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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/29/2026 has been entered.
Response to Amendments
The amendments to claims 1, 4-9, 11-12, 14-17, and 21-23 are acknowledged and the claim objections are withdrawn.
Response to Arguments
Applicant’s arguments, see page 2, filed 05/29/2026, with respect to the rejection(s) of claim(s) 1 under Maeda et al. (US 20080294093) have been fully considered and are persuasive. The examiner agrees that Maeda fails discloses or suggests “two clips coupled to the deformable plate and extending along opposite sides of the first surface of the deformable plate, the clips configured to apply pressure to a sheet-like implant to releasably hold the implant against the first surface”. Therefore, the rejection of claim 1 has been withdrawn. However, upon further consideration, a new 103 rejection is presented over Maeda in view of Zannis et al. (US 20040267277)
Claim Objections
Claim 28 is objected to because of the following informalities:
Claim 28, line 1: “the shaft” should recite “the extended shaft”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a deformation mechanism” in claims 1, 6, 19 and 23. The limitation introducing the deformation mechanism in claim 1 fails to include sufficient structure to perform the recited function of “deformation". In the specification, the deformation mechanism is described as comprising “at least one ramp-like structure” which is also referred to as “angled edges” and/or “a wire” (page 7 lines 18-20 and lines 24-29; page 8 lines 29-30). Therefore, the limitation will be interpreted as at least one ramp-like structure, angled edges, a wire, or any structural equivalent thereof capable of deforming the deformable plate between a substantially flat first configuration and a substantially cylindrical second configuration.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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.
Claims 3, 13-14, and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claim 3 (line 3), claim 13 (line 1) and claim 14 (line 3) recites the limitation “an implant” or “a graft or implant”. It is unclear to the examiner if “an implant” is meant to further define the “sheet-like implant” introduced in claim 1 or a new, additional, implant. For examination purposes, “an implant” is interpreted as “the sheet-like implant”.
Claim 16 recites “a slider knob” in line 2. It is unclear to the examiner if “a slider knob” is meant to further the slider knob introduced in claim 15 or a new, additional, slider knob. For interpretation purposes, “a slider knob” is interpreted as “the slider knob” of claim 15.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-7, 11-14, 25-26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Maeda et al. (US 20080294093) [hereinafter Maeda] in view of Zannis et al. (US 20040267277) [hereinafter Zannis].
Regarding claim 1, Maeda discloses an implant delivery device 10 (Fig. 1, para. 0044; see note below in regards to intended use) comprising:
an extended shaft 12, 17 with a distal portion (interpreted as portion comprising connecting member 17) (see Figs. 4, 7-8, para. 0047, 0053);
a deformable plate 13 attached to the distal portion of the extended shaft 12 (Figs. 1, 3, 7, para. 0044, 0046-0047), the deformable plate 13 comprising a first surface 13a (Figs. 10-11, para. 0086), and
a deformation mechanism (interpreted as at least one ramp-like structures or angled edges 13c of the deformable plate as defined in the 112(f) interpretation above) that deforms the deformable plate 13 between a substantially flat first configuration (Fig. 11, para. 0053) and a substantially cylindrical second configuration (Fig. 15, para. 0055).
Maeda further discloses that the deformable plate comprises a retainer mechanism (interpreted as frictional coating/adhesive layer described in para. 0059 capable of retaining and releasably holding a sheet-like implant against the first surface of the deformable plate) coupled to the deformable plate 13 and extending along the first surface 13a of the deformable plate 13 (Fig. 11, para. 0059), and the frictional coating/adhesive layer is configured to releasably hold a sheet-like implant 30 against the first surface 13a (Fig. 11, para. 0059).
However, Maeda fails to disclose two clips coupled to the deformable plate and extending along opposite sides of the first surface of the deformable plate, the clips configured to apply pressure to a sheet-like implant to releasably hold the implant against the first surface (see note below).
Zannis in the same field of endeavor of implant delivery devices 10G (Figs. 24-25, para. 0117) teaches that it is known in the art for the delivery device to include two clips 112G coupled to an implant carrier portion 24G and extending along opposite sides of a first surface 110G of the implant carrier portion 24G (see Fig. 25, para. 0119: “Portions of the implant can be received between the end clip portion 112G and the underlying planar portion 110G of the arms 100G”), the clips 112G configured to apply pressure to a sheet-like implant 16 (best shown in Fig. 2A) to releasably hold the implant 16 against the first surface 110G (Fig. 25, para. 0119: “The end clip portions 112G of the arms 100G of the implant carrier 24G of the seventh illustrated surgical instrument 10G are provided for temporary mounting of the orthopaedic implant 16 to the implant carrier 24G. The end clip portions 112G may be integral or discrete spring action clips that bear against portions of the implant to secure a part of the implant to each arm as illustrated in FIGS. 24-25”).
The substitution of one known retainer mechanism (two clips as shown in Zannis) for another (frictional coating/adhesive layer as shown in Maeda) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the two clips shown in Zannis would have yielded predictable results, namely, an alternative way to secure the implant to the deformable plate (para. 0119 of Zannis); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Note: The limitation “the clips configured to apply pressure to a sheet-like implant to releasably hold the implant against the first surface” is interpreted as functional language that describes the intended use of the clips. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed clips are capable of doing and the “sheet-like implant” is not positively claimed. Modified Maeda discloses the structural component i.e. the clips of Zannis (Figs. 24-25, para. 0119 of Zannis) to necessitate the functional language of claim 1. The examiner notes that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 3, modified Maeda discloses all of the limitations set forth above in claim 1. However, modified Maeda fails to disclose further comprising at least one hole through the deformable plate through which a surgical fastening tool can deliver an anchor or suture to an implant (interpreted as the sheet-like implant, see 112(b) rejection above) carried by the deformable plate.
Zannis further teaches that it is known in the art of implant delivery devices 10C (Figs. 10-11, para. 0085-0086) to utilize at least one hole 42 through a deformable plate 24C for fastener attachment (Figs. 10-11, para. 0087).
In light of this teaching, one skilled in the art would have readily recognized that providing the deformable plate of modified Maeda with the at least one hole of Zannis, would provide an area for fastener attachment (para. 0087 of Zannis) and provide the capability of the deformable plate to receive a surgical fastening tool that could deliver an anchor or suture to the implant carried by the deformable plate as claimed (see note below); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Note: The limitation “through which a surgical fastening tool can deliver an anchor or suture to an implant carried by the deformable plate” is interpreted as functional language that describes the intended use of the at least one hole. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Modified Maeda discloses the structural component i.e. at least one hole through the deformable plate (Figs. 10-11, para. 0087 of Zannis) to necessitate the functional language of claim 3. For example, the user can position the deformable plate at a target site and position a surgical fastener tool at a location of the at least one hole, as taught by Zannis, to deliver an anchor or suture through the at least one hole of the deformable plate to the implant. The examiner notes that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 4, modified Maeda discloses further comprising a sleeve 11 with the extended shaft 12 extending through the sleeve 11 (Figs. 1-2, para. 0044) wherein the extended shaft 12 can slide in a proximal and distal direction through the sleeve 11 (Figs. 1-2, para. 0044 of Maeda).
Regarding claims 5 and 7, modified Maeda discloses wherein the deformation mechanism comprises at least one ramp-like structure 13c at a proximal edge of the deformable plate 13 (Fig. 3, para. 0046 of Maeda), wherein, when the sleeve 11 translates in a distal direction relative to the extended shaft 12, the sleeve applies pressure to the ramp-like structure 13c and deforms the plate 13 into the substantially cylindrical second configuration (Fig. 12, para. 0053 of Maeda).
Regarding claim 6, modified Maeda discloses wherein the deformable plate 13 assumes the substantially flat first configuration at rest (Fig. 11, para. 0046 of Maeda) and is elastically deformed into the substantially cylindrical second configuration by the deformation mechanism (Fig. 12, para. 0053 of Maeda).
Regarding claim 11, modified Maeda discloses wherein the distal portion of the extended shaft 12 comprises a first radius (Fig. 8, para. 0048 of Maeda), and a distal end of the extended shaft 12 comprises a second radius smaller than the first radius (see Fig. 8 of Maeda which illustrates a beveled, tapered end of the extended shaft 12 such that the distal end of the extended shaft has a smaller radius than the distal portion), wherein the distal end of the extended shaft meets a proximal portion of the deformable plate 13 at a ramp or step (Figs. 7-8, para. 0048 of Maeda).
Regarding claim 12, modified Maeda discloses wherein a distal end of the extended shaft 12 presents at least a portion of a cylindrical surface to the deformable plate 13 (see Fig. 7 of Maeda which illustrates a distal face of the distal end of the extended shaft having at least a portion of a cylindrical surface), inhibiting the deformable plate 12 from collapsing into configurations other than the substantially cylindrical second configuration (Figs. 11-15, para. 0053-0055 of Maeda).
Regarding claim 13, modified Maeda discloses wherein when an implant (interpreted as the sheet-like implant 30, see 112(b) rejection above) is loaded onto the deformable plate 13 and the deformable plate 13 is deformed into the substantially cylindrical second configuration (Figs. 11-15, para. 0004, 0053-0055 of Maeda), then the deformable plate 13 substantially surrounds and covers the implant 30 (Figs. 14-15, para. 0053-0055 of Maeda).
Regarding claim 14, modified Maeda discloses further comprising a sleeve 11 (Figs. 1-2, para. 0044 of Maeda), with the extended shaft 12 extending through the sleeve (Figs. 1-2, para. 0044 of Maeda), wherein the extended shaft 12 can slide in a proximal and distal direction through the sleeve 11 (Figs. 1-2, para. 0044 of Maeda) and further wherein, when an implant (interpreted as the sheet-like implant 30, see 112(b) rejection above) is loaded onto the deformable plate 13 and the deformable plate 13 is deformed into the substantially cylindrical second configuration (Figs. 11-15, para. 0004, 0053-0055 of Maeda), then the deformable plate 13 substantially inhibits contact between the implant 30 and the sleeve 11 (Figs. 14-15, para. 0053-0055 of Maeda).
Regarding claim 25, modified Maeda discloses wherein each of the two clips 112G extends along the first surface 110G proximate to a respective edge of the deformable plate as taught by Zannis (see Fig. 25 of Zannis which illustrates the clips 112G proximate with respect to an edge of the implant carrier portion 24G) and defines a proximal end coupled to the deformable plate and an open distal end configured to receive the sheet-like implant as taught by Zannis (see Fig. 25 of Zannis which illustrates the clips 112G defining a proximal end 102G coupled with the implant carrier portion 24G and an open distal end configured to receive the sheet-like implant 16, para. 0119 of Zannis).
Regarding claim 26, modified Maeda discloses further comprising a sleeve 11 with the extended shaft 12 extending through the sleeve 11 (Figs. 1-2, para. 0044), wherein the deformable plate 13 of Maeda and the two clips as taught by Zannis above are positionable in the sleeve 11 when the deformable plate is in the substantially cylindrical second configuration as disclosed by Maeda (Fig. 12, para. 0053 of Maeda).
Regarding claim 28, modified Maeda discloses wherein the distal portion (interpreted as portion comprising connecting member 17) of the extended shaft 12 comprises a beveled face sloping toward the first surface 13a (see Fig. 7 of Maeda, para. 0047, 0053 of Maeda).
Claim(s) 8-10, 20 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Maeda et al. (US 20080294093) [hereinafter Maeda] in view of Zannis et al. (US 20040267277) [hereinafter Zannis] as applied to claim 1 above, and further in view of Kucklick (US 20220338910).
Regarding claims 8 and 9, modified Maeda discloses all of the limitations set forth above in claim 1. Maeda further disclose wherein the deformable plate 13 comprises at least one flat sheet of elastically deformable material (para. 0058 of Maeda). However, modified Maeda fails to disclose wherein the flat sheet of the elastically deformable material is reinforced in a longitudinal direction parallel to an axis of the extended shaft with a one or more rigid members attached to the flat sheet of elastically deformable material (claim 8)/ wherein the deformable plate comprises one or more reinforcing structures that inhibit deformation of the deformable plate in a longitudinal direction parallel to an axis of the extended shaft (claim 9).
Kucklick in the same field of endeavor of implant delivery devices teaches that is known in the art to have a flat sheet of deformable material 52 reinforced in a longitudinal direction parallel to an axis of a shaft with one or more rigid members/reinforcing structures 52A attached to the flat sheet of deformable material 52 (Figs. 13, 18 para. 0043-0044), wherein the one or more reinforcing structures 52A inhibit deformation of the deformable plate in the longitudinal direction parallel to an axis of the extended shaft (Fig. 18, para. 0044; see note below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the deformable plate in modified Maeda to include the one or more rigid members/reinforcing structures of Kucklick in order to provide structural support to the plate in the longitudinal direction as well as the orthogonal direction (para. 0044 of Kucklick), thereby directing the deformation along those directions to provide dimensional stability when the plate transitions from the first configuration to the substantially cylindrical second configuration (para. 0044 of Kucklick).
Note: “wherein the one or more reinforcing structures inhibit deformation of the deformable plate in the longitudinal direction parallel to an axis of the extended shaft” is interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. The modification of claims 8 and 9 resulted in the reinforcing structure of Kucklick being provided on the deformable plate of Maeda. Since the newly modified Maeda includes all of the structure required for the claim (i.e. the one or more reinforcing structures 52A of Kucklick in the longitudinal direction parallel to an axis of the extended shaft, Fig. 18, para. 0043-0044 of Kucklick ) to necessitate the functional language, modified Maeda also meets the functional limitation of the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 10, modified Maeda discloses wherein the reinforcing structures (interpreted as the strut-like members forming spring material component 52A) comprise living hinges of the deformable plate 49 (Figs. 12-13, 18, para. 0043-0044 of Kucklick illustrate that the reinforcing structures bend and fold during delivery of the plate 52, therefore the structures comprise living hinges).
Regarding claim 20, modified Maeda discloses all of the limitations set forth above in claim 1. However, modified Maeda fails to disclose wherein the deformable plate comprises at least two flat pieces of material joined together to form a substantially flat sheet of elastically deformable material.
Kucklick in the same field of endeavor of implant delivery devices teaches that it is known in the art to include at least two flat pieces of material 52 joined together to form a substantially flat sheet of elastically deformable material and a reinforcing structure 52A (Fig. 18, para. 0044 teaches that two sheets may be laminated together to attach a reinforcing structure therebetween).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the deformable plate in modified Maeda to include the at least two flat pieces of material and reinforcing structure of Kucklick in order to provide structural support to the plate in the longitudinal direction as well as orthogonal direction (para. 0044 of Kucklick), thereby directing the deformation along those directions to provide dimensional stability when the plate transitions from the first configuration to the substantially cylindrical second configuration (para. 0044 of Kucklick).
Regarding claim 27, modified Maeda discloses all of the limitations set forth above in claim 1. Modified Maeda further discloses wherein the deformable plate 13 comprises a second surface (interpreted as the surface which does not directly contact the sheet-like implant 30) opposite the first surface 13a (see Fig. 7 of Maeda). However, modified Maeda fails to disclose a backbone coupled to the extended shaft and extending from a proximal end of the deformable plate toward a distal end of the deformable plate along a center of the second surface.
Kucklick in the same field of endeavor of implant delivery devices teaches that it is known in the art to have a flat sheet of deformable material 52 to comprise a backbone 52A coupled to an extended shaft 3 and extending from a proximal end of the deformable material 52 toward a distal end of the deformable material along a center of a second surface opposite a first surface (interpreted as the surface in which the backbone 52A is not directly contacting) (see Figs. 13, 18, para. 0044)
In light of this teaching, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second surface of the deformable plate in modified Maeda to include the backbone of Kucklick in order to provide structural support to the plate in the longitudinal direction as well as the orthogonal direction (para. 0044 of Kucklick), thereby directing the deformation along those directions to provide dimensional stability when the plate transitions from the first configuration to the substantially cylindrical second configuration (para. 0044 of Kucklick).
Claim(s) 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Maeda et al. (US 20080294093) [hereinafter Maeda] in view of Zannis et al. (US 20040267277) [hereinafter Zannis] as applied to claims 1 and 5 above, and further in view of Seiler et al. (US 20090209804) [hereinafter Seiler].
Regarding claims 15 and 16, modified Maeda discloses all of the limitations set forth above in claims 1 and 5. Maeda further discloses wherein the deformable plate 13 comprises at least one flat sheet of elastically deformable material (Fig. 11, para. 0058 of Maeda) with angled edges 13c at a proximal portion of the deformable plate (Fig. 3, para. 0046 of Maeda), the device further comprising: a sleeve 11 slidably disposed over the extended shaft 12 (Figs. 1-2, para. 0044 of Maeda), wherein when the sleeve 11 translates in a distal direction relative to the extended shaft 12, the sleeve 11 applies pressure to the angled edges 13c and deforms the plate into the substantially cylindrical second configuration (Figs. 11-15, para. 0053-0055 of Maeda); a handle 15 at a proximal end of the extended shaft operable to push the sleeve 11 in the distal direction over the extended shaft 12 to deform the plate into the substantially cylindrical second configuration (Figs. 1-2, para. 0044 of Maeda).
However, modified Maeda fails to disclose the device/the deformation mechanism further comprising a slider knob operable to push the sleeve in the distal direction over the extended shaft to deform the plate into the substantially cylindrical second configuration.
Seiler in the same field of endeavor teaches an implant delivery device (Figs. 2A-B, para. 0037) comprising a handle 210 at a proximal end of a shaft 250 (Fig. 3, para. 0037); and a slider knob 220 on the handle 210 operable to push a sleeve 240 in a distal direction 204 over the extended shaft 250 to retain an implant 202 (Figs. 5A-C, para. 0039).
The substitution of one known handle (handle comprising slider knob as shown in Seiler) for another (finger ring handle as shown in modified Maeda) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the slider knob handle shown in Seiler would have yielded predictable results, namely, an alternative way to actuate the sleeve during use (Figs. 5A-C, para. 0039 of Seiler); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 17, modified Maeda discloses wherein the handle 210 includes a ridge 338 operable to lock the slider knob 220 in a position to thereby hold the plate in the substantially cylindrical second configuration, enclosed within a distal portion of the sleeve 240, during the use of the implant delivery device (Figs. 3, 5A, para. 0044-0045, 0050 of Seiler).
Regarding claim 18, modified Maeda discloses wherein the slider knob 220 includes a spring (interpreted as the resilient member formed by slits 331a-b) that biases the slider knob 220 into a locked position at the ridge (Figs. 5A-B, para. 0042 of Seiler).
Regarding claim 19, modified Maeda discloses wherein the deformation mechanism allows a user to deliver the graft through an incision and to a surgical site holding the implant delivery device with only one hand and only by the handle of the device (Figs. 2A-B, para. 0039, 0050 of Seiler).
Allowable Subject Matter
Claims 23-24 are allowable due to the claim amendment filed on 10/30/2025 (see reasons for allowance in the office action filed 07/31/2025).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
Prosecution Insights