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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 2117285, filed on May 7th, 2021.
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., claim(s) 1-10 and 13, drawn to implant device.
Group II., claim(s) 14-20, drawn to an implanting tool.
Group III., claims 22-24, drawn to method of implanting an implant device.
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-III. lack unity of invention because even though the inventions of these groups require the technical feature of a foldable implant device, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Leibinger et al. EP 0654250 A1, herein referred to as Leibinger.
Leibinger discloses an implant device (Fig 5, implant grid system 60) for treating an orbital floor fracture (Fig 1,18; Col 1, lines 28-43), wherein the implant device is foldable in a first direction between a folded state and an unfolded state (Col 1, lines 5-27), wherein in the folded state the implant device has a greater curvature in the first direction than in the unfolded state (Col 4, lines 51-Col 5, lines 12); and wherein the implant device is plastically extendible in a second direction from an unextended state to an extended state (Col 1, lines 28-43), wherein in the extended state the implant device has a longer extension in the second direction than in the unextended state (capable of this configuration); wherein the implant device is plastically extendible in the second direction to a length in the second direction equal to or greater than an aperture distance of a human maxillary sinus in an anterior-posterior direction (Col 1, lines 5-27 and Col 1, lines 28-43).
During a telephone conversation with Katheryn E. Noll on 03/04/2026 a provisional election was made 03/05/2026 traverse to prosecute the invention of group I, claims 1-10 and 13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-20 and 22-24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
Regarding claim 1, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 7, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leibinger et al. EP 0654250 A1, herein referred to as Leibinger.
Regarding claim 1, Leibinger discloses an implant device (Fig 5, implant grid system 60) for treating an orbital floor fracture (Fig 1, 18; Col 1, lines 28-43), wherein the implant device is foldable in a first direction between a folded state and an unfolded state (Col 1, lines 5-27), wherein in the folded state the implant device has a greater curvature in the first direction than in the unfolded state (Col 4, lines 51-Col 5, lines 12); and wherein the implant device is plastically extendible in a second direction from an unextended state to an extended state (Col 1, lines 28-43), wherein the second direction is preferably substantially perpendicular to the first direction (capable of claimed limitation), wherein in the extended state the implant device has a longer extension in the second direction than in the unextended state (Col 1, lines 28-43); wherein the implant device is plastically extendible in the second direction to a length in the second direction equal to or greater than an aperture distance of a human maxillary sinus in an anterior-posterior direction (Col 1, lines 5-27; Col 1, lines 28-43; Col 4,line 26 to Col 7, line 48; and Figs 1,5,7, 9,11 and 12).
Regarding claim 2, Leibinger discloses wherein the implant device (Fig 5, implant grid system 60) is extendible in the second direction to a length in the second direction 5% to 20% greater than an aperture distance of a human maxillary sinus in an anterior-posterior direction (Leibinger teaches the size of the maxillary sinus it is being placed in which, is variable depending on the individual patient see Col 1, lines 50-57).
Regarding claim 3, Leibinger discloses wherein the implant device (Fig 5, implant grid system 60) is extendible in the second direction to a length in the second direction of at least 25 mm (Leibinger teaches forming and sizing mesh desired shape see Col 1, lines 50-57).
Regarding claim 4, Leibinger discloses wherein the implant device (Fig 5, implant grid system 60) is bendable in the second direction, such that the implant device can simultaneously extend in the second direction and bend in the second direction (Col 4, line 26-51: “These areas all have different contours and shapes and thus the mesh implant that is used must be contoured for the particular area”; teaches a plurality of directions for stretch).
Regarding claim 6, Leibinger, discloses wherein the implant device (Fig 5, implant grid system 60) comprises at least one extensible portion (Fig 3, bend 46) and at least one stabilization portion (Fig 3, plate 40), wherein the at least one extensible portion is plastically extendible in the second direction to said length in the second direction equal to or greater than an aperture distance of a human maxillary sinus in an anterior-posterior direction (Col 5 lines 39-57; Fig 5; Leibinger teaches the size of the maxillary sinus it is being placed in which, is variable depending on the individual patient), and wherein the at least one stabilization portion has a reduced extensibility in the second direction compared to the at least one extensible portion (Col 8, lines 5-8; Teaches fixation of bone fragments. Therefore, providing fixation of implant based on contoured components).
Regarding claim 7, Leibinger discloses wherein the implant device comprises a first support edge (Fig 5, 43) and a second support edge (Fig 5, 61) arranged at opposed ends of the implant device in the second direction (can be configured as claimed), wherein the first and second support edges are configured for abutting against opposing sidewalls of a cavity (Col 5 lines 39-57), in particular of a human maxillary sinus, such that the implant device is held by tension against said sidewalls (Col 4, lines 26-50; implant would be tensioned as claimed after placement).
Regarding claim 8, Leibinger discloses wherein the implant device (Fig 5, implant grid system 60) is a mesh-like (Col 1, lines 1-3) device comprising at least one first mesh segment (Fig 5, left section) and at least one second mesh segment (Fig 5, right section), wherein the at least one first mesh segment is foldable in the first direction (Col 1, lines 14-25; teaches folding in at least one direction, with the rest implant in the other direction to meet implantation site needs), and wherein the at least one second mesh segment is plastically extendible in the second direction (Col. 1 lines 51-57, described as moldable; The Oxford English Dictionary defines plastically: “In a plastic manner; as a plastic substance; by molding or modelling”) .
Regarding claim 9, Leibinger disclose wherein in the unfolded state the implant device (Fig 5, implant grid system 60) has a width in the first direction equal to or smaller than an aperture distance of a human maxillary sinus in a left-right direction (Col 1, lines 5-27; Col 1, lines 28-43; Col 4, line 26 to Col 7, line 48; and Fig 1; Leibinger teaches sizing as desired, capable of meeting claimed limitation).
Regarding claim 10, Leibinger discloses wherein in the folded state the implant device (Fig 5, implant grid system 60) is wrapped around the second direction with a wrapping radius of 10 mm or less (Col. 7, lines 25-44, teaches grid unit radius of 1.25 mm, with bends of two allowing folding; folding then requiring 2-3 grid units having a total radius below 10 mm as claimed).
Regarding claim 13, wherein the implant device (Fig 5, implant grid system 60) comprises or is made of a metallic biocompatible material (Col 6, lines 44- 51).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leibinger.
Regarding claim 5, Leibinger does not explicitly disclose wherein in the unextended state the implant device has a length in the second direction 10% to 50% smaller than in the unextended state.
But in another embodiment Leibinger teaches wherein in the unextended state the implant device has a length in the second direction 10% to 50% smaller than in the unextended state (Fully capable of sizing as need for implantation site, see Col 1, lines 50-57).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the base invention of Leibinger to incorporate wherein in the unextended state the implant device has a length in the second direction 10% to 50% smaller than in the unextended state, as taught and suggested by Leiibinger in order to conform to implant site (Col. 1 lines 51-57).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571) 272-1450. The examiner can normally be reached M-F, 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.F./ /THOMAS C BARRETT/Patent Examiner, Art Unit 3774 SPE AU 3799
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