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 .
Detailed Action
This is in response to the preliminary amendment filed 06/04/2025.
Claim Interpretation - 35 USC § 112(f)
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 § 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 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, 7, 8, 14, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast)
Regarding claims 1, 7, 8, 15 Kraemer et al. discloses as shown Figures 7A-7C, a system for 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 of couplers 218, see paragraph [0069]) configured to be delivered to a first lumen inside the patient's body; and a second anastomosis device component (the other one of couplers 218, see paragraph [0069]) configured to be delivered to a second lumen inside the patient's body, the second anastomosis device component configured to interact with the first anastomosis device component, the second anastomosis device component comprising: one or more second sensors (sensor, see paragraph [0073]) configured to capture sensor data capable of 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, an ultrasound module (module from ultrasound imaging device contemplated, see paragraph [0078]) configured to emit ultrasound and receive a component of the emitted ultrasound after reflection from a target; and a controller (control module, see paragraph [0073]) configured to receive sensor information from the first anastomosis device, the second anastomosis device, wherein the second anastomosis device component comprises a catheter with a lumen, wherein the first anastomosis device comprises a magnetic element.
Kraemer et al. fails to disclose the controller configured to provide instructions for output at a display, a representing of anatomy produce by an output of the ultrasound module information from the one or more first sensors or the one or more second sensors.
Mast, from a similar field of endeavor teaches a similar system as shown in Figure 1, where the controller (14) is configured to receive sensor information from the ultrasound module, for the purpose of controlling the ultrasound module, configured to provide instructions for output at a display (14), a representing of anatomy produce by an output of the ultrasound module information from the one or more first sensors or the one or more second sensors. See paragraph [0022].
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 Kraemer such that the controller was configured to receive sensor information from the ultrasound module in order to control the ultrasound module.
Regarding claim 8, Kraemer et al. fails to disclose wherein the lumen has a diameter between 0.3 mm and 3 mm.
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 lumen has a diameter between 0.3 mm and 3 mm as a matter of engineering dcuresign choice. Applicant has not disclosed that that the diameter of the lumen provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Kraemer’s catheter, and applicant’s invention, to perform equally well with either the diameter taught by Kraemer’s or the claimed 0.3 mm and 3 mm diameter because both dimensions would perform the same function of providing a lumen equally well considering the relative dimensions disclosed.
Regarding claim 14, Kraemer et al. fails to disclose wherein the first anastomosis device comprises an approximately cylindrical element with a face with a diameter between 8 mm and 16 mm.
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 first anastomosis device to have a diameter between 8 mm and 16 mm as a matter of engineering design choice. Applicant has not disclosed that that the diameter of the lumen provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Kraemer’s catheter, and applicant’s invention, to perform equally well with either the diameter taught by Kraemer’s or the claimed 8-16 mm diameter because both dimensions would perform the same function of providing a surface of form an anastomosis equally well considering the relative dimensions disclosed.
Claim(s) 2, 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2008/0243151 (Binmoeller et al.)
Regarding claims 2, 3 Kraemer et al. fails to disclose where the first anastomosis device comprises one or more electromagnetic sensors, wherein the one or more electromagnetic sensors comprises a first electromagnetic sensor and a second electromagnetic sensor separated by a preset distance.
Binmoeller, from the same field of endeavor teaches a similar system as shown in Figure 8 where an anastomosis device includes a sensor, in the form of an electromagnetic sensors. See paragraph [0077].
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 Kraemer by substituting each of the sensors disclosed by Kraemer the electromagnetic sensors taught by Binmoeller because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
So modified, Kraemer in view of Mast and Binmoeller is considered to disclose wherein the one or more electromagnetic sensors comprises a first electromagnetic sensor and a second electromagnetic sensor separated by a preset distance.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2009/0227828 (Swain et al.)
Regarding claim 4, Kraemer et al. fails to disclose wherein the first anastomosis device component comprises an endoscope.
Swain, from the same field of endeavor teaches a similar system, where the first anastomosis device comprises an endoscope for the purpose of delivering a part of the first anastomosis device component to an area of the body. See paragraph [0053].
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 Kraemer by including the endoscope taught by in order to guide couplers 218 to an area of the body.
Claim(s) 5, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast), U.S. Patent Publication Number 2009/0227828 (Swain et al.) as applied to claim 4 above, and further in view of U.S. Patent Publication Number 2005/0165314 (Tanaka et al.)
Regarding claims 5, 6 Kraemer et al. fails to disclose wherein the ultrasound module is integrated into an insertion tube of the endoscope, wherein the ultrasound module is affixed to an insertion tube of the endoscope.
Tanaka et al, from the same field of endeavor teaches a similar system, wherein the ultrasound module is integrated into an insertion tube of the endoscope, wherein the ultrasound module is affixed to an insertion tube of the endoscope. See paragraph [0031].
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 Kraemer such that the ultrasound module is integrated into an insertion tube of the endoscope, wherein the ultrasound module is affixed to an insertion tube of the endoscope because it would only require the simple substitution of one known alternative configuration 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) 9, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast) as applied to claim 7 above, and further in view of U.S. Patent Publication Number 2008/0243151 (Binmoeller et al.)
Regarding claims 9, 10 Kraemer et al. fails to disclose where the first anastomosis device comprises one or more electromagnetic sensors, wherein the one or more electromagnetic sensors comprises a first electromagnetic sensor and a second electromagnetic sensor separated by a preset distance.
Binmoeller, from the same field of endeavor teaches a similar system as shown in Figure 8 where an anastomosis device includes a sensor, in the form of an electromagnetic sensors. See paragraph [0077].
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 Kraemer by substituting each of the sensors disclosed by Kraemer the electromagnetic sensors taught by Binmoeller because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
So modified, Kraemer in view of Mast and Binmoeller is considered to disclose wherein the one or more electromagnetic sensors comprises a first electromagnetic sensor and a second electromagnetic sensor separated by a preset distance.
Claim(s) 11 s/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2004/0024316 (Xi et al.)
Regarding claim 11, Kraemer fails to disclose wherein the ultrasound module comprises a curvilinear array.
Xi et al. from a related field of endeavor teaches a similar ultrasound module which comprises a curvilinear array. See claim 13.
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 Kraemer by substituting the ultrasound module disclosed by Kraemer for the ultrasound module taught by Xi et al. because it would only require the simple substation of one known alternative configuration 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) 12 s/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2005/0165314 (Tanaka et al.)
Regarding claim 12, Kraemer fails to disclose wherein the ultrasound module comprises a radial array.
Tanaka et al. from a related field of endeavor teaches a similar ultrasound module which comprises wherein the ultrasound module comprises a radial array. See paragraph [0029].
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 Kraemer by substituting the ultrasound module disclosed by Kraemer for the ultrasound module taught by Xi et al. because it would only require the simple substation of one known alternative configuration 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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2012/0191086 (Moll et al.)
Regarding claim 13 Kraemer et al. fails to disclose wherein at least one sensor is an optical fiber sensor.
Moll et al, from the same field of endeavor teaches a similar system as shown in Figure 5c where wherein at least one sensor is an optical fiber sensor. See paragraph [0038].
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 Kraemer by substituting at least one sensor disclosed by Kraemer for the optical fiber sensor taught by Moll et al. because it would only require the simple substitution of one known alternative 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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2017/0303790 (Bala et al.)
Regarding claim 16, Kraemer fails to disclose wherein the controller comprises a microprocessor module executing machine learning-based algorithms
Bala et al., from a related field of endeavor teaches a similar controller with a microprocessor module executing machine learning-based algorithms, for the purpose of analyzing images. See paragraph [0066].
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 controller disclosed by controller disclosed by Kraemer to include microprocessor module executing machine learning-based algorithms in order to configure the controller to analyze images.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast) as applied to claim 14 above, and further in view of U.S. Patent Publication Number 2017/0303790 (Bala et al.)
Regarding claim 17 Kraemer fails to disclose wherein the machine learning-based algorithms are based on convolutional neural network architectures
Bala et al., from a related field of endeavor teaches a similar controller with a microprocessor module executing machine learning-based algorithms, wherein the machine learning-based algorithms are based on convolutional neural network architectures, for the purpose of analyzing images. See paragraph [0066].
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 controller disclosed by controller disclosed by Kraemer to include microprocessor module executing machine learning-based algorithms based on convolutional neural network architectures, in order to configure the controller to analyze images.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast) as applied to claim 14 above, and further in view of U.S. Patent Publication Number 2007/0167846 (Sternickel et al.)
Regarding claim 18 Kraemer fails to disclose wherein the machine learning-based algorithms are based on transformer architectures.
Sternickel et al., from a related field of endeavor teaches a similar controller with a microprocessor module executing machine learning-based algorithms, wherein the machine learning-based algorithms are based on convolutional neural network architectures, for the purpose of classifying data. See paragraph [0008].
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 controller disclosed by controller disclosed by Kraemer to include microprocessor module executing machine learning-based algorithms wherein the machine learning-based algorithms are based on transformer architectures in order to configure the controller to analyze images.
Claim(s) 19 s/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2014/0276684 (Huennekens et al.)
Regarding claim 19, Kraemer et al. fails to disclose the controller is configured to superimpose a first marker corresponding to the first anastomosis device component or a second maker corresponding to the second anastomosis device component.
Huennekens et al., from a related field of endeavor teaches a similar controller as shown in Figures 1 and 4, where the controller is configured to superimpose a marker corresponding to a surgical device for the purpose of tracking that surgical device on a display. See paragraph [0034].
It would have been obvious to one of ordinary skill in the art, before the effetective filing date of the claimed invention to modify the controller disclosed by Kraemer in view of Mast to superimpose a first marker corresponding to the first anastomosis device component or a second maker corresponding to the second anastomosis device component in order to track either of those markers on a display.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0218476 (Kraemer et al.) in view of U.S. Patent Publication Number 2005/0234438 (Mast), U.S. Patent Publication Number 2014/0276684 (Huennekens et al.) as applied to claim 19 above, and further in view of U.S. Patent Publication Number 2009/0227828 (Swain et al.)
Regarding claim 20, Kraemer et al. fails to disclose wherein the first anastomosis device component comprises an endoscope.
Swain, from the same field of endeavor teaches a similar system, where the first anastomosis device comprises an endoscope for the purpose of delivering a part of the first anastomosis device component to an area of the body. See paragraph [0053].
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 Kraemer by including the endoscope taught by in order to guide couplers 218 to an area of 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 Kraemer in view of Mast and Swain by rearranging the location of the marker such that the first marker corresponds to a location of the tip of the endoscope because it would only require a rearrangement of parts without changing how the resulting system operates (marker would still indicate a location). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 21, 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 Kraemer in view of Mast and Swain by rearranging the location of the marker such that the first marker visually indicates an orientation of the first anastomosis device component or the tip of the endoscope because it would only require a rearrangement of parts without changing how the resulting system operates (marker would still indicate a location). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771