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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/23/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot in view of the amendments to the claims, which now require both an ingress valve and an egress valve. With respect to applicant’s comments on page 7 of the remarks filed 6/23/2026, the examiner relied on the valve structure (26/28) disclosed in figs. 3 and 4 of Jackson, described as a “flutter valve” by Jackson, not the slits 28a in fig. 8 of Jackson. With respect to applicant’s comments on page 6 of the remarks, the examiner relied on the valve structure 26 in figs. 1b, 1c of Muni, described as an “elastomeric sleeve valve 26” by Muni to teach a valve, not the openings 31.
Claim Rejections - 35 USC § 112
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 43, 44, 56 and 57 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. Each of claims 43, 44, 56 and 57 recites “the valve”, which lacks clear antecedent basis as there are two previously recited valves –an ingress valve and an egress valve– and it is unclear which one is being referenced by “the valve”. For purposes of claim interpretation, the claim is being treated as though it reads “the ingress valve” as best understood in view of the specification.
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) 37-40, 43, 46-48, 51-52, 56, and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gifford, III et al. (US 5,071,425; “Gifford”) in view of Honda et al. (US 5,152,277), Muni et al. (US 2008/0015540), and Briscoe (US 5,807,328).
Regarding claim 37, Gifford discloses an atherectomy device for removing atherosclerotic material within a blood vessel comprising a tubular housing (96) coupled to or extending from a distal end of a catheter (82) (see col. 4, ll. 52-55), wherein the tubular housing comprises a housing lumen configured to be in fluid communication with a catheter lumen of the catheter, a cutting window (100) defined along a portion of the tubular housing, and a rotatable cutter (98) configured to debulk atherosclerotic material extending into the cutting window, a collection chamber (106; fig. 3) coupled to the tubular housing, wherein the collection chamber is configured to collect the atherosclerotic material debulked by the cutter (col. 5, ll. 62-68), and an inflatable balloon (102) coupled to an exterior side of the tubular housing (see figs. 1, 3), the balloon comprising a balloon lumen (space inside balloon). Gifford fails to disclose that the balloon lumen is in fluid communication with the housing lumen such that fluid introduced into the housing lumen via the catheter lumen clears a field in proximity to the cutting window and inflates the inflatable balloon. Instead, Gifford discloses a dedicated inflation channel for inflating the balloon, which is not in fluid communication with the housing lumen.
Regarding claim 48, Gifford discloses a method of debulking atherosclerotic material within a blood vessel, comprising: introducing a tubular housing (96) of an atherectomy device into the blood vessel and into proximity to the atherosclerotic material (col. 1, ll. 27-50), wherein the tubular housing is coupled to or extending from a distal end of a catheter (82), and wherein the tubular housing comprises: a housing lumen (see fig. 5) configured to be in fluid communication with a catheter lumen of the catheter, a cutting window (100; fig. 3) defined along a portion of the tubular housing, and a rotatable cutter (98); inflating a balloon (102) coupled to an exterior side of the tubular housing (col. 1, ll. 35-36) and flushing a field in proximity to the tubular housing with the fluid introduced into the housing lumen (via flush port 20 and annular lumen 91; col. 5, ll. 15-22). Gifford does not expressly disclose inflating the balloon using a fluid introduced into the housing lumen via the catheter lumen, wherein a balloon lumen of the balloon is in fluid communication with the housing lumen.
Honda discloses another catheter comprising a single, multi-purpose lumen (4c; fig. 9) and a balloon (3c) near the distal end of the catheter. Flushing fluid introduced into the lumen (4c) clears a field in proximity to an opening at the distal end of the catheter (see fig. 11; col. 11, ll. 46-65). Honda discloses that the catheter may have an opening (5c) that allows this same fluid to also serves as the balloon inflating liquid (col. 11, ll. 9-40). In this manner, the catheter tube can be reduced in diameter because the number of necessary lumens is reduced (col. 11, ll. 35-40). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Gifford to remove the dedicated inflation channel and place the balloon lumen in fluid communication with the housing lumen and catheter lumen via an aperture in view of the teachings of Honda in order to reduce the diameter of the catheter. Regarding claim 48, with such a modification, it would have been obvious to inflate the balloon of Gifford using the fluid introduced into the housing lumen via the catheter lumen (i.e., via flush port 20) and through the balloon lumen (i.e., balloon interior) since this fluid serves as both the flushing fluid and inflation fluid as taught by Honda.
Gifford in view of Honda discloses the invention of claims 37 and 48 substantially as stated above including a balloon, but fails to disclose that the balloon further comprises an ingress valve configured to control fluid entry into the balloon lumen and an egress valve configured to control fluid exit from the balloon lumen.
Muni discloses another catheter (figs. 1a-1c) having a balloon (14) disposed on a distal end thereof, the balloon lumen being in fluid communication with a central lumen of the catheter via an aperture (28) formed in the central lumen. Muni discloses a one-way valve (26) that prevents backflow from the balloon into the central lumen (13) by only allowing fluid flow into the balloon lumen (see [0096]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Gifford in view of Honda to include a one-way valve as taught by Muni in order to ensure that the balloon remains inflated by preventing backflow from the balloon into the central lumen ([0022]). With respect to method claim 48, as taught by Muni, the valve controls fluid entry into the balloon lumen (by preventing backflow through the valve) during inflation of the balloon.
Briscoe discloses another catheter including an inflatable balloon disposed on a distal end thereof. The balloon includes an egress valve (180; figs. 17, 18) formed by distal end of balloon configured to control fluid exit from the balloon lumen (col. 9, ll. 35-64). The egress valve serves as a check valve to prevent over inflation of the balloon and thus prevent damage to surrounding tissue associated with over inflation as understood by one of ordinary skill in the art. It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Gifford/Honda/Muni to include an egress valve configured to control fluid exit from the balloon lumen as taught by Briscoe in order to prevent accidental over-inflation of the balloon. Additionally, all the claimed elements were known in the art before the effective filing date of the instant application and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have merely yielded predictable results. With respect to method claim 48, as taught by Briscoe, the egress valve allow fluid to seep out of the balloon lumen via the egress valve anytime the balloon pressure exceeds a certain threshold (i.e., when balloon is over-inflated).
Regarding claims 38 and 52, the tubular housing further comprises a dorsal side (side with balloon) and a ventral side (side with cutting window) opposite the dorsal side. The tubular housing has an opening as taught by Honda (see 5c in fig. 9 of Honda) to allow fluid to flow from the housing lumen into the balloon lumen. Honda discloses that there should be at least one side aperture per balloon and thus makes obvious the use of multiple apertures connecting the tubular housing lumen with the balloon lumen, which are considered the claimed “housing port openings” (col. 11, ll. 10-23). As understood by one of ordinary skill in the art, it would have been obvious to position the housing port openings on the side of the housing over which the balloon is disposed (i.e., the dorsal side) since they serve to pass inflation fluid into the balloon. Since the step of flushing also results in inflation of the balloon as taught by Honda, the step of flushing further directs the fluid through the plurality of housing port openings (and into the balloon).
Regarding claim 39, the fluid may be a saline solution (col. 10, ll. 46-52 of Honda).
Regarding claim 40, it is noted that the fluid is not part of the claimed atherectomy device. Because heparinized saline can be introduced into the housing lumen via the catheter lumen, the prior art of Gifford in view of Honda meets this limitation.
Regarding claims 46 and 59, the rotatable cutting is coupled to the drive shaft (94) extending through the catheter and the tubular housing, wherein the rotatable cutter is translatable longitudinally within the housing lumen via the drive shaft (col. 5, ll. 30-47 of Gifford).
Regarding claim 47, the balloon and tubular housing are configured to substantially restrict fluid flow through the blood vessel when the balloon is inflated in the same manner as the device of the instant application (i.e., by blocking a portion of the blood vessel).
Regarding claims 43 and 56, see the 35 USC 112b rejections above. The ingress valve is unidirectional as taught by Muni.
Regarding claim 51, Honda further teaches that an imaging catheter (bundle 7a may be coated in Teflon, which is considered to form the catheter; col.6, ll. 3-15) and a fiber optic wire/cable (7a) extending at least partially through the imaging catheter, wherein the fiber optic wire/cable is configured to image the blood vessel and material surrounding the tubular housing (as understood in view of col. 5, ll. 58-col. 6, ll. 2). Honda teaches flushing the field in proximity to the distal end of the fiber optic wire in order to clear a visual field (col. 6, ll. 18-25; col. 9, ll. 21-30; fig. 11). Gifford discloses flushing the field in proximity to the tubular housing. It would have been obvious to modify the prior art of Gifford to include imaging, and to perform the imaging after flushing with the fluid in order to ensure a clearer view as taught by Honda.
Claim(s) 41 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gifford in view of Honda, Muni, and Briscoe as applied to claims 37 and 48 above, and further in view of Maschke (US 2010/0241147). Gifford in view of Honda, Muni, and Briscoe discloses the invention substantially as stated above with respect to claims 37 and 48.
As discussed above (see discussion of claim 51 above), Honda further teaches that an imaging catheter (bundle 7a may be coated in Teflon, which is considered to form the catheter; col.6, ll. 3-15) and a fiber optic cable (7a) extending at least partially through the imaging catheter, wherein the fiber optic cable is configured to image the blood vessel and material surrounding the tubular housing (as understood in view of col. 5, ll. 58-col. 6, ll. 2). Honda teaches flushing the field in proximity to the distal end of the fiber optic cable in order to clear a visual field (col. 11, ll. 45-67). Gifford discloses flushing the field in proximity to the tubular housing. It would have been obvious to modify the prior art of Gifford to include an imaging catheter and fiber optic cable as taught by Honda in order to be able to visualize the area of interest during the procedure. Honda does not expressly disclose imaging through optical coherence tomography (OCT).
Maschke discloses another atherectomy catheter and further discloses that the device may comprise optical fibers configured to transmit light to an analysis apparatus where the interference of the reflected light with the reference light is analyzed in order to generate an image based on optical coherence tomography ([0025]). According to Maschke, OCT imaging delivers high-resolution images which comparatively accurately reproduce in particular the structures close to the vessel surface ([0025]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Gifford as modified by Honda, Muni and Briscoe to configure the fiber optic cable to transmit an optical coherence tomography signal, and to include the step of imaging the blood vessel and atherosclerotic material through optical coherence tomography in order to deliver high-resolution images of structures close to the vessel surface as taught by Maschke.
Claim(s) 37-40, 44, 46-48, 51-52, 57, and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gifford, III et al. (US 5,071,425; “Gifford”) in view of Honda et al. (US 5,152,277), Jackson (US 3,565,079), and Briscoe (US 3,794,036).
Regarding claim 37, Gifford discloses an atherectomy device for removing atherosclerotic material within a blood vessel comprising a tubular housing (96) coupled to or extending from a distal end of a catheter (82) (see col. 4, ll. 52-55), wherein the tubular housing comprises a housing lumen configured to be in fluid communication with a catheter lumen of the catheter, a cutting window (100) defined along a portion of the tubular housing, and a rotatable cutter (98) configured to debulk atherosclerotic material extending into the cutting window, a collection chamber (106; fig. 3) coupled to the tubular housing, wherein the collection chamber is configured to collect the atherosclerotic material debulked by the cutter (col. 5, ll. 62-68), and an inflatable balloon (102) coupled to an exterior side of the tubular housing (see figs. 1, 3), the balloon comprising a balloon lumen (space inside balloon). Gifford fails to disclose that the balloon lumen is in fluid communication with the housing lumen such that fluid introduced into the housing lumen via the catheter lumen clears a field in proximity to the cutting window and inflates the inflatable balloon. Instead, Gifford discloses a dedicated inflation channel for inflating the balloon, which is not in fluid communication with the housing lumen.
Regarding claim 48, Gifford discloses a method of debulking atherosclerotic material within a blood vessel, comprising: introducing a tubular housing (96) of an atherectomy device into the blood vessel and into proximity to the atherosclerotic material (col. 1, ll. 27-50), wherein the tubular housing is coupled to or extending from a distal end of a catheter (82), and wherein the tubular housing comprises: a housing lumen (see fig. 5) configured to be in fluid communication with a catheter lumen of the catheter, a cutting window (100; fig. 3) defined along a portion of the tubular housing, and a rotatable cutter (98); inflating a balloon (102) coupled to an exterior side of the tubular housing (col. 1, ll. 35-36) and flushing a field in proximity to the tubular housing with the fluid introduced into the housing lumen (via flush port 20 and annular lumen 91; col. 5, ll. 15-22). Gifford does not expressly disclose inflating the balloon using a fluid introduced into the housing lumen via the catheter lumen, wherein a balloon lumen of the balloon is in fluid communication with the housing lumen.
Honda discloses another catheter comprising a single, multi-purpose lumen (4c; fig. 9) and a balloon (3c) near the distal end of the catheter. Flushing fluid introduced into the lumen (4c) clears a field in proximity to an opening at the distal end of the catheter (see fig. 11; col. 11, ll. 46-65). Honda discloses that the catheter may have an opening (5c) that allows this same fluid to also serves as the balloon inflating liquid (col. 11, ll. 9-40). In this manner, the catheter tube can be reduced in diameter because the number of necessary lumens is reduced (col. 11, ll. 35-40). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Gifford to remove the dedicated inflation channel and place the balloon lumen in fluid communication with the housing lumen and catheter lumen via an aperture in view of the teachings of Honda in order to reduce the diameter of the catheter. Regarding claim 48, with such a modification, it would have been obvious to inflate the balloon of Gifford using the fluid introduced into the housing lumen via the catheter lumen (i.e., via flush port 20) and through the balloon lumen (i.e., balloon interior) since this fluid serves as both the flushing fluid and inflation fluid as taught by Honda.
Gifford in view of Honda discloses the invention substantially as stated above including an aperture (see 5c in figs. 9 and 11 of Honda) that allow fluid to flow into the balloon lumen from the tubular housing lumen, but fails to disclose that the balloon further comprises an ingress valve configured to control fluid entry into the balloon lumen and an egress valve configured to control fluid exit from the balloon lumen.
Jackson discloses another catheter having a balloon disposed on a distal end thereof, the balloon lumen being in fluid communication with a central lumen of the catheter such that flushing fluid delivered out the distal end of the catheter also serves to inflate the balloon. Jackson discloses a bi-directional valve (sheet 46 and slit 44) that prevents over and under-inflation of the balloon (col. 3, ll. 10-15). The valve permits inflation of the balloon (ingress of fluid into balloon) until pressure in the balloon equalizes pressure inside the central lumen of the catheter and no further inflation fluid will pass therein (col. 3, ll. 20-40). When the pressure inside the tube drops, inflation fluid will slowly exit from the inflatable balloon through the valve. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Gifford in view of Honda to include an ingress valve in the form of a bidirectional valve as taught by Jackson that allows controlled flow into and out of the balloon lumen in order to prevent over and under-inflation of the balloon.
Briscoe discloses another catheter including an inflatable balloon disposed on a distal end thereof. The balloon includes an egress valve (180; figs. 17, 18) formed by distal end of balloon configured to control fluid exit from the balloon lumen (col. 9, ll. 35-64). The egress valve serves as a check valve to prevent over inflation of the balloon and thus prevent damage to surrounding tissue associated with over inflation as understood by one of ordinary skill in the art. It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Gifford/Honda/Jackson to include an egress valve configured to control fluid exit from the balloon lumen as taught by Briscoe in order to provide an additional means of preventing accidental over-inflation of the balloon by providing an additional means of fluid egress in the event of an over-inflation of the balloon. Additionally, all the claimed elements were known in the art before the effective filing date of the instant application and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have merely yielded predictable results. With respect to method claim 48, as taught by Briscoe, the egress valve allow fluid to seep out of the balloon lumen via the egress valve anytime the balloon pressure exceeds a certain threshold (i.e., when balloon is over-inflated).
With respect to method claim 48, as made obvious in view of Jackson and Briscoe, the ingress valve taught by Jackson controls fluid entry into the balloon lumen during inflation of the balloon, which will occur while fluid seeps out of the egress valve taught by Briscoe any time overinflation has occurred.
Regarding claims 38 and 52, the tubular housing further comprises a dorsal side (side with balloon) and a ventral side (side with cutting window) opposite the dorsal side. The tubular housing has an opening as taught by Honda (see 5c in fig. 9 of Honda) to allow fluid to flow from the housing lumen into the balloon lumen. Honda discloses that there should be at least one side aperture per balloon and thus makes obvious the use of multiple apertures connecting the tubular housing lumen with the balloon lumen, which are considered the claimed “housing port openings” (col. 11, ll. 10-23). As understood by one of ordinary skill in the art, it would have been obvious to position the housing port openings on the side of the housing over which the balloon is disposed (i.e., the dorsal side) since they serve to pass inflation fluid into the balloon. Since the step of flushing also results in inflation of the balloon as taught by Honda, the step of flushing further directs the fluid through the plurality of housing port openings (and into the balloon).
Regarding claim 39, the fluid may a saline solution (col. 10, ll. 46-52 of Honda).
Regarding claim 40, it is noted that the fluid is not part of the claimed atherectomy device. Because heparinized saline can be introduced into the housing lumen via the catheter lumen, the prior art of Gifford in view of Honda meets this limitation.
Regarding claims 46 and 59, the rotatable cutting is coupled to the drive shaft (94) extending through the catheter and the tubular housing, wherein the rotatable cutter is translatable longitudinally within the housing lumen via the drive shaft (col. 5, ll. 30-47 of Gifford).
Regarding claim 47, the balloon and tubular housing are configured to substantially restrict fluid flow through the blood vessel when the balloon is inflated in the same manner as the device of the instant application (i.e., by blocking a portion of the blood vessel).
Regarding claims 44 and 57, as noted above, the ingress valve taught by Jackson is bidirectional.
Regarding claim 51, Honda further teaches that an imaging catheter (bundle 7a may be coated in Teflon, which is considered to form the catheter; col.6, ll. 3-15) and a fiber optic wire/cable (7a) extending at least partially through the imaging catheter, wherein the fiber optic wire/cable is configured to image the blood vessel and material surrounding the tubular housing (as understood in view of col. 5, ll. 58-col. 6, ll. 2). Honda teaches flushing the field in proximity to the distal end of the fiber optic wire in order to clear a visual field (col. 11, ll. 45-67). Gifford discloses flushing the field in proximity to the tubular housing. It would have been obvious to modify the prior art of Gifford to include imaging, and to perform the imaging after flushing with the fluid in order to ensure a clearer view as taught by Honda.
Claim(s) 41 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gifford in view of Honda, Jackson, and Briscoe as applied to claim 48 above, and further in view of Maschke (US 2010/0241147). Gifford in view of Honda, Jackson, and Briscoe discloses the invention substantially as stated above with respect to claims 37 and 48. Honda further teaches that an imaging catheter (bundle 7a may be coated in Teflon, which is considered to form the catheter; col.6, ll. 3-15) and a fiber optic wire/cable (7a) extending at least partially through the imaging catheter, wherein the fiber optic wire/cable is configured to image the blood vessel and material surrounding the tubular housing (as understood in view of col. 5, ll. 58-col. 6, ll. 2). Honda teaches flushing the field in proximity to the distal end of the fiber optic wire in order to clear a visual field (col. 11, ll. 45-67). Gifford discloses flushing the field in proximity to the tubular housing. It would have been obvious to modify the prior art of Gifford to include an imaging catheter and fiber optic cable as taught by Honda in order to be able to visualize the area of interest during the procedure. Honda does not expressly disclose imaging through optical coherence tomography (OCT).
Maschke discloses another atherectomy catheter and further discloses that the device may comprise optical fibers configured to transmit light to an analysis apparatus where the interference of the reflected light with the reference light is analyzed in order to generate an image based on optical coherence tomography ([0025]). According to Maschke, OCT imaging delivers high-resolution images which comparatively accurately reproduce in particular the structures close to the vessel surface ([0025]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Gifford as modified by Honda, Jackson, and Briscoe to configure the fiber optic wire bundle to transmit an optical coherence tomography signal, and to include the step of imaging the blood vessel and atherosclerotic material through optical coherence tomography in order to deliver high-resolution images of structures close to the vessel surface as taught by Maschke.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 7/21/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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