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 .
This action is in response to the amendment filed on 06/25/2026. Claims 1-11 and 13-30 are pending. Claims 1, 16, 25, and 29 are independent. Claims 16-24 are withdrawn. Claim 12 is canceled.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, the line for the limitation “an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target” is not properly indented because the ultrasound module is neither part of the first anastomosis device component nor part of the second anastomosis device component. Instead, the ultrasound module is another part of the system.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-11, 13-15, 25-30 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.
- Claim 1 recites the limitation “an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target” which does not have sufficient support in the original disclosure and is considered as new matter. Although the specification describes that system includes an ultrasound module, however it does not describe that the ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target.
- Claim 15 recites the limitation “an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target” which does not have sufficient support in the original disclosure and is considered as new matter. Although the specification describes that system includes an ultrasound module, however it does not describe that the ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target. Furthermore, claim 15 recites the limitations “wherein the first anastomosis device or the second anastomosis device comprises a flange during a therapeutic configuration; an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target” which is redundant of the limitations in claim 1 from which it depends and raise new matter issue because the disclosure does not further disclose another ultrasound module and that either the first anastomosis device or the second anastomosis device has another flange.
- Claim 25 recites the limitation “an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target” which does not have sufficient support in the original disclosure and is considered as new matter. Although the specification describes that system includes an ultrasound module, however it does not describe that the ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target.
- Claim 29 recites the limitation “an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target” which does not have sufficient support in the original disclosure and is considered as new matter. Although the specification describes that system includes an ultrasound module, however it does not describe that the ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target.
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.
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.
Claim(s) 1, 2, 5-7, 25, 29, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison et al. (US Pub. No.: 2013/0253548) in view of Carson et al. (US Pub. No.: 2005/0080439) and Requarth (US Pub. No.: 2012/0197061).
Regarding claims 1, 2, 5, and 6, Harrison discloses [claim 1] a system (300, Fig. 3; alternatively, 400, Fig. 4) capable of forming an anastomosis between a first layer of tissue and a second layer of tissue of a patient’s body, the system comprising: a first anastomosis device component (first implant 110, see paragraph [0016]) capable of being delivered to a first lumen inside the patient’s body; and a second anastomosis device component (second implant 120, see paragraph [0016]) configured to be delivered to a second lumen inside the patient’s body, the second anastomosis device component capable of interacting with the first anastomosis device component, the second anastomosis device component comprising: one or more sensors (force sensor 310 or 410, Fig. 3 or 4 and see paragraph [0020]) capable of capturing sensor data for determining an alignment of the second anastomosis device component relative to the first anastomosis device component or for characterizing the position or orientation of the second anastomosis device component in three- dimensional space (Paras. [0022]-[0024]). [claim 2] a controller configured to receive the sensor data captured by the one or more sensors of the second anastomosis device component and configured to determine a distance between the first anastomosis device component and the second anastomosis device component (Para. [0024], as measured or determined data gathered from a sensor and displayed indicates the presence of a controller or processor to enable the transmission and display of such data); [claim 5] wherein the first anastomosis device component comprises one or more magnetic elements (magnet 114, see paragraph [0024]), and wherein the second anastomosis device component comprises one or more magnetic elements (magnet 124, see paragraph [0024]) capable of interacting with the one or more magnetic elements of the first anastomosis device component through the first layer of tissue and the second layer of tissue; and [claim 6] wherein the one or more sensors comprise a force sensor configured to sense a force exerted on the second anastomosis device component due to an interaction between the one or more magnetic elements of the first anastomosis device component and the one or more magnetic elements of the second anastomosis device component (Paras. [0022]-[0024]). However, Harrison does not disclose that the first anastomosis device component or the second anastomosis device component comprises a flange during a therapeutic configuration; and an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target.
Carson teaches, in the same field of endeavor (anastomosis device), anastomosis device (622, Fig. 68A) comprising a flange (628, Fig. 68A) during a therapeutic configuration (Fig. 68A and Para. [0247]).
Before effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the first anastomosis device component or the second anastomosis device component of Harrison to include a flange during a therapeutic configuration as taught by Carson in order to obtain the advantage of allowing adhesive to be placed between the anastomosis device component and the vessel bond the anastomosis device component to the vessel wall in fluid-tight fashion (Carson, Para. [0247]).
Requarth teaches, in the same field of endeavor (anastomosis forming system), an ultrasound module (Paras. [0053] and [0075]) configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target (Paras. [0053] and [0075]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Harrison to include an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target as taught by Requarth in order to obtain the advantage of confirming the correction positions of the anastomosis device components and/or the catheter for delivering the anastomosis device components (Requarth, Paras. [0053] and [0075]).
Regarding claim 7, Harrison discloses wherein the one or more magnetic elements of the first anastomosis device component and the one or more magnetic elements of the second anastomosis device component are selected such that, when the first anastomosis device component and second anastomosis device component are separated by a distance, a magnetic force between the first anastomosis device component and second anastomosis device component is created.
Harrison is silent about the distance being 4mm, and the magnetic force being between 0.2 Newtons and 20 Newtons.
Harrison recognizes the magnetic force and the distance between the devices are result effective variables for the purpose of creating an anastomosis. See paragraphs [0007], [0018].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Harrison in view of Carson and Requarth by adjusting the strength of the magnetic materials such that the one or more magnetic elements of the first anastomosis device component and the one or more magnetic elements of the second anastomosis device component are selected such that, when the first anastomosis device component and second anastomosis device component are separated by 4mm, a magnetic force between the first anastomosis device component and second anastomosis device component is between 0.2 Newtons and 20 Newtons because it would only represent optimizing a result effective variable since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 25, Harrison discloses a system for anastomosis creation (system 400, Fig. 4), comprising: a first anastomosis device component configured to be delivered to a first lumen inside a patient's body (first implant 110, Fig. 4 and Paras. [0018]-[0019]); a second anastomosis device component configured to be delivered to a second lumen inside the patient's body (second implant 120, Fig. 4 and Paras. [0018]-[0019]); one or more sensors configured to capture sensor data for determining an alignment of the second anastomosis device component relative to the first anastomosis device component, or determining a position and orientation of the first anastomosis device component and the second anastomosis device component (Hall effect sensor 110, Fig. 4 and Para. [0024]); and a display for displaying information derived from the sensor data captured by the ·one or more sensors (measured or determined data can then be displayed to the surgeon, Para. [0024]). However, Harrison does not disclose that the first anastomosis device component or the second anastomosis device component comprises a flange during a therapeutic configuration; and an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target.
Carson teaches, in the same field of endeavor (anastomosis device), anastomosis device (622, Fig. 68A) comprising a flange (628, Fig. 68A) during a therapeutic configuration (Fig. 68A and Para. [0247]).
Before effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the first anastomosis device component or the second anastomosis device component of Harrison to include a flange during a therapeutic configuration as taught by Carson in order to obtain the advantage of allowing adhesive to be placed between the anastomosis device component and the vessel bond the anastomosis device component to the vessel wall in fluid-tight fashion (Carson, Para. [0247]).
Requarth teaches, in the same field of endeavor (anastomosis forming system), an ultrasound module (Paras. [0053] and [0075]) configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target (Paras. [0053] and [0075]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Harrison to include an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target as taught by Requarth in order to obtain the advantage of confirming the correction positions of the anastomosis device components and/or the catheter for delivering the anastomosis device components (Requarth, Paras. [0053] and [0075]).
Regarding claim 29, Harrison discloses a system for anastomosis creation (system 400, Fig. 4), comprising: a first device component configured to be delivered to a first lumen inside a patient's body and configured to create an anastomosis (first implant 110, Fig. 4 and Paras. [0018]-[0019]); a second device component configured to be delivered to a second lumen inside the patient's body (second implant 120, Fig. 4 and Paras. [0018]-[0019]); one or more sensors configured to capture sensor data for determining an alignment of the second device component relative to the first device component, or determining a position and orientation of the first device component and the second device component (Hall effect sensor 110, Fig. 4 and Para. [0024]); and a display for displaying information derived from the sensor data captured by the one or more sensors (measured or determined data can then be displayed to the surgeon, Para. [0024]). However, Harrison does not disclose that the first anastomosis device component or the second anastomosis device component comprises a flange during a therapeutic configuration; and an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target.
Carson teaches, in the same field of endeavor (anastomosis device), anastomosis device (622, Fig. 68A) comprising a flange (628, Fig. 68A) during a therapeutic configuration (Fig. 68A and Para. [0247]).
Before effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the first anastomosis device component or the second anastomosis device component of Harrison to include a flange during a therapeutic configuration as taught by Carson in order to obtain the advantage of allowing adhesive to be placed between the anastomosis device component and the vessel bond the anastomosis device component to the vessel wall in fluid-tight fashion (Carson, Para. [0247]).
Requarth teaches, in the same field of endeavor (anastomosis forming system), an ultrasound module (Paras. [0053] and [0075]) configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target (Paras. [0053] and [0075]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Harrison to include an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target as taught by Requarth in order to obtain the advantage of confirming the correction positions of the anastomosis device components and/or the catheter for delivering the anastomosis device components (Requarth, Paras. [0053] and [0075]).
Regarding claim 30, Carson further discloses a device component of a system for anastomosis creation that includes a stent (second portion 470 of magnetic anastomotic component 466, Figures 53A-53B; see also Para. [0220]).
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Harrison in view of Carson and Requarth to further include that the first device component includes a stent, as taught by Carson in order the obtain the advantage of having a configuration exerts pressure against the interior surface of the wall of a hollow body in a manner that secures the magnetic anastomotic component to the hollow wall (Carson, Para. [0220]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison et al. (US Pub. No.: 2013/0253548) in view of Carson et al. (US Pub. No.: 2005/0080439) and Requarth (US Pub. No.: 2012/0197061) applied to claim 1 above, and further in view of Wakefield (US Pub. No.: 2004/0199054).
Regarding claim 4, Harrison in view of Carson and Requarth discloses all the limitations of claim 1 as taught above but fails to disclose the one or more sensors comprise at least one accelerometer, gyroscope, ultrasound sensor, and light-based oxygen sensor.
Wakefield, from a related field of endeavor teaches a similar system with a device with one or more sensors, where one sensor comprises a gyroscope or accelerometer, for the purpose of tracking the position of the device.
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Harrison in view of Carson and Requarth to include one of the gyroscopes or accelerometers disclosed by Wakefield into the system disclosed by in order to track the position of the device.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison et al. (US Pub. No.: 2013/0253548) in view of Carson et al. (US Pub. No.: 2005/0080439) and Requarth (US Pub. No.: 2012/0197061) applied to claim 1 above, and further in view of Beisel (US Pub. No.: 2013/0253550). Regarding claims and 8 and 9, Harrison in view of Carson and Requarth discloses all the limitations of claim 1 as taught above but fails to disclose wherein the first anastomosis device component comprises a first structure that can be filled with a gas or liquid, and wherein the second anastomosis device component comprises a second structure that can be filled with a gas or liquid, wherein at least one of the first structure of the first anastomosis device and the second structure of the second anastomosis device enlarges and becomes rigid upon forcing the gas or liquid into said structure.
Beisel et al., from the same field of endeavor teaches a similar first anastomosis structure as shown in Figure 11, where first anastomosis structure comprises a first structure (balloon material) that can be filled with a gas or liquid, wherein at least one of the first structure of the first anastomosis device and the second structure of the second anastomosis device enlarges and becomes rigid upon forcing the gas or liquid into said structure, for the purpose of serving as an anchor to the magnet.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Harrison in view of Carson and Requarth to include a first structure that can be filled with a gas or liquid in the first anastomosis device component and a second structure that can be filled with a gas or liquid, wherein at least one of the first structure of the first anastomosis device and the second structure of the second anastomosis device enlarges and becomes rigid upon forcing the gas or liquid into said structure, as suggested by Beisel, in order to anchor the first and second anastomosis devices.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison et al. (US Pub. No.: 2013/0253548) in view of Carson et al. (US Pub. No.: 2005/0080439), Requarth (US Pub. No.: 2012/0197061), and Beisel (US Pub. No.: 2013/0253550) as applied to claim 8 above, and further in view of Stack et al. (US Pub. No.: 2002/0042625).
Regarding claim 10, Harrison in view of Carson, Requarth, and Beisel discloses all the limitations of claim 8 as taught above but fails to disclose the liquid is saline, and wherein at least one of the first structure and the second structure is made of nylon.
Stack, from a related field of endeavor teaches a similar fillable structure as shown in Figure 1 where wherein at least one of the first structure and the second structure is made of nylon. see paragraph [0052].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the claimed invention such that liquid is saline, and wherein at least one of the first structure and the second structure is made of nylon by substituting the fluid used to fill the balloon and the material of the balloon disclosed by Harrison in view of Carson, Requarth, and Beisel for the fluid used to fill the balloon and the material of the balloon disclosed by Stack because it would only require the simple substitution of one known material for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison et al. (US Pub. No.: 2013/0253548) in view of Carson et al. (US Pub. No.: 2005/0080439) and Requarth (US Pub. No.: 2012/0197061) applied to claim 1 above, and further in view of Dinger et al. (US Pub. No.: 2002/0128672).
Regarding claim 11, Harrison in view of Carson and Requarth discloses all the limitations of claim 1 as taught above but fails to disclose the first anastomosis device component comprises a first mesh or woven structure that can be transitioned between a deployment configuration and a therapeutic configuration, and wherein the second anastomosis device component comprises a second mesh or woven structure that can be transitioned between a deployment configuration and a therapeutic configuration.
Dinger, from the same field of endeavor teaches a similar system as shown in Figure 22 where the first anastomosis device has a mesh structure (section 24, see paragraph [0039]) capable of being transitioned between a deployment configuration and a therapeutic (dinger discloses the mesh 24 capable of at least two configurations biased and unbiased), for the purpose of biasing a graft between the first and second anastomosis devices and providing a surface through which sutures may be attached.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the claimed invention of Harrison in view of Carson and Requarth such that wherein the first anastomosis device component comprises a first mesh or woven structure that can be transitioned between a deployment configuration and a therapeutic configuration, and wherein the second anastomosis device component comprises a second mesh or woven structure that can be transitioned between a deployment configuration and a therapeutic configuration as taught by Dinger in order to configure the first and second anastomosis devices to bias a graft from either end and provide a surface through which sutures may be attached.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison et al. (US Pub. No.: 2013/0253548) in view of Carson et al. (US Pub. No.: 2005/0080439) and Requarth (US Pub. No.: 2012/0197061) applied to claim 1 above, and further in view of Lukin (US Pub. No.: 2016/0022266).
Regarding claim 13, Harrison in view of Carson and Requarth discloses all the limitations of claim 1 as taught above but fails to disclose one or more effectors for manipulating at least one of the first anastomosis device component and the second anastomosis device component based at least on the sensor data captured by the one or more sensors of the second anastomosis device component.
Lukin et al., from the same field of endeavor teaches a similar system as shown in Figure 26 with one or more effectors (laparoscopic grasper 1740, see paragraph [0093) capable of manipulating at least one of the first anastomosis device component and the second anastomosis device component based at least on the sensor data captured by one or more sensors of second anastomosis device component (if read by the surgeon and manipulated by hand), for the purpose of adjusting the position of the devices.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Harrison in view of Carson and Requarth to include the laparoscopic grasper 1740 such that the system had one or more effectors for manipulating at least one of the first anastomosis device component and the second anastomosis device component based at least on the sensor data captured by the one or more sensors of the second anastomosis device component in order to adjust the position of the devices.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Harrison et al. (US Pub. No.: 2013/0253548) in view of Carson et al. (US Pub. No.: 2005/0080439) and Requarth (US Pub. No.: 2012/0197061) and Lukin et al. (US Pub. No.: 2016/0022266) as applied to claim 13 above, and further in view of Crew (US Pub. No.: 2004/0215214)
Regarding claim 14, Harrison in view of Carson and Requarth and Lukin discloses all the limitations of claim 13 as taught above but fails to disclose wherein the one or more effectors comprise one of an end effector of an endoscopic robotic surgical system and an end effector of a laparoscopic robotic surgical system.
Crews, from a related field of endeavor, teaches a similar system as shown in Figure 9A where the system includes similar effectors used for the same purpose of manipulating the system, where the effector is an end effector of a laparoscopic robotic surgical system. See paragraph [0059]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Harrison in view of Carson and Requarth and Lukin by substituting the effector disclosed by Harrison in view of Carson and Requarth and Lukin for the end effector of a laparoscopic robotic surgical system disclosed by Crews because it would only require the simple substitution of one known material for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison et al. (US Pub. No.: 2013/0253548) in view of Carson et al. (US Pub. No.: 2005/0080439) and Requarth (US Pub. No.: 2012/0197061) applied to claim 1 above, and further in view of Lukin (US Pub. No.: 2016/0022266) and Berman et al. (US Pub. No.: 2019/0000560)
Regarding claim 15, Harrison in view of Carson and Requarth discloses all the limitations of claim 1 as taught above but fails to disclose a first endoscope configured to hold the first anastomosis device component to deliver the first anastomosis device component to the first lumen inside the patient’s body, the first endoscope comprising one or more endoscope sensors for determining a position and orientation of a tip of the first endoscope; a second endoscope configured to hold the second anastomosis device component to deliver the second anastomosis device component to the second lumen inside the patient’s body, the second endoscope comprising one or more endoscope sensors for determining a position and orientation of a tip of the second endoscope; and a display device for displaying configured to display a video feed overlaid with a first marker corresponding to the first endoscope and a second marker corresponding to the second endoscope, wherein a position of the first marker and a position of the second marker are determined based on sensor information captured by the one or more sensors of the first endoscope and the one or more sensors of the second endoscope.
Lukin et al., from the same field of endeavor teaches a similar system as shown in Figure 20B where the system includes a first endoscope configured to hold the first anastomosis device component to deliver the first anastomosis device component to the first lumen inside the patient’s body; see paragraph [0060]; a second endoscope configured to hold the second anastomosis device component to deliver the second anastomosis device component to the second lumen inside the patient’s body. See paragraph [0085]; for the purpose of facilitating independently delivering the first and second anastomosis device into the body.
Berman, from a related field of endeavor teaches a similar system as shown in Figure 17, where an endoscope includes one or more endoscope sensors for determining a position and orientation of a tip of the second endoscope; see paragraph [0113]; and a display device for displaying capable of displaying a video feed overlaid with a first marker corresponding to the first endoscope and a second marker corresponding to the second endoscope, wherein a position of the first marker and a position of the second marker are determined based on sensor information captured by the one or more sensors of the first endoscope and the one or more sensors of the second endoscope; see paragraph [0056]; for the purpose of tracking the position of the endoscope. See paragraph [0113].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Harrison in view of Carson and Requarth by including the first and second endoscopes disclosed by Lukin in order to facilitate independently delivering the first and second anastomosis device into the body.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Harrison in view of Carson, Requarth and Lukin to include one or more endoscope sensors on each endoscope, as taught by Berman, in order to track the position of each endoscope.
To be clear, since Berman discloses a display capable of displaying a video feed overlaid with a first marker corresponding to the first endoscope, it follows it would be capable of displaying a second marker corresponding to the second endoscope, wherein a position of the first marker and a position of the second marker are determined based on sensor information captured by the one or more sensors of the first endoscope and the one or more sensors of the second endoscope.
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison et al. (US Pub. No.: 2013/0253548) in view of Carson et al. (US Pub. No.: 2005/0080439) and Requarth (US Pub. No.: 2012/0197061) as applied to claim 25 above, and further in view of Zemlok et al. (US Pub. No.: 2015/0122870).
Regarding Claim 26, Harrison in view of Carson and Requarth discloses all the limitations of claim 25 as taught above but fails to explicitly disclose that the display is adapted to be a head-mounted display.
Zemlok teaches, in the same field of endeavor (surgical system for applying fasteners to the tissue of a patient), a display that is adapted to be a head-mounted display (HUD display 622, Para. [0191]).
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the display of Harrison in view of Carson and Requarth to further include that it is adapted to be a head-mounted display, as taught by Zemlok in order to obtain the advantage of allowing the user to visualize the vital feedback information from a feedback controller without losing focus on the procedure (Zemlok, Para. [0191]; see also Harrison, Para. [0024]).
Regarding Claim 27, Harrison in view of Carson and Requarth discloses the system of claim 25 as taught above, but fails to explicitly disclose that the display is configured to display a location of the first anastomosis device component and a location of the second anastomosis device component as virtual objects overlaid on an image or video feed of the patient's body.
Zemlok teaches, in the same field of endeavor (surgical system for applying fasteners to the tissue of a patient), a display that is configured to display a location of a first anastomosis device component and a location of a second anastomosis device component as virtual objects overlaid on an image or video feed of a patient's body (Paras. [0191]-[0192], as a display that includes an OSD module capable of overlaying text and/or graphical information from a feedback controller over video images from a surgical site to provide a modified video signal would be capable of providing such a display).
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the display of Harrison in view of Carson and Requarth to further include that it is configured to display a location of the first anastomosis device component and a location of the second anastomosis device component as virtual objects overlaid on an image or video feed of the patient's body, as taught by Zemlok in order to obtain the advantage of allowing the user to visualize useful feedback information from an instrument and/or feedback controller while still
observing the surgical site, and therefore maintaining focus on the procedure (Zemlok, Paras. [0191]-[0192]; see also Harrison, Para. [0024]).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison et al. (US Pub. No.: 2013/0253548) in view of Carson et al. (US Pub. No.: 2005/0080439) and Requarth (US Pub. No.: 2012/0197061) as applied to claim 25 above, and further in view of Beisel (US Pub. No.: 2013/0253550).
Regarding claim 28, Harrison in view of Carson and Requarth discloses all the limitations of claim 25 as taught above but fails to explicitly disclose that at least one of the first anastomosis device component and the second anastomosis device component has a tissue-contacting face that is approximately circular with a diameter between 1mm and 50mm.
Beisel teaches, in the same field of endeavor (anastomosis system), at least one of the first anastomosis device component and the second anastomosis device component has a tissue-contacting face that is approximately circular with a diameter between 1mm and 50mm (Fig. 56 and Para. [0184], such as 10 mm to 30 mm).
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Harrison in view of Carson and Requarth to include that at least one of the first anastomosis device component and the second anastomosis device component has a tissue-contacting face that is approximately circular with a diameter between 1mm and 50mm as taught by Beisel, since it has been discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kraemer et al. (US Pub. No.: 2011/0218476) in view of Carson et al. (US Pub. No.: 2005/0080439) and Requarth (US Pub. No.: 2012/0197061).
Regarding claims 1-3, Kraemer et al. discloses [claim 1], as shown in Figures 7A-7C, a system capable of forming an anastomosis between a first layer of tissue and a second layer of tissue of a patient’s body, the system comprising: a first anastomosis device component (one coupler 218, see Para. [0069]) capable of being delivered to a first lumen inside the patient’s body; and a second anastomosis device component (the other coupler 218, see Para. [0069]) configured to be delivered to a second lumen inside the patient’s body, the second anastomosis device component capable of interacting with the first anastomosis device component, the second anastomosis device component comprising: one or more sensors (indicator 260 or sensor, see Para. [0073]) capable of capturing sensor data for determining an alignment of the second anastomosis device component relative to the first anastomosis device component or for characterizing the position or orientation of the second anastomosis device component in three- dimensional space; [claim 2] a controller (controller module, see Para. [0073]) configured to receive the sensor data captured by the one or more sensors of the second anastomosis device component and configured to determine a distance between the first anastomosis device component and the second anastomosis device component; and [claim 3] wherein the one or more sensors comprises a first sensor and a second sensor separated by a preset distance, and wherein controller is further capable of determining an angle between the first anastomosis device component and the second anastomosis device component based on sensor data captured by the first sensor and sensor data captured by the second sensor (Para. [0073]). However, Kraemer does not disclose that the first anastomosis device component or the second anastomosis device component comprises a flange during a therapeutic configuration; and an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target.
Carson teaches, in the same field of endeavor (anastomosis device), anastomosis device (622, Fig. 68A) comprising a flange (628, Fig. 68A) during a therapeutic configuration (Fig. 68A and Para. [0247]).
Before effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the first anastomosis device component or the second anastomosis device component of Kraemer to include a flange during a therapeutic configuration as taught by Carson in order to obtain the advantage of allowing adhesive to be placed between the anastomosis device component and the vessel bond the anastomosis device component to the vessel wall in fluid-tight fashion (Carson, Para. [0247]).
Requarth teaches, in the same field of endeavor (anastomosis forming system), an ultrasound module (Paras. [0053] and [0075]) configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target (Paras. [0053] and [0075]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Kraemer to include an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target as taught by Requarth in order to obtain the advantage of confirming the correction positions of the anastomosis device components and/or the catheter for delivering the anastomosis device components (Requarth, Paras. [0053] and [0075]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11, 13-15, and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13-15, and 24-29 of U.S. Patent No. 11,607,222 in view of Requarth (US Pub. No.: 2012/0197061). Claims 1-11, 13-15, and 24-29 of U.S. Patent No. 11,607,222 all the limitations of claims 1-11, 13-15, and 25-30 but fails to disclose an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target.
Requarth teaches, in the same field of endeavor (anastomosis forming system), an ultrasound module (Paras. [0053] and [0075]) configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target (Paras. [0053] and [0075]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of claims 1-11, 13-15, and 24-29 of U.S. Patent No. 11,607,222 to include an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target as taught by Requarth in order to obtain the advantage of confirming the correction positions of the anastomosis device components and/or the catheter for delivering the anastomosis device components (Requarth, Paras. [0053] and [0075]).
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Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11, 13-15, and 25-3 have been considered but are moot in view of new ground(s) of rejection.
Carson teaches, in the same field of endeavor (anastomosis device), anastomosis device (622, Fig. 68A) comprising a flange (628, Fig. 68A) during a therapeutic configuration (Fig. 68A and Para. [0247]).
Before effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the first anastomosis device component or the second anastomosis device component of each of Harrison and Kraemer to include a flange during a therapeutic configuration as taught by Carson in order to obtain the advantage of allowing adhesive to be placed between the anastomosis device component and the vessel bond the anastomosis device component to the vessel wall in fluid-tight fashion (Carson, Para. [0247]).
Requarth teaches, in the same field of endeavor (anastomosis forming system), an ultrasound module (Paras. [0053] and [0075]) configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target (Paras. [0053] and [0075]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of each of Harrison and Kraemer to include an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target as taught by Requarth in order to obtain the advantage of confirming the correction positions of the anastomosis device components and/or the catheter for delivering the anastomosis device components (Requarth, Paras. [0053] and [0075]).
Claims 1-11, 13-15, and 24-29 of U.S. Patent No. 11,607,222 all the limitations of claims 1-11, 13-15, and 25-30 but fails to disclose an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target.
Requarth teaches, in the same field of endeavor (anastomosis forming system), an ultrasound module (Paras. [0053] and [0075]) configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target (Paras. [0053] and [0075]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of claims 1-11, 13-15, and 24-29 of U.S. Patent No. 11,607,222 to include an ultrasound module configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target as taught by Requarth in order to obtain the advantage of confirming the correction positions of the anastomosis device components and/or the catheter for delivering the anastomosis device components (Requarth, Paras. [0053] and [0075]).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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