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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/15/26 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 15, ‘cava’ is misspelled. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 8, and 25-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alferness et al (US Pub 2005/0187425).
Re claim 1: Alferness discloses a system for supporting cardiac function in a patient, the system comprising:
an elongate housing configured for implantation either into a right atrium or a portion of a superior vena cava into in the patient, the housing having an inlet and an outlet spaced longitudinally from the inlet, the inlet and the outlet defining a primary blood flow path from a left atrium through at least a portion of the housing to an aorta [0024, figure 2; see the pump housing 62 with blood flow path from the left atrium 22 to the aorta 26];
wherein the housing comprises
a first tube coupled to the inlet and configured to extend through a septal wall between the right atrium and the left atrium, and a first anchor coupled to the first tube, the first anchor configured to engage at least one side of the septal wall to fix a position of the first tube relative to the septal wall such that, when the first anchor is engaged, the inlet is positioned in fluid communication with the left atrium being configured for anchoring the first tube to a septal wall between the right atrium and a left atrium [0024-0026; figure 2; see the first anchor 64 for the septal wall and input tube 66]; and
a second tube coupled to the outlet and a second anchor coupled to the second tube,the second anchor configured to engage a wall between the superior vena cave and the aorta to fix a position of the outlet relative thereto such that, when the second anchor is engaged, the outlet is positioned in fluid communication with the aorta being configured for coupling the outlet with a wall between the superior vena cava and the aorta [0024-0026, abstract, figure 2; see the second anchor 70 for the cusp/wall between the aorta and SVC and see the output tube 68];
a motor coupled to the housing [0028; see incorporated references which have a motor]; and
an impeller coupled to the motor and configured to propel blood through the primary blood flow path [0028; see incorporated references which have an impeller].
Re claim 8: The motor comprises a stator coupled to the housing and a rotor disposed within the housing, wherein the impeller is coupled to the rotor [0028; see the incorporated references which disclose the stator and rotor].
Re claim 25: Alferness discloses a method for supporting cardiac function in a patient (abstract; see the heart pump), the method comprising:
implanting a pump comprising a motor and an impeller as an intracardiac device into either into a right atrium or a portion of a superior vena cava in the patient [0024, 0028; see the pump 62 implanted in the right atrium and see incorporated references which have a motor and impeller];
implanting the pump such that an inlet of the pump is located within the right atrium or the superior vena cava [0024, figure 2; see the implanted pump into the RA with input 66];
generating a fluid path from a left atrium to the inlet of the pump through the right atrium or the superior vena cava [0026, 0027; see the path from the left atrium 22 through the RA and to the aorta 26];
generating a fluid path from an outlet of the pump to an aorta [0027; see the path to the aorta 26 with output 68]; and
operating the pump to draw drawing blood from the left atrium into an inlet of the pump through a primary flow path such that the blood flows through an outlet of the pump and into the aorta [0026, 0027; see the path from the LA and output to the aorta].
Re claims 26, 28: A tube is anchored through a wall between the left atrium and the right atrium and fluidly coupling the tube to the inlet of the pump [0024-0026; figure 2; see the first anchor 64 for the septal wall and input tube 66].
Re claim 27: An anchor is implanted within the wall and securing the tube to the anchor [0024-0026; figure 2; see the first anchor 64 for the septal wall and input tube 66].
Re claims 29, 30: A tube is anchored through a wall between the right atrium and the an aorta and fluidly coupling the tube to the outlet of the pump, wherein an anchor is implanted within the wall and securing the tube to the anchor [0024-0026, abstract, figure 2; see the second anchor 70 for the cusp/wall between the aorta and SVC and see the output tube 68].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Alferness, as applied to claim 1, in view of Stanfield et al (US Pub 2019/0125948 -cited by applicant).
Re claims 9-12: Alferness discloses a rotor with an external surface and rotational elements [0028; see incorporated references which disclose the rotor], but do not disclose a second inlet within the housing defining a secondary blood flow path to couple to the right atrium through the housing, a second outlet coupled to the secondary flow path and configured to be fluidly coupled to the right atrium, a tube configured to fluidly couple the second inlet to the left atrium, an anchor coupled to an outlet of the tube, wherein the anchor is configured for securing the tube across the septal wall between the right atrium and the left atrium, or wherein the secondary path is in the same or opposite direction as the primary path. However, Stanfield teaches a second inlet within the housing defining a secondary blood flow path through the housing and a second outlet coupled to the secondary flow path and configured to be fluidly coupled to the right atrium (Fig 1, 0068; see second inlet 22 defining a second path into bore 28, structurally capable of being coupled to the right atrium and see first end 16 that defines a second outlet that is coupled to second path defined by inlet 22 and capable of being coupling to the right atrium). Further, Stanfield teaches a tube configured to fluidly couple the second inlet to the left atrium, an anchor coupled to an outlet of the tube, wherein the anchor is configured for securing the tube across the septal wall between the right atrium and the left atrium, or wherein the secondary path is in the same or opposite direction as the primary path (0047, 0098, 0100; see the cannulas capable of coupling to the left atrium and see the anchor assembly that at least indirectly anchors the tube; 0089; see the normal flow direction into the inlet and then the reverse capability of the flow path).
It would have been obvious to the skilled artisan to modify Alferness, to incorporate the features of a second inlet and second outlet for a secondary blood flow path as taught by Stanfield, in order to facilitate flow through the pump to establish a desired blood flow path.
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 1-16 and 25-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of copending Application No. 18/177,290. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘290 features a system including a housing to be implanted in a right atrium with an inlet and outlet from a left atrium to the aorta. While ‘290 includes other limitations such as a power source, it would have been obvious to the skilled artisan to conclude that the instant claims are an obvious variant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 and 25-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of copending Application No. 18/056,749. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘749 features a system including a housing to be implanted in a right atrium with an inlet and outlet from a left atrium to the aorta. While ‘290 includes other limitations such as a resonator, it would have been obvious to the skilled artisan to conclude that the instant claims are an obvious variant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 and 25-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 15, 16, 18, 21, 22, and 24-31 of copending Application No. 18/574,215. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘215 features a system including a housing to be implanted along with a rotor and impeller. While ‘215 includes other limitations such as a clearance, it would have been obvious to the skilled artisan to conclude that the instant claims are an obvious variant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to claims 1, 8-16, and 25-30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The prior claim objections are withdrawn due to amendment and the double patenting rejections are maintained as they have not been addressed.
Conclusion
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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