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
Applicant’s election without traverse of species 1a (bent catheter), species 2a (bent housing), subspecies 2 (housing and catheter are bent at a different angle), species 3b (inflow and outflow regions of the catheter are positioned farther apart), species 4b (the reinforcement region of figures 5a-b), and species 5a (the sleeve of figures 8-11) in the reply filed on 10/10/25 is acknowledged.
Claims 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/10/25.
Claim Objections
Claims 2, 6-11 are objected to because of the following informalities:
Claims 2 and 9 are objected to for referring to “a point within the distal bearing” with improper antecedent basis.
Claim 6 is objected to for referring to “the restriction element” with improper antecedent basis.
Claim 7 is objected to for referring to “a point within the proximal bearing with improper antecedent basis.
The claim is further objected to for referring to “the restriction element” with improper antecedent basis.
Claim 8 is objected to for referring to “a point within the restriction element” and “a point within the distal bearing” with improper antecedent basis.
Claim 9 is objected to for referring to “the restriction element” and “a point within the distal bearing” with improper antecedent basis.
Claims 10-11 is objected to for referring to “a point within the proximal bearing” and “a point within the distal bearing” with improper antecedent basis.
Appropriate correction is required.
Drawings
The drawings are objected to because item “3” and “H” are both used to represent the patient’s heart, and item “2” and “V” are both used to represent ventricle.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the bend angle of the tubing and catheter being different, the bend angle of the tubing being 30°+-10° and the bend angle of the catheter being 45° +- 10° must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 6, 8, 12, 28 are 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 pre-AIA the applicant regards as the invention.
Claim 6 is indefinite for claiming the portion of reduced diameter extends from a point at or “substantially near” where the catheter is attached, when it is unclear how close the point needs to be to be “substantially near” the location of attachment. The specification does not explain or describe exactly how close this must be in order to anticipate the claim, meaning the boundaries of the claim are unclear.
Claims 12 and 28 are indefinite for referring to “Ultra-Stiff Nitinol” when it is unclear what this material is and how it differs from Nitinol.
Remaining claims are rejected for depending on a rejected claim.
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 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.
Claim(s) 1-4, 13, 28, 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Skrzypczak et al. (US 20230052997 A1) hereinafter known as Skrzypczak.
Regarding claims 1 and 35 Skrzypczak discloses an intravascular blood pump (Abstract) comprising:
a catheter (5),
a housing (11) in which a rotor is housed (10), the housing being attached to a distal end of the catheter (Figure 1); and
a drive shaft (12) extending through the catheter and connected to the rotor (Figure 2), at least a portion of the drive shaft being flexible (Abstract), the shaft comprising an outer layer of wound/braided wires (Figure 9a item 28), an inner layer of wound/braided wires (Figure 9a item 29), and a reinforcement element arranged within the outer layer of wires (Figure 12b item 35),
wherein the drive shaft is rotatably supported (Abstract) in a proximal bearing (13) located proximal of the rotor (Figure 12b) and a distal bearing located distal of the rotor ([0038]), and
wherein the reinforcement element extends from at least a point within the proximal bearing to a point within the distal bearing ([0014]).
Regarding claim 2 Skrzypczak discloses the pump of claim 1 substantially as is claimed,
wherein Skrzypczak further discloses the reinforcement element extends from a point proximal to the proximal bearing to a point within the distal bearing ([0014]; with reference to [0038] for the location of the distal bearing).
Regarding claim 3 Skrzypczak discloses the pump of claim 1 substantially as is claimed,
wherein Skrzypczak further discloses the proximal bearing comprises a bearing sleeve (30) attached to the drive shaft ([0114]), and an outer bearing ring (32) attached to the housing ([0116]), the bearing sleeve being configured to rotate within the outer bearing ring (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Skrzypczak discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0016] the sleeve 30 and ring 32 form a radial bearing.).
Regarding claim 4 Skrzypczak discloses the pump of claim 3 substantially as is claimed,
wherein Skrzypczak further discloses a restriction element (33) attached to the housing and located proximal of the proximal bearing (Figure 12b) configured to prevent the bearing sleeve from becoming dislodged from the outer bearing ring (This is likewise stated as a functional limitation (see the explanation above). See also [0212]).
Regarding claim 13 Skrzypczak discloses the pump of claim 1 substantially as is claimed,
wherein Skrzypczak further discloses the housing comprises a cage ([0087]) including a plurality of struts (Figure 12b shows the housing 11 made of struts) surrounding the rotor.
Regarding claim 28 Skrzypczak discloses the pump of claim 1 substantially as is claimed,
wherein Skrzypczak further discloses the housing comprises nitinol ([0040], [0087]).
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skrzypczak as is applied above in view of Seiss et al. (US 20220134085 A1) hereinafter known as Seiss.
Regarding claim 12 Skrzypczak discloses the pump of claim 1 substantially as is claimed,
but is silent with regards to the reinforcement comprising nitinol.
However, regarding claim 12 Skrzypczak teaches the reinforcement element can comprise stainless steel or a metal wire ([0014]), and Seiss teaches nitinol and stainless steel are obvious alternatives in the art ([0057]). Skrzypczak and Seiss are involved in the same field of endeavor, namely catheter blood pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was field to modify the pump of Skrzypczak by having the reinforcement element comprise nitinol as is taught by Seiss since the two materials are considered obvious substitutes for one another in the art.
Claim 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skrzypczak as is applied above in view of Higgins (US 20200030511 A1).
Regarding claim 30 Skrzypczak discloses the pump of claim 1 substantially as is claimed,
wherein Skrzypczak further discloses a downstream tubing (Figure 2 item 20) attached to the housing ([0084]; Figure 2) and through which the catheter is disposed (Figure 2)
but is silent with regards to the downstream tubing being bent.
However, regarding claim 30 Higgins teaches tubing of a pump can be bent (Figure 3 item 14). Skrzypczak and Higgins are involved in the same field of endeavor, namely blood pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pump of Skrzypczak so the tubing is bent as is taught by Higgins in order to help position the pump at a desired location within the heart while accommodating the natural curvatures within the vasculature.
Regarding claim 31 the Skrzypczak Higgins Combination teaches the pump of claim 30 substantially as is claimed,
wherein Skrzypczak further discloses the downstream tubing is made of a flexible material ([0084]) such that it may be compressed/expanded (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Skrzypczak was considered capable of performing the cited intended use. See, for example [0084].).
Regarding claim 32 the Skrzypczak Higgins Combination teaches the pump of claim 31 substantially as is claimed,
wherein the Combination further teaches a bend angle of the tubing is different than a bend angle of the catheter (see at least Skrzypczak Figure 1, along with Higgins Figure 3. In Combination, it is seen that the tubing has a bend angle (seen in Higgins Figure 3, and the catheter has a bend angle, for example, around the aortic arch (Skrzypczak Figure 1) which is different).
Regarding claim 33 the Skrzypczak Higgins Combination teaches the pump of claim 32 substantially as is claimed,
but is silent with regards to the bend angle of the tubing being 30°+-10° and the bend angle of the catheter being 45° +- 10°.
However, regarding claim 33 Higgins teaches the bend angle of the tubing is 45 degrees ([0013] 135 degrees (180-135=45 degrees). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 (I). In this case, 40° (30°+10°) is considered to be close to 45 degrees.
Further, regarding claim 33 Skrzypczak shows their catheter (Figure 1 item 5) which includes a variety of bend angles. As is annotated in the figure below, at least the shown angle of the catheter 5 is seen to be about 45 degrees (and within 45° +- 10°). While the figures of Skrzypczak are not understood to be drawn to-scale, they are also not considered to be wholly inaccurate. The person of ordinary skill in the art would accordingly view Figure 1 of Skrzypczak and view the bend angle shown to be 45° +- 10°, since this is what is depicted.
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Allowable Subject Matter
Claims 5-11 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 5 is not rejected with prior art, since while prior art teaches shafts, lines, and/or reinforcing layers within catheters can be stepped (Lobbins et al. (US 20070250039 A1), [0045]; O’Connell et al. (CN 102970945 A) [0056]; Gianotti et al. (WO 2012037510 A1) page 23 lines 19-27; Chow et al. (US 20090157162 A1) [0123]), none of the prior art teaches a proximal end of a reinforcement element that is arranged in an outer layer of braided or wound wires within a drive shaft, to be stepped so that a proximal end has a reduced diameter, as well as a portion of increased diameter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 11/06/25