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 § 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.
Claim(s) 1-9 and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Menon (US Patent 5,273,024) in view of Agee (US PGPub 2015/0320436) and Re (2010/0049200).
Regarding Claim 1, Menon teaches a medical device for carpal tunnel release surgery in a patient (abstract), the device (30; Figures 5-10; Column 4, Lines 47-67 and Column 5 Lines 1-13) comprising:
an elongated element (32; Figures 5-10) configured for insertion into a carpal tunnel region of the patient’s wrist via an incision (Figure 5);
an exposed groove (40; Figure 10) extending via a longitudinal axis of the elongated element (32; Figure 10), the groove (40) being configured for accommodating a light endoscope (50; Figure 6; Column 5, Lines 29-32) and a scalpel device (54; Figure 6) for severing the patient’s transverse carpal ligament (Column 5, Lines 45-53);
a rim (66 and 64; Figure 9-10) extending around the groove (Column 5, Lines 65-67 and Column 6, Lines 1-6) which serve as maintain proper orientation under the ligament (Column 6, Lines 4-11)
a top cover (handle 36; see Figure 6, 8, and 10) of the groove (40) located at the proximal end of the device (30; see Figure 6, 8, and 10 where the groove extends within the handle and thus the handle is a top cover at a proximal end of the groove); and
an orifice (44) in the proximal end of the device that extends through the top cover (36) and provides access to the groove (40; Figure 8), the orifice (44) configured for insertion of the light endoscope (50; Figure 6) and the scalpel device (the Examiner notes that the scalpel is not positively claimed and scalpel can be placed within orifice 44 and extend to the groove 40)
Menon fails to disclose:
a flange extending outwards from, and co-extensive with, an entire rim of the groove, the flange comprising a flat plate configured for preventing the patient’s medial nerve from entering the groove during the surgery.
Agee teaches a medical device for the treatment of carpal tunnel (abstract; Figure 3) comprising an elongate element (36; Paragraph 0042) for directing a blade (36) and an light endoscope (18; see Figures 3-4; Paragraph 0043-0043), a flange (26) extending along the rim of shaft (36) for the purpose of preventing a patients medial nerve (48; see Figure 4A; Paragraph 0050) from being cut by the blade.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Menon to include a flange, as taught by Agee, for the advantage of protecting the medial nerve from the cutting blade.
Since Agee teaches two separate devices, one for the right hand (Figure 4A) and one for the left hand (Figure 4B) (see Paragraphs 0049-0050), Agee teaches that the ledge is only on one side of the elongate element (Figures 4A-4B) and thus Agee fails to disclose that the ledge would be across the entire rim of the groove.
Re teaches a medical device for tunnelling to repair a ligament (ACL repair; see Abstract), wherein the device has an elongate shaft (105; see Figure 7C; Paragraph 0040) has an exposed groove (see Figure 8C; Paragraph 0040), and a ledge (115) extending along the entire rim of the elongate shaft (115) for the purpose of service as a reference point for tracking along a ligament (Paragraph 0042).
Therefore, it would have been obvious one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references disclosed above, such that the flange extends over the rim, as taught by Re, for the advantage of further assisting in referencing the target ligament and protecting the surrounding nerves while the device is being inserted through the incision.
Regarding Claim 2, the combination of references disclosed above teaches the medical device of claim 1, wherein Menon teaches further comprising a barrier (34) located at a distal end of the elongated element (34) that terminates the groove (40; Figure 8; Menon).
Regarding Claim 3, the combination of references disclosed above teaches the medical device of claim 2, wherein Menon teaches the elongated element (32) comprises a shaft (Figure 8; Menon).
Regarding Claim 4, the combination of references disclosed above teaches the medical device of claim 3, wherein Menon teaches the groove (40) comprises a gutter having a semi-circular cross section (See Figures 9-10).
Regarding Claim 5, the combination of references disclosed above teaches the medical device of claim 4, wherein both Agee and Re teach an entirety of the top surface of the flange is co-planar (26; Figure 4A; Agee) (115; 9C; Re).
Regarding Claim 6, the combination of references disclosed above teaches the medical device of claim 4, wherein Menon teaches the top cover (36) comprises a portion of material that covers a top of the groove (40) at the proximal end of the device (best seen in Figure 6 and 8).
Regarding Claim 7, the combination of references disclosed above teaches the medical device of claim 6, wherein Menon teaches the orifice (44) in the proximal end of the device is colinear with the groove (42; Figure 8).
Regarding Claim 8, the combination of references disclosed above teaches the medical device of claim 7, wherein Menon teaches the orifice (44) in the proximal end of the device faces a proximal direction of the device (Figure 8).
Regarding Claim 9, the combination of references disclosed above teaches the medical device of claim 8, wherein the orifice (44) in the proximal end of the device is configured to allow for the insertion of the light endoscope and the scalpel device from a proximal direction and towards a distal direction (orifice 44 is a entry hole for entering the channel 40 and thus is configured to allow an endoscope or a scalpel into the channel; the examiner notes that the scalpel and endoscope are not positively recited in the claims and the “configured to allow insertion” is an intended use).
Regarding Claim 11, teaches a medical device for carpal tunnel release surgery in a patient, the device comprising:
an elongated element configured for insertion into a carpal tunnel region of the patient’s wrist via an incision;
an exposed groove extending via a longitudinal axis of the elongated element, the groove being configured for accommodating a light endoscope and a scalpel device for severing the patient’s transverse carpal ligament, and a barrier located at a distal end of the elongated element that terminates the groove;
a flange extending outwards from, and co-extensive with, an entire rim of the groove, the flange comprising a flat plate configured for preventing the patient’s medial nerve from entering the groove during the surgery;
a top cover of the groove located at the proximal end of the device; and
an orifice in the proximal end of the device that extends through the top cover and provides access to the groove, the orifice configured for insertion of the light endoscope and the scalpel device.
Regarding Claim 11, Menon teaches a medical device for carpal tunnel release surgery in a patient (abstract), the device (30; Figures 5-10; Column 4, Lines 47-67 and Column 5 Lines 1-13) comprising:
an elongated element (32; Figures 5-10) configured for insertion into a carpal tunnel region of the patient’s wrist via an incision (Figure 5);
an exposed groove (40; Figure 10) extending via a longitudinal axis of the elongated element (32; Figure 10), the groove (40) being configured for accommodating a light endoscope (50; Figure 6; Column 5, Lines 29-32) and a scalpel device (54; Figure 6) for severing the patient’s transverse carpal ligament (Column 5, Lines 45-53) and a barrier (34) located at a distal end of the elongated element (34) that terminates the groove (40; Figure 8);
a rim (66 and 64; Figure 9-10) extending around the groove (Column 5, Lines 65-67 and Column 6, Lines 1-6) which serve as maintain proper orientation under the ligament (Column 6, Lines 4-11)
a top cover (handle 36; see Figure 6, 8, and 10) of the groove (40) located at the proximal end of the device (30; see Figure 6, 8, and 10 where the groove extends within the handle and thus the handle is a top cover at a proximal end of the groove); and
an orifice (44) in the proximal end of the device that extends through the top cover (36) and provides access to the groove (40; Figure 8), the orifice (44) configured for insertion of the light endoscope (50; Figure 6) and the scalpel device (the Examiner notes that the scalpel is not positively claimed and scalpel can be placed within orifice 44 and extend to the groove 40)
Menon fails to disclose:
a flange extending outwards from, and co-extensive with, an entire rim of the groove, the flange comprising a flat plate configured for preventing the patient’s medial nerve from entering the groove during the surgery.
Agee teaches a medical device for the treatment of carpal tunnel (abstract; Figure 3) comprising an elongate element (36; Paragraph 0042) for directing a blade (36) and an light endoscope (18; see Figures 3-4; Paragraph 0043-0043), a flange (26) extending along the rim of shaft (36) for the purpose of preventing a patients medial nerve (48; see Figure 4A; Paragraph 0050) from being cut by the blade.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Menon to include a flange, as taught by Agee, for the advantage of protecting the medial nerve from the cutting blade.
Since Agee teaches two separate devices, one for the right hand (Figure 4A) and one for the left hand (Figure 4B) (see Paragraphs 0049-0050), Agee teaches that the ledge is only on one side of the elongate element (Figures 4A-4B) and thus Agee fails to disclose that the ledge would be across the entire rim of the groove.
Re teaches a medical device for tunnelling to repair a ligament (ACL repair; see Abstract), wherein the device has an elongate shaft (105; see Figure 7C; Paragraph 0040) has an exposed groove (see Figure 8C; Paragraph 0040), and a ledge (115) extending along the entire rim of the elongate shaft (115) for the purpose of service as a reference point for tracking along a ligament (Paragraph 0042).
Therefore, it would have been obvious one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references disclosed above, such that the flange extends over the rim, as taught by Re, for the advantage of further assisting in referencing the target ligament and protecting the surrounding nerves while the device is being inserted through the incision.
Regarding Claim 12, the combination of references disclosed above teaches the medical device of claim 11, wherein Menon teaches the barrier (34) comprises a semicircular wall (Figure 10).
\Regarding Claim 13, the combination of references disclosed above teaches the medical device of claim 12, wherein Menon teaches the elongated element (32) comprises a shaft (Figure 8; Menon).
Regarding Claim 14, the combination of references disclosed above teaches the medical device of claim 13, wherein Menon teaches the groove (40) comprises a gutter having a semi-circular cross section (See Figures 9-10).
Regarding Claim 15, the combination of references disclosed above teaches the medical device of claim 14, wherein both Agee and Re teach an entirety of the top surface of the flange is co-planar (26; Figure 4A; Agee) (115; 9C; Re).
Regarding Claim 16, the combination of references disclosed above teaches the medical device of claim 14, wherein Menon teaches the top cover (36) comprises a portion of material that covers a top of the groove (40) at the proximal end of the device (best seen in Figure 6 and 8).
Regarding Claim 17, the combination of references disclosed above teaches the medical device of claim 16, wherein Menon teaches the orifice (44) in the proximal end of the device is colinear with the groove (42; Figure 8).
Regarding Claim 18, the combination of references disclosed above teaches the medical device of claim 17, wherein Menon teaches the orifice (44) in the proximal end of the device faces a proximal direction of the device (Figure 8).
Regarding Claim 19, the combination of references disclosed above teaches the medical device of claim 18, wherein the orifice (44) in the proximal end of the device is configured to allow for the insertion of the light endoscope and the scalpel device from a proximal direction and towards a distal direction (orifice 44 is a entry hole for entering the channel 40 and thus is configured to allow an endoscope or a scalpel into the channel; the examiner notes that the scalpel and endoscope are not positively recited in the claims and the “configured to allow insertion” is an intended use).
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Menon (US Patent 5,273,024) in view of Agee (US PGPub 2015/0320436) and Re (2010/0049200) as applied to claim 9 and 19 above, and further in view of Murakami (US PGPub 2010/0069944).
Regarding Claims 10 and 20, the combination of references disclosed above teaches the medical device of claim 9 and 19, but fails to disclose wherein the medical device is composed of stainless steel.
Murakami teaches a device for operating on tendons comprising a guide tube (120; Figure 1) (420 has an exposed groove; Figure 5) and a tendon cutter (110; Figure 1) (410; Figure 6), wherein the medical device is composed of stainless steel (Paragraph 0102).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the material of the medical device taught by the combination of references using the materials as taught by Murakami, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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