DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Acknowledgement is made to Applicant’s claim to priority to PCT/GB2022/000025 filed February 21, 2022 and to Foreign App. No. GB2103603.3 filed March 16, 2021.
Status of Claims
This Office Action is responsive to the preliminary amendment filed on August 16, 2023. As directed by the amendment: claims 1-11 have been cancelled; and claims 12-22 have been added. Thus, claims 12-22 are presently pending in this application.
Claim Objections
Claims 12, 19 and 22 are objected to because of the following informalities:
Claim 12 recites “an inflatable cuff towards the forward,”, ln 1-2 should read --an inflatable cuff towards a forward,--;
Claim 12 recites “from the inside of the cuff”, ln 3 should read --from the inside of a cuff--;
Claim 12 recites “along the wall of an inner tubular component”, ln 3-4 should read -- along a wall of an inner tubular--;
Claim 12 recites “positioned along the length of the cuff”, ln 6 should read -- positioned along a length of the cuff--;
Claim 19 recites “along the outside of the inner component”, ln 3 should read --along an outside of the inner component--;
Claims 19 and 22 recite “towards the patient end”, ln 4 should read --towards a patient end--;
Claims 19 and 22 recite “a major part at least of its length and over the open patient end”, ln 5-6 should read -- a major part at least of a length of the inner component and over an open patient end--.
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 12, 19, and 22, and claims 13-18 and 20-21 by dependency, 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 12 recites “that the tube includes an outer tubular component extending along a major part at least of the inner component”, ln 7-8 it is unclear whether “major part” is an element or a relative term of amount. The term “major” being a relative term renders the claim indefinite. The term “major part” 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. For the purpose of this Office Action “that the tube includes an outer tubular component extending along a major part at least of the inner component” has been interpreted such that the outer tubular component extending along a majority (i.e. more than half) of at least the inner component.
Similar rational is applied to independent claims 19 and 22.
Claim 12 recites “that the lumen is arranged to open externally at a second location rearwardly of the first location and positioned along the length of the cuff within an inflatable region of the cuff and that the tube includes an outer tubular component extending”…“over the first location such as to occlude the lumen at the first location.”, ln 5-9 it is unclear how the outer tubular component can occlude the lumen at the first location when the lumen only extends to the second location within the inflatable region. For the purpose of this Office Action the outer tubular component has been interpreted as extending to the first location past the second location of the lumen.
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) 12-14, 17-20, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shapiro et al. (U.S. Pat. No. 5,027,812; hereinafter: “Shapiro”).
Regarding Claim 12, Shapiro discloses a medico-surgical tube including a shaft (10; Fig. 1, 2), an inflatable cuff (12; Fig. 1, 2, 6) towards a forward, patient end (16; Fig. 1, 2) of the shaft and a lumen (13; Fig. 1, 2) by which inflation fluid is supplied to or from the inside of the cuff (col 3, ln 50-56; col 5, ln 17-38), characterised in that the lumen is formed along a wall (A, Fig. A annotated below) of an inner tubular component (11a; Fig. 1-6) and extends to a first location (B, Fig. A annotated below) towards the patient end of the component, that the lumen is arranged to open externally at a second location (C, Fig. A annotated below) rearwardly of the first location (Fig. 1-2; Examiner notes: The limitation “rearwardly” is a relative term and the claim has fail to established directionality. For the purpose of this Office Action “rearwardly” has been interpreted as away from the forward patient end, such that the second location is further away from the forward patient end compared to the first location.) and positioned along the length of the cuff within an inflatable region (D, Fig. A annotated below) of the cuff, and that the tube includes an outer tubular component (15; Fig. 1-5) extending along a major part at least of the inner component and over the first location such as to occlude the lumen at the first location [col 3, ln 62 to col 5, ln 38; Examiner notes: Shapiro discloses the outer tubular component (sheath 15) extending over at least the majority of the inner tubular component and the cuff until index line 34 (Fig. 2A; col 5, ln 39-46). Therefore, the outer tubular component at least extends past (i.e. occlude) the lumen and to the first location. See Interpretation above].
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Figure A, Adapted from Figures 1-6 of Shapiro.
Regarding Claim 13, Shapiro discloses the medico-surgical tube characterised in that the lumen extends along a rib (E, Fig. A annotated above) projecting externally of the inner component.
Regarding Claim 14, Shapiro discloses the medico-surgical tube characterised in that the rib terminates (at 21; Fig. 1) a short distance (F, Fig. A annotated above) rearwardly of the patient end of the inner component (Examiner notes: Broadest reasonable interpretation has been applied to the relative term “short” in the element “short distance.).
Regarding Claim 17, Shapiro discloses the medico-surgical tube characterised in that the cuff is of a silicone (col 4, ln 47-50).
Regarding Claim 18, Shapiro discloses the medico-surgical tube characterised in that the tube is a tracheal tube (Abstract; col 3, ln 68 to col 4, ln 3).
Regarding Claims 19-20, Shapiro discloses the medico-surgical tube of claims 12 and 14, shown above. Claims 19-20 which are interpreted as product by process claim(s), the product disclosed by the prior art is identical to the claimed product, even though the prior art is silent on the method of making. There is no evidence to show that the claimed process imparts any patentable distinction between the claimed product and that of the prior art. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim is unpatentable although produced by a different process. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP § 2113.
Regarding Claim 21, Shapiro discloses the medico-surgical tube of claim 12, shown above. Claim 21 which is interpreted as product by process claim(s), the product disclosed by the prior art is identical to the claimed product, even though the prior art is silent on the method of making. There is no evidence to show that the claimed process imparts any patentable distinction between the claimed product and that of the prior art. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim is unpatentable although produced by a different process. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP § 2113.
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) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Shapiro in view of Burnett et al. (U.S. Pub. No. 2011/0146691; hereinafter: “Burnett”).
Regarding Claim 16, Shapiro discloses the medico-surgical tube of claim 12, shown above.
Shapiro does not specifically disclose the medico-surgical tube characterised in that the lumen opens into the cuff at two places spaced longitudinally of one another.
Burnett teaches a tracheal tube comprising a shaft (16; Fig. 1-3), an inflatable cuff (12; Fig. 1-3) and a lumen (30, 32; Fig. 1) by which inflation fluid is supplied to the cuff (¶ 0021); wherein the lumen opens into the cuff at two places spaced longitudinally of one another (31; Fig. 1-3; ¶ 0021) for the purpose of decreased or prevented blocking of the lumen from inflating the cuff.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the medico-surgical tube of Shapiro to include the lumen opening into the cuff at two places spaced longitudinally of one another as taught by Burnett for the purpose of decreased or prevented blocking of the lumen from inflating the cuff.
Allowable Subject Matter
Claims 15 and 21 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.
The following is a statement of reasons for the indication of allowable subject matter: Prior art of Shapiro and Burnett alone or in combination fails to disclose or render obvious the medico-surgical tube characterised in that the tube includes a reinforcement member between the inner and outer tubular components, and that reinforcement member extends a part way around the inner component leaving a longitudinal gap along which the rib extends, as recited in dependent claim 15 and similarly in dependent claim 21.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
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