a ratio of 1.5333 both which fit exactly within the ratios provided.).
Washburn discloses the claimed invention except for explicitly stating the ratios of the outer and inner diameters. However, Washburn discloses that the outer diameter of the hypotube may range from 0.1mm to 0.3mm and the outer cannula can have an inner diameter of 0.1-10mm, specifically 1.6mm as clearly disclosed in paragraphs 77 and 137. Since Washburn clearly discloses that the outer diameter of the hypotube can be 0.1mm to 0.3mm, it would be obvious to use the diameters with the stated inner diameter of the outer cannula. Therefore, It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Washburn, to use a hypotube using the stated outer diameter range of 0.1-0.3mm to have a ratio between 1:5 and 1:25 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 10, Washburn discloses the system according to claim 1, wherein the flexible hypotube is positioned within the first lumen (Fig. 5G).
Regarding claim 11, Washburn discloses the system according to claim 1, wherein the flexible hypotube is positioned outside the first lumen (Fig. 5I).
Regarding claim 12, Washburn discloses the system according to claim 1, wherein at least a first portion of the flexible hypotube is positioned within the first lumen, and at least a second portion of the flexible hypotube is positioned outside the first lumen (Par. 99: “In particular embodiments, the outer tubular body 1126 is not retractable/extendible; instead, the outer tubular body 1126 and the inner hypotube 1128 have a fixed length. For example, the inner hypotube 1128 may be the same length as the outer tubular body 1126 or may be shorter, so that the inner hypotube 1128 is offset inside the outer tubular body 1126.”).
Claim(s) 2, 9, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Washburn (US PGPUB 2017/0265879), in view of Muller (US PGPUB 2015/0290372).
Regarding claim 2, Washburn discloses the system according to claim 1 including the fiber being connected to the hypotube at the proximal end (e.g. see Figs. 3A-3E, ¶85; [notes that single unit defines attached]), and wherein the fiber has a longer linear length than hypotube (e.g. 1134; see Fig. 4; [wherein the fiber 1134 entends further into the handle than the hypotube thereby having a longer length]). Washburn does not disclose wherein the optical fiber is arranged to freely move within the second lumen. However, Muller, in the same field of endeavor of intravascular catheter systems, discloses “the embodiments disclosed herein enable the use of fiber optic sensors, because the sensor pathways are sufficiently sized to allow for passage of the optical fibers” (Par. 179). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to enable the optical fiber to move within the lumen, as taught and suggested by Muller, in order to “allow for passage of the optical fibers without imparting excessive stresses on the fibers” (Par. 179).
Regarding claim 9, Washburn discloses the system according to claim 1. Washburn does not disclose the system comprising a pump operably connected to a proximal portion of the first lumen. However, Muller discloses the system comprising a pump operably connected to a proximal portion of the first lumen (Fig. 1: catheter pump 10; catheter system 80). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to connect a pump to the first lumen, as taught and suggested by Muller, in order to “assist the pumping function of the heart” (Par. 7).
Regarding claim 13, Washburn discloses the system according to claim 12. Washburn does not disclose wherein the second portion extends into an inflow cage of a pumping device. However, Muller, in the same field of endeavor of intravascular catheter systems, discloses “cannula 508 can include one or more fluid inlets 523 near a distal portion of the cannula 508” (Par. 128). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to have a portion of the hypotube extend into the inflow cage, as taught and suggested by Muller, so that “blood can be pulled from a left ventricle through the inlets 523 and can propagate within the cannula 508” (Par. 128).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Washburn (US PGPUB 2017/0265879), in view of Muller (US PGPUB 2015/0290372), further in view of Glawdel (2020/0390350).
Regarding claim 3, Washburn, in view of Muller, discloses the system according to claim 2. Washburn does not disclose wherein a ratio R2 of a diameter of an outer surface of the optical fiber to a diameter of the inner surface of the flexible hypotube is 1:3 >R2> 1:1.1. However, Glawdel, in the same field of endeavor of vascular catheter systems, discloses “standard optical fibers of 0.155 mm diameter” (Par. 17) and “a stainless steel hypotube having an inside diameter of e.g., 0.285 mm to accommodate the optical fiber and optical sensor” (Par. 78). Therefore, it would have been obvious to include a ratio of 1:3>R2> 1:1.1, as taught and suggested by Glawdel, for the purpose of “accommodate the optical fiber and optical sensor” (Par. 78).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Washburn (US PGPUB 2017/0265879), in view of Bolling (US PGPUB 2005/0085683).
Regarding claim 4, Washburn discloses the system according to claim 1. Washburn does not disclose wherein the cannula is a flexible flow cannula. However, Bolling, in the same field of endeavor of intravascular catheter systems, discloses “the multilumen cannula 484 preferably is made of material sufficiently flexible and resilient to permit the patient 12 to comfortably move about while the cannula 484 is indwelling in the patient's blood vessels without causing any vascular trauma” (Par. 84). Therefore, it would have been obvious to include a flexible flow cannula, as taught and suggested by Bolling, for the purpose of not “causing any vascular trauma” (Par. 84).
Claim(s) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Washburn (US PGPUB 2017/0265879), in view of Muller (US PGPUB 2015/0290372) and further in view of Tan et al. (PUB 2020/0405929 hereinafter “Tan”).
Regarding claim 5, Washburn discloses the system according to claim 1. Washburn does not disclose the system further comprising an inflow cage connected at or near a distal portion of the cannula. However, Muller, in the same field of endeavor of intravascular catheter systems, discloses “The cannula 508 can include one or more fluid inlets 523 near a distal portion of the cannula 508” (Par. 128). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to include a fluid inlet near the distal portion of the cannula, as taught and suggested by Muller, for the purpose of “pulling fluid in a proximal direction relative to the catheter assembly” (Par. 128). Washburn in view of Muller teaches the system with an inflow cage but fails to explicitly state that the cage has a plurality of apertures. However, Tan, in the same field of endeavor of intravascular catheter systems, discloses “let apertures 122 are shown in FIG. 1 as being formed in the distal end of cannula 108, they may alternatively be formed in a blood inflow cage structure
attached to the distal end of cannula 108 (which may be considered a part of cannula 108)” (Par. 24). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to include a fluid inlet cage with multiple apertures near the distal portion of the cannula, as taught and suggested by Tan, for the purpose of allowing fluid to easily flow through the cannula. (Par. 24).
Regarding claim 6, Washburn in view of Muller and Tan discloses the system according to claim 5. Muller further discloses wherein a distal portion of the optical fiber is attached to the internal surface of the inflow cage (Par. 123: “In some embodiments, for example, the proximal and/or distal sensor assemblies 521, 524 comprise pressure sensors, e.g., optical pressure sensors.”; Par. 124: “For example, for optical pressure sensors, the proximal and distal sensor assemblies 521, 524 can be in optical communication with the controller 502 by way of one or more optical fibers.”; Fig. 19: inlet 523, sensor assembly 524). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to include wherein a portion of the optical fiber is attached to the inflow cage, as taught and suggested by Muller, for the reason that “being disposed near the inlets 523, the first and second distal sensor locations 524A, 524B can provide accurate fluid measurements (e.g., pressure measurements) of blood as it flows through the inlets 523” (Par. 131).
Regarding claim 7, Washburn in view of Muller and Tan discloses the system according to claim 6. Muller further discloses wherein the optical fiber comprises an optical fiber sensor head at a distal end of the optical fiber (Par. 150: “the ventricular pressure is detected by the distal sensor assembly 524”; Par. 173: “In some embodiments, the proximal sensor assembly 521 can comprise a pressure sensor assembly, such as an optical fiber sensor”). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to use an optical fiber sensor head, as taught and suggested by Muller, for the purpose of detecting ventricular pressure (Par. 150).
Regarding claim 8, Washburn in view of Muller and Tan discloses the system according to claim 7. Muller further discloses wherein the optical fiber sensor is configured to measure ventricular pressure (Par. 150: “the ventricular pressure is detected by the distal sensor assembly 524”; Par. 173: “In some embodiments, the proximal sensor assembly 521 can comprise a pressure sensor assembly, such as an optical fiber sensor”). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to measure ventricular pressure, as taught and suggested by Muller, for the reason that “if the pressure plot moves from curve A or curve B to curve C as the clinician pushes the pump distally, the impeller housing 592 is moving from proximal the aortic valve towards the target position.” (Par. 150).
Claim(s) 14-17 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Washburn (US PGPUB 2017/0265879), in view of Landon (US PGPUB 2019/0008639).
Regarding claim 14, Washburn discloses the system according to claim 1. Washburn does not disclose wherein the flexible hypotube has a distal end, a proximal end, and a tubular portion having one or more cuts that extend at least partially from an outer surface of the hypotube to an inner surface of the hypotube. However, Landon, in the same field of endeavor of cardiac catheter systems, discloses “The rail hypotube 136 can generally be broken into a number of different sections. At the most proximal end is an uncut (or unslotted) hypotube section 131. This can take up approximately one quarter to one third of the rail hypotube 136. Moving distally, the next section is the proximal slotted hypotube section 133… At the distalmost end of the distal slotted hypotube section 135…” (Par. 138-140). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing fate of the claimed invention, to include a hypotube having one or more cuts, as taught and suggested by Landon, for the purpose of “creating a bending pathway for the delivery system to follow” (Par. 128).
Regarding claim 15, Washburn in view of Landon discloses the system according to claim 14. Landon further discloses wherein the tubular portion includes at least one cut extending completely through the flexible hypotube and extending from the outer surface towards the inner surface, optionally wherein each cut has a width of between 0.01 and 0.1 mm (Par. 129: “The outer hypotube 104, shown in FIG. 7 (distal end towards the right), can include a number slots 103 transverse to its lumen axis along most of the length of the outer hypotube 104.”). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing fate of the claimed invention, to include cuts extending completely through the hypotube, as taught and suggested by Landon, for the purpose of “allowing the entirety of the outer hypotube 104 to more easily bend” (Par. 129).
Regarding claim 16, Washburn in view of Landon discloses the system according to claim 14. Washburn further discloses wherein the tubular portion is a distal portion (Par. 90: “schematically depicted in FIG. 3A, down the “tunnel” of the interior of the hypotube 1128.”).
Regarding claim 17, Washburn in view of Landon discloses the system according to claim 14. Washburn further discloses wherein the flexible hypotube has a proximal portion, a distal portion, and a middle portion between the proximal portion and distal portion (Par. 91: “The distal end of the hypotube 1128 may extend laterally away from the outer tubular body 1126.” – The existence of a distal end implies the existence of a proximal end and a middle portion).
Regarding claim 19, Washburn in view of Landon discloses the system according to claim 17. Landon further discloses wherein the at least one cut comprises a plurality of identical laser cuts (Fig. 7: slots 103). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing fate of the claimed invention, to include a plurality of laser cuts, as taught and suggested by Landon, for the purpose of “creating a bending pathway for the delivery system to follow” (Par. 128).
Regarding claim 20, Washburn in view of Landon discloses the system according to claim 19. Landon further discloses wherein each of the plurality of identical laser cuts are offset only axially from all other laser cuts of the plurality of identical laser cuts (Par. 130: “in some embodiments the spine 105 of the outer hypotube 104 may be straight, and the particular configuration of the spine is not limiting.” – The straight spine is formed by the axially offset slots.). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing fate of the claimed invention, to include a plurality of offset laser cuts, as taught and suggested by Landon, for the purpose of “allowing the entirety of the outer hypotube 104 to more easily bend” (Par. 129).
Regarding claim 21, Washburn in view of Landon discloses the system according to claim 19. Landon further discloses wherein each of the plurality of identical laser cuts are offset axially from all other laser cut openings of the plurality of identical laser cuts, and at least one laser cut is offset circumferentially from a neighboring laser cut (Fig. 7; Par. 130: “the slot locations may be staggered such that the spine 105 circumferentially rotates while progressing from the proximal end to the distal end of the outer hypotube 104. For example, the distal end of the spine 105 can be approximately 30°, 45°, 90°, 135°, or 180° offset from the proximal end of the spine 105.”). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing fate of the claimed invention, to offset the laser cuts, as taught and suggested by Landon, for the reason that “the curve of the spine helps direct the outer hypotube” (Par. 130).
Regarding claim 22, Washburn in view of Landon discloses the system according to claim 21. Landon further discloses wherein at least one laser cut is offset circumferentially by 45°, 90°, or 180° from a neighboring laser cut (Fig. 7; Par. 130: “the slot locations may be staggered such that the spine 105 circumferentially rotates while progressing from the proximal end to the distal end of the outer hypotube 104. For example, the distal end of the spine 105 can be approximately 30°, 45°, 90°, 135°, or 180° offset from the proximal end of the spine 105.”). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing fate of the claimed invention, to offset the laser cuts, as taught and suggested by Landon, for the reason that “the curve of the spine helps direct the outer hypotube” (Par. 130).
Claim(s) 18 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Washburn (US PGPUB 2017/0265879), in view of Landon (US PGPUB 2019/0008639), further in view of Griffin (US PGPUB 2012/0078285).
Regarding claim 18, Washburn in view of Landon discloses the system according to claim 17. Washburn in view of Landon does not disclose wherein the at least one cut defines a helical cut extending axially along the middle portion of the flexible hypotube. However, Griffin, in the same field of endeavor of intravascular catheter systems, discloses a helical cut extending axially along the middle portion of the hypotube (Fig. 2: hypotube 40, first helical cut 46). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing fate of the claimed invention, to include a helical cut axially along the hypotube, as taught and suggested by Griffin, for the purpose of “confer[ring] increased flexibility” (Par. 23).
Regarding claim 23, Washburn in view of Landon discloses the system according to claim 19. Washburn does not disclose wherein the plurality of identical laser cuts define at least two helical patterns. However, Griffin, in the same field of endeavor of intravascular catheter systems, discloses wherein the plurality of identical laser cuts define at least two helical patterns (Fig. 2: hypotube 40, first helical cut 46, second helical cut 48). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing fate of the claimed invention, to include at least two helical patterns, as taught and suggested by Landon, for the purpose of “offset spiral cuts 46 and 48 provide an interference locking mechanism to confer stretch resistance in hypotube 40 while at the same time preserving lateral flexibility” (Par. 23).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Landon et al. (2019/0008639) – teaches a steerable catheter system with a flexible guidewire lumen (hypotube).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REX R HOLMES/Primary Examiner, Art Unit 3796
Prosecution Insights