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 . Claims 1-19 are pending and examined below.
Response to Arguments
Applicant's arguments filed on 07/28/2025 have been fully considered but they are not persuasive. The applicant argues, on pages 6-7, Siess et al does not teach or disclose wherein the inlet conduit extends between a distal end of the proximal body portion and a proximal end of the proximal body portion; however the examiner respectfully disagrees; Siess et al discloses the inlet conduit in annotated fig. 2a below, also see 35 USC § 102 below. In addition, Siess et al discloses wherein the inlet conduit has a first inner diameter at the distal end that is less than a second inner diameter at the proximal end (annotated fig. 2a below), also see 35 USC § 102 below.
In addition, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the soft tip being part of the blood inlet, on page 6) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
(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.
Claims 1-14, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siess et al (US 2019/0046702 A1).
Regarding claim 1, Siess et al discloses a heart pump assembly comprising (abstract): a motor housing (Fig. 1: pump section (2), paragraph 0036), the motor housing including an impeller (paragraph 0036) and a motor therewithin (the blood pump is driven by a motor included in the blood pump, paragraph 0002); a cannula connected to the motor housing (Fig. 1: flow cannula (3), paragraph 0036); and a blood inlet connected to the cannula (Fig. 1: end portion (EP), paragraphs 0036-0037), the blood inlet having a distal body portion (see annotated fig. 2a below), a proximal body portion (see annotated fig. 2a below), and a plurality of cage openings separated by struts, wherein the cage openings are defined and positioned between the distal and proximal body portions (Fig. 2A: blood flow-through openings (16), paragraph 0037; also see annotated fig. 2a below), the proximal body portion defines an inlet conduit therewithin (Fig. 2A: sleeve (4), paragraph 0038), wherein the inlet conduit has one of a tapered portion (paragraph 0038), a frustrum-shaped portion, or both a tapered portion and a frustrum-shaped portion, adapted to reduce flow turbulence at the blood inlet and increase the blood flow into the heart pump assembly (the funnel shape of the sleeve can increase the blood flow rate, paragraph 0038; in addition also see MPEP 2111.04), wherein the inlet conduit extends between a distal end of the proximal body portion and a proximal end of the proximal body portion (annotated fig. 2a below shows the inlet conduit between the distal body portion and the proximal body portion), and wherein the inlet conduit has a first inner diameter at the distal end that is less than a second inner diameter at the proximal end (Fig. 2A: a first end includes an enlarged diameter compared to a second end of the inlet conduit, paragraph 0036).
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Regarding claim 2, Siess et al discloses the heart pump assembly of claim 1, further comprising an atraumatic tip extending from the distal body portion of the blood inlet for stabilizing the heart pump assembly, when placed in a patient's heart (Fig. 1: soft tip (20), paragraph 0036; also see MPEP 2114(II)).
Regarding claim 3, Siess et al discloses the heart pump assembly of claim 1, wherein each of a plurality of blood exhaust outlets are located adjacent to or on the motor housing for blood to exit the heart pump assembly (Fig. 1: blood flow outlets (12), paragraph 0036).
Regarding claim 4, Siess et al discloses the heart pump assembly of claim 2, wherein the distal body portion of the blood inlet includes a connector for connecting the atraumatic tip to the blood inlet (see annotated fig. 2c below).
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Regarding claims 5-6, Siess et al discloses the heart pump assembly of claim 1, wherein the inlet conduit of the proximal body portion of the blood inlet extends between a first open end of the proximal body portion and a second open end of the proximal body portion (see annotated fig. 2C-1 below; also see paragraphs 0038-0040).
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Regarding claim 7, Siess et al discloses the heart pump assembly of claim 1, wherein the plurality of cage openings is oriented radially around a circumference of the blood inlet with an evenly spaced distance between each of the plurality of cage openings (Fig. 2B: show the structs (17) are evenly spaced, also see paragraph 0037).
Regarding claim 8, Siess et al discloses the heart pump assembly of claim 1, wherein each of the plurality of cage openings has an associated height measured parallel to a longitudinal axis, a width measured transverse to the longitudinal axis, and an area (though not explicitly disclosed, the openings (16) would inherently have an associated height, width, and an area, see MPEP 2112; also see paragraph 0040 which discloses a bending to the struts (17), which would then change the shape of the openings (16)).
Regarding claim 9, Siess et al discloses the heart pump assembly of claim 1, wherein each of the plurality of cage openings are the same in height, width, and area (Fig. 2A-C: paragraph 0037).
Regarding claim 10, Siess et al discloses the heart pump assembly of claim 1, wherein each of the struts has flat distal and proximal edges and curved outer edges, forming a bowed shape that define each of the plurality of cage openings (Fig. 2A-C: shows the opening have a bowed shape, paragraph 0036-0037; in addition flat as described in Merriam-webster dictionary; “having a relatively smooth or even surface” though not explicitly disclosed, the distal and proximal edges as shown in Fig. 2C appear to have an even surface with no divots or bumps)
Regarding claim 11, Siess et al discloses the heart pump assembly of claim 10, wherein the distal edge and the proximal edge of each of the plurality of cage openings are bounded by a portion of the distal body portion and a portion of the proximal body portion of the blood inlet (Figs 1-2: paragraphs 0036-0037).
Regarding claim 12, Siess et al discloses the heart pump assembly of claim 11, wherein the blood inlet further includes a plurality of struts that are connected to the distal body portion and proximal body portion of the blood inlet (Fig. 2A: structs (17), paragraph 0037).
Regarding claim 13, Siess et al discloses the heart pump assembly of claim 12, wherein the outer edges of each of the plurality of cage openings are defined by the plurality of struts such that each of the plurality of cage openings is separated by the plurality of struts (Fig. 2A: the blood flow-through openings (16) are formed by a frame structure, such as a cage that includes struct (17), paragraph 0037).
Regarding claim 14, Siess et al discloses the heart pump assembly of claim 13, wherein each of the plurality of struts are outwardly bowed or curved to provide a smooth transition into a curve-shaped distal body portion of the blood inlet (Fig. 2C: the structs (17) are curved, also see paragraphs 0037 and 0040) and the tapered portion that is a tapered proximal body portion to reduce force that is absorbed when it is inserted into a patient's body (Fig. 2A: paragraphs 0036-0037; also see MPEP 2114(II)) .
Regarding claim 17, Siess et al discloses the heart pump assembly of claim 2, wherein the blood inlet, cannula, motor housing, and atraumatic tip are all connected and are all in fluid communication with each other (Fig. 1: shows the blood inlet, canula, motor hours, and atraumatic tip all connected to each other, also see paragraph 0036.
Regarding claim 18, Siess et al discloses the heart pump assembly of claim 1, wherein each of the plurality of cage openings are oblong, oval, square, tear-shaped or round (Fig. 2A: the openings are oval shaped, paragraph 0037).
Regarding claim 19, Siess et al discloses the heart pump assembly of claim 11, wherein the distal edge and the proximal edge of each cage opening are filleted (paragraph 0037; also product by process claims are not limited to the manipulations of the steps, only by the structure, see MPEP 2113)
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 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al (US 2019/0046702 A1), in view of Jarvik et al (US 2004/0191116 A1).
Regarding claim 15, Siess et al discloses the heart pump assembly of claim 1, however doesn’t specifically disclose wherein the blood inlet further includes a cutoff defined on an outer surface of the proximal body portion of the blood inlet.
Jarvik et al discloses a pressure transducer (94) on the outer surface of a proximal portion of the inlet (70), paragraph 0056).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the blood inlet taught by Siess et al with inlet having a pressure transducer taught by Jarvik et al in order to monitor the pressure within the heart for continues monitoring that can alert the user if the pressure drops, paragraph 0086.
Regarding claim 16, Siess et al discloses the heart pump assembly of claim 1, however doesn’t specifically disclose wherein a barb is defined on an outer surface of the proximal body portion of the blood inlet for providing a secure connection for the cannula to the blood inlet.
Jarvik et al discloses cylindrical mounting portions 20a and 20b with barbs (Fig. 2B), which are used connect the pump to the cannula (paragraphs 0044-0046).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the connection portions taught by Siess et al to include an inlet connection portion with barbs taught by Jarvik et al because courts have found prima facie obviousness where the modification requires combing prior art elements according to know method to yield predicable results (see MPEP 2143). Here, the predictable results are that the bards of the connection portion would provide additional internal forces on the cannula to provide a more secure connection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE H TREVINO III whose telephone number is (703)756-4678. The examiner can normally be reached Monday - Friday: 9-6 EST.
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, 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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/J.H.T./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774