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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS, see IDS filed 11/21/2025, have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper filed of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this Office Action.
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 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites “displacement of the second end to under-inflate the expandable member based on blood pressure of the patient”, it is unclear what is meant by the term “under-inflate”. The term “under-inflate” is ambiguous as to whether the ballon is inflated below a certain pressure, below a certain volume, below its physical maximum, below the therapeutic level, below the total occlusion level. The term “under-inflate” leaves the reader in doubt as to what would constitutes the ballon being under inflated, therefore the term is unclear. Clarification is required. Claim 1 recites “the volume of air corresponding to the air mover limited configuration”, it is unclear what is meant by the phrase “the volume of air corresponding to the air mover limited configuration”. A volume of air is limited between two positions of the displaceable second end of the air mover, however the “air mover limiter configuration” only relates to one of the positions. Clarification is required. Claim 4 recites the limitation "the first pressure" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 8 recites the limitation "the stop pin" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 10 recites the limitation "the rotor" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 14 recites the limitation "the bellows" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 15 recites the limitation "the bellows" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 16 recites the limitation "the bellows" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 18 recites the limitation "the pneumatic load" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 19 recites the limitation "the bellows" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 19 recites the limitation "the pneumatic load" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 2-20 directly or indirectly depend from claim 1 and are also rejected to for the reasons stated above regarding claim 1. Claims 10-12 and 14-15 directly or indirectly depend from claim 4 and are also rejected to for the reasons stated above regarding claim 4. Claims 11-12 are directly or indirectly depend from claim 10 and are also rejected to for the reasons stated above regarding claim 10. Claim 15 directly depends from claim 14 and is also rejected to for the reasons stated above regarding claim 14. Claim 17 directly depends from claim 16 and is also rejected to for the reasons stated above regarding claim 16. It is noted that the numerous antecedent basis issues within claims 4,8,10,14-16 and 18-19 and those claims that depend from claims 4,8,10,14-16 and 18-19 have made it difficult to determine the metes and bounds of those claims in order to perform a proper search of the prior art. As best understood, for the purposes of examination, claim 1 has been interpreted to be a ballon with inflated below a certain volume and the air mover moving a volume of air into and out of the expandable member.
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)(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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/038566 to Johnson et al. (Johnson) (cited by applicant).
In reference to at least claim 1
Johnson discloses a system for limiting inflation of an expandable member in an intravascular circulatory support system of a patient (e.g. system 100) , the system comprising: a drive unit including an air mover and a motor (e.g. controller unit 700 that includes drive mechanism 708; “drive mechanism 708 may be a syringe pump designed to inject or remove fluid from the balloon to inflate or deflate the balloon via the exit ports in fluid communication with the lumen of catheter 102.”, para. [0073]), the air mover having a pneumatic output in fluid connection with the expandable member (e.g. connected via catheter 102, “drive mechanism 708 of catheter controller unit 700 will iteratively introduce small aliquots of gas or fluid, e.g., carbon dioxide, saline, or a mixture of contrast and saline, into the balloon”, para. [0068]), a first end and a second end, wherein the first end is fixed, and the second end is displaceable (e.g. inherently disclosed with syringe pump 708); and an air mover limiter configured to restrict displacement of the second end to under- inflate the expandable member based on the blood pressure of the patient, wherein displacement of the second end moves a volume of air into or out of the expandable member, the volume of air corresponding to the air mover limiter configuration (e.g. para. 0048, figure 1: "catheter 102 may be designed to be used for EPACC"; para. 0021: "The concept of EPACC, in contrast to techniques such as REBOA, works with only partial occlusion of the aorta"; para. 0052: "Sensors 106 may record data indicative of the measured physiological information[. .. ] This data may then be used to determine whether more or less restriction of aortic blood flow is required'; para. 0051 : "For example, sensors 106 may measure physiological parameters including[. .. ] blood pressure proximal or distal or in between the two expandable blood flow regulation devices"; para. 0054: "catheter controller unit 700 automatically adjusts expansion and contraction of expandable blood flow regulation device 104 to adjust the amount of blood flow through the aorta if the measured physiological information falls outside the target physiological range"; therefore, the balloon is controllably under-inflated in order to produce only partial occlusion, i.e. under-inflation, based on the blood pressure of the patient).
Claim(s) 1-3 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 5,169,379 to Freed et al. (Freed) (cited by applicant).
In reference to at least claim 1
Freed discloses a system for limiting inflation of an expandable member in an intravascular circulatory support system of a patient (e.g. system that includes pump 10 having bladder 12) , the system comprising: a drive unit including an air mover (e.g. chamber 85 defined by cylinder 83 and piston 80) and a motor (e.g. drive means 84 that includes a motor lead screw combination, Col. 9, ll. 14), the air mover having a pneumatic output in fluid connection with the expandable member (e.g. outlet 86 connected to conduit line 56, catheter 26, bladder 12), a first end (e.g. for connection to conduit line 56) and a second end (e.g. piston 80), wherein the first end is fixed, and the second end is displaceable (e.g. piston 80); and an air mover limiter configured to restrict displacement of the second end to under- inflate the expandable member based on the blood pressure of the patient, wherein displacement of the second end moves a volume of air into or out of the expandable member, the volume of air corresponding to the air mover limiter configuration (e.g. Col. 8, ll. 29-44; figures 1, 4: "Pressure sensor 27 [. .. ] operably connected to processor 30 [. .. ] to provide a signal corresponding to the drive pressure (DP) of the shuttle gas in pumping bladder 12 or conduit 56. Processor 30 then compares the pressure of shuttle gas in pumping bladder 12, or conduit 56, to the patient's aortic pressure (AP) as monitored by pressure sensor 20 to determine a difference therebetween. If that difference falls above or below predetermined threshold levels, processor 30 generates signals to operate a respective one of the helium fill valve 60 or helium exhaust valve 62 to add or exhaust shuttle gas to shuttle gas circuit 40"; Col. 8, ll. 6-15: "it is possible, in at least one embodiment of the system of the present invention, to perform all of the described functions of common valve 58 by appropriately sensitive manipulation of control valves 48 and 50 to time the inflation and deflation of the pumping bladder. Moreover, and as described in more detail later, control valves 48 and 50 may be replaced with a reciprocating piston type drive for pressurizing and depressurizing the shuttle gas circuit; Col. 8, ll. 44-47: "The threshold levels of the pressure difference are preferably selected to insure complete inflation of pumping bladder 12 without causing over-inflation"; therefore, the piston arrangement 80, 82, 85 of figure 4 can be used to control inflation of bladder 12 based on aortic pressure AP in order to avoid over-inflation of bladder 12, i.e. bladder 12 is controlled to inflate below its physical maximum inflation volume and the volume of air introduced therein corresponds to the controllably limited position of the piston 80).
In reference to at least claim 2
Freed discloses wherein an internal volume of the expandable member is greater than the volume of air (e.g. Col. 8, ll. 6-15, 29-47).
In reference to at least claim 3
Freed discloses wherein the blood pressure of the patient includes a lowest therapeutic diastolic blood pressure for the patient (e.g. aortic pressure at point 128, Fig. 5, Col. 11, ll. 45-56, Col. 13, ll. 52-65).
In reference to at least claim 13
Freed discloses wherein the processor is further configured to control the motor based on one or more EKG signals, wherein the one or more EKG signals are of a patient undergoing therapy (e.g. Fig. 5, “With reference to FIG. 5 there is shown a typical readout of the electrocardiogram (ECG), aortic pressure (AP), and drive line pressure (DP) in conduit 56 for one heart beat represented by successive QRS waves on the electrocardiogram.”, Col. 13, l. 57-Col. 14, l. 8).
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) 5-7 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/038566 to Johnson et al. (Johnson) in view of US 2006/0155161 to Yambe et al. (Yambe).
In reference to at least claim 5
Johnson teaches a system according to claim 1 and further discloses screw actuation of the syringe of drive mechanism 708 (e.g. para. [0080]), therefore a ball screw that includes a helical raceway is disclosed.
However, Johnson does not explicitly disclose the motor includes a rotor and a stator; a ball nut carrying a ball screw, wherein the ball nut is affixed to the rotor.
Yambe in the analogous art of support devices discloses that utilizing a motor (e.g. 24) that has a stator (e.g. 24a) and rotor (e.g. 24b) and a ball nut carrying a ball screw (e.g. 23) to convert rotational motion from the motor into reciprocating motion was known in the art (e.g. “The ball screw 23 converts rotational motion of the motor 24 into reciprocating motion by means of a ball screw. As is well-known, the ball screw 23 has a housing 23b of for example, a cylindrical shape which accommodates a screw bolt 23a and a ball (not shown). The ball in the housing 23b is fitted with the screw bolt 23a. The motor 24 has a stator 24a and a rotor 24b provided within the stator 24a”, para. [0021]).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Johnson to include within screw actuation of the drive mechanism a motor that includes a rotor and a stator and a ball nut carrying a ball screw, wherein the ball nut is affixed to the rotor, as taught by Yambe, as such technique for providing reciprocating motion was well-known in the art and would have been a simple substitution of one known element for another to yield the predictable result of providing screw actuation of the drive mechanism.
In reference to at least claim 6
Johnson modified by Yambe renders obvious a device according to claim 5. Johnson further discloses the second end is defined by a dynamic flange configured to receive the ball screw (e.g. screw actuation of the syringe of drive mechanism 708, para. [0080], therefore the second end is defined by a dynamic flange); and the ball nut includes a plurality of balls that ride within the helical raceway, such that rotation of the rotor causes the plurality of balls to translate such rotation into linear motion of the ball screw within the ball nut, and the second end is fixed to the ball screw (see modified arrangement of Johnson in view of Yambe above within claim 5).
In reference to at least claim 7
Johnson modified by Yambe renders obvious a device according to claim 6. Johnson further discloses wherein the air mover limiter includes one or more of processor-executable instructions for restricting an output of the air mover and a mechanical restriction for restricting the output of the air mover (e.g. “having instructions stored thereon, wherein the instructions, when executed by a processor coupled to the one or more sensors, cause the processor to compare the measured physiological information with a target physiological range such that the catheter controller unit automatically adjusts expansion and contraction of the expandable aortic blood flow regulation device”, para. [0027], [0066]).
In reference to at least claim 20
Johnson modified by Yambe renders obvious a device according to claim 5. Johnson modified by Yambe discloses a helical raceway but does not explicitly teach the pitch of the raceway being approximately 3.5mm and 5.5 mm. It would have been an obvious matter of design choice to modify Johnson modified by Yambe, to have the pitch of the raceway being approximately 3.5mm and 5.5 mm, since applicant has not disclosed that having the pitch of the raceway being approximately 3.5mm and 5.5 mm solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to criticality that the pitch of the raceway is approximately 3.5mm and 5.5 mm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04. Additionally or alternatively, it would have been an obvious matter of design choice to have the pitch of the raceway being approximately 3.5mm and 5.5 mm , since such a modification would have involved a mere change in the size of the component. A change in size is generally recognized as being within the ordinary skill in the art, see MPEP 2144.04 (IV).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2006/0052659 to Topaz et al. which teaches a cardiac device and method which utilizes blood pressure to direct a pneumatic driver. US 2022/0401718 to Kapur et al. which teaches a system for selectively occluding a superior vena cava in which control signals for the drive mechanism monitor physiologic parameters such as blood pressure.
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/JENNIFER L GHAND/Examiner, Art Unit 3796