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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06 March 2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 06 March 2026. As directed by the amendment: claims 1, 4, 15, and 16 have been amended, claims 10-12 are cancelled, and claims 21-23 are newly added. Claims 1-9 and 13-23 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the previous rejections under 35 U.S.C. 112(b) listed in the previous Office Action, which are accordingly withdrawn. Further rejections under 35 U.S.C. 112(b) as necessitated by the current claim amendments are presented below.
Response to Arguments
Applicant's arguments filed 03 November 2025, with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) and 35 U.S.C. 103, have been fully considered but they are not persuasive. Applicant contends that Barry (US 2017/0348032) discloses an insert 200 having flexible arms 206 that are biased inward to pinch an implant therebetween, but that the space between Barry’s arms 206 is an open, unbound three-sided opening that does not have “a circumferential shape corresponding to a cross-section of the interphalangeal implant” as recited in claim 1. Applicant contends that Barry’s flexible arms 206 form an open-ended gap rather than a defined circumferential aperture with a shape that corresponds to the cross-section of an implant. Examiner respectfully submits that the implant aperture formed between Barry’s arms 206 does have a circumferential shape, where the term circumferential refers to the edge of the object, which in this case is the aperture, i.e. any object has a circumferential shape which is the shape at its outside edge. In this case, the circumferential shape of the implant aperture (negative space) is the interior circumferential shape taken at the outer edge of the aperture/at the inner edges of the arms 206/208 that create the aperture. The shape of this defined circumferential aperture corresponds to the cross-section of an implant since the aperture receives the implant and would thus correspond to, or match at least in general size and shape, the implant cross-section in order to properly hold the implant. The circumferential shape of Barry’s aperture corresponds to the cross-section of the implant because it holds the implant, at least where the implant is disposed within the aperture.
Applicant further contends that Barry does not disclose “at least three retaining protrusions extending into the implant aperture from a surrounding edge” because the tips of arms 206 and protrusions on abutment surface 208 do not extend into an implant aperture from a surrounding edge of the aperture. Examiner respectfully submits that the surrounding edge of the aperture is the interior edge of the aperture that is not protruding, with the protrusions on the tips of 206s and the protrusions on 208 extending from this relatively recessed surrounding edge. The surrounding edge may also be interpreted as the exterior edge of 200, where the protrusions extend inwardly into the aperture and inwardly from the exterior surrounding edge.
Markforged was not relied upon for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 22, the limitation that the at least three retaining protrusions are evenly distributed around the implant aperture is not supported by the specification as originally filed. The specification makes no mention of the distribution of the retaining protrusions, evenly or otherwise.
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.
Claim 20 is rejected under 35 U.S.C. 112(b) 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.
As to claim 20, the limitations “a circumferential shape” and “a cross-section shape” render the claim indefinite because it is unclear if they refer back to the circumferential shape and the cross-section of the interphalangeal implant recited previously in claim 1, or to a different circumferential shape and a different cross-section shape. For examination purposes, the limitations will be interpreted in the former instance, and the claim is suggested to be amended as follows:
20. The interphalangeal implant retainer according to claim 1, wherein the is taken perpendicular to a direction of insertion of the interphalangeal implant into the implant aperture.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6, and 13-23 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent Application Publication No. US 2017/0348032 to Barry et al. (hereinafter, “Barry”).
As to claim 1, Barry discloses an interphalangeal implant retainer for retaining an interphalangeal implant (interpreted as language of intended use) and to be used with an implantation tool (interpreted as language of intended use), the interphalangeal implant retainer comprising: a jig part (200), FIG. 11C, wherein the jig part has a plate shape, FIG. 11C; and an implant aperture (space between 206s) configured to retain the interphalangeal implant (par. [0076]) (interpreted as language of intended use without positive recitation of the interphalangeal implant), wherein the implant aperture is formed as a through-hole (an opening all the way through the jig part) configured to receive the interphalangeal implant therethrough (interpreted as language of intended use without positive recitation of an interphalangeal implant; fully capable of receiving an interphalangeal implant), wherein the implant aperture has a circumferential shape corresponding to a cross-section of the interphalangeal implant (interpreted as language of intended use without positive recitation of an interphalangeal implant; the interior circumferential shape of the implant aperture is fully capable of corresponding to a cross-section of the interphalangeal implant, since the aperture receives the implant and would thus correspond to, or match at least in general size and shape, the implant cross-section in order to properly hold the implant) and includes at least three retaining protrusions (tips of 206s that extend inward toward each other, and protrusions on 208) extending into the implant aperture from a surrounding edge (the interior edge of the aperture that is not protruding), FIG. 11C, configured to retain the interphalangeal implant by friction (the retaining protrusions are biased inward as part of the legs 206 which pinch the implant therebetween, retaining the implant frictionally in a direction away from the aperture between the legs, with the protrusions on 208 retaining the implant by friction at least due to frictional abutment) and form fit (because the legs comprising the retaining protrusions are biased inwardly to form fit to the implant and the implant is pressed against the protrusions on 208).
As to claim 2, Barry 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, Barry discloses the interphalangeal implant retainer according to claim 1, further comprising: an implant casing (112) defining an implant receiving space (negative space of 114) and a jig retaining structure (post, not shown; par. [0076]), wherein the jig part comprises a casing retaining structure (204s), wherein the jig retaining structure is configured to releasably engage the casing retaining structure.
As to claim 4, Barry discloses the interphalangeal implant retainer according to claim 3, wherein the casing retaining structure is a groove (long narrow cut between 204s) positioned on an inner side and/or an outer side of the jig part (the groove is on an inner side of the jig part between the 204s).
As to claim 6, Barry discloses the interphalangeal implant retainer according to claim 3, wherein the engagement between the jig retaining structure and the casing retaining structure is configured as a snap-fit connection (due to flexibility of legs that snap around the post).
As to claim 13, Barry discloses the interphalangeal implant retainer according to claim 1, wherein the jig part of the interphalangeal implant retainer comprises a holding means (means for holding the implant and the post) formed as two through holes (hole between 206s and hole between 204s) at opposite ends of the jig part, FIG. 11C.
As to claim 14, Barry 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 if either interpreted as including tool 112 or a tool or tool components not shown) 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 (e.g. the cannulated end of 112 and the post in 114; portion 112 can guide the implant therein to anywhere as a handle), 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 (hole between 206s and hole between 204s) that is configured to correspond to the implant holder (interpreted as language of intended use; fully capable of corresponding to the implant holder, e.g. the post).
As to claim 15, Barry discloses the interphalangeal implant retainer according to claim 14, wherein the jig part comprises the holding means (hole between 206s and hole between 204s) that is configured to correspond to the implant holder (interpreted as language of intended use; fully capable of corresponding to the implant holder, e.g. the post), wherein the holding means is such that the jig part can be held by and can be movable (during insertion/assembly) relative to the female guide member (e.g. the cannulated end of 112) and the male guide member (e.g. the post in 114) of the implant guiding means of the interphalangeal implant (the jig part can be held by and can be movable relative to the cannulated end of 112 because one end of the jig part including the hole between 204s is movable into the cannulated end to then be held by the cannulated end, and the jig part can be held by and can be movable relative to the post in 114 because one end of the jig part including the hole between 204s is movable into the cannulated end to receive the post and then be held by the post; this comprises implant guiding means of the implant because it is used to guide the implant into connection with 112 and also to guide the connected implant therein as a handle).
As to claim 16, Barry discloses the interphalangeal implant retainer according to claim 15, wherein two through holes (hole between 206s and hole between 204s) are configured to 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 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 (interpreted as language of intended use; the through holes are fully capable of slidingly interacting with two pins of an implant holder for holding the interphalangeal implant, wherein the implant holder is part of a female guide member or a male guide member of an implant guiding means of the interphalangeal implant, the implant holder not shown, since the holes are through holes and can slidingly accept an appropriately sized pin).
As to claim 17, Barry 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 (interpreted as language of intended use; not shown but fully capable).
As to claim 18, Barry 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 (interpreted as language of intended use; not shown but fully capable).
As to claim 19, Barry 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 (interpreted as language of intended use; not shown but fully capable).
As to claim 20, Barry discloses the interphalangeal implant retainer according to claim 1, wherein the implant aperture is of a circumferential shape that is configured to correspond to a cross- section shape of the interphalangeal implant (interpreted as language of intended use without positive recitation of the interphalangeal implant; the interior circumferential shape of the implant aperture is fully capable of corresponding to a cross-section shape of the interphalangeal implant, since the aperture receives the implant and would thus correspond to, or match at least in general size and shape, the implant cross-section shape in order to properly hold the implant) perpendicular to a direction of insertion of the interphalangeal implant into the implant aperture (the implant may be inserted into the implant aperture from the top of 200, so that the cross-section shape is in a plane perpendicular to this direction of insertion).
As to claim 21, Barry 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 (due to flexibility of legs 206 that snap around the implant, and since the implant can be removed/released from the snap fit).
As to claim 22, Barry discloses the interphalangeal implant retainer according to claim 1, wherein the at least three retaining protrusions are evenly distributed around the implant aperture (evenly distributed on either side of the implant aperture, since the aperture is symmetrical across a longitudinal axis therethrough; evenly distributed at least as much as the instant invention).
As to claim 23, Barry discloses the interphalangeal implant retainer according to claim 3, wherein the implant receiving space (negative space of 114) is at least partially enclosed, FIG. 11C, such that independent of an orientation of the implant casing (112), the interphalangeal implant retained via the jig part cannot contact a flat surface on which the implant casing is placed (interpreted as language of intended use without positive recitation of the interphalangeal implant; the implant is fully capable of being of a size and shape that is completely or sufficiently surrounded in the implant aperture of the jig part, or is at least dimensioned smaller than the thickness of the implant casing, so that the implant retained via the jig part cannot contact a flat surface on which the implant casing is placed since it would hover over the flat surface with only the sides of the implant casing touching the flat surface).
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 5, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Barry in view of the non-patent literature “3D Printed Joinery: Simplifying Assembly” to Markforged; and claim 9 is rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by Barry, or in the alternative, under 35 U.S.C. 103 as being unpatentable over Barry in view of Markforged.
Barry discloses the claimed invention except for wherein the jig retaining structure is formed as a slit, the slit having sidewalls engageable with opposite grooves 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 (claim 5).
Markforged teaches retaining structures of telescoping relatively sliding parts (pages 6-7), comprising a casing (outer component) defining a jig retaining structure (slit or negative space that receives the inner component and the dovetail sidewalls forming/bounding the slit), and a jig part (inner component) having a plate shape and a casing retaining structure comprising opposite grooves (dovetail grooves on either side of the inner component, where a groove is a long narrow cut, the cut forming the angle of the dovetail as opposed to a flat face), where the slit of the jig retaining structure has sidewalls (dovetail sidewalls forming/bounding the slit) engageable with the opposite grooves 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 (see figures on page 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 modify the interaction between Barry’s jig part and the implant casing as taught by Markforged, by forming the end of the jig part (end at 204s) that slides into the implant casing as a plate shape with dovetail grooved sides on both long sides (the casing retaining structure), and forming the inner sides of the implant casing that are adjacent to the long sides of the jig part as dovetail sidewalls forming/bounding the slit 114 (the jig retaining structure), so that the complementary dovetail sidewalls engage each other as taught by Markforged and relatively slide to guide the jig part and the implant casing towards and away from each other, since the simple substitution of one known element for another (replacing the legs/post of Barry with the complementary dovetail sidewalls of Markforged) to obtain predictable results (relative reversible sliding) is within the ordinary skill in the art. Markforged also teaches a detent to lock the telescoping components in the nested position, which would achieve the secure fit required by Barry when the jig part is inside the implant casing.
As to claim 7, Barry teaches wherein the engagement between the jig retaining structure and the casing retaining structure is configured as a snap-fit connection (due to flexibility of legs that snap around the post), but is silent as to 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).
Markforged teaches wherein the engagement between the jig retaining structure and the casing retaining structure is configured as a snap-fit connection (due to detent, see page 7), wherein at least one pair of engaging structures of the snap-fit connection is formed as a protrusion (protruding detent, see figure on page 6) and as a recess (not shown, but receives the detent), configured to receive the protrusion; wherein the recess is a through hole (since it is a hole that penetrates through the surface).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the detent as taught by Markforged to lock the telescoping components in the nested position (reversibly locking the jig part when it is fully inside the implant casing), so that the implant casing can securely carry and manipulate the jig part and attached implant, while also later allowing the disassembly of the jig part from the implant casing for deployment of the implant, reuse of the implant casing, or disposal. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to reverse the locations of the detent protrusion and the recess from the positions as shown in Markforged, since the mere reversal of the essential working parts of a device involves only routine skill in the art. The protrusion would be formed on the inwardly facing sidewall of the implant casing that engages with the groove (dovetail sidewall) of the casing retaining structure of the jig part, which would accordingly form a narrowed down portion at an entrance of the slit (since the dovetail sidewalls of the implant casing form/bound the slit), and the recess would be formed at a corresponding position of one of the grooves of the casing retaining structure of the jig part (on a dovetail sidewall of the jig part), configured to receive the protrusion when the components are nested in the engaged/seated position.
As to claim 9, Barry discloses wherein the snap-fit connection comprises two pairs of engaging structures (each leg with a respective adjacent side of the post) with two recesses (indentations formed by/adjacent to tip protrusions on the legs) formed on opposite sides of the jig part.
Assuming arguendo, Barry is silent as to wherein the snap-fit connection comprises two pairs of engaging structures with two recesses formed on opposite sides of the jig part.
Markforged teaches retaining structures of telescoping relatively sliding parts (pages 6-7), comprising a casing (outer component) defining a jig retaining structure (slit or negative space that receives the inner component and the dovetail sidewalls forming/bounding the slit), and a jig part (inner component) having a plate shape and a casing retaining structure (dovetail sidewalls on either side of the inner component), wherein the engagement between the retaining structures is a snap-fit connection (due to detent, see page 7).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the interaction between Barry’s jig part and the implant casing as taught by Markforged, by forming the end of the jig part (end at 204s) that slides into the implant casing as a plate shape with dovetail sides on both long sides (the casing retaining structure), and forming the inner sides of the implant casing that are adjacent to the long sides of the jig part as dovetail sidewalls forming/bounding the slit 114 (the jig retaining structure), so that the complementary dovetail sidewalls engage each other as taught by Markforged and relatively slide to guide the jig part and the implant casing towards and away from each other, since the simple substitution of one known element for another (replacing the legs/post of Barry with the complementary dovetail sidewalls of Markforged) to obtain predictable results (relative reversible sliding) is within the ordinary skill in the art. Markforged also teaches a detent to lock the telescoping components in the nested position, which would achieve the secure fit required by Barry when the jig part is inside the implant casing. It also would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the detent as taught by Markforged to lock the telescoping components in the nested position (reversibly locking the jig part when it is fully inside the implant casing) by snap-fitting the retaining structures together, so that the implant casing can securely carry and manipulate the jig part and attached implant, while also later allowing the disassembly of the jig part from the implant casing for deployment of the implant, reuse of the implant casing, or disposal. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to reverse the locations of the detent protrusion and the recess from the positions as shown in Markforged, since the mere reversal of the essential working parts of a device involves only routine skill in the art. The protrusion would be formed on the inwardly facing sidewall of the implant casing that engages with the dovetail sidewall of the casing retaining structure of the jig part, which would accordingly form a narrowed down portion at an entrance of the slit (since the dovetail sidewalls of the implant casing form/bound the slit), and the recess would be formed at a corresponding position of one of the dovetail sidewalls of the casing retaining structure of the jig part (on a dovetail sidewall of the jig part), configured to receive the protrusion when the components are nested in the engaged/seated position. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide two pairs of detent protrusions and recesses, one on each pair of dovetail interacting sidewalls, since the mere duplication of the essential working parts of a device involves only routine skill in the art. Then, there would be two recesses, one on each side of the jig part facing outward toward the respective sidewall of the implant casing.
Conclusion
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