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 .
Election/Restrictions
Claims 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II and Species II-VII, there being no allowable generic or linking claim. Because the Applicant did not specify whether the election was made with or without traverse, Examiner will assume that the election was made without traverse in the reply filed on November 3rd, 2025.
Applicant’s election without traverse of Invention I and Species I (Claims 1-10 and 19-20) in the reply filed on November 3rd, 2025 is acknowledged.
Abstract
The abstract of the disclosure is objected to because of the following informality:
Line 1 of the Abstract recites “body in disclosed”, but should read “body is disclosed”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 1-10 and 19-20 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
The term “proximal” in claims 1, 7-8, and 19 seem to be used by the claims to mean “closest to the patient” while the accepted meaning is “farthest from the patient.” The term “distal” in claims 1 and 19 seem to be used by the claim to mean “farthest from the patient” while the accepted meaning is “closest to the patient.” The terms are indefinite because the specification does not clearly redefine the terms. Clarification is requested.
Claim 2 recites “at least one of” in line 1. Further in line 2, Claim 2 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or both limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 20 recites “wherein the endoscopic device, the monitor computer, the hosted server, and the database each comprises a computer-readable medium” in lines 1-3. It is unclear as to whether the endoscopic device, the monitor computer, the hosted server, and the database each comprises its own, separate computer-readable medium, or if they are all connected to one computer-readable medium.
Claim 20 recites the limitation "the steps of" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites “an aspiration” in line 7. It is unclear as to whether this is referring to the “aspiration” previously introduced in line 1 of Claim 19, or a separate element.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmidt (U.S. Publication No. 2003/0114796; cited by Applicant).
Regarding Claim 1, Schmidt discloses an endoscopic device for use in a patient's body (device and method for minimally invasive access to the pericardial space of a human; Abstract), comprising:
an outer sheath (exterior sheath 60) having a proximal end and a distal end (exterior sheath 60 has a proximal end and a distal end; Figure 7);
a suction tube (guide tube 14) inside the outer sheath and configured to advance out of the outer sheath (a suction or aspiration force is applied to the lumen of the guide tube to form a bleb of pericardial tissue in the distal lumen of the guide tube. That is, the suction draws the bleb of pericardium into the distal port such that it passes through the lumen opening between the axial shoulders and extends proximal thereto; [0013]);
a removable guidewire (guidewire 19) encapsulated in the suction tube and configured to be pushed towards the proximal end of the outer sheath or pulled out of the suction tube towards the distal end of the outer sheath (An axial lumen 20, is present throughout the length of penetrating body 12, opens distally at penetrating end 47 and proximally at the guide wire port 18 to provide a channel for passing guide wire 19 through the access device 10 into the pericardial space. The outside diameter of the penetrating body 12 should provide for axial mobility within the guide tube lumen 13. The inside diameter of the guide tube lumen 20 should allow for passage of the guide wire 19; [0038])
a handle (handle region 16) coupled to the distal end of the outer sheath (The handle region 16 can include a vacuum inlet assembly 17 and a guide wire port 18 for passing a guide wire 19 through the lumen 20 of penetrating body 12; [0030]); and
a cap (removable cap 62) on the proximal end of the outer sheath (cap 62 is shown on the proximal end of the outer sheath 60; Figure 7), positioned to seal the proximal end of the outer sheath (the exterior sheath 60 is reversibly sealed with a removable cap 62; [0032]; Figure 7),
wherein the suction tube comprises an internal cavity (lumen 13 of guide tube 14) protected by the outer sheath (exterior sheath 60) and the cap (removable cap 62) (Figures 7-8), and
wherein the cap is structured to open in response to a force generated by the guidewire and applied through the suction tube (The removable cap 62 can be forced open by distal advancement of the device 10 within the sheath 60; [0043]).
Regarding Claim 2, Schmidt discloses wherein the cap comprises at least one of: a plastic, a glucose, and any other material that is nontoxic in the body (The distal penetrating end 47 of the penetrating body 12, including the piercing tip 45, should be prepared from a material that can resist deformation when functioning to pierce the pericardium. Suitable materials include, for example, stainless steel, titanium, titanium alloys, etc…if proximal segments are used they can be prepared from any material which is sufficient to maintain a guidewire lumen and function to advance the piercing tip 45 into the pericardium, such as, plastic, stainless steel, titanium, titanium alloy, ceramic, etc; [0039]).
Regarding Claim 4, Schmidt discloses wherein the force comprises at least air pressure, water pressure, or sterile gases, or any combination of air pressure, water pressure, and/or sterile gases exerted by the guidewire that is configured to deploy through a middle of the suction tube (The removable cap 62 can be forced open by distal advancement of the device 10 within the sheath 60; [0043]; Figure 7; Examiner’s Note: The distal advancement of the guidewire would create air pressure through the middle portion of the suction tube).
Regarding Claim 5, Schmidt discloses wherein the suction tube comprises at least one hole (open end at bottom of guide tube 14; Figure 6) or a plurality of holes for carrying out aspiration at a target site inside the patient's body (aspiration is applied to create a suction force (arrow B) to the lumen 13 of guide tube 14 to form a bleb 40 of parietal pericardium 41 which surrounds the heart 42; [0036]; Figure 6).
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 (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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt in view of Gazdzinski (U.S. Publication No. 2002/0103417; cited by Applicant).
Regarding Claim 3, Schmidt fails to disclose wherein the cap comprises a material that is dissolvable in the body.
In a similar technical field, Gazdzinski discloses an improved endoscopic device (Abstract), wherein the cap comprises a material that is dissolvable in the body (The lens cover 308 of the present embodiment is a thin membrane (on the order of a few thousandths of an inch thick) and is comprised of a substantially clear gelatin-like substance comparable to that commonly used to contain and deliver pharmaceutical products (such as so-called “gel caps” which are well known in the pharmaceutical arts) or equivalent thereof. The design and composition of the lens gel substance is, in the present embodiment, controlled so as to provide a timed dissolution within the patient; [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the dissolvable material teachings of Gazdzinski into the invention of Schmidt in order to provide a timed dissolution within the patient (Gazdzinski [0045]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt in view of Kondo (U.S. Patent No. 5,746,696; cited by Applicant).
Regarding Claim 6, Schmidt fails to disclose wherein the outer sheath comprises a metal coil.
In a similar technical field, Kondo discloses a flexible sheathing tube particularly suitable for use on an endoscopic insertion rod (Abstract), wherein the outer sheath comprises a metal coil (Of the flexible sheathing tube 20 with the basic construction as described above, the two helical coil members 21a and 21b are constituted by two separate metal strips which are helically wound in a predetermined open pitch; Column 4 Lines 36-40; Figure 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the metal coil teachings of Kondo into the invention of Schmidt in order to provide a flexible sheathing tube construction particularly suitable for use on endoscopic insertion rods, endoscopic light guide cables and the like (Kondo Column 1 Lines 6-8).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt in view of Annest et al (WO 2009/046343 A1; cited by Applicant).
Regarding Claim 7, Schmidt fails to disclose an inflatable balloon that is stored near the proximal end of the outer sheath and is configured to deploy outside the outer sheath by a force exerted by the guidewire that is configured to deploy through a middle of the suction tube.
In a similar technical field, Annest discloses medical devices, systems, and methods for treating dysfunctional cardiac tissue (Abstract), comprising: an inflatable balloon (balloon 575) that is stored near the proximal end of the outer sheath (As shown in Fig. 14, balloon 575 is expanded; [0086]; Figures 13-15) and is configured to deploy outside the outer sheath by a force exerted by the guidewire (Fig. 13 shows introducer catheter 560 with balloon dilator 570 advanced over guidewire 511; [0086]) that is configured to deploy through a middle of the suction tube (A guidewire or dilator may be advanced through device lumen 12525 while suction may be affected through suction lumen 12515 to stabilize second catheter sheath 12510; [0135]; Figures 125A-125C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the inflatable balloon teachings of Annest into the invention of Schmidt in order to facilitate distal advancement of the system through the heart wall (Annest [0086]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt in view of Fung et al (U.S. Publication No. 2014/0303721 cited by Applicant).
Regarding Claim 8, Schmidt fails to disclose an elliptical basket that is stored near the proximal end of the outer sheath and is configured to deploy outside the outer sheath by a force exerted by the guidewire that is configured to deploy through a middle of the suction tube.
In a similar technical field, Fung discloses methods and devices for accessing and delivering devices (Abstract), comprising: an elliptical basket that is stored near the proximal end of the outer sheath and is configured to deploy outside the outer sheath (Expandable members (1532) and (1534) may be any suitable expandable structure, such as those described above (e.g., a balloon, an expandable mesh, basket, cage, or the like); [0114]; Figure 15D) by a force exerted by the guidewire (The lumen (706) may be configured for the passage of tools or fluids therethrough. For example, the lumen (706) may provide for the passage of a guide element (with or without an alignment member), a guidewire, a tissue-access device, a suture cutter, fluids and/or drugs, and the like; [0075]) that is configured to deploy through a middle of the suction tube (the access devices may be used to assist in the positioning and operation of devices within the heart…a piercing member and guide wire may be advanced thereto and create an access site in the left atrial appendage as previously described; [0062]; [0126]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the expandable basket teachings of Fung into the invention of Schmidt in order to provide access of the interior and exterior of the heart, as well as the delivery of devices from the exterior to the interior of the heart, and vice versa (Fung [0062]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt in view of Chikama (U.S. Patent No. 5,154,166; cited by Applicant).
Regarding Claim 9, Schmidt discloses wherein the handle is configured to be connected to a syringe filled with gas (The handle region 16 can include a vacuum inlet assembly 17 and a guide wire port 18 for passing a guide wire 19 through the lumen 20 of penetrating body 12; [0030]).
Schmidt fails to disclose wherein the syringe is connected to the suction tube in order to remove the cap through gas pressure generated by the syringe.
In a similar technical field, Chikama discloses an endoscope cover (Abstract), wherein the syringe is connected to the suction tube in order to remove the cap through gas pressure generated by the syringe (air is injected into the covering member 7 from the air-injecting opening 7a to separate the endoscope cover from the endoscope; Column 4 Lines 38-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the gas pressure teachings of Chikama into the invention of Schmidt in order to facilitate removal of the cover without contaminating the endoscope (Chikama Column 4 Lines 38-50).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt in view of Mobasser et al (U.S. Publication No. 2014/0031668; cited by Applicant).
Regarding Claim 19, Schmidt discloses a system for carrying out an aspiration inside a patient's body (a device and method for safe access to the pericardial space without injury to the heart, in order to aspirate fluids directly from or to directly deliver fluids, i.e., therapeutic drugs, to the heart muscle or associated vasculature; [0011]) comprising:
an endoscopic device (insertion of an endoscope into the thoracic cavity; [0042]) comprising:
an outer sheath (exterior sheath 60) having a proximal end and a distal end (exterior sheath 60 has a proximal end and a distal end; Figure 7);
a suction tube (guide tube 14) inside the outer sheath and configured to advance out of the outer sheath (a suction or aspiration force is applied to the lumen of the guide tube to form a bleb of pericardial tissue in the distal lumen of the guide tube. That is, the suction draws the bleb of pericardium into the distal port such that it passes through the lumen opening between the axial shoulders and extends proximal thereto; [0013]);
a removable guidewire (guidewire 19) encapsulated in the suction tube and configured to be pushed towards the proximal end of the outer sheath or pulled out of the suction tube towards the distal end of the outer sheath (An axial lumen 20, is present throughout the length of penetrating body 12, opens distally at penetrating end 47 and proximally at the guide wire port 18 to provide a channel for passing guide wire 19 through the access device 10 into the pericardial space. The outside diameter of the penetrating body 12 should provide for axial mobility within the guide tube lumen 13. The inside diameter of the guide tube lumen 20 should allow for passage of the guide wire 19; [0038]);
a handle (handle region 16) coupled to the distal end of the outer sheath (The handle region 16 can include a vacuum inlet assembly 17 and a guide wire port 18 for passing a guide wire 19 through the lumen 20 of penetrating body 12; [0030]); and
a cap (removable cap 62) on the proximal end of the outer sheath (cap 62 is shown on the proximal end of the outer sheath 60; Figure 7) and positioned to seal the proximal end of the outer sheath (the exterior sheath 60 is reversibly sealed with a removable cap 62; [0032]; Figure 7),
wherein the suction tube comprises an internal cavity (lumen 13 of guide tube 14) protected by the outer sheath (exterior sheath 60) and the cap (removable cap 62) (Figures 7-8), and
wherein the cap is structured to open in response to a force generated by the guidewire and applied through the suction tube (The removable cap 62 can be forced open by distal advancement of the device 10 within the sheath 60; [0043]).
Schmidt fails disclose a network; a monitor computer; a hosted server; and a database, wherein the network, the monitor computer, the hosted server, the database are all coupled to each other via communication links.
In a similar technical field, Mobasser discloses surgical and medical instrument tracking using a depth-sensing device (Abstract), comprising
a network (Computer system 1010 includes…Fibre Channel network 1090; [0070]; Figure 9);
a monitor computer (display their location relative to the patient's radiographic anatomy on a computer monitor; [0043]; display 202 or monitor, such as a high resolution monitor or other device; [0053]; Computer system 1010 includes…display screen 1024; [0070]);
a hosted server (Modem 1047 may provide a direct connection to a remote server via a telephone link or to the Internet via an Internet service provider (ISP). Network interface 1048 may provide a direct connection to a remote server; [0072]; a network architecture 1100 in which client systems 1110, 1120 and 1130, as well as storage servers 1140A and 1140B…such a client allows client systems 1110, 1120, and 1130 to access data hosted by storage server 1140A or 1140B; [0074-0075]);
a database (it may be advantageous for the memory 208 to have a database of instruments available to the surgeon. The database may have specification information regarding the various available instruments including, for example, length, width, height, circumference, angles, and the like such that even if only a portion of the instrument is visible, processor 204 or 320 can determine the orientation and hence the location of the entire instrument. In one exemplary embodiment, the processor obtains, for example, a set of dimensions of the visible instrument 212 and compares the same to a database of instrument dimensions stored in memory 208; [0060]),
wherein the network, the monitor computer, the hosted server, the database are all coupled to each other via communication links (Computer system 1010 includes a bus 1012 which interconnects major subsystems of computer system 1010, such as a central processor 1014, a system memory 1017…Bus 1012 allows data communication between central processor 1014 and system memory 1017…applications can be in the form of electronic signals modulated in accordance with the application and data communication technology when accessed via network modem 1047 or interface 1048; [0070-0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the computer network teachings of Mobasser into the invention of Schmidt in order to provide centralized monitoring, feedback, and/or input for multiple procedures occurring either in the same procedure or operating room, in different operating rooms in the same building or campus, or located at multiple locations and facilities (Mobasser [0058]).
Regarding Claim 20, Schmidt discloses removing the cap (The removable cap 62 can be forced open by distal advancement of the device 10 within the sheath 60; [0043]); deploying the suction tube (The removable cap 62 can be forced open by distal advancement of the device 10 within the sheath 60; [0043]); and carrying out an aspiration via at least one hole or a plurality of holes of the suction tube in order to collect a sample from the patient's body (a suction or aspiration force is applied to the lumen of the guide tube to form a bleb of pericardial tissue in the distal lumen of the guide tube; [0013]).
Schmidt fails to disclose, wherein the endoscopic device, the monitor computer, the hosted server, and the database each comprises a computer-readable medium tangibly embodying a computer readable program code having computer readable instructions.
Mobasser discloses a monitor computer (display their location relative to the patient's radiographic anatomy on a computer monitor; [0043]; display 202 or monitor, such as a high resolution monitor or other device; [0053]; Computer system 1010 includes…display screen 1024; [0070]), the hosted server (Modem 1047 may provide a direct connection to a remote server via a telephone link or to the Internet via an Internet service provider (ISP). Network interface 1048 may provide a direct connection to a remote server; [0072]; a network architecture 1100 in which client systems 1110, 1120 and 1130, as well as storage servers 1140A and 1140B…such a client allows client systems 1110, 1120, and 1130 to access data hosted by storage server 1140A or 1140B; [0074-0075]); the database (it may be advantageous for the memory 208 to have a database of instruments available to the surgeon. The database may have specification information regarding the various available instruments including, for example, length, width, height, circumference, angles, and the like such that even if only a portion of the instrument is visible, processor 204 or 320 can determine the orientation and hence the location of the entire instrument. In one exemplary embodiment, the processor obtains, for example, a set of dimensions of the visible instrument 212 and compares the same to a database of instrument dimensions stored in memory 208; [0060]) each comprises a computer-readable medium tangibly embodying a computer readable program code having computer readable instructions (Applications resident with computer system 1010 are generally stored on and accessed via a computer readable medium, such as a hard disk drive (e.g., fixed disk 1044), an optical drive (e.g., optical drive 1040), a floppy disk unit 1037, or other storage medium. Additionally, applications can be in the form of electronic signals modulated in accordance with the application and data communication technology when accessed via network modem 1047 or interface 1048; [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the computer readable medium teachings of Mobasser into the invention of Schmidt in order to store digital data or software instructions in a structured format that computers can automatically read, process, and interpret.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt and Chikama as applied to claim 9 above, and further in view of Parker et al (WO 2012/051545 A2; cited by Applicant).
Regarding Claim 10, Schmidt and Chikama fail to disclose wherein the gas is an inert gas.
In a similar technical field, Parker discloses an endoscopic sheath assembly (Abstract), wherein the gas is an inert gas (A source of air (or other gas, such as helium) can then be used to pressurize the scope lumen 44; [0051]; Examiner’s Note: Helium is an inert gas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the inert gas teachings of Parker into the invention of Schmidt in order to prevent unwanted chemical reactions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J JHIN whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J JHIN/Examiner, Art Unit 3791