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 .
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 17 – 18 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.
The term “substantially” in claims 17 and 18 is a relative term which renders the claim indefinite. The term “substantially” 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. It is unclear what “substantially” entails.
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 – 2, 8 – 9 and 14 - 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makel et al (US 20150335913 A1, hereinafter “Makel”).
Regarding claim 1, Makel teaches a fixation element (“brachytherapy applicator device 1” [0024], Figure 1) for an applicator for use in brachytherapy ([0024]), the fixation element comprising:
a first component comprising a camming portion (“perineal bar 7” [0025] Figure 1) and a lever portion (“a knob or lever 10” [0025] Figure 1); and
a second component comprising a securement portion forming an opening for receiving the applicator (Figure 1),
the securement portion comprising an abutment portion (Figure 1), and a first component receiving portion (Figure 1),
wherein, in a first position, the first component is received in the first component receiving portion (Figure 1), and
wherein the fixation element (Figure 1) is configured to transition from the first position to a second position as the lever portion is actuated ([0025]),
wherein actuation of the lever portion causes the camming portion to exert a force against the abutment portion ([0025]), and
wherein, as the force is exerted against the abutment portion, the opening formed by the securement portion constricts ([0025]).
Regarding claim 2, Makel teaches all limitations of claim 1. Makel teaches the fixation element is resiliently deformable between the first position and the second position ([0025]).
Regarding claim 8, Makel teaches all limitations of claim 1. Makel teaches the fixation element is configured for receiving a rectal applicator (Makel: “can be inserted into a body cavity such as the vagina or rectum” [0042] Figure 8).
Regarding claim 9, Makel teaches all limitations of claim 1. Makel teaches the camming portion (Makel: “perineal bar 7” [0025] Figure 1) is asymmetric (Makel: Figure 1).
Regarding claim 14, Makel teaches all limitations of claim 1. Makel teaches the fixation element (“perineal bar 7” and “a knob or lever 10” [0025] Figure 1) is configured to transition from the first position to the second position (“A connectable handle 7 known as a perineal bar is slidingly engageable in a corresponding slot 8.” [0025] Figure 1) by a deformation of the camming portion (“perineal bar 7” [0025] Figure 1) (“A connectable handle 7 known as a perineal bar is slidingly engageable in a corresponding slot 8.” [0025] Figure 1; Examiner interprets that a user moving the perineal bar reads on “a deformation of the camming portion”.).
Regarding claim 15, Makel teaches all limitations of claim 14. Makel teaches the deformation of the camming portion is a compression of the camming portion (“A connectable handle 7 known as a perineal bar is slidingly engageable in a corresponding slot 8.” [0025] Figure 1; Examiner interprets that a user moving the perineal bar reads on “a compression of the camming portion”.).
Regarding claim 16, Makel teaches an applicator (“applicator 3” [0025] – [0026] Figures 1 - 2) for brachytherapy ([0024]), comprising; a fixation element comprising:
a first component comprising a camming portion (“perineal bar 7” [0025] Figure 1) and a lever portion (“a knob or lever 10” [0025] Figure 1); and
a second component comprising a securement portion forming an opening for receiving the applicator (Figure 1),
the securement portion comprising an abutment portion (Figure 1), and a first component receiving portion (Figure 1),
wherein, in a first position, the first component is received in the first component receiving portion (Figure 1), and
wherein the fixation element (Figure 1) is configured to transition from the first position to a second position as the lever portion is actuated ([0024] - [0025] Figure 1),
wherein actuation of the lever portion causes the camming portion to exert a force against the abutment portion ([0025]), and
wherein, as the force is exerted against the abutment portion, the opening formed by the securement portion constricts ([0025]).
Regarding claim 17, Makel teaches all limitations of claim 16. Makel teaches the applicator (“applicator 3” [0025] – [0026] Figures 1 - 2) comprises a substantially cylindrical body (Figure 1) on which the fixation element (“perineal bar 7” and “a knob or lever 10” [0025] Figure 1) is slidably mounted when the fixation element (Figure 1) is in the first position (“connectable handle 7 known as a perineal bar is slidingly engageable” [0025]), and restrained on the substantially cylindrical body when in the second position ([0025] Figure 1).
Regarding claim 18, Makel teaches all limitations of claim 17. Makel teaches the opening is substantially circular (Figure 1).
Regarding claim 19, Makel teaches all limitations of claim 16. Makel teaches the applicator is a rectal applicator (Makel: “can be inserted into a body cavity such as the vagina or rectum” [0042] Figure 8).
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.
Claims 3 – 7 and 10 - 13 are rejected under 35 U.S.C. 103 as being unpatentable over Makel in view Brewaeys et al (GB 2102490 A).
Regarding claim 3, Makel teaches all limitations of claim 1. Makel does not teach the first component further comprises at least one extending portion protruding from the camming portion, and
wherein the first component receiving portion comprises a respective at least one groove arranged to receive the at least one extending portion.
However, Brewaeys discloses a “adjustable clamp e.g. for a tracheostomy tube” (abstract) and teaches the first component (Figures 1 - 5) further comprises at least one extending portion (see Brewaeys’s annotated Figure 1 below; Figures 1 - 5) protruding from the camming portion (“cam member 34” page 2 lines 63 – 65; Figures 1 - 5), and
wherein the first component receiving portion comprises a respective at least one groove (see Brewaeys’s annotated Figure 1 below) arranged to receive the at least one extending portion (see Brewaeys’s annotated Figure 1 below; Figures 1 - 5).
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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 element of Makel such that the first component further comprises at least one extending portion protruding from the camming portion, and
wherein the first component receiving portion comprises a respective at least one groove arranged to receive the at least one extending portion, as taught by Brewaeys, for the benefit of limiting rotation during usage for the safety of the patient (Brewaeys: page 2 lines 92 - 93).
Regarding claim 4, Makel and Brewaeys teach all limitations of claim 3. The modified invention of Makel and Brewaeys teaches the at least one extending portion (see Brewaeys’s annotated Figure 1 under claim 3) is oblong (see Brewaeys’s annotated Figure 1 under claim 3).
Regarding claim 5, Makel and Brewaeys teach all limitations of claim 3. The modified invention of Makel and Brewaeys teaches the first component receiving portion (see Brewaeys’s annotated Figure 1 under claim 3) comprises a respective at least one recess (see Brewaeys’s annotated Figure 1 under claim 3) coupled to the respective at least one groove (see Brewaeys’s annotated Figure 1 under claim 3),
the respective at least one recess arranged such that, in the first position, the at least one extending portion (see Brewaeys’s annotated Figure 1 under claim 3) is removable from the respective at least one recess (see Brewaeys’s annotated Figure 1 under claim 3) via the respective at least one groove (see Brewaeys’s annotated Figure 1 under claim 3; Figures 1 - 5), and
in the second position, the at least one extending portion (see Brewaeys’s annotated Figure 1 under claim 3) is retained in the respective at least one recess (see Brewaeys’s annotated Figure 1 under claim 3; Figures 1 - 5).
Regarding claim 6, Makel teaches all limitations of claim 1. Makel teaches the second component (Figure 1).
Makel does not teach a fastening portion for securing a position of the fixation element with respect to a patient.
However, Brewaeys discloses a “adjustable clamp e.g. for a tracheostomy tube” (abstract) and teaches a fastening portion (“cuff 13”) for securing a position of the fixation element with respect to a patient (“At the patient end 11 of the tube 1 there is provided a cuff 13 that embraces the tube and that can be inflated to make a seal with the trachea 3 via an inflation line 14 that opens into the cuff through a lumen (not shown) extending within the wall of the tubing 10” page 2 lines 16 - 20).
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 element of Makel to incorporate a fastening portion for securing a position of the fixation element with respect to a patient, as taught by Brewaeys, for the benefit of embracing the tube and making a seal with the targeted area such as the trachea during usage for the safety of the patient (Brewaeys: page 2 lines 19 - 20).
Regarding claim 7, Makel teaches all limitations of claim 1. Makel teaches the second component (Figure 2).
Makel does not teach an attachment portion for securing a position of the fixation element with respect to a patient support surface.
However, Brewaeys discloses a “adjustable clamp e.g. for a tracheostomy tube” (abstract) and teaches an attachment portion (“cuff 13”) for securing a position of the fixation element with respect to a patient support surface (“At the patient end 11 of the tube 1 there is provided a cuff 13 that embraces the tube and that can be inflated to make a seal with the trachea 3 via an inflation line 14 that opens into the cuff through a lumen (not shown) extending within the wall of the tubing 10” page 2 lines 16 - 20).
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 element of Makel to incorporate an attachment portion for securing a position of the fixation element with respect to a patient support surface, as taught by Brewaeys, for the benefit of embracing the tube and making a seal with the targeted area such as the trachea during usage for the safety of the patient (Brewaeys: page 2 lines 19 - 20).
Regarding claim 10, Makel teaches all limitations of claim 1. Makel does not teach the second component is resiliently compressible.
However, Brewaeys discloses a “adjustable clamp e.g. for a tracheostomy tube” (abstract) and teaches a component is resiliently compressible (Figures 4 – 5; “As the actuating lever 37 is moved further anticlockwise the distance between the axle 33 and the point of contact of the camming surface 36 with the collar 27 begins to decrease and the lever snaps against the collar in an over-centre cam action, to the position shown in Figure 5, the lever 34 limiting further rotation. The clamp unit 2 can readily be released for displacement relative to the tube 1 by moving the actuating lever 37 clockwise to the position shown in Figure 4.”).
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 element of Makel such that the second component is resiliently compressible, as taught by Brewaeys, for the benefit of embracing the tube and making a seal with the targeted area such as the trachea during usage for the safety of the patient (Brewaeys: page 2 lines 19 - 20).
Regarding claim 11, Makel teaches all limitations of claim 1. Makel teaches the fixation element (“perineal bar 7” and “a knob or lever 10” [0025] Figure 1) is configured to transition from the first position to the second position ([0024] - [0025] Figure 1).
Makel does not teach through a pivoting motion of the component.
However, Brewaeys discloses a “adjustable clamp e.g. for a tracheostomy tube” (abstract) and teaches through a pivoting motion of the component (“cam member 34 is pivotally mounted” page 2 line 69).
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 element of Makel to incorporate through a pivoting motion of the first component, as taught by Brewaeys, for the benefit of preventing the experience of “disadvantages of being difficult, or requiring a special tool, to tighten or release” (Brewaeys: page 2 lines 19 - 20) during usage for the safety of the patient.
Regarding claim 12, Makel and Brewaeys teach all limitations of claim 11. The modified invention of Makel and Brewaeys teaches the pivoting motion of the first component causes a rotation of the first component (Brewaeys: “An actuating lever 37 projects radially of the cam member 34 being formed integrally with the disc portion 35.The cam member 34 is pivotally mounted on the axle 33” page 2 lines 66 – 71 Figures 1 - 5).
Regarding claim 13, Makel and Brewaeys teach all limitations of claim 12. The modified invention of Makel and Brewaeys teaches the actuation of the lever portion rotates the camming portion (Brewaeys: “An actuating lever 37 projects radially of the cam member 34 being formed integrally with the disc portion 35.The cam member 34 is pivotally mounted on the axle 33” page 2 lines 66 – 71 Figures 1 - 5),
the rotation of the camming portion causing the camming portion to exert a force against the abutment portion (Brewaeys: “As the actuating lever 37 is moved further anticlockwise the distance between the axle 33 and the point of contact of the camming surface 36 with the collar 27 begins to decrease and the lever snaps against the collar in an over-centre cam action, to the position shown in Figure 5” page 2 lines 66 – 71 Figures 4 - 5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Steller et al (US 10596390 B2) discloses “systems, methods, and apparatuses are provided for an advanced gynecological applicator” (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE T TRAN whose telephone number is (703)756-4677. The examiner can normally be reached Monday - Friday from 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE THI TRAN/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
