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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 14 April 2026. As directed by the amendment: Claims 1, 2, 7, 10, and 11 have been amended, Claims 14-20 have been cancelled, and Claims 21-27 have been added. Thus, Claims 1-13 and 21-27 are presently pending in this application.
The amendments to the Specification (Abstract) have been reviewed and accepted by the Examiner.
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, 2, 8, and 9 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 § 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 12 and 23 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 12, the claim recites “wherein the guidewire comprises a coupler for translatably coupling to the guidewire insertion aide”. However, Claim 7 (from which Claim 12 depends) has been amended to recite “wherein the guidewire insertion aide includes a coupler with an opening configured to receive the guidewire”. Therefore, it is unclear and therefore indefinite whether this is the same coupler or a different element. For purposes of examination, this limitation will be interpreted as “wherein the coupler is configured to translatably couple to the guidewire insertion aide and guidewire”. Appropriate correction or clarification is required.
Regarding Claim 23, the claim recites “wherein the coupler includes an outer tube and an internal sleeve polymer defining a lumen”. However, Claim 2 (from which Claim 23 depends) recites “the coupler for translatably coupling to the guidewire is a tube having a lumen sized to receive an end of the guidewire”. It is unclear as to whether the “outer tube” and/or the “internal sleeve” as recited in Claim 23 includes the “tube” recited in Claim 2, or if these are separate elements. Therefore these limitations are indefinite. For purposes of examination, the Examiner is interpreting this limitation as “wherein the tube is an outer tube and the coupler includes an internal sleeve polymer defining a lumen”. Appropriate correction or clarification is required.
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 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Campbell et al. (US Publication No. 2011/0004046, previously cited).
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 includes
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 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 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 2-5 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US Publication No. 2011/0004046, previously cited) in view of Anderson (US Publication No. 2016/0129239, previously cited).
Regarding Claims 2, 7, 11, and 12, 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),
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.
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). Campbell et al. also does not explicitly disclose wherein the coupler includes a tube having an opening and lumen sized to receive an end of the guidewire.
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, and tube 70, 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, and tube 70, Figs. 4D and 4E) includes a coupler which includes a tube (tube 70, Figs. 4D and 4E) having an opening and lumen sized to receive an end of the guidewire (guidewire 72; Figs. 4D-4E),
wherein the guidewire insertion aide (tether 66, 68, 69, and tube 70, 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, wherein the coupler includes a tube having an opening and lumen sized to receive an end of the guidewire, 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 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).
Claims 21, 22, 24, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US Publication No. 2011/0004046, previously cited) in view of Anderson (US Publication No. 2016/0129239, previously cited), further in view of Su et al. (International Pub No. WO 2022/191977).
Regarding Claims 21, 22, 24, 25, and 26, Campbell et al. discloses 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. As described above, Anderson teaches wherein the guidewire insertion aide (tether, 66 68, 69, and tube 70, Figs. 4D and 4E) includes a coupler which includes a tube (tube 70, Figs. 4D and 4E) having an opening and lumen sized to receive an end of the guidewire (guidewire 72; Figs. 4D-4E). However, neither Campbell et al. nor Anderson discloses wherein the tube includes a collapsible braided structure encapsulated in an outer sleeve or wherein the tube includes opposed narrow portions or bends within the lumen configured to frictionally engage the guidewire.
Su et al. teaches a delivery system for a cardiac support device (Abstract) comprising a guidewire insertion aid comprising a tube (702, Fig. 7A) which includes a collapsible braided structure (Paragraph 0071, 0073) encapsulated in an outer sleeve (704, Fig. 7A; Paragraph 0067, 0069, 0070), and wherein the tube includes opposed narrow portions or bends (crimped portions 716, Fig. 7A; Paragraph 0070) within the lumen (lumen of 702, 708, Fig. 7A; Paragraph 0070) configured to frictionally engage the guidewire (crimped portions engage guidewire sheath 706, Fig. 7A; Paragraph 0070, 0073, 0076).
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 tube in the system disclosed by Campbell et al. and Anderson in combination to include a collapsible braided structure encapsulated in an outer sleeve or wherein the tube includes opposed narrow portions or bends within the lumen configured to frictionally engage the guidewire, as taught by Su et al., in order to allow for faster navigation/delivery of the cardiac support structures without catching and to reduce complications during delivery, as also taught by Su et al. (Paragraphs 0036-0041).
Allowable Subject Matter
Claim 27 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 23 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. It is noted that the interpretation of Claim 23 is based on the interpretation as noted in the 35 U.S.C. 112(b) rejection section above.
Response to Arguments
The previous Objections to the Specification (Abstract) have been withdrawn due to the Applicant’s amendments to the Abstract as made in the Response/Amendment filed 14 April 2026.
The Double Patenting rejections have not been withdrawn. The Applicant has requested that the rejection be held in abeyance until allowable subject matter has been indicated (see Page 7 of Remarks).
The Applicant’s arguments with respect to the previous 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 rejections of Claims 1-13 have been considered but are not persuasive.
The Applicant specifically argues (Page 7-8 of Remarks) that Cambell et al. does not disclose all of the claimed elements of Claims 1 and 7 as amended, particularly, “wherein the guidewire insertion aide includes a coupler for translatably coupling to a guidewire.” However, the Examiner disagrees with this argument. As described above, Campbell et al. explicitly discloses 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 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).
The Applicant further argues that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning (Pages 8-9 of Remarks). However, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The Examiner maintains that 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, and tube 70, 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, and tube 70, Figs. 4D and 4E) includes a coupler which includes a tube (tube 70, Figs. 4D and 4E) having an opening and lumen sized to receive an end of the guidewire (guidewire 72; Figs. 4D-4E), wherein the guidewire insertion aide (tether 66, 68, 69, and tube 70, 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).
Therefore, the Examiner maintains that 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, wherein the coupler includes a tube having an opening and lumen sized to receive an end of the guidewire, 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.
New Claims Claims 21, 22, 24, 25, and 26 have been rejected under 35 U.S.C. 103 with the addition of the new Su et al. reference as described in detail above.
Therefore, Claims 1-13, 21, 22, 24, 25, and 26 are rejected as described above. Claim 27 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 23 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to the Applicant's disclosure:
Schmitt (US Publication No. 2012/0210569) discloses a guidewire insertion aide tool (Abstract) with polymer portions to deformably engage the guidewire during insertion (Paragraph 0019; see Fig. 1).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 10:00am - 6:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
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