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 04/29/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 7, 9, 10, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 8, 15, and 16 of copending Application No. 19193320 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference application contains all of the limitations of claim 1 of the instant application except for the additional limitation of “an external shape of the inner tube is an irregular shape.” However, the prior art Saab (US20050273145A1) discloses: an external shape of the inner tube is an irregular shape” (See FIG 7 where the external shape of the inner tube is an irregular shape, as interpreted under 112 below, not a perfect circle). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have an inner tube with an irregular external shape. Claims 3, 7, 8, 15, and 16 are identical to claims 6, 7, 9, 10, and 11, of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-11 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.
Regarding claim 1, the term “irregular shape” is seen as unclear since it is not defined what an “irregular shape” is. According to applicant specification [0020], “The irregular shape means a shape other than perfect circular shapes, and the perfect circular shapes do not include elliptical shapes or oval shapes,” however, this is contradicted in the following lines of the applicant specification [0020] as it states that elliptical shapes and oval shapes are now seen as perfect circular shapes, “the circular shape encompasses shapes such as perfect circular shapes, elliptical shapes, and oval shapes.” For examination purposes, the term “irregular shape” is interpreted as any shape that is not a perfect circle.
Regarding claims 2-11, these claims are also seen as unclear as they inherit the deficiencies of independent claim 1.
Claim Rejections - 35 USC § 102
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.
Claims 1, 4, 6-7, and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saab (US20050273145A1) herein referred to as “Saab.”
Regarding claim 1, Saab teaches: A cryoablation catheter ([Abstract] heat transfer catheter which is seen as a cryoablation catheter) comprising: an outer tube having a distal end and a proximal end and extending in a longitudinal direction; (See FIG 1 where the outer tube is seen as 140) an inner tube extending in the longitudinal direction and disposed in an inner cavity of the outer tube; ([0043] contains an inner tube) and a discharge flow path, ([0061] the outlet fluid lumens are seen as the discharge flow path) wherein: in a cross section perpendicular to the longitudinal direction, an external shape of the inner tube is an irregular shape; (See FIG 7 where the external shape of the inner tube is an irregular shape, as interpreted under 112 above, not a perfect circle) the inner tube comprises a guide wire lumen ([0043] the inner tube contains a central conduit for receiving a guide wire, which is seen as comprising a guidewire lumen) and a plurality of supply lumens, ([0061] lumens 126, 127, 128, and 130 are seen as a plurality of supply lumens) wherein, in the cross section perpendicular to the longitudinal direction, the plurality of supply lumens are formed in regions different from a region in which the guide wire lumen is formed, (See FIG 7 and [0061] where the lumens 126, 127, 128, and 130 are formed in regions different from a region in the guide wire lumen) wherein: the guide wire lumen is configured to have a guide wire inserted; ([0043] the central conduit which is seen as the guidewire lumen has a guide wire inserted) and the plurality of supply lumens are configured to allow a fluid to pass therethrough from a proximal side to a distal side of the inner tube; ([0061] lumen could be provided with apertures in its sidewall ) the discharge flow path is located between an inner surface of the outer tube and an outer surface of the inner tube and is configured to allow the fluid to pass therethrough from a distal side to a proximal side of the outer tube; ([0061] lumens 126 and 130 could contain apertures in their side walls to permit fluid to pass from the distal side to the proximal side of the outer tubes) and the inner tube comprises a hole located in a distal portion of the inner tube, wherein any of the supply lumens and the discharge flow path are in communication with each other through the hole ([0061] lumens 126 and 130 also contains a hole, and the lumens are in fluid communication with each other as they contain apertures for fluid to pass between them).
Regarding claim 4, Saab teaches: The cryoablation catheter according to claim 1, wherein: in the cross section perpendicular to the longitudinal direction, the inner tube has a vertex portion protruding outward in a radial direction of the outer tube; (See annotated FIG 7 below where the vertex portion protrudes outward in the direction of the outer tube) and the hole is formed in the vertex portion (See annotated FIG 7 below showing the hole in the vertex).
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Regarding claim 6, Saab teaches: The cryoablation catheter according to claim 1, wherein, in the cross section perpendicular to the longitudinal direction, the guide wire lumen is formed at a position that overlaps with a centroid of the inner tube, (See FIG 7 where the cross-section of the lumen 124 is formed at a position that overlaps with a centroid of the inner tube) and each of the supply lumens is formed at a position that does not overlap with the centroid of the inner tube (See FIG 7 where each of the lumens 126, 127, 128, and 130 is formed at a position that does not overlap with the centroid of the inner tube).
Regarding claim 7, Saab teaches: The cryoablation catheter according to claim 1, wherein, in the cross section perpendicular to the longitudinal direction, the plurality of supply lumens are located on an imaginary circle having a center at a centroid of the guide wire lumen (See FIG 7 where in the cross-section, the lumens 126, 127, 128, and 130 are located on an imaginary circle having a center at a centroid of the inner tube which is seen as the guide wire lumen).
Regarding claim 9, Saab teaches: The cryoablation catheter according to claim 1, wherein the outer tube comprises, on a distal portion thereof, a balloon which is expandable and shrinkable in a radial direction of the outer tube (See FIG 3 and [0054] contains a balloon segment 72, in the outer tube, which is expandable and shrinkable in a radial direction of the outer tube).
Regarding claim 10, Saab teaches: The cryoablation catheter according to claim 1, further comprising a distal tip comprising a lumen extending in the longitudinal direction, wherein: the distal tip has an outer diameter decreasing from a proximal side toward a distal side; (See FIG 3 and FIG 4 where the outer diameter decreases from the proximal side to the distal side) and a distal end portion of the outer tube and a distal end portion of the inner tube are fixed to a proximal end portion of the distal tip (See FIG 3 and FIG 4 where the distal end portions of the outer tube and inner tubes are fixed to a proximal end of the distal tip).
Regarding claim 11, Saab teaches: A cryoablation catheter system (See rejection of claim 1 above) comprising: the cryoablation catheter according to claim 1; (See rejection of claim 1 above) and a fluid supply device configured to supply the fluid to the supply lumens, wherein the inner tube is connected to the fluid supply device (See FIG 1 and [0045]- [0046] contains a fluid supply device which comprises an inlet valve, seen as being connected to the inner tube, and supplies the supply lumens).
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 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Saab.
Regarding claim 2, Saab teaches: The cryoablation catheter according to claim 1, wherein, in the cross section perpendicular to the longitudinal direction, however, Saab does not explicitly disclose: the external shape of the inner tube is a polygonal shape.
It would have been an obvious matter of design choice to make the external shape of the inner tube whatever form or shape was desired or expedient. Additionally, there is no criticality placed on the external shape of the inner tube being a polygonal shape according to the Applicant’s specification, stating simply “The external shape of the inner tube may be any of polygonal shapes including triangular shapes and quadrangular shapes, semi-circular shapes, fan shapes, wedge shapes, protruding shapes, a combination of these shapes, and the like” (Applicant specification [0047]). A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 3, Saab teaches: The cryoablation catheter according to claim 1, wherein, in the cross section perpendicular to the longitudinal direction, however, Saab does not explicitly disclose: the external shape of the inner tube is a triangular shape.
It would have been an obvious matter of design choice to make the external shape of the inner tube whatever form or shape was desired or expedient. Additionally, there is no criticality placed on the external shape of the inner tube being a triangular shape according to the Applicant’s specification, stating simply “The external shape of the inner tube may be any of polygonal shapes including triangular shapes and quadrangular shapes, semi-circular shapes, fan shapes, wedge shapes, protruding shapes, a combination of these shapes, and the like” (Applicant specification [0047]). A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Saab in view of Leipsic et al (“Multidetector computed tomography in transcatheter aortic valve implantation.”) herein referred to as “Leipsic.”
Regarding claim 5, Saab discloses: The cryoablation catheter according to claim 1, : wherein: in the cross section perpendicular to the longitudinal direction, a roundness of an external shape of the outer tube is higher than a roundness of the external shape of the inner tube (See FIG 7 where the roundness of the shape of the outer tube is higher than the roundness of the shape of the inner tube since the external shape of the inner tube is irregular), however, Saab does not explicitly disclose: the roundness is obtained according to the following formula:(Rmax-Rmin)/Rmin, where: Rmax represents a radius of a circumscribed circle, and Rmin represents a radius of an inscribed circle.
Leipsic discloses: the roundness is obtained according to the following formula: (Rmax-Rmin)/Rmin, where: Rmax represents a radius of a circumscribed circle, and Rmin represents a radius of an inscribed circle ([page 12: 3] the formula disclosed for circularity is (1-Dmin/Dmax) where Dmin and Dmax are the smallest and largest diameters respectively. This formula can be easily manipulated by one of ordinary skill in the art to achieve (Dmax-Dmin)/Dmax. The denominator being Dmax as opposed to Dmin still tells whether the ratio is higher or lower and is seen as interchangeable. Although Leipsic does not explicitly disclose the formula in terms of Radius, it is known in the art that the diameter is simply twice the radius hence the stated formula can be achieved by dividing the Diameter by 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify roundness of the tubes as disclosed in Saab to include the formula as disclosed in Leipsic. The motivation being that calculating the diameter of the catheter allows for the construction of a minimal profile catheter which reduces vascular complications. (Leipsic [Page 2: paragraph 4]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Saab in view of Evans et al (US20030060761A1) herein referred to as “Evans”.
Regarding claim 8, Saab discloses: The cryoablation catheter according to claim 1, however, Saab does not explicitly disclose: wherein, in the cross section perpendicular to the longitudinal direction, a maximum width of each of the supply lumens is smaller than a maximum width of the guide wire lumen.
Evans discloses: wherein, in the cross section perpendicular to the longitudinal direction, a maximum width of each of the supply lumens is smaller than a maximum width of the guide wire lumen (See FIG 3 and [0029] where the width of the supply lumens 42 and 46 are smaller than the central lumen 44 which is seen as the guidewire lumen).
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 width of the guide wire lumen as disclosed in Saab to include the width of the guidewire lumen to be larger than that of the supply lumens as disclosed in Evans. The motivation being that making the guidewire lumen with a larger diameter allows for it to better support a guidewire. (Evans [0029]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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