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
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0180013 (“Hanlon”) in view of U.S. Publication No. 2005/0267478 (“Corradi”) and U.S. Publication No. 2013/0006286 (“Lavelle”).
Regarding Claim 1, Hanlon discloses a trocar assembly (100) for placement of multiple cannulas (130), the assembly comprising:
a body of the assembly with a handle (120);
a trocar blade (110) extending from the body (see Fig. 3), the system including “retention members” (such as a crush-rib, for example) which can be used to “prevent unintentional movement of the cannulas” (Par. 25); and
a plurality of at least three cannulas (130; see Fig. 3) provided about the trocar blade (see Fig. 3 and 7), wherein each cannula of the at least three cannulas is slid along the trocar blade by manual manipulation of the user prior to being deployed.
Hanlon discloses the invention substantially as claimed except that that the system includes “at least two detents” extending from an outer surface of the blade, the detents being “sized to frictionally engage at least two cannulas of the at least three cannulas” to “place the at least three cannulas sequentially in the body, one at a time”. As discussed above, Hanlon does contemplate retention members to assist in placement of the cannulas by preventing unintentional movement, but Hanlon (while not explicitly showing these retention members) appears to disclose them as being part of the handle (120) not the blade (110) (see Fig. 3; Par. 25).
However, similar appliances (see Corradi – 100) are known to the prior art comprising a handle (100) having a pilot/blade/obturator (140) which is used to create a puncture point in tissue to permit the installation of a plurality of tubular cannulated implants/fasteners (10) which are loaded on the body of the blade (see Fig. 9) in a manner analogous to that described by Hanlon. In order to assist in retaining the cannulated implants on the blade and advancing the cannulated implants into the body Corradi discloses that the outer surface of the blade should include at least one detent (148) extending therefrom, the detent being sized to frictionally engage and hold at least one of cannulated implant of the plurality of cannulated implants relative to the blade as the blade is inserted into the body to place the cannulated implant to permit sequential insertion of the cannulated implants into the body, one at a time (see Fig. 9, 12, 17 – Par. 126, 130, 131), the detent comprising a distal-most detect which is sized to frictionally engage each cannula as the cannula is deployed into the body (see Fig. 9, 12, 17 – Par. 126, 130, 131).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a detent on the outer surface of the blade of Hanlon to serve as the retention member, as disclosed by Corradi, in order to provide a specific, known implementation found in the prior art to be useful as a retention feature thereby preventing accidental dislodging of the cannulas prior to their desired insertion and assisting their sequential emplacement into the body. As discussed above, Hanlon already explicitly contemplates employing a retention feature, but fails to explicitly reduce this concept to an actual reduction to practice by illustrating its exact implementation. Corradi therefore serves to provide an obvious solution to the specific problem to be solved by Hanlon in a known, expected, and predictable manner to resolve the invention to actual practice via a particular implementation of retention member.
Halon, as modified, discloses the invention substantially as claimed except that the detent comprises “at least two detents”. Rather Corradi only explicitly illustrates a singular detent (148). However, it is noted that Halon does use the plurality “retention members” (Par. 25) to describe the retention features, suggesting that Halon does envisage a plurality of such retention members. Furthermore, it has been held that duplication of the parts of an invention is generally obvious and requires only routine and customary skill in the art when only predictable and expected results are to be obtained, see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
For example Lavelle discloses a related deployment system (200) which uses a blade (204) to deploy cannulated implants (210) loaded on the blade (see Fig. 2). Lavelle discloses that in some embodiments (see 300 – Fig. 3) the cannulated implants can be retained and maintained separate via a plurality of retention members (306b), i.e. at least two, distributed along the blade with the retention members comprising respective first, second, third…etc. detents corresponding to the number of implants and distributed along the longitudinal length of the blade with detents being configured to frictionally engage but yet allow the cannulas to be advanced sequentially into emplacement in the body by manual manipulation by a user, with the additional detents located on the trocar blade spaced apart longitudinally from one another in order to maintain spatial separation of the implants, and each detent is configured to frictionally engage respective cannulated implant of a plurality of such cannulated implants (see Fig. 3 – Par. 31) to assist in maintaining separation of the implants and serving as means for providing tactile feedback so that the user can confirm movement of the implants along the surface of the blade (Par. 32-33).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the device of modified Hanlon to have a plurality of detent-type retention members (148 – see Corradi) disposed between each successive cannula, as disclosed by Lavelle (see 306b as provided to separate each implant 310 – Par. 3), in order to help retain the cannulas in a separated fashion prior to redeployment preventing the cannulas from interfering with deployment of one another with the respective detents being configured to frictionally engage but yet allow the cannulas to be advanced over the detents (see Corradi – Fig. 9-14 in view of Lavell – Fig. 3) in order to stage the cannulas sequentially at a distal most detent through manual manipulation by a user, with each cannula being configured to slide along the blade toward the distal-most detent (see Fig. 9-14 – Corradi) by manual manipulation by the user prior to being deployed, with the distal-most detent being sized to frictionally engage each cannula as the cannula is deployed into the body (see Fig. 9-14, Corradi).
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Regarding Claim 7, Hanlon discloses each cannula of the plurality comprises:
a hub (inter alia 136, 134) for securing at an outer surface location of the an eye (Par. 3); and
a tubular extension (inter alia 132) coupled to the hub and for providing access to an interior of the body (see Fig. 6 – Par. 3).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Specifically, the instant amendments are substantially similar to limitations presented in Claims 4-6, for which Lavelle was applied in order to suggest pluralizing the detents of Corradi in modification of Halon in order to ensure spatial separation of each cannula and serve as tactile feedback for the user to confirm advancement of the cannulas over the trocar blade during installation of the cannulas. Applicant has failed to furnish any specific arguments concerning the prior application of Lavelle.
Specifically, Corradi establishes detents on the blade to be a suitable retention member for cannulated implants which can assist in frictionally retaining the implant during storage and assisting in advancing of the implant during installation. While Corradi only illustrates a single, distal detent duplication of the parts of an invention is an obvious modification, requiring only routine and customary skill in the art, with Lavelle establishing that such duplication of retention members such that they lie between each cannula implant is known and useful for keeping the implants spatially separated during storage and assisting in their sequential advancement. While Lavelle illustrates a different type of detent/retention feature the disclosure by Lavelle is sufficient to establish that detents of the type of Corradi would likewise benefit from obvious duplication to affect the same benefits and therefore would have been obvious to apply in modification of Hanlon. Here the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 04/20/2026
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