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 Objections
Claim 17 is objected to because of the following informalities: “top locking geometry” should be changed to -- a top locking geometry --. Appropriate correction is required.
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.
Claim 7, 14 and 20 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 7 recites the limitation "the biopsy cap" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim.
The term “approximately 0.05 inches” in claim 14 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The degree to which the through hole of the sponge must be near 0.05 inches in order to be considered “approximately” 0.05 inches is unclear . Accordingly, the claim is rendered indefinite. Appropriate correction is required.
The term “substantially cylindrical” in claim 20 is a relative term which renders the claim indefinite. The term “substantially cylindrical” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The degree to which the wetting device has a substantially cylindrical shape while having a flange is unclear. Accordingly, the claim is rendered indefinite. Appropriate correction is required.
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) 1-8 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baror (US 2006/0149128 A1).
Regarding claim 1, Baror discloses a cap system, comprising: a cap (44; Fig. 1; par. [0025]) for a port of a first medical device (par. [0025]); and a wetting device (12/24/26/28/30/32/34; Fig. 1; par. [0023]) configured to couple to a portion of the cap (44; par. [0026]) and wet a second medical device passing through the cap system (22; Fig. 2; par. [0023]).
Regarding claim 2, Baror discloses the cap system of claim 1, wherein the wetting device includes a bottom film (30; Fig. 1; par. [0023], [0027], [0029] and [0034]) at a bottom of the wetting device.
Regarding claim 3, Baror discloses the cap system of claim 2, wherein the bottom film (30) may be pierced to form an opening in the bottom film (par. [0023], [0027], [0029] and [0034]).
Regarding claim 4, Baror discloses the cap system of claim 1, wherein the wetting device includes a top film (28; Fig. 1; par. [0023], [0027], [0029] and [0034]) at a top of the wetting device.
Regarding claim 5, Baror discloses the cap system of claim 4, wherein the top film (28) may be pierced to form an opening in the top film (par. [0023], [0027], [0029] and [0034]).
Regarding claim 6, Baror discloses the cap system of claim 1, further comprising: a wetting liquid (26; Fig. 1; par. [0023], [0027], [0029] and [0034]) between a top film (28) and a bottom film (30) of the wetting device.
Regarding claim 7, Baror discloses the cap system of claim 1, wherein a flange (48; Fig. 1; par. [0026]) of the wetting device defines a bottom opening (Fig. 1 – opening of wetting device between 30 and 48, for coupling to 44; par. [0026]) configured to receive the portion of the biopsy cap.
Regarding claim 8, Baror discloses the cap system of claim 7, wherein the flange (48) is a bottom portion of the wetting device (Fig. 1) and extends below a bottom film (30), wherein the bottom opening (Fig. 1 - opening of wetting device between 30 and 48, for coupling to 44; par. [0026]) is radially inward of the flange (Fig. 1).
Regarding claim 16, Baror discloses a wetting device (Fig. 1), comprising: a tube (16; Fig. 1; par. [0023]) having a substantially cylindrical shape defining an interior to receive and hold a liquid (26; par. [0023]; Fig. 1) and permit a first medical device to pass through (22; Fig. 2), wherein the tube (16; Fig. 1) is configured to be placed over a top of a base of a cap (44; Fig. 1; par. [0025]) of a port of a second medical device, the tube (16; Fig. 1) including bottom locking structure (48; Fig. 1; par. [0026]) to couple the tube to the base (44).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dejima et al. (US 2023/0061631 A1).
Regarding claim 18, Dejima discloses a wetting device, comprising: a sponge (24; Fig. 3; par. [0047]) defining a through hole (via 27/28; Fig. 3; par. [0047]) extending within the sponge (24) from a top of the sponge to a bottom of the sponge (Fig. 3), the though hole (via 27/28) being open at the top of the sponge (Fig. 3) and open at the bottom of the sponge (Fig. 3) to allow a first medical device (6; Fig. 3) to pass through the through hole, wherein the sponge (24) includes a flange (23/21; Fig. 5; par. [0040] and [0050]) at the bottom of the sponge (24), the flange (23/21) defining a bottom opening (within 21A; par. [0038; Figs. 6 and 8) configured to receive a portion of a cap (14; Figs. 5 and 8; par. [0037]) of a port of a second medical device (2; Fig. 1; par. [0028]); and a coating (25; Fig. 3; par. [0045] and [0050]) on an exterior side of the sponge to inhibit leakage of a liquid absorbed by the sponge (capable of this intended use).
Regarding claim 19, Dejima discloses the wetting device of claim 18, wherein the flange (23/21) includes a first opening configured (par. [0038]-[0039] – “21C to 21F are formed at positions and sizes that do not interfere with the attachment arm 14C and the knob portion 14D of the forceps valve 14”) to fit around and accommodate a grip (14D; Fig. 5; par. [0037]) of the cap and a second opening (par. [0038]-[0039] – “21C to 21F are formed at positions and sizes that do not interfere with the attachment arm 14C and the knob portion 14D of the forceps valve 14”) configured to fit around and accommodate a connector (14C; Fig. 5; par. [0037]) connecting a lid (14B; Fig. 5; par. [0037]) of the cap to a base (14A; Fig. 5; par. [0037]) of the cap.
Regarding claim 20, Dejima discloses the wetting device of claim 18, wherein the wetting device has a substantially cylindrical shape (Fig. 3).
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) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baror, as applied to the claims above, in view of Watanabe (US 2007/0167685 A1) in view of Dejima et al. (US 2023/0061631 A1).
Regarding claim 9, Baror discloses the cap system of claim 8, but does not specifically disclose wherein the flange defines a first opening to fit around and accommodate a grip of the cap. Watanabe teaches a cap (64; Fig. 6; par. [0043]) for a medical device (Figs. 1 and 3-4) that also includes a lid (66; Fig. 6; par. [0043]), a grip (protruding part of 66; see Figs. 3 and 6) and a connector (68; Fig. 6; par. [0043]). Watanabe teaches using the cap with the lid attached when a medical device having a small diameter is used (par. [0048]) in order to prevent fluid, etc. from flowing out of the first medical device (par. [0050]) and using the cap without the lid attached when larger diameter medical devices are used (par. [0050]). It would have been obvious to one having ordinary skill in the art to use a cap having a connector, a lid and a grip in the cap system when the second medical device has a small diameter in order to prevent prevent fluid, etc. from flowing out of the first medical device and into the cap, as taught by Watanabe.
Dejima teaches a first medical device (Fig. 2) having a port with a cap (14A; Fig. 5; par. [0037]) having a connector (14C; Fig. 5; par. [0037]), a lid (14B; Fig. 5; par. [0037]) and a grip (14D; Fig. 5; par. [0037]). The cap and lid are covered by a device (20; Fig. 5) having flanges (21; Figs. 5-6; par. [0038]-[0039]) that have a first opening to fit around and accommodate a grip (14D; Fig. 5) of the cap (14A; par. [0038]-[0039] – “21C to 21F are formed at positions and sizes that do not interfere with the attachment arm 14C and the knob portion 14D of the forceps valve 14”). It would have been obvious to one having ordinary skill in the art to modify the flange of the cap of Baror such the opening is formed at positions and sizes that does not interfere with the connector and the grip, as taught by Dejima, thereby preventing interference and ensuring a tight fit between the components.
Regarding claim 10, Baror in view of Watanabe in view of Dejima discloses the cap system of claim 9, wherein the flange (48; Dejima - 21; Figs. 5-6; par. [0038]-[0039]) defines a second opening to fit around and accommodate a connector connecting a lid of the cap to a base of the cap (Dejima - “14C; par. [0038]-[0039] – 21C to 21F are formed at positions and sizes that do not interfere with the attachment arm 14C and the knob portion 14D of the forceps valve 14”).
Claim(s) 11-15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baror, as applied to the claims above, in view of Carrillo et al. (US 6,663,598 B1).
Regarding claim 11, Baror discloses the cap of claim 1, but does not specifically disclose wherein the wetting device comprises a sponge configured to hold a wetting liquid. Carrillo teaches a sponge (340; Figs. 4A-4B; col. 6, ll. 30-57) provided in an analogous device (112; Figs. 4A-4B). Like Baror, Carrillo teaches that the wetting device can include a liquid (440; Figs. 5A-5B; col. 7, ll. 7-25). However, Carrillo also teaches the device can include a liquid (440) or a sponge (340). It would have been obvious to one having ordinary skill in the art to substitute the sponge of Carrillo for the liquid of Baror, as taught by Carrillo, as being a simple substitution of one component that can wet a medical instrument for another, having the predictable result of wetting the medical instrument thereby minimizing friction and facilitating the passage of the instrument into a patient’s body.
Regarding claim 12, Baror in view of Carrillo disclose the cap of claim 11, wherein the sponge (340 of Carrillo within 24 of Baror; Fig. 1) is configured to be placed over and coupled to the portion of the cap (44).
Regarding claim 13, Baror in view of Carrillo disclose the cap of claim 12, wherein the sponge (Carrillo - 340) defines a through hole centrally located within the sponge and extending from a top of the sponge to a bottom of the sponge (Carrillo – col. 6, ll. 60-65; when instrument is inserted therethrough).
Regarding claim 14, Baror in view of Carrillo disclose the cap of claim 13, wherein the through hole has a diameter of approximately 0.05 inches (accommodates catheters and other elongate devices.; see par. [0039] of published specification).
Regarding claim 15, Baror in view of Carrillo disclose the cap of claim 12, further comprising a coating (24; Fig. 1) on at least one exterior side of the sponge.
Regarding claim 17, Baror discloses the wetting device of claim 16, wherein the tube (16) further comprises: a top opening (20; Fig. 1). However, Baror does not specifically disclose that the top opening is configured to receive a lid of the cap; and top locking geometry to couple the tube to the lid. Carrillo teaches an analogous device wherein the tube (112; Fig. 1) has a top opening (121; Fig. 4B) that is configured to receive a lid (20; Fig. 1) of the cap; and top locking geometry to couple the tube to the lid (121/28; Fig. 1; col. 4, ll. 1-6 and 17-28) when no devices are present therein to effectively seal the device (col. 4, ll. 17-28). It would have been obvious to one having ordinary skill in the art to include a lid for the cap that can couple with the top opening of the tube in order to effectively seal the device when no devices are present therein, as taught by Carrillo, thereby preventing contamination.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Palestrant US 5,242,428 A Apparatus For Wetting Hydrophilic-coated…
Or US 2006/0149131 A1 Surgical Tool For Endoscope
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYNAE E BOLER whose telephone number is (571)270-3620. The examiner can normally be reached Mon - Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
2/2/26