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
As of the Preliminary Amendment filed 12/01/2025, claims 6-8, 10, 25-36, and 45-48 are pending. Claims 1-5, 9, 11-24, and 37-44 have been cancelled while claims 6, 8, 10, 25-27, and 30-36 have been amended. Claims 45-48 are new.
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 6-8, 10, and 25-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 15-16 of U.S. Patent No. 12,383,704 B2 (hereinafter known as the ‘704 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘704 patent anticipate the present claims as described below.
With respect to claim 6, the ‘704 patent discloses a variable stiffness distal extension for a blood pump system (claim 1, lines 4-5), the distal extension comprising:
an integrally formed body having a distal end and a proximal end, an exterior wall extending between the distal end and the proximal end, and an interior wall that forms an interior lumen extending between the distal end and the proximal end, the interior lumen configured to receive a longitudinally extending element (claim 1, lines 6-15);
the integrally formed body further comprising:
a proximal portion configured to be connected to the blood pump system and having a first inner diameter along the interior wall and a first outer diameter along the exterior wall (claim 1, lines 16-18, although the inner diameter is not explicitly recited the recitation of a lumen reads on this limitation since any lumen would have a diameter); and
a distal tip portion that is distal of the proximal portion, the distal tip portion having a second inner diameter along the interior wall and a second outer diameter along the exterior wall (claim 1, lines 19-22, see also lines 12-13 which discuss the lumen extending through the distal end),
wherein the first outer diameter decreases continuously along the proximal portion in a distal direction, wherein the body has a variable stiffness (claim 1, lines 25-28).
Regarding claim 7, the ‘704 patent discloses wherein the longitudinally extending element is a guidewire loading lumen (claim 2).
Regarding claim 8, the ‘704 patent discloses wherein the longitudinally extending element is a stylet (claim 2)
Regarding claim 10, the ‘704 patent fails to disclose an intermediate portion that is distal of the proximal portion and proximal of the distal tip (claim 15).
Regarding claim 25, the ‘704 patent discloses wherein the distal extension is integrally formed of a single material (claim 1, line 6).
Regarding claim 26, the ‘704 patent further discloses wherein the distal tip portion is a pigtail portion and a material of the pigtail portion comprises at least one polymer (claim 4).
Regarding claim 27, the ‘704 patent further discloses wherein the at least one polymer comprises at least one of polyurethane, a polyamide, and an elastomer (claim 5).
Regarding claim 28, the ‘704 patent further discloses wherein the polyamide comprises at least one of PEBAX and nylon (claim 6).
Regarding claim 29, the ‘704 patent further discloses wherein the elastomer comprises a thermoplastic polyurethane (claim 7).
Regarding claim 30, the ‘704 patent further discloses wherein the material of the pigtail portion further comprises at least one of an additive, a colorant, and a filler (claim 8).
Regarding claim 31, the ‘704 patent further discloses wherein the distal tip portion is j-shaped or pigtail-shaped (claim 9).
Regarding claim 32, the ‘704 patent further discloses wherein the distal tip portion is configured to have a lower stiffness than the intermediate portion (claim 16).
Regarding claim 33, the ‘704 patent further discloses wherein the intermediate portion is configured to have a lower stiffness than the proximal portion (claim 16).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 6, last line: “the body” should recite “the integrally formed body” instead to match the previously established antecedent basis.
Appropriate correction 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.
(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.
Claims 6-8, 10, 25, 31-34, 36, 45, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campbell et al. (US 2012/0172655 A1).
With respect to claim 6, Campbell et al. discloses a variable stiffness distal extension (602 in Figs. 13A-19A) for a blood pump system (see blood pump system 10 in Fig. 1), the distal extension (602D in Fig. 19A) comprising:
an integrally formed body (see body of 602D in Fig. 19A) having a distal end (end near 616D) and a proximal end (end near 608D), an exterior wall extending between the distal end and the proximal end (see exterior wall of 602D in Fig. 19A), and an interior wall that forms an interior lumen extending between the distal end and the proximal end (see interior wall of 602D defining lumen 676D), the interior lumen (676D) configured to receive a longitudinally extending element (lumen 676D is configured to receive a longitudinally extending element);
the integrally formed body (body of 602D) further comprising:
a proximal portion (612D) configured to be connected to the blood pump system (see Fig. 1A, the proximal portion of comparable element 182 is configured to be connected to the blood pump system) and having a first inner diameter along the interior wall and a first outer diameter along the exterior wall (see diameters of outer and interior walls of 612D in Fig. 19A); and
a distal tip portion (616D) that is distal of the proximal portion (612D), the distal tip portion (616D) having a second inner diameter along the interior wall and a second outer diameter along the exterior wall (see diameters of outer and interior walls of 616D in Fig. 19A),
wherein the first outer diameter decreases continuously along the proximal portion in a distal direction (PP [0112]: “the proximal portion 612D can have a tapered outer diameter that tapers distally towards the intermediate portion 620D”), wherein the body has a variable stiffness (PP [0112]: “The tapered outer diameter of the proximal portion 612D can advantageously contribute to the atraumatic and pliable nature of the flexible member 602D through a gradually decreasing wall thickness (stiffness) from proximal to distal portion of the member”, the change in wall thickness provides variable stiffness).
Regarding claim 7, Campbell et al. further discloses wherein the longitudinally extending element is a guidewire loading lumen (lumen 676D in Fig. 19A is configured to receive a guidewire loading lumen).
Regarding claim 8, Campbell et al. further discloses wherein the longitudinally extending element is a stylet (lumen 676D in Fig. 19A is configured to receive a stylet).
Regarding claim 10, Campbell et a. further discloses wherein the distal extension (602D in Fig. 19A) further comprises:
an intermediate portion (620D) that is distal of the proximal portion (612D) and proximal of the distal tip portion (616D).
Regarding claim 25, Campbell et al. further discloses wherein the distal extension (600D in Fig. 19A) is integrally formed of a single material (see Fig. 19A, 602D is integrally formed).
Regarding claim 31, Campbell et a. further discloses wherein the distal tip portion (616D in Fig. 19A) is j-shaped or pigtail-shaped (PP [0112]: “The curvature of the intermediate portion 620D can take any suitable form, such as those described herein with respect to the atraumatic tip 182. For example, the intermediate portion 620D can take the shape of a j-tip or a pigtail tip”, 620D and 616D are both pigtail portions).
Regarding claim 32, Campbell et a. further discloses wherein the distal tip portion (616D in Fig. 19A) is configured to have a lower stiffness than the intermediate portion (620D, PP [0112]: “the distal portion 616D can have a tapered outer diameter that can be configured to reduce trauma to the patient upon insertion and/or retrieval”, the tapered diameter makes distal tip portion 616D less stiff than intermediate portion 620D).
Regarding claim 33, Campbell et al. further discloses wherein the intermediate portion (620D in Fig. 19A) is configured to have a lower stiffness than the proximal portion (at least part of proximal portion 612D has a larger diameter than intermediate portion 620D, giving it a greater overall average stiffness than intermediate portion 620D).
Regarding claim 34, Campbell et al. further discloses wherein the second outer diameter of the distal tip portion (616D in Fig. 19A) decreases between a proximal end and a distal end of the distal tip portion (PP [0112]: “the distal portion 616D can have a tapered outer diameter that can be configured to reduce trauma to the patient upon insertion and/or retrieval”).
Regarding claim 36, Campbell et al. further discloses wherein the second inner diameter of the distal tip portion (616D in Fig. 19A) is constant (PP [0112]: “although the outer diameters of the proximal portion 612D and the distal portion 616D may taper distally, the inner diameter of these structures can remain constant, e.g., the lumen 676D that extends through the flexible tip assembly 600D can have a constant diameter”).
Regarding claim 45, Campbell et al. further discloses wherein the intermediate portion has a third inner diameter along the interior wall and a third outer diameter along the exterior wall, wherein the third inner diameter and the third outer diameter are each constant along the intermediate portion (620D in Fig. 19A, PP [0112]: “the intermediate portion 620D can be curved and/or can include a constant outer diameter… although the outer diameters of the proximal portion 612D and the distal portion 616D may taper distally, the inner diameter of these structures can remain constant, e.g., the lumen 676D that extends through the flexible tip assembly 600D can have a constant diameter”).
Regarding claim 47, Campbell et al. further discloses wherein the distal tip portion (616D in Fig. 19A) is pigtail-shaped (PP [0112]: “The curvature of the intermediate portion 620D can take any suitable form, such as those described herein with respect to the atraumatic tip 182. For example, the intermediate portion 620D can take the shape of a j-tip or a pigtail tip”, 620D and 616D are both pigtail portions) and has a constant radius of curvature (see annotated Fig. 19A, the radius of curvature is constant).
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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.
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.
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US PGPub 2012/0172655 A1), as applied to claim 6 above, and further in view of Scheckel (US PGPub 2020/0360581 A1).
Regarding claim 26, Campbell et al. further discloses wherein the distal tip portion (616D in Fig. 19A) is a pigtail portion (PP [0112]: “The curvature of the intermediate portion 620D can take any suitable form, such as those described herein with respect to the atraumatic tip 182. For example, the intermediate portion 620D can take the shape of a j-tip or a pigtail tip”, 620D and 616D are both pigtail portions).
However, Campbell et al. fails to disclose wherein a material of the pigtail portion comprises at least one polymer.
In the same field of catheter blood pump systems (PP [0002]), Scheckel teaches a distal extension (1.2 in Fig. 3A) comprising a j-shaped pigtail (1.2.2), wherein a material of the pigtail portion comprises at least one polymer (PP [0053]: “The catheter device 1 can further comprise an atraumatic tip, for instance designed as a pigtail tip 1.2.2. The atraumatic tip 1.2.2 can for instance be made of Pebax®, PU, or another flexible medical grade polymer and it can comprise an elongated portion 1.2.1”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Campbell et al. device according to the teachings of Scheckel to include wherein a material of the pigtail portion comprises at least one polymer. One of ordinary skill in the art would have been motivated to perform this modification because doing so is a simple substitution of pigtail materials that would have yielded predictable results, as Campbell et al. is silent on any required pigtail material and Scheckel teaches that flexible medical grade polymers (such as PEBAX and polyurethane) are appropriate for use in manufacturing flexible distal extensions for blood pumps. Since Campbell et al. only requires an “atraumatic”, “pliable”, and “flexible” distal extension (602D in Fig. 19A, PP [0112]), and the flexible materials listed by the Scheckel reference fulfill these requirements, the combination as proposed would not have altered the main inventive concept of the Campbell et al. device.
Regarding claim 27, Campbell et al. as modified by Scheckel further discloses wherein the at least one polymer comprises at least one of polyurethane, a polyamide, and an elastomer (PP [0053]: “The catheter device 1 can further comprise an atraumatic tip, for instance designed as a pigtail tip 1.2.2. The atraumatic tip 1.2.2 can for instance be made of Pebax®, PU, or another flexible medical grade polymer and it can comprise an elongated portion 1.2.1”, emphasis added, PU is polyurethane).
Regarding claim 28, Campbell et al. as modified by further discloses wherein the polyamide comprises at least one of PEBAX and nylon (PP [0053]: “The catheter device 1 can further comprise an atraumatic tip, for instance designed as a pigtail tip 1.2.2. The atraumatic tip 1.2.2 can for instance be made of Pebax®, PU, or another flexible medical grade polymer and it can comprise an elongated portion 1.2.1”, emphasis added).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US PGPub 2012/0172655 A1) and Scheckel (US PGPub 2020/0360581 A1), as applied to claims 26-27 above, and further in view of Graffam et al. (US PGPub 2011/0152842 A1).
Regarding claim 29, Campbell et al. as modified by Scheckel further discloses wherein the elastomer comprises a polyurethane (Scheckel PP [0053]: “The catheter device 1 can further comprise an atraumatic tip, for instance designed as a pigtail tip 1.2.2. The atraumatic tip 1.2.2 can for instance be made of Pebax®, PU, or another flexible medical grade polymer and it can comprise an elongated portion 1.2.1”, emphasis added, PU is polyurethane).
However, Campbell et al. as modified by Scheckel is silent on the elastomer comprising a thermoplastic polyurethane.
In the related field of percutaneous drainage catheters (PP [0002]), which is related to the present application due to its concern with the transfer of fluid within a patient, Graffam et al. teaches a pigtail catheter (100 in Fig. 1B with pigtail portion 104) comprising a thermoplastic polyurethane (PP [0027]: “The catheter 100 may be constructed of thermoplastic polymer such as polyurethane, ethyl vinyl acetate (EVA), polyether block amide elastomer, polypropylene, or polyolefin elastomers”, emphasis added).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the Campbell et al. and Scheckel combination to incorporate the teachings of Graffam et al. and specifically include wherein a material of the pigtail portion comprises a thermoplastic polyurethane. One of ordinary skill in the art would have recognized that since Scheckel already contemplates using polyurethane or “another flexible medical grade polymer” (PP [0053]) and since Campbell et al. requires an “atraumatic”, “pliable”, and “flexible” distal extension (602D in Fig. 19A, PP [0112]) that it would be obvious to specifically include a thermoplastic polyurethane, which includes a greater flexibility and pliancy as opposed to a thermoset polyurethane. The combination as proposed would not have altered the main operating principle of the Campbell et al. device, but would have simply and predictably provided a flexible material with characteristics suitable for manufacturing the distal extension.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US PGPub 2012/0172655 A1) and Scheckel (US PGPub 2020/0360581 A1), as applied to claim 26 above, and further in view of Corbett et al. (US PGPub 2015/0328382 A1).
Regarding claim 30, Campbell et al. as modified by Scheckel fails to disclose wherein the material of the pigtail portion further comprises at least one of an additive, a colorant, and a filler.
In the same field of blood pumps (abstract), Corbett et al. teaches a cannula assembly (see Fig. 1) comprising an integrally formed distal pigtail extension (106 or 206 in Fig. 2) with a proximal portion (first half of 208 in Fig. 2), an intermediate portion (next half of 208 in Fig. 2), and a distal tip portion portion (207), wherein the material of the pigtail portion further comprises at least one of an additive, a colorant, and a filler (PP [0007]: "The pigtail extension includes a proximal section having a first stiffness and a distal section having a second stiffness, the first stiffness greater than the second stiffness", PP [0008]: "The stiffness of the proximal portion may be altered by the addition of other materials such as glass filler or metal or fiber braids").
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Campbell et al. and Scheckel combination to incorporate the teachings of Corbett et al. and include wherein the material of the pigtail portion further comprises at least one of an additive, a colorant, and a filler. One of ordinary skill in the art would have been motivated to perform this modification in order to ensure that the more proximal intermediate portion is stiff enough to substantially resist buckling while keeping the distal tip portion soft and flexible enough to be atraumatic (see PP [0019] of Corbett et al.). The combination as proposed would not alter the main operating principle of the Campbell et al. device but would simply and predictably increase the stiffness along the proximal and intermediate portions in order to desirably achieve the resistance to buckling as discussed by the Corbett et al. reference.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US PGPub 2012/0172655 A1) as applied to claim 6 above, and further in view of Corbett et al. (US PGPub 2015/0328382 A1).
Regarding claim 35, Campbell et al. fails to disclose wherein a material of the distal tip portion has a lower flexural modulus than a material of the intermediate portion.
In the same field of blood pumps (abstract), Corbett et al. teaches a cannula assembly (see Fig. 1) comprising an integrally formed distal extension (106 or 206 in Fig. 2) with a proximal portion (first half of 208 in Fig. 2), an intermediate portion (next half of 208 in Fig. 2), and a distal tip portion portion (207), wherein a material of the third portion has a lower flexural modulus than a material of the second portion (PP [0007]: "The pigtail extension includes a proximal section having a first stiffness and a distal section having a second stiffness, the first stiffness greater than the second stiffness", PP [0008]: "The stiffness of the proximal portion may be altered by the addition of other materials such as glass filler or metal or fiber braids").
It would have been prima facie obvious for one of ordinary skill in the art to have modified the Campbell et al. device according to the teachings of Corbett et al. to include wherein the distal tip portion has a lower flexural modulus than a material of the intermediate portion by including the filler additions as taught by Corbett et al. on the proximal and intermediate portions. One of ordinary skill in the art would have been motivated to perform this modification in order to ensure that the more proximal intermediate portion is stiff enough to substantially resist buckling while keeping the distal tip portion soft and flexible enough to be atraumatic (see PP [0019] of Corbett et al.). The combination as proposed would not alter the main operating principle of the Campbell et al. device but would simply and predictably increase the stiffness along the proximal and intermediate portions in order to desirably achieve the resistance to buckling as discussed by the Corbett et al. reference.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US PGPub 2012/0172655 A1) and Scheckel (US PGPub 2020/0360581 A1), as applied to claim 6 above, and further in view of Ciaglia et al. (US Patent No. 6,637,435 B2).
Regarding claim 46, Campbell et al. fails to disclose wherein the first inner diameter of the proximal portion decreases continuously along the proximal portion in the distal direction.
In the relevant field of dilators (abstract, relevant in that dilators are also generally concerned with atraumatic insertion of the device into a patient while providing a lumen for the insertion of other elongate elements therethrough), Ciaglia et al. teaches a dilator (10 in Fig. 3) comprising an interior lumen (24) and an external taper (see taper of 12 and 16). Ciaglia et al. further discloses wherein the interior lumen (24) has an inner diameter that decreases continuously along the distal direction from the proximal end to the distal end (see Fig. 3).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Langston reference to incorporate the teachings of Ciaglia et al. and include the inner and outer diameter tapers as described above in order to gradually increase the flexibility of the shaft along the distal direction (Ciaglia et al. col. 2, lines 1-5: "the curved tapered distal portion has a gradual transition in flexibility from very flexible at the short distal tip portion to generally rigid at the generally linear shaft portion, such as by gradually changing its wall thickness"). Increasing the flexibility would improve the atraumatic qualities of the distal end while still maintaining a basic level of rigidity to the proximal end, which would be a desirable trait of the Campbell et al. device to incorporate, as Campbell et al.
Conclusion
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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