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 .
Status of Claims
Claim 1 is currently amended.
Claims 2, 8, 12, 16 and 21-25 are cancelled.
Response to Arguments
Applicant’s arguments, see pages 6-16, filed 2/12/2026, with respect to 35 U.S.C. 112(a) and 35
U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(a) and 35 U.S.C. 112(b) rejections of claims 1-7, 9-15, 17-20, and 25-31 has been withdrawn.
35 U.S.C. 112(a):
Regarding claim 1, applicant argues that there is ample support within the specification for the
claimed intravascular device, specifically, “the exact way to determine whether the non-thrombogenic surface texture is configured to preferentially adsorb at least one human blood plasma protein not associated with a thrombosis response on to at least a portion of the surface; and the exact way to determine the non-thrombogenic surface texture is configured to prevent adsorption of the at least one human blood plasma protein associated with a thrombogenic response on to at least a portion of the surface of the cage or the impeller.”
After further consideration from the applicant’s drawings and specifications (fig. 13-15;
paragraphs 51-52, 55, 58, 103, 106-107, 110). The examiner agrees that the applicant’s disclosure provides sufficient structure and methods to satisfy the 35 U.S.C. 112(a) argument above. Therefore, the rejection is withdrawn.
35 U.S.C. 112(b):
Regarding claim 1, applicant has amended the claim to remove “associated.” Furthermore, the
applicant amended the limitation to clearly recite “the expandable member facilitates flow into the one or more inlet openings through the cage to the one or more outlet openings by funneling flow therein.” Therefore, the term, facilitate is clearly defined and the 35 U.S.C. 112(b) rejection is withdrawn.
Applicant’s arguments, see pages 16-19, filed 2/12/2026, with respect to the rejection(s) of claim(s) 1-9, 13-15, 17-20, 25-28, and 30-31 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made by Nitzan in view of Shiratori in further view of Bedworth.
35 U.S.C. 103:
Regarding claim 1, applicant argues that the amended claims are not obvious over any of Nitzan,
Shiratori, Alt, or Bedworth, alone or in any proposed combination. Specifically, the applicant argues that the examiner’s rejection reliant on a combination of references does not provide an articulated reasoning or support to show that “one of ordinary skill in the art would be motivated to combine” said references. InTOuch Technologies, Inc. v. VGo Communications, 751111 F.3d 1327, 1352 (Fed. Cir. 2014). The examiner respectfully disagrees and argues that the combination of references provide sufficient prima facie case of obviousness and reasoning as to why “one of ordinary skill in the art would be motivated” to make the combination.
It is disclosed in Shiratori [43] that “although the depth of the spatial asperities may depend on
the thickness of the antithrombogenic laminated film, it is preferably 15 nm to 200 nm for effective expression of the antithrombogenic property.” Shiratori clearly teaches an antithrombogenic laminated film, with a preferred thickness of less than 175 nm (paragraph 43), which may be applied on the surface of Nitzan to promote a resistance to blood clotting.
It is further disclosed in Shiratori that the antithrombogenic laminated film may be “made of
stainless steel, which is made available as the material to be coated, and the surface thereof is hydrophilized by introduction of OH groups onto the surface and made negatively (-) charged 104 as the initial surface charge. When the surface of the negatively charged substrate 101 is then brought into contact with a positively charged electrolyte polymer compound, the positively charged electrolyte polymer compound is adsorbed on the surface of the substrate 101 by Coulomb force, forming a polycation layer” (paragraph 41). A polycation layer are typically positively charged which can interact strongly with the negatively charged components of blood cells and plasma proteins, such as albumin.
Alt teaches that it is well-known that stainless steel can be a medical grade 316L metal which is
biologically compatible (biocompatible) with the fluids and tissue of the human body (paragraph 21). This reference is used to provide support for the stainless steel laminated film of Shiratori to be a biocompatible component. Although biocompatibility is required in the claim, the examiner argues that biocompatibility, in itself, is also motivation to combine Nitzan with the laminated film from Shiratori.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric material of Nitzan and coating it with the stainless steel, anti-thrombogenic film from Shiratori for the benefit of providing a hydrophilized surface, which will in turn prevent blood clotting and thrombus formation.
It is disclosed in Bedworth (col. 16, lines 25-55) that “Two-dimensional materials in which pores
are intentionally created are referred to herein as “perforated,” such as “perforated graphene-based materials,” “perforated two-dimensional materials,” or “perforated graphene. Two-dimensional materials include metal oxide.”
It is further disclosed that materials employed in making an enclosure are preferably
biocompatible (col. 56, lines 25-44), the perforated graphene material is supported on a biocompatible porous polymer (col. 58, lines 25-35). The porous material is preferably biocompatible and in some embodiments is preferably suitable for implantation in a human or animal body (col. 59-60, lines 61-67 and 1-14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surface of Nitzan with the metal oxide layer from Bedworth for the benefit of increasing stability of the medical device, and increase biocompatibility by resisting corrosion and delamination over long periods of time.
The examiner respectfully argues that each prior art discloses a reason as to why it would have
been obvious to one of ordinary skill in the art to be motivated to combined said references. Therefore the 35 U.S.C. 103 rejection is maintained.
Furthermore, applicant argues under Graham v. John Deere, the office has an obligation to
compare the scope of the claims at issue with the content of the prior art. Applicant submits that Nitzan, alone or in combination with the prior art, does not teach the amended limitations of claim 1, specifically, “an interstitial surface on a portion of an exterior surface to which an expandable member is attached such that, when in an expanded configuration, a proximal portion of the expandable member facilitates flow into the one or more inlet openings through the cage to the one or more outlet openings by funneling flow therein; the surface layer comprises an arithmetic average roughness (Ra) that is less than a linear dimension of at least one of a fibrinogen, a von Willebrand factor or a y-globulin and an average depth of roughness (Rz) of less than 175 nm such that the non-thrombogenic surface texture is configured to preferentially adsorb at least albumin on to at least a portion of the surface of the cage or the impeller and prevent adsorption of the fibrinogen, a von Willebrand factor or a y-globulin of the surface of the cage or the impeller.”
The examiner respectfully disagrees and argues that Nitzan teaches “an interstitial surface on a portion of an exterior surface to which an expandable member (2a) is attached such that, when in an expanded configuration, a proximal portion of the expandable member (2a) facilitates flow into the one or more inlet openings (108) through the cage (102) to the one or more outlet openings (114) by funneling flow therein (fig. 1-2; paragraph 111 and 118-122).”
Furthermore, the examiner argues that Shiratori teaches “the surface layer comprises an arithmetic average roughness (Ra) that is less than a linear dimension of at least one of a fibrinogen, a von Willebrand factor or a y-globulin and an average depth of roughness (Rz) of less than 175 nm such that the non-thrombogenic surface texture is configured to preferentially adsorb at least albumin on to at least a portion of the surface of the cage or the impeller and prevent adsorption of the fibrinogen, a von Willebrand factor or a y-globulin of the surface of the cage or the impeller (paragraph 41 and 43-45).” The thickness of the antithrombogenic laminated film is preferably 15 nm to 200 nm for effective expression of the antithrombogenic property. For favorable expression of antithrombogenicity, the surface roughness (root mean square average roughness: RMS) of the spatial asperities is preferably 2 nm to 40 nm. The linear dimension of fibrinogen is approximately 47.5 nm. Therefore, the roughness of the laminated film meets this requirement as disclosed. A polycation layer are typically positively charged which can interact strongly with the negatively charged components of blood cells and plasma proteins, such as albumin.
Alt teaches that it is well-known that stainless steel can be a medical grade 316L metal which is
biologically compatible (biocompatible) with the fluids and tissue of the human body (paragraph 21). This reference is used to provide support for the stainless steel laminated film of Shiratori to be a biocompatible component.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric material of Nitzan and coating it with the stainless steel, anti-thrombogenic film from Shiratori for the benefit of providing a hydrophilized surface, which will in turn prevent blood clotting and thrombus formation.
Lastly, the examiner argues that process limitation cannot impart patentability to a product
claim where the product is not patentably distinguished over the prior art. A functional statement cannot serve to distinguish a claim, which is not a process claim, from a reference since it does not define any structure. This is particularly so where the functional statement is conditional in nature, as to a possibility that may or may not occur. In this case, the limitation, “the non-thrombogenic surface texture is configured to preferentially adsorb at least albumin on to at least a portion of the surface of the cage or the impeller and prevent adsorption of the fibrinogen, a von Willebrand factor or a y-globulin of the surface of the cage or the impeller,” is a functional statement. The examiner has shown all the necessary structure and motivational statements in the combination of art as applied to perform the functional statement. Therefore, the 35 U.S.C. 103 rejection is maintained.
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.
Claims 1, 3-7, 9, 13-15, 17-20, 26-28, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan et al (US Patent Application Publication Number: US 2019/0223877 A1, hereinafter “Nitzan”) in view of Shiratori et al. US Pub.: US 2011/0084019 A1, hereinafter Shiratori (expedited by Alt US Pub.: US 2004/0039438 A1) in view of Bedworth et al. US Pat.: US 10653824 B2, hereinafter Bedworth.
Regarding claims 1, 3- 6, and 9, Nitzan teaches an intravascular device (e.g. Abstract), the device comprising: catheter (1) dimensioned for insertion into a vein (e.g. [0009]), the catheter (1) comprising a proximal portion and a distal portion (fig. 1-2; paragraph 118-122); The entire embodiment of figure 2 comprise of the distal portion of the catheter. Figure 1 discloses both the proximal and distal portion of the catheter.
and a cage (102) attached to the distal portion of the catheter (1), the cage comprising an impeller (110) disposed therein, one or more inlet openings (108), one or more outlet opening (114), and an interstitial surface on a portion of an exterior surface to which an expandable member (2a) is attached such that, when in an expanded configuration, a proximal portion of the expandable member (2a) facilitates flow into the one or more inlet openings (108) through the cage (102) to the one or more outlet openings (114) by funneling flow therein, wherein the cage and/or impeller (110) configured for contact with human blood (fig. 1-2; paragraph 111 and 118-122).
However, Nitzan does not teach a non-thrombogenic surface texture, wherein the non-thrombogenic surface texture comprises a biocompatible metal comprising a surface layer comprising a metal oxide layer comprising one or more of a titanium oxide, a chromium oxide, a nickel oxide, and an aluminum oxide, wherein the non-thrombogenic surface layer is generated by processing the metal oxide layer via one or more of tumbling, polishing, electropolishing, grinding, lapping, or abrasive blasting such that the metal oxide layer comprises a thickness of less than or equal to 5000 picometers and the surface layer comprises an arithmetic average roughness (Ra) that is less than a linear dimension of at least one of a fibrinogen, a von Willebrand factor or a y-globulin and an average depth of roughness (Rz) of less than 175 nm such that the non-thrombogenic surface texture is configured to preferentially adsorb at least albumin on to at least a portion of the surface of the cage or the impeller and prevent adsorption of the fibrinogen, a von Willebrand factor or a y-globulin of the surface of the cage or the impeller, wherein the non-thrombogenic surface texture facilitates the flow of the human blood through the cage.
Shiratori, in a similar field of endeavor, teaches the surface layer comprises an arithmetic average roughness (Ra) that is less than a linear dimension of at least one of a fibrinogen, a von Willebrand factor or a y-globulin and an average depth of roughness (Rz) of less than 175 nm such that the non-thrombogenic surface texture is configured to preferentially adsorb at least albumin on to at least a portion of the surface of the cage or the impeller and prevent adsorption of the fibrinogen, a von Willebrand factor or a y-globulin of the surface of the cage or the impeller, wherein the non-thrombogenic surface texture facilitates the flow of the human blood through the cage (paragraph 41, 43-45 and claims 8-9). It is disclosed in Shiratori [43] that “although the depth of the spatial asperities may depend on the thickness of the antithrombogenic laminated film, it is preferably 15 nm to 200 nm for effective expression of the antithrombogenic property.” Shiratori clearly teaches an antithrombogenic laminated film, with a preferred thickness of less than 175 nm (paragraph 43), which may be applied on the surface of Nitzan to promote a resistance to blood clotting. It is further disclosed in Shiratori that the antithrombogenic laminated film may be “made of stainless steel, which is made available as the material to be coated, and the surface thereof is hydrophilized by introduction of OH groups onto the surface and made negatively (-) charged 104 as the initial surface charge. When the surface of the negatively charged substrate 101 is then brought into contact with a positively charged electrolyte polymer compound, the positively charged electrolyte polymer compound is adsorbed on the surface of the substrate 101 by Coulomb force, forming a polycation layer” (paragraph 41). A polycation layer are typically positively charged which can interact strongly with the negatively charged components of blood cells and plasma proteins, such as albumin.
Alt teaches that it is well-known that stainless steel can be a medical grade 316L metal which is
biologically compatible (biocompatible) with the fluids and tissue of the human body (paragraph 21). This reference is used to provide support for the stainless steel laminated film of Shiratori to be a biocompatible component. Although biocompatibility is required in the claim, the examiner argues that biocompatibility, in itself, is also motivation to combine Nitzan with the laminated film from Shiratori.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric material of Nitzan and coating it with the stainless steel, anti-thrombogenic film from Shiratori for the benefit of providing a hydrophilized surface, which will in turn prevent blood clotting and thrombus formation.
Bedworth, in a similar field of endeavor, teaches a device for insertion into a tissue canal (e.g. Abstract) and further teaches a non-thrombogenic surface texture comprising a surface layer comprising a metal oxide comprising one or more of a titanium oxide, a chromium oxide, a nickel oxide, and an aluminum oxide (col 16, lines 25-55). It is disclosed that “Two-dimensional materials are, most generally, those which have atomically thin thickness from single-layer sub-nanometer thickness to a few nanometers and which generally have a high surface area. Two-dimensional materials include transition metal oxide.” 5000 picometers are equivalent to 5 nanometers. The thickness range disclosed includes a metal oxide thickness of less than 5000 picometers because a sub-nanometer thickness is disclosed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surface of Nitzan with the metal oxide layer from Bedworth for the benefit of increasing stability of the medical device, while resisting to corrosion and delamination over long periods of time.
Regarding claim 7, Nitzan in view of Shiratori in view of Bedworth teaches the invention as claimed and because they teach the cage or the impeller is metal and has a non-thrombogenic surface texture as discussed above, they teach that the non- thrombogenic surface texture is generated by processing the metal. (Note: This limitation is interpreted as a product-by-process limitation).
Regarding claim 13, the current embodiment (fig. 2) of Nitzan does not teach wherein the expandable member is a balloon.
However, in another embodiment (fig. 7), Nitzan teaches wherein the expandable member is a balloon (fig. 7, 318; paragraph 125-126). It is disclosed in [125] that the expandable members/balloon 318 is attached around the outside of the cage.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment to include an expandable member attached around an outside of the cage as taught by the second embodiment of Nitzan combine the two embodiments of Nitzan for the benefit of controlling the blood flow within the patient’s tissue.
Regarding claim 14, the current embodiment (fig. 2) of Nitzan does not teach wherein upon expansion of the balloon when the catheter is in the vein, the balloon occludes the vein and directs blood flow into an inlet of the cage
However, in another embodiment (fig. 7), Nitzan teaches wherein upon expansion of the balloon (fig. 7, 318) when the catheter is in the vein, the balloon (fig. 7, 318) occludes the vein and directs blood flow into an inlet of the cage (paragraph 125-126). The restrictor 318 is also a balloon that occludes the vein. This prevents recirculation of blood into the inlet disclosed as 308 in this embodiment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the two embodiments of Nitzan for the benefit of controlling the blood flow within the patient’s tissue.
Regarding claim 15, Nitzan teaches wherein, when the balloon (fig. 7-9, 318) is inflated, a distal portion of the balloon (fig. 7, 318) is aligned over outlets of the cage to mitigate blood recirculation (paragraph 125-126). It is disclosed that the balloon 318 is aligned over the outlets of the cage in a longitudinal direction to inhibit the possibility of blood recirculation back into the inlet.
Regarding claim 17, Nitzan teaches wherein a distal portion of a shaft of the impeller (fig. 2, 112) and a distal portion of the cage (fig. 2, 102) defines a gap (paragraph 118-122).
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Regarding claim 18, the current embodiment (fig. 2) of Nitzan does not teach wherein when the balloon is inflated blood flow is directed through the cage.
However, in another embodiment (fig. 7), Nitzan teaches wherein when the balloon (fig. 7, 318) is inflated blood flow is directed through the cage (paragraph 125-126). It is disclosed that when the balloon 318 is activated/inflated blood flow is directed to the inlet 308 through the cage 302 and to outlet 316.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the two embodiments of Nitzan for the benefit of controlling the blood flow within the patient’s tissue.
Regarding claim 19, Nitzan teaches wherein blood flowing through the cage (fig. 2, 102) is accelerated by a geometry of the cage (fig. 2, 102) and the action of the impeller (paragraph 122-125). It is disclosed that the impeller is activated using a motor. It is also disclosed in figure that the outlet 8 is proximal to the impeller and that the outlet allows blood to flow within the cage. Therefore, blood flow is accelerated within the cage using the impeller.
Regarding claim 20, Nitzan teaches wherein at least one of the distal portion of the shaft or the distal portion of the cage defining the gap (paragraph 118-122). The gap is shown in the edited version of figure 2 above.
However, Nitzan in view of Bedworth does not explicitly teach the gap comprises the non-thrombogenic surface texture.
Shiratori, in the same field of endeavor, teaches a non-thrombogenic surface texture (paragraph 43-45 and claims 8-9). It is disclosed that “an antithrombogenic laminated film is present and that the peak-to-peak distance of spatial asperities is preferably 200 nm to 2 nm, and a peak-to-peak distance of spatial asperities of less than 200 nm or more than 2 nm may lead to deterioration or disappearance of antithrombogenicity.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surface of the gap from Nitzan in view of Bedworth with the non-thrombogenic surface of Shiratori for the benefit of applying less resistance when inserting the catheter into the tissue of the patient. This will also lessen damage or scarring to surrounding tissue.
Regarding claim 26, Nitzan in view of Shiratori in view of Bedworth teaches the claimed invention and Shiratori further teaches wherein the Ra is less than 32 nanometers and greater than 7.5 nanometers (paragraph 43-45 and claims 8-9). It is disclosed that “an antithrombogenic laminated film is present and that the peak-to-peak distance of spatial asperities is preferably 200 nm to 2 nm, and a peak-to-peak distance of spatial asperities of less than 200 nm or more than 2 nm may lead to deterioration or disappearance of antithrombogenicity.”
Regarding claim 27, Nitzan in view of Shiratori in view of Bedworth
teaches the claimed invention and Shiratori further teaches wherein the Ra is less than 25 nanometers and greater than 7.5 nanometers (paragraph 43-45 and claims 8-9). It is disclosed that “an antithrombogenic laminated film is present and that the peak-to-peak distance of spatial asperities is preferably 200 nm to 2 nm, and a peak-to-peak distance of spatial asperities of less than 200 nm or more than 2 nm may lead to deterioration or disappearance of antithrombogenicity.”
Regarding claim 28, Nitzan in view of Shiratori in view of Bedworth teaches the claimed invention and Shiratori further teaches wherein the non-thrombogenic surface texture comprises an average depth of roughness (Rz) of less than 100 nm (paragraph 43-45 and claims 8-9). It is disclosed that “an antithrombogenic laminated film is present and that the peak-to-peak distance of spatial asperities is preferably 200 nm to 2 nm, and a peak-to-peak distance of spatial asperities of less than 200 nm or more than 2 nm may lead to deterioration or disappearance of antithrombogenicity.”
Regarding claim 30, Nitzan in view of Shiratori in view of Bedworth teaches the claimed invention and Nitzan further teaches wherein the cage (fig. 2,102) comprises an interior lumen connecting the one or more inlet (fig. 2, 108) openings, the interior lumen configured to facilitate the blood flow through the interior lumen to the distal portion of the catheter (fig. 1, 1), the cage housing an impeller (fig. 2, 110), the cage and/or impeller (fig. 2, 110) configured for contact with human blood (paragraph 111 and 118-122).
Regarding claim 31, Nitzan in view of Bedworth teaches the claimed invention and Nitzan further teaches an interior lumen (fig. 2; paragraph 122).
However Nitzan in view of Bedworth does not teach wherein the interior lumen comprises the non-thrombogenic surface texture
Shiratori, in the same field of endeavor, teaches wherein the interior lumen comprises the non-thrombogenic surface texture (paragraph 43-45 and claims 8-9). It is disclosed that “an antithrombogenic laminated film is present and that the peak-to-peak distance of spatial asperities is preferably 200 nm to 2 nm, and a peak-to-peak distance of spatial asperities of less than 200 nm or more than 2 nm may lead to deterioration or disappearance of antithrombogenicity. 2 nm is an Ra that is less than a linear dimension of one or more of a fibrinogen, a von Willebrand factor, and a y-globulin, and greater than a linear dimension of an albumin”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify all the surfaces of the interior lumen of Nitzan in view of Bedworth with the non-thrombogenic surface of Shiratori in order to provide the predictable results of increasing the efficiency of blood flow and circulation within the catheter.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan in view Shiratori (expedited by Alt) in view of Bedworth and in further view of Campbell US Pub.: US 2012/0178986 A1.
Regarding claim 10, Nitzan in view of Shiratori in view of Bedworth teaches the claimed invention and Nitzan further teaches a catheter (fig. 1, 1) and a cage (fig. 2, 102).
However, Nitzan in view of Shiratori in view of Bedworth does not teach a cuff providing a smooth transition between an outer surface of the catheter and a proximal portion of the cage.
Campbell, in the same field of endeavor, teaches a cuff (fig. 3, 228) providing a smooth transition between an outer surface of the catheter (fig. 3, 204) and a proximal portion of the cage (paragraph 60-62).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter from Nitzan in view of Shiratori in view of Bedworth with the cuff from Campbell for the benefit of supporting the distal portion of the catheter and provides bearing from the rotation of the impeller.
Regarding claim 11, Nitzan in view of Shiratori in view of Bedworth teaches the claimed invention and Shiratori further teaches a non-thrombogenic surface texture (paragraph 43-45 and claims 8-9).
However, Nitzan in view of Shiratori in view of Bedworth does not teach a cuff. Campbell, in the same field of endeavor, teaches a cuff (fig. 3, 228; paragraph 60-62).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter from Nitzan in view of Shiratori in view of Bedworth with the cuff from Campbell for the benefit of supporting the distal portion of the catheter and provides bearing from the rotation of the impeller.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Nitzan in view of Shiratori (expedited by Alt) in view of Bedworth and in further view of Itaoka et al. US Pub.: US 5019040 A, hereinafter Itaoka.
Regarding claim 29, Nitzan in view of Shiratori in view of Bedworth teaches a non-thrombogenic surface texture (Shiratori; paragraph 43-45 and claims 8-9).
However, Nitzan in view of Shiratori in view of Bedworth does not teach wherein the non-thrombogenic surface texture reduces shear-related platelet activation to facilitate the flow of the human blood.
Itaoka, in the same field of endeavor, teaches wherein the non-thrombogenic surface texture reduces shear-related platelet activation to facilitate the flow of the human blood (col. 2, lines 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify all the surfaces of the interior lumen of Nitzan in view of Shiratori in view of Bedworth with the non-thrombogenic surface of Itaoka in order to deter platelet coagulation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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, Benjamin Klein can be reached on (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792