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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-9, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kirn et al (Pub. No.: US 2017/0360288) in view of Lund et al (Pub. No.: US 2019/0216298) and further in view of Pryor et al (Pub, No.: US 2020/0327973).
Regarding claim 1, Kirn et al disclose a camera device for attachment to a medical device (enteral tube), the medical device having a distal end and a proximal end [see 0010, 0042] by disclosing the enteral tube includes a tube having a distal end portion for placement within a patient and a proximal end portion [see abstract];
the medical device being capable of being partially placed inside the body of a patient [see abstract, 0010]
the camera device comprising:
a. a light source connected to a first power source [see 0023-0024, 0042];
b. a camera for capturing image data connected to (i) the first power source and/or a
second power source [see 0024, 0042], and (ii) an interface with a computer processor [see 0043];
c. a housing (20) containing the light source and the camera (18) [see 0042], the housing comprising a plurality of different sized adapters, wherein the housing is attachable to the distal end of the medical device using one of the adapters (98/99) [see 0063, 0072, fig 9] by disclosing a releasable fitting or collet 98 which grips the tube 12 ensuring that the camera 18 remain in position during placement [see 0063] and the fitting 98 has clamping capabilities [see 0072];
d. a cable (26) attached to the camera device on one end [see 0042, fig 7], the cable extending to the proximal end of the medical device [see 0042];
e. wherein the camera captures image data that is enhanced by the light source and which
image data is transmitted through the interface to the computer processor which is then used
to display the image data to provide information concerning the patient and the use of the
medical device [see abstract, 0043, 0067, 0069] by disclosing the display 94 is attached to the enclosure 88 and processor 96 via a video output cable 102 for displaying images from the camera 18 [see 0067, fig 9];
Kirn et al disclose the tube has a lumen increasing in cross section from the proximal end portion toward the distal end portion along at least a portion of the tube [see 0010, 0016, 0056] by disclosing having the gradual increase in cross section makes clogging less likely [see 0056]
Kirn et al don’t disclose wherein the cable increases stiffness to avoid coiling of the medical device and assists with the placement and use of the medical device inside the body of the patient
Nonetheless, Lung et al disclose wherein the cable (steering wire) increases stiffness to avoid coiling of the medical device and assists with the placement and use of the medical device inside the body of the patient [see 0004-005, 0028, 0065, 0148-0151].
Kirn et al and Lund don’t disclose different adapters.
Nonetheless, Pryor et al disclose different adapters [see 0011-0012].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kirn et al, Lung et al and Pryor et al by using a cable increases stiffness to avoid coiling of the medical device and assists with the placement and use of the medical device inside the body of the patient; to provide a track for the device to follow through the tortuous path of the colon, providing a means for advancing or retracting the device and by using different sizes adapters; for accommodating different devices.
Regarding claim 2, Kirn et al disclose wherein the medical device is a gastrointestinal device for examination [see 0044], diagnosis, and/or treatment of the gastrointestinal system of the patient [see 0048].
Regarding claim 3, Kirn et al disclose wherein the medical device is selected from the group consisting of a nasogastric tube [see 0041], a small intestine Keo feeding tube, a rectal tube, and an
esophageal manometry probe.
Regarding claim 4, Kirn et al disclose wherein the adapter (98/99) [see 0063, 0072, fig 9] that attaches to the distal end of a nasogastric tube [see 0041], a small intestine Keo feeding tube, a rectal tube, or an esophageal manometry probe.
Regarding claim 5, Kirn et al disclose wherein the adapter comprises one or more passages (irrigation channels 82, fig 6) to permit the passage of air and/or fluids through the housing [see 0059].
Regarding claim 6, Kirn et al disclose wherein the cable connects the camera to the first power source and/or the second power source, and the cable transmits the image data through the
interface to the computer processor [see 0042, 0054, 0067, 0069 and fig 8]
Regarding claim 7, Kirn et al disclose wherein the cable comprises a passage for air for
insufflation and/or liquid for cleaning the camera lens [see 0020, 0059-0060] by disclosing the tip includes at least one channel for directing a fluid onto the lens of the camera [see 0019-0020]
Regarding claim 8, Kirn et al disclose wherein the cable comprises wire to assist with placement
of the medical device (tube 12) [see 0052]
Regarding claim 9, Kirn et al disclose one or more clips (98) to attach the housing to the medical device (tube 12) [see 0063, 0072] and fitting 98 has clamping capabilities [see 0072].
Regarding claim 11, Kirn et al disclose wherein the camera device is a single use device and it is
disposed of after one use [see 0043] by disclosing the camera 18 may be a single use disposable camera or a multiple use camera suitable for cleaning and/or sterilization [see 0043].
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 12 is rejected under 35 U.S.C. 102(a) as being anticipated by Kirn et al (Pub. No.: US 2017/0360288).
Regarding claim 12, Kirn et al disclose a method for an operator conducting a gastrointestinal medical procedure with a medical device,
the medical device having a distal end and a proximal end, the medical device being capable of being partially placed inside the body of a patient [see abstract];
the medical device being selected from the group consisting of a nasogastric tube [see 0041], a small intestine Keo feeding tube, a rectal tube, and an esophageal manometry probe,
the method comprising:
attaching a camera device (18) to the medical device [see 0024, 0042];
the camera device comprising:
(i)a light source connected to a first power source [see 0023-0024, 0042];
(ii) a camera for capturing image data connected to:
(A) the first power source and/or a second power source [see 0024, 0042];
(B) an interface with a computer processor [see 0043];
(iii) a housing (20) containing the light source and the camera [see 0042];
the housing (20) comprising an adapter (98/99), wherein the housing is attachable to the distal end of the medical device using the adapter (98/99) [see 0063, 0072, fig 9] by disclosing a releasable fitting or collet 98 which grips the tube 12 ensuring that the camera 18 remain in position during placement [see 0063] and the fitting 98 has clamping capabilities [see 0072];
(iv) a cable attached to the camera device on one end, the cable extending to the proximal end of the medical device [see 0042], wherein the cable assists with the placement of the medical device inside the body of the patient [see 0042];
capturing image data with the camera device [see abstract, 0043, 0067, 0069] by disclosing the display 94 is attached to the enclosure 88 and processor 96 via a video output cable 102 for displaying images from the camera 18 [see 0067, fig 9];
transmitting the image data to the computer processor; [see 0042, 0054, 0067, 0069 and fig 8];
displaying the image data for the operator to see [see abstract, 0043, 0067, 0069] by disclosing the display 94 is attached to the enclosure 88 and processor 96 via a video output cable 102 for displaying images from the camera 18 [see 0067, fig 9].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kirn et al (Pub. No.: US 2017/0360288) in view of Lund et al (Pub. No.: US 2019/0216298) and further in view of Pryor et al (Pub, No.: US 2020/0327973) as applied to claim 1 above and further in view of Simmons (Pub. No.: US 2012/0130174).
Regarding claim 5, Kirn et al disclose one or more passages (irrigation channels 82, fig 6) to permit the passage of air and/or fluids through the housing [see 0059].
Kirn et al, Pryor et al and Lund don’t disclose the adapter comprises one or more passages for fluid delivery.
Nonetheless, Simmons discloses adapter comprises one or more passages [see 0029]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kirn et al, Pryor et al and Lund and Simmons by using an adapter that comprises one or more passages; to allow for the delivery and aspiration of fluids such as saline, water, carbon dioxide, air, and other fluids and matter through the medical device into and out of the patient.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kirn et al (Pub. No.: US 2017/0360288) in view of Lund et al (Pub. No.: US 2019/0216298) and further in view of Pryor et al (Pub, No.: US 2020/0327973) as applied to claim 1 above and further in view of Brawn et al (Pub. No.: US 2015/0138329)
Regarding claim 10, Kirn et al disclose wherein the computer processor is in a display device, a
desktop computing device, a laptop computing device, a tablet computing device, or a mobile
phone device [see 0067];
the computer processor provides direct live viewing and recording of the image data during placement of the medical device [see 0025, 0067]
Kirn et al, Pryor et al and Lund don’t disclose viewing blood and any active gastrointestinal bleeding.
Nonetheless, Brawn et al disclose viewing blood and any active gastrointestinal bleeding [see 0101].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kirn et al, Pryor et al, Lund and Brawn et al by viewing blood and any active gastrointestinal bleeding; to diagnose pathological conditions of, for example, the GI tract.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kirn et al (Pub. No.: US 2017/0360288) in view of Brawn et al (Pub. No.: US 2015/0138329)
Regarding claim 13, Kirn et al disclose camera device for attachment to one of a plurality of different sized gastrointestinal medical devices, each of the medical devices having a distal end and a proximal end [see 0010, 0042] by disclosing the enteral tube includes a tube having a distal end portion for placement within a patient and a proximal end portion [see abstract];
the medical devices being capable of being partially placed inside the body of a patient [see 0010, 0042, abstract];
the camera device comprising:
a. a light source connected to a first power source [see 0042];
b. a camera for capturing image data connected to:
(i) the first power source and/or a second power source [see 0042];
(ii) an interface with a computer processor [see 0043];
c. a housing (20) containing the light source and the camera [see 0042], the housing comprising a plurality of different adapters each of which is sized to fit with one of the plurality of medical
devices, wherein the housing is attachable to the distal end of one of the medical devices [see 0063, 0072, fig 9] by disclosing a releasable fitting or collet 98 which grips the tube 12 ensuring that the camera 18 remain in position during placement [see 0063] and the fitting 98 has clamping capabilities [see 0072];
d. a cable attached to the camera device on one end, the cable extending to the proximal end
of one of the medical devices [see abstract, 0042], wherein the cable assists with the placement of the medical device inside the body of the patient [see abstract, 0042];
c. wherein the camera captures image data that is enhanced by the light source and which
image data is transmitted through the interface to the computer processor which is then used
to display the image data to provide information concerning the patient and the use of the
medical device [see abstract, 0043, 0067, 0069] by disclosing the display 94 is attached to the enclosure 88 and processor 96 via a video output cable 102 for displaying images from the camera 18 [see 0067, fig 9];
Kirn et al disclose information including the detection of bleeding in the patient.
Nonetheless, Brawn et al disclose detection of bleeding in the patient [see 0101].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Kirn et al and Brawn et al by viewing blood and any active gastrointestinal bleeding; to diagnose pathological conditions of, for example, the GI tract.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798