DETAILED ACTION
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 5, 8, 9, 12, 13, 15, 17, 19-21, 25, and 26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2010/0081880 (Widenhouse) in view of U.S. Patent No. 6,090,041 (Clark).
Regarding claim 1, Widenhouse discloses a medical device (50) adapted to be positioned in relation to an incision made in the skin of the patient, the medical device comprising; an external portion (78/56/54) adapted to be positioned outside of the body of the patient, the external portion comprising a device chamber (interior of housing 56, see Fig. 1D) configured to be positioned outside of the body of the patient; a sealing device (80), comprising an internal sealing member (80) adapted to be positioned inside the body of the patient; a connecting member (82) connecting the external portion of the medical device to the internal sealing member such that a fluid connection between the inside of the body of the patient (opening in the body, see paragraph [0125]) and the device chamber outside of the patient is created (fluid may flow between interior of housing 56 and the opening in the body of the patient, similar to how instrument 116 shown in Fig. 1D passes within the open space formed by the interior of housing 56, the interior of connecting member 82, and into the interior of the body of the patient), wherein the internal sealing member and the connecting member are adapted to form an internal chamber such that a sealed chamber is created which comprises the device chamber configured to be positioned outside of the body of the patient and the internal chamber inside of the body of the patient (see paragraphs [0108] and [0109]; sealing device 80 and connecting member 82 sealing enclose an area inside the patient to maintain insufflation of a body cavity and allow access to the inside of the patient by a surgical instrument 116).
Further regarding claim 1, Widenhouse fails to disclose the internal sealing member of the internal sealing device being an internal vacuum sealing member adapted to encircle a portion of a human organ or tissue and apply a pressure below atmospheric pressure between the portion of the human organ or tissue and the internal vacuum sealing member such that the encircled portion of human organ or tissue forms part of the internal chamber in which the fluid connection is created. However, Clark discloses a medical device (10) in which an internal vacuum sealing member (14/22) is adapted to encircle a portion of a human organ or tissue and apply a pressure below atmospheric pressure between the portion of the human organ or tissue and the internal vacuum sealing member such that the encircled portion of human organ or tissue forms part of the internal chamber (34) in which a fluid connection is created (see Figs. 13A and 13B, Abstract, col. 6, lines 27-40, and col. 9, line 31 – col. 10, line 16).
Regarding claim 5, Clark suggests wherein the internal vacuum sealing member comprises a vacuum groove (20) creating a vacuum chamber together with said human organ or tissue inside the body of the patient (see col. 6, lines 27-40).
Regarding claim 9, Clark suggests wherein the internal vacuum sealing members is circular (see Fig. 12B).
Regarding claim 26, Clark suggests further comprising a pressure adjustment device (16/17/18) connected to a sealing device (10), for creating a pressure below atmospheric pressure in at least one internal vacuum sealing member (see col. 5, line 16 – col. 6, line 12).
Further regarding claims 1, 5, 9, and 26, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to modify the medical device of Widenhouse such that the internal sealing member is an internal vacuum sealing member that can be adapted to encircle a portion of a human organ or tissue and apply a pressure below atmospheric pressure between the portion of the human organ or tissue and the internal vacuum sealing member as suggested by Clark in order to allow for atraumatic attachment and sealing of a retractor to tissue inside a patient such that a user may perform a surgical procedure as needed (see Clark, col. 1, lines 48-51 and col. 9, line 31 – col. 10, line 16).
Regarding claim 8, Widenhouse discloses the medical device comprising a holding device (58) that can be adapted to hold the medical device positioned in relation to the skin of the patient and further adapted to at least one of: be holding the medical device from inside the body of the patient; be holding the medical device from both the inside of the body of the patient and the skin on the outside of the body; be holding by clamping on both side of at least one of; the abdominal wall, the thoraxial wall and the wall of a created body cavity, and be integrated with the sealing device (medical device 50 held in an incision and on the patient’s skin by retractor 58).
Regarding claim 9, Widenhouse discloses wherein the internal sealing member is circular (see Figs. 1A-1D).
Regarding claims 12 and 13, Widenhouse discloses wherein the medical device comprises a closable body port (12) adapted to enable transfer from the outside of the body of the patient to the inside of the body of the patient, through the incision made in the skin of the patient (see Fig. 1D) (claim 12); and wherein the medical device comprise at least two closable body ports (12) adapted to enable transfer from the outside of the body of the patient to the inside of the body of the patient, through the incision made in the skin of the patient (see Fig. 1D) (claim 13).
Regarding claim 15, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the device chamber to have volume within the recited range since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 17, Widenhouse discloses wherein a wall of the connecting member is flexible and/or elastic (see paragraph [0118]).
Regarding claims 19-21, Widenhouse discloses further comprising a coupling (54) adapted to connect an inset to the medical device (claim 19), wherein the coupling is placed in at least one of: a device wall (see Figs. 1A-1D), and an incision made in the skin of the patient (claim 20); and further comprising an inset (multiport inset 12) selected from: a. a glove inset, b. a hand access inset, c. a port inset, d. a multiport inset, and e. a gel port inset (claim 21).
Regarding claim 25, Widenhouse in view of Clark suggests a medical device system comprising the medical device according to claim 1 (see analysis of claim 1 above).
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Widenhouse in view of Clark, and further in view of U.S. Patent No. 6,641,604 (Adelman).
Regarding claim 6, Widenhouse in view of Clark fails to suggest wherein the internal vacuum sealing device comprises a second internal vacuum sealing member comprising a second vacuum groove creating a second vacuum chamber together with another portion of said human organ or tissue inside the body of the patient. However, Adelman discloses that a medical device (176) that includes multiple vacuum sealing members creating multiple vacuum chambers for contacting human tissue (see col. 12, lines 38-57). It would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to make the device of Widenhouse in view of Clark comprise multiple vacuum sealing members, grooves, and chambers as suggested by Adelman in order to allow for independent sealing members such that a rupture in one part of the device to result in total loss of suction/pressure (see Adelman, col. 12, lines 38-57).
Claims 10 and 11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Widenhouse in view of Clark, and further in view of U.S. Patent Application Publication No. 2002/0042595 (Palmer).
Regarding claims 10 and 11, Widenhouse in view of Clark fails to suggest wherein the sealing device further comprises an external vacuum sealing member adapted to seal against the skin of the patient, on the outside thereof (claim 10); wherein the external vacuum sealing member is a loop shaped external vacuum sealing member adapted to encircle the incision made in the skin of the patient and connect to the skin of the patient, on the outside thereof (claim 11). However, Palmer discloses a medical port device (10) wherein the device includes a loop shaped external vacuum sealing member (1218) that can be adapted to encircle an incision made in the skin of the patient and connect/seal against the skin (see paragraph [0143]). It would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to modify the device of Widenhouse in view of Clark to adapt at least the loop shaped outer upper rim (24) of Widenhouse to be a vacuum sealing member for sealing/connecting against tissue/skin as suggested by Palmer to facilitate secure attachment of the device on and around a tissue/skin incision.
Claims 27-33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Widenhouse in view of Clark, and further in view of U.S. Patent Application Publication No. 2002/0022770 (Borsody).
Regarding claims 27-33, Widenhouse in view of Clark fails to suggest further comprising a control unit for controlling the pressure adjustment device, and further comprising at least one sensor, and wherein the control unit is adapted to control the pump on the basis of input from the at least one sensor, wherein the at least one sensor is adapted to sense a physiological parameter of the body of the patient, wherein the physiological parameter is a parameter selected from: a. the blood flow of the patient, b. the saturation of the blood of the patient, c. an ischemia marker of the patient, d. the temperature at the skin of the patient, and e. the skin tone of the patient, and wherein the control unit is adapted to control the pressure of the vacuum sealing device, such that the pressure of the vacuum sealing device does not substantially affect the blood flow of the patient. However, Borsody discloses an access medical device (2) wherein the device comprises a control unit for controlling a pressure adjustment device (see paragraph [0028]), and further comprising at least one sensor (see paragraph [0028]), and wherein the control unit can be adapted to control the pump on the basis of input from the at least one sensor (see paragraph [0028]), wherein the at least one sensor can be adapted to sense a physiological parameter of the body of the patient (see paragraph [0028]), wherein the physiological parameter is a parameter selected from: a. the blood flow of the patient, b. the saturation of the blood of the patient, c. an ischemia marker of the patient, d. the temperature at the skin of the patient, and e. the skin tone of the patient (see paragraph [0028]), and wherein the control unit can be adapted to control the pressure of the pressure adjustment device such that the pressure of the pressure adjustment device does not substantially affect the blood flow of the patient (see paragraph [0028]), and wherein the at least one sensor is adapted to sense a physical parameter of the medical device (see paragraph [0028]), and wherein the physical parameter is a parameter selected from: a. the pressure in the sealing device, b. the pressure in the chamber, and c. the direct or indirect leakage of fluid from the chamber (see paragraph [0028]). It would have been prima facie obvious to modify the pressure adjustment device/vacuum sealing device of Widenhouse in view of Clark to include a control unit for controlling the pressure adjustment device/vacuum sealing device based on sensor signals from a sensor measuring blood flow of a patient, as suggested by Borsody, in order to ensure that tissue affected by the access medical device retains a healthy blood flow. Additionally, it would have been prima facie obvious to modify the pressure adjustment device/vacuum sealing device of Widenhouse in view of Clark to include a control unit for controlling the pressure adjustment device/vacuum sealing device based on sensor signals from a sensor measuring a parameter of the medical device, such as pressure in the device, as suggested by Borsody, in order to ensure that pressure in the device does not vary from a desired range.
Claims 27, 28, 31, and 32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Widenhouse in view of Clark and further in view of U.S. Patent Application Publication No. 2010/0286479 (Ashida).
Regarding claims 27, 28, 31, and 32, Widenhouse in view of Clark fails to suggest further comprising a control unit for controlling the pressure adjustment device, and further comprising at least one sensor, and wherein the control unit is adapted to control the pump on the basis of input from the at least one sensor, wherein the at least one sensor is adapted to sense a physical parameter of the medical device, and wherein the physical parameter is a parameter selected from: a. the pressure in the sealing device, b. the pressure in the chamber, and c. the direct or indirect leakage of fluid from the chamber. However, Ashida discloses an access medical device (10) wherein the device comprises a control unit (70) for controlling a pressure adjustment device (72), and further comprising at least one sensor (74), and wherein the control unit can be adapted to control the pump on the basis of input from the at least one sensor (see paragraph [0054]), and wherein the at least one sensor is adapted to sense a physical parameter of the medical device (see paragraph [0054]), and wherein the physical parameter is a parameter selected from: a. the pressure in the sealing device, b. the pressure in the chamber, and c. the direct or indirect leakage of fluid from the chamber (see paragraph [0054]). It would have been prima facie obvious to modify the pressure adjustment device/vacuum sealing device of Widenhouse in view of Clark to include a control unit for controlling the pressure adjustment device/vacuum sealing device based on sensor signals from a sensor measuring a parameter of the medical device, such as pressure in the device, as suggested by Ashida, in order to ensure that pressure in the device does not vary from a desired range.
Claim 34 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Widenhouse in view of Clark, and further in view of U.S. Patent Application Publication No. 2010/0261974 (Shelton).
Regarding claim 34, Widenhouse in view of Clark fails to suggest wherein the internal vacuum sealing member has an adjustable circumference, such that the size of the encircled portion of human organ or tissue can be adjusted. However, Shelton discloses an access medical device (218) that has an adjustable circumference (see Fig. 12, e.g.), such that the side of an area enclosed or encircled by the device can be adjusted (see paragraph [0030], e.g.). It would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to modify the device of Widenhouse in view of Clark to have an adjustable circumference as suggested by Shelton in order to allow a user to adjust the size of working surgical channel created by the device as desired by the user.
Response to Arguments
Applicant’s arguments with respect to claims 1, 5, 6 , 8-13, 15, 17, 19-21, and 25-34 have been considered but are moot in view of the new grounds of rejection.
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.
This action is a final rejection and closes the prosecution of this application. Applicant’s reply under 37 CFR 1.113 to this action is limited to an appeal to the Patent Trial and Appeal Board, an amendment complying with the requirements set forth below, or a request for continued examination (RCE) to reopen prosecution where permitted. Please note that the Office also offers initiatives that are available to applicants after the close of prosecution. See https://www.uspto.gov/patents/initiatives/uspto-patent-applications-iniatives-timeline for more information.
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A reply under 37 CFR 1.113 to a final rejection must include cancellation of or appeal from the rejection of, each rejected claim. The filing of an amendment after final rejection, whether or not it is entered, does not stop the running of the statutory period for reply to the final rejection unless the examiner holds all of the claims to be in condition for allowance.
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The application will become abandoned unless a Notice of Appeal, an after final reply that places the application in condition for allowance, or an RCE has been filed properly within the period for reply, or any extension of this period obtained under either 37 CFR 1.136(a) or (b).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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