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
This Office Action is responsive to the amendment filed on 16 June 2026. As directed by the amendment: claims 1 and 20 have been amended, claims 10-12 and 22 are cancelled, and claim 24 is newly added. Claims 1-9, 13-21, 23, and 24 currently stand pending in the application.
The cancellation of claim 22 has rendered moot its relevant rejection under 35 U.S.C. 112(a), which is accordingly withdrawn.
The amendments to the claims are sufficient to overcome the previous rejection under 35 U.S.C. 112(b) listed in the previous Office Action, which is accordingly withdrawn.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 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.
Claim Objections
Claim 24 is objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendment is suggested:
Claim 24 / line 2: “within the implant aperture”
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.
Claims 1-5, 14-21, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 10,299,877 to Volk et al. (hereinafter, “Volk”), in view of U.S. Patent Application Publication No. US 2003/0033016 to Dees, JR. (hereinafter, “Dees”).
As to claim 1, Volk discloses an interphalangeal implant retainer, FIGS. 5A-5B, for retaining an interphalangeal implant (interpreted as language of intended use; medical device, 70) and to be used with an implantation tool (interpreted as language of intended use), the interphalangeal implant retainer comprising: a jig part (20a) (col. 3 / lines 17-20), wherein the jig part has a plate shape (at outer rim, shown in FIGS. 1A-1C); and an implant aperture (34) fully capable of retaining the interphalangeal implant (col. 3 / lines 1-7; interpreted as language of intended use – the implant aperture 34 is fully capable of retaining an end of a complementarily sized implant therein), FIG. 1A, wherein the implant aperture is formed as a fully enclosed hole having a continuous circumferential edge (col. 3 / lines 1-7), FIGS. 1A and 1C, fully capable of receiving the interphalangeal implant therethrough (the hole is fully capable of receiving a complementarily sized implant therein), wherein the implant aperture has a circumferential shape corresponding to a cross-section of the interphalangeal implant (interpreted as language of intended use – the implant aperture is fully capable of having a shape corresponding to a cross-section of the interphalangeal implant with a complementary shape which is inserted therein) and includes at least three retaining protrusions (four sides 36 which extend inward to form an hourglass shape) extending into the implant aperture from the continuous circumferential edge fully capable of retaining the interphalangeal implant by friction and form fit (interpreted as language of intended use – the retaining protrusions are fully capable of retaining a complementarily sized implant by friction and form fit).
As to claim 2, Volk discloses the interphalangeal implant retainer according to claim 1, wherein the implantation tool comprises: a limb support for supporting a phalangeal limb; a driving rod, wherein the driving rod is movable for moving the interphalangeal implant towards the limb support; and an actuation mechanism for actuating the driving rod (limitations regarding the implantation tool and its components in this claim and the following claims are interpreted as language of intended use without positive recitation of the implantation tool; the implant retainer is fully capable of use with an implantation tool comprising the above features, with a proximal end of the implant retainer inserted into a distal end of the implantation tool).
As to claim 3, Volk discloses the interphalangeal implant retainer according to claim 1, further comprising: an implant casing (40) defining an implant receiving space (44) and a jig retaining structure (46), wherein the jig part comprises a casing retaining structure (outer rim of 20a), wherein the jig retaining structure is configured to releasably engage the casing retaining structure (col. 2 / lines 36-57).
As to claim 4, Volk discloses the interphalangeal implant retainer according to claim 3, wherein the casing retaining structure is a groove (rim of 20a is recessed relative to protrusion 28, forming a groove at the outer rim; alternatively, a reverse taper/notch in the outer rim, col. 2 / lines 54-57) positioned on an inner side and/or an outer side of the jig part (22 and 24 are each on a circumferentially outer side of the jig part).
As to claim 5, Volk discloses the interphalangeal implant retainer according to claim 3, wherein the jig retaining structure is formed as a slit, FIGS. 2A, 2D, and 5A-5B, the slit having sidewalls engageable with opposite grooves (at 22 and at 24 which are on opposite ends of the jig part) of the casing retaining structure of the jig part by a relative sliding or translatory movement of the jig part and the implant casing towards and away from each other, respectively (as the jig part is inserted into the implant casing).
As to claim 14, Volk discloses the interphalangeal implant retainer according to claim 2, wherein the implantation tool (all of the limitations regarding the implantation tool are interpreted as language of intended use without positive recitation of the implantation tool; the implantation tool is fully capable of including such features and the implant retainer is fully capable of use with such an implantation tool) further comprises an implant guiding means configured to guide the interphalangeal implant towards the limb support, the implant guiding means comprises a female guide member and a male guide member, the female guide member and/or the male guide member comprises an implant holder configured to hold the interphalangeal implant, and the jig part is provided with a holding means (outer rim of 20a) that is configured to correspond to the implant holder.
As to claim 15, Volk discloses the interphalangeal implant retainer according to claim 14, wherein the jig part comprises the holding means that is configured to correspond to the implant holder, wherein the holding means is such that the jig part can be held by and can be movable relative to the female guide member and the male guide member of the implant guiding means of the interphalangeal implant (all of the limitations regarding the implantation tool are interpreted as language of intended use without positive recitation of the implantation tool; the implantation tool is fully capable of including such features and the implant retainer is fully capable of use with such an implantation tool; the holding means is fully capable of being such that the jig part can be held by and can be movable relative to the female guide member and the male guide member).
As to claim 16, Volk discloses the interphalangeal implant retainer according to claim 15, wherein two through holes are configured to slidingly interact with two pins of the implant holder for holding the interphalangeal implant (all of the limitations regarding the implantation tool are interpreted as language of intended use without positive recitation of the implantation tool; the implantation tool is fully capable of including such features and the implant retainer is fully capable of use with such an implantation tool; the tool is fully capable of including two through holes that slidingly interact with two pins of the implant holder for holding the interphalangeal implant), wherein the implant holder is part of the female guide member or the male guide member (interpreted as language of intended use) of the implant guiding means of the interphalangeal implant, so that the jig part can be held by and can be movable relative to the female guide member and the male guide member.
As to claim 17, Volk discloses the interphalangeal implant retainer according to claim 14, wherein the female guide member of the implant guiding means includes a limb abutment side, the limb abutment side being formed as two contact surfaces protruding from the female guide member, the two contact surfaces arranged on opposite sides of a female guide member aperture (all of the limitations regarding the implantation tool are interpreted as language of intended use without positive recitation of the implantation tool; the implantation tool is fully capable of including such features and the implant retainer is fully capable of use with such an implantation tool; the tool is fully capable of having a female guide member with the above components).
As to claim 18, Volk discloses the interphalangeal implant retainer according to claim 14, wherein the male guide member comprises a hole that extends parallel to the driving rod of the implantation tool, wherein the implant holder is a pin that extends into the hole of the male guide member (all of the limitations regarding the implantation tool are interpreted as language of intended use without positive recitation of the implantation tool; the implantation tool is fully capable of including such features and the implant retainer is fully capable of use with such an implantation tool; the tool is fully capable of having a male guide member and an implant holder with the above components).
As to claim 19, Volk discloses the interphalangeal implant retainer according to claim 14, wherein the male guide member of the implant guiding means further comprises a driver engagement portion for a releasable engagement of the driving rod of the implantation tool (all of the limitations regarding the implantation tool are interpreted as language of intended use without positive recitation of the implantation tool; the implantation tool is fully capable of including such features and the implant retainer is fully capable of use with such an implantation tool; the tool is fully capable of having a male guide member with the above components).
As to claim 20, Volk discloses the interphalangeal implant retainer according to claim 1, wherein the cross-section of the interphalangeal implant is taken perpendicular to a direction of insertion of the interphalangeal implant into the implant aperture (interpreted as language of intended use – since an end of an implant is fully capable of being inserted into the implant aperture of a perpendicularly oriented jig part).
As to claim 21, Volk discloses the interphalangeal implant retainer according to claim 1, wherein the implant aperture is dimensioned to hold the interphalangeal implant by a releasable snap fit (interpreted as language of intended use – the implant aperture is fully capable of holding an implant by a releasable snap fit, where the implant is of a complementary size and shape to snap into the aperture).
As to claim 23, Volk discloses the interphalangeal implant retainer according to claim 3, wherein the implant receiving space (44) is at least partially enclosed such that independent of an orientation of the implant casing, the interphalangeal implant retained via the jig part cannot contact a flat surface on which the implant casing is placed, FIG. 5B.
As to claim 24, Volk discloses the interphalangeal implant retainer according to claim 1, wherein the retaining protrusions are fully capable of retaining the interphalangeal implant within the aperture by friction in a direction perpendicular to the implant aperture (interpreted as language of intended use – the retaining protrusions are fully capable of retaining an implant within the aperture by friction in a direction perpendicular to the implant aperture, e.g. the protrusions provide friction against a complementarily sized implant in an inward direction or in a direction further into the aperture) and by a form fit in directions parallel to a cross-section of the implant aperture (interpreted as language of intended use – the retaining protrusions are fully capable of retaining an implant within the aperture by a form fit in directions parallel to a cross-section of the implant aperture, e.g. the protrusions form fit around a complementarily sized and shaped implant in an inward direction).
Volk is silent as to the implant aperture is formed as a through-hole configured to receive the interphalangeal implant therethrough.
Dees teaches an interphalangeal implant retainer for retaining an interphalangeal implant and to be used with an implantation tool (interpreted as language of intended use), the interphalangeal implant retainer comprising: a jig part (20), FIG. 1; and an implant aperture (30) configured to retain the interphalangeal implant (par. [0026]), FIG. 2, wherein the implant aperture is formed as a fully enclosed through-hole having a continuous circumferential edge configured to receive the interphalangeal implant therethrough, wherein the implant aperture has a circumferential shape corresponding to a cross-section of the interphalangeal implant.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the implant aperture in Volk configured to retain the implant and receive the implant therethrough, as taught by Dees, to provide greater protection during shipment. The interior shape of the implant aperture would remain as disclosed by Volk, with the retaining protrusions which provide decreased crushability of the jig part as required by Volk. The jig part would be used with an implant of complementary size and shape to the implant aperture. As taught by Dees, the jig part can be slightly compressed during shipment to retain the implant therein by friction and form fit. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the implant aperture in Volk as a through-hole, so that the implant aperture can accommodate implants of various lengths, as taught by Dees.
Claims 6-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Volk in view of Dees (hereinafter, “Volk/Dees”), as applied to claims 1-5, 14-21, 23, and 24 above, and further in view of U.S. Patent No. US 6,749,077 to McAlpine et al. (hereinafter, “McAlpine”).
Volk/Dees are silent as to wherein the engagement between the jig retaining structure and the casing retaining structure is configured as a snap-fit connection (claim 6); wherein the snap-fit connection comprises two pairs of engaging structures with two recesses formed on opposite sides of the jig part (claim 9); wherein the engagement between the jig retaining structure and the casing retaining structure is configured as a snap-fit connection, wherein at least one pair of engaging structures of the snap-fit connection is formed on a side of the implant casing as a protrusion that forms a narrowed down portion at an entrance of the slit and as a recess at a corresponding position of one of the grooves of the casing retaining structure of the jig part, configured to receive the protrusion (claim 7); wherein the recess is a through hole (claim 8); wherein the jig part of the interphalangeal implant retainer comprises a holding means formed as two through holes at opposite ends of the jig part (claim 13).
McAlpine teaches an engagement between two parts that are slid into engagement with each other, comprising a snap-fit connection, wherein at least one pair of engaging structures of the snap-fit connection is formed as a protrusion (45) that forms a narrowed down portion at an entrance of a slit (slit between 44a and 44b; at least one protrusion is at the end of the slit where the panel 12 enters), FIGS. 6-7, and as a recess (47) at a corresponding position of the panel (12), configured to receive the protrusion (col. 4 / lines 55-62); wherein the recess is a through hole, FIG. 6.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the sliding engagement between the jig retaining structure and the casing retaining structure as a snap-fit connection, to increase the security of the engagement by preventing inadvertent backout of the jig part from the implant casing during shipment. As taught by McAlpine, each end (on either side of 44) of the slit (46) in Volk/Dees would be provided with a protrusion that forms a narrowed down portion at an entrance of the slit (where each slit has entrances at the top of 40 on either side of 44, where the jig part enters the slit), by providing one side of the slit with a protrusion and the other side of the slit with an aperture to receive the protrusion. The jig part would correspondingly have a recess at a corresponding position of one of the grooves (rim of 20a is recessed relative to protrusion 28, forming a groove at the outer rim) of the casing retaining structure of the jig part, configured to receive the protrusion once the jig part is fully seated in the implant casing. As taught by McAlpine, the recess through the casing retaining structure of the jig part is a through hole so that the protrusion can also snap into the aperture on the other side of the slit. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide such a pair of engaging structures on each side/end of the slit (on either side of 44), since the mere duplication of the essential working parts of a device involves only routine skill in the art. Then, the snap-fit connection comprises two pairs of engaging structures with two recesses formed on opposite sides of the jig part, for interaction with complementary protrusions on either end of the slit. In another interpretation, these recesses can be interpreted as a holding means formed as two through holes at opposite ends of the jig part.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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