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.
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 1-9 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.
Regarding Claim 1, it is unclear the metes and bounds of the limitations. It is unclear if the limitations are intended to be interpreted as the “and” or “or” of the recited limitation following the “…“...the assembly being characterised in that the orifice is shaped as a slot…” limitations of the state determination unit in the claims. For the purpose of examination “and/or” will be interpreted as “or”.
Regarding Claim 8, is written as a dependent of claim 1 but is unclear which aspects of the guide limitations are intended to included in the limitation “…a guide of an assembly according to claim 1…” . It is unclear if only the limitations of the base and support from claim 1 is intended to be incorporated in the guide of claim 8 or a combination of the base, support and aspects of the assembly limitations of claim 1 or something else. The metes and bounds are unclear.
Regarding Claim 9, it is unclear if the “apparatus” and the “medical imaging probe” in the limitation “…as well as an apparatus comprising a medical imaging probe” are the same or different components from that of claim 1. Claim 9 is written in dependent form but is unclear which aspects of the assembly of claim 1 are incorporated and also if additional components or different components are recited in the limitations. The metes and bounds are unclear.
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 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krieger et. al. (U.S. 20180199851, July 19, 2018)(hereinafter, “Krieger”).
Regarding Claim 1, Krieger teaches: An assembly comprising a guide and a medical instrument (Fig. 10, [0084]), the guide comprising:
a base intended to be carried by an apparatus comprising a medical imaging probe associated to the medical instrument (“…a transperineal guidance system 1000… The embodiment of the mechanism shown may be removably attached to an imaging probe…” [0084]. See reproduced Fig. 10 below) , and
a support extending the base and in which is formed at least one column comprising at least one orifice, the column extending according to a first axis, the medical instrument being able to extend through at least the orifice between a proximal face and a distal face of the support (“As shown in the embodiment of FIGS. 10 and 11A, frame 1004 includes a series of needle holes 1110 through which catheters and needles are placed during interventional procedures. Needle hole reference scale 1102 serves as a positioning guide for needle hole locations across the surface of frame 1004.” [0088]. See reproduced Fig. 10 below),
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the assembly being characterised in that the orifice is shaped as a slot and/or extends over only a portion of the support between the distal face and the proximal face of the guide such that the guide allows a displacement of at least a portion of the medical instrument relative to the distal face of the support according to at least one axis of displacement that is inclined or orthogonal to the first axis (“…FIGS. 10 and 11A, frame 1004 includes a series of needle holes 1110 through which catheters and needles are placed during interventional procedures. Needle hole reference scale 1102 serves as a positioning guide for needle hole locations across the surface of frame 1004. For example, in the embodiment shown, needle hole reference scale 1102 contains an alphabetical scale on one axis and a numerical scale on the other axis, to assist in identifying a spatial location of a particular needle hole across the frame 1004… cam 1104 can be turned so as to move, front plate 1106 relative to back plate 1108 along a guiding mechanism…” [0088-0089]. See reproduced Fig. 10 above and Fig. 11).
Regarding Claim 2, Krieger teaches the claim limitations as noted above.
Krieger further teaches: wherein the medical instrument is a needle (“As shown in the embodiment of FIGS. 10 and 11A, frame 1004 includes a series of needle holes 1110 through which catheters and needles are placed during interventional procedures.” [0088]).
Regarding Claim 3, Krieger teaches the claim limitations as noted above.
Krieger further teaches: wherein the orifice has a cross-section that widens or narrows between the proximal face and the distal face (“…cam 1104 can be turned so as to move, front plate 1106 relative to back plate 1108 along a guiding mechanism, such as a rail (not shown), which can provide frictional engagement against an interventional device inserted through a needle hole 1110 of front plate 1106 and back plate 1108, such as a needle, catheter or other medical instrument. In some embodiments, front plate 1106 and back plate 1108 can be offset to reduce shear forces on needles and control locking force on needles of slightly different diameters…” [0089]. See reproduced Fig. 10 above and Fig. 11).
Regarding Claim 4, Krieger teaches the claim limitations as noted above.
Krieger further teaches: wherein the orifice opens at its distal end into a slot formed in the support such that the slot itself opens at the distal face (“…cam 1104 can be turned so as to move, front plate 1106 relative to back plate 1108 along a guiding mechanism, such as a rail (not shown), which can provide frictional engagement against an interventional device inserted through a needle hole 1110 of front plate 1106 and back plate 1108, such as a needle, catheter or other medical instrument. In some embodiments, front plate 1106 and back plate 1108 can be offset to reduce shear forces on needles and control locking force on needles of slightly different diameters…” [0089]. See reproduced Fig. 10 above and Fig. 11).
Regarding Claim 5, Krieger teaches the claim limitations as noted above.
Krieger further teaches: comprising several orifices (“As shown in the embodiment of FIGS. 10 and 11A, frame 1004 includes a series of needle holes 1110 through which catheters and needles are placed during interventional procedures.” [0088]. See reproduced Fig. 10 above).
Regarding Claim 6, Krieger teaches the claim limitations as noted above.
Krieger further teaches: wherein several orifices open into said slot (“…cam 1104 can be turned so as to move, front plate 1106 relative to back plate 1108 along a guiding mechanism, such as a rail…which can provide frictional engagement against an interventional device inserted through a needle hole 1110 of front plate 1106 and back plate 1108, such as a needle, catheter or other medical instrument…front plate 1106 and back plate 1108 can be offset to reduce shear forces on needles and control locking force on needles of slightly different diameters…” [0089]. See reproduced Fig. 10 above and Fig. 11).
Regarding Claim 7, Krieger teaches the claim limitations as noted above.
Krieger further teaches: wherein the orifice allows at least a portion of the instrument to be locked in position (“…transperineal guidance system 1000 comprises lock 1002 and frame 1004. In exemplary operation, apparatus 802 is inserted into frame 1004 where it can be secured with lock 1002 and maintain its position when in use, such as when performing transperineal intervention on a patient.” [0085];“FIG. 10, frame 1004 is fastened to neck 104 by frictional engagement with coil lock 1002. Neck 104 is inserted through opening 1006 in frame 1004 and secured into place by mechanically reducing the size of opening 1006 by setting lock 1002 to the locked position.” [0086]).
Regarding Claim 8, Krieger teaches the claim limitations as noted above.
Krieger further teaches: A guide of an assembly according to claim l (“…a transperineal guidance system 1000… The embodiment of the mechanism shown may be removably attached to an imaging probe…” [0084]; “As shown in the embodiment of FIGS. 10 and 11A, frame 1004 includes a series of needle holes 1110 through which catheters and needles are placed during interventional procedures. Needle hole reference scale 1102 serves as a positioning guide for needle hole locations across the surface of frame 1004.” [0088]. See reproduced Fig. 10 above).
Regarding Claim 9, Krieger teaches the claim limitations as noted above.
Krieger further teaches: An installation comprising an assembly according to claim 1, as well as an apparatus comprising a medical imaging probe (“…a transperineal guidance system 1000… The embodiment of the mechanism shown may be removably attached to an imaging probe…” [0084]; “…FIGS. 10 and 11A, frame 1004 includes a series of needle holes 1110 through which catheters and needles are placed during interventional procedures. Needle hole reference scale 1102 serves as a positioning guide for needle hole locations across the surface of frame 1004. For example, in the embodiment shown, needle hole reference scale 1102 contains an alphabetical scale on one axis and a numerical scale on the other axis, to assist in identifying a spatial location of a particular needle hole across the frame 1004… cam 1104 can be turned so as to move, front plate 1106 relative to back plate 1108 along a guiding mechanism…” [0088-0089]. See reproduced Fig. 10 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Allaway U.S. 20160022309 teaches a transperineal prostate biopsy system that includes a biopsy guide coupled with a transrectal probe.
Ellard U.S. 5871448 teaches an imaging and treatment system that includes a stepper assembly, probe and vertical oriented needle guide.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMAL FARAG whose telephone number is (571)270-3432. The examiner can normally be reached 8:30 - 5:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798
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