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 amendment filed 10/15/2025.
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 33-34, 38-43, 51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 33 refers to the marker element. This renders the claim unclear because it is unclear which marker element the applicant is referring to (the marker element carried on the guidewire or the marker element on the tube).
Claims 38 and 39 are recited as dependent on claim 37 which has been cancelled making the scope of claim 38 unclear. The applicant should amend claims 38 and 39 to depend on claim 32.
Claim 41 refers to said marker elements. This limitation lacks antecedent basis. Claim 32 only recites at least one marker element. It is also unclear which marker element the applicant is intending to refer back to (guidewire or tube). It appears the applicant is intended to refer to the marker element of the tube. The Office suggest the following amendment to withdraw the rejection:
41. (currently amended) The apparatus according to claim 32, wherein the at least one marker element of the tube comprises
Claim 51 refers to the at least first and second marker elements. It is unclear if these are intended to be new marker elements or refer back to the at least one marker element recited in claim 29.
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) 29-31, 35, 38, 44, 45, 49, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2002/0016607 (Bonadio et al.) in view of U.S. Patent Publication Number 2008/0146967 (Richardson et al.)
Regarding claim 29-31, 35, 38, 44 Bonadio et al. discloses as shown in Figure 3, 4, a gastro-intestinal-tract endoluminal apparatus for assisting creation of an anastomosis between spaced apart positions in the gastro-intestinal tract of a patient, the apparatus being retrievably insertable into the gastro-intestinal tract, and able to follow a curved path of the small intestine, comprising: a flexible tube (tubular sleeve 10, see paragraph [0060]) introducible into the gastro-intestinal tract of a patient with the tube in an at least partly invaginated state, the tube having a stationary end (end attached to collar 15, see paragraph [0060]) and a mobile lumen (lumen 19, see paragraph [0060]), the tube being extendable within the tract without substantial movement of the stationary end, by inflating an inflatable region of the tube around the lumen, the inflation causing distal-most invaginated material to evert outwardly such that the everted material extends a deployed length of the tube distally along a path of the gastro-intestinal tract, invaginated material of the lumen being drawn distally within the deployed tube to feed the distal extension, wherein the tube is retrievable by drawing an inner portion of the tube in a proximal direction to collapse and/or invaginate the tube from its distal-most region, a sheath (collar 15, see paragraph [060]) coupled to the stationary end of the tube, for facilitating introduction of the apparatus into the gastro-intestinal tract, wherein the lumen comprises a non-evertable region (12e) that is pulled distally within the tube as the tube extends, the non-evertable region defining a working channel for insertion of a guidewire and/or one or more tools, configured to be introduced into an intestine of a patient through the patient's stomach. See paragraphs [0060], [0063].
Bonadio et al. fails to disclose a guidewire insertable through the lumen towards a distal end of the tube wherein the guidewire carries at least one marker element for marking a predetermined length or position along the guidewire.
Richardson et al., from a related field of endeavor teaches a similar apparatus as shown in Figure 26 with a guidewire, where the guidewire is insertable through a lumen towards a distal end of a tube where the guidewire carries at least one marker element (one of markers 225 see paragraph [0139]) for marking a predetermined length or position along the guidewire, wherein the marker element is radio-opaque to facilitate detection by fluoroscopic imaging, further comprising a plurality of said marker elements (other of markers 225).
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 gastro-intestinal-tract endoluminal apparatus disclosed by Bonadio to include the guidewire with the at least one marker taught by Richardson et al., in order to guide the gastro-intestinal-tract endoluminal apparatus through the body over the guidewire and track the location of the guidewire.
Regarding claims 45, 49 Bonadio et al. in view of Richardson et al. discloses as shown in Figure 3, 4 of Bonadio et al. a method of introducing an apparatus into the gastro-intestinal-tract of a patient; see paragraph [0063]; the apparatus being an apparatus according to claim 29; see rejection of claim 29; comprising a flexible tube (tubular sleeve 10, see paragraph [0060]) introducible into the gastro-intestinal tract of a patient with the tube in an at least partly invaginated state, the tube having a stationary end (end attached to collar 15, see paragraph [0060]) and a mobile lumen (lumen 19, see paragraph [0060]), the method comprising: inflating an inflatable region of the tube around the lumen, the inflation causing distal-most invaginated material to evert outwardly such that the everted material extends a deployed length of the tube distally along a path of the gastro-intestinal tract, invaginated material of the lumen being drawn distally within the deployed tube to feed the distal extension, whereby the tube is extendable within the tract without substantial movement of the stationary end, a step of introducing the tube into the gastro-intestinal tract through the patient's mouth and stomach. See paragraph [0060], [0063].
Claim(s) 32-34, 41- 43, 46, 48, 50, 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2002/0016607 (Bonadio et al.) in view of U.S. Patent Publication Number 2008/0146967 (Richardson et al.) as applied to claim 29 above, and further in view of U.S. Patent Publication Number 2011/0118817 (Gunderson et al.)
Regrading claims 32-34, 41-43, 46, 48 Bonadio et al. in view of Richardson et al. fail to disclose wherein the tube comprises at least one marker element for marking one of a predetermined length or position along the deployed portion of the tube, wherein the marker element is radio-opaque to facilitate detection by fluoroscopic imaging, further comprising a step of deploying at least a second marker element.
Bondadio in view of Richardson et al. fail to disclose wherein the tube comprises at least one marker element for marking one of a predetermined length or position along the deployed portion of the tube, wherein the marker element is expandable from a collapsed configuration to an expanded configuration.
Gunderson et al., from the same field of endeavor teaches a similar apparatus where a similar tube as shown in Figure 8, where the tube includes at least one marker element (marker of bands 638a-638c, see paragraph [0045]), a plurality of marker elements for marking one of a predetermined length or position along the deployed portion of the tube, wherein the marker element is radio-opaque to facilitate detection by fluoroscopic imaging, wherein the marker element is expandable from a collapsed configuration to an expanded configuration, wherein first and second marker elements are spaced apart by a predetermined distance, wherein at least some of the markers are spaced apart by a uniform repeating, comprising a step of deploying at least a second marker element for the purpose of tracking the position of the tube.
It would have been obvious to one of ordinary skill in the art before effective filing date of the claimed invention to modify the apparatus and method disclosed by Bonadio in view of Richardson et al. to include the markers disclosed by Gunderson, and a step of deploying at least a second marker element, in order to track the position of the tube
Regarding claim 50, Bonadio et al. in view of Richardson et al. discloses as shown in Figure 3, 4 of Bonadio et al. a method of identifying a target position in a gastro-intestinal-tract of a patient, the method comprising: providing an apparatus according to claim 29; see rejection of claim 29; comprising a flexible tube (tubular sleeve 10, see paragraph [0060]) introducible into the gastro-intestinal tract of a patient with the tube in an at least partly invaginated state, the tube having a stationary end (end attached to collar 15, see paragraph [0060]) and a mobile lumen (lumen 19, see paragraph [0060]), inflating an inflatable region of the tube around the lumen; see paragraph [0060]; the inflation causing distal-most invaginated material to evert outwardly such that the everted material extends a deployed length of the tube distally along a path of the gastro-intestinal tract, invaginated material of the lumen being drawn distally within the deployed tube to feed the distal extension.
Bonadio et al. in view of Richardson et al. fail to disclose causing deployment of at least one marker element for identifying the target site.
Gunderson et al., from the same field of endeavor teaches a similar apparatus where a similar tube as shown in Figure 8, where the tube includes at least one marker element (marker of bands 638a-638c, see paragraph [0045]), a plurality of marker elements for marking one of a predetermined length or position along the deployed portion of the tube, wherein the marker element is radio-opaque to facilitate detection by fluoroscopic imaging, wherein the marker element is expandable from a collapsed configuration to an expanded configuration, comprising a step of deploying at least a second marker element for the purpose of tracking the position of the tube, identifying a target position in a tact of patient using at least one marker element.
It would have been obvious to one of ordinary skill in the art before effective filing date of the claimed invention to modify the method disclosed by Bonadio in view of Richardson et al. to include the step of causing deployment of at least one marker element for identifying the target site, in order to track the position of the tube.
So modified the Office interprets Bondaio in view of Richardson and Gunderson as disclosing identifying a target position in a gastro-intestinal tract, because Gunderson discloses measuring a position in the body at a tract and Bondaio teaches the position is in a gastrointestinal tract.
Regarding claim 51, Bonadio et al. in view of Richardson et al. discloses as shown in Figure 3, 4 a method of measuring a distance in a gastro-intestinal-tract of a patient, the method comprising: providing an apparatus according to claim 29; see rejection of claim 29; comprising a flexible tube (tubular sleeve 10, see paragraph [0060]) introducible into the gastro-intestinal tract of a patient with the tube in an at least partly invaginated state, the tube having a stationary end (end attached to collar 15, see paragraph [0060]) and a mobile lumen (lumen 19, see paragraph [0060]), inflating an inflatable region of the tube around the lumen; see paragraph [0060]; the inflation causing distal-most invaginated material to evert outwardly such that the everted material extends a deployed length of the tube distally along a path of the gastro-intestinal tract, invaginated material of the lumen being drawn distally within the deployed tube to feed the distal extension.
Bonadio et al. fails to disclose causing deployment of at least a first marker element and a second marker element having a predetermined separation, measuring a distance in a gastro-intestinal tract of a patient using the at least first and second marker elements.
Gunderson et al., from the same field of endeavor teaches a similar apparatus where a similar tube as shown in Figure 8, where the tube includes at least one marker element (marker of bands 638a-638c, see paragraph [0045]), a plurality of marker elements for marking one of a predetermined length or position along the deployed portion of the tube, wherein the marker element is radio-opaque to facilitate detection by fluoroscopic imaging, wherein the marker element is expandable from a collapsed configuration to an expanded configuration, comprising a step of deploying at least a second marker element for the purpose of tracking the position of the tube, measuring a distance in tract of a patient using the at least first and second marker elements.
It would have been obvious to one of ordinary skill in the art before effective filing date of the claimed invention to modify the method disclosed by Bonadio in view of Richardson et al. to include the step of causing deployment of at least a first marker element and a second marker element having a predetermined separation, in order to track the position of the tube.
So modified the Office interprets Bondaio in view of Richardson and Gunderson as disclosing measuring a distance in a gastro-intestinal tract, because Gunderson discloses measuring a tract in the body and Bondaio teaches the tract is a gastrointestinal tract.
Claim(s) 39, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2002/0016607 (Bonadio et al.) in view of U.S. Patent Publication Number 2008/0146967 (Richardson et al.), U.S. Patent Publication Number 2011/0118817 (Gunderson et al.) as applied to claim 32 above, and further in view of U.S. Patent Publication Number 2010/0145267 (Bishop)
Regarding claims 39, 40 Bonadio fails to disclose wherein the marker element is expandable from a collapsed condition on the guidewire, to an expanded condition laterally larger than a main portion of the guidewire, wherein the marker element comprises (i) an anchor for expanding against tissue of the gastro-intestinal tract, and/or (ii) an expandable cage.
Bishop, from a related field of endeavor teaches a similar apparatus as shown in Figure 1A, where the marker element (118, see paragraph [0059]) is expandable from a collapsed condition, to an expanded condition laterally larger than a main portion, wherein the marker element comprises (i) an anchor for expanding against tissue of the gastro-intestinal tract, and/or (ii) an expandable cage.
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 apparatus disclosed by Bonadio in view of Gunderson and Andreas by substituting the marker elements disclosed by Bonadio in view of Gunderson and Andreas for the marker elements taught by Bishop such that wherein the marker element is expandable from a collapsed condition on the guidewire, to an expanded condition laterally larger than a main portion of the guidewire, wherein the marker element comprises (i) an anchor for expanding against tissue of the gastro-intestinal tract, and/or (ii) an expandable cage because it would only require a simple substation of one known element 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) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2002/0016607 (Bonadio et al.) in view of U.S. Patent Publication Number 2008/0146967 (Richardson et al.), U.S. Patent Publication Number 2011/0118817 (Gunderson et al.), as applied to claim 46 above, and further in view of U.S. Patent Publication Number 2010/0145267 (Bishop)
Regarding claim 47 Bonadio fails to disclose wherein the step of deploying a marker element comprises causing the marker element to expand.
Bishop, from a related field of endeavor teaches a similar apparatus as shown in Figure 1A, where the marker element (118, see paragraph [0059]) is expandable and wherein the step of deploying a marker element comprises causing the marker element to expand.
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 apparatus disclosed by Bonadio in view of Gunderson by substituting the marker elements disclosed by Bonadio in view of Gunderson for the marker elements taught by Bishop and include the steps of deploying a marker element comprises causing the marker element to expand because it would only require a simple substation of one known element for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Response to Arguments
Applicant’s arguments with respect to claim(s) 29 have been considered but are moot because they do not apply to the new ground of rejection of Richardson et al.
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