DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 Amendment
2. According to the Amendment, filed 27 January 2026, the status of the claims is as follows:
Claims 1 and 8 are currently amended;
Claims 2-7 are previously presented;
Claims 10-18 are new; and
Claim 9 is canceled.
3. The rejection of claims 1-8 and 10 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in view of the Amendment, filed 27 January 2026.
Response to Arguments
4. Applicant’s arguments, see Remarks, pp. 6-7, filed 27 January 2026, with respect to the rejection of claims 1-7 and 10 under 35 U.S.C. 102(a)(1) as being anticipated by Young et al., U.S. Patent Application Publication No. 2011/0066046 A1 (“Young”), have been fully considered, and are persuasive in view of the Amendment, filed 27 January 2026. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
5. Applicant’s arguments, see Remarks, p. 7, filed 27 January 2026, with respect to the rejection of claims 8 under 35 U.S.C. 103 as being unpatentable over Reich et al., U.S. Patent Application Publication No. 2003/0045772 A1 (“Reich”), in view of Young, have been fully considered, and are persuasive in view of the Amendment, filed 27 January 2026. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
Claim Objections
6. Claim 2 is objected to because of the following informalities:
In line 1, “the sensor housing” lacks proper antecedent basis, and should be amended to “the .
Appropriate correction is required.
7. Claim 7 is objected to because of the following informalities:
In lines 1-2, “the sensor” lacks proper antecedent basis, and should be amended to “the pressure sensor”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
8. 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.
9. 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.
10. Claims 1-7 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bullara, U.S. Patent No. 4,127,110 A (“Bullara”).
As to Claim 1, Bullara teaches the following:
A pressure sensor (“pressure transducer”) 10 (see “A wireless, surgically implantable pressure transducer for measuring pressure of fluid or tissue in a body chamber such as a brain ventricle of a patient suffering hydrocephalus or a head injury.” in Abstract, and see figs. 1, 2, and 7) comprising:
a housing (“hollow dome-shaped housing”) 81 (see “In an epidural configuration 81 as shown in FIG. 7, the transducer subassembly is seated in a hollow dome-shaped housing 83 which includes a base 84 and a cover 85.” in col. 7, ll. 2-5) made of a biocompatible material (see “… a hollow cylindrical cup of cast epoxy resin as sold under the trademark "Hysol".” in col. 3, ll. 35-40) and comprising:
an open portion (“opening”) 86 in the housing 81 (see “Base 84 is a flat circular plate of an implantable material such as acrylic plastic, and an opening 86 is formed in the center of the plate.” in col. 7, ll. 6-8);
a flexible membrane (“thin and flexible cap-shaped diaphragm”) 95 made of a biocompatible flexible material (“… of "Silastic" plastic or a comparable sheet material surrounds the transducer bellows”) and covering the open portion 86 in the housing 81 (see “A thin and flexible cap-shaped diaphragm 95 of "Silastic" plastic or a comparable sheet material surrounds the transducer bellows, and is secured in place by a clamping ring 96 cemented to the housing base.” in col. 7, ll. 29-32);
an attachment portion (“clamping ring”) 96 made of a biocompatible material and at least partly surrounding the open portion 86 in the housing 81 and the flexible membrane 95 (see “A thin and flexible cap-shaped diaphragm 95 of "Silastic" plastic or a comparable sheet material surrounds the transducer bellows, and is secured in place by a clamping ring 96 cemented to the housing base.” in col. 7, ll. 29-32), the attachment portion 96 being configured to attach the housing 81 to a surface of an object (“skull”) 18 (see “When used to measure intracranial pressures, a small hole is formed through the skull, and the bellows "shank" of the transducer is fitted into the skull opening.” in col. 8, ll. 6-9);
a pressure transferring medium (“Elliot's `B` solution or a comparable fluid”, not labeled) in a space (“space”, not labeled) between an inner wall (“base”) 84 of the housing 81 and the flexible membrane 95, and in communication with one surface of the flexible membrane 95 (see “The space between the bellows and diaphragm is filled with Elliot's `B` solution or a comparable fluid as explained above.” in col. 7, ll. 31-35);
a pressure sensitive sensor (“transducer subassembly”) 68 attached to an inner surface of the housing 84 via a circuit (“variable-resonant-frequency L-C circuit”, not labeled) and in communication with the pressure transferring medium (see “A more sensitive embodiment of the invention includes a transducer subassembly 68 in FIG. 6, and is characterized by the use of an antenna coil 70 connected to a coupling coil 71 which is inductively coupled to an inductor coil 72 wound on an open-ended mandrel or hollow sleeve 73. A solid cylindrical ferrite core 74 is movably positioned within sleeve 73 to form a variable inductor with coil 72. A capacitor 75 is connected across inductor coil 72 to provide a variable-resonant-frequency L-C circuit.” in col. 6, ll. 38-47); and
an electrical connector (“antenna coil”) 70 configured to connect the pressure sensitive sensor 68 to a control unit (“external equipment”, not labeled) (see “The antenna and coupling coils in effect form an inductive link between the transducer subassembly and an external transmitting-antenna coil of a grid-dip oscillator (illustrated schematically in FIG. 10) used as already described to sense the resonant frequency of the L-C circuit which is in turn indicative of the fluid pressure being sensed. The relatively large diameter of antenna coil 70 provides good inductive coupling with the transmitting-antenna coil of the external grid-dip oscillator, and the small diameter of coupling coil 71 insures good coupling with inductor coil 72. The result is a significant increase in overall system sensitivity and "Q" or sharpness of the resonant frequency of the L-C circuit.” in col. 8, ll. 16-30).
As to Claim 2, Bullara teaches the following:
wherein the [housing] 81 is made of hard polyurethane, hard silicone, or biocompatible metal (see col. 3, ll. 35-40).
As to Claim 3, Bullara teaches the following:
wherein the attachment portion 96 is made of Dacron, ePTFE, or polyester (see col. 7, ll. 29-32).
As to Claim 4, Bullara teaches the following:
wherein the pressure sensitive sensor 68 comprises a small-scale microelectromechanical system (MEMS) sensor or a nanoelectromechanical system (NEMS) sensor (see col. 6, ll. 38-47).
As to Claim 5, Bullara teaches the following:
wherein the flexible membrane 24 is made of polyurethane, silicone or blood compatible material (see col. 7, ll. 29-32).
As to Claim 6, Bullara teaches the following:
wherein the pressure transferring medium 29 in the housing 12 comprises a biocompatible, implantable oil (see col. 7, ll. 31-35).
As to Claim 7, Bullara teaches the following:
wherein the [pressure] sensor 10 is implantable and measures one of pulmonary, systemic circulatory, thorax, kidney, urinary bladder, or intestinal for a heart prosthesis, a total artificial heart or a heart assist pump (since this limitation merely further limits the functional characteristic of the pressure sensor, this is a matter of intended use of the pressure sensor for which Bullara’s “pressure transducer 10” is capable of measuring pressure within other body cavities).
As to Claim 10, Bullara teaches the following:
wherein the biocompatible, implantable oil is medical grade silicone (see col. 7, ll. 31-35).
As to Claim 11, Bullara teaches the following:
wherein the attachment portion is configured to tissue ingrowth with natural tissue of the object (see “The transducer assembly and housing is surgically installed as discussed above to be fully implanted without need for wired or tubing connections to external equipment. When used to measure intracranial pressures, a small hole is formed through the skull, and the bellows "shank" of the transducer is fitted into the skull opening. Base 84 and domed cover 85 are seated against the skull, and the overlying scalp is then sutured to close the incision and seal the transducer assembly under the skin.” in col. 8, ll. 3-12).
As to Claim 12, Bullara teaches the following:
wherein the electrical connector 70 is electrical wire (see col. 8, ll. 16-30).
As to Claim 13, Bullara teaches the following:
wherein the object is an artificial heart prothesis or a heart assist pump (since this limitation merely further limits the functional characteristic of attaching the housing to the surface of the object, this is a matter of intended use of the pressure sensor for which Bullara’s “pressure transducer 10” is capable of attaching to an artificial heart prothesis or a hear assist pump and measuring pressure within those objects).
As to Claim 14, Bullara teaches the following:
wherein the pressure sensor covers the opening in the object so that the flexible membrane directly contacts a fluid within the object (see col. 7, ll. 29-32).
As to Claim 15, Bullara teaches the following:
wherein the attachment portion 96 is substantially ring-shaped (see col. 7, ll. 29-32).
As to Claim 16, Bullara teaches the following:
wherein the object is an artificial conduit carrying blood (see “The epidural configuration just described is readily modified to measure intraventricular fluid pressure by adding a hollow elongated cannula 105 as shown in FIG. 8. One end 106 of the cannula is fitted over and secured to a tubular extension 107 of a hollow annular adapter plate 108 cemented and sealed to the floor of base 84 and cover 85. Holes 110 in the distal end of the cannula permit cerebrospinal fluid in the ventricle to fill the interior of the cannula, the fluid pressure thus being sensed by bellows 77 of transducer subassembly 68.” in col. 8, ll. 31-40).
As to Claim 17, Bullara teaches the following:
wherein the object is a patient's heart, vein, or artery (since this limitation merely further limits the functional characteristic of attaching the housing to the surface of the object, this is a matter of intended use of the pressure sensor for which Bullara’s “pressure transducer 10” is capable of attaching to other bodily cavity surfaces and measuring pressure within those body cavities).
As to Claim 18, Bullara teaches the following:
wherein the object is tissue located in a patient so that the pressure sensor measures pressure of a patient's thorax cavity (since this limitation merely further limits the functional characteristic of attaching the housing to the surface of the object, this is a matter of intended use of the pressure sensor for which Bullara’s “pressure transducer 10” is capable of attaching to other bodily cavity surfaces and measuring pressure within those body cavities).
Claim Rejections - 35 USC § 103
11. 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.
12. 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.
13. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Reich et al., U.S. Patent Application Publication No. 2003/0045772 A1 (“Reich”), in view of Bullara.
As to Claim 8, Reich teaches the following:
A controller unit (“electrical processor or controller”) 30 for controlling a cardiac pump (“Left Ventricular Assist Device (LVAD)”, not labeled), the cardiac pump 30 comprising:
at least one pump portion (“blood pump”) 20 (see “In accordance with the present invention, a blood pump 20 in the form of a Left Ventricular Assist Device (LVAD) is suitably implanted in the chest of the patient closely adjacent to the heart in flow communication between the left ventricle 16 and the aorta 18 for supplementing pumping capability of the left ventricle.” in para. [0016]; and see “The blood pump may have any conventional form, and in the preferred embodiment is a rotary or centrifugal pump having a suction inlet joined to the left ventricle and pressure outlet joined to the aorta. Performance of the rotary pump is conventionally rated by corresponding performance curves in which the flowrate through the pump corresponds with the differential pressure across the pump between the inlet and outlet thereof, and varies as the speed of the rotary impeller increases. Increasing impeller speed generally corresponds with increasing differential pressure and increasing flowrate through the pump.” in para. [0017]),
an inlet (“suitable inlet tube or catheter”) 24 connected to the at least one pump portion (see “The inlet pressure sensor 22 and its integral cannula are preferably formed integrally with the blood pump, and a suitable inlet tube or catheter 24 joins the inlet pressure sensor to the left ventricle by being sutured thereto.” in para. [0019]),
an outlet (“outlet tube or catheter”) 28 connected to the at least one pump portion (see “The blood pump preferably also includes means in the form of an outlet pressure sensor 26 joined to the outlet side of the pump in flow communication with the aorta by an outlet tube or catheter 28 suitably sutured thereto.” in para. [0020]),
a pressure sensor (“pressure sensor”) 22 … and configured to measure pressure of a fluid flowing from the inlet to the outlet (see “In accordance with the present invention, the inlet pressure sensor 22 provides means for measuring inlet pressure P1 of the blood flow to the pump from the left ventricle. The electrical pressure signal from the sensor 22 is suitably provided to the controller 30 by an electrical connection therebetween, and the controller 30 is preferably configured in suitable software for using the inlet pressure for controlling operation of the pump.” in para. [0026]),
a pump actuator (“brushless DC electric motor”, not labeled) configured to induce the flow of the fluid flow (see “In the preferred embodiment, the blood pump 20 includes a brushless DC electric motor which powers its impeller, and a suitable battery supply is preferably implanted in the patient for powering the pump.” in para. [0021]),
wherein the controller unit 30 further comprising a memory (“suitable memory”, not labeled) (see “The control system illustrated in FIG. 2 may also include a fourth level of control 64 specifically configured for monitoring the inlet and outlet pressures P1,P2, and performance of the pump 20 to diagnose abnormalities therewith. All of the various operating parameters of the pump and associated pressure sensors may be monitored and temporarily stored in suitable memory for use in diagnostic monitoring of system performance for comparing present performance with past performance to diagnose any abnormalities which may develop.” in para. [0073]) and a processing unit (“digitally programmable microprocessor”, not labeled) (see “An electrical processor or controller 30 is also preferably implanted in the patient for controlling all operation of the pump. The controller may have any conventional configuration, and is preferably in the form of a digitally programmable microprocessor of sufficiently small size to be integrated directly with the blood pump for minimizing the overall size thereof.” in para. [0021]), wherein the controller unit 30 is configured to:
receive a pressure value from the pressure sensor 22 (see “In accordance with the present invention, the inlet pressure sensor 22 provides means for measuring inlet pressure P1 of the blood flow to the pump from the left ventricle. The electrical pressure signal from the sensor 22 is suitably provided to the controller 30 by an electrical connection therebetween, and the controller 30 is preferably configured in suitable software for using the inlet pressure for controlling operation of the pump.” in para. [0026]),
receive a desired value for the pressure of the fluid flowing into the at least one pump portion 20 (see “In a fundamental or first level of pump control, the desired level of the inlet pressure P1 may be suitably set in the control system, and the inner feedback loop 40 is used to control motor speed until the difference or error signal between measured and set pressures is reduced to substantially zero, at which time the measured inlet pressure P1 matches the desired value therefor.” in para. [0029]),
calculate an error signal equal to the difference of desired value for the pressure and the measured pressure (see “The controller compares the measured inlet pressure to a setpoint and uses the difference as an error signal.” in para. [0122]; and see “The error signal is integrated with respect to time and multiplied by a suitable value K. In equation form, the basic control is: d/dt(Flow)=K*(inlet pressure-setpoint pressure); that is, the rate of change in flow pumped through the blood pump is calculated by multiplying K times the error.” in para. [0123])), and
control the output of the at least one pump portion 20 such that the measured pressure is near or equal to the desired pressure, by controlling a pump control parameter, the pump control parameter comprising at least one of a pump stroke rate, a pump stroke volume, or a pump speed (see “The primary pump speed control rule is to maintain the LVDFP at a desired selectable value within selectable limits. The secondary pump speed control rule is to maintain the AoP within a desired selectable range. If the AoP approaches a limit, then the LVDFP value is allowed to change value within its selectable range. Thus the primary LVDFP range takes precedence over the secondary AoP range.” in para. [0115]; and see “The Level-2 mode for the physiologic controller algorithm adjusts the impeller speed (always staying in the Level-1 range for the LVDFP) so that the AOP increases with the heart rate as derived from the input pressure sensor. The controller 30 preferably also include a left ventricular collapse detection algorithm and a retrograde flow detection algorithm. Note that flow can be calculated using the pressure differential across the blood pump 20 in conjunction with the rotary speed and the pressure versus flow characteristics of the pump.” in para. [0116])).
Reich generally teaches a “pressure sensor 22” (see “As shown schematically in FIG. 1, the pump includes means in the form of an inlet pressure sensor 22 for measuring inlet pressure of the blood flow between the left ventricle and inlet side of the pump. The inlet pressure sensor may have any suitable form such as that disclosed in U.S. Pat. No. 6,171,253 and U.S. Pat. No. 6,367,333, both assigned to the present assignee, and both incorporated herein by reference. In these patents, a flat diaphragm is formed in a cannula through which the blood is channeled into the pump, and strain gauges are mounted on the diaphragm for measuring strain thereof which is indicative of pressure of the blood flow thereat.” in para. [0022]); but does not teach the following:
a pressure sensor according to claim 1…
However, Bullara teaches pressure sensor of claim 1 as discussed above for claim 1. Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Reich’s “pressure sensor 22” to have the elements of Bullara’s “pressure transducer 10” because it would have been simple substitution of one known element, i.e. Reich’s “pressure sensor 22”, for another, i.e. Bullara’s “pressure transducer 10”, to obtain predictable results, i.e. measuring pressure within a body cavity.
Conclusion
14. 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.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 04/23/2026
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