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 I (Claim 1-7, 10-13) in the reply filed on 4/30/26 is acknowledged.
Specification
The disclosure is objected to because of the following informalities: reference character “104” has been used to designate both “shrink elements 104” and “tubular member 104”.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “104” has been used to designate both “shrink elements 104”/fig. 10; and, “tubular member 104”/fig. 9 and 11. 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. 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.
Claim 2-7 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 phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Likewise in claim 2, the recitations of “preferably” also render the claim indefinite, because they do not clearly define the metes and bounds of the claim. For the above reasons the claim does not clearly define the metes and bounds of the claim and is indefinite. The claims depending from this claim share this issue and are likewise rejected.
Claim 2 contains the trademark/trade name “EpoTek”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe chemical compound and, accordingly, the identification/description is indefinite. The claims depending from this claim share this issue and are likewise rejected.
Claim 3 recites the term “film like portion” which is a relative term which renders the claim indefinite. The term “film like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What makes something “film like” is it being made of some sort of polymer? Or is it stretchiness? Etc. Turning to the specification it never recites a material for the “film like portion” either to clear this up, it just repeats “film like” while for nearly every other element the specification recites examples for materials (for example: potting materials in [0006] (using Pg Pub for paragraph numbers), “posts 70, the backplate 76 and the backbone 80 are composed of a soft magnetic material, such as electrical steel or a suitable alloy,” in [0054], “spacer 82, the frontplate 86 and the frontsheet 88 are made of a thermoplastic material, like polyetheretherketone (PEEK).” in [0058] etc.). As there are no examples recited for “film like” to breathe life into the claims and which can serve as a standard for ascertaining the requisite degree, the claim element does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims depending from this claim share this issue and are likewise rejected.
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.
Claim(s) 1-3, 5-6, 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200330666 to Siess et al. (hereinafter Siess).
Regarding Claim 1, an interpretation of Siess discloses a blood pump, in particular an intravascular blood pump (Abstract, which teaches “An intravascular blood pump (1)”), comprising:
a pump housing having a blood flow inlet and a blood flow outlet connected by a passage ([0068] including “The blood pump 1 comprises a pump casing 2 with a blood flow inlet 21 and a blood flow outlet 22 … The blood flow inlet 21 is at the end of a flexible cannula 23 which may be placed through a heart valve, such as the aortic valve, during use. The blood flow outlet 22 is located in a side surface of the pump casing 2 and may be placed in a heart vessel, such as the aorta,”, [0070] including “The blood is conveyed along a passage 24 connecting the blood flow inlet 21 and the blood flow outlet 22”),
an impeller disposed in said pump housing ([0070] including “An impeller 3 is provided for conveying blood along the passage 24”), and
a drive unit configured to drive the impeller ([0070] including “Rotation of the impeller 3 is caused by a drive unit 4”), wherein the drive unit comprises a stator ([0082] including “a gap 65 is provided between the drive unit 4 (i.e. the stator)”),
the pump housing comprises a drive unit casing with a catheter attachment portion at one axial end (25 Figure 1, catheter 25, [0068] including “blood pump 1 is connected to the catheter 25”) and an impeller supporting portion at the other axial end ([0039], [0070], Figs. 2a-b, 12; opposite side of the drive unit around the first bearing and pin),
wherein the stator is disposed within the drive unit casing ([0082]-[0083] including “the drive unit 4 (i.e. the stator)”, Figs. 7-8), and
wherein the drive unit casing is at least partially filled with a potting material ([0038] including “The coil windings may be embedded in a thermally conductive matrix, which is electrically non-conductive (i.e. electrically insulting) … the matrix may comprise an epoxy resin with aluminum additives,” [0071] including “FIG. 2a illustrates in more detail the interior of the blood pump 1, in particular the impeller 3 and the drive unit 4 … Coil windings are arranged about the shaft portions 41 of the posts 40”).
Regarding Claim 2, an interpretation of Siess further discloses wherein the potting material contacts the impeller supporting portion ([0038] including “The coil windings may be embedded in a thermally conductive matrix . . . For instance, the matrix may comprise an epoxy resin with aluminum additives.”, [0077] including “In FIG. 7 the same arrangement is illustrated including coil windings 47 about the posts 40”, Figs. 2A-B, 7),
wherein the potting material preferably comprises an epoxy resin ([0038] including “The coil windings may be embedded in a thermally conductive matrix . . . For instance, the matrix may comprise an epoxy resin with aluminum additives.”, Figs. 2A-B, 7).
Regarding Claim 3, an interpretation of Siess further discloses wherein the impeller supporting portion comprises a film-like portion ([0039], [0070], [0077], Figs. 2a-b, 8, 12) and a protruding pin ([0039], [0070] including “pin 15”, [0078]-[0079], Figs. 2A-B, 7-9), wherein the protruding pin is configured to rotatably support the impeller ([0039], [0070] including “pin 15”, [0078]-[0079], Figs. 2A-B, 7-9).
Regarding Claim 5, an interpretation of Siess further discloses wherein the protruding pin is integrally formed with the film-like portion ([0039], [0070] including “pin 15”, [0078]-[0079], Figs. 2A-B, 7-9).
Regarding Claim 6, an interpretation of Siess further discloses wherein the center axis of the protruding pin is concentric with an axis of rotation (X) of the impeller ([0039], [0070]-[0071], Figs. 2a-b, 10b, 12).
Regarding Claim 10 an interpretation of Siess further discloses wherein
the impeller has at least one primary blade configured to establish a primary blood flow ([0070], Fig. 2a-b, 12) and wherein the impeller has a casing-side end ([0031], [0040], [0070], Fig. 2a-b, 12),
wherein the casing-side end points to the drive unit casing ([0031], [0040], [0070]-[0071], [0073], Fig. 2a-b, 12), and
wherein a plurality of secondary blades ([0040]-[0041]) are provided on the casing-side end configured to establish a secondary blood flow ([0040]-[0041] including “secondary blades may be provided on the side of the magnet or magnets that faces the drive unit, i.e. in the gap between the impeller and the drive unit.”).
Claim Rejections - 35 USC § 102/103
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Siess or, in the alternative, under 35 U.S.C. 103 as obvious over Siess.
Regarding Claim 7, an interpretation of Siess further discloses wherein a rounded transition portion is provided between the film-like portion and the protruding pin ([0026]-[0027] including “Alternatively, the inclined surfaces may face radially inwards to form a concave shape.”).
It would have been an obvious matter of design choice to make the portion of the drive unit housing facing the impeller of Siess of whatever form or shape was desired or expedient (rounded). A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim Rejections - 35 USC § 103
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siess in view of US 20190001034 to Taskin et al.
Regarding Claim 11, an interpretation of Siess further disclose wherein the impeller has an axis of rotation ([0039], [0070]-[0071], Figs. 2a-b, 10b, 12) and wherein each of the secondary blades extends relative to the axis of rotation ([0039]-[0040], [0070]-[0071], Figs. 2a-b, 12).
an interpretation of Siess may not explicitly disclose recite the secondary blades extend non-radially.
However, in the same field of endeavor (medical devices), Taskin teaches secondary blades extend non radially ([0053]-[0055] including “the blades 145 and fluid channels between the blades have arcuate shape”, Figs. 3-4B).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pump device of Siess with its second blades to include secondary blades extending in a arcuate shape for circulating the downstream blood as recited by Taskin because this stops blood from gathering in a low flow area and solidifying ([0010]-[0011], [0053]).
Regarding Claim 12, an interpretation of Siess may not explicitly disclose wherein each of the secondary blades has a base point and an end point wherein the base points are located on a base circle and wherein the end points are located on an end circle, wherein the base circle and the end circle are concentric with a common center point, and wherein a straight line connecting the base point and the end point of any one of the secondary blades is not running through the common center point.
However, in the same field of endeavor (medical devices), Taskin teaches wherein each of the secondary blades has a base point and an end point ([0053]-[0055] including “the blades 145 and fluid channels between the blades have arcuate shape”, Figs. 3-4B),
wherein the base points are located on a base circle and wherein the end points are located on an end circle ([0053]-[0055], Figs. 3-4B; look at Fig. 4a, base point is either inner or outer side of curved blades, with the end point being the opposite of what is determined for base point. The curved blades are aligned where a circle on the inner side could be drawn touching the blades respective inner ends (essentially expand the diameter of 146 in fig. 4a a little bit)),
wherein the base circle and the end circle are concentric with a common center point ([0053]-[0055], Figs. 3-4B; look at Fig. 4a), and
wherein a straight line connecting the base point and the end point of any one of the secondary blades is not running through the common center point ([0053]-[0055], Figs. 3-4B; look at Fig. 4a).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pump device of Siess with its second blades to include secondary blades extending in a arcuate shape for circulating the downstream blood as recited by Taskin because this stops blood from gathering in a low flow area and solidifying ([0010]-[0011], [0053]).
Regarding Claim 13, an interpretation of Siess may not explicitly disclose each of the plurality of secondary blades is curved relative to the respective straight line.
However, in the same field of endeavor (medical devices), Taskin teaches each of the plurality of secondary blades is curved relative to the respective straight line ([0053]-[0055], Figs. 3-4B; look at Fig. 4a).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pump device of Siess with its second blades to include secondary blades extending in a arcuate shape for circulating the downstream blood as recited by Taskin because this stops blood from gathering in a low flow area and solidifying ([0010]-[0011], [0053]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20150051436 see [0021], Fig. 3; recites a low resistance and micrometer thick element which could be a coating on the drive unit
US 20180228953 (cited in IDS dated 7/23/24) see secondary blades [0032], [0099], [0100], figs. 19-22
US 20140030122 see Figs. 2
US 20170157309 (cited in IDS dated 7/23/24) see Fig. 2
EP 3711787 see Fig. 2
US 20210015981 see Fig. 3
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R MOSS whose telephone number is (571)272-3506. The examiner can normally be reached Monday - Friday (9:30 am - 5:30 pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James Moss/Examiner, Art Unit 3792
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