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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/07/2025 has been entered.
Response to Arguments
Applicant’s arguments, see page 7, filed 11/07/2025, with respect to claim objections have been fully considered and are persuasive. The claim objection has been obviated by an amendment to claim 53. The claim objection of claim 53 has been withdrawn.
Applicant’s arguments, see page 7, filed 11/07/2025, with respect to 35 U.S.C. 112(b) rejections have been fully considered but they are not persuasive. While the objection to claim 54 is obviated by cancellation of claim 54, 35 U.S.C. 112(b) rejections to claims 1 and 52 are still necessary following the amendments to these claims. Please see 35 U.S.C. 112(b) rejections below.
Applicant’s arguments, see pages 7-11, filed 11/07/2025, with respect to 35 U.S.C. 102 rejections have been fully considered but they are not persuasive. The Applicant argues that amended claim 1 is not anticipated by Heuring. The Applicant argues that Heuring does not teach or suggest features designed to minimize recirculation as fluid flows through the cage from the inlet to the outlet. The Applicant points to Fig. 11 of Heuring and asserts that the device of Heuring includes sudden expansions, as well as an abrupt step in diameter between the support and the impeller core. The Applicant argues that each of these features alone is assured to create a region of recirculation. The Applicant argues that Heuring’s lack of design features to prevent recirculation is a notable omission, though an expected omission in view of Heuring’s disclosure. The Applicant argues that Fig. 11 of Heuring shows that fluid is drawn into the distal inlet to the proximal housing, contrary to the configuration recited in amended claim 1. The Applicant further argues that this configuration in Heuring is a “pull” configuration based on Heuring’s Par. [0094]. The Applicant argues that the design of the device of Heuring to reverse flow within the device necessarily does not allow for stepped portions defining changes in an inner diameter of the inner lumen configured to manipulate the flow of fluid from the proximal inlet and through the cage to the distal outlet such that recirculation of the flow of fluid and shear forces acting on blood particles traveling through the cage to the distal outlet are minimized, as recited in amended claim 1. The Applicant also argues that Heuring’s teaching in Par. [0100] wholly fails to teach or suggest amended claim 1.
This is not found persuasive. The Examiner finds Heuring to still anticipate independent claim 1, as amended. Specifically, the Examiner notes that the flow director 120 of Heuring’s Fig. 11 corresponds to the claimed “cuff”, and that Heuring teaches the limitation “wherein a proximal portion of the cage comprises a cuff configured to taper towards the inner lumen to facilitate the flow of fluid into the proximal inlet and to the impeller without recirculation, wherein a proximal face of the impeller is positioned adjacent to a distal face of the cuff to reduce recirculation of the flow of fluid and shear forces acting on blood traveling through the cage to the distal outlet”. Please see 35 U.S.C. 102 rejections below. Heuring’s flow director 120 does help facilitate the flow of fluid axially from the proximal inlet 118 to the impeller 112, and does so without recirculation. Heuring does not say that the arrangement and features of Heuring’s Fig. 11 are assured to create recirculation, as the Applicant appears to suggest. Instead, Heuring appears to teach in Par. [0102] that configurations without and with recirculation are both contemplated: “In some embodiments, the diameter of the pump 110 will be less than the diameter of the vessel or chamber it is implanted in to provide a bypass region around the pump and move on without passing through the pump. Alternatively, fluids can recirculate through the pump one or more times by moving through the bypass region from the outlet of the pump to the inlet of the pump”. Also, as previously explained, Heuring discusses circulation and perfusion enhancements can lead to laminar flow, which corresponds to minimizing recirculation and shear forces acting on blood particles (Par. [0080]; Par. [0174]). Therefore, the 35 U.S.C. 102 rejection of claim 1 over Heuring is maintained. Please see 35 U.S.C. 102 rejections below. The Examiner notes that Applicant’s arguments directed to 35 U.S.C. 103 rejections are found moot as a result of the finding that Heuring continues to anticipate independent claim 1 under 35 U.S.C. 102. Therefore, the 35 U.S.C. 103 rejections are maintained as well. Please see 35 U.S.C. 103 rejections below.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1-7, 12, 15-18, 21-22, 25, 27, 29, 31, 42, 45-49, 52-53, and 55-56 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the flow of fluid" in lines 11-12. There is insufficient antecedent basis for this limitation in the claim.
Claim 52 recites the limitation “an inner surface of the inner lumen” in line 2, whereas an inner surface of the inner lumen was already introduced in a claim that claim 52 depends from (claim 1, line 15). It is unclear whether the Applicant intended to claim the same or a different interior surface of the inner lumen. Consider changing to “the inner surface of the inner lumen”.
*All other claims are rejected due to their dependency on a rejected claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 12, 15-18, 21, 25, 29, 31, 45, 47-49, and 55-56 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Heuring, et al. (U.S. PGPub No. 2014/0128659). The article “Stainless Steel 101” by UnifiedAlloys (previously cited) is relied upon as evidence. The article “Can stainless steel corrode?” by thyssenkrupp (see attached) is also relied upon as evidence.
Regarding claim 1, Heuring teaches (Figs. 1B-C and 11) an intravascular device (Par. [0079] – systems for using intravascular blood pumps; Par. [0096] – Fig. 11 shows an embodiment of an intravascular pumping module; Par. [0098]), the device comprising:
a catheter dimensioned for inserting into a vein, the catheter comprising a proximal portion and a distal portion (Par. [0084] – the systems and methods discussed herein may allow a pump to be deployed through a catheter percutaneously or by minor surgical access to the vasculature; Par. [0086] – the system may be delivered via catheter with a single access site at or near the femoral or iliac or other major artery or vein); and
(Fig. 11, # 114, 116, 118 – the outlet housing 114, the flexible cannula 116, and the inlet housing 118 together represent the cage) a cage attached to the distal portion of the catheter (Par. [0084] – since the intravascular pump may be deployed through the catheter, the cage must be attached to the distal portion of the catheter; Par. [0096]), the cage comprising:
(Fig. 11, # 114, 116, 118 – these components that represent the cage are shown to be a substantially cylindrical member, which form an inner lumen therethrough, as this lumen comprises an impeller, motor, and flow director) a substantially cylindrical member forming an inner lumen through the cage (Par. [0037]; Par. [0096] – the inner lumen is configured to facilitate flow from the inlet to the outlet);
(Fig. 11, # 112 – impeller) an impeller housed within the cage (Par. [0096] – the impeller 112 lies inside the outlet housing 114), (Fig. 1B-C, # 115; Fig. 11, # 112) the impeller comprising one or more blades and configured to rotate in a clearance with the inner lumen to thereby define a gap region between the rotating impeller and the cage (Par. [0096] – the impeller 112 lies inside the outlet housing 114 – there is shown to be a clearance (i.e., defining a gap region) between the impeller 112 and outlet housing 114 in Fig. 11 (see annotated Figure below); Par. [0100] – impeller 115 may be mounted on a shaft .. for rotation within housing 114);
(Fig. 11, # 118 – inlet housing – the arrows pointing into the inlet housing are representative of inlet flow, 120 – inlet flow detector) a proximal inlet comprising one or more openings configured to direct the flow of fluid into and through the inner lumen axially towards the impeller (Par. [0096]); and
(Fig. 11, # 114 – outlet housing – the arrows pointing out adjacent the distal outlet housing are representative of a distal outlet) a distal outlet comprising one or more openings configured to direct the flow of fluid radially from the inner lumen (Par. [0096]), wherein (Figs. 1B-1C and Fig. 11, # 114 – outlet housing, i.e. a portion of a surface of the cage) at least a portion of an exterior surface of the cage and a portion of an inner surface of the inner lumen comprises a hydrophilic non-thrombogenic metallic interface (Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel, which is a bio-compatible material – The Examiner notes that Applicant’s specification considers stainless steel as a non-thrombogenic metal (page 2, lines 19-27; page 5, lines 12-13; page 19, lines 4-13) – The Examiner also notes that metals (e.g., stainless steel) are naturally hydrophilic.; Par. [0105] – housing 114 is placed in descending aorta 98 or other vessel or chamber. Housing 114 therefore has an exterior surface and interior surface in contact with blood. The entire housing 114 is made of a suitable metallic material (e.g., stainless steel), which is used in the hydrophilic non-thrombogenic metallic interface), and wherein (Fig. 11, # 120 – flow director, i.e. cuff; Fig. 25A, # 188) a proximal portion of the cage comprises a cuff configured to taper towards the inner lumen to facilitate the flow of fluid into the proximal inlet and to the impeller without recirculation (Par. [0096] – the inlet housing comprises an inlet flow director; Par. [0102] – in some embodiments, the diameter of the pump 110 will be less than the diameter of the vessel or chamber it is implanted in to provide a bypass region around the pump and move on without passing through the pump (i.e., without recirculation); Par. [0134-0135] – Flow directors that modify flow into (e.g., Fig. 10 (102) and Fig. 11(120)) are referred to as “flow-around” flow directors. Fig. 25a shows a flow-around flow director (188) as an element of the inlet housing (190); Par. [0174]; from Fig. 11, it is seen that the inlet flow director (i.e., cuff) tapers towards the inner lumen and to the impeller 112), wherein (Fig. 11, # 112 – impeller, 120 – flow director, i.e., cuff) a proximal face of the impeller is positioned adjacent to a distal face of the cuff to reduce recirculation of the flow of fluid and shear forces acting on blood traveling through the cage to the distal outlet (Par. [0080] – circulation and perfusion enhancement system may create enhancements including laminar flows (i.e., representative of manipulating the flow of fluid therethrough to thereby minimize shear forces acting on blood particles. – It is noted by the Examiner that Applicant explains on page 9 of the instant specification (2nd paragraph from the bottom) that laminar flow is advantageous as it may reduce shear forces acting on blood cells; [0093] – laminar; [0096] – the inner lumen is configured to facilitate flow from the inlet to the outlet. The inlet housing comprises an inlet flow director (120); [0174] – laminar; From Fig. 11, it is seen that the proximal face of the impeller 112 is adjacent to a distal face of the flow director 120 (i.e., cuff).).
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Annotated Fig. 11
Therefore, claim 1 is unpatentable over Heuring, et al.
Regarding claims 2-3, Heuring teaches the device of claim 1, wherein (Fig. 11, # 114) the non-thrombogenic metallic interface comprises a primary metallic element that is selected from period 4 transition metals of the periodic table of elements and wherein the period 4 transition metal comprises one of titanium, vanadium, chromium, iron, cobalt, or nickel (Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel – As evidenced by UnifiedAlloys in “Stainless Steel 101”, stainless steel is an iron and chromium alloy. Iron and chromium are both period 4 transition metals).
Therefore, claims 2-3 are unpatentable over Heuring, et al.
Regarding claim 4, Heuring teaches the device of claim 3, wherein (Fig. 11, # 114) the non-thrombogenic metallic interface further comprises a secondary metallic element that comprises one of:
an element from the group of period 4 transition metals (Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel – As evidenced by UnifiedAlloys, stainless steel is an iron and chromium alloy. UnifiedAlloys also evidences that nickel and manganese are common additives. Chromium, iron, nickel, and manganese are all period 4 transition metals);
molybdenum (UnifiedAlloys evidences that molybdenum is a common additive to stainless steel as well); or
tungsten, gold, tantalum or platinum.
Therefore, claim 4 is unpatentable over Heuring, et al.
Regarding claims 5-7, Heuring teaches the device of claim 1, wherein (Fig. 11, # 114) the non-thrombogenic metallic interface comprises an alloy, wherein the alloy comprises a chromium alloy or titanium alloy, and wherein the chromium alloy comprises a stainless-steel alloy or a cobalt chromium alloy (Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel – As evidenced by UnifiedAlloys, stainless steel is an iron and chromium alloy.).
Therefore, claims 5-7 are unpatentable over Heuring, et al.
Regarding claim 12, Heuring teaches the device of claim 1, wherein (Fig. 11, # 114) the non-thrombogenic metallic interface comprises an oxygen active material (Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel – The article “Can stainless steel corrode?” by thyssenkrupp evidences that stainless steel comprises an oxygen active material. Thyssenkrupp explains that oxygen reacts with the chromium atoms in stainless steel to form a chromium oxide protective layer that blocks the material from the environment.).
Therefore, claim 12 is unpatentable over Heuring, et al.
Regarding claim 15, Heuring teaches the device of claim 1, wherein (Fig. 11, # 114) the non-thrombogenic metallic interface comprises a surface layer in contact with blood, wherein the surface layer is comprising an oxide film (Par. [0096] and Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel. As evidenced by UnifiedAlloys in “Stainless Steel 101”, stainless steel is an iron and chromium alloy. The article “Can stainless steel corrode?” by thyssenkrupp evidences that stainless steel comprises an oxygen active material. Thyssenkrupp explains that oxygen reacts with the chromium atoms in stainless steel to form a chromium oxide protective layer (i.e., oxide film) that blocks the material from the environment. Therefore, the stainless steel housing in Heuring necessarily comprises an oxide film.).
Therefore, claim 15 is unpatentable over Heuring, et al.
Regarding claims 16-17, Heuring teaches the device of claim 15, wherein (Fig. 11, # 114) the exterior surface of the cage or a surface of the impeller comprises a metallic substructure that is enveloped with the oxide film, wherein the oxide film is a continuous oxide film that defines the exterior surface of the cage or the surface of the impeller, and wherein the continuous oxide film comprises an oxide film of a metallic element of said metallic substructure (Par. [0096] and Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel. The article “Can stainless steel corrode?” by thyssenkrupp evidences that stainless steel comprises an oxygen active material. Thyssenkrupp explains that oxygen reacts with the chromium atoms in stainless steel to form a chromium oxide protective layer (i.e., oxide film) that blocks the material from the environment. The Examiner notes that such a continuous oxide film on the exterior surface of the cage would necessarily be present as the stainless steel of the housing 114 reacts with oxygen and creates the chromium oxide protective layer).
Therefore, claims 16-17 are unpatentable over Heuring, et al.
Regarding claim 18, Heuring teaches the device of claim 17, wherein (Fig. 11, # 114) the continuous oxide film is configured so as to substantially preclude oxides of thrombogenic metallic elements or promote oxides of non-thrombogenic elements (Par. [0096] and Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel. – The Examiner notes that since stainless steel is considered non-thrombogenic, the oxide film of the stainless steel housing of Heuring necessarily substantially precludes oxides of thrombogenic metallic elements or promote oxides of non-thrombogenic elements.).
Therefore, claim 18 is unpatentable over Heuring, et al.
Regarding claim 21, Heuring teaches the device of claim 18, wherein (Fig. 11, # 114) the continuous oxide film comprises TiO2 or Cr2O3 or A1203 or a mixture of two or more of these oxides (Par. [0096] and Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel. The article “Can stainless steel corrode?” by thyssenkrupp evidences that stainless steel comprises an oxygen active material. Thyssenkrupp explains that oxygen reacts with the chromium atoms in stainless steel to form a chromium oxide (i.e., Cr2O3) protective layer (i.e., oxide film) that blocks the material from the environment.).
Therefore, claim 21 is unpatentable over Heuring, et al.
Regarding claim 25, Heuring teaches the device of claim 15, wherein (Fig. 11, # 114) the non-thrombogenic metallic interface comprises a plurality of hydrophilic groups attached to the oxide film (Par. [0096] and Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel. – The Examiner notes that since metals (e.g., stainless steel) are considered to be hydrophilic, the stainless steel housing in Heuring would necessarily have a plurality of hydrophilic groups attached).
Therefore, claim 25 is unpatentable over Heuring, et al.
Regarding claim 29, Heuring teaches the device of claim 1, wherein (Fig. 11, # 114) the non-thrombogenic metallic interface comprises a transition metal or a post-transition metal (Par. [0096]; Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel – As evidenced by UnifiedAlloys, stainless steel is an iron and chromium alloy. UnifiedAlloys also evidences that nickel and manganese are common additives. Chromium, iron, nickel, and manganese are all period 4 transition metals).
Therefore, claim 29 is unpatentable over Heuring, et al.
Regarding claim 31, Heuring teaches the device of claim 1, wherein (Fig. 11, # 114) the non-thrombogenic metallic interface exhibits hydrophilic properties that inhibit blood clots while the catheter is inside the vein (Par. [0084] – the systems and methods discussed herein may allow a pump to be deployed through a catheter percutaneously or by minor surgical access to the vasculature; Par. [0086] – the system may be delivered via catheter with a single access site at or near the femoral or iliac or other major artery or vein; Par. [0096]; Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel – The Examiner notes that Applicant’s specification considers stainless steel as a non-thrombogenic metal (page 2, lines 19-27; page 5, lines 12-13; page 19, lines 4-13) – The Examiner also notes that metals (e.g., stainless steel) are naturally hydrophilic and therefore would exhibit hydrophilic properties).
Therefore, claim 31 is unpatentable over Heuring, et al.
Regarding claim 45, Heuring teaches the device of claim 25, wherein (Fig. 11, # 114) the plurality of hydrophilic groups attached to the oxide film comprises a triol (Par. [0096] and Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel. – The Examiner notes that a well-known triol (i.e., organic compound containing three hydroxyl groups) is glycerol, which is found abundantly in the blood. It is well-known that hydrophilic materials, such as Heuring’s stainless steel housing, attaches to hydroxyl groups. Therefore, the plurality of hydrophilic groups of Heuring’s stainless steel housing would necessarily include glycerol (i.e., a triol) due to its location in the blood).
Therefore, claim 45 is unpatentable over Heuring, et al.
Regarding claim 47, Heuring teaches the device of claim 1, wherein (Fig. 11, # 110 – shaft, i.e. drive shaft) the impeller comprises a drive shaft extending from the distal portion to the proximal portion (Par. [0096] – a motor 108 driving a shaft 110 connected to an impeller).
Therefore, claim 47 is unpatentable over Heuring, et al.
Regarding claim 48, Heuring teaches the device of Claim 1, wherein (Fig. 11, # 112 – impeller, 114 – outlet housing, 124 – outlet flow director – arrows pointing out in the outlet housing indicate the outlet as well) a proximal portion of the impeller is proximal to the outlet (Par. [0096]).
Therefore, claim 48 is unpatentable over Heuring, et al.
Regarding claim 49, Heuring teaches the device of Claim 1, wherein (Fig. 11, # 112 – impeller, 114 – outlet housing, 118 – inlet housing, 120 – inlet flow director – arrows pointing in the inlet housing indicate the inlet as well) a proximal portion of the impeller is distal to the inlet and inside the inner lumen (Par. [0096]), and (Fig. 11, # 112 – impeller, 114 – outlet housing, 124 – outlet flow director – arrows pointing out in the outlet housing indicate the outlet as well) a distal portion of the impeller is adjacent to the outlet (Par. [0096]).
Therefore, claim 49 is unpatentable over Heuring, et al.
Regarding claim 55, Heuring teaches the device of claim 1, wherein (Fig. 11, # 112 – impeller, 120 – inlet flow director, i.e., cuff) the proximal impeller face comprises an outer diameter and the distal face of the cuff comprises an outer diameter, wherein the outer diameter of the proximal impeller face and the outer diameter of the distal face of the cuff are substantially equal (Par. [0096] – the outer diameter of the impeller 112 and cuff 120 are both bound by an outlet housing 112 and inlet housing 118, respectively; Please see annotated Fig. 11 below – The outlet and inlet housing, which encapsulate the impeller 112 and cuff 120, are shown to be substantially the same size in Fig. 11. Therefore, the impeller and cuff have substantially equal diameters. From Fig. 11, it is shown that the outer diameter of the proximal impeller face and the outer diameter of the distal face of the cuff are substantially equal).
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Annotated Fig. 11
Therefore, claim 55 is unpatentable over Heuring, et al.
Regarding claim 56, Heuring teaches the device of claim 1, wherein (Fig. 11, # 112 – impeller, 120 – inlet flow director, i.e., cuff) the proximal impeller face opposes the distal face of the cuff with a proximal gap between the proximal impeller face and the distal face of the cuff (Par. [0096] – please see annotated Fig. 11 below).
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Annotated Fig. 11
Therefore, claim 56 is unpatentable over Heuring, et al.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Heuring, et al. (U.S. PGPub No. 2014/0128659). The article “Stainless Steel 101” by UnifiedAlloys (previously cited) is relied upon as evidence. The article “Can stainless steel corrode?” by thyssenkrupp (see attached) is also relied upon as evidence.
Regarding claim 22, Heuring teaches the device of claim 18, as indicated hereinabove. Heuring does not explicitly teach the limitation of instant claim 22, that is wherein at least 90% of the metal content of the continuous oxide film comprises TiO2 or Cr2O3 or Al203 or a mixture thereof.
As explained hereinabove, Heuring teaches (Fig. 11, # 114) a stainless steel housing (Par. [0096] and Par. [0100] – Housing 114 is preferably made of a suitable metallic or plastic material, such as stainless steel.).
As evidenced by UnifiedAlloys in “Stainless Steel 101”, stainless steel is an iron and chromium alloy. The article “Can stainless steel corrode?” by thyssenkrupp evidences that stainless steel comprises an oxygen active material. Thyssenkrupp explains that oxygen reacts with the chromium atoms in stainless steel to form a chromium oxide protective layer (i.e., oxide film) that blocks the material from the environment.
Based on the teaching of Heuring and the evidence provided by UnifiedAlloys and thyssenkrupp in regards to stainless steel, it is clear that the primary component of the oxide film is chromium oxide (i.e., Cr2O3). 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] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Therefore, claim 22 is unpatentable over Heuring, et al.
Claims 27 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Heuring, et al. (U.S. PGPub No. 2014/0128659) in view of Franano, et al. (U.S. PGPub No. 2019/0282741). The article by Biran, et al. (“Heparin coatings for improving blood compatibility of medical devices”) is relied upon as evidence (please see attached).
Regarding claim 27, Heuring teaches the device of claim 1, as indicated hereinabove. Heuring does not explicitly teach the limitation of instant claim 27, that is wherein the impeller comprises the non-thrombogenic metallic interface.
Franano is directed to analogous art and teaches various inflow and outflow conduits, conduit tips, and support structures for use with the blood pump system (Title, Abstract, Par. [0002]). Franano teaches that the pump includes an impeller suspended within the housing wherein a first gap between the impeller and a top portion of the housing is in a first range between about 0.05 mm and about 0.2 mm (Par. [0021] and [0027]). Franano teaches (Figs. 1-4, # 25) that the body and impeller of the blood pump, including blood-contacting surfaces, are made from a variety of rigid biocompatible materials (Par. [0239]). Franano teaches that in some embodiments, the blood-contacting surfaces of the blood pump are made of titanium alloys (Par. [0239]). Franano further teaches that the surfaces of the pump components to be exposed to the patient’s blood may have antithrombotic coatings, such as a heparin coating (Par. [0239]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Franano’s non-thrombogenic metallic interface of the impeller into Heuring’s impeller, because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired implementing Franano’s antithrombotic metallic interface into Heuring’s impeller to further prevent blood clots and the harm they can cause.
Therefore, claim 27 is unpatentable over Heuring, et al. and Franano, et al.
Regarding claim 52, Heuring teaches the device of claim 1, as indicated hereinabove. Heuring does not explicitly teach the limitations of instant claim 52, that is wherein the non-thrombogenic metallic interface comprises a coating on an inner surface of the inner lumen, wherein a coating thickness is small in comparison to the gap region between the impeller and the cage, wherein the thickness is less than 20% of the gap region between the impeller and the cage.
Franano is directed to analogous art and teaches various inflow and outflow conduits, conduit tips, and support structures for use with the blood pump system (Title, Abstract, Par. [0002]). Franano teaches that the pump includes an impeller suspended within the housing wherein a first gap between the impeller and a top portion of the housing is in a first range between about 0.05 mm and about 0.2 mm (Par. [0021] and [0027]). Franano teaches (Figs. 1-4, # 25) that the body and impeller of the blood pump, including blood-contacting surfaces, are made from a variety of rigid biocompatible materials (Par. [0239]). Franano teaches that in some embodiments, the blood-contacting surfaces of the blood pump are made of titanium alloys (Par. [0239]). Franano further teaches that the surfaces of the pump components to be exposed to the patient’s blood may have antithrombotic coatings, such as a heparin coating (Par. [0239]). Franano does not explicitly teach the thickness of such a heparin coating, but Biran, et al. evidences in “Heparin coatings for improving blood compatibility of medical devices” (see attached) that such heparin coatings are a few hundred nanometers thick (4.8 CARMEDA BioActive Surface). Therefore, for example, a 500 nm thick heparin coating would only be 1% of a 0.05 mm thickness of the gap region between the impeller and the cage/housing (i.e., less than 20%).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Franano’s antithrombotic heparin coating and thickness relationship with respect to the gap region to Heuring’s non-thrombogenic metallic interface and gap region between the impeller and cage, as doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired implementing Franano’s antithrombotic heparin coating and coating/gap thickness relationship into Heuring’s intravascular device to further prevent blood clots and the harm they can cause.
Therefore, claim 52 is unpatentable over Heuring, et al. and Franano, et al.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Heuring, et al. (U.S. PGPub No. 2014/0128659) in view of Nitzan, et al. (U.S. PGPub No. 2018/0250456 – cited on IDS).
Regarding claim 42, Heuring teaches the device of claim 1, as indicated hereinabove. Heuring does not explicitly teach the limitation of instant claim 42, that is wherein the catheter further comprises an atraumatic tip extending from a distal portion of the cage.
Nitzan teaches systems and methods for reducing pressure at an outflow of a duct (title, abstract). Nitzan teaches that the soft atraumatic tip may facilitate smooth, safe introduction of the catheter into the vein (Par. [0126]). Nitzan teaches (Fig. 2, # 100, 104, and 110) a catheter that includes soft, distally-tapering atraumatic tip and an impeller (Par. [0131]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the atraumatic tip of Nitzan into the device of Heuring, because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired implementing the soft atraumatic tip of Nitzan in order to facilitate smooth, safe introduction of the catheter into the vein (see Par. [0126] of Nitzan).
Therefore, claim 42 is unpatentable over Heuring, et al. in view of Nitzan, et al.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Heuring, et al. (U.S. PGPub No. 2014/0128659) in view of Yamazaki (U.S. PGPub No. 2003/0039544).
Regarding claim 46, Heuring teaches the device of claim 1, as indicated hereinabove. Heuring does not explicitly teach the limitation of instant claim 46, that is wherein the clearance is between 7 and 110 micrometers inclusive.
Yamazaki is directed to analogous art and teaches a blood pump used in a ventricular assist device (Title, Par. [0002]). Yamazaki teaches (Figs. 1-2, # 2 – second casing’s inner wall, 11 – impeller) that the clearance between the second casing’s inner wall and the impellers’ outer outline is 0.1 mm or above and 3.0 mm or below (Par. [0035]). Yamazaki teaches that by reducing the clearance to 3.0 mm or below, sufficient pump function is effectuated also in the vicinity of the second casing’s inner wall (Par. [0035]). Yamazaki teaches that by increasing the clearance to 0.1 mm or above it is prevented that the impeller’s outer outline collides with the second casing’s inner wall, even if the rotation shaft is slightly off its center axis due to the pump’s vibration or the like (Par. [0036]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Yamazaki’s disclosed clearance of 0.1 mm (i.e., 100 micrometers) as the specified clearance value for the clearance between Heuring’s impeller and housing, as doing so would allow for sufficient pump function near the wall while also preventing contact between the two components (see Par. [0036] of Yamazaki). One of ordinary skill in the art would have recognized the clearance between Heuring’s impeller and the inlet housing in Heuring’s Fig. 11, and would have therefore looked to Yamazaki to determine possible clearance measurements for optimal function.
Therefore, claim 46 is unpatentable over Heuring, et al. in view of Yamazaki.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Heuring, et al. (U.S. PGPub No. 2014/0128659) in view of Stotz, et al. (U.S. PGPub No. 2021/0330958).
Regarding claim 53, Heuring teaches the device of claim 1, as indicated hereinabove. Heuring does not explicitly teach the limitation of instant claim 53, that is wherein a radial dimension of the blade varies across a proximal portion and a distal portion of the impeller.
Stotz is directed to analogous art and teaches an axial-flow pump for a ventricular assist device and a method for producing an axial-flow pump for a ventricular assist device (Title, Abstract). Stotz explains that the invention is based on the knowledge that particularly gentle and efficient fluid conveyance can be achieved by using a blade on an impeller for an axial centrifugal pump of a cardiac support system which is curved at least in sections in a wavy manner, in conjunction with a suitable positioning of the impeller relative to outlet openings on a pump housing (Par. [0006-0007]). Stotz teaches (Figs. 2 and 4, # 102 and 202) that the wavy blade curvature of the axial flow pump varies in the direction of a radial extension of the blade section (Par. [0070]; claim 31).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Stotz’s wavy blade curvature into Heuring’s impeller blade because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired implementing Stotz’s wavy blade curvature design in order to produce an impeller that results in increased efficiency with reduced blood damage (see Par. [0007] of Stotz).
Therefore, claim 53 is unpatentable over Heuring, et al. and Stotz, et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kanz (U.S. PGPub No. 2021/0170081)
Hata, et al. (WO2017/159849)
Siess, et al. (CN107771089)
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/MICHAEL T. HOLTZCLAW/Examiner, Art Unit 3796