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 .
This office action is in response to the preliminary amendment filed 9/12/23. As directed by the amendment, claims 1-7 have been cancelled and claims 8-14 have been added. As such, claims 8-14 are pending in the instant application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “30” has been used to designate both the machine end and the shallow rib. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "32" and "30" have both been used to designate the machine end. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 216. 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. 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 Objections
Claims 8-9 and 12-14 are objected to because of the following informalities:
Regarding claim 8, the language “the tube” (line 3, 4, 6, two instances, and 10) is objected to for not maintaining consistency in claim terminology; Examiner suggests amending to read –the medical tube--.
Regarding claim 8, the language “the longitudinal axis of the shaft” (line 8-9) lacks antecedent basis for ‘the longitudinal axis’; however, this does not rise to the level of indefiniteness as one of ordinary skill would recognize that a shaft would have a longitudinal axis. Examiner suggests amending to read –a longitudinal axis of the shaft--.
Regarding claim 9, the language “the aperture” (line 3) is objected to for not maintaining consistency in claim terminology; Examiner suggests amending to read –the central aperture--.
Regarding claim 12, the language “the tube” (line 3) is objected to for not maintaining consistency in claim terminology; Examiner suggests amending to read –the medical tube--.
Regarding claim 13, the language “the tube” (line 1, 1-2, 3, 4, 6, 7, and 10) is objected to for not maintaining consistency in claim terminology; Examiner suggests amending to read –the medical tube--.
Regarding claim 13, the language “the longitudinal axis of the shaft” (line 9) lacks antecedent basis for ‘the longitudinal axis’; however, this does not rise to the level of indefiniteness as one of ordinary skill would recognize that a shaft would have a longitudinal axis. Examiner suggests amending to read –a longitudinal axis of the shaft--.
Regarding claim 14, the language “the tube” (line 1) is objected to for not maintaining consistency in claim terminology; Examiner suggests amending to read –the medical tube--.
Appropriate correction is required.
Claim Interpretation
Claim 8 is being interpreted to be an open-ended type claim similar to claims which use the transitional phrase ‘comprising’ as claim 8 uses the phrase “having” (line 1) and thus is being interpreted in light of the disclosure and in view of MPEP 2111.03 IV to be open-ended and not excluding additional, unrecited elements.
Claim 13 uses the term “including” (line 1) which is synonymous with the transitional term “comprising” and thus claim 13 is interpreted to be open-ended and not excluding additional, unrecited elements. See MPEP 2111.03 I.
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 8-14 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 8 recites the limitation "the machine end of the shaft" in line 8. There is insufficient antecedent basis for this limitation in the claim. Note: a machine end of the medical tube and a machine end of the obturator has been previous set forth but not a machine end of the shaft.
Claim 13 recites the limitation "the machine end of the shaft" in line 8. There is insufficient antecedent basis for this limitation in the claim. Note: a machine end of the medical tube and a machine end of the obturator has been previous set forth but not a machine end of the shaft.
Claims 9-12 and 14 are rejected based on dependency on a rejected claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 8-9 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Poulsen et al. (2010/0307488).
Regarding claim 8, Poulsen discloses an obturator for a medical tube (see Figs. 1-2, 5-8, and 13, abstract, obturator 2, medical tube 1), the medical tube including a patient end and a machine end (see Fig. 5 patient end at 10 and machine end at 11), the obturator having a patient end shaped with a tapered nose arranged to protrude from the patient end of the tube (see Fig. 7-8 showing obturator 2, and including 4, with patient end having tapered nose 20, see para. 0032, and machine end at 21; Fig. 1 showing tapered nose protruding from patient end of tube), a machine end adapted to fasten with the machine end of the tube and a shaft extending between the patient end and the machine end of the obturator (see Fig. 7-8, machine end of obturator at 21 and including clip 4, fastens with machine end of tube via clip 4 as shown in Fig. 1-2, see also para. 0032; shaft 22), the machine end of the obturator being in the form of a clip releasable from engagement with the machine end of the tube by twisting relative to the tube (see Fig. 5-8 showing machine end clip 4 which interfaces in releasable engagement with the machine end of the tube, see para. 0031-0032, 4 is a clip per the ordinary definition of the term which is ‘a device that grip, clasp, or hook’), characterized in that the clip and the shaft are separately formed components (see Fig. 7-8 and 13, para. 0034), and that the clip is rotatably mounted with the machine end of the shaft for at least limited rotation relative to the shaft about the longitudinal axis of the shaft so that the clip can be rotated to release it from engagement with the machine end of the tube without applying any substantial torque to the shaft (see Fig. 1-2 and 5-8, para. 0031-0034, clip 4 is loosely fitted and allowed to rotate axially on the obturator and thus is able to rotate to release from engagement without applying substantial torque to the shaft).
Regarding claim 9, the Poulsen device is characterized in that the clip includes a central aperture and the machine end of the shaft includes a spigot rotatably received in the aperture in the clip (see Fig. 13 which shows clip 4 having a central aperture which rotatably receives 21 which is a spigot as claimed as it is received through the central aperture and allows rotation of the clip 4 relative to the shaft 22).
Regarding claim 13, Poulsen discloses an assembly including a medical tube and an obturator fitted in the tube (see Figs. 1-2, 5-8, and 13, abstract, obturator 2, medical tube 1) the tube having a patient end and a machine end (see Fig. 5 patient end at 10 and machine end at 11), the obturator having a patient end shaped with a tapered nose arranged to protrude from the patient end of the tube (see Fig. 7-8 showing obturator 2 with patient end having tapered nose 20, see para. 0032, and machine end at 21; Fig. 1 showing tapered nose protruding from patient end of tube), a machine end adapted to fasten with the machine end of the tube and a shaft extending between the patient end and the machine end of the obturator (see Fig. 7-8, machine end of obturator at 21 and including clip 4, fastens with machine end of tube via clip 4 as shown in Fig. 1-2, see also para. 0032; shaft 22), the machine end of the obturator being in the form of a clip releasable from engagement with the machine end of the tube by twisting relative to the tube (see Fig. 5-8 showing machine end clip 4 which interfaces in releasable engagement with the machine end of the tube, see para. 0031-0032, 4 is a clip per the ordinary definition of the term which is ‘a device that grip, clasp, or hook’), characterized in that the clip and the shaft are separately formed components (see Fig. 7-8 and 13, para. 0034), and that the clip is rotatably mounted with the machine end of the shaft for at least limited rotation relative to the shaft about the longitudinal axis of the shaft so that the clip can be rotated to release it from engagement with the machine end of the tube without applying any substantial torque to the shaft (see Fig. 1-2 and 5-8, para. 0031-0034, clip 4 is loosely fitted and allowed to rotate axially on the obturator and thus is able to rotate to release from engagement without applying substantial torque to the shaft).
Regarding claim 14, the Poulsen device’s tube is a tracheostomy tube (see abstract and para. 0001 and 0027 for example).
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.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poulsen in view of Neame (6,481,436).
Regarding claim 12, Poulsen is silent as to the machine end of the obturator including two resilient arms each having a catch at its patient end shaped to engage a lip on the outside of the machine end of the tube; however, Neame teaches a similar obturator which includes a machine end including two resilient arms having a catch shaped to engage a lip on the outside of the machine end of the tube (see Neame Fig. 1-2, machine end 32 having resilient arms 34 with a catch 35 that engages lip 15 on the outside of the machine end of the tube, see col. 3 ln. 8-60). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Poulsen device’s machine end of the obturator to include two resilient arms with catch to engage lips on the outside of the machine end of the tube, as taught by Neame, as this would have been obvious substitution of one known element for another (swapping notch 41 and grooves 42, 43 of Poulsen with the resilient arms and lip of Neame) and one would expect the modified Poulsen device to perform equally as well.
Allowable Subject Matter
Claims 10-11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
When read in light of the limitations of the claimed obturator for a medical device, the prior art does not disclose, either alone or suggest in combination, an obturator including the limitations set forth in claim 8 and further wherein the obturator is characterized in that the machine end of the shaft and the clip having cooperating detents that retain the clip angularly relative to the shaft until sufficient force is applied to rotate the clip relative to the shaft as set forth in dependent claim 10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Lester (GB 2316321), Lester (5,928,198), Nash et al. (GB 2341102), LaBombard (5,042,475), and Stuart et al. (5,546,937) disclose obturators for medical tubes similar to the claimed/disclosed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COLIN W STUART/Primary Examiner, Art Unit 3785