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 .
Election/Restrictions
Claims 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II and Species B-G, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03 February 2026 of Invention I and Species A, directed to Claims 1-12 and 19-20.
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.
Claims 1, 3-5, and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mullen et al. (US Publication No. 2019/0374198).
Regarding Claim 1, Mullen et al. discloses a sleeve (sleeve/cover, see 130, 120, 20, Figs. 1-6; Abstract), comprising:
a distal member with a first through-hole (see Fig. 6 annotated below; Paragraph 0019, 0021, 0027-0028); a proximal member with a second through-hole (see Fig. 6 annotated below; Paragraph 0019, 0021, 0027-0028);
and an elongated flexible tubular member (130, see Fig. 6 annotated below; Paragraph 0019, 0021, 0027-0028) including a distal end affixed to the distal member and a proximal end affixed to the proximal member (see Fig. 6 annotated below; Paragraph 0019, 0021, 0027-0028), the tubular member including a channel therethrough (through-channel through with cord 16/probe 10 extends, see Figs. 1-6, Paragraph 0019, 0021, 0027-0028; Abstract) the channel in communication with the first through-hole at the distal end and in communication with the second through-hole at the proximal end (through-channel through with cord/probe extends, see Figs. 1-6, Paragraph 0019, 0021, 0027-0028; Abstract).
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Regarding Claims 3-5, Mullen et al. discloses a sleeve (sleeve/cover, see 130, 120, 20, Figs. 1-6; Abstract) wherein the distal member and the proximal member are releasably coupled to each other (Paragraph 0019, 0024, 0027, 0034, 0036), either with releasable adhesive between the distal member and the proximal member (adhesive or hook and loop fasteners between distal and proximal elements, Paragraph 0019, 0024, 0027, 0034, 0036) or wherein the distal member includes a threaded distal portion (corresponding attachment threads between distal and proximal elements, Paragraph 0019, 0024, 0027, 0034, 0036).
Regarding Claim 7, Mullen et al. discloses a sleeve (sleeve/cover, see 130, 120, 20, Figs. 1-6; Abstract) further wherein the tubular member is fluidproof (the tubular member and attached components may be plastic, nylon, latex, nitrile rubber, or any suitable material to maintain sterile environment inside sleeve/member, Paragraph 0020, 0021, 0002, 0003, 0015).
Regarding Claim 8, Mullen et al. discloses a sleeve (sleeve/cover, see 130, 120, 20, Figs. 1-6; Abstract) further wherein each of the distal member and the proximal member has a generally circular cross-section configuration (generally tubular/circular cross-section, see Fig. 6 annotated above, see also Figs. 1-5).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 6, 9-12, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mullen et al. (US Publication No. 2019/0374198) in view of Yabe et al. (US Patent No. 5,575,753).
Regarding Claims 2, 9, and 11, Mullen et al. discloses a protective sleeve (sleeve/cover, see 130, 120, 20, Figs. 1-6; Abstract) for use with a probe holder/handle (20, 22, Figs. 3-6), comprising:
an elongated tubular member (130, see Fig. 6 annotated below, see also Figs. 1-5) including a distal end, a proximal end and a body portion between the distal end and the proximal end (see Fig. 6 annotated below, see also Figs. 1-5),
the distal end configured for attachment to the probe holder/handle (20, 22, Figs. 3-6; Paragraph 0019, 0024, 0027, 0034, 0036), the proximal end and the body portion configured to extend proximally from the probe holder/handle (see Fig. 6 annotated below; Paragraph 0021, 0027),
wherein the distal end of the tubular member includes a portion configured to wedge into a slit provided in the probe holder/handle (corresponding attachment detents, snaps, screws, or male/female connectors, Paragraph 0019, 0024, 0027, 0034, 0036).
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However, Mullen et al. does not explicitly disclose wherein the protective sleeve is used with a probe holder/handle that is specifically a catheter control handle. Yabe teaches a protective/sterile elongate tubular sleeve cover (13A, 2A, Fig. 1; Col. 1, Lines 30-45) for an endoscope/catheter (Abstract; Col. 1, Lines 5-30) with a distal end configured for attachment to the endoscope/catheter control handle (12B, 2B, Fig. 1; configured to be gripped/controlled, Col. 4, Line 53 – Col. 5, Line 29; Col. 9, Lines 6-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the protective sleeve cover for a catheter control handle, as taught by Yabe, instead of the ultrasound probe holder/handle disclosed by Mullen et al., in order to perform medical procedures requiring an endoscope/catheter, since both Mullen et al. and Yabe disclose that the protective sleeve protects the similar cable/cord structures while maintaining a sterile environment during medical procedures (see Yabe, Col. 1, Lines 30-45, Col. 4, Lines 45-55; and Mullen et al., Paragraph 0002, 0003, 0015).
It is noted that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claim 10, Mullen et al. discloses a protective sleeve (sleeve/cover, see 130, 120, 20, Figs. 1-6; Abstract) further comprising an elastic loop member (securement bands 131, 132, Figs. 5-7) configured to extend circumferentially around the distal end of the sleeve (see securement bands 131, 132, Figs. 5-7; Paragraph 0021, 0025, 0029).
However, Mullen et al. does not explicitly disclose wherein the elastic loop member also extends around the holder/handle. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the elastic loop members (securement bands 131, 132, Figs. 5-7) in the sleeve disclosed by Mullen et al. to also extend around the holder/handle, in order to additionally secure/attach the sleeve while maintaining the sterile environment, since it has been held that rearranging parts (such as the elastic loops) of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding Claim 19, Mullen et al. discloses a protective sleeve (sleeve/cover, see 130, 120, 20, Figs. 1-6; Abstract) for use with an electrical cable (cord 16, Figs, 3-6), the electrical cable configured for attachment to a connector cable extending from a medical probe device (12, 10, see annotated Fig. 6 below), comprising:
an elongated tubular member (sleeve/cover 130, Figs. 3-6) including a distal end, a proximal end and a middle portion extending therebetween (see annotated Fig. 6 below),
the distal end configured for attachment to a proximal end of the connector cable that is attached at its distal end to a handle/holder (see annotated Fig. 6 below; Paragraph 0027, 0028, 0035), the proximal end and the middle portion of the elongated tubular member (sleeve cover 130, Figs. 3-6) extends proximally over the electrical cable (cord 16, Figs, 3-6) when the distal end of the electrical cable is connected to a proximal end of the connector cable (see annotated Fig. 6 below; Paragraph 0027, 0028).
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However, Mullen et al. does not explicitly disclose wherein the protective sleeve is used with a probe holder/handle that is specifically a catheter control handle. Yabe teaches a protective/sterile elongate tubular sleeve cover (13A, 2A, Fig. 1; Col. 1, Lines 30-45) for an endoscope/catheter (Abstract; Col. 1, Lines 5-30) with a distal end configured for attachment to the endoscope/catheter control handle (12B, 2B, Fig. 1; configured to be gripped/controlled, Col. 4, Line 53 – Col. 5, Line 29; Col. 9, Lines 6-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the protective sleeve cover for a catheter control handle, as taught by Yabe, instead of the ultrasound probe holder/handle disclosed by Mullen et al., in order to perform medical procedures requiring an endoscope/catheter, since both Mullen et al. and Yabe disclose that the protective sleeve protects the similar cable/cord structures while maintaining a sterile environment during medical procedures (see Yabe, Col. 1, Lines 30-45, Col. 4, Lines 45-55; and Mullen et al., Paragraph 0002, 0003, 0015).
It is noted that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding Claims 6, 12, and 20, Mullen et al. discloses a sleeve (sleeve/cover, see 130, 120, 20, Figs. 1-6; Abstract) further wherein the tubular member of the sleeve is fluidproof (material to maintain sterile environment inside sleeve/member, Paragraph 0020, 0021, 0002, 0003, 0015) and constructed of a flexible thin film including “latex, nitrile rubber, or any suitable material” (see Figs. 3-6, Paragraph 0021).
Although Mullen et al. does disclose other components such as the base may comprise plastic (Paragraph 0020), Mullen et al. does not explicitly disclose wherein the flexible thin film of the sleeve is constructed of plastic. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the flexible thin film of the sleeve/tubular member to comprise plastic, which is commonly known/used in medical devices and covers,
since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796