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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 41-62, drawn to a device.
Group II, claim 63, drawn to a method.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of “An implant delivery device comprising: a shaft; an elastically deformable plate attached to a distal portion of the shaft, the deformable plate comprising a first surface and at least one retaining mechanism on the first surface configured to retain a sheet-like implant relative to the deformable plate; and a deformation mechanism that elastically deforms the deformable plate between an open first configuration and a closed second configuration”, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Zannis et al. (US PGPub 2004/0267277) in view of Mizuno et al. (US PGPub 2021/0378650), hereinafter known as “Zannis” and “Mizuno,” respectively.
Zannis discloses an implant delivery device 10C (Figs. 10-11, para. 0086) comprising:
a shaft 26C (Figs. 10-11, para. 0072, 0085);
an elastically deformable plate 24C attached to a distal portion of the shaft 26C (Figs. 10-11, para. 0072, 0085-0086), the deformable plate 24C comprising a first surface (interpreted as the surface having the implant 16 positioned on top of it, see Fig. 10, para. 0086) and at least one retaining mechanism (interpreted as sutures 44, Figs. 10-11, para. 0087; see 112(f) interpretation below) on the first surface (Figs. 10-11, para. 0087) configured to retain a sheet-like implant 16 relative to the deformable plate 24C (Fig. 11, para. 0087, 0091 of Zannis).
Zannis further discloses wherein the deformable plate 24 has a circular shape with rounded edges (see Figs. 10-11 of Zannis).
However, Zannis fails to disclose a deformation mechanism (interpreted as angled structures as defined in the 112(f) interpretation below) that elastically deforms the deformable plate between an open first configuration and a closed second configuration.
Mizuno in the same field of endeavor of implant delivery devices comprises a deformable plate 830 used to deliver an implant 910 (Figs. 16-18, para. 0237), wherein the deformable plate 830 has a substantially square shape that is known in the art (Fig. 17, para. 0237) and a deformation mechanism (interpreted as angled structures extending from tongue part 832 of the plate 830 at a proximal edge of the deformable plate 830; see annotated Fig. 17 below, para. 0021) that elastically deforms the deformable plate 830 between an open first configuration (Fig. 17) and a closed second configuration (Fig. 16, para. 0239, 0242).
It would have been an obvious matter of design choice to modify the shape of the deformable plate of Zannis for the square shape comprising the at least one angled structure taught in Mizuno, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
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Annotated Fig. 17 of Mizuno
The combination of Zannis in view of Mizuno would result in a product wherein the deformable plate 24C of Zannis has the square shape taught by Mizuno such that the deformation mechanism comprises the at least one angled structure at a proximal edge of the deformable plate (see annotated Fig. 17 of Mizuno above), wherein, when a sleeve 12C translates in a distal direction 23 relative to the shaft 26C of Zannis, the sleeve 12C applies pressure to the angled structure and deforms the plate 24C into the second configuration (Figs. 16-17 of Mizuno illustrate that a maximum transverse dimension in the first configuration (Fig. 17) is larger than a maximum transverse dimension in the second configuration (Fig. 16) and thereby the inner diameter of the sleeve as well. Therefore, when transitioning from an enlarged shape (Fig. 17) to a rolled shape (Fig. 16), the sleeve is capable of applying pressure to the angled structure to deform the place 24C back into the second configuration, in light of the specifications of the instant application page 7, lines 19-21).
During a telephone conversation with Brian Tomkins on 08/11/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 41-62. Affirmation of this election must be made by applicant in replying to this Office action. Claim 63 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 44, 47, 50 and 61 are objected to because of the following informalities:
Claim 44 lines 4-5 “elastically deformable plate” is suggested to read “the elastically deformable plate” for better antecedent basis.
Claim 47 line 2 “an at least one angled structure” is suggested to read “at least one angled structure” for better claim language consistency.
Claim 47 line 3 “a distal direction” is suggested to read “the distal direction” for better antecedent basis.
Claim 47 lines 3-4 “the angled structure” is suggested to read “the at least one angled structure” for better claim language consistency.
Claim 47 line 4 “the plate” is suggested to read “the deformable plate” for better claim language consistency.
Claim 50 line 3 “the interior” is suggested to read “an interior” for better antecedent basis.
Appropriate correction is required.
Claim 61 line 4 “the angled structure” is suggested to read “the at least one angled structure” for better claim language consistency.
Claim 61 lines 5 and 7 “the plate” is suggested to read “the deformable plate” for better claim language consistency.
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 claim 1. 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.
“retaining mechanism” in claim 1. The limitation introducing the deformation mechanism in claim 1 fails to include sufficient structure to perform the recited function of “retaining". In the specification, the retaining mechanism is either a pin or a clip (page 9 line 21). Therefore, the limitation will be interpreted as a pin, clip, or any structural equivalent thereof capable of retaining and releasably holding a sheet-like implant against the first surface of the deformable plate.
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 § 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.
Claims 41-42, 45-47, 50-51, 58-60, and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Zannis in view of Mizuno.
With regards to claim 41, Zannis discloses an implant delivery device 10C (Figs. 10-11, para. 0086) comprising:
a shaft 26C (Figs. 10-11, para. 0072, 0085);
an elastically deformable plate 24C attached to a distal portion of the shaft 26C (Figs. 10-11, para. 0072, 0085-0086), the deformable plate 24C comprising a first surface (interpreted as the surface having the implant 16 positioned on top of it, see Fig. 10, para. 0086) and at least one retaining mechanism (interpreted as sutures 44, Figs. 10-11, para. 0087; see 112(f) interpretation below) on the first surface (Figs. 10-11, para. 0087) configured to retain a sheet-like implant 16 relative to the deformable plate 24C (Fig. 11, para. 0087, 0091 of Zannis).
Zannis further discloses wherein the deformable plate 24 has a circular shape with rounded edges (see Figs. 10-11 of Zannis).
However, Zannis fails to disclose a deformation mechanism (interpreted as at least one angled structure as defined in the 112(f) interpretation above) that elastically deforms the deformable plate between an open first configuration and a closed second configuration.
Mizuno in the same field of endeavor of implant delivery devices comprises a deformable plate 830 used to deliver an implant 910 (Figs. 16-18, para. 0237), wherein the deformable plate 830 has a substantially square shape that is known in the art (Fig. 17, para. 0237) and a deformation mechanism (interpreted as at least one angled structure extending from tongue part 832 of the plate 830 at a proximal edge of the deformable plate 830; see annotated Fig. 17 below, para. 0021) that elastically deforms the deformable plate 830 between an open first configuration (Fig. 17) and a closed second configuration (Fig. 16, para. 0239, 0242).
It would have been an obvious matter of design choice to modify the shape of the deformable plate of Zannis for the square shape comprising the at least one angled structure taught in Mizuno, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
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Annotated Fig. 17 of Mizuno
The combination of Zannis in view of Mizuno would result in a product wherein the deformable plate 24C of Zannis has the square shape taught by Mizuno such that the deformation mechanism comprises the at least one angled structure at a proximal edge of the deformable plate (see annotated Fig. 17 of Mizuno above), wherein, when a sleeve 12C translates in a distal direction 23 relative to the shaft 26C of Zannis, the sleeve 12C applies pressure to the angled structure and deforms the plate 24C into the second configuration (Figs. 16-17 of Mizuno illustrate that a maximum transverse dimension in the first configuration (Fig. 17) is larger than a maximum transverse dimension in the second configuration (Fig. 16) and thereby the inner diameter of the sleeve as well. Therefore, when transitioning from an enlarged shape (Fig. 17) to a rolled shape (Fig. 16), the sleeve is capable of applying pressure to the angled structure to deform the place 24C back into the second configuration, in light of the specifications of the instant application page 7, lines 19-21).
With regards to claim 42, the combination of Zannis/Mizuno disclose wherein the open first configuration (figure 17 of Mizuno) of the elastically deformable plate (24C of Zannis) is a substantially flat first configuration, and the closed second configuration (figure 16 of Mizuno) of the deformable plate (24C of Zannis) is a substantially cylindrical second configuration.
With regards to claim 45, Zannis further discloses wherein the elastically deformable plate 24C defines at least one opening 42 (Figs. 10-11, para. 0082 of Zannis) through which a surgical fastening tool can deliver an anchor or suture to the sheet-like implant carried by the plate (see note below).
Note: The limitation “through which a surgical fastening tool can deliver an anchor or suture to the sheet-like implant carried by the plate” is interpreted as functional language that describes the intended use of the openings. 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 Zannis discloses the structural component i.e. at least one opening through the deformable plate (Figs. 10-11, para. 0082 of Zannis) to necessitate the functional language of claim 45. For example, the user can position the deformable plate 24C to a target site, cut and remove the sutures 44 from the holes 42 such that the user is capable of using a surgical fastener tool to deliver an anchor or suture small enough to fit through the holes of the deformable plate 24C, to the implant 16. 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.
With regards to claim 46, Zannis further discloses further comprising a sleeve 12C with the shaft 26C positioned through the sleeve 12C in a proximal and distal direction, wherein the shaft 26C and sleeve 12C are configured to slide in the proximal and distal direction relative to one another (Figs. 10-11, para. 0086, 0091 of Zannis).
With regards to claim 47, the combination of Zannis/Mizuno disclose wherein the deformation mechanism comprises the sleeve (12C of Zannis) and an at least one angled structure at a proximal edge of the deformable plate (see annotated Fig. 17 of Mizuno above, para. 0237 of Mizuno), wherein, when the sleeve (12C of Zannis) translates in a distal direction relative to the shaft 26C of Zannis), the sleeve (12C of Zannis) applies pressure to the angled structure and deforms the plate into the second configuration (see rejection of claim 41 above explaining the functionality of the combination).
With regards to claim 50, the combination of Zannis/Mizuno discloses wherein the elastically deformable plate (24C of Zannis) assumes the first configuration at rest (Fig. 11, para. 0086 of Zannis) and is elastically deformed into the second configuration (Fig. 10, para. 0086 of Zannis) by the deformation mechanism of Mizuno (Fig. 18, para. 0237, 0242 of Mizuno; see explanation above in the rejection of claim 41).
With regards to claim 51, Zannis further discloses wherein the elastically deformable plate 24C includes a perimeter, the perimeter defining at least one notch 42 (Figs. 10-11, para. 0082 of Zannis) through which a surgical fastening tool can deliver an anchor or suture to the sheet-like implant carried by the deformable plate (see note below).
Note: The limitation “through which a surgical fastening tool can deliver an anchor or suture to the sheet-like implant carried by the deformable plate” is interpreted as functional language that describes the intended use of the openings. 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 Zannis discloses the structural component i.e. at least one notch through the deformable plate (Figs. 10-11, para. 0082 of Zannis) to necessitate the functional language of claim 51. For example, the user can position the deformable plate 24C to a target site, cut and remove the sutures 44 from the notches 42 such that the user is capable of using a surgical fastener tool to deliver an anchor or suture small enough to fit through the holes of the deformable plate 24C, to the implant 16. 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.
With regards to claim 58, Zannis further discloses wherein the at least one retaining mechanism 44 includes a length extending from a proximal end to a distal end, wherein the proximal end is elastically mounted to the first surface of the elastically deformable plate 24C (see distal-most suture 44 where the proximal end is elastically mounted to the deformable plate 24C) and the distal end is configured to elastically deform from a first position (figure 10) to a second position (figure 11), wherein the distal end is closer to the first surface of the deformable plate 24C in the first position (figure 10) than in the second position (figure 11) (when deformable plate 24C is rolled within the sleeve 12C, the retaining mechanism 44 is closer to the first surface of the deformable plate 24C due to being tightly wound, as opposed to the second position of figure 11 where the deformable plate 24C is laid flat).
With regards to claim 59, Zannis further discloses wherein when the sheet-like implant 16 (functionally recited in claim 41) is retained by the at least one retaining mechanism 44, and the elastically deformable plate 24C is deformed into the closed second configuration (figure 10), the sheet-like implant 16 is configured to be within the interior of the closed configuration of the deformable plate 24C (figure 10; paragraphs 86-87).
With regards to claim 60, Zannis further discloses further comprising a sleeve 12C, with the shaft 26C positioned through the sleeve 12C, wherein the shaft 26C and sleeve 12C are configured to slide in a proximal and distal direction relative to one another, wherein when the sheet-like implant 16 (functionally recited in claim 41) is retained by the at least one retaining mechanism 44, and the elastically deformable plate 24C is deformed into the closed second configuration (figure 10), the deformable plate 24C substantially inhibits contact between the sheet-like implant 16 and the sleeve 12C (paragraphs 86 and 91; see Note below).
Note: The examiner notes that “substantially” under broadest reasonable interpretation is defined as “being largely by not wholly that which is specified” (see attached Merriam-Webster dictionary definition of substantial). Fig. 10 illustrates the deformable plate 24C “largely but not wholly” inhibiting contact between the graft/implant 16 and the sleeve 12C, therefore the limitation is met.
With regards to claim 62, Zannis further discloses wherein the at least one retaining mechanism 44 is attached to the first surface of the elastically deformable plate 24C at a proximal end (see distal-most suture 44 where the proximal end is elastically mounted to the deformable plate 24C) and a distal end of the at least one retaining mechanism 44 is configured to elastically deform from a first position (figure 10) to a second position (figure 11), wherein the distal end is closer to the first surface of the deformable plate 24C in the first position (figure 10) than in the second position (figure 11) (when deformable plate 24C is rolled within the sleeve 12C, the retaining mechanism 44 is closer to the first surface of the deformable plate 24C due to being tightly wound, as opposed to the second position of figure 11 where the deformable plate 24C is laid flat), wherein the distal end of the at least one retaining mechanism 44 is capable of elastically moving from the first position (figure 10) towards the second position (figure 11) to accept the sheet-like implant 16 in between the first surface of the deformable plate 24C and the distal end of the at least one retaining mechanism 44.
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Zannis in view of Mizuno, and further in view of Euteneuer et al. (US PGPub 2012/0209401), hereinafter known as “Euteneuer.”
With regards to claims 43-44, the combination discloses the device as claimed in claim 41. The combination is silent wherein the at least one retaining mechanism includes at least one clip (claim 43); and wherein the at least one clip includes a first clip and a second clip, wherein the first clip and the second clip are positioned at a first location and a second location, respectively, on the first surface of the elastically deformable plate, the first location and second location are on opposite sides of a longitudinal axis of the shaft and elastically deformable plate (claim 44).
However, in the same field of endeavor in implant delivery devices, Euteneuer teaches wherein the at least one retaining mechanism includes at least one clip 520, 522 (Figs. 12 and 15, para. 0087) as opposed to a retaining mechanism comprising sutures 146 (Figs. 10A-B, para. 0075); and
wherein the at least one clip includes a first clip 520 and a second clip 522, wherein the first clip 520 and the second clip 522 are positioned at a first location (where 220 is in figure 12) and a second location (where 222 is in figure 12), respectively, on the first surface of the elastically deformable plate 50, the first location and second location are on opposite sides of a longitudinal axis of the shaft 230 and elastically deformable plate 50 (figures 12 and 15; paragraphs 79-83 and 87).
The substitution of one known retaining mechanism (clips as taught by Euteneuer) for another (sutures as shown in modified Zannis) 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 clips as taught by Euteneuer would have yielded predictable results, namely, an alternative way to retain the implant on the deformable plate during delivery to prevent separation or disengagement of the implant (para. 0087 of Euteneuer); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claims 48-49 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Zannis in view of Mizuno, and further in view of Seiler et al. (US PGPub 2009/0209804), hereinafter known as “Seiler.”
With regards to claims 48 and 61, the combination of Zannis/Mizuno disclose the device as claimed in claim 47 and 41, respectively. The combination further discloses wherein the deformable plate (24C of Zannis) comprises at least one flat sheet of elastically deformable material (Fig. 11, para. 0087 of Zannis) with at least one angled structure at a proximal portion of the deformable plate (see annotated Fig. 17 of Mizuno above, para. 0237 of Mizuno), the device further comprising: a sleeve (12C of Zannis) slidably disposed over the shaft (26C; Fig. 10, para. 0086 of Zannis), wherein as the sleeve (12C of Zannis) translates in a distal direction relative to the shaft (26C; Figs. 10-11, para. 0067, 0086 of Zannis), the sleeve (12C of Zannis) is configured to apply pressure to the angled structure and elastically deforms the plate into the second configuration (see rejection of claim 41 above explaining the functionality of the combination).
The combination is silent to further comprising a handle at a proximal end of the shaft, wherein the deformation mechanism further includes an actuator on the handle configured to push the sleeve in the distal direction over the shaft to deform the elastically deformable plate into the second configuration (claim 48); a handle at a proximal end of the shaft; and an actuator on the handle configured to push the sleeve in the distal direction over the shaft to elastically deform the plate into the second configuration (claim 61).
However, in the same field of endeavor teaches an implant delivery device, Seiler teaches (Figs. 2A-B, para. 0037) comprising a handle 210 at a proximal end of a shaft 250 (Fig. 3, para. 0037), and an actuator 220 on the handle 210 configured to push a sleeve 240 in a distal direction 204 over the shaft 250 to retain an implant 202 (Figs. 5A-C, para. 0039).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Seiler (i.e. the handle) to the device of modified Zannis would have yielded predictable results and resulted in an improved system, namely, a system that would allow the user to single handedly translate the shaft relative to the sleeve (Figs. 5A-C, para. 0039 of Seiler) to deform the plate into the second configuration (in light of the combination with modified Zannis), thereby making the device more ergonomic and increasing the ease of use of the device (para. 0040 of Seiler). KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
With regards to claim 49, the combination discloses wherein the deformation mechanism allows a user to deliver the graft through an incision and to a surgical site holding the device with only one hand and only by the handle of the device (Figs. 2A-B, para. 0039, 0050 of Seiler).
Claims 52-57 are rejected under 35 U.S.C. 103 as being unpatentable over Zannis in view of Mizuno, and further in view of Kucklick (US PGPub 2022/0338910).
With regards to claims 52-57, the combination of Zannis/Mizuno disclose the device as claimed in claim 41. Zannis further disclose wherein the deformable plate 24C comprises at least one flat sheet of elastically deformable material (Fig. 11, para. 0088), wherein the deformable plate 24C elastically deforms along a direction perpendicular to the longitudinal direction (see transition from figure 10 to 11 – plate 24C is rolled up into a cylindrical shape in figure 10 and deforms along a direction perpendicular to the longitudinal direction to lay flat in figure 11). The combination is silent wherein the elastically deformable plate comprises at least one rigid member positioned along a longitudinal direction of the deformable plate (claim 52); wherein the at least one rigid member and the at least one retaining mechanism are monolithic with one another (claim 53); wherein the elastically deformable plate and the at least one rigid member are formed of the same material (claim 54); wherein the deformable plate, the at least one retaining mechanism, and the at least one rigid member are formed of the same material (claim 55); wherein the elastically 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 shaft (claim 56); and wherein the elastically deformable plate further comprises at least one rigid member, wherein the at least one rigid member and the at least one retaining mechanism are monolithic with one another (claim 57).
However, in the same field of endeavor of implant delivery devices, Kucklick teaches wherein the elastically deformable plate 49 comprises at least one rigid member 49A positioned along a longitudinal axis of the deformable plater 49;
wherein the at least one rigid member 49A and the at least one retaining mechanism 49X are monolithic with one another (figure 14);
wherein the elastically deformable plate 49 and the at least one rigid member 49A are formed of the same material (paragraph 5 discloses “self-deploying sheets include spring material components made of bio-absorbable material which are attached to biologic sheet-like implants”; paragraph 44 discloses “Self-deploying sheets such as sheets 49, 50, 51 and 52 include spring material components 49A, 50A, 51A and 52A. Present as a preferred option, the spring material components are made of laser or die cut Poly (D,L-lactic acid) (PLA) and/or poly (D,L-lactic-co-glycolic acid)(PLGA) biodegradable polymers or other suitable bio-absorbable material or biocompatible metal. The spring material components 49A, 50A, 51A and 52A are attached to their respective biologic sheets” – therefore both are made from the same biological material);
wherein the deformable plate 49, the at least one retaining mechanism 49X, and the at least one rigid member 49A are formed of the same material (see explanation above);
wherein the elastically deformable plate 49 comprises one or more reinforcing structures 49A inhibit deformation of the deformable plate in the longitudinal direction parallel to an axis of the shaft (Figs. 14-15, para. 0044; see note below); and
wherein the elastically deformable plate 49 further comprises at least one rigid member 49A, wherein the at least one rigid member 49A and the at least one retaining mechanism 49X are monolithic with one another (figure 14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the deformable plate of Zannis for the deformable plate of Kucklick. The difference between the prior art and the claimed invention is that Zannis does not teach a rigid member/reinforcing structure. Kucklick teaches (see Figs. 14-15) a similar deformable sheet comprising a rigid member/reinforcing structure. Accordingly, the prior art references teach that it is known that the deformable plate of Zannis and the deformable plate of Kucklick are elements that are functional equivalents for providing an implant. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the deformable plate taught by Kucklick for the deformable plate of Zannis because both elements were known equivalents for providing and would have resulted in the predictable results of providing the delivery of implants.
Note: “wherein the one or more reinforcing structures inhibit deformation of the deformable plate in the longitudinal direction parallel to an axis of the 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 resulted in the reinforcing structure of Kucklick being provided on the deformable plate of modified Zannis. Since the newly modified Zannis includes all of the structure required for the claim (i.e. the one or more reinforcing structures 49A of Kucklick in the longitudinal direction parallel to an axis of the shaft, see annotated Figs. 15-16, 19 of Kucklick, para. 0044-0045 of Kucklick) to necessitate the functional language, modified Zannis 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 41-43, 45-47, 50-51, 58-60, and 62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 9, 15, 17, and 19 of U.S. Patent No. 11,779,371 (hereinafter “Levy”) in view of Zannis.
With regards to claim 41, Levy claims an implant delivery device comprising:
a shaft (claim 1);
a deformable plate attached to a distal portion of the shaft, the deformable plate comprising a first surface and at least one retaining mechanism on the first surface configured to retain a sheet-like implant relative to the deformable plate (claim 1); and
a deformation mechanism that deforms the deformable plate between an open first configuration and a closed second configuration (claim 1).
Levy does not claim wherein the deformable plate is elastic and can be elastically deformed.
However, Zannis teaches an elastically deformable plate 24C attached to a distal portion of the shaft 26C (Figs. 10-11, para. 0072, 0085-0086),
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levy to include wherein the deformable plate is elastic as taught by Zannis for the purpose of providing further flexibility of the deformable plate.
With regards to claim 42, Levy/Zannis claim wherein the open first configuration of the elastically deformable plate is a substantially flat first configuration, and the closed second configuration of the deformable plate is a substantially cylindrical second configuration (claim 1 of Levy).
With regards to claim 43, Levy claims wherein the at least one retaining mechanism includes at least one clip (claim 19).
With regards to claim 45, Levy/Zannis claim wherein the elastically deformable plate defines at least one opening through which a surgical fastening tool can deliver an anchor or suture to the sheet- like implant carried by the plate (claim 15 of Levy).
With regards to claim 46, Levy claims further comprising a sleeve with the shaft positioned through the sleeve in a proximal and distal direction, wherein the shaft and sleeve are configured to slide in the proximal and distal direction relative to one another (claims 9 and 17 – sleeve is interpreted as the trocar in claim 17).
With regards to claim 47, Levy/Zannis claim wherein the deformation mechanism comprises the sleeve (trocar) and an at least one angled structure at a proximal end of the deformable plate wherein, when the sleeve translates in a distal direction relative to the shaft, the sleeve applies pressure to the angled structure and deforms the plate into the second configuration (claim 17 of Levy).
With regards to claim 50, Levy/Zannis claim wherein the elastically deformable plate assumes the first configuration at rest and is elastically deformed into the second configuration by the deformation mechanism (claim 5 of Levy).
With regards to claim 51, Levy/Zannis claim wherein the elastically deformable plate includes a perimeter, the perimeter defining at least one notch through which a surgical fastening tool can deliver an anchor or suture to the sheet-like implant carried by the deformable plate (claim 15 of Levy).
With regards to claim 58, Levy/Zannis claim the device of claim 41. The combination does not claim wherein the at least one retaining mechanism includes a length extending from a proximal end to a distal end, wherein the proximal end is elastically mounted to the first surface of the elastically deformable plate and the distal end is configured to elastically deform from a first position to a second position, wherein the distal end is closer to the first surface of the deformable plate in the first position than in the second position.
However, Zannis further teaches wherein the at least one retaining mechanism 44 includes a length extending from a proximal end to a distal end, wherein the proximal end is elastically mounted to the first surface of the elastically deformable plate 24C (see distal-most suture 44 where the proximal end is elastically mounted to the deformable plate 24C) and the distal end is configured to elastically deform from a first position (figure 10) to a second position (figure 11), wherein the distal end is closer to the first surface of the deformable plate 24C in the first position (figure 10) than in the second position (figure 11) (when deformable plate 24C is rolled within the sleeve 12C, the retaining mechanism 44 is closer to the first surface of the deformable plate 24C due to being tightly wound, as opposed to the second position of figure 11 where the deformable plate 24C is laid flat).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levy/Zannis to include wherein the at least one retaining mechanism includes a length extending from a proximal end to a distal end, wherein the proximal end is elastically mounted to the first surface of the elastically deformable plate and the distal end is configured to elastically deform from a first position to a second position, wherein the distal end is closer to the first surface of the deformable plate in the first position than in the second position as taught by Zannis for the purpose of elastically deforming the retaining mechanism with the deformable plate so that both elements can be utilized in sync.
With regards to claim 59, Levy/Zannis claim the device of claim 41. The combination does not claim wherein when the sheet-like implant is retained by the at least one retaining mechanism, and the elastically deformable plate is deformed into the closed second configuration, the sheet-like implant is configured to be within the interior of the closed configuration of the deformable plate.
However, Zannis further teaches wherein when the sheet-like implant 16 (functionally recited in claim 41) is retained by the at least one retaining mechanism 44, and the elastically deformable plate 24C is deformed into the closed second configuration (figure 10), the sheet-like implant 16 is configured to be within the interior of the closed configuration of the deformable plate 24C (figure 10; paragraphs 86-87).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levy/Zannis to include wherein when the sheet-like implant is retained by the at least one retaining mechanism, and the elastically deformable plate is deformed into the closed second configuration, the sheet-like implant is configured to be within the interior of the closed configuration of the deformable plate as taught by Zannis for the purpose of protecting/covering the sheet-like implant when not in use.
With regards to claim 60, Levy/Zannis claim the device of claim 41. The combination does not claim further comprising a sleeve, with the shaft positioned through the sleeve, wherein the shaft and sleeve are configured to slide in a proximal and distal direction relative to one another, wherein when the sheet-like implant is retained by the at least one retaining mechanism, and the elastically deformable plate is deformed into the closed second configuration, the deformable plate substantially inhibits contact between the sheet-like implant and the sleeve.
However, Zannis further teaches further comprising a sleeve 12C, with the shaft 26C positioned through the sleeve 12C, wherein the shaft 16C and sleeve 12C are configured to slide in a proximal and distal direction relative to one another, wherein when the sheet-like implant 16 (functionally recited in claim 41) is retained by the at least one retaining mechanism 44, and the elastically deformable plate 24C is deformed into the closed second configuration (figure 10), the deformable plate 24C substantially inhibits contact between the sheet-like implant 16 and the sleeve 12C (paragraphs 86 and 91; see Note below).
Note: The examiner notes that “substantially” under broadest reasonable interpretation is defined as “being largely by not wholly that which is specified” (see attached Merriam-Webster dictionary definition of substantial). Fig. 10 illustrates the deformable plate 24C “largely but not wholly” inhibiting contact between the graft/implant 16 and the sleeve 12C, therefore the limitation is met.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levy/Zannis to include further comprising a sleeve, with the shaft positioned through the sleeve, wherein the shaft and sleeve are configured to slide in a proximal and distal direction relative to one another, wherein when the sheet-like implant is retained by the at least one retaining mechanism, and the elastically deformable plate is deformed into the closed second configuration, the deformable plate substantially inhibits contact between the sheet-like implant and the sleeve as taught by Zannis for the purpose of actuating/deploying the deformable plate by use of reciprocal movements, and to protect the sheet-like implant from the edges of the sleeve.
With regards to claim 62, Levy/Zannis claim the device of claim 41. The combination does not claim wherein the at least one retaining mechanism is attached to the first surface of the elastically deformable plate at a proximal end and a distal end of the at least one retaining mechanism is configured to elastically deform from a first position to a second position, wherein the distal end is closer to the first surface of the deformable plate in the first position than in the second position, wherein the distal end of the at least one retaining mechanism is capable of elastically moving from the first position towards the second position to accept the sheet-like implant in between the first surface of the deformable plate and the distal end of the at least one retaining mechanism.
However, Zannis further teaches wherein the at least one retaining mechanism 44 is attached to the first surface of the elastically deformable plate 24C at a proximal end (see distal-most suture 44 where the proximal end is elastically mounted to the deformable plate 24C) and a distal end of the at least one retaining mechanism 44 is configured to elastically deform from a first position (figure 10) to a second position (figure 11), wherein the distal end is closer to the first surface of the deformable plate 24C in the first position (figure 10) than in the second position (figure 11) (when deformable plate 24C is rolled within the sleeve 12C, the retaining mechanism 44 is closer to the first surface of the deformable plate 24C due to being tightly wound, as opposed to the second position of figure 11 where the deformable plate 24C is laid flat), wherein the distal end of the at least one retaining mechanism 44 is capable of elastically moving from the first position (figure 10) towards the second position (figure 11) to accept the sheet-like implant 16 in between the first surface of the deformable plate 24C and the distal end of the at least one retaining mechanism 44.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levy/Zannis to include wherein the at least one retaining mechanism is attached to the first surface of the elastically deformable plate at a proximal end and a distal end of the at least one retaining mechanism is configured to elastically deform from a first position to a second position, wherein the distal end is closer to the first surface of the deformable plate in the first position than in the second position, wherein the distal end of the at least one retaining mechanism is capable of elastically moving from the first position towards the second position to accept the sheet-like implant in between the first surface of the deformable plate and the distal end of the at least one retaining mechanism as taught by Zannis for the purpose of elastically deforming the retaining mechanism with the deformable plate so that both elements can be utilized in sync.
Claim 44 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of U.S. Patent No. 11,779,371 (Levy) in view of Zannis, and further in view of Euteneuer.
With regards to claim 44, Levy/Zannis claim the device as claimed in claim 43. The combination does not claim wherein the at least one clip includes a first clip and a second clip, wherein the first clip and second clip are positioned at a first location and a second location, respectively, on the first surface of the elastically deformable plate, the first location and second location are on opposite sides of a longitudinal axis of the shaft and elastically deformable plate.
However, Euteneuer teaches wherein the at least one clip includes a first clip 520 and a second clip 522, wherein the first clip 520 and the second clip 522 are positioned at a first location (where 220 is in figure 12) and a second location (where 222 is in figure 12), respectively, on the first surface of the elastically deformable plate 50, the first location and second location are on opposite sides of a longitudinal axis of the shaft 230 and elastically deformable plate 50 (figures 12 and 15; paragraphs 79-83 and 87).
The substitution of one known retaining mechanism (clips as taught by Euteneuer) for another (clip as shown in Levy) 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 clips as taught by Euteneuer would have yielded predictable results, namely, an alternative way to retain the implant on the deformable plate during delivery to prevent separation or disengagement of the implant (para. 0087 of Euteneuer); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claims 48-49 and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 and 17 of U.S. Patent No. 11,779,371 (Levy) in view of Zannis, and further in view of Seiler.
With regards to claim 48, Levy/Zannis claim the device as claimed in claim 47. The combination does not claim further comprising a handle at a proximal end of the shaft, wherein the deformation mechanism further includes an actuator on the handle configured to push the sleeve in the distal direction over the shaft to deform the elastically deformable plate into the second configuration.
However, in the same field of endeavor teaches an implant delivery device, Seiler teaches (Figs. 2A-B, para. 0037) comprising a handle 210 at a proximal end of a shaft 250 (Fig. 3, para. 0037), and an actuator 220 on the handle 210 configured to push a sleeve 240 in a distal direction 204 over the shaft 250 to retain an implant 202 (Figs. 5A-C, para. 0039).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Seiler (i.e. the handle) to the device of Levy/Zannis would have yielded predictable results and resulted in an improved system, namely, a system that would allow the user to single handedly translate the shaft relative to the sleeve (Figs. 5A-C, para. 0039 of Seiler) to deform the plate into the second configuration (in light of the combination with Levy/Zannis), thereby making the device more ergonomic and increasing the ease of use of the device (para. 0040 of Seiler). KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
With regards to claim 49, the combination claims wherein the deformation mechanism allows a user to deliver the graft through an incision and to a surgical site holding the device with only one hand and only by the handle of the device (Figs. 2A-B, para. 0039, 0050 of Seiler).
With regards to claim 61, Levy/Zannis claim the device of claim 41. Levy/Zannis further claim wherein the elastically deformable plate comprises at least one angled structure at a proximal portion of the deformable plate, the device further comprising: a sleeve slidably disposed over the shaft, wherein as the sleeve translates in a distal direction relative to the shaft, the sleeve is configured to apply pressure to the angled structure and elastically deforms the plate into the second configuration (claims 1, 9 and 17 of Levy). The combination does not claim a handle at a proximal end of the shaft; and an actuator on the handle configured to push the sleeve in the distal direction over the shaft to elastically deform the plate into the second configuration.
However, in the same field of endeavor teaches an implant delivery device, Seiler teaches (Figs. 2A-B, para. 0037) comprising a handle 210 at a proximal end of a shaft 250 (Fig. 3, para. 0037), and an actuator 220 on the handle 210 configured to push the sleeve 240 in a distal direction 204 over the shaft 250 to retain an implant 202 (Figs. 5A-C, para. 0039).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Seiler (i.e. the handle) to the device of Levy/Zannis would have yielded predictable results and resulted in an improved system, namely, a system that would allow the user to single handedly translate the shaft relative to the sleeve (Figs. 5A-C, para. 0039 of Seiler) to deform the plate into the second configuration (in light of the combination with Levy/Zannis), thereby making the device more ergonomic and increasing the ease of use of the device (para. 0040 of Seiler). KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claims 52-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,779,371 (Levy) in view of Zannis, and further in view of Kucklick.
With regards to claims 52-57, the combination of Levy/Zannis claim the device as claimed in claim 41. The combination does not claim wherein the elastically deformable plate further comprises at least one flat sheet of elastically deformable material and at least one rigid member positioned along a longitudinal direction of the deformable plate, wherein the deformable plate elastically deforms along a direction perpendicular to the longitudinal direction (claim 52); wherein the at least one rigid member and the at least one retaining mechanism are monolithic with one another (claim 53); wherein the elastically deformable plate and the at least one rigid member are formed of the same material (claim 54); wherein the deformable plate, the at least one retaining mechanism, and the at least one rigid member are formed of the same material (claim 55); wherein the elastically 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 shaft (claim 56); and wherein the elastically deformable plate further comprises at least one rigid member, wherein the at least one rigid member and the at least one retaining mechanism are monolithic with one another (claim 57).
However, Kucklick teaches wherein the elastically deformable plate 49 further comprises at least one flat sheet of elastically deformable material and at least one rigid member 49A positioned along a longitudinal axis of the deformable plater 49, wherein the deformable plate 49 elastically deforms along a direction perpendicular to the longitudinal direction (see transition from figure 14 to figure 13);
wherein the at least one rigid member 49A and the at least one retaining mechanism 49X are monolithic with one another (figure 14);
wherein the elastically deformable plate 49 and the at least one rigid member 49A are formed of the same material (paragraph 5 discloses “self-deploying sheets include spring material components made of bio-absorbable material which are attached to biologic sheet-like implants”; paragraph 44 discloses “Self-deploying sheets such as sheets 49, 50, 51 and 52 include spring material components 49A, 50A, 51A and 52A. Present as a preferred option, the spring material components are made of laser or die cut Poly (D,L-lactic acid) (PLA) and/or poly (D,L-lactic-co-glycolic acid)(PLGA) biodegradable polymers or other suitable bio-absorbable material or biocompatible metal. The spring material components 49A, 50A, 51A and 52A are attached to their respective biologic sheets” – therefore both are made from the same biological material);
wherein the deformable plate 49, the at least one retaining mechanism 49X, and the at least one rigid member 49A are formed of the same material (see explanation above);
wherein the elastically deformable plate 49 comprises one or more reinforcing structures 49A inhibit deformation of the deformable plate in the longitudinal direction parallel to an axis of the shaft (Figs. 14-15, para. 0044; see note below); and
wherein the elastically deformable plate 49 further comprises at least one rigid member 49A, wherein the at least one rigid member 49A and the at least one retaining mechanism 49X are monolithic with one another (figure 14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the deformable plate of Levy/Zannis for the deformable plate of Kucklick. The difference between the prior art and the claimed invention is that Levy/Zannis does not teach a rigid member/reinforcing structure. Kucklick teaches (see Figs. 14-15) a similar deformable sheet comprising a rigid member/reinforcing structure. Accordingly, the prior art references teach that it is known that the deformable plate of Levy/Zannis and the deformable plate of Kucklick are elements that are functional equivalents for providing an implant. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the deformable plate taught by Kucklick for the deformable plate of Levy/Zannis because both elements were known equivalents for providing and would have resulted in the predictable results of providing the delivery of implants.
Note: “wherein the one or more reinforcing structures inhibit deformation of the deformable plate in the longitudinal direction parallel to an axis of the 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 resulted in the reinforcing structure of Kucklick being provided on the deformable plate of modified Zannis. Since the newly modified Levy includes all of the structure required for the claim (i.e. the one or more reinforcing structures 49A of Kucklick in the longitudinal direction parallel to an axis of the shaft, see annotated Figs. 15-16, 19 of Kucklick, para. 0044-0045 of Kucklick) to necessitate the functional language, modified Levy 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.
Claim 41-52, 56, and 58-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-6, 8-9, 13-16, 19 and 23 of copending Application No. 18/471,655 (hereinafter “Levin”) in view of Zannis.
With regards to claim 41, Levin claims an implant delivery device comprising:
a shaft (claims 1 and 23);
a deformable plate attached to a distal portion of the shaft, the deformable plate comprising a first surface and at least one retaining mechanism on the first surface configured to retain a sheet-like implant relative to the deformable plate (claims 1 and 23); and
a deformation mechanism that deforms the deformable plate between an open first configuration and a closed second configuration (claims 1 and 23).
Levin does not claim wherein the deformable plate is elastic and can be elastically deformed.
However, Zannis teaches an elastically deformable plate 24C attached to a distal portion of the shaft 26C (Figs. 10-11, para. 0072, 0085-0086),
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levin to include wherein the deformable plate is elastic as taught by Zannis for the purpose of providing further flexibility of the deformable plate.
With regards to claim 42, Levin/Zannis claim wherein the open first configuration of the elastically deformable plate is a substantially flat first configuration, and the closed second configuration of the deformable plate is a substantially cylindrical second configuration (claims 1 and 23 of Levin).
With regards to claim 43, Levin claims wherein the at least one retaining mechanism includes at least one clip (claims 1 and 23).
With regards to claim 44, Levin claims wherein the at least one clip includes a first clip and a second clip, wherein the first clip and second clip are positioned at a first location and a second location, respectively, on the first surface of the elastically deformable plate, the first location and second location are on opposite sides of a longitudinal axis of the shaft and elastically deformable plate (claims 1 and 23).
With regards to claim 45, Levin/Zannis claim wherein the elastically deformable plate defines at least one opening through which a surgical fastening tool can deliver an anchor or suture to the sheet- like implant carried by the plate (claim 3 of Levin).
With regards to claim 46, Levin claims further comprising a sleeve with the shaft positioned through the sleeve in a proximal and distal direction, wherein the shaft and sleeve are configured to slide in the proximal and distal direction relative to one another (claim 4).
With regards to claim 47, Levin claims wherein the deformation mechanism comprises the sleeve and an at least one angled structure at a proximal end of the deformable plate wherein, when the sleeve translates in a distal direction relative to the shaft, the sleeve applies pressure to the angled structure and deforms the plate into the second configuration (claims 5 and 15).
With regards to claim 48, Levin claims further comprising a handle at a proximal end of the shaft, wherein the deformation mechanism further includes an actuator on the handle configured to push the sleeve in the distal direction over the shaft to deform the elastically deformable plate into the second configuration (claims 15 and 16).
With regards to claim 49, Levin claims wherein the deformation mechanism allows a user to deliver the sheet-like implant through an incision and to a surgical site holding the device with only one hand by the handle of the device (claim 19).
With regards to claim 50, Levin/Zannis claim wherein the elastically deformable plate assumes the first configuration at rest and is elastically deformed into the second configuration by the deformation mechanism (claim 6).
With regards to claim 51, Levin claims wherein the elastically deformable plate includes a perimeter, the perimeter defining at least one notch through which a surgical fastening tool can deliver an anchor or suture to the sheet-like implant carried by the deformable plate (claim 3).
With regards to claim 52, Levin/Zannis claim the device of claim 41. The combination further claims wherein the elastically deformable plate further comprises at least one flat sheet of elastically deformable material and at least one rigid member positioned along a longitudinal direction of the deformable plate (claim 8 of Levin). The combination does not claim wherein the deformable plate elastically deforms along a direction perpendicular to the longitudinal direction.
However, Zannis further teaches wherein the deformable plate 24C elastically deforms along a direction perpendicular to the longitudinal direction (see transition from figure 10 to 11 – plate 24C is rolled up into a cylindrical shape in figure 10 and deforms along a direction perpendicular to the longitudinal direction to lay flat in figure 11).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levin/Zannis to include wherein the deformable plate elastically deforms along a direction perpendicular to the longitudinal direction as taught by Zannis for the purpose of rolling the deformable plate into a sleeve for protection.
With regards to claim 56, Levin/Zannis claim wherein the elastically 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 shaft (claim 9 of Levin).
With regards to claim 58, Levin/Zannis claim the device of claim 41. The combination does not claim wherein the at least one retaining mechanism includes a length extending from a proximal end to a distal end, wherein the proximal end is elastically mounted to the first surface of the elastically deformable plate and the distal end is configured to elastically deform from a first position to a second position, wherein the distal end is closer to the first surface of the deformable plate in the first position than in the second position.
However, Zannis further teaches wherein the at least one retaining mechanism 44 includes a length extending from a proximal end to a distal end, wherein the proximal end is elastically mounted to the first surface of the elastically deformable plate 24C (see distal-most suture 44 where the proximal end is elastically mounted to the deformable plate 24C) and the distal end is configured to elastically deform from a first position (figure 10) to a second position (figure 11), wherein the distal end is closer to the first surface of the deformable plate 24C in the first position (figure 10) than in the second position (figure 11) (when deformable plate 24C is rolled within the sleeve 12C, the retaining mechanism 44 is closer to the first surface of the deformable plate 24C due to being tightly wound, as opposed to the second position of figure 11 where the deformable plate 24C is laid flat).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levin/Zannis to include wherein the at least one retaining mechanism includes a length extending from a proximal end to a distal end, wherein the proximal end is elastically mounted to the first surface of the elastically deformable plate and the distal end is configured to elastically deform from a first position to a second position, wherein the distal end is closer to the first surface of the deformable plate in the first position than in the second position as taught by Zannis for the purpose of elastically deforming the retaining mechanism with the deformable plate so that both elements can be utilized in sync.
With regards to claim 59, Levin/Zannis claim wherein when the sheet-like implant is retained by the at least one retaining mechanism, and the elastically deformable plate is deformed into the closed second configuration, the sheet-like implant is configured to be within the interior of the closed configuration of the deformable plate (claim 13 of Levin).
With regards to claim 60, Levin/Zannis claim further comprising a sleeve, with the shaft positioned through the sleeve, wherein the shaft and sleeve are configured to slide in a proximal and distal direction relative to one another, wherein when the sheet-like implant is retained by the at least one retaining mechanism, and the elastically deformable plate is deformed into the closed second configuration, the deformable plate substantially inhibits contact between the sheet-like implant and the sleeve (claim 14 of Levin).
With regards to claim 61, Levin/Zannis claim wherein the elastically deformable plate comprises at least one angled structure at a proximal portion of the deformable plate, the device further comprising: a sleeve slidably disposed over the shaft, wherein as the sleeve translates in a distal direction relative to the shaft, the sleeve is configured to apply pressure to the angled structure and elastically deforms the plate into the second configuration; a handle at a proximal end of the shaft; and an actuator on the handle configured to push the sleeve in the distal direction over the shaft to elastically deform the plate into the second configuration (claim 15 of Levin).
With regards to claim 62, Levin/Zannis claim the device of claim 41. The combination does not claim wherein the at least one retaining mechanism is attached to the first surface of the elastically deformable plate at a proximal end and a distal end of the at least one retaining mechanism is configured to elastically deform from a first position to a second position, wherein the distal end is closer to the first surface of the deformable plate in the first position than in the second position, wherein the distal end of the at least one retaining mechanism is capable of elastically moving from the first position towards the second position to accept the sheet-like implant in between the first surface of the deformable plate and the distal end of the at least one retaining mechanism.
However, Zannis further teaches wherein the at least one retaining mechanism 44 is attached to the first surface of the elastically deformable plate 24C at a proximal end (see distal-most suture 44 where the proximal end is elastically mounted to the deformable plate 24C) and a distal end of the at least one retaining mechanism 44 is configured to elastically deform from a first position (figure 10) to a second position (figure 11), wherein the distal end is closer to the first surface of the deformable plate 24C in the first position (figure 10) than in the second position (figure 11) (when deformable plate 24C is rolled within the sleeve 12C, the retaining mechanism 44 is closer to the first surface of the deformable plate 24C due to being tightly wound, as opposed to the second position of figure 11 where the deformable plate 24C is laid flat), wherein the distal end of the at least one retaining mechanism 44 is capable of elastically moving from the first position (figure 10) towards the second position (figure 11) to accept the sheet-like implant 16 in between the first surface of the deformable plate 24C and the distal end of the at least one retaining mechanism 44.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levin/Zannis to include wherein the at least one retaining mechanism is attached to the first surface of the elastically deformable plate at a proximal end and a distal end of the at least one retaining mechanism is configured to elastically deform from a first position to a second position, wherein the distal end is closer to the first surface of the deformable plate in the first position than in the second position, wherein the distal end of the at least one retaining mechanism is capable of elastically moving from the first position towards the second position to accept the sheet-like implant in between the first surface of the deformable plate and the distal end of the at least one retaining mechanism as taught by Zannis for the purpose of elastically deforming the retaining mechanism with the deformable plate so that both elements can be utilized in sync.
Claim 53-55 and 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 18/471,655 (hereinafter “Levin”) in view of Zannis, and further in view of Kucklick.
With regards to claims 53-55 and 57, the combination of Levin/Zannis claims the device of claim 41. The combination does not claim wherein the at least one rigid member and the at least one retaining mechanism are monolithic with one another (claim 53); wherein the elastically deformable plate and the at least one rigid member are formed of the same material (claim 54); wherein the deformable plate, the at least one retaining mechanism, and the at least one rigid member are formed of the same material (claim 55); and wherein the elastically deformable plate further comprises at least one rigid member, wherein the at least one rigid member and the at least one retaining mechanism are monolithic with one another (claim 57).
However, Kucklick teaches wherein the at least one rigid member 49A and the at least one retaining mechanism 49X are monolithic with one another (figure 14);
wherein the elastically deformable plate 49 and the at least one rigid member 49A are formed of the same material (paragraph 5 discloses “self-deploying sheets include spring material components made of bio-absorbable material which are attached to biologic sheet-like implants”; paragraph 44 discloses “Self-deploying sheets such as sheets 49, 50, 51 and 52 include spring material components 49A, 50A, 51A and 52A. Present as a preferred option, the spring material components are made of laser or die cut Poly (D,L-lactic acid) (PLA) and/or poly (D,L-lactic-co-glycolic acid)(PLGA) biodegradable polymers or other suitable bio-absorbable material or biocompatible metal. The spring material components 49A, 50A, 51A and 52A are attached to their respective biologic sheets” – therefore both are made from the same biological material);
wherein the deformable plate 49, the at least one retaining mechanism 49X, and the at least one rigid member 49A are formed of the same material (see explanation above); and
wherein the elastically deformable plate 49 further comprises at least one rigid member 49A, wherein the at least one rigid member 49A and the at least one retaining mechanism 49X are monolithic with one another (figure 14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the deformable plate of Levin/Zannis for the deformable plate of Kucklick. The difference between the prior art and the claimed invention is that Levin/Zannis does not teach a rigid member/reinforcing structure. Kucklick teaches (see Figs. 14-15) a similar deformable sheet comprising a rigid member/reinforcing structure. Accordingly, the prior art references teach that it is known that the deformable plate of Levin/Zannis and the deformable plate of Kucklick are elements that are functional equivalents for providing an implant. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the deformable plate taught by Kucklick for the deformable plate of Levin/Zannis because both elements were known equivalents for providing and would have resulted in the predictable results of providing the delivery of implants.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 08/21/2026
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