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
Applicant’s election without traverse of Group I, claims 1-13 and 19-20 in the reply filed on March 30, 2026 is acknowledged. Claims 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “opposing arms” (claim 5) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 6 and 13 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.
As to claim 6, term “the flexible opposing arms” lacks antecedent basis as only “opposing arms” have previously been recited.
As to claim 13, the scope of this claim is ambiguous as to whether the “endoscope” is intended to be positively claimed (e.g. conditional phrase “when the endoscope is sheathed by the disposable endoscope sheath”), and if NOT, and the endoscope is NOT sheathed by the disposable endoscope sheath, does the sheath body still comprise a “channel region”. For purposes of examination, this claim is being interpreted as NOT positively reciting the endoscope.
Claim Rejections - 35 USC § 102
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) 1-2, 5, 7-8, 10, 13 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakao (US 2005/0085694).
As to claim 1, Nakao discloses a disposable endoscope sheath for removably sheathing an endoscope, the disposable endoscope sheath comprising:
a sheath body (sheath 16, Fig.1 or 76, Fig.5) configured to define an endoscope lumen (when wrapped, the inner confines defined a lumen, as shown in Fig.3) and to sheath the endoscope in the endoscope lumen (lumen can accommodate an endoscope 10, Fig.3, [0034]), the sheath body comprising a proximal end portion (upper right portion of 16 in Fig.1) and a distal end portion (lower left portion of 16 in Fig.1) spaced apart along a longitudinal axis (as shown in Fig.1), the proximal end portion configured to connect to an endoscope controller device (proximal end of sheath 16 wraps around shaft of the endoscope and thus is configured to connect to the proximal end (handle end) of the endoscope via the shaft) and the distal end portion configured to be inserted into a subject (endoscope is inserted into patient, [0037], so sheath is configured to be as well), the sheath body comprising an elongate central portion (mid-portion of sheath between longitudinal edges 48 and 50, Fig.1) and first and second wrapping flaps extending from opposite sides of the elongate central portion to respective free longitudinal edge margins (portions of sheath between the mid-portion and the longitudinal edges 48,50, Fig.1), the sheath body configured to releasably sheath the endoscope by wrapping the first and second wrapping flaps around the endoscope and securing the free longitudinal edge margins of the first and second wrapping flaps at a seam (shown wrapped around the endoscope in Fig.3, the overlapping edges shown at top of that figure).
As to claim 2, wherein the first and second wrapping flaps are configured to be wrapped around the endoscope such that the first and second wrapping flaps form an overlapping seam (longitudinal edges 48,50 overlap at a seam, Fig.3).
As to claim 5, wherein the elongate central portion has a generally U-shaped cross-sectional shape, including opposing arms connected to the first and second wrapping flaps (u-shaped cross-sectional shape below the dashed line, see annotated figure below).
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As to claim 7, wherein the sheath body comprises a plurality of channels (catheter tubes 72,74, Fig.4, [0047]) configured for administering treatment to the subject.
As to claim 8, further comprising a distal endcap (endcap 18, Fig.1) configured to releasably attach to the distal end portion (Fig.2, [0039]).
As to claim 10, wherein the distal endcap comprises an endoscope alignment peg configured to align the distal endcap to the endoscope by reception in the endoscope lumen (tube 14, Fig.2, constitutes an “alignment peg” since it is accommodated in opening 69 of distal endcap 1 and extends back into the endoscope lumen, thus aligning the opening 69 with channel 30, Figs.2,3).
As to claim 13, as best understood (see 112(b) rejection above), wherein when the endoscope is sheathed by the disposable endoscope sheath, the sheath body comprises an overlapping seam and a channel region opposite the overlapping seam (the sheath body, e.g. 76, can include channel regions, 72, 74, Fig.4, that are opposite the overlapping seam, as shown in Fig.6).
As to claim 19, Nakao discloses a method for using an endoscope, wherein the method comprises:
loading the endoscope radially onto a central portion of a disposable endoscope sheath (endoscope shaft 10 disclosed onto mid-portion of sheath 16 as shown in Fig.2, [0039]);
wrapping first and second wrapping flaps of the disposable endoscope sheath around the endoscope (Fig.3, [0039]);
joining the first and second wrapping flaps together at a longitudinal seam (seam formed at overlapping of edges, Fig.3, [0039]).
Claim(s) 1-2, 5-6, 7, 13, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reydel et al. (U.S. Pat. 5,259,366, hereinafter “Reydel”).
As to claim 1, Reydel discloses a disposable endoscope sheath for removably sheathing an endoscope, the disposable endoscope sheath comprising:
a sheath body (sheath 10, Figs.1,3,5B) configured to define an endoscope lumen (space defined by wall of sheath 10, Fig.1,3,5B) and to sheath the endoscope in the endoscope lumen (can sheath an endoscope, as shown in Fig.2), the sheath body comprising distal end portion (shown in Fig.1) and a proximal end portion (opposite proximal end, not shown in figures) spaced apart along a longitudinal axis (sheath has a longitudinal length along an axis, Fig.1), the proximal end portion configured to connect to an endoscope controller device (proximal end of sheath 10 wraps around shaft of the endoscope and thus is configured to connect to the proximal end (handle end) of the endoscope via the shaft) and the distal end portion configured to be inserted into a subject (inserted into body, col.4, lines 57-63), the sheath body comprising an elongate central portion (e.g. portion of sheath wall including channels 16,17,18, see annotated figure below) and first and second wrapping flaps extending from opposite sides of the elongate central portion to respective free longitudinal edge margins (see flaps in annotated figure below, terminating in edge margins at 15, Fig.4), the sheath body configured to releasably sheath the endoscope by wrapping the first and second wrapping flaps around the endoscope and securing
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the free longitudinal edge margins of the first and second wrapping flaps at a seam (overlapping seam in annotated figure above, col.5, lines 14-22).
As to claim 2, wherein the first and second wrapping flaps are configured to be wrapped around the endoscope such that the first and second wrapping flaps form an overlapping seam (wrapped around endoscope as shown in Fig.2, overlapping seam in annotated figure above).
As to claim 5, wherein the elongate central portion has a generally U-shaped cross-sectional shape (Fig.3, upper half of circular cross-section is “generally U-shaped”), including opposing arms connected to the first and second wrapping flaps (see opposing arms in annotated figure above).
As to claim 6, wherein in cross-section (Fig.3), the elongate central portion has a thickness, the thickness tapering outwardly along the flexible opposing arms (thickness of sheath wall tapers from maximum at central portion to smaller wall thickness along opposing arms, as shown in annotated figure above).
As to claim 7, wherein the sheath body comprises a plurality of channels configured for administering treatment to the subject (Fig.3, channels 16,17,18, col.5, lines 23-30).
As to claim 13, as best understood (see 112(b) rejection above) wherein when the endoscope is sheathed by the disposable endoscope sheath, the sheath body comprises an overlapping seam and a channel region opposite the overlapping seam (the sheath 10 can include channel regions, 16,17,18, Fig.3, that are on opposite side (i.e. upper half) than the overlapping seam (i.e. 15 on lower half).
As to claim 19, Reydel discloses a method for using an endoscope, wherein the method comprises:
loading the endoscope radially onto a central portion of a disposable endoscope sheath (endoscope 12 placed radially inside lumen formed by sheath 10, Fig.2);
wrapping first and second wrapping flaps of the disposable endoscope sheath around the endoscope (flaps, e.g ends of sheath at portion 15, Fig.4, are wrapped around endoscope and pulled together to connect, Fig.3,4);
joining the first and second wrapping flaps together at a longitudinal seam (shown in Fig. 3 as joined at 15, col.5, lines 14-22).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakao et al. (U.S. Pat. 5,217,001, hereinafter “Nakao2”).
As to claim 19, Nakao2 discloses a method for using an endoscope, wherein the method comprises: loading the endoscope radially onto a central portion of a disposable endoscope sheath (sheath 22 disposed about endoscope insertion member, col.5, lines 36-41); wrapping first and second wrapping flaps of the disposable endoscope sheath around the endoscope (ends 32 of flaps 38 wrapped around endoscope insertion member, Figs.2,3); joining the first and second wrapping flaps together at a longitudinal seam (flaps secured by ribs 40,42 and cooperating grooves 44,46, Figs.2,3, col.6, lines 15-28).
As to claim 20, further comprising conducting a procedure using the endoscope sheathed by the disposable endoscope sheath (sheath disposed about endoscope and both inserted into patient, col.3, lines 22-41, to perform a procedure, col.3, lines 42-58), and after conducting the procedure, removing the endoscope from the disposable endoscope sheath by separating the first and second wrapping flaps (sheath removed from endoscope insertion member, col.3, lines 35-41) by separating the flaps (separation of ribs/grooves, which requires separation of flaps, allows removal of sheath from endoscope, col.6, lines 29-35).
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.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakao (US 2005/0085694).
As to claim 3, Nakao, as set forth above with respect to claim 2, discloses that the flaps overlap but not by how much, and thus fails to disclose that the first and second wrapping flaps are configured so that the overlapping seam has an overlap width in an inclusive range of 13 mm to 25 mm. At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have configured the flaps of Nakao to provide an overlap width of somewhere between 13 mm and 25 mm because Applicant has not disclosed that an overlap width of somewhere between 13 mm and 25 mm provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with an overlap width outside of Applicant’s range (e.g. 8-12 mm) or (26-30 mm) because such other overlap widths will provide the predictable result of equally providing enough overlap to be sealed with adhesive tape, while allowing variation in size of the endoscope lumen to accommodate different diameter scopes. One of ordinary skill would have also obviously recognized that the amount of overlap is dependent on the diameter of the scope on which it is being used, and that the larger the overlap, the better the capability of the sheath to accommodate a larger scope, e.g. an overlap of 15 mm would allow for greater versatility in accommodating larger scopes than, say, a 10 mm overlap width.
As to claim 4, Nakao, as set forth above with respect to claim 1, disclose that the first and second wrapping flaps are configured to be secured together by a pressure sensitive adhesive (note adhesive material with cover strips 54,56, pressed to from a bond, [0039]), but fails to disclose that such adhesive is “biocompatible”. If not inherently “biocompatible”, one of ordinary skill in the art would recognize that since such sheath is being inserted into a patient’s body, it would be desirable to form the sheath and all components thereof from biocompatible materials, to avoid any negative interactions between the material and the patient. It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a biocompatible adhesive for the adhesive of Nakao.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakao (US 2005/0085694) in view of Jones (U.S. Pat. 5,201,908).
As to claim 11, Nakao discloses the sheath as set forth above with respect to claim 8, wherein a tube for providing irrigation/suction extends to the endcap (14, Figs.1,2, [0021],[0040]) but fails to disclose that endcap comprises a water diverter configured to direct water over a distal face of the distal endcap. However, Jones teaches, in a similar sheath for protecting an endoscope, to provide a spray port (water diverter) on the endcap and in fluid communication with an irrigation channel for spraying the optically clear window of the endcap with cleaning fluid during a procedure (Jones: Figs.2,3, spray port 70 on endcap 40 in communication with channel 60B for cleaning window 48, col.5, lines 60-68). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a water diverter on the endcap of Nakao in order to provide the predictable result of diverting fluid onto the surface of the endcap to keep it clean and visually unobscured, as taught by Jones.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakao (US 2005/0085694) in view of Pauker (US 2002/0055668).
As to claim 12, Nakao, as set forth above with respect to claim 1, fails to disclose the size of endoscope in which the sheath is to wrap, and particularly that the sheath body is configured to fit endoscopes in an inclusive outer diameter size range of 9 mm to 13.5 mm. Pauker evidences that typical endoscopes can range in diameter on the order of about 9-15 mm. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have produced the Nakao sheath to fit any diameter of endoscope known in the art, including one of a diameter in the range of 9 mm to 13.5 mm, to provide the predictable result of beneficially enabling the Nakao sheath to be used with any endoscope.
Claim(s) 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reydel et al. (U.S. Pat. 5,259,366, hereinafter “Reydel”) in view of Pauker (US 2002/0055668).
As to claim 12, Reydel, as set forth above with respect to claim 1, fails to disclose the size of endoscope in which the sheath is to wrap, and particularly that the sheath body is configured to fit endoscopes in an inclusive outer diameter size range of 9 mm to 13.5 mm. Pauker evidences that typical endoscopes can range in diameter on the order of about 9-15 mm. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have produced the Reydel sheath to fit any diameter of endoscope known in the art, including one of a diameter in the range of 9 mm to 13.5 mm, to provide the predictable result of beneficially enabling the Reydel sheath to be used with any endoscope.
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reydel et al. (U.S. Pat. 5,259,366, hereinafter “Reydel”) in view of Nakao et al. (U.S. Pat. 5,217,001, hereinafter “Nakao2”).
As to claim 20, Reydel, as set forth above with respect to claim 19, discloses conducting a procedure using the endoscope sheathed by the disposable endoscope sheath (col.5, lines 4-30), but fails to disclose what happens after the procedure, and particularly that the endoscope is removed from the disposable endoscope sheath by separating the first and second wrapping flaps. If not implicit that such sheath would be removed by the same means that it is attached to the endoscope, Nakao explicitly teaches, in a similar endoscope sheath with a similar attachment means (note Figs.1-3, sheath 22, flaps 38, zip-lock ribs 40,42), that, at the end of the procedure, the sheath is removed from the endoscope (col.3, lines 22-41) by separating the sheath flaps by separating the zip-lock ribs 40,42 from grooves 44,46 (col.6, lines 29-35). Provided with the teaching of Nakao, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have removed the sheath of Reydel from the endoscope by the same means that it is attached, i.e. separating the securement mechanism on the flaps, as taught by Nakao.
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited on PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P LEUBECKER whose telephone number is (571)272-4769. The examiner can normally be reached Generally, M-F, 5:30-2:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan T 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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/JOHN P LEUBECKER/Primary Examiner, Art Unit 3795
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