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 .
Specification
The abstract of the disclosure is objected to because it is not descriptive of the currently claimed invention. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Election/Restrictions
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 October 2025 of Invention I, directed to Claims 1-13.
Claim Interpretation
Claims 1, 2, 7, 11, and 12 recite “translatably coupled” or “translatably coupling”. The Examiner is interpreting this limitation as “attached such that the components are moveable together”, which is consistent with the instant Specification/Drawings (e.g., see Fig. 2, Paragraph [0064]).
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 1-3 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-20 of copending Application No. 18/617,010. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to nearly identical percutaneous circulatory support systems, wherein Claims 1-6 of the instant Application are broader in scope Claims 1-20 of copending Application No. 18/617,010 as explained below.
Claim 1 of the instant application is fully encompassed by and corresponds to Claims 1 and 8 of copending Application No. 18/617,010.
Claim 2 of the instant application is fully encompassed by and corresponds to Claims 1, 2, 8, and 9 (e.g. ‘coupler’ corresponds to ‘coupling portion’ and section the components are ‘coupled’) of copending Application No. 18/617,010.
Claim 3 of the instant application is fully encompassed by and corresponds to Claims 1, 3-5, 8, and 10-11 of copending Application No. 18/617,010.
Claim 6 of the instant application is fully encompassed by and corresponds to Claims 7 and 13 of copending Application No. 18/617,010.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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, 2, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campbell et al. (US Publication No. 2011/0004046).
Regarding Claim 1, Campbell et al. discloses a percutaneous circulatory support system (blood pump system, Abstract, Paragraph 0058), comprising:
a percutaneous circulatory support device (blood pump 10, Figs. 1, 2A-C, 3; Paragraph 0058, Abstract), comprising:
a housing (cannula 40 and cannula components 42, 50, 44, 48; Figs. 1, 2B; Paragraph 0066-0067);
an impeller carried in the housing (rotatable impeller 20 within cannula 40; Figs. 1, 2A-B, 3; Paragraph 0058-0059, 0066; and
a guidewire insertion aide (first guidewire preassembled into cannula 40, Paragraph 0117) configured to be removably carried in the housing (“Once the cannula 40 has been advanced to the desired position, the first and second guidewires are removed prior to activating drive shaft”, Paragraph 0117);
wherein the guidewire insertion aide (first guidewire preassembled into cannula 40, Paragraph 0117) is configured to be translatably coupled to a guidewire (second guidewire, “The proximal portion of the second guidewire, e.g., a portion that is in the patient, can be attached to the distal end of the first guidewire preassembled into cannula 40, and cannula 40 can be advanced along two connected guidewires to the desired position”, Paragraph 0117).
Regarding Claim 2, Campbell et al. discloses a percutaneous circulatory support system further wherein the guidewire insertion aide (first guidewire preassembled into cannula 40, Paragraph 0117) comprises a coupler (attachment/connection point between first and second guidewire, “The proximal portion of the second guidewire, e.g., a portion that is in the patient, can be attached to the distal end of the first guidewire preassembled into cannula 40, and cannula 40 can be advanced along two connected guidewires to the desired position. In these embodiments, the connected first and second guidewires are configured to run coaxially”, Paragraph 0117) for translatably coupling to the guidewire (second guidewire, Paragraph 0117).
Regarding Claim 6, Campbell et al. discloses a percutaneous circulatory support system further wherein the guidewire insertion aide (first guidewire preassembled into cannula 40, Paragraph 0117) lacks a through lumen (guidewires are configured within cannula lumen 70, therefore guidewires lack lumens themselves, e.g. see 72, Fig. 3, 9; Paragraph 0025, 0081, 0117; guidewires are heavy duty and/or stiff, Paragraph 0117; exemplary Amplatz or Lunderquist® guidewires [Paragraph 0117] lack through lumens due to steel/solid cores; embodiment of guidewires with plug 76 lack through lumen, see Fig. 5; Paragraph 0060).
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.
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 3-5 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US Publication No. 2011/0004046) in view of Anderson (US Publication No. 2016/0129239).
Regarding Claim 7, Campbell et al. discloses a percutaneous circulatory support system (blood pump system, Abstract, Paragraph 0058), comprising:
a percutaneous circulatory support device (blood pump 10, Figs. 1, 2A-C, 3; Paragraph 0058, Abstract), comprising:
a housing (cannula 40 and cannula components 42, 50, 44, 48; Figs. 1, 2B; Paragraph 0066-0067);
an impeller carried in the housing (rotatable impeller 20 within cannula 40; Figs. 1, 2A-B, 3; Paragraph 0058-0059, 0066; and
a guidewire insertion aide (first guidewire preassembled into cannula 40, Paragraph 0117) removably carried in the housing (“Once the cannula 40 has been advanced to the desired position, the first and second guidewires are removed prior to activating drive shaft”, Paragraph 0117); and
a guidewire (second guidewire, Paragraph 0117);
wherein the guidewire insertion aide (first guidewire preassembled into cannula 40, Paragraph 0117) and the guidewire (second guidewire, Paragraph 0117) are configured to be translatably coupled (second guidewire translatably coupled to first guidewire, “The proximal portion of the second guidewire, e.g., a portion that is in the patient, can be attached to the distal end of the first guidewire preassembled into cannula 40, and cannula 40 can be advanced along two connected guidewires to the desired position”, Paragraph 0117).
However, Campbell et al. does not explicitly disclose wherein the guidewire insertion aide and the guidewire are configured to be translatably coupled such that subsequent removal of the guidewire insertion aide from the housing causes the guidewire to be pulled through the housing, since Campbell et al. is silent as to which direction the attached guidewire/insertion aid (first and second guidewires, Paragraph 0117) are removed through the housing (cannula 40 and cannula components 42, 50, 44, 48; Figs. 1, 2B; Paragraph 0066-0067).
Anderson teaches a percutaneous cardiac support system (Abstract) comprising a housing of a percutaneous cardiac support device (housing 40, Figs. 4D-4E; Paragraph 0040), and a guidewire insertion aide (tether 66 68, 69, Figs. 4D and 4E) removably carried in the housing (Paragraph 0060, 0068-0069); and a guidewire (guidewire 72; Figs. 4D-4E),
wherein the guidewire insertion aide (tether 66 68, 69, Figs. 4D and 4E) and the guidewire (guidewire 72; Figs. 4D-4E) are configured to be translatably coupled (attachment point 80, Figs. 4D-E; intertwined/adhesive, Paragraph 0066) such that subsequent removal of the guidewire insertion aide from the housing causes the guidewire to be pulled through the housing (see annotated Figs. 4D and 4E below; “Prior to pulling on tether 69, tether 69 was extending through the hole defined by housing 40. As the clinician pulls on second tether portion 68, first tether portion 66 is pulled through the hole define by housing 40, such that the proximal guidewire portion of guidewire 72, which is attached to first tether portion 66, is fed through the hole defined by housing 69. In this way, guidewire 72 may replace tether 69, as shown in FIG. 4E.”, Paragraph 0068).
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Therefore, it would have been obvious to one having ordinary skill in the art to configure the guidewire insertion aide and the guidewire in the percutaneous circulatory support system disclosed by Campbell et al. to be translatably coupled such that subsequent removal of the guidewire insertion aide from the housing causes the guidewire to be pulled through the housing, as taught by Anderson, in order to “provid[e] a relatively quick and simple way to thread guidewire 72 through the hole in housing 40 while housing 40 is implanted in patient” (Anderson, Paragraph 0069) and “Advantageously, the use of two or more guidewires can ease the threading and implantation process of the pump 10” (Campbell et al., Paragraph 0117), since this would allow for an smooth/simple transition between the guidewire insertion aide and the guidewire. Furthermore, changing the locations of the guidewire insertion aide and the guidewire would require simply rearranging the two parts, and it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding Claims 3 and 8, Campbell et al. discloses a percutaneous circulatory support system (blood pump system, Abstract, Paragraph 0058) further wherein the percutaneous circulatory support device comprises a blood inlet (52, Figs. 1, 3, 5) and a blood outlet (54, Figs. 1, 3, 4), and the guidewire insertion aide and guidewire are configured to be removable from the housing (“Once the cannula 40 has been advanced to the desired position, the first and second guidewires are removed prior to activating drive shaft”, Paragraph 0117), and wherein they are configured to extend through the blood outlet (guidewires 72 extend though outlet end 54, see Figs. 1, 3, 4, 6A-B, 9; Paragraph 0060, 0067, 0071, 0121).
However, Campbell et al. does not explicitly disclose wherein the removal of the guidewire insertion aide causes the guidewire to be pulled through the housing, since Campbell et al. is silent as to which direction the attached guidewire/insertion aid (first and second guidewires, Paragraph 0117) are removed through the housing (cannula 40 and cannula components 42, 50, 44, 48; Figs. 1, 2B; Paragraph 0066-0067).
Anderson teaches a percutaneous cardiac support system (Abstract) comprising a housing of a percutaneous cardiac support device (housing 40, Figs. 4D-4E, see above; Paragraph 0040), and a guidewire insertion aide (tether 66 68, 69, Figs. 4D and 4E) removably carried in the housing (Paragraph 0060, 0068-0069); and a guidewire (guidewire 72; Figs. 4D-4E),
wherein the guidewire insertion aide (tether 66 68, 69, Figs. 4D and 4E) and the guidewire (guidewire 72; Figs. 4D-4E) are configured to be translatably coupled (attachment point 80, Figs. 4D-E; intertwined/adhesive, Paragraph 0066) such that subsequent removal of the guidewire insertion aide from the housing causes the guidewire to be pulled through the housing (see annotated Figs. 4D and 4E above; “Prior to pulling on tether 69, tether 69 was extending through the hole defined by housing 40. As the clinician pulls on second tether portion 68, first tether portion 66 is pulled through the hole define by housing 40, such that the proximal guidewire portion of guidewire 72, which is attached to first tether portion 66, is fed through the hole defined by housing 69. In this way, guidewire 72 may replace tether 69, as shown in FIG. 4E.”, Paragraph 0068).
Therefore, it would have been obvious to one having ordinary skill in the art to configure the guidewire insertion aide and the guidewire in the percutaneous circulatory support system disclosed by Campbell et al. to be configured such that subsequent removal of the guidewire insertion aide from the housing causes the guidewire to be pulled through the housing, as taught by Anderson, in order to “provid[e] a relatively quick and simple way to thread guidewire 72 through the hole in housing 40 while housing 40 is implanted in patient” (Anderson, Paragraph 0069) and “Advantageously, the use of two or more guidewires can ease the threading and implantation process of the pump 10” (Campbell et al., Paragraph 0117), since this would allow for an smooth/simple transition between the guidewire insertion aide and the guidewire. Furthermore, changing the locations of the guidewire insertion aide and the guidewire would require simply rearranging the two parts, and it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding Claims 4, 5, 9, and 10, Campbell et al. discloses a percutaneous circulatory support system (blood pump system, Abstract, Paragraph 0058) further wherein the guidewire insertion aide (first guidewire preassembled into cannula 40, Paragraph 0117) comprises a proximal end portion (portion of inserted guidewire 72 which extends though outlet 54; see Figs. 1, 3, 4, 6A-B, 9) and a distal end portion (J-tip 74 of inserted guidewire 72, Fig. 3, 5), and the distal end portion is disposed distally relatively to the blood inlet (J-tip 74 of inserted guidewire 72 extends distally to inlet 52, 56, Fig. 3), and wherein the proximal end portion of the guidewire insertion aide is disposed outwardly from the blood outlet (guidewires 72 extend though outlet end 54 in both directions, see Figs. 1, 3, 4, 6A-B, 9; Paragraph 0060, 0067, 0071, 0121).
Regarding Claims 11 and 12, Campbell et al. discloses a percutaneous circulatory support system (blood pump system, Abstract, Paragraph 0058) further wherein the guidewire insertion aide (first guidewire preassembled into cannula 40, Paragraph 0117) and the guidewire (second guidewire, Paragraph 0117) comprises a coupler (attachment/connection point between first and second guidewire, “The proximal portion of the second guidewire, e.g., a portion that is in the patient, can be attached to the distal end of the first guidewire preassembled into cannula 40, and cannula 40 can be advanced along two connected guidewires to the desired position. In these embodiments, the connected first and second guidewires are configured to run coaxially”, Paragraph 0117) for translatably coupling to each other. It is also noted that Anderson also teaches a coupler on both the guidewire and guidewire insertion aide (attachment point 80, Figs. 4D-E; intertwined/adhesive, Paragraph 0066).
Regarding Claim 13, Campbell et al. discloses a percutaneous circulatory support system further wherein the guidewire insertion aide (first guidewire preassembled into cannula 40, Paragraph 0117) lacks a through lumen (guidewires are configured within cannula lumen 70, therefore guidewires lack lumens themselves, e.g. see 72, Fig. 3, 9; Paragraph 0025, 0081, 0117; guidewires are heavy duty and/or stiff, Paragraph 0117; exemplary Amplatz or Lunderquist® guidewires [Paragraph 0117] lack through lumens due to steel/solid cores; embodiment of guidewires with plug 76 lack through lumen, see Fig. 5; Paragraph 0060).
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