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 .
Election/Restrictions
The Applicant's election with traverse of Invention II in the reply filed on 24 February 2026 is acknowledged. The traversal is on the grounds that Claims 1 and 8 have been amended to be directed to Invention II, and Claims 17-20 have been cancelled. The Examiner agrees with these arguments, therefore all remaining Claims 1-16 and 21, directed to Invention II, will be examined.
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 21 is 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 21, the claim recites “the lumen of the repositioning sheath”. However, this limitation lacks antecedent basis in the claims, since Claim 8 (from which Claim 21 depends), only recites “a lumen of the outer body”, “a first lumen”, and “a second lumen”. It is therefore unclear and indefinite which lumen this limitation is referring to. Appropriate correction or clarification is required. For purposes of examination, the Examiner is interpreting this limitation as “the lumen of the outer body”.
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.
Claims 1-3, 5, 8, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mooney et al. (US Publication No. 2004/0167478).
Regarding Claims 1 and 8, Mooney et al. discloses a delivery system for positioning at least one medical device into a blood vessel (introducer for medical implements into blood vessels, Paragraph 0010, 0011, 0141, 0167), the delivery system comprising:
a repositioning sheath including (positioning/repositioning, 500, Fig. 24; 650, Fig. 34; 700, Fig. 39):
an outer body (500, Fig. 24; 650, Fig. 34; 700, Fig. 39) having a proximal end and a distal end opposite the proximal end, the outer body defining a lumen extending between the proximal end and the distal end (lumen within outer sheath/wall 680, Fig. 35B; 684, Fig. 35C; 708, Fig. 40B; Paragraph 0156-0158, 0161), the outer body having an outer wall surface and an inner wall surface (lumen within outer sheath/wall 680, Fig. 35B; 684, Fig. 35C; 708, Fig. 40B; Paragraph 0156-0158, 0161), and the repositioning sheath configured for insertion into the blood vessel (Paragraph 0010, 0011, 0141, 0167; see Fig. 24 with vessel 520),
a first tube defining a first lumen, the first tube disposed within the lumen of the outer body (multiple tubes within sheath/wall 680, Fig. 35B; 684, Fig. 35C; 708, Fig. 40B; Paragraph 0156-0158, 0161), and
a second tube defining a second lumen, the second tube disposed within the lumen of the outer body (multiple tubes within sheath/wall 680, Fig. 35B; 684, Fig. 35C; 708, Fig. 40B; Paragraph 0156-0158, 0161),
wherein the first tube is radially spaced from the inner wall surface of the outer body and the second tube is radially spaced from the inner wall surface of the outer body (multiple tubes within sheath/wall, which are spaced from sheath/wall to allow for fluid flow between the wall and the tubes, see 680, Fig. 35B; 684, Fig. 35C; 708, Fig. 40B; Paragraph 0156-0158, 0161); and
a hemostasis valve hub (hubs/housing 656, 654, Fig. 34; 708/706, Fig. 39; Paragraph 0156-0158, 0161) engaged with the proximal end of the repositioning sheath.
Regarding Claim 2, Mooney et al. discloses a delivery system further wherein the first tube and the second tube are arranged such that the first tube and the second tube are in contact with one another (multiple tubes in contact with one another within sheath/wall 680, Fig. 35B; 684, Fig. 35C; 708, Fig. 40B; Paragraph 0156-0158, 0161).
Regarding Claims 3 and 13, Mooney et al. discloses a delivery system further wherein the first tube has a first inner diameter, wherein the second tube has a second inner diameter, wherein the first inner diameter is larger than the second inner diameter (see embodiments of Figs. 35C and 40B with tubes of multiple sizes/diameters, Paragraph 0156-0158, 0161).
Regarding Claim 5, Mooney et al. discloses a delivery system further wherein the distal end of the repositioning sheath comprises a tapered distal tip (tapered tips, Paragraph 0091, 0150, 0182-0183; see Fig. 23A-B, 24, 25A-B, 29-34).
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.
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.
Claims 4, 9, 10, 11, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mooney et al. (US Publication No. 2004/0167478).
Regarding Claim 9, Mooney et al. discloses a delivery system further wherein polymer and plastic components of the system/sheath/hub are thermomoulded and cooled such that the components are fixed, in order to simplify manufacturing (Paragraph 0102, 0108, 0120, 0128, 0131, 0154), and wherein the hemostasis valve hub (hubs/housing 656, 654, Fig. 34; 708/706, Fig. 39; Paragraph 0156-0158, 0161) is engaged with the proximal end of the repositioning sheath, such that the axial and radial positioning of the first tube and the second tube (multiple tubes within sheath/wall 680, Fig. 35B; 684, Fig. 35C; 708, Fig. 40B; Paragraph 0156-0158, 0161) is located at the proximal end of the repositioning sheath. However, Mooney et al. does not explicitly disclose wherein the hub is thermomoulded with the proximal end of the repositioning sheath such that the axial and radial positioning of the first tube and the second tube is fixed at the proximal end of the repositioning sheath.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the hub to be thermomoulded with the proximal end of the repositioning sheath such that the axial and radial positioning of the first tube and the second tube is fixed at the proximal end of the repositioning sheath, since Mooney et al. does disclose wherein polymer and plastic components of the system/sheath/hub are thermomoulded and cooled such that the components are fixed, in order to simplify manufacturing (Paragraph 0108, 0120, 0128, 0131, 0154), and since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893). In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding Claim 10, Mooney et al. discloses a delivery system further wherein the distal end of the repositioning sheath comprises a tapered distal tip (tapered tips, Paragraph 0091, 0150, 0182-0183; see Fig. 23A-B, 24, 25A-B, 29-34), further wherein polymer and plastic components of the system/sheath/hub are thermomoulded and cooled such that the components are fixed, in order to simplify manufacturing (Paragraph 0102, 0108, 0120, 0128, 0131, 0154). However, Mooney et al. does not explicitly disclose wherein the distal tip is formed of molded polymer material such that the axial and radial positioning of the first tube and the second tube is fixed at the distal end.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the distal tip to be formed of molded polymer material such that the axial and radial positioning of the first tube and the second tube is fixed at the distal end, as generally taught by Mooney et al. (Paragraph 0102, 0108, 0120, 0128, 0131, 0154), 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. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and further since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893). In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding Claim 11, Mooney et al. discloses a delivery system further wherein the distal end of the repositioning sheath comprises a tapered distal tip (tapered tips, Paragraph 0091, 0150, 0182-0183; see Fig. 23A-B, 24, 25A-B, 29-34), but does not explicitly disclose wherein the tapered distal tip has a length of approximately 3 cm. However, it would have been an obvious matter of design choice to configure the distal tip to have a length of approximately 3 cm, in order to be configured for size/shape of the intended medical implements to be used with the system, and/or in order to be configured for size/shape of the intended implantation blood vessel location, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding Claims 4, 14, and 15, Mooney et al. discloses a delivery system further wherein the first tube has a first inner diameter, wherein the second tube has a second inner diameter, wherein the first inner diameter is larger than the second inner diameter (see embodiments of Figs. 35C and 40B with tubes of multiple sizes/diameters, Paragraph 0156-0158, 0161), and that diameters of the sheaths/lumens are on the order of millimeters (Paragraph 0098-00100).
However, Mooney et al. does not explicitly disclose wherein the first inner diameter is approximately 2.4 mm, wherein the second inner diameter is approximately 1 mm. It would have been an obvious matter of design choice to configure the he first inner diameter to be approximately 2.4 mm and the second inner diameter to be approximately 1 mm, in order to be configured for size/shape of the intended medical implements to be used with the system, and/or in order to be configured for size/shape of the intended implantation blood vessel location, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claims 6, 7, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mooney et al. (US Publication No. 2004/0167478) in view of Kawai (US Publication No. 2009/0264865).
Regarding Claims 6, 7, 12, and 16, Mooney et al. discloses a delivery system further wherein discloses a delivery system further wherein the distal end of the repositioning sheath comprises a tapered distal tip (tapered tips, Paragraph 0091, 0150, 0182-0183; see Fig. 23A-B, 24, 25A-B, 29-34), further wherein polymer and plastic (including polyether, Paragraph 0108) components of the system/sheath/hub are thermomoulded and cooled such that the components are fixed, in order to simplify manufacturing (Paragraph 0102, 0108, 0120, 0128, 0131, 0154).
However, Mooney et al. does not explicitly disclose wherein the tapered distal tip is composed of a 40 durometer Polyether-Block-Amide or wherein the outer body of the repositioning sheath is composed of 55 durometer Polyether-Block-Amide. Kawai teaches a delivery system including an introducer sheath (Abstract), comprising a tip comprising Polyether-Block-Amide (PEBAX®, Paragraph 0033, 0041) with a shore hardness of 59 or 33 durometer (Paragraph 0033, 0041) and an outer portion comprising Polyether-Block-Amide (PEBAX®, Paragraph 0033, 0041) with a shore hardness of 63 or other durometer ratings depending on the area (Paragraph 0033, 0042). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the tapered distal tip to be composed of a 40 durometer Polyether-Block-Amide and the outer body of the repositioning sheath to be composed of 55 durometer Polyether-Block-Amide, as generally taught by Kawai, in order to adjust flexibly and/or structural integrity of the system components by configuring the specific composition, 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. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Mooney et al. (US Publication No. 2004/0167478) in view of Kanz (US Publication No. 2021/0170081).
Regarding Claim 21, Mooney et al. discloses a delivery system for positioning at least one medical device into a blood vessel, wherein the at least one medical device is advanceable through the lumen of the repositioning sheath (introducer for medical implements into blood vessels, Paragraph 0010, 0011, 0141, 0167). However, Mooney et al. does not explicitly disclose wherein the medical device/medical implement is a percutaneous intravascular blood pump advanceable through the lumen of the repositioning sheath.
Kanz teaches a system comprising a percutaneous intravascular blood pump advanceable through a lumen of a repositioning sheath into a blood vessel of the patient (Abstract, Paragraph 0010-0014, 0123, 0135; see Figs. 1-3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the delivery system disclosed by Mooney et al. to be used to position a percutaneous intravascular blood pump, as taught by Kanz, in order to safely and effectively deliver a percutaneous intravascular blood pump into a vessel to provide augmented blood flow rates for a damaged or diseased heart, as also taught by Kanz (see Paragraph 0003-0007, 0014).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796