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 Amendment
This Office Action is responsive to the amendment filed on 09/03/2025. As directed by the amendment: Claims 51, 61, and 62 have been amended, Claims 1-50 have been cancelled, and no claims have been added. Claims 68-70 were previously withdrawn due to a Restriction Requirement. Thus, Claims 51-67 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see page 5, filed 09/03/2025, with respect to 35 U.S.C. 112(b) have been fully considered and are persuasive in view of the claim amendments. The previous 35 U.S.C. 112(b) rejections of the claims have been withdrawn. However, new 35 U.S.C. 112(b) of the claims have been made below.
Applicant’s arguments, see pages 5-7, filed 09/03/2025, with respect to 35 U.S.C. 103 have been fully considered and are persuasive. Applicant argues on page 6 that “the intended purpose of Kantrowitz is to assist cardiac function by "elevat[ing] aortic blood pressure immediately after aortic valve closure" (Kantrowitz at col. 1, lines 34-38) or during the beginning of diastole to prevent backflow into the left atrium. By being located in the descending aorta, Kantrowitz receives blood from the left ventricle (the recited "chamber"). Altering the timing of inflation/deflation of balloons in the descending aorta as in Kantrowitz, "to decrease pressure in the chamber (the left ventricle) of the heart during diastole and increase the pressure in the chamber of the heart during systole," allegedly as according to Moreschi, would not serve the intended purpose of improving heart function at all. If the device of Kantrowitz were operated as recited, it would decrease pressure in the left ventricle during diastole. This modification would fail to open the aortic valve (because decreased pressure in the left ventricle would not overcome the high pressure within the aorta), and would hinder cardiac function rather than improve it as intended by Kantrowitz. Similarly, Kantrowitz operates by helping move blood through the aorta, for example by inflating and increasing aortic pressure during diastole to help close the aortic valve (Kantrowitz at col. 1, lines 33-40). Therefore, the proposed modification would both impermissibly render Kantrowitz unsatisfactory for its intended purpose of improving cardiac function as well as impermissibly change the principle of operation of the Kantrowitz reference by increasing aortic pressures (rather than chamber pressure) during another phase of the cardiac cycle (e.g., during systole as recited, rather than during diastole as disclosed).” Examiner agrees because both Kantrowitz and Moreschi both increase pressure during diastole and decrease pressure during systole, and furthermore, would not be combinable together as Kantrowitz is directed to aortic chamber and Moreschi is directed to the LV chamber. The previous 35 U.S.C. 103 rejections of the claims have been withdrawn.However, new 35 U.S.C. 102(a)(1) rejections of the claims have been made below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 51-67 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP 2163 (II)(2).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See MPEP 2163(III)(a)(ii).
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species). See MPEP 2163(III)(a)(ii).
Claims 51 and 62 fails to sufficiently describe the control circuitry configured to operate the pressurizing element to decrease a pressure in the chamber of the heart during diastole and increase the pressure in the chamber of the heart during systole in enough detail for one skilled in the art to have possession of the broadly claimed genus. Although the term chamber is used in the instant specification, the instant specification only defines the following chambers in which the decrease in pressure during diastole and increase in pressure for systole occurs: [0064] “Although not visible in FIG. 2 , system 100 also includes control circuitry configured to operate the pressurizing element 102 to decrease a pressure in the LA [left atrium] during atrial diastole to draw oxygenated blood out of the lungs of the patient by simulating an increase in left atrial reservoir strain and a relative increase in the volume of the LA to reduce a filling pressure in the LA. The control circuitry also operates the pressurizing element 102 to increase the pressure in the LA during atrial systole to simulate an increase left atrial active strain by reducing the relative volume of the LA to increase left atrial pressure during atrial systole. The increase in the left atrial pressure during atrial systole increases a pressure differential between the LA and Left Ventricle that improves diastolic filling of the Left Ventricle.” [0093] “Pressurizing elements 102 and 104 can be operated to generate coordinated pressure changes (e.g., pressure increases and/or pressure decreases) in the LA and Pulmonary Artery respectively, in coordination with various portions of the cardiac cycle based on the signals from the sensor.” The only chambers disclosed are the LA and pulmonary artery, and only the LA is the one defined to decrease in pressure during diastole and increase in pressure for systole. Similar to Lizardtech, there is no evidence that the specification contemplated a more generic device of targeting any chamber for the decrease in pressure during diastole and increase in pressure for systole. The instant specification fails to disclose any other embodiment/species, and therefore does not have a representative number of species to claim the genus, as instantly claimed. Therefore, claims 51-67 do not provide sufficient detail for a person skilled in the art to have been in possession of the invention as broadly claimed.
Claim Interpretation
Regarding claim 51, for purposes of examination, the Examiner is interpreting “control circuitry configured to operate the pressurizing element to decrease a pressure in the chamber of the heart during diastole and increase the pressure in the chamber of the heart during systole” as a ventricular blood pump that is capable of decreasing pressure in the LV during diastole and increasing pressure in the LV during systole.
Claim Rejections - 35 USC § 102
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)(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) 51, 53, and 60 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dague et al. (US 20200093972)(Hereinafter Dague).
Regarding claim 51, Dague teaches A system/method for improving cardiac output ([0005] “controlling a rotational speed of a continuous flow blood pump, and related mechanical circulatory assist systems, modulate the rotational speed of the blood pump based on pump blood flow rate… ventricular assist device”), comprising:
a pressurizing element (Fig. 3 (140));
a three-dimensional surface defining an interior volume at least partially surrounding the pressurizing element, wherein the interior volume is configured to receive blood from within a chamber of a heart (See Figs. 2-3 3D surface 14, see Fig. 3 where 112 is found within the LV which allows for blood to flow through to the interior volume. [0052] “the VAD 14 includes a dividing wall 115 within the housing 110 defining a blood flow conduit 103 [interior volume]. The blood flow conduit 103 extends from an inlet opening 101 of the inlet cannula 112 through the stator 120 to an outlet opening 105 defined by the housing 110. The rotor 140 is positioned within the blood flow conduit 103. The stator 120 is disposed circumferentially about a first portion 140a of the rotor 140, for example about a permanent magnet 141. The stator 120 is also positioned relative to the rotor 140 such that, in use, blood flows within the blood flow conduit 103 through the stator 120 before reaching the rotor 140.”) and the pressurizing element is configured to displace the blood received within the interior volume ([0061] “Blood also flows through the gap 108 between the rotor 140 and the dividing wall 115 and through the gap 109 between the shroud 145 and the inner surface 108a of the cap 118.”); and
control circuitry configured to operate the pressurizing element to decrease a pressure in the chamber of a heart during diastole and increase a pressure in the chamber of the heart during systole ([0005] “During ventricular diastole, the pressure within the ventricle decreases, thereby increasing the pressure differential across the blood pump and causing the flow rate through the blood pump to decrease.” [0071] “During ventricular systole, contraction of the ventricles closes the AV valves and increases the ventricular pressures. During left ventricular systole, the left ventricular pressure 302 increases to a level slightly greater than the aortic pressure 306, thereby causing the native aortic valve to open.” [0081] “the current blood flow rate 312 and the current rate of change in the blood flow rate 312 are processed (by a controller) to determine whether continued operation of the blood pump I”).
Regarding claim 53, Dague teaches wherein the three-dimensional surface is concave towards the pressurizing element (See Fig. 4 see the concave U shape of the device at the bottom.).
Regarding claims 60, Dague teaches wherein the three-dimensional surface and the pressurizing element are configured to be positioned in the chamber of the heart (See Fig. 3.).
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.
Claim(s) 52 and 54-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dague et al. (US 20200093972)(Hereinafter Dague) in view of Sun (US 20180193543)(Hereinafter Sun).
Regarding claim 52, Dague teaches the invention of claim 51. Dague does not teach the pressurizing element being a balloon. Sun, in the same field of endeavor, teaches a LVAD that pumps blood (Abstract), and further teaches wherein the pressurizing element is a balloon ([0007] “The devices generally utilize a pump and a prosthetic valve in combination with a self-expandable or balloon expandable stent or frame”) to increase blood flow to the heart ([0007]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Dague, with the balloon of Sun, because such a modification would allow to increase blood flow to the heart.
Regarding claim 54, Dague teaches the invention of claim 51. Dague does not teach the shield that is expandable from a compressed to expanded state. Sun, in the same field of endeavor, teaches a LVAD that pumps blood (Abstract), and further teaches wherein the three-dimensional surface comprises a shield that is expandable from a compressed configuration to an expanded configuration ([0008] “a pump disposed within the expandable frame and including attachment means configured to align with the receiving means disposed on the expandable frame to allow securement of the pump to the expandable frame.”) to increase blood flow to the heart ([0007]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Dague, with the shield that is expandable from a compressed to expanded state of Sun, because such a modification would allow to increase blood flow to the heart.
Regarding claim 55, Dague teaches the invention of claim 51. Dague does not teach the shield that is expandable from a compressed to expanded state. Sun, in the same field of endeavor, teaches a LVAD that pumps blood (Abstract), and further teaches wherein the three-dimensional surface is provided at a distal end of a sheath configured to extend into the chamber of the heart ([0041] “In FIG. 8A, pump 14 is sized and configured to extend further out of expandable frame 2 such that pump 14 may reach across a native aortic valve (not shown in FIG. 8A) and into the left ventricle (not shown in FIG. 8A) to further blood flow within the individual.”) to increase blood flow to the heart ([0007]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Dague, with the shield that is expandable from a compressed to expanded state of Sun, because such a modification would allow to increase blood flow to the heart.
Regarding claim 56, Dague teaches the invention of claim 51. Dague does not teach the shield that is expandable from a compressed to expanded state. Sun, in the same field of endeavor, teaches a LVAD that pumps blood (Abstract), and further teaches wherein the sheath is pre-formed with a bend for stabilization within the chamber of the heart ([0026] “Referring now to the Figures, and specifically to FIG. 1, there is shown an expandable frame 2 having disposed therein prosthetic valve 4.” Fig. 1 is pre-formed.) to increase blood flow to the heart ([0007]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Dague, with the shield that is expandable from a compressed to expanded state of Sun, because such a modification would allow to increase blood flow to the heart.
Regarding claim 57, Dague teaches the invention of claim 51. Dague does not teach the shield that is expandable from a compressed to expanded state. Sun, in the same field of endeavor, teaches a LVAD that pumps blood (Abstract), and further teaches wherein the pressurizing element is displaced from the distal end of the sheath (Fig. 4) to increase blood flow to the heart ([0007]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Dague, with the shield that is expandable from a compressed to expanded state of Sun, because such a modification would allow to increase blood flow to the heart.
Regarding claim 58, Dague teaches the invention of claim 51. Dague does not teach the shield that is expandable from a compressed to expanded state. Sun, in the same field of endeavor, teaches a LVAD that pumps blood (Abstract), and further teaches wherein the three-dimensional surface comprises a full cage surrounding the pressurizing element (Fig. 8A [0026] “As noted above, the intravascular ventricular assist devices of the present disclosure generally include an expandable frame or cage (also referred to as a “stent”)”) to increase blood flow to the heart ([0007]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Dague, with the shield that is expandable from a compressed to expanded state of Sun, because such a modification would allow to increase blood flow to the heart.
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dague et al. (US 20200093972)(Hereinafter Dague) in view of Choy (US 20080207986)(Hereinafter Choy).
Regarding claim 59, Dague teaches the invention of claim 51. Dague does not teach wherein the three-dimensional surface comprises a spherical or ellipsoid shape. Choy, in the same field of endeavor, teaches a heart assist device that pumps blood with balloon (Abstract), and further teaches wherein the three-dimensional surface comprises a spherical or ellipsoid shape (Fig. 1 (16)) to facilitate increased ejection of the blood ([0027]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Dague, with wherein the three-dimensional surface comprises a spherical or ellipsoid shape of Choy, because such a modification would allow to facilitate increased ejection of the blood.
Potentially Allowable Subject Matter
Claims 61-67 overcome the prior art but are still rejected under 35 U.S.C. 112(a) as indicated above.
The following is a statement of reasons for the indication of the claim 62 overcoming the prior art:
The treatment of HF, via the catheter that is advanced into the heart, using three-dimensional surface defining an interior volume at least partially surrounding the pressurizing element, wherein the interior volume is configured to receive blood from within a chamber of a heart and the pressurizing element is configured to displace the blood received within the interior volume, the pressurized element being a balloon which contains a control circuitry configured to operate the pressurizing element to decrease a pressure in the chamber of the heart during diastole and increase the pressure in the chamber of the heart during systole are not conventionally relied upon in blood pumps and cardiac assistant devices and are therefore allowable over the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Miyagi et al. (“Novel approaches for left atrial pressure relief: Device-based monitoring and management in heart failure”, Front. Cardiovasc. Med., 10 August 2022) and Fukamachi et al. (“Left atrial assist device to treat patients with heart failure with preserved ejection fraction: Initial in vitro study”, The Journal of Thoracic and Cardiovascular Surgery Volume 162, Issue 1, July 2021, Pages 120-126)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/PAMELA M. BAYS/Primary Examiner, Art Unit 3796