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 .
Response to Arguments
Applicant’s arguments filed 01/28/2026 have been fully considered but are not persuasive.
Applicant argues, “…in contrast to the presently claimed subject matter reciting an impeller within the pump-outlet tube within the left ventricle, Gandhi provides rotary pumping device (50) that is not located in proximity to sensor head (30) and the blood inlet openings in the left ventricle but rather is located in proximity to the blood outlet in the aorta, remotely from the blood inlet openings and sensor head (30) in the ventricle. Therefore, Gandhi would have no reason to apply the proximal conical frame portion of Pfeffer for use with sensor head (30) for measuring blood pressure in the ventricle. This is at least because, as explained above, coupling of the distal portion of the optical fiber to the proximal conical portion as recited by the claimed subject matter, is, inter alia, for the purpose of positioning the fiber in direct fluid communication with left-ventricular bloodstream of the subject at a location that is proximal to the proximal-most portion of blood-inlet opening…. Since Gandhi does not provide the impeller in proximity to sensor head (30) in the left ventricle, he does not have the particular use for the conical portion that is configured to have the optical fiber coupled thereto in a manner that facilitates extending the fiber radially from the outer surface of pump-outlet tube to measure left ventricle pressure itself that is not affected by any pressure variations that are generated by the impeller in vicinity of the inlets.”
In response to applicant's argument that Gandhi would have no reason to apply the proximal conical frame portion of Pfeffer for use with sensor head (30) for measuring blood pressure in the ventricle, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In this instance, Pfeffer is used to teach an impeller cage with a conical proximal portion that widens from a proximal end of the frame to the cylindrical portion of the frame in order to properly protect the impeller/rotor and not negatively impact blood flow [0067-0068].
Thus, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the similar conical design that widens from a proximal end of the frame to the cylindrical portion of the frame, as taught by Pfeffer, to the known device of Gandhi, to improve the device by providing a design to protect the impeller/rotor and not negatively impact blood flow.
Applicant argues, “the sensor can also detect vibrations in the pump housing, the rotor, the motor, or the cannula, and that the signals received from the sensor can assist in determining a mechanical failure event associated with the pump. This is described for example in paragraphs [0004]- [0006], [0032] and [0037] in Gandhi. Thus, it would make sense for Gandhi to dispose the sensor (particularly sensor (60)) as close as possible to the pump and the housing, to detect signals directly related to pump operation. Therefore, it would not be obvious for Gandhi to apply the conical structure of Pfeffer to the optical fiber of Gandhi. In particular it would not be obvious to couple the sensors heads of Gandhi to the proximal conical portion of the frame in a manner that causes the fiber to radially extend from the frame portion and to be positioned proximally to the proximal-most portion of blood-inlet opening.”
In response to applicant's argument that Gandhi would have no reason to apply the conical structure of Pfeffer to the optical fiber of Gandhi, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In this instance, the combined teachings of the references, specifically, that a conical proximal portion that widens from a proximal end of the frame to the cylindrical portion of the frame would properly protect an impeller/rotor and would not negatively impact blood flow (Pfeffer: [0067-0068]), as taught by Pfeffer, would have suggested to those of ordinary skill in the art at the time the instant invention was filed to provide an improvement as discussed above through a similar conical design.
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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gandhi et al. (US 2020/0093973) in view of Pfeffer et al. (US 2009/0093796).
In re claim 1, Gandhi discloses an apparatus (fig. 1: intracardiac blood pump; [0032]) comprising:
a pump-outlet tube ([032]: proximal outlet) configured to traverse an aortic valve of a subject [0032-0033], such that a proximal end of the pump-outlet tube is disposed within an aorta of the subject [0032-0033] and a distal end (fig. 1: bottom portion of 5) of the pump-outlet tube is disposed within a left ventricle (16) of the subject (fig. 1);
an impeller ([0032]: pump section has a rotor) configured
to be disposed within the left ventricle within the pump-outlet tube (fig. 1), and
to pump blood through the pump-outlet tube [0018, 0032-0033];
a frame disposed around the impeller (fig. 1: outer portion of 52),
the frame defining a cylindrical portion (fig. 1) and a proximal portion (53) that is disposed proximally to the cylindrical portion (fig. 1; [0032]);
at least one optical fiber (fig. 1: either of 28, 29),
a proximal end [0033] of which is configured to be disposed outside a body of the subject (fig. 1; [0033] and a distal portion [0033] of which is coupled to the proximal portion of the frame such that a distal end of the optical fiber extends to outside the pump-outlet tube (fig. 1; [0033]) and is configured to be disposed in direct fluid communication with left-ventricular bloodstream of the subject outside the pump-outlet tube [0033, 0037].
Gandhi fails to disclose a proximal conical portion that is disposed proximally to the cylindrical portion and that widens from a proximal end of the frame to the cylindrical portion of the frame.
Pfeffer teaches a device [0014-0015] for supporting a heart [0014] without a need for surgical intervention [0014] comprising an impeller cage with a conical proximal portion that widens from a proximal end of the frame to the cylindrical portion of the frame in order to properly protect the impeller/rotor and not negatively impact blood flow [0067-0068].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify apparatus taught by Gandhi, to provide the similar conical design that widens from a proximal end of the frame to the cylindrical portion of the frame, as taught by Pfeffer, to improve the device by providing a design to protect the impeller/rotor and not negatively impact blood flow.
In re claim 2, the proposed combination (all mapping is directed to Gandhi unless otherwise disclosed) yields a light source [0035] and a light detector ([0035]: camera receives incoming light) disposed at a proximal end of the optical fiber [0035], and configured to detect blood pressure at the distal end of the optical fiber ([0004]: optical fiber and sensor deformation is used to detect perturbations in blood; [0035]) by directing light via the optical fiber [0035] and detecting reflected light [0035].
In re claim 3, the proposed combination (all mapping is directed to Gandhi unless otherwise disclosed) yields a computer processor [0035] that is configured to receive the blood pressure detected at the distal end of the optical fiber [0004, 0035] and to control pumping of blood by the impeller in response to the blood pressure detected at the distal end of the optical fiber [0004, 0035]
In re claim 4, the proposed combination (all mapping is directed to Gandhi unless otherwise disclosed) yields a computer processor (see in re claim 3 above) that is configured to receive the blood pressure detected at the distal end of the optical fiber (see in re claim 3 above),
wherein the computer processor is configured to derive at least one physiological parameter of the subject ([0004]: detect perturbations in blood), at least partially based upon the blood pressure detected at the distal end of the optical fiber [0004, 0035],
the at least one physiological parameter of the subject being selected from the group consisting of:
native cardiac output ([0033]: The sensor head 60 is in contact with blood flowing into the aorta and is thus able to detect optical signals within the blood flowing in the aorta (to measure aortic pressure and detect pump vibration). Sensor head 30 (when used) is positioned near the distal end of the pump within the left ventricle, so it contacts blood within the left ventricle to measure left ventricular pressure (and also detect pump or cannula vibration),
total cardiac output ,
arterial compliance, and
peripheral resistance.
In re claim 5, the proposed combination (all mapping is directed to Gandhi unless otherwise disclosed) yields
the pump-outlet tube defines one or more blood-inlet openings (54) via which blood is pumped into the pump-outlet tube [0054], and
wherein the distal end of the optical fiber is configured to be in direct fluid communication with left-ventricular bloodstream of the subject at a location that is proximal to a proximal-most portion of the one or more blood-inlet openings ([0033]; fig. 1: sensors 30/60).
In re claim 6, the proposed combination (all mapping is directed to Gandhi unless otherwise disclosed) yields the distal end of the fiber is exposed to blood that has a pressure that reflects the blood pressure of the left ventricle itself and that is not affected by pressure variations that are generated in the vicinity of the one or more blood-inlet openings as a result of fluid flow dynamics generated at the one or more blood-inlet openings ([0033]: “Sensor head 30 (when used) is positioned near the distal end of the pump within the left ventricle, so it contacts blood within the left ventricle to measure left ventricular pressure (and also detect pump or cannula vibration)” and positioning is done to not be affected by other pressure variations).
In re claim 7, the proposed combination (all mapping is directed to Gandhi unless otherwise disclosed) yields the distal end of the optical fiber is configured to be in direct fluid communication with left-ventricular bloodstream of the subject at a location that is at least 1 cm proximal to the proximal-most portion of the one or more blood-inlet openings (fig. 1: sensor 30 is adjacent to inlet 54).
In re claim 8, the proposed combination (all mapping is directed to Gandhi unless otherwise disclosed) yields
the at least one optical fiber comprises two or more optical fibers (28, 29),
wherein the apparatus further comprises a computer processor ([0033]: inherent that processing would have a computer processor) that is configured to receive the blood pressure detected at the distal end of each of the optical fibers and to thereby determine whether the distal end of one of the optical fibers is not exposed to the left-ventricular bloodstream [0033].
In re claim 9, the proposed combination (all mapping is directed to Gandhi unless otherwise disclosed) yields in response to determining that the distal end of one of the optical fibers is not exposed to the left ventricular bloodstream ([0033]: during a failure event), the computer processor determines the subject's left-ventricular pressure based upon blood pressure measured using a different one of the two or more optical fibers ([0033]: both are used in conjunction to assess left ventricular pressure and volume flow especially during a failure).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Aboul-Hosn et al. (US 9545468) discloses a cannula (abstract) for measuring fluid pressure (abstract) and is pertinent to applicant’s disclose for disclosing a blood pump (fig. 3: 12; Col. 11, lines 8-10) comprising
an impeller (48) comprising a hub (56),
a frame (fig. 3: outer portion of 14) disposed around the impeller (fig. 2-3),
the frame defining a cylindrical portion (fig. 2: inner portion of 14)
wherein the hub is generally conical (fig. 3; Col. 11, lines 33-37) and is disposed proximally (fig. 3: positioned near center of 14) to the cylindrical portion (fig. 3: hub 56 is positioned near the center of 14).
Contact
THIS ACTION IS MADE FINAL. 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 RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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