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 .
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.
Claim Objections
Claim 17 is objected to because of the following informalities: “a slit(s)” (line 11) appears that it should be “a slit.”
Claim 17 is objected to because of the following informalities: “the sheath” (line 10) appears that it should be “the sheath member.”
Claim 17 is objected to because of the following informalities: “the slit(s)” (line 12) appears that it should be “the slit.”
Claim 17 is objected to because of the following informalities: the claim ends with a semicolon.
Claim 18 is objected to because of the following informalities: “the slit(s)” (line 1) appears that it should be “the slit.”
Claim 18 is objected to because of the following informalities: “the slit(s)” (line 3) appears that it should be “the slit.”
Claim 18 is objected to because of the following informalities: “a endometrial sample” (line 4) appears that it should be “an endometrial sample.”
Claim 19 is objected to because of the following informalities: “the slit(s)” (line 2) appears that it should be “the slit.”
Claim 19 is objected to because of the following informalities: “the slit(s)” (line 3) appears that it should be “the slit.”
Claim 19 is objected to because of the following informalities: “an uterine cavity” (line 4) appears that it should be “a uterine cavity.”
Claim 20 is objected to because of the following informalities: “the slit(s)” (line 1) appears that it should be “the slit.”
Claim 21 is objected to because of the following informalities: “the slit(s)” (line 1) appears that it should be “the slit.”
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(s) 17-25 is/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.
For claim 17, the claim term “having” (line 2) is ambiguous. “Transitional phrases such as ‘having’ must be interpreted in light of the specification to determine whether open or closed claim language is intended. See, e.g., Lampi Corp. v. American Power Products., 228 F.3d 1365, 1376, 56 USPQ2d 1445, 1453 (Fed. Cir. 2000) (quoting MPEP 2111.03(IV)). Here, it is unclear whether “having” is intended to be open or closed claim language. The claim is examined as meaning that the claim language is open.
For claim 17, the claim language “a handle having … a first portion” (line 2) and “a first portion of the handle” (line 6) is ambiguous. It is unclear whether this is the same first portion of the handle or different portions of the handle. The claim is examined under the former interpretation.
For claim 17, the claim language “a portion of the wand” (line 7) and “a portion of the wand” (line 8) is ambiguous. It is unclear whether this is the same portion of the wand or different portions of the wand. The claim is examined under the former interpretation.
For claim 17, the claim term “the first end of a selectively moveable actuator” (line 8) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 17, the claim term “the second portion of the handle” (line 9) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 17, the claim language “a distal end portion of the sheath member” (line 11) and “a distal end portion of the sheath member” (line 12) is ambiguous. It is unclear whether this is the same portion of the sheath member or different portions of the sheath member. The claim is examined under the former interpretation.
For claim 18, the claim language “the opposing edges of the slit substantially adjoin to substantially seal the sample collection cavity” (lines 2-3) is ambiguous. It is unclear how much the opposing edge adjoin to be considered to “substantially” adjoin. Similarly, it is unclear how much the sample collection cavity has to be sealed to “substantially” seal. The claim is examined as meaning “the opposing edges of the slit adjoin to seal the sample collection cavity.”
For claim 19, the claim language “the closed position” (line 2) lacks antecedent basis. The claim is examined as depending from claim 18.
For claim 19, the claim language “the open position” (line 3) lacks antecedent basis. The claim is examined as depending from claim 18.
Dependent claim(s) 18-25 fail to cure the ambiguity of independent claim 17, thus claim(s) 17-25 is/are rejected under 35 U.S.C. 112(b).
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) 17-19, 21, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2008/0208230 to Chin et al. (hereinafter "Chin").
For claim 17, Chin discloses an endometrial sampling device (Abstract), comprising:
a handle ("grip or structure located about outer tube 4 to facilitate handling by the user," para [0044]) having a distal end (distal end of grip or grip or structure located about outer tube 4, see Fig. 2), a first portion (first portion of grip or grip or structure located about outer tube 4, see Fig. 2), a second portion (second portion of grip or grip or structure located about outer tube 4, see Fig. 2), a longitudinal axis (longitudinal axis of grip or grip or structure located about outer tube 4, see Fig. 2), and suction components (“suction system,” para [0044]) comprising a syringe (“syringe,” para [0037]), a pump (“pump,” para [0037]), or an internal piston;
an elongate wand (56) (Figs. 6A-C) (para [0066]) extending outwardly from the distal end of the handle along the longitudinal axis (as can be seen in Figs. 6A-C), wherein the wand has an exterior surface (exterior surface of 56), a front end (front end of 56) and a back end (back end of 56), and wherein the back end is fixedly mounted to the distal end of a first portion of the handle (as can be seen in Figs. 6A-C);
a sheath member (48/50) (Figs. 6A-C) (para [0055]) selectively encapsulating a portion of the wand (as can be seen in Figs. 6A-C) and fixedly mounted to a portion of the wand proximate the front end of the wand (see Figs. 7A-B, as the sheath member is pushed from the proximal end, it doesn’t move at a location that is proximal to element 74) (also see para [0066]) and to a portion of the first end of a selectively moveable actuator member (70/78) (Figs. 6A-C) (para [0062]) that is coupled to the second portion of the handle and to the sheath (see Figs. 6A-7B);
wherein the sheath member defines a slit (51) (Fig. 6A-C) (para [0056]) on a distal end portion of the sheath member (see Figs. 6A-C), the slit being bordered by opposing edges (58, 60) (Figs. 6A-C), wherein the distal end portion of the sheath member and a portion of the exterior surface of the wand underlying the distal end portion of the sheath member define a sample collection cavity (as can be seen in Figs. 6A-7B).
For claim 18, Chin further discloses wherein the slit(s) is selectively movable between a closed position, in which the opposing edges of the slit substantially adjoin to substantially seal the sample collection cavity (as can be seen in Figs. 6A and 7A), and an open position, in which the opposing edges of the slit(s) are spaced from each other for obtaining an endometrial sample when positioned within a uterine cavity (as can be seen in Figs. 6B, 6C, and 7B).
For claim 19, Chin further discloses wherein the actuator member is selectively rotatable about the distal end of the handle (para [0062]-[0063]) between a first position, in which the slit(s) is positioned in the closed position (as can be seen in Figs. 6A and 7A), and a second position, in which the slit(s) is positioned in the open position (as can be seen in Figs. 6B, 6C, and 7B).
For claim 21, Chin further discloses wherein the slit(s) is a longitudinal slit (see Figs. 6A-7B).
For claim 23, Chin further discloses wherein the endometrial sampling device is a single-use device or a multiple-use device (para [0097]).
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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin in view of U.S. Patent Application Publication No. 2012/0245487 to Eells et al. (hereinafter “Eells”).
For claim 20, Chin does not expressly disclose wherein the slit(s) is a helical slit that extends about the longitudinal axis.
However, Eells teaches wherein a slit is a helical slit that extends about a longitudinal axis (see Fig. 1).
It would have been obvious to a skilled artisan to modify Chin wherein the slit(s) is a helical slit that extends about the longitudinal axis, in view of the teachings of Eells, because such a modification would be the simple substitution of the shape of the slit that would lead to the predictable result of capturing tissue, which is what Chin wants to do.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin in view of U.S. Patent No. 3,400,708 to Scheidt.
For claim 22, Chin does not expressly disclose wherein the front end of the wand defines an atraumatic tip.
However, Scheidt teaches wherein a front end of a wand defines an atraumatic tip (either 7 or 12) (see Fig. 1).
It would have been obvious to a skilled artisan to modify Chin wherein the front end of the wand defines an atraumatic tip, in view of the teachings of Scheidt, for the obvious advantage of lessening the risk of perforation or damage when the wand is inserted into the human body.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin in view of U.S. Patent Application Publication No. 2013/0053725 to Beck et al. (hereinafter “Beck”).
For claim 24, Chin does not expressly disclose a depth stop located slidably on the sheath.
However, Beck teaches a depth stop (360) located slidably (“slidably,” para [0080]) on a sheath (320) (see Fig. 20).
It would have been obvious to a skilled artisan to modify Chin to include a depth stop located slidably on the sheath, in view of the teachings of Beck, for the obvious advantage of controlling the depth of insertion of the device.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin in view of U.S. Patent Application Publication No. 2013/0172778 to Teschendorf.
For claim 25, Chin does not expressly disclose a coating of lubricant on at least a portion of the sheath member.
However, Teschendorf teaches a coating of lubricant on at least a portion of the sheath member (para [0019]).
It would have been obvious to a skilled artisan to modify Chin to include a coating of lubricant on at least a portion of the sheath member, in view of the teachings of Teschendorf, for the obvious advantage of making the sheath member have less friction when being slid into a body orifice.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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