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 .
Specification
The disclosure is objected to because of the following informalities: Reference character “140” has been used to designate both “lip 140” and “channel 140” in Paragraph [0051] and “side edges 140” in Paragraph [0040] of the specification. It is noted that 140 appears to designate a lip in Fig. 5, and a side edge in Fig. 4, neither of which depict a channel. Distinct structural features should have their own designation number in the specification. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “one or more shielding surfaces” as recited in Claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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
Claim 1 is objected to because of the following informalities and should be amended as follows:
“1. A surgical device for cutting bone comprising: a main body comprising a proximate end and a distal end, with a length extending therebetween, wherein the distal end has an opening therein and terminates in a foot plate; a rotatable shaft operably supported within the main body; a working end provided on a distal end of the rotatable shaft and positioned at least partially within the opening in the distal end of the main body, wherein the working end comprises one or more cutting edges, and wherein the working end eccentrically rotates such that in a first position the one or more cutting surfaces of the working end are protected by one or more surfaces of the distal end of the main body and in a second position at least one
Claim 3 is objected to because of the following informalities: In Line 2, the first instance of the word “to” should be deleted. Appropriate correction is required.
Claim 10 is objected to because of the following informalities and should be amended as follows: “10. The method of claim 9 wherein when inserting the distal end of the surgical device into the selected space, the one or more cutting surfaces
Claim 11 is objected to because of the following informalities and should be amended as follows: “11. A surgical tool [[with]] comprising: a working end comprising an opening and one or more shielding surfaces for one or more cutting surfaces eccentrically rotatable about a longitudinal axis of the working end such that when the one or more cutting surfaces are stationary, the one or more cutting surfaces are configured to be shielded by the one or more shielding surfaces and when the one or more cutting surfaces are rotating, the one or more cutting surfaces are configured to be cyclically exposed at the opening, the working end further comprising a foot plate for guiding insertion of the surgical tool, protecting one or more structures adjacent an area to be contacted with the one or more cutting surfaces, or a combination thereof.” Appropriate correction is required.
Claim 12 is objected to because of the following informalities: In Line 2, the word --degrees-- should be added after the number “30”. 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.
Claims 1-8, 12 & 14-15 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 1 at Lines 9-10 recites the limitation “the one or more cutting surfaces”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “the one or more cutting edges”. Appropriate correction is required.
Claim 3 at Line 2 recites the angle range “about 30 degrees to about 90 degrees or more”. Firstly, the term “about” is a relative term which renders the claim indefinite. The term “about” 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. Thus, it is unclear what angle “about 30 degrees” and “about 90 degrees” is and the range “about 30 degrees to about 90 degrees” is rendered indefinite by use of the relative term. Secondly, with respect to the portion of the limitation that says “or more” it is unclear what the upper boundary of the range since 90 degrees or more seems to recite angles above 90 degrees. Appropriate correction is required.
Claim 4 at Line 2 recites the limitation “a thickness of less than approximately 0.075 inches”. The term “approximately” is a relative term which renders the claim indefinite. The term “approximately” 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. Thus, it is unclear what “approximately 0.075” is and the limitation is rendered indefinite by use of the relative term. Appropriate correction is required.
Claim 5 at Lines 1-2 recites “wherein the working end comprises a plurality of cutting edges” which renders the claim indefinite as it is unclear if the recited plurality of cutting edges are the same cutting edges as the “one or more cutting edges” of the working end previously recited in Line 8 of Claim 1 or different/in addition thereto. For purposes of examination, the limitation is being interpreted as “wherein the one or more cutting edges comprise a plurality of cutting edges spaced apart on a length of the working end.” Appropriate correction is required.
Claim 6 at Lines 1-2 recites “wherein the working end comprises a plurality of cutting edges” which renders the claim indefinite as it is unclear if the recited plurality of cutting edges are the same cutting edges as the “one or more cutting edges” of the working end previously recited in Line 8 of Claim 1 or different/in addition thereto. For purposes of examination, the limitation is being interpreted as “wherein the one or more cutting edges comprise a plurality of cutting edges at one or more locations on the length of the working end.” Appropriate correction is required.
Claim 11 recites the limitation “A surgical tool with a working end comprising an opening” and Claim 14 recites the limitation “and further comprising a main body housing a rotatable shaft for operable connection to the one or more cutting surfaces of the working end.” which renders the claims indefinite as it is unclear 1) how the working end comprises the opening when the opening is disclosed as being on the main body, 2) how the tool further comprises a main body and a rotatable shaft in addition to the working end when the working end is the distal end of the rotatable shaft, and 3) how the rotatable shaft is housed in the main body for operable connection to the one or more cutting surfaces when the cutting surfaces are disclosed as being located on the rotatable shaft. It appears that claim 11 may be erroneously reciting the working end comprising the opening instead of the main body, since the specification and drawings disclose the main body comprising the opening. For purposes of examination, claim 11 is being interpreted as “A surgical tool comprising a working end, an opening, one or more shielding surfaces for one or more cutting surfaces, and a foot plate…” and Claim 14 is being interpreted as “further comprising a main body comprising the opening and the one or more shielding surfaces, the main body housing a rotatable shaft defining the working end and the one or more cutting surfaces” Appropriate correction is required.
Claim 12 at Lines 2-3 recites the angle range “about 30 degrees to about 90 degrees”. The term “about” is a relative term which renders the claim indefinite. The term “about” 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. Thus, it is unclear what angle “about 30 degrees” and “about 90 degrees” is and the range “about 30 degrees to about 90 degrees” is rendered indefinite by use of the relative term. Appropriate correction is required.
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) 1-3, 5-9, & 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubin (US PG Pub No. 2014/0288560).
Regarding Claim 1 as best understood, Rubin discloses a surgical device (30, Figs. 1-4B, Paragraphs [0019-0037]) for cutting bone (Paragraph [0036]) comprising: a main body (outer tubular member 44, Figs. 1-4B) comprising a proximate end (end of 44 adjacent 36, Fig. 1) and a distal end (end of 44 at 230, Fig. 1), with a length extending therebetween (overall length of 44, Fig. 1), wherein the distal end has an opening therein (window 46, Figs. 2-3B, Paragraph [0019]) and terminates in a foot plate (vertically extending distal-most end wall of 44, Figs. 3A-3B, See examiner annotated Figs. 4A-4B below); a rotatable shaft (inner tubular member 40, Figs. 1-3B) operably supported within the main body (Paragraph [0019]); a working end (cutting end 42, Figs. 2-3B) provided on a distal end of the rotatable shaft (tip portion of 40, Figs. 3A-3B) and positioned at least partially with the opening in the distal end of the main body (Figs. 3A-3B), wherein the working end comprises one or more cutting edges (serrations/teeth of 42, Fig. 3A-3B), and wherein the working end eccentrically rotates (Paragraphs [0021, 0023-0025]; the cutting end 42 eccentrically rotates as it is not symmetrical about the longitudinal/rotating axis extending therethrough in a manner similar to the Applicant’s invention) such that in a first position the one or more cutting edges of the working end are capable of being protected by one or more surfaces (peripheral side edges of window 46 as seen in Fig. 3B) of the distal end of the main body (rotation of 40 relative to 44 or vice versa by the motor of handpiece 36 causes selective exposing of the cutting tip 42 within window 46, and thus when the cutting tip is in the opposite position depicted in Fig. 3A with the serrated edges of 42 facing the bottom of the lumen of 44, the serrations/teeth are protected within the window 46) and in a second position at least one of the one or more surfaces of the distal end are exposed (when the cutting tip 42 is rotated such that it is in a position where the serrations/teeth are exposed within the cutting window 46 as seen in Figs. 3A-3B, Paragraphs [0023-0024]).
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Regarding Claims 2-3 as best understood, Rubin discloses wherein the foot plate is a vertical foot plate (Fig. 3B) positioned at an angle with respect to a horizontal axis of the length extending between the proximate and distal ends of the main body (See examiner annotated Figs. 4A-4B above); wherein the angle is in the range of 30 degrees to 90 degrees (See examiner annotated Figs. 4A-4B above).
Regarding Claim 5 as best understood, Rubin discloses wherein the one or more cutting edges comprise a plurality of cutting edges spaced apart on a length of the working end (serrations/teeth of 42, Fig. 3A-3B).
Regarding Claim 6 as best understood, Rubin discloses wherein the one or more cutting edges comprise a plurality of cutting edges at one or more locations on the length of the working end (serrations/teeth of 42, Fig. 3A-3B).
Regarding Claim 7, Rubin discloses wherein the distal end of the main body (end of 44 at 230, Fig. 1) has an arcuate shape and the opening spans a top and at least one side of the distal end (Figs. 3A-4B).
Regarding Claim 8, Rubin discloses wherein the foot plate is separable from the main body (Paragraphs [0020-0021] state that tubular member 44 can be bendable and thus the foot plate is capable of being bent manually with enough force or cut to separate the foot plate from the main body).
Regarding Claim 9, Rubin discloses a method of removing bone (Paragraphs [0035-0037]) comprising: inserting a distal end (230, Fig. 1) of a surgical device (30, Fig. 1) into a selected space between a portion of bone to be removed and adjacent tissue (“uncinectomy and maxillary sinus antrostomy, maxillary polypectomy or removal of fungus, cysts, or other pathology in the maxillary sinus, either through the maxillary antrostomy or through an anterior maxillary trephination, lateral and medial frontal sinusotomy procedures in which the cutting window is applied to cutting laterally, medially, and posteriorly, acoustic neuroma, debulking of laryngeal, tracheal, and bronchial lesions, and spinal disc space nucleostomy”, Paragraph [0036]); using an angled foot plate (vertically extending distal-most end wall of 44, Figs. 3A-3B, See examiner annotated Figs. 4A-4B below) of the distal end of the surgical device to guide the surgical device into the selected space (Paragraphs [0024, [0033]); actuating the surgical device (via motor in handpiece 36, Paragraph [0023]) and rotating a working end (cutting end 42, Figs. 2-3B) of the surgical device (Paragraph [0024]) to cyclically expose one or more cutting surfaces (serrations/teeth of 42, Figs. 3A-3B) to the bone for cutting the bone (as the inner tubular member 40 rotates with respect to the outer tubular member 44, the cutting end 42 with serrations/teeth are exposed in a cyclic manner every time they pass through the cutting window 46 as seen in Figs. 3A-3B); and sliding the surgical device along the bone to continue removing bone without removing the surgical device from the selected space (“uncinectomy and maxillary sinus antrostomy, in which the cutting window is repositioned (without requiring overt movement of the handpiece and/or removal of the cutting implement from the target site”, Paragraph [0036]).
Regarding Claims 11-15 as best understood, Rubin discloses a surgical tool comprising a working end (cutting end 42, Figs. 2-3B), an opening (window 46, Figs. 2-3B, Paragraph [0019]), a shielding surface (bottom inner wall of 44 within window 46 at 46b, Fig. 3B) for one or more cutting surfaces (serrations/teeth of 42, Fig. 3A-3B), and a foot plate for guiding insertion of the surgical tool and/or protecting one or more structures adjacent an area to be contacted with the one or more cutting surfaces, (vertically extending distal-most end wall of 44, Figs. 3A-3B, See examiner annotated Figs. 4A-4B above)(the vertically extending distal-most end wall of 44 is fully and structurally capable of guiding insertion of the tool into a surgical site as it is the distal-most structural feature of the tool which would be the first to be inserted toward the surgical site, and is further capable of protecting structures adjacent the surgical site to be contacted with the cutting surfaces of the tool since it is a solid wall), wherein the foot plate is positioned at an angle in the range of 30 degrees to 90 degrees with respect to the longitudinal axis of the working end (See examiner annotated Figs. 4A-4B above), wherein the foot plate is removable from the working end (Paragraphs [0020-0021] state that tubular members 40 & 44 can be bendable and thus the foot plate is capable of being bent manually with enough force or cut to separate the foot plate from 44 and the working end), wherein the one or more cutting surfaces are eccentrically rotatable about a longitudinal axis of the working end (longitudinal axis extending centrally through length of 40)(Paragraphs [0021, 0023-0025])(the cutting end 42 eccentrically rotates as it is not symmetrical about the longitudinal/rotating axis extending therethrough in a manner similar to the Applicant’s invention) such that when the one or more cutting surfaces are stationary, the one or more cutting surfaces are shielded by the shielding surface and when the one or more cutting surfaces are rotating, the one or more cutting surfaces are cyclically exposed at the opening (rotation of 40 relative to 44 or vice versa by the motor of handpiece 36 causes selective exposing of the cutting tip 42 within window 46, and thus when the cutting tip is in the opposite position depicted in Fig. 3A with the serrated edges of 42 facing the bottom of the lumen of 44, the serrations/teeth are shielded by the shielding surface, and when the cutting tip 42 is rotating, the serrations/teeth are exposed in a cyclic manner every time they pass through the cutting window 46 as seen in Figs. 3A-3B); the tool further comprising a main body (outer tubular member 44, Figs. 1-4B) comprising the opening and the shielding surface (Fig. 3A), the main body housing a rotatable shaft (inner tubular member 40, Figs. 1-3B) defining the working end and the one or more cutting surfaces (Paragraph [0019]), wherein the working end (42) is removable from the main body (44)(the inner tubular member 40 can be removed from within the lumen of the outer tubular member 44 once separated from the handpiece 36).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubin (US PG Pub No. 2014/0288560).
Regarding Claim 4 as best understood, Rubin discloses the claimed invention as stated above in Claim 1, except wherein the foot plate has a thickness of less than approximately 0.075 inches. Rubin does not disclose a specific foot plate thickness. In Paragraphs [0027-0037], Rubin discloses various dimensional relationships for the distal end of the tubular member 44, and further discloses that “the distal opening may be elongated as desired for a given diameter of cutting instrument (which, along with the thicknesses of materials chosen, manufacturing tolerances and clearances, and similar factors, allows one to determine the approximately value of D).”, and even further discloses that “Of course, it should be remembered that the parameters A through E denote endpoints of measurements and thus the measurements themselves may be made directly between such points along straight lines, or along the edges and surfaces of the cutting tip that lie between the points, as appropriate. In doing so, this discussion should be understood as relying on two-dimensional representations of three-dimensional components as a matter of convenience and example only. [0033] Note that while the cutting tip described above is optimally configured for increased throughput of tissue (i.e., reduced clogging or increased amount of tissue per unit time), this result is achieved not by increasing the dimensions of the device, which would intuitively reduce the chance that a tissue particle of given dimensions would clog the device. Rather, and counter-intuitively, the device has a decreased cutting window, measured with respect to the dimensions of the aspiration path (e.g., tube inner diameter [or ID]), yet achieves reduced clogging. Optimally configuring the cutting window (i.e., optimizing shape, size, orientation and similar factors in the physical construction of the cutting window) enables a single device to address multiple types of target tissue (soft tissue, thin bone, and the like) with reduced clogging and without requiring the surgeon to change the apparatus during the procedure.”
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the foot plate of Rubin to have a thickness of less than approximately 0.075 inches as an obvious matter of design choice which would enable the device to address multiple types of target tissue and since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 105 USPQ 233.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubin (US PG Pub No. 2014/0288560) in view of Kimura et al. (US PUG Pub No. 2009/0318944).
Regarding Claim 10, Rubin discloses the claimed invention as stated above in Claim 9, except wherein when inserting the distal end of the surgical device into the selected space, the one or more cutting surfaces are present in the distal end of the surgical device but remain shielded by one or more surfaces of the distal end. Rubin does not specifically disclose what position the inner tubular member and serrations/teeth are in when the device is inserted into the selected space.
Kimura et al. discloses various embodiments of a surgical cutting apparatus which cuts or shaves hard tissues (Abstract), wherein one particular embodiment depicted in Figs. 18A-20 comprises an outer tubular member (sheath 20, Fig. 19) with a window (25) at a distal end (22) thereof, and an inner tubular member (30) having a working end (treatment portion 31, Figs. 19-20) at a distal end thereof, the working end having a cutting face (48b) thereon, wherein the outer tubular member is configured to be rotationally moved around the inner tubular member so that the working end is moved to from a retracted or standby state as seen in Fig. 20 to an exposed state for carrying out a surgical treatment on an object by movement transmitted from the inner tubular member (Paragraphs [0134-0138]), such that “As shown in FIG. 19, the treatment end face 48b is exposed to the open part 25. In this state, the treatment end face 48b is made to contact an object part of a living tissue. When the probe 30 ultrasonically vibrates, the treatment end face 48b ultrasonically operates on the contacting object part. Further, as explained in the first embodiment, when the sheath 20 is rotationally moved about 180 degrees from the state shown in FIG. 19 as in the first embodiment, the treatment end face 48b is retracted into the distal end member 20b as shown in FIG. 20. Even if the hand switch 15 or foot switch 70 is mistakenly operated in this state, the treatment end face 48b is retracted into the distal end member 20b, and ultrasonic vibration is not transmitted to an object part through the treatment end face 48b. Thus, an object part is not ultrasonically operated on. Namely, the treatment portion 31 stays in a standby state. As described above, in this modification, by setting the treatment portion 31 to a standby state, it is possible to prevent damages of an unexpected part of a living tissue except for an object part by erroneous operation of the hand switch 15 or foot switch 70. Therefore, this modification improves safety.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Rubin such that when inserting the distal end of the surgical device into the selected space, the one or more cutting surfaces are present in the distal end of the surgical device but remain shielded by one or more surfaces of the distal end as taught by Kimura et al. in order to prevent damages to an unexpected part of a living tissue until a user confirms correct placement of the device and is ready to remove the tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775