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 .
Response to Amendment
In response to the amendment filed on 08/18/2023, Claims 5 and 8-12 have been cancelled, and Claims 1-4, 6-7, and 13-15 and newly added Claims 16-26 are pending.
Election/Restrictions
Applicant’s election WITH traverse of GROUP I in the reply filed on 11/11/2025 is acknowledged. Claims 16-26 have been withdrawn from further consideration and claims 1-4, 6-7, and 13-15 are pending.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claim(s) 1, 3, 7, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McNamara (US Patent 5,620,446).
Regarding Claim 1, McNamara teaches a surgical system for minimally invasive treatment of a trigger finger, the system comprising:
a handle (60) with a lumen provided therein (Figure 1 and 4; Column 7, Lines 4-5);
a tubular member (22 “sleeve member”) with a proximal end (closest to element 60; Figure 1) and a distal end (38; Figure 1), wherein the tubular member (22) forms a lumen and is attached to the handle (60; Column 7, Lines 1-5);
a palpitation tool (24; Figure 2) for palpating a pulley of a finger, that palpitation tool having a proximal end and an atraumatic distal end (74; Column 7, Lines 18-21), wherein the palpitation tool (24) is configured to be slidably disposed in and extracted from the lumen of the tubular member (22; Column 6, Lines 33-41); and
an incision tool (110) with a proximal end and a distal end (116; Figures 14-15), wherein the incision tool (110) comprises a cutter (124; Figures 14-15), wherein the incision tool (110) is configured to be slidably disposed in the lumen of the tubular member (22; Column 6, Lines 33-41), wherein the incision tool (110) is configured to be disposed in the tubular member (22) after the extraction of the palpitation tool (22; Column 6, Lines 37-41).
The recitation in the claims that “the incision tool is configured to be disposed in the tubular member after the extraction of the palpitation tool is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that McNamara discloses a sleeve which can independently house both a palpitation tool and an incision tool as presently claimed, it is clear that the sleeve of McNamara would be capable of performing the intended use, i.e. (housing the incision tool after the palpitation tool), presently claimed as required in the above cited portion of the MPEP.
Regarding Claim 3, McNamara teaches the surgical system according to claim 1, wherein the distal end of the palpitation tool (24) in a maximally distally extended position extends further in the distal direction that the distal end of the tubular member (22; Figure 8; Column 7, Lines 47-52).
Regarding Claim 7, McNamara teaches the surgical system according to claim 1, wherein the palpitation tool (24) is rigid and/or substantially solid (Column 7, Lines 50-52; it’s the examiners that obturator 24 is rigid enough to separate tissue and is substantially solid in Figure 2 aside from the lumen).
Regarding Claim 15, McNamara teaches the surgical system according to claim 1, the system further comprising a pre-incision tool (250; Figures 27-28) for cutting an insertion hole (Column 11, Lines 47-67 and Column 12, Lines 1-3).
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) 4 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNamara (US Patent 5,620,446).
Regarding Claim 4, McNamara teaches the surgical system according to claim 3, in a separate embodiment, the incision tool is element 250, and wherein the cutter (262) of the incision tool (250) is oriented in the distal direction (Column 27-28; Column 11, Lines 59-67 and Column 12, Lines 1-3), but fails to explicitly state wherein the distal end of the incision tool (250) in a maximally distally extended position extends further in the distal direction from the distal end of the tubular member (22) than the palpation tool (24) in the maximally distally extended position.
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 length of the shaft of the incision tool such that the incision tool extends in a maximally distally extended position extends further in the distal direction from the distal end of the tubular member than the palpation tool since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955), In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984). (See MPEP 2144.04)
Regarding Claim 13, McNamara teaches the surgical system according to claim 1, but fails to disclose wherein the tubular member is fixed to the handle by a fixation member extending through the handle.
In a separate embodiment McNamara teaches an instrument handle (130) which is fixed to a plurality of tubular instruments (112; Figures 16-17; Column 8, Lines 36-52) by a fixation member (142) extending through the handle (130; Figures 16-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tubular member and handle of the previous embodiment to be detachable via a fixation member extending through the handle, as disclosed in the embodiment of Figures 16-17, for the advantage of switching out different size and/or different length tubular members to the same handle during the same operation.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNamara (US Patent 5,620,446) as applied to claim 1 above, and further in view of Janese (US Patent 4,781,202).
Regarding Claim 2, McNamara teaches the surgical system according to claim 1, but fails to disclose wherein the tubular member has a sharp distal edge at the distal end for inserting the tubular member through the skin.
Janese teaches a surgical system comprising a handle (12; Figure 1) and a tubular member (26) attached to the handle (12; Figure 1 and Figure 4), the tubular member (26) configured to house an incision tool (19; blade; Figure 1; Column 5, Lines 10-36), wherein the tubular member (26) has a sharp distal end (17; Column 5, Lines 15; Figure 4) for inserting the tubular member (26) through the skin.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tubular member of McNamara to include a sharp distal tip, as taught by Janese, for the advantage of being able to cut through the skin when used with a blunt tip obturator, as taught by McNamara, such that the tubular member precisely cuts its way towards the target tissue.
Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNamara (US Patent 5,620,446) as applied to claim 1 above, and further in view of Albans (US PGPub 2006/0116689).
Regarding Claim 6, McNamara teaches the surgical system according to claim 3, but fails to disclose the system further comprising an elastic member that biases the palpation tool in the proximal direction when the palpation tool is moved in the distal direction.
Albans teaches a surgical instrument (Figure 14) comprising an handle (1024) and a tubular member (1050) attached to the handle (1024) and a palpitation tool (1034, 1028) disposed within the tubular member (1050), the instrument further comprising an elastic member (1082; Figure 14 and 16) that biases the palpation tool (1032) in the proximal direction when the palpation tool (1032) is moved in the distal direction (as seen in Figure 16).
It would have been obvious to one of ordinary skill in the art before the effective date of the invention to modify the system of McNamara to include an elastic member to bias the tools proximally within the tubular member, as taught by Albans, for the advantage of keeping the tools within the tubular member in a proximal retracted safe configuration until the operator actuates the handles against the biasing mechanism to distally deploy the tools.
Regarding Claim 14, McNamara teaches the surgical system according to claim 1, but fails to disclose the system further comprising an elastic member that biases the incision tool in the proximal direction when the incision tool is moved in the distal direction.
Albans teaches a surgical instrument (Figure 14) comprising an handle (1024) and a tubular member (1050) attached to the handle (1024) and a incision tool (1034, 1028) disposed within the tubular member (1050), the instrument further comprising an elastic member (1082; Figure 14 and 16) that biases the incision tool (1032) in the proximal direction when the incision tool (1032) is moved in the distal direction (as seen in Figure 16).
It would have been obvious to one of ordinary skill in the art before the effective date of the invention to modify the system of McNamara to include an elastic member to bias the tools proximally within the tubular member, as taught by Albans, for the advantage of keeping the tools within the tubular member in a proximal retracted safe configuration until the operator actuates the handles against the biasing mechanism to distally deploy the tools.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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 GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771