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 .
Claim Objections
Claims 5 are objected to because of the following informalities:
Claim 5 is objected to for referring to ‘the nose” with improper antecedent basis.
Appropriate correction is required.
Drawings
Further, the claims are objected to for not depicting all the claimed features, including “a stop”, “a gap”.
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 9 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 9 is objected to for claiming that purge fluid is guided through the fluid line with “suitable” pressure, but it is unclear what Applicant might consider to be “suitable” to have the fluid exist between the static support member and the distal end of the rotor. The specification does not appear to elaborate on what Applicant believes to be “suitable pressure”, or even mention this sufficient pressure anywhere. Without an understanding of what this amount of pressure might be, the Examiner cannot determine the limits of the claim and what might be ‘suitable.
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) 1-2, 4-6, 10, 17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schumacher et al. (US 20160348688 A1) hereinafter known as Schumacher.
Regarding claims 1 and 17 Schumacher discloses an intravascular blood pump and method of using ([0003]) comprising:
a catheter (Figure 1 items 10/11), and
a pumping device which comprises:
a drive shaft (Figure 2 item 10),
a rotor (Figure 2 item 15) at a distal end of the drive shaft;
a housing in which the rotor is housed (Figure 2 item 3), and
a distal bearing (Figure 2 item 17) for rotatably supporting a distal end of the rotor (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 Schumacher 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 [0067]) which include a static support member (Figure 2 item 18) which protrudes into or is placed up against the distal end of the rotor (Figure 2; [0067]-[0068]).
Regarding claim 2 Schumacher discloses the pump of claim 1 substantially as is claimed,
wherein Schumacher further discloses the pump is expandable (Abstract) and
a cannula is provided around a drive shaft in a vicinity of the rotor (Figure 2 item 8),
wherein the housing and rotor are configured to be transferred at least in part into the cannula, where an expandable section of the housing and rotor can be compressed along a radial direction transverse to a longitudinal direction from an expanded state to a compressed state (Abstract; Figure 2; [0070]).
Regarding claim 4 Schumacher discloses the pump of claim 2 substantially as is claimed,
wherein Schumacher further discloses the static member is located at a distance from the rotor in the compressed state of the housing (this is considered inherent, since two items are inherently at some “distance” from one another if they are distinct items).
Regarding claim 5 Schumacher discloses the pump of claim 2 substantially as is claimed,
wherein Schumacher further discloses the rotor comprises a nose at the distal end there of (Figure 2 item 16),
and wherein when the housing is in its expanded state, the static support member (Figure 2 item 18) is placed up against the distal end of the rotor with the nose (Figure 2 item 16) protruding into the static support member (Figure 2).
Regarding claim 6 Schumacher discloses the pump of claim 1 substantially as is claimed,
wherein Schumacher further discloses the rotor (Figure 2 item 15) defines a stop for the support member (Figure 2 item 18) (Figure 2; [0067] if mounted directly the support 18 is inherently a stop for the rotor 15).
Regarding claim 10 Schumacher discloses the pump of claim 1 substantially as is claimed,
wherein Schumacher further discloses a distal end of the static member (Figure 2 item 18) is mounted at a distal end of the housing (Figure 2; “distal” is defined by Merriam-Webster as being “situated away from the point of attachment or origin or a central point especially of the body”, and “end” as “the part of an area that lies at the boundary”. The location where the static member 18 is connected to the housing 3 is considered a distal end since it is a boundary situated away from the point of attachment or origin).
Regarding claim 1 Schumacher discloses an intravascular blood pump ([0003]) comprising:
a catheter (Figure 1 items 10/11), and
a pumping device which comprises:
a drive shaft (Figure 2 item 10),
a rotor (Figure 2 item 15) at a distal end of the drive shaft;
a housing in which the rotor is housed (Figure 2 item 3), and
a distal bearing (Figure 2 item 17) for rotatably supporting a distal end of the rotor (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 Schumacher 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 [0067]) which include a static support member (Figure 2 item 16) which protrudes into or is placed up against the distal end of the rotor (Figure 2; [0067]).
Regarding claim 2 Schumacher discloses the pump of claim 1 substantially as is claimed,
wherein Schumacher further discloses the pump is expandable (Abstract) and
a cannula is provided around a drive shaft in a vicinity of the rotor (Figure 2 item 8),
wherein the housing and rotor are configured to be transferred at least in part into the cannula, where an expandable section of the housing and rotor can be compressed along a radial direction transverse to a longitudinal direction from an expanded state to a compressed state (Abstract; Figure 2; [0070]).
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.
Claims 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher as is applied above in view of Kerkhoffs et al. (EP 3542836 A1) hereinafter known as Kerkhoffs.
Regarding claim 7 Schumacher discloses the pump of claim 1 substantially as is claimed,
but is silent with regards to a fluid line being inside the distal end of the drive shaft configured to guide a purge fluid to the distal bearing.
However, regarding claim 7 Kerkhoffs teaches a fluid line (Figure 2 item 15) being inside the distal end of the drive shaft (Figure 2) configured to guide a purge fluid to the distal bearing (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 Kerkhoffs 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 [0029]). Schumacher and Kerkhoffs 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 Schumacher to have a fluid line in the drive shaft to deliver purge fluid as is taught by Kerkhoffs in order to keep the pump parts substantially free of blood, thus eliminating the possibility of clotting and blood cell injury during use.
Regarding claim 9 the Schumacher Kerkhoffs Combination teaches the pump of claim 7 substantially as is claimed,
wherein the Combination further teaches when the purge fluid is guided through the fluid line with suitable pressure, at least a portion of the fluid is capable of exiting between the static support member and the distal end of the rotor (in order for the purge fluid to work as intended, as is taught by Kerkhoffs [0029], the purge fluid, when used in the Combination, would obviously use suitable pressure to accommodate exiting the specific distal end geometry of Schumacher in order to function.).
Claim 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher as is applied above.
Regarding claim 3 Schumacher discloses the pump of claim 2 substantially as is claimed,
wherein Schumacher further discloses the static support member (Figure 2 item 16) is placed up against the distal end of the rotor in the expanded state of the housing (Figure 2),
but is silent with regards to the force the rotor is placed against the housing.
However, regarding claim 3 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 Schumacher so that the rotor is placed against the housing with any amount of force, including 1.8 N, as long as it is a force suitable for maintaining the rotor in place during use. It has been held by the courts that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. See MPEP 2144.05(II)(A).
Claims 11, 13, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher as is applied above in view of Jarvik et al. (US 5851174 A) hereinafter known as Jarvik.
Regarding claim 11 Schumacher discloses the pump of claim 2 substantially as is claimed,
wherein Schumacher further discloses the static support member (Figure 2 item 16) comprises a pin (Figure 2 item 16),
but is silent with regards to whether it extends into the distal end of the rotor.
However, regarding claim 11 Jarvik teaches a pin (Figure 2 item 48) can extend into a distal end of a rotor (Figure 2 item 58) within a heart pump. Schumacher and Jarvik are involved in the same field of endeavor, namely heart 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 Schumacher by having the pin 16 extend into the distal end of the rotor as is taught by Jarvik since this is a known connection between parts of pump, which would be obvious to try. The courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known connection between a pin and rotor would be obvious to try.
Regarding claim 13 the Schumacher Jarvik Combination teaches the pump of claim 11 substantially as is claimed,
but is silent with regards to the distance the pin protrudes into the distal end of the rotor during an operational state of the pump.
However, regarding claim 13 it would have been obvious to one of ordinary skill to have the pin protruding into the end of the rotor while operating in any range, including from 0.5-8mm as long as the pin and rotor are connected and the pin stays in place. It has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 (IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art.
Regarding claim 15 the Schumacher Jarvik Combination teaches the pump of claim 11 substantially as is claimed,
wherein Jarvik further discloses the pin is made of MP35N, 35NLT, Nitinol, stainless steel, or ceramic (Column 4 lines 48-52). It would have been obvious to one of ordinary skill at the time the invention was filed to modify the material of the pin so it is ceramic as is taught by Jarvik since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07.
Regarding claim 16 Schumacher discloses the pump of claim 1 substantially as is claimed,
but is silent with regards to an inner diameter at the distal end of the rotor into which the static support member protrudes.
However, regarding claim 16 it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the inner diameter at the rotor
However, regarding claim 16 Jarvik teaches a pin (Figure 2 item 48) can extend into a distal end of a rotor (Figure 2 item 58) within a heart pump. Schumacher and Jarvik are involved in the same field of endeavor, namely heart 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 Schumacher by having the pin 16 extend into the distal end of the rotor as is taught by Jarvik since this is a known connection between parts of pump, which would be obvious to try. The courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known connection between a pin and rotor would be obvious to try. It would have further been obvious to have the inner diameter at the distal end of the rotor into which the pin protrudes to be any diameter, including 0.5-1.5 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. See MPEP 2144.05(II)(A).
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher as is applied above in view of Granegger et al. (CN 109789257 A) hereinafter known as Granegger.
Regarding claim 12 the Schumacher Jarvik Combination teaches the pump of claim 11 substantially as is claimed,
but is silent with regards to the width between a gap between the pin and a recess of the rotor.
However, regarding claim 12 Granegger teaches a blood pump which includes a bearing gap with a 5 micron width (page 7 paragraph 2 of the attached translation). Schumacher and Granegger 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 the Schumacher Jarvik Combination so that the gap between the pin and recess of the rotor is 5 microns as is suggested by Granegger in order to ensure there is enough space for a liquid dynamic lubrication.
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher and Jarvik as is applied above, further in view of Toellner et al. (EP 2407187 A1) hereinafter known as Toellner.
Regarding claim 14 the Schumacher Jarvik Combination teaches the pump of claim 11 substantially as is claimed,
but is silent with regards to whether or not the pin has sufficient length to remain within the distal end of the rotor when the housing and rotor are in the compressed state.
However, regarding claim 14 Toellner teaches that while a compressible rotor of a blood pump is in the compressed configuration (Figure 2) the rotor remains axially connected (Figure 2). Schumacher and Toellner 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 the Schumacher Jarvik Combination to ensure the device stays connected during axial compressed as is taught by Toellner (and in the case of the Combination, which has an axial connection based on a pin/recess connection, meaning to have the pin sufficiently long in order to remain connected) in order to ensure the device can be delivered through the catheter as is desired without having to deal with a misalignment of parts upon expansion.
Allowable Subject Matter
Claim 8 is 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.
Regarding claim 8 the Schumacher Kerkhoffs Combination teaches the pump of claim 7 substantially as is claimed,
wherein Kerkhoffs further teaches a hollow section as a part of the fluid line (Figure 2),
wherein the pump is configured to guide the purge fluid through the hollow section of the rotor to the distal bearing ([0029]),
but does not teach the rotor comprising a hollow section as a part of the fluid line. The prior art includes teachings of having the fluid extend around parts of the rotor’s shaft (e.g. see Barry US 20180169312 A1 or Aboul-Hosn et al. US 7022100 B1), but does not actually teach having the rotor comprise a hollow section as part of the fluid line. Claim 8 is accordingly not rejected with prior art.
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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 03/03/26