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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). A certified copy of Parent Application 202411065509.4, filed in China on 05 August 2024 has been received.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 1 calls for “… comprising an intracorporeal catheter [[extending]] configured to extend into a descending aorta and …” which should be revised to remove the descending aorta from the claim scope.
Applicant is recommended to use inferential language (e.g. configured to, adapted to or whereby) to avoid positively claiming the human body.
Claims 2-17 are rejected for depending on a rejected parent claim.
Claim Rejections - 35 USC § 112(b)
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 1-17 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 1 calls for “… when the elastic respiratory chamber membrane expands, a vacuum is formed inside the respiratory chamber, allowing the extracorporeal balloon to be blown in an opposite direction …”
This language is ambiguous because the extracorporeal balloon does not appear to travel or relocate itself, but instead expands and contracts under the influence of external pressure.
This language is also ambiguous because the claim does not describe or suggest any first direction to define the “opposite direction.”
Examiner suggests to revise this feature in terms of “… when the elastic respiratory chamber membrane expands, a vacuum is formed inside the respiratory chamber, [[allowing]] causing the extracorporeal balloon to [[be blown in an opposite direction]] inflate …”
Claim 4 calls for “… and the first end and the second end of the diaphragm are inclined, such that …” This language is ambiguous because Figs. 6-7 depict a cross-section of the diaphragm’s sides, but not its ends. The diaphragm’s sides form a crescent or horn shape, while the two ends are not depicted in detail.
Examiner suggests to revise this feature in terms of “… and [[the]] a first [[end]] side and [[the]] a second [[end]] side of the diaphragm are inclined, such that …”
Claims 2, 3 and 5-17 are rejected for depending on a rejected parent claim.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter.
Robinson; William J. et al. (US 4240409 A), the closest art of record, discloses a pulsation device with an extracorporeal respiratory chamber (col. 3, lines 5-10, FIG. 1 and includes a valveless blood pump 20 which is powered by a pneumatic driver 22);
comprising an intracorporeal catheter configured to communicate with a descending aorta (col. 5, lines 25-30, the circulatory assist device may be connected as shown in FIG. 2 to a left heart position such as the thoracic aorta (68), abdominal aorta (70), or femoral artery (72)); and
a respiratory chamber assembly located outside a body (col. 3, lines 40-45, FIG. 1 … a separate pulse limiter 24 interposed between driver 22 and pump 20);
an outer end of the intracorporeal catheter is hermetically connected to an extracorporeal balloon (col. 3, lines 60-65, Pump 20 comprises a flexible bladder 26 … Bladder 26 may be fabricated of polyurethane); and
the respiratory chamber assembly comprises a housing, a piston driving mechanism and an elastic respiratory chamber membrane (col. 3, lines 45-50, Diaphragm 30 forms part of a closed pneumatic system confining a fixed quantity of compressible gas in the volume between diaphragm 30 and the bladder 26);
However, Robinson does not wrap an open end of the elastic respiratory chamber membrane around the extracorporeal balloon. Instead, Robinson arranges the membrane and balloon in separate housings (Fig. 1, diaphragm 30 is arranged inside pulse limiter 24 and bladder 26 are arranged inside pump 20).
Robinson does not teach or suggest to arrange bladder 26 inside the pulse limiter 24, or to enclose bladder 26 inside diaphragm 30. Robinson teaches away from arranging bladder 26 inside the pulse limiter 24, since the pulse limiter 24 relies on the precise dimensions of its housing to define a limited volume and to constrain the bladder 26 against deforming too far (col. 3, lines 45-60, Diaphragm 30 forms part of a closed pneumatic system confining a fixed quantity of compressible gas in the volume between diaphragm 30 and the bladder 26 … limits the magnitude of the pulses transmitted to bladder 26 to a predetermined maximum independently of the magnitude of the pulses applied by driver 22).
Also of record, Hu, Sheng-shou et al. (CN 114733063 A) discloses a pulsation device including a respiratory chamber assembly (¶ [0026], As shown in FIG. 3, the in vitro pressing part comprises hard cavity 21); and
an extracorporeal balloon (¶ [0026], in vitro flexible bag 13);
However, Hu does not wrap an open end of an elastic respiratory chamber membrane around the extracorporeal balloon. Instead, Hu actuates the balloon with a rigid plate (¶ [0026], In this embodiment, the pressing member 22 by a push plate, the push rod 23 connected with the motor 24, the motor through the power supply line 25 connected with the controller 26; ¶ [0031], by pushing plate pressing way is an example, linear motor 24 through the push plate 22 connected with the push rod 23).
Another cited reference, Wang, Zong-Tao et al. (CN 216877594 U), discloses a counterpulsation device comprising an intracorporeal catheter (¶ [0001], a left ventricular auxiliary device; ¶ [0025], As shown in FIG. 1 is an embodiment of a left ventricle auxiliary device, comprising a catheter 1);
a respiratory chamber assembly (¶ [0026], Specifically, it further comprises an elastic bracket 5 sleeved on the outer wall of the outer sacculus 3, the elastic bracket 5 is used for limiting the volume expansion of the external sacculus 3);
the outer end of the intracorporeal catheter is hermetically connected to an extracorporeal balloon (¶ [0025], the sealing balloon 2 is connected with the catheter 1);
an open end of an elastic respiratory chamber membrane wraps around the extracorporeal balloon and is hermetically connected to an outer side of a base of the extracorporeal balloon (¶ [0025], an external balloon 3 wrapping the sealing balloon 2).
However, Wang’s respiratory chamber assembly lacks a piston driving mechanism. Instead, Wang operates the respiratory chamber assembly solely with pneumatic pressure (¶ [0029], when the air supply device 4 the external balloon 3 of the gas, sealing the sacculus 2 pressure is reduced, due to the negative pressure action, suction flap 101 will be opened, discharging valve 102 will be closed, left ventricular blood into the conduit 1 into the sealing balloon 2. after a period of time, the air supply device 4 is started, injecting inert gas such as nitrogen into the external balloon 3).
The following newly cited references fail to teach or suggest all limitations of the amended claims.
Pfeifer; Joerg et al. (US 20170056574 A1) discloses a catheter system (¶ [0008], [0009], [0063] FIGS. 2A and 2B show in a schematic section view an improved catheter 1);
including an intracorporeal catheter (¶ [0061], The fluid line 6 is open on the end thereof which faces away from the internal space, such that the fluid is transported from the internal space V through the line 6 and can exit at the end thereof);
a respiratory chamber assembly (¶ [0061], a metal cage as a frame 2); and
an extracorporeal balloon (¶ [0063], The balloon 14 of the balloon catheter 4).
However, Pfeifer does not hermetically connect an outer end of the intracorporeal catheter to the extracorporeal balloon. Instead, Pfeifer’s balloon connects to a fluid pump (¶ [0063], The balloon 14 of the balloon catheter 4 is arranged in the internal space V of the sleeve 3, the auxiliary fluid line 8 of which is guided out through the third opening 7 to the pump P).
Pfeifer also lacks a piston driving mechanism and instead propels fluid through the catheter pneumatically (¶ [0061], an extracorporeal pump P which alternatingly pumps the auxiliary fluid into the balloon catheter and withdraws the same therefrom);
Pfeifer; Joerg et al. (US 20200121838 A1) discloses a similar pulsation system with the same deficiencies.
Sun, Xingguo (WO 2019024111 A1) discloses a piston pump (p. 7, lines 20-30, The pulsating member 2 is slidable within the cylinder block 31 and is kept sealed from the inner wall of the cylinder block 31 … Thus, when the pulsating member 2 slides in the cylinder block 31, the volume of the chamber 1 changes, Thereby simulating the pulsation of the ventricle; p. 9, lines 25-30, as shown in Figs. 1, 2, the pulsating member 2 is preferably a piston. Accordingly, the cardiac simulation device can also include a rotary machine and a linkage assembly 41 that forms a crank linkage with the piston).
However, Sun lacks an elastic respiratory chamber membrane that wraps around an extracorporeal balloon and instead divides the chamber into two compartments with a membrane (p. 8, lines 1-15, Further preferably, as shown in FIG. 1, a soft film 32 may be disposed between the pulsating member 2 and the sealing end, and an edge of the soft film 32 is sealingly connected to the sealing member. Thus, encapsulation between the soft film 32 and the sealed end forms a substantially sealed area that acts as the chamber 1).
Lu; Pong-Jeu et al. (EP 4267232 B1) discloses a system including an extracorporeal balloon (¶ [0061], The blood sac 529 is formed by an oval-shaped sac membrane 526).
However, Lu lacks does not wrap an elastic membrane around the extracorporeal balloon and instead encloses the balloon in a rigid shell (¶ [0061], the blood sac 529 is anchored via a proximal stem 530 to the proximal shell 523 of the pump housing 52h and via a distal stem 540 to the distal shell 525 of the pump housing 52h).
Each of the following newly cited references describes a piston pump for operating an intravascular device. However, none of the references discloses an elastic membrane that wraps around an extracorporeal balloon.
Steingräber; Robert (US 20220111196 A1)
Barzilay; Amir et al. (US 20060030809 A1)
Steingräber; Robert et al. (US 20220387780 A1)
Rahat; Shumel et al. (US 5098370 A)
Clay; Warren C. (US 4047849 A)
Imanishi Kaoru et al. (DE 19637723 A1)
Li, Jin-Shan et al. (CN 116159238 A)
Each of the following newly cited references describes an intravascular catheter system. However, none of the references discloses an elastic membrane wraps that around an extracorporeal balloon. Instead, these references rely on a flat membrane that divides a chamber into two compartments.
Yu, Yang et al. (CN 115192893 A)
Zhang, Hai-Jun et al. (CN 113967316 A)
Conclusion
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights