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 .
Election/Restrictions
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species A-H, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on 16 December 2025 of Species I (Fig.12 of the Drawings), which are readable on Claims 1-11.
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 2 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.
Regarding Claim 2, the claim recites “wherein the inflatable portion comprises an oblong torus when inflated, and wherein the web portion is within the oblong torus”. However, it is unclear within Fig. 12 of the Drawings (as elected by the Applicant in the reply filed 16 December 2025) which section is considered an ‘oblong torus’. From the Specification/Drawings, it appears that this was intended to be a cross-sectional shape. For purposes of examination, the Examiner is interpreting this limitation as “wherein the inflatable portion comprises an oblong torus shape within a cross-sectional portion, when inflated, and wherein the web portion is within the oblong torus shape within the cross-sectional portion.” 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 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans (US Publication No. 2013/0303831).
Regarding Claim 7, Evans discloses a medical pump (Paragraph 0006, 0066, 0073-0076; Abstract) comprising:
an elongate drive shaft (408/406, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7) defining a lumen (central lumen can be seen in Figs. 4B, 5B, 5E, 7B; hollow center, Paragraph 0159, 0174);
and an impeller (400, Figs. 4A-B; 500, Figs. 5A-E and 6; Paragraph 0091, 0095-0098, 0105-0108) attached to a distal end portion of the drive shaft (408/406, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7) and comprising:
a first inflatable blade member (blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123; multiple blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174, 0190) extending spirally (see spiral shapes of blade members 502, Figs. 4-6; Paragraph 0095-0100) between a proximal end and a distal end of the first inflatable blade member, wherein the proximal and distal ends of the first inflatable blade member (blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123; multiple blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174, 0190) are each attached to the distal end portion of the drive shaft (attached at distal end portion of drive shaft, 408/406/16, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7);
a second inflatable blade member (blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123; multiple blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174, 0190) extending spirally (see spiral shapes of blade members 502, Figs. 4-6; Paragraph 0095-0100) between a proximal end and a distal end of the second inflatable blade member, wherein the proximal end distal ends of the second inflatable blade member (blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123; multiple blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174, 0190) are each attached to the distal end portion of the drive shaft (attached at distal end portion of drive shaft, 408/406/416, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7);
a first noninflatable web portion (flexible web material attached to blade portions and distal end portion of shaft, see web/material sections 402, Figs. 4A-B; 504, Figs. 5-6, Paragraph 0073, 0078, 0083, 0087, 0089-0091, 0104-0108, 0123-0125) attached to the first inflatable blade member and to the distal end portion of the drive shaft;
and a second noninflatable web portion (flexible web material attached to blade portions and distal end portion of shaft, see web/material sections 402, Figs. 4A-B; 504, Figs. 5-6, Paragraph 0073, 0078, 0083, 0087, 0089-0091, 0104-0108, 0123-0125) attached to the second inflatable blade member and to the distal end portion of the drive shaft.
Regarding Claim 8, Evans discloses a medical pump (Paragraph 0006, 0066, 0073-0076; Abstract) further wherein the impeller further comprises: a third inflatable blade member (multiple blades, such as 2-4 blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174; see blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123) extending spirally (see spiral shapes of blade members 502, Figs. 4-6; Paragraph 0095-0100) between a proximal end and a distal end of the third inflatable blade member, wherein the proximal end distal ends of the third inflatable blade member (blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123; multiple blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174) are each attached to the distal end portion of the drive shaft (attached at distal end portion of drive shaft, 408/406/416, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7); and a third noninflatable web portion (flexible web material attached to blade portions and distal end portion of shaft, see web/material sections 402, Figs. 4A-B; 504, Figs. 5-6, Paragraph 0073, 0078, 0083, 0087, 0089-0091, 0104-0108, 0123-0125) attached to the third inflatable blade member and to the distal end portion of the drive shaft.
Regarding Claim 9, Evans discloses a medical pump (Paragraph 0006, 0066, 0073-0076; Abstract) further wherein the impeller is reconfigurable between a deflated low-profile delivery configuration and an inflated operable configuration that is radially expanded in comparison to the low-profile delivery configuration (deflated, low-profile configuration for implantation, and expanded configuration for blood flow/pumping after deployment, Paragraphs 0066-0070, 0076-0077, 0087-0090, 0094, 0105-106, 0110, 0174, 0190).
Regarding Claims 10 and 11, Evans discloses a medical pump (Paragraph 0006, 0066, 0073-0076; Abstract) further wherein, when the impeller is in the inflated operable configuration (expanded configuration for blood flow/pumping after deployment, Paragraphs 0066-0070, 0076-0077, 0087-0090, 0094, 0105-106, 0110, 0174, 0190), the first and second impeller blades each spiral around (see spiral shapes of blade members 502, Figs. 4-7; Paragraph 0095-0100) the distal end portion of the drive shaft by at least 120° or by at least 180° (blades 502 spiral around drive shaft by at least 180 degrees, see Figs. 4-6; blade angles, see Paragraph 0098-0105).
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Evans (US Publication No. 2013/0303831) in view of McBride et al. (US Publication No. 2013/0066140).
Regarding Claim 1, Evans discloses a medical pump (Paragraph 0006, 0066, 0073-0076; Abstract) comprising an elongate drive shaft (408/406, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7) defining a lumen (central lumen can be seen in Figs. 4B, 5B, 5E, 7B; hollow center, Paragraph 0159, 0174) and an impeller (400, Figs. 4A-B; 500, Figs. 5A-E and 6; Paragraph 0091, 0095-0098, 0105-0108) attached to a distal end of the drive shaft (408/406/416, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7) and comprising: an inflatable portion (inflatable/expandable, Paragraph 0077, 0087, 0174, 0190) and a noninflatable web portion (flexible web, 402, Figs. 4A-B; 504, Figs. 5-6, Paragraph 0073, 0078, 0083, 0087, 0089-0091, 0104-0108, 0123-0125) attached to the inflatable portion (Paragraph 0077, 0087, 0174).
Although Evans discloses that the impeller has inflatable portions and noninflatable web portions that are attached to one another (Paragraph 0073, 0078, 0083, 0087, 0089-0091, 0104-0108, 0123-0125), and that the inflatable portions may be inflated with a fluid using conduits (Paragraph 0077, 0174, 0190), Evans does not explicitly disclose wherein the inflatable portion is fluidly coupled to the lumen; and that the noninflatable web portion is peripherally surrounded by the inflatable portion.
McBride et al. teaches a medical pump (Abstract; Paragraph 0006) comprising an elongate drive shaft (630, Fig. 15A; Paragraph 0137, 0152-0154) defining a lumen (internal lumen 670, Fig. 23A; Paragraph 0137), and an impeller (605, Figs. 15A, 23A-C; Paragraph 0137-0138, 0148, 0155) comprising an inflatable portion which is fluidly coupled to the lumen (liquid/gas infused through lumen of shaft to inflate impeller 605, Paragraph 0174); and a noninflatable material portion is peripherally surrounded by the inflatable portion (flexible material portion surrounds inflated portion as impeller remains inflated, Paragraph 0059, 0086-0093, 0174; see Fig. 15A, 23A).
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 medical pump disclosed by Evans to have the inflatable portion be fluidly coupled to the lumen; and the noninflatable web portion be peripherally surrounded by the inflatable portion, as taught by McBride et al., in order to allow for the expansion of the impeller with the attached web portions to form a spiral surface to allow for fluid/blood flow by the impeller, as taught by both Evans (Paragraph 0006, 0066, 0073-0076; Abstract) and McBride et al. (Abstract; Paragraph 0006). Furthermore, this this would merely require rearranging the lumen/web portion in the medical pump, 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 Claim 2, Evans discloses a medical pump (Paragraph 0006, 0066, 0073-0076; Abstract) further wherein the a cross section of the inflatable portion comprises a variety of shapes when expanded/inflated (see 400, Figs. 4A-B; 500, Figs. 5A-E and 6; Paragraph 0077, 0174, 0190), including sections which may be considered an oblong torus shape (e.g., see Figs. 4A, 4B, 5A, 5B, 5C, 6), wherein the noninflatable web portion (flexible web, 402, Figs. 4A-B; 504, Figs. 5-6, Paragraph 0073, 0078, 0083, 0087, 0089-0091, 0104-0108, 0123-0125) is within the cross section. See 35 USC 112(b) rejection made above, as interpreted by the Examiner. Although Evans does not explicitly disclose wherein the inflatable portion comprises an oblong torus when inflated, 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 inflatable portion to comprise an oblong torus when inflated, since such a modification would have involved a mere change in the form or shape of a component (e.g. the inflatable portion). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding Claim 3, Evans discloses a medical pump (Paragraph 0006, 0066, 0073-0076; Abstract) further wherein the inflatable portion comprises a first inflatable blade member (blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123; multiple blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174) extending from the distal end of the drive shaft (408/406, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7) and a second inflatable blade member (blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123; multiple blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174) extending from the distal end of the drive shaft (408/406, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7), and wherein distal end portions of the first and second inflatable blade members are conjoined at a distal end of the inflatable portion (distal ends of blades 502 are conjoined at a distal end, see Figs. 4A, 5A, 5B, 6, 7; Paragraph 0095, 0097, 0123).
Regarding Claim 4, Evans discloses a medical pump (Paragraph 0006, 0066, 0073-0076; Abstract) further wherein the first and second inflatable blade members (blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123; multiple blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174) extend along spiral paths from the distal end of the drive shaft (408/406, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7) to the distal end of the inflatable portion (see spiral shapes of blade members 502, Figs. 4-7; Paragraph 0095-0100).
Regarding Claims 5 and 6, Evans discloses a medical pump (Paragraph 0006, 0066, 0073-0076; Abstract) further wherein the inflatable portion comprises three or more inflatable blade members (multiple blades, such as 2-4 blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174; see blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123) that each extend from the distal end of the drive shaft (408/406, Figs. 4A-B; 508/518, Figs. 5A-E; 610/612, Figs. 6-7) and that conjoin at a distal end of the inflatable portion (distal ends of blades 502 are conjoined at a distal end, see Figs. 4A, 5A, 5B, 6, 7; Paragraph 0095, 0097, 0123), wherein the three or more inflatable blade members (multiple blades, such as 2-4 blades, Paragraph 0187; inflatable/expandable, Paragraph 0077, 0087, 0174; see blades, 502, Figs. 5-6; Paragraph 0087, 0090, 0094, 0095, 0107, 0123) extend along spiral paths from the distal end of the drive shaft to the distal end of the inflatable portion (see spiral shapes of blade members 502, Figs. 4-7; Paragraph 0095-0100).
Conclusion
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 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796