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 .
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.
1. Claims 5-7 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 5-7 and 16, “an internal surface” and “an external surface” has already been claimed. It is unclear if this is the same surface or a different one. For Examination purposes, the Examiner is interpreting these to be the same surfaces claimed in claim 1.
In regards to claim 5-7 and 16, “an oligomer or copolymer” has already been claimed. It is unclear if this is the same oligomer or copolymer or a different one. For Examination purposes, the Examiner is interpreting these to be the same as the ones claimed in claim 1.
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.
2. Claim(s) 1, 3-10, 20, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanz (US 20210170081 A1) in view of Jeevanadam (WO 2011050279 A2).
In regards to claim 1, Kanz discloses a blood pump (Abstract), comprising:
a blood flow section operably coupled to a distal end of a catheter, the blood flow section configured to cause blood to flow into a blood flow inlet of the blood flow section, through the blood flow section, and out of a blood flow outlet (Par. 0123 teaches a cannula, i.e. catheter, having an inlet for allowing blood to flow into a blood pump, i.e. blood flow section, and out of an outlet);
While Kanz teaches the cannula and inlet/outlet ports being made of silicone or polymers, they do not teach wherein at least one external and/or internal surface of the blood flow section comprises at least a portion of a surface modified by one or more fluorinated end groups and/or silicone end groups of an oligomer or copolymer.
However, in the same field of endeavor, Jeevanadam teaches an intra-aortic blood pump (Abstract) wherein the blood pump is made of polymers and includes silicone end groups (Par. 0048 and 0035 teach all of the components of the system, including the pump, as well as the inner walls of the pump are made of polymers and silicone end groups) in order to keep the air inside of the balloon as dry as possible (Par. 0048).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Kanz and modified them by having the blood pump be made of silicone end groups, as taught and suggested by Jeevanadam, in order to keep the air inside of the balloon as dry as possible (Par. 0048 of Jeevanadam).
In regards to claim 3, the combined teachings of Kanz and Jeevanadam as applied to claim 1 disclose the blood pump of claim 1, wherein the at least a portion of a surface is modified by one or more silicone end groups of a copolymer (Par. 0048 of Jeevanadam- see claim 1 rejection).
In regards to claim 4, the combined teachings of Kanz and Jeevanadam as applied to claim 1 disclose the blood pump of claim 1, wherein the oligomer or copolymer comprises a silicone, a polycarbonate, a polyurethane, a polyamide, a polyethylene, a polypropylene, a polysulfone, or a polyvinyl chloride (Par. 0048 of Jeevanadam – see claim 1 rejection).
In regards to claim 5, the combined teachings of Kanz and Jeevanadam as applied to claim 1 disclose the blood pump of claim 1, wherein a portion of both an internal surface and an external surface are modified by one or more fluorinated end groups and/or silicone end groups of an oligomer or copolymer (Par. 0048 and 0035 of Jeevanadam teach all of the components having copolymer materials – see claim 1 rejection)
In regards to claim 6, the combined teachings of Kanz and Jeevanadam as applied to claim 1 disclose the blood pump of claim 1, wherein all of an external and/or internal surface of the blood flow section are surface modified by one or more fluorinated end groups and/or silicone end groups of an oligomer or copolymer (Par. 0048 of Jeevanadam teaches the internal surface of the pump having copolymer surface – see claim 1 rejection).
In regards to claim 7, the combined teachings of Kanz and Jeevanadam as applied to claim 1 discloses the blood pump of claim 1, wherein a first portion of an external and/or internal surface of the blood flow section is surface modified by one or more first fluorinated end groups and/or silicone end groups of a first oligomer or copolymer, wherein a second portion of the external and/or internal surface of the blood flow section is surface modified by one or more second fluorinated end groups and/or silicone end groups of a second oligomer or copolymer where the first portion and second portions are different portions; wherein: the first fluorinated end groups and/or silicone end groups are different from the second fluorinated end groups and/or silicone end groups; and/or the first oligomer or copolymer are different from the second oligomer or copolymer (Par. 0048 and 0035 of Jeevanadam teach all of the components having copolymer materials – see claim 1 rejection).
While Jeevanadam teaches using different copolymers on the balloon pump, they do not explicitly teach wherein different sections are made of different types of copolymer materials. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have section of different materials, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
In regards to claim 8, the combined teachings of Kanz and Jeevanadam as applied to claim 1 discloses the blood pump of claim 1, wherein at least one portion of the blood flow section is expandable (Par. 0136 of Kanz teaches the pump being expandable).
In regards to claim 9, the combined teachings of Kanz and Jeevanadam as applied to claim 1 discloses the blood pump of claim 8, wherein the blood flow section includes an expandable pump housing (Par. 0136 of Kanz teaches there being a self-expanding housing/means).
In regards to claim 10, the combined teachings of Kanz and Jeevanadam as applied to claim 9 discloses the blood pump of claim 9, wherein the expandable pump housing includes at least one strut (Par. 0136 of Kanz teaches using support blades, i.e. struts)
In regards to claim 20, the combined teachings of Kanz and Jeevanadam as applied to claim 8 discloses the blood pump of claim 8, wherein the blood flow section includes an expandable inlet (Par. 0158 of Kanz teaches the inlet is expandable).
In regards to claim 26, the combined teachings of Kanz and Jeevanadam as applied to claim 1 discloses the blood pump of claim 1, wherein the blood flow section includes a motor housing coupled to a pump housing, the pump housing defining the blood flow inlet and a pump housing outlet (Par. 0163 of Kanz teaches the system comprising a motor).
3. Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanz and Jeevanadam, and in further view of Hills (US 4627419 A).
In regards to claim 2, the combined teachings of Kanz and Jeevanadam as applied to claim 1 discloses the blood pump of claim 1, except for wherein the at least a portion of a surface is modified by one or more fluorinated end groups of an oligomer.
However, in the same field of endeavor, Hills discloses a blood pump (Abstract) wherein the pump is made of a liquid fluorocarbon oligomer (Col. 4, lines 54-65) in order to minimize direct contact by the blood with any solid surface, thus minimizing blood trauma and reducing microthrombus formations (Col. 4, lines 54-65 of Hills).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Kanz and Jeevanadam and modified them by having the pump made of an oligomer, as taught and suggested by Hills, in order to minimize direct contact by the blood with any solid surface, thus minimizing blood trauma and reducing microthrombus formations (Col. 4, lines 54-65 of Hills).
4. Claim(s) 11-14 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanz and Jeevanadam, and in further view of Siess (US 20190083690 A1).
In regards to claims 11-14, the combined teachings of Kanz and Jeevanadam as applied to claim 10 discloses the blood pump of claim 10, except for wherein the at least one strut is a helical strut configured to form a plurality of geometric apertures, wherein the at least one strut is a polymer, wherein the at least one strut is coupled to a polymer, wherein the polymer is coupled to an inner surface of the at least one strut.
However, in the same field of endeavor, Siess teaches a blood pump assembly (Abstract) wherein the pump comprises struts that extend helically and are made from and coupled to polymers (Par. 0016 and 0020-0021), in order to create a flexible material that allows for the blood flow to be divided into separate blood flow openings (Par. 0016 and 0020 of Seiss).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Kanz and Jeevanadam and modified them by having the struts formed helically and made of polymers, as taught and suggested by Siess, in order to create a flexible material that allows for the blood flow to be divided into separate blood flow openings (Par. 0016 and 0020 of Seiss).
In regards to claim 16, the combined teachings of Kanz, Jeevanadam, and Seiss as applied to claim 11 discloses the blood pump of claim 12, wherein the polymer defines the at least one external and/or internal surface of the blood flow section that are at least partially surface modified by the one or more fluorinated end groups and/or silicone end groups of an oligomer or copolymer (Par. 0035 and 0048 of Jeevanadam teach the pump being made of silicone end groups and polymers – see claim 1 rejection).
In regards to claims 17 and 18 the combined teachings of Kanz, Jeevanadam, and Seiss as applied to claim 12 discloses the blood pump of claim 12, wherein the polymer is disposed on at least one intermediate portion of the expandable pump housing, the intermediate portion starting a distance dl > 0 from a distal end of the expandable pump housing and a distance d2 > 0 from a proximal end of the expandable pump housing, wherein the polymer forms an inner liner preventing blood from flowing radially through the blood flow section in the intermediate portion (Par. 0035 and 0048 of Jeevanadam teach the pump being made of silicone end groups and polymers that line the pump. The polymers would inherently extend from one portion of the pump to another portion of the pump).
5. Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanz and Jeevanadam, and in further view of Siess ’58 (US 20210170158 A1)
In regards to claim 30, the combined teachings of Kanz and Jeevanadam as applied to claim 1 discloses the blood pump of claim 1, wherein the blood flow section further comprises at least one filter placed over the blood flow inlet as a filter sleeve, wherein the filter sleeve filters the blood entering the blood flow inlet.
However, in the same field of endeavor, Seiss ’58 discloses a blood pump assembly (Abstract) wherein the pump comprises a filter sleeve (Par. 0040-0041) in order to prevent blood clots from entering the blood pump or adhering to the inflow openings of the pump (Par. 0007 of Seiss ’58).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Kanz and Jeevanadam and modified them by having the blood pump comprise a filter, as taught and suggested by Siess ’58, in order to prevent blood clots from entering the blood pump or adhering to the inflow openings of the pump (Par. 0007 of Seiss ’58).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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