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 .
Information Disclosure Statement
The IDS filed 11/11/2024 has been considered by the Examiner. However, the NPL reference by Firstov, et al. could not be fully considered because only the cover page/abstract was included instead of the entire reference (i.e., pp. 4863-71). Please file full reference.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 952 and 954. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
*Reference characters 952 and 954 are included in Fig. 7 but are not mentioned in the Applicant’s specification.
Specification
The disclosure is objected to because of the following informalities:
Par. [0029], line 3: A period (“.”) is needed after “FIGS. 5A-5C”.
Par. [0029], line 5: A period (“.”) is needed after “(right side of FIG. 3B)”.
Appropriate correction is required.
Claim Objections
Claim 11 objected to because of the following informalities:
Line 2: “silsequioxane” should be “silsesquioxane”.
Appropriate correction is required.
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.
Claim 16 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.
The limitation “the bifunctional modifier is selected to have a hydration layer with a thickness of no more than 1 nm from the metal or ceramic surface being modified” renders claim 16 indefinite. It is unclear what the meaning of “hydration layer” is, as “hydration layer” isn’t defined by the specification and also doesn’t appear to be a known term in the art.
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 1-2, 4, 8-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Guo, et al. (U.S. PGPub No. 2021/0162200 – cited on IDS). “Aminopropylsilsesquioxane in Aqueous Solution” by Gelest is relied upon as evidence for claims 17-18.
Regarding claim 1, Guo teaches (Fig. 1, # 10 – heart pump, i.e. blood pump; Fig. 2) a percutaneous blood pump (Title, Abstract, Par. [0017] – this may lead to better and more consistent blood flow with decreased blood hemolysis through the device and an improved sleekness for the advancement and retraction of the relevant delivery catheter system; Par. [0023]) comprising:
(Figs. 2-3, # 14 – motor, 100 – catheter assembly, 116 – impeller housing, 146 – drive assembly, 148 – drive cable, 168 – impeller shaft) a pumping device coupled to a catheter, the pumping device comprising a motor section coupled to a pump section, the pump section configured to cause blood to flow from a blood inlet of the pumping device to a blood outlet of the pumping device (Par. [0007] – inlet zone, outlet zone; Par. [0023] – Fig. 2 illustrates one embodiment of a catheter assembly to be used with the heart pump 10. An impeller housing 116 disposed at distal end 108 is configured to pump blood proximally or distally through or along a portion of heart pump 10 to convey blood from one body cavity to another.; Par. [0027] – A torque coupling system is provided for transferring torque from motor 14 to impeller shaft 168; Par. [0029] – Impeller housing 116 and impeller 165 are also carefully integrated to maintain an appropriate flow regime, e.g., from distal to proximal within the housing),
wherein a metal or ceramic surface of the pumping device comprises a bifunctional modifier (Par. [0033] – shape memory alloy for the impeller housing 116, such as nickel-titanium (nitinol), copper-zinc, copper-zinc-aluminum, copper-aluminum-nickel, and gold-cadmium. Can also include shape memory ceramics; Par. [0034]; Par. [0038] – the base coating is formed by applying one or more multifunctional organosilane (i.e., a bifunctional modifier) coupling compounds to the substrate (namely housing mesh or other medical device component generally formed from a shape memory alloy) to be coated. The multifunctional coupling compound comprises at least two functional groups that will convert to highly reactive silanol groups upon reaction with water, and at least one functional group selected from the group consisting of amines isocyanates, oxiranes and combinations thereof; Par. [0043]).
Therefore, claim 1 is unpatentable over Guo, et al.
Regarding claim 2, Guo teaches the percutaneous blood pump of claim 1, wherein (Figs. 2-3, # 202) the metal or ceramic surface is a surface of a shaft, bearing, rotor, or stator (Par. [0018] – it should be recognized that it is within the scope of the present disclosure for other components of the percutaneous heart pumps described herein to include the polymer coatings of the present disclosure; Par. [0034] – housing mesh 202 is itself a shaft and the distal end of drive cable 148).
Therefore, claim 2 is unpatentable over Guo, et al.
Regarding claim 4, Guo teaches the percutaneous blood pump of claim 1, wherein the metal or ceramic surface comprises Cu, Fe, Al, Pb, Ti, Be, Ni, Si, Zr, Mn, Mo, Co, Bi, Zn, Mg, and/or Cr (Par. [0033] – impeller housing 116 comprises a metallic, housing mesh. Examples of amin
suitable shape memory alloys include nickel-titanium (nitinol), copper-zinc, copper-zinc-aluminum, copper-aluminum-nickel).
Therefore, claim 4 is unpatentable over Guo, et al.
Regarding claim 8, Guo teaches the percutaneous blood pump of claim 1, wherein the bifunctional modifier is a functionalized aminosilane (Par. [0008] – multifunctional organosilane; Par. [0018]; Par. [0038]; Par. [0043] – amine-containing organosilane coupling compounds).
Therefore, claim 8 is unpatentable over Guo, et al.
Regarding claim 9, Guo teaches the percutaneous blood pump of claim 8, wherein the functionalized aminosilane is 4-aminobutyltriethoxysilane (Par. [0043]).
Therefore, claim 9 is unpatentable over Guo, et al.
Regarding claim 10, Guo teaches the percutaneous blood pump of claim 1, wherein the bifunctional modifier is a functionalized aminosiloxane (Par. [0018] – the polymeric coatings described herein generally provide a base coating formulation comprising one or more specialty multifunctional organosilane coupling compounds and other compounds, which form a thin siloxane polymer film, or siloxane monolayer directly on the metallic surfaces of the mesh of a shape memory alloy; Par. [0050] – The base coating, after curing, comprises the crosslinked silicone polymer material having a functional group (R’) and/or amine-rich and/or hydroxyl-rich and/or polyurea-rich species that imparts an enhanced molecular mechanism of adherence to the top coating via intermolecular hydrogen and/or covalent bonding).
Therefore, claim 10 is unpatentable over Guo, et al.
Regarding claim 11, Guo teaches the percutaneous blood pump of claim 10, wherein the bifunctional modifier is a functionalized aminoalkyl silsequioxane (Par. [0050] – The base coating, after curing, comprises the crosslinked silicone polymer material having a functional group (R’) and/or amine-rich and/or hydroxyl-rich and/or polyurea-rich species that imparts an enhanced molecular mechanism of adherence to the top coating via intermolecular hydrogen and/or covalent bonding.; Silsesquioxane is a molecule made of silicons and oxygens. Aminoalkyl is any amino derivative of an alkyl radical).
Therefore, claim 11 is unpatentable over Guo, et al.
Regarding claim 12, Guo teaches the percutaneous blood pump of claim 10, wherein the functionalized aminosiloxane is an aminoethylaminopropyl / methylsilsesquioxane, an aminopropyl / methylsilsesquioxane, an aminopropylsilsesquioxane, and/or an aminopropyl / vinylsilsesquioxane (Par. [0018]; Par. [0043-0045]; Par. [0050]; Par. [0068]).
Therefore, claim 12 is unpatentable over Guo, et al.
Regarding claim 13, Guo teaches the percutaneous blood pump of claim 1, wherein the bifunctional modifier is a functionalized silanetriol (Par. [0043] – N-(α-aminoethy)-3-aminopropylsilanetriol).
Therefore, claim 13 is unpatentable over Guo, et al.
Regarding claim 14, Guo teaches the percutaneous blood pump of claim 13, wherein the functionalized silanetriol is a carboxyalkylsilanetriol (Par. [0043]).
Therefore, claim 14 is unpatentable over Guo, et al.
Regarding claim 15, Guo teaches the percutaneous blood pump of claim 14, wherein the carboxyalkylsilanetriol comprises carboxyethylsilanetriol (Par. [0043]).
Therefore, claim 15 is unpatentable over Guo, et al.
Regarding claim 17, Guo teaches the percutaneous blood pump of claim 1, wherein the bifunctional modifier has a pH of 10-11 (Par. [0043-0045]; Par. [0050] - aminoalkyl silsequioxane, such as aminopropylsilsesquioxane, has a pH of 10-10.5, as evidenced by Gelest (please see attached)).
Therefore, claim 17 is unpatentable over Guo, et al.
Regarding claim 18, Guo teaches the percutaneous blood pump of claim 1, wherein the bifunctional modifier has a viscosity of 3-15 cSt (Par. [0043-0045]; Par. [0050] - aminoalkyl silsequioxane, such as aminopropylsilsesquioxane, has a viscosity of 5-15 cSt, as evidenced by Gelest (please see attached)).
Therefore, claim 18 is unpatentable over Guo, et al.
Regarding claim 19, Guo teaches the percutaneous blood pump of claim 1, wherein the bifunctional modifier has a mole % of a functional group in the bifunctional modifier of 60-75% (Par. [0042] – By way of example and not limitation, if one organosilane compound having an amine/amino group is used in conjunction with an organosilane having either an isocyanate or epoxy group, the mole ratio of the two coupling compounds should be from 10:1 to 1:10 and all values in between (i.e., would include 60-75%)).
Therefore, claim 19 is unpatentable over Guo, et al.
Regarding claim 20, Guo teaches a method for creating a microenvironment for delaying initiation of coagulation (Par. [0017] – heart pumps that include components that reduces overall friction and increases lubricity. This may lead to better and more consistent blood flow with decreased blood hemolysis (i.e., delays initiation of coagulation)), comprising:
providing (Fig. 1, # 10 – heart pump, i.e. blood pump; Fig. 2) a percutaneous blood pump (Title, Abstract, Par. [0017] – this may lead to better and more consistent blood flow with decreased blood hemolysis through the device and an improved sleekness for the advancement and retraction of the relevant delivery catheter system; Par. [0023]) comprising a metal or ceramic surface that has been modified with a bifunctional modifier (Par. [0033] – shape memory alloy for the impeller housing 116, such as nickel-titanium (nitinol), copper-zinc, copper-zinc-aluminum, copper-aluminum-nickel, and gold-cadmium. Can also include shape memory ceramics; Par. [0034]; Par. [0038] – the base coating is formed by applying one or more multifunctional organosilane (i.e., a bifunctional modifier) coupling compounds to the substrate (namely housing mesh or other medical device component generally formed from a shape memory alloy) to be coated. The multifunctional coupling compound comprises at least two functional groups that will convert to highly reactive silanol groups upon reaction with water, and at least one functional group selected from the group consisting of amines isocyanates, oxiranes and combinations thereof; Par. [0043]).
Therefore, claim 20 is unpatentable over Guo, 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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Guo, et al. (U.S. PGPub No. 2021/0162200 – cited on IDS) in view of Firstov, et al. (“Surface oxidation of NiTi shape memory alloy” – cited on IDS – full article attached).
Regarding claim 3, Guo teaches the percutaneous blood pump of claim 1, as indicated hereinabove. Guo does not explicitly teach the limitation of instant claim 3, that is wherein the metal or ceramic surface comprises an oxide.
Firstov teaches surface oxidation of NiTi (Nitinol) shape memory alloy. Firstov teaches wherein the metal or ceramic surface comprises an oxide (Title, Abstract – the oxidation produces a smooth protective nickel-free oxide layer with a relatively small amount of Ni species at the air/oxide interface, which is in favor of good biocompatibility of NiTi implants).
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 Firstov’s teaching of surface oxidation for Nitenol shape memory alloys in implants into Guo’s blood pump 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 recognized that Guo teaches Nitenol as a metal surface of the pumping device, and would have desired oxidizing Nitenol for its benefit of improved biocompatibility (see Abstract of Firstov).
Therefore, claim 3 is unpatentable over Guo, et al. and Firstov, et al.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Guo, et al. (U.S. PGPub No. 2021/0162200 – cited on IDS) in view of Spanier, et al. (U.S. PGPub No. 2015/0051436).
Regarding claim 5, Guo teaches the percutaneous blood pump of claim 1, as indicated hereinabove. Guo does not explicitly teach the limitation of instant claim 5, that is wherein at least one metal or ceramic surface defines a radial gap and/or axial gap in the motor section and/or the pump section.
Spanier teaches (Fig. 1) an intravascular blood pump having a drive section, a catheter fastened to the drive section proximally and a pump section fastened to the drive section distally, and possesses an electric motor whose motor shaft is mounted in the drive section with two radial sliding bearings and an axial sliding bearing (Abstract). Spanier teaches that it is preferred when the surfaces forming the bearing gap of the axial sliding bearing are made of ceramic, preferably zirconium oxide (Par. [0016]). Spanier also teaches (Fig. 3) wherein at least one metal or ceramic surface defines a radial gap and/or axial gap in the motor section and/or the pump section (Par. [0011] – the motor housing itself is filled with a suitable fluid which forms a lubricating film in the bearing gap of the axial sliding bearing; Par. [0040] – bearing gap of the radial of the radial sliding bearing 31 is formed; Par. [0041] – bearing gap of the axial sliding bearing 40 is formed).
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 Spanier’s radial and/or axial gaps in the motor section into Guo’s blood pump, 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 such a radial/axial gap in the motor section in order for a purge fluid to flow through the bearing gaps in order to form a lubricating film that lowers the motor current for driving the motor that is necessary for overcoming frictional forces (see Par. [0011] and [0022] of Spanier).
Therefore, claim 5 is unpatentable over Guo, et al. and Spanier, et al.
Regarding claim 6, Guo teaches the percutaneous blood pump of claim 1, as indicated hereinabove. Guo does not explicitly teach the limitation of instant claim 6, that is wherein the percutaneous blood pump is configured to have a purge fluid pass through at least a portion of the motor section and/or the pump section.
Spanier teaches (Fig. 1) an intravascular blood pump having a drive section, a catheter fastened to the drive section proximally and a pump section fastened to the drive section distally, and possesses an electric motor whose motor shaft is mounted in the drive section with two radial sliding bearings and an axial sliding bearing (Abstract). Spanier teaches that it is preferred when the surfaces forming the bearing gap of the axial sliding bearing are made of ceramic, preferably zirconium oxide (Par. [0016]). Spanier also teaches (Fig. 3) wherein the percutaneous blood pump is configured to have a purge fluid pass through at least a portion of the motor section and/or the pump section (Par. [0011]; Par. [0022] – during operation, the blood pump is attached to a purge-fluid source, and fluid passed into the motor housing through the purge-fluid line.; Par. [0036]; Par. [0041]).
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 Spanier’s feature of having a purge fluid pass through the motor section into Guo’s blood pump, 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 using a purge fluid in order to form a lubricating film that lowers the motor current for driving the motor that is necessary for overcoming frictional forces (see Par. [0011] and [0022] of Spanier).
Therefore, claim 6 is unpatentable over Guo, et al. and Spanier, et al.
Regarding claim 7, Guo, in view of Spanier, renders obvious the percutaneous blood pump of claim 6, as indicated hereinabove. Spanier also teaches the limitation of instant claim 7, that is wherein the purge fluid is free of anticoagulants (Abstract; Par. [0022-0023] – example of purge fluid being a 20% glucose solution; It is noted that there is no mention of the purge fluid including anticoagulants, such as heparin, aspirin, or warfarin. Therefore, it is understood from Spanier that the purge fluid is free of anticoagulants).
Therefore, claim 7 is unpatentable over Guo, et al. and Spanier, et al.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Guo, et al. (U.S. PGPub No. 2021/0162200 – cited on IDS) in view of Taha, et al. (WO2022/211865).
Regarding claim 16, Guo teaches the percutaneous blood pump of claim 1, as indicated hereinabove. Guo does teach that the base coating applied to the nitinol (or other shape memory alloy or the like) has a thickness of less than 500 μm, less than 400 μm, less than 300 μm, less than 200 μm, less than 100 μm, or even less than 50 μm (Par. [0036]). Guo teaches that in some aspects, the base coating is a monolayer (Par. [0036]).
However, Guo does not explicitly teach the limitation of instant claim 16, that is wherein the bifunctional modifier is selected to have a hydration layer with a thickness of no more than 1 nm from the metal or ceramic surface being modified.
There is no evidence of record that establishes that changing the thickness of a hydration layer would result in a difference in function of Guo’s blood pump. Further, a person having ordinary skill in the art, being faced with modifying the thickness of the hydration layer of the bifunctional modifier in Guo, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed hydration layer thickness. Lastly, Applicant has not disclosed that the claimed range solves any stated problem, indicating that the bifunctional modifiers “may” be selected to have a hydration layer with a thickness of no more than 1 nm, and offering other acceptable ranges (e.g., the hydration layer may have other suitable thickness, Specification – Par. [0031]). Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hydration layer thickness of Guo, et al. to have a hydration layer thickness of no more than 1 nm from the metal or ceramic surface being modified as an obvious matter of design choice within the skill of the art. It is also noted that a 35 U.S.C. 112(b) rejection is associated with this claim hereinabove.
Therefore, claim 16 is unpatentable over Guo, et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Keating, et al. (U.S. PGPub No. 2021/0379329)
Das, et al. (U.S. PGPub No. 2021/0339003)
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/MICHAEL T. HOLTZCLAW/Examiner, Art Unit 3796