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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, and 11 of U.S. Patent No. 11,839,754.
instant application 19/011,892
co pending 18/958,200
us patent 11,839,754 app 16275559
An apparatus, comprising: an impeller defining a proximal end and a distal end, the impeller comprising:
claim 1:an impeller comprising proximal and distal bushings
Claim 1: Apparatus comprising: a rotating impeller comprising: proximal and distal bushings;
an axial element extending from the proximal end to the distal end of the impeller, the axial element defining a lumen therethrough;
claim 3: an axial element that is disposed inside of the helical elongate element and extends from the proximal bushing to the distal bushing
claim 1: a coil spring, the coil spring being disposed inside of the helical elongate element between the proximal and distal bushings, and the coil spring defining a lumen therethrough
at least one impeller blade comprising: at least one curved elongate element;
claim 3: the impeller comprises: at least one curved elongate element that extends from the proximal bushing to the distal bushing;
claim 1: at least one impeller blade comprising: at least one helical elongate element;
and material supported between the curved elongate element and the axial element
claim 3: and material supported between the curved elongate element and the axial element
claim 1: and a film of material supported between the helical elongate element and the coil spring
and an axial shaft extending from the proximal end of the impeller to the distal end of the impeller via the lumen defined by the axial element
claim 1: an axial shaft configured to pass through the proximal and distal bushings of the impeller,
claim 1: a rigid shaft configured to extend from the proximal bushing to the distal bushing via the lumen defined by the coil spring, such that the coil spring extends around the rigid shaft
claim 2
claim 10
claim 2
claim 3
claim 4
claim 3
claim 4
claim 5
claim 1
claim 5
claim 1
claim 6
claim 4
claim 7
claim 8
claim 1
claim 8
claim 5
claim 9
claim 7
claim 10
claim 9
claim 11
claim 11
claim 12
claim 1
claim 13
claim 6
claim 14
claim 3
claim 15
claim 7
claim 16
claim 1
claim 17
claim 5
claim 18
claim 1
Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 1, 12 and 13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 of U.S. Patent No. 11,291,825 AND U.S. Patent No.11,260,212. Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 1-4, 7 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5,8, and 10 of copending Application No. 18/958,200 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 17/176,344 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 1-2, 4-8, 12-13, and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmitz-Rode et al (US Patent 6,533,716).
Referring to Claim 1, Schmitz-Rode et al teaches an apparatus, comprising: an impeller defining a proximal end and a distal end (e.g. Figure 3), the impeller comprising: an axial element extending from the proximal end to the distal end of the impeller (e.g. Figure 3, elastic band/spring 9), the axial element defining a lumen there through (e.g. Figure 3 lumen for shaft 6); at least one impeller blade comprising :at least one curved elongate element (e.g. Figure 3, Element 8); material supported between the curved elongate element and the axial element (e.g. Figure 3, Element 10); and an axial shaft extending from the proximal end of the impeller to the distal end of the impeller via the lumen defined by the axial element (e.g. Figure 3, Element 6).
Referring to Claim 2 , Schmitz-Rode et al teaches the apparatus according to claim 1, wherein the impeller is configured to be placed within the subject's left ventricle (e.g. Figure 1 and Column 1 lines 65-66).
Referring to Claim 4, Schmitz-Rode et al teaches the apparatus according to claim 1, wherein the axial element comprises an axial spring (e.g. Figure 3, Element 9 and Column 2 lines 49-57 discloses under compressed state elastic band (spring) 9 is under maximum tension and upon deployment the helix wire 8 takes shape).
Referring to Claim 5, Schmitz-Rode et al teaches the apparatus according to claim 1, wherein the curved elongate element comprises a helical elongate element (e.g. Figure 3, Element 8).
Referring to Claim 6, Schmitz-Rode et al teaches the apparatus according to claim 5, wherein, when the impeller is disposed in a non- radially-constrained configuration, a pitch of the helical elongate element varies along a length of the helical elongate element (e.g. Figure 3).
Referring to Claims 7 and 16, Schmitz-Rode et al teaches the claimed apparatus, wherein the material comprises a film of material (e.g. Figure 3, Element 10).
Referring to Claims 8 and 17, Schmitz-Rode et al teaches the claimed apparatus, wherein the impeller is configured to be radially constrained by the curved elongate element and the axial element being axially elongated, and wherein in response to the axial elongation of the curved elongate element and the axial element, the film of material is configured to change shape without the film of material breaking (e.g. Column 2 lines 49-57).
Referring to Claim 12, Schmitz-Rode et al teaches an apparatus comprising: an impeller defining a proximal end and a distal end (e.g. Figure 3), the impeller comprising: at least one impeller blade comprising: at least one curved elongate element (e.g. Figure 3, Element 8); a spring extending from the proximal end to the distal end of the impeller (e.g. Figure 3, elastic band/spring 9), the spring defining a lumen therethrough (e.g. Figure 3 lumen for shaft 6); and material supported between the curved elongate element and the spring (e.g. Figure 3, Element 10).
Referring to Claim 13, Schmitz-Rode et al teaches the apparatus according to claim 12, wherein the spring, when disposed in a non-radially- constrained configuration thereof, is configured such that there are substantially no gaps between windings of the spring and adjacent windings thereto (e.g. Column 2, lines 49-57).
Referring to Claim 18, Schmitz-Rode et al teaches the apparatus according to claim 12, further comprising an axial shaft extending from the proximal end of the impeller to the distal end of the impeller via the lumen defined by the spring (e.g. Figure 3, Element 6).
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.
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.
Claim(s) 3, 9 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmitz-Rode et al (US Patent 6,533,716) in view of Nunez (US Patent 8,690,749).
Referring to Claims 3 and 14, Schmitz-Rode et al teaches the claimed apparatus, except wherein the impeller comprises a plurality of blades each of which comprises a respective curved elongate element and the material supported between the curved elongate element and the axial element. Nunez teaches that it is known to use a plurality of blades each of which comprises a respective curved elongate element and the material supported between the curved elongate element and the axial element as set forth in Figure 1 blades 5 to provide enhanced pumping efficiency and flow uniformity. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Schmitz-Rode et al, with the impeller comprises a plurality of blades each of which comprises a respective curved elongate element and the material supported between the curved elongate element and the axial element as taught by Nunez, since such a modification would provide the predictable results of enhance pumping efficiency and flow uniformity.
In addition, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to use a plurality of blades, since it has been held by the courts making an integral structure separable (e.g. in a plurality of pieces), if so is desired, would require only ordinary skill. In re Dulberg, 129 USPQ 348, 349 (CCPA 1961). See MPEP 2145.04(V)(C).
In addition, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use a plurality of blades since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. See MPEP 2145.04(VI)(B).
Referring to Claims 9 and 15, Schmitz-Rode et al teaches the claimed apparatus, further comprising: a tube configured to traverse an aortic valve of a subject (e.g. Figure 1, tube 1), such that a proximal end of the tube is disposed within an aorta of the subject and a distal end of the tube is disposed within a left ventricle of the subject (e.g. Figure 1), the tube comprising a blood-impermeable material (e.g. Column 2 lines 26-28); impeller is configured to rotate such as to pump blood from the left ventricle to the aorta (e.g. Figure 1). However, Schmitz-Rode et al does not disclose a frame disposed within at least a portion of the tube, wherein the impeller is disposed inside the frame and is configured to rotate such as to pump blood from the left ventricle to the aorta.
Nunez teaches that it is known to use a tube (e.g. Column 3 lines 31-33 and Column 5, lines 37-47 and Figures 5 and 9) with a frame disposed within at least a portion of the tube (e.g. Figures 9-12 outer stent body composed of 45, 47, 49, and 51 or Figure 19A and 19b, sheath 105); an impeller disposed inside the frame (e.g. Column 5 lines 37-56) and the impeller being configured to rotate such as to pump blood from the left ventricle to the aorta via the elongate tube as set forth in Figure 11, impeller 5 with rotatable member 17 and Column 5 lines 37-50) to provide a structure to improve mechanical support and stability which assists with consistent blood flow. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Schmitz-Rode et al, with a tube with a frame disposed within at least a portion of the tube; an impeller disposed inside the frame and the impeller being configured to rotate such as to pump blood from the left ventricle to the aorta via the elongate tube as taught by Nunez, since such a modification would provide the predictable results of improving mechanical support and stability which assists with consistent blood flow.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmitz-Rode et al (US Patent 6,533,716) in view of Nunez (US Patent 8,690,749), as applied above, ad further in view of Siess (US Publication 2008/0103591).
Referring to Claims 10-11, Schmitz-Rode et al teaches the apparatus according to claim 9, except wherein the impeller is configured such that, when the impeller and the tube are deployed within the subject, a gap between an outer edge of the impeller and an inner surface of the tube is less than 1 mm; wherein the impeller is configured to be stabilized with respect to the tube, such that, during rotation of the impeller, a gap between the outer edge of the impeller and the inner surface of the tube is maintained.
Siess teaches that it is known to use a deflection channel 42 is defined through which the blood can flow, while the small distance of approximately 0.1 mm between the front supporting wall 44 and the envelope 24 allows only a comparably small amount of blood to flow as set forth
in Paragraph [0032] and Figure 1 to provide prevention of an undesirable return flow of blood. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Schmitz-Rode et al, with the gap is approximately 0.1 mm as taught by Siess, since such a modification would provide the predictable results of prevention of an undesirable return flow of blood and provide sufficient space to allow the impeller to properly spin while maximizing flow. In addition, it would have been an obvious matter of design choice to a person of
ordinary skill in the art to modify the system as taught by Nunez with the gap is less than 1 mm, because Applicant has not disclosed that the gap size of less than 1 mm provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with air gap as taught by Schmitz-Rode et al, because it provides a distance between the impeller and the tube allowing the impeller to rotate and since it appears to be an arbitrary design consideration which
fails to patentably distinguish over Nunez.
Therefore, it would have been an obvious matter of design choice to modify Nunez to obtain the invention as specified in the claim(s).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Evans (US Publication 2013/0303831) discloses an impeller with a helical curved elongate element (506) and material between the axial element (catheter 508) and 506, see Figures 5C-5E.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796
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