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 .
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 22-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,257,425. Although the claims at issue are not identical, they are not patentably distinct from each other because US 12,257,425 B2 has been found to anticipate each and every element of the present invention, for instance both provide:
19/061,441 (claim 22)
US 12,257,425 (claim 1)
an indwelling catheter comprising a proximal portion and a distal portion;
an indwelling catheter comprising a proximal portion and a distal portion;
an impeller assembly mounted at the distal portion of the catheter,
an impeller assembly mounted at the distal portion of the catheter,
the impeller assembly comprising: an impeller housing with an impeller disposed therein,
the impeller assembly comprising an impeller housing with an impeller disposed therein,
wherein the catheter distal portion and the impeller assembly are dimensioned to be navigated through a blood vessel of a patient; and
wherein the catheter distal portion and the impeller assembly are dimensioned to be navigated through a blood vessel of a patient, and
a cuff comprising a distal surface wherein a proximal end of a core diameter of the impeller rotates in clearance of the distal surface of the cuff and defines a proximal gap;
a cuff comprising a distal surface wherein a proximal end of a core diameter of the impeller rotates in clearance of the distal surface of the cuff;
Since there is a clearance there is necessarily a space or “gap” that is formed.
and a catheter lumen,
“a drive cable extending through the catheter from the motor to the impeller”
Therefore, there is necessarily a catheter lumen in order to enable the drive cable to extend
wherein the proximal gap is in fluid communication with the catheter lumen.
an impermeable sleeve extending through the catheter over the drive cable, the sleeve comprising a distal seal adjacent the impeller and/or a proximal seal adjacent the motor such that a body fluid external to the impermeable sleeve is prevented from entering the impermeable sleeve and contacting the drive cable.
As set forth above, the present invention is not viewed to be patentably distinct from US 12,257,425 B2.
Claims 22-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,724,095. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,724,095 B2 has been found to anticipate each and every element of the present invention, for instance both provide:
19/061,441 (claim 22)
11,724,095 (claim 1)
an indwelling catheter comprising a proximal portion and a distal portion;
an indwelling catheter comprising a proximal portion and a distal portion;
an impeller assembly mounted at the distal portion of the catheter,
an impeller assembly mounted at the distal portion of the catheter,
the impeller assembly comprising: an impeller housing with an impeller disposed therein,
the impeller assembly comprising an impeller housing with an impeller disposed therein,
wherein the catheter distal portion and the impeller assembly are dimensioned to be navigated through a blood vessel of a patient; and
wherein the catheter distal portion and the impeller assembly are dimensioned to be navigated through a blood vessel of a patient, and
a cuff comprising a distal surface wherein a proximal end of a core diameter of the impeller rotates in clearance of the distal surface of the cuff and defines a proximal gap;
a cuff comprising a distal surface wherein a proximal end of a core diameter of the impeller rotates in clearance of the distal surface of the cuff;
Since there is a clearance there is necessarily a space or “gap” that is formed.
and a catheter lumen,
“a drive cable extending through the catheter from the motor to the impeller”
Therefore, there is necessarily a catheter lumen in order to enable the drive cable to extend.
wherein the proximal gap is in fluid communication with the catheter lumen.
an impermeable sleeve extending through the catheter over the drive cable, the sleeve comprising a distal seal adjacent the impeller and/or a proximal seal adjacent the motor such that a body fluid external to the impermeable sleeve is prevented from entering the impermeable sleeve and contacting the drive cable.
As set forth above, the present invention is not viewed to be patentably distinct from US 11,724,095 B2.
Claims 22-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,318,561 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 12,318,561 B2 has been found to anticipate each and every element of the present invention, for instance both provide:
19/061,441 (claim 22)
12,318,561 (claim 1)
an indwelling catheter comprising a proximal portion and a distal portion;
a catheter with a proximal portion and a distal portion;
an impeller assembly mounted at the distal portion of the catheter,
an impeller assembly connected to the distal portion,
the impeller assembly comprising: an impeller housing with an impeller disposed therein,
the impeller assembly comprising a housing with an inlet region, an outlet region, and an axis, and an impeller operably disposed within the impeller assembly;
wherein the catheter distal portion and the impeller assembly are dimensioned to be navigated through a blood vessel of a patient; and
“the impeller operates within a blood vessel, blood flows through the housing of the impeller without recirculation” (claim 20).
a cuff comprising a distal surface wherein a proximal end of a core diameter of the impeller rotates in clearance of the distal surface of the cuff and defines a proximal gap;
“a cuff positioned at the distal portion of the catheter and extending into a proximal portion of the impeller assembly” (claim 6);
“a proximal end of the cylindrical core is spaced apart from a distal surface of the cuff, wherein the proximal end of the cylindrical core and the distal surface of the cuff comprise a controlled gap” (claim 8).
and a catheter lumen, wherein the proximal gap is in fluid communication with the catheter lumen.
“wherein the gap is configured to remain fixed during operation of the impeller to define a transition between the cuff and the impeller such that blood flows across the gap without flow disturbance, flow recirculation, and/or vortices” (claim 9)
As set forth above, the present invention is not viewed to be patentably distinct from US 12,318,561 B2.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 34 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 34 recites the limitation "the inflation lumen" in line 1. There is insufficient antecedent basis for this limitation in the claim.
NOTE: Claim 32, from which claim 34 depends, does not recite an inflation lumen. However, claim 33 does recite “an inflation lumen” in line 3. Examiner recommends amending the dependency of claim 34 from “of claim 32” to --of claim 33--.
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 22-27, 35-38 and 40-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nitzan et al. (US 2016/0331378 A1).
As to claim 22, Nitzan et al. discloses an indwelling catheter (Abstract) comprising a proximal portion and a distal portion (Figures 2-9); an impeller assembly mounted at the distal portion of the catheter (Figures 2-9), the impeller assembly comprising: an impeller housing (shaft, depicted as 102, 202, 302 in Figure 2-9, respectively; [0119-0121]) with an impeller (depicted as 110, 210, 310 in Figures 2-9, respectively; [0119-0121]) disposed therein, wherein the catheter distal portion and the impeller assembly are dimensioned to be navigated through a blood vessel of a patient (Abstract); and a cuff (atraumatic tip, depicted as 104, 204304 in Figure 2-9, respectively; [0119-0121]) comprising a distal surface wherein a proximal end of a core diameter of the impeller rotates in clearance of the distal surface of the cuff and defines a proximal gap (Figure 2-9); and a catheter lumen (Figures 2-9), wherein the proximal gap is in fluid communication with the catheter lumen (Figures 2-9).
As to claim 23, Nitzan et al. discloses the proximal gap comprises an annular gap (Figures 2-9).
As to claim 24, Nitzan et al. discloses the catheter lumen is in fluid communication with a fluid reservoir exterior of a patient (via inlet openings; Figures 2-9; [0119-0121]).
As to claim 25, Nitzan et al. discloses the catheter lumen comprises a purge channel (distal inlet opening; depicted as 116, 216, 316 in Figures 2-9) at a distal end of the catheter lumen, wherein the annular gap forms substantially a right angle to at least a portion of the purge channel (Figures 2-9).
As to claim 26, Nitzan et al. discloses the purge channel comprises an annular channel over at least a portion of a length of the purge channel (Figures 2-4).
As to claim 27, Nitzan et al. discloses the device further comprises a drive cable (drive shaft; [0119-0121]) extending through the catheter to the impeller and extending through the annular channel of the purge channel over a portion of its length (Figures 2-9).
As to claim 35, Nitzan et al. discloses a distal end of a core diameter of the impeller rotates in clearance with a distal surface of the impeller housing defining a distal gap wherein the distal gap is in fluid communication with the catheter lumen (Figures 2-9).
As to claim 36, Nitzan et al. discloses the distal gap is in fluid communication with a lumen positioned on the exterior of the impeller housing (Figures 2-9).
As to claim 37, Nitzan et al. discloses the device further comprises a motor (depicted as 212, 312 in Figures 3-9; [0119-0121]) connected to the proximal portion of the catheter (Figures 2-9), and a drive shaft (102, m202, 302, in Figures 2-9, respectively) extending through the catheter in a drive lumen from the motor to the cuff and from the cuff to the impeller (Figures 2-9).
As to claim 38, Nitzan et al. discloses the drive lumen is surrounded by an impermeable sleeve (flexible membrane, depicted as 28 in Figures 10 and 10A; [0123-0125]).
As to claim 40, Nitzan et al. discloses cuff comprises a profiled extrusion mounted inside the cuff (discharge opening in the atraumatic tip; Figures 2-9) and configured for purge fluid to flow therethrough, wherein the profiled extrusion comprises at least two projections (openings; 206, 216 in Figure 6) extending one or more of inward and outward from a central hub encasing the drive shaft (Figures 2-9).
As to claim 41, Nitzan et al. discloses an outer hub encasing the drive shaft to define a purge lumen in the space therethrough (Figure 2-9).
As to claim 42, Nitzan et al. discloses the proximal gap is configured to remain fixed during operation (since the components are fixed components, the proximal gap necessarily remains fixed during operation).
As to claim 43, Nitzan et al. discloses the annular gap is configured to allow a purge fluid to flow through a circumference of the annular gap (Figures 2-9; the annual gap forms space and is thus under the broadest reasonable interpretation “configured” to allow a fluid to flow through a circumference).
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 28-34 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan et al. (US 2016/0331378 A1).
As to claims 28-32 and 39, Nitzan et al. discloses the invention substantially as claimed but does not explicitly disclose the employment of a resistive fluid pressure or purge fluid to prevent blood from entering the proximal gap. Employing a purge fluid, such as saline, for providing a resistive fluid pressure and flush blood from an enclosure or lumen of a medical device (i.e. a saline flush prior to the delivery of intravenous fluids or medication). It would have been obvious to one having ordinary skill in the art at the time the invention was made to incorporate a purge fluid for resistive fluid pressure to flush blood from the proximal gap in order to provide the predictable results of enhancing operation and ensuring no ingress or contamination of blood is present within the medical device.
As to claims 33-34, the modified Nitzan et al. discloses the invention substantially as claimed with at least a first expandable member connected to the distal portion of the catheter (restrictor, depicted as 318 in Figure 7; [0118, 0121]) and a fluid for inflating the member ([0091]), but does not explicitly disclose the fluid is also a purge fluid. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the fluid used to inflate the inflatable member to be the same fluid as the purge fluid in order to provide the predictable results of optimizing material cost and device performance.
Additionally, as to claim 34, as best understood in light of the rejection under 35 U.S.C. 112 above, the modified Nitzan et al. discloses the inflation lumen is external to the catheter lumen (Figures 7-10).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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