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 information disclosure statement (IDS) submitted on 03/27/2025 is being considered by the examiner.
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.
(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
A rejection on this statutory basis (35 U.S.C. 102(g) as in force on March 15, 2013) is appropriate in an application or patent that is examined under the first to file provisions of the AIA if it also contains or contained at any time (1) a claim to an invention having an effective filing date as defined in 35 U.S.C. 100(i) that is before March 16, 2013 or (2) a specific reference under 35 U.S.C. 120, 121, or 365(c) to any patent or application that contains or contained at any time such a claim.
Claim(s) 1-4 and 50-53 is/are rejected under 35 U.S.C. 102(a)/(1) as being anticipated by Dobak et al. (US 20020007202 A1) herein referred to as “Dobak embodiment A”.
Regarding claim 1, Dobak embodiment A teaches: A heat exchange catheter insertable into a vasculature of a patient ([Abstract]), the heat exchange catheter comprising: a catheter body ([Figure 12]; a catheter body (202)), the catheter body comprising: a delivery lumen ([0114]; a working fluid catheter, which is seen as a delivery lumen); a return lumen, the delivery lumen and the return lumen configured to receive a working fluid there through ([0114, Figure 12]; return lumen between 202 and 222); an inner wall separating the delivery and return lumens ([Figure 12]; a wall between lumen 222 and return lumen 202), the inner wall defining an opening in communication with the delivery and return lumens ([0114, Figure 12]; openings 214 that are in communication with both lumen 222 and lumen 202); and a side wall defining at least one opening in communication with the delivery lumen ([Figure 12]; a side wall in tapered section (see annotated figure 12 below) that contains an opening that is in communication with delivery lumen 222); and a heat exchange region ([Figure 12]; D openings also in communication with heating region, which is seen as heat element 204) , the heat exchange region comprising a first end and a second end, the first end of the heat exchange region coupled to the delivery lumen of the catheter body through the at least one opening ([Figure 12]; multiple openings that are in communication with the heat exchange region and the delivery lumen 222), wherein, the heat exchange region is configured to be in fluid communication with the delivery and return lumens ([Figure 12]; heat exchange region being in fluid communication with the return lumen because it comprises the return lumen further in communication with the delivery lumen via openings) of the catheter body to receive the working fluid ([0114]; working fluid supplied to lumen 222) and thereby effect heat exchange with blood flowing through the vasculature of the patient [0015]; the working fluid being used to transfer heat between the apparatus and vasculature), and wherein the opening of the inner wall is located such that the working fluid flowing through the delivery lumen of the catheter body is bifurcated between the heat exchange region and the return lumen. ([Figure 12]; multiple openings that are in communication with both the heat element 204 and therefore the heat exchange region, and in communication with return lumen 202, which is seen as bifurcated communication with the heat exchange region and the return lumen)
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Regarding claim 2, Dobak embodiment A teaches: The heat exchange catheter according to claim 1, wherein the opening in the inner wall is upstream of the heat exchange region. ([Figure 12]; Multiple opening in lumen 222, which is seen as openings in the inner wall. The most proximal of which is upstream from the heat exchange region)
Regarding claim 3, Dobak embodiment A teaches: The heat exchange catheter according to claim 2, wherein the heat exchange region projects through the at least one opening such that the heat exchange region is supported about the catheter body. ([Figure 12]; Dobak teaches heat exchange element 204 projecting from an opening in the catheter body)
Regarding claim 4, Dobak embodiment A teaches: The heat exchange catheter according to claim 2, wherein the working fluid flowing through the heat exchange region bypasses a portion of the delivery lumen of the catheter body. ([Figure 12]; Dobak teaches heat element 204 in communication with a distal portion of the delivery lumen 222 which is seen as bypassing the proximal region)
Regarding claim 50, Dobak embodiment A teaches: A heat exchange catheter insertable into a vasculature of a patient ([Abstract]), the heat exchange catheter comprising: a catheter body including a delivery lumen ([Figure 12]; Dobak teaches a catheter body (202) , [0114]; Dobak teaches a working fluid catheter, which is seen as a delivery lumen), a return lumen ([0114, Figure 12]; return lumen between 202 and 222), and an inner wall separating the delivery and return lumens ([0114, Figure 12]; Dobak teaches openings 214 that are in communication with both lumen 222 and lumen 202); configured to receive a working fluid therethrough ([0114]; Dobak teaches the return catheter, which is seen as the return lumen receiving the working fluid), the inner wall defining at least one opening ([Figure 12]; Dobak embodiment A teaches multiple openings 214 in the inner wall ); a heat exchange region configured to be in fluid communication with the delivery and return lumens ([Figure 12]; Dobak teaches heat exchange region being in fluid communication with the return lumen because it comprises the return lumen further in communication with the delivery lumen via openings) of the catheter body to receive the working fluid ([0114]; Dobak teaches working fluid supplied to lumen 222) and thereby effect heat exchange with blood flowing through the vasculature of the patient [0015]; Dobak teaches the working fluid being used to transfer heat between the apparatus and vasculature), and wherein the at least one opening of the inner wall is defined proximal of the heat exchange region ([Figure 12]; the most proximal opening) such that a portion of the working fluid supplied through the delivery lumen of the catheter body flows proximally through the return lumen prior to reaching the heat exchange region. ([Figure 12]; Dobak teaches opening that is proximal to the heat element 204, [0014]; Dobak teaches the working fluid communicating through the outlets)
Regarding claim 51, Dobak embodiment A teaches: The heat exchange catheter according to claim 50, wherein the catheter body further includes a side wall defining at least one opening in communication with the delivery lumen. ([Figure 12]; Debok teaches a side wall in tapered section as shown in the picture of figure 12 as shown above that contains an opening that is in communication with delivery lumen 222);
Regarding claim 52, Dobak embodiment A teaches: The heat exchange catheter according to claim 51, wherein the heat exchange region projects through the at least one opening of the side wall such that the heat exchange region is supported about the catheter body. ([Figure 12]; Dobak teaches heat exchange element 204 projecting from an opening in the catheter body)
Regarding claim 53, Dobak embodiment A teaches: The heat exchange catheter according to claim 52, wherein the working fluid flowing through the heat exchange region bypasses a portion of the delivery lumen of the catheter body. ([Figure 12]; Dobak teaches heat element 204 in communication with a distal portion of the delivery lumen 222 which is seen as bypassing the proximal region)
Claim Rejections - 35 USC § 103
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 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(s) 5 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dobak embodiment A in view of Dobak embodiment B.
Regarding claim 5, Dobak embodiment A teaches: The heat exchange catheter according to claim 4. Dobak embodiment A does not explicitly disclose: wherein the catheter body further includes a pair of plugs disposed in the delivery lumen to establish a fluid-tight seal against the delivery lumen such that the working fluid is directed through the heat exchange region.
However, Dobak embodiment B discloses: wherein the catheter body further includes a pair of plugs disposed in the delivery lumen to establish a fluid-tight seal against the delivery lumen such that the working fluid is directed through the heat exchange region. ([0115]; Dobak teaches ballon 244 which is seen as a plug, used to seal delivery lumen 242 and direct the working fluid to heating element 204)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the heat exchange catheter as disclosed by Dobak with the plug as further disclosed by Dobak embodiment B. The motivation being to creat a fluid-tight seal in order to allow fluid to dispense from other outlets ([0115]).
Regarding claim 54, Dobak embodiment A teaches: The heat exchange catheter according to claim 53. Dobak embodiment A does not explicitly disclose: wherein the catheter body further includes a pair of plugs disposed in the delivery lumen to establish a fluid-tight seal against the delivery lumen such that the working fluid is directed through the heat exchange region.
However, Dobak embodiment B discloses: wherein the catheter body further includes a pair of plugs disposed in the delivery lumen to establish a fluid-tight seal against the delivery lumen such that the working fluid is directed through the heat exchange region. ([0115]; Dobak teaches ballon 244 which is seen as a plug, used to seal delivery lumen 242 and direct the working fluid to heating element 204)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the heat exchange catheter as disclosed by Dobak with the plug as further disclosed by Dobak embodiment B. The motivation being to creat a fluid-tight seal in order to allow fluid to dispense from other outlets ([0115]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dobak embodiment A in view of Dobak embodiment B further in view of Dobak embodiment C.
Regarding claim 6, Dobak embodiment A in view of Dobak embodiment B discloses: The heat exchange catheter according to claim 5. Dobak embodiment A in view of Dobak embodiment B does not explicitly disclose: wherein the catheter body further defines a working lumen dimensioned to receive a guidewire therethrough.
However, Dobak embodiment C discloses: wherein the catheter body further defines a working lumen dimensioned to receive a guidewire therethrough. ([0116]; Dobak discloses guide wire 232 that is received through a hole in heat element 204, which comprises the body of the catheter, therefore, it is seen as received through a hole in the catheter body)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the heat exchange catheter as disclosed by Dobak embodiment A in view of Dobak embodiment B with the lumen and guidewire as disclosed by Dobak embodiment C. The motivation being to dispose the heat transfer element in the desired artery ([0116]).
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dobak embodiment A in view of Dobak embodiment C.
Regarding claim 55, Dobak embodiment A discloses: The heat exchange catheter according to claim 50. Dobak does not explicitly disclose: wherein the catheter body further defines a working lumen dimensioned to receive a guidewire therethrough.
However, Dobak embodiment C discloses: wherein the catheter body further defines a working lumen dimensioned to receive a guidewire therethrough. ([0116]; Dobak discloses fuide wire 232 that is received through a hole in heat element 204, which comprises the body of the catheter, therefore, it is seen as received through a hole in the catheter body)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the heat exchange catheter as disclosed by Dobak embodiment A with lumen and guidewire as disclosed by Dobak embodiment C. The motivation being to dispose the heat transfer element in the desired artery ([0116]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dobak embodiment A.
Regarding claim 7, Dobak embodiment A discloses: The heat exchange catheter according to claim 1. Dobak does not explicitly disclose: wherein the catheter body has a diameter ranging between about 5 Fr and about 6 Fr.
However, Dobak discloses the use of the catheter in blood vessels ([0016]). Further, Dobak discloses that the catheter diameter be optimized in order to be inserted into target arteries and is disclosed as to be a result effective variable which effects insertion into arteries ([0074, 0047]). Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter as disclosed by Dobak with the size between 5 fr and 6 fr as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dobak embodiment A in view of Dobak embodiment B.
Regarding claim 56, Dobak embodiment A in view of Dobak embodiment B disclose: The heat exchange catheter according to claim 55. Dobak embodiment A in view of Dobak embodiment B do not explicitly disclose: wherein the catheter body has a diameter ranging between about 5 Fr and about 6 Fr.
However, Dobak discloses the use of the catheter in blood vessels ([0016]). Further, Dobak discloses that the catheter diameter be optimized in order to be inserted into target arteries and is disclosed as to be a result effective variable which effects insertion into arteries ([0074, 0047]). Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter as disclosed by Dobak with the size between 5 fr and 6 fr as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 8 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dobak embodiment A in view of Catteneo et al. (US 20180303663 A1) herein referred to as “Catteneo”.
Regarding claim 8, Dobak embodiment A teaches: The heat exchange catheter according to claim 1. Dobak embodiment A does not explicitly disclose: wherein the heat exchange region is an inflatable balloon.
However, Cattaneo discloses: wherein the heat exchange region is an inflatable balloon. ([0083]; Cattaneo discloses heat exchange ballons 12)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter as disclosed by Dobak with the heat exchange balloons as disclosed by Cattaneo. The motivation being endovascular temperature control of blood and occlude the vessels using the ballon ([0083-0085]).
Regarding claim 57, Dobak embodiment A teaches: The heat exchange catheter according to claim 50. Dobak embodiment A does not explicitly disclose: wherein the heat exchange region is a tubular balloon.
However, Cattaneo discloses: wherein the heat exchange region is an inflatable balloon. ([0083]; Cattaneo discloses heat exchange ballons 12 that are tubular in shape)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter as disclosed by Dobak with the heat exchange balloons as disclosed by Cattaneo. The motivation being endovascular temperature control of blood and occlude the vessels using the ballon ([0083-0085]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY GEORGE CHA whose telephone number is (571)272-0749. The examiner can normally be reached Monday-Friday 8:30-5:00.
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/CASEY GEORGE CHA/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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