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 .
Maintenance Fees
Review of the file indicates that applicant’s window for the 3.5 year maintenance fee for US Pat. No. 11,337,486 (hereinafter “the ‘486 patent”) without surcharge opened 24 May 2025 and will close 24 November 2025. Payment of the maintenance fee with surcharge begins 25 November 2025 and will close on 24 May 2026. If the last day for paying a maintenance fee with or without surcharge falls on a Saturday, Sunday, or a federal holiday within the District of Columbia, the fee plus surcharge if applicable may be paid on the next succeeding day which is not a Saturday, Sunday or federal holiday. Applicant is encouraged to ensure all payments are current and proper. See 37 CFR §1.362(d) and (e).
Recapture
Claims 1-10 are not rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984). A broadening aspect is present in the reissue which was not present in the application for patent. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
As stated in M.P.E.P. § 1412.02,
In Clement, 131 F.3d at 1468-70, 45 USPQ2d at 1164-65, the Court of Appeals for the Federal Circuit set forth a three step test for recapture analysis. In North American Container, 415 F.3d at 1349, 75 USPQ2d at 1556, the court restated this test as follows:
PNG
media_image1.png
18
19
media_image1.png
Greyscale
We apply the recapture rule as a three-step process:
(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims;
(2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and
(3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In North American Container, the court cited Pannu, 258 F.3d at 1371, 59 USPQ2d at 1600; Hester, 142 F.3d at 1482-83, 46 USPQ2d at 1649-50; and Clement, 131 F.3d at 1468, 45 USPQ2d at 1164-65 as cases that lead to, and explain the language in, the North American Container recapture test.
Step 1: Claim 1 is broader than original patent claim 1.
Amended claim 1 does not include the claim limitations of “associated with the orthodontic appliance” and “revising the proposed specification of the orthodontic appliance based in part on the target digital image” which was part of original patent claim 1.
Therefore step 1 of the three-step test is met for claims 1-10.
Step 2: Surrendered Subject Matter
A) In the prosecution of US Application 15/552,599 (hereinafter “the ‘599 application”) resulting in the ‘486 patent, applicant argued in response to the non-final rejection mailed 09/17/2019 that the prior art (US Pat. No. 10,136,966 to Reybrouck) does not teach the limitation of “forming the arch member body and an arch member coupling integral with the arch member body by removing a portion of the sheet of material to form the arch member body and the arch member coupling.” See Application No. 15/552,599, Remarks, filed 12/11/2019, pp. 6-7. After a Final Rejection mailed 01/22/2020, applicant filed an After Final Amendment and provided in their remarks that one skilled in the art would not have combined the references in order to teach “wherein forming the orthodontic appliance comprises forming the arch member body and an arch member coupling integral with the arch member body by removing a portion of a sheet of material to form the arch member body and the arch member coupling.” See Application No. 15/552,599, Remarks, filed 03/20/2020, p. 7. Applicant filed an Appeal Brief on 06/19/2020 asserting the same overall arguments as that present in their After Final remarks. The Appeal Brief also includes that since the claims at issue are method claims, the purpose of the prior art devices should be taken into consideration regarding the suitability of the combination. The Reply Brief filed by applicant 11/04/2020 asserts “that the statements in Appellant’s Brief on Appeal filed on June 19, 2020 and June 30, 2020 remain accurate and compelling. Additionally, the Reply Brief also argues the combination of Lewis and Hansen. Importantly, in the Decision on Appeal, the PTAB reversed the examiner’s rejections and stated,
PNG
media_image2.png
485
738
media_image2.png
Greyscale
Subsequent to the Decision, the examiner mailed a Notice of Allowance which stated,
PNG
media_image3.png
578
644
media_image3.png
Greyscale
The reasons for allowance noted that none of the prior art taught the “revision method as claimed;” however, none of the remarks by applicant asserted the prior art did not teach the method step of “revising the proposed specification…”
B) The claim language removed from claims 1-10, “associated with the orthodontic appliance” and “revising the proposed specification of the orthodontic appliance based in part on the target digital image,” which resulted in the broadening of claims 1-10 is not the claim language or related claim language of the surrendered subject matter by applicant.
Therefore, step 2 of the three-step test is not met for claims 1-10 and the recapture analysis ends here.
The omission of “associated with the orthodontic appliance” and “revising the proposed specification of the orthodontic appliance based in part on the target digital image” from amended claims 1-10 does not invoke impermissible recapture of surrendered subject matter. Therefore, claims 1-10 are not rejected under 35 U.S.C. 251 as indicated above.
Claim Rejections - 35 USC § 251
Original Patent
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are "for the invention disclosed in the original patent" as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application.
The presence of some disclosure (description and enablement) in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be his or her invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC 251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. at 1356. The Federal Circuit adopted the Supreme Court's explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed inventions, but not if the broader claims ‘are [] merely suggested or indicated in the original specification’ ”. Id. at 1359. The Federal Circuit further stated that although wording in 35 USC 251 was changed from “same invention” to “original patent” no change in substance was intended. Id. at 1360.
Based on Antares a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims. Like in Antares, the specification states “revising the proposed specification of the orthodontic appliance based in part on the target digital image.” See the ‘486 patent, Abstract, column 3, lines 2-3 and column 30, lines 52-54. Additionally, the specification states, “The proposed specification of the orthodontic appliance 10 can be revised based at least in part on the target digital image.” Id., column 27, lines 14-16 and 27-29. However, the specification does not disclose “wherein the proposed specification of the orthodontic appliance is based in part on the target digital image” without “revising the proposed specification.”
Therefore, claims 1-10, which are directed to “wherein the proposed specification of the orthodontic appliance is based in part on the target digital image” without “revising the proposed specification” do not satisfy the “original patent” requirement.
Claims 1-10 are rejected under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant cites to column 27, lines 8-31 in the ‘486 patent as providing support for the claim amendments. However, this portion of the specification only refers to the proposed specification of the orthodontic appliance being “revised based at least in part on the target digital image.” In short, the ‘486 patent specification only discloses revision of the proposed specification with the target digital image. The ‘486 patent specification does not support a method of providing a proposed specification of the orthodontic appliance without revising the proposed specification.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 7, and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat. No. 3,803,715 to Wallshein (hereinafter “Wallshein ‘715”) in view of US Pat. No. 3,896,549 to Wallshein (hereinafter “Wallshein ‘549”) and in further view of US Pub. No. 2002/0042038 to Miller et al. (hereinafter “Miller”).
Regarding claim 1, Wallshein ‘715 discloses an orthodontic appliance comprising: an arch member (20) comprising an arch member body (22) and an arch member coupling (24-27) integral with the body (see Figs. 2, 8 and 9), and a set of anchors (see Fig. 1), each anchor comprising an anchor coupling (16a-16d) and a base (10’-13’) adapted to connect the anchor to a surface of a tooth (see Fig. 1), wherein each arch member coupling is releasably connectable to the anchor coupling (See column 2, lines 13-16 stating “It is an additional object of the present invention to provide an orthodontic band as above described which can be easily mounted as well as removed from brackets mounted on teeth.”), and wherein the arch member body comprises a cross-sectional geometry that varies along a length of the body (see Fig. 26 having a twist that will necessarily change the cross section geometry at the section of the twist). It is considered inherently necessary that Wallshein ‘715 includes a method of specifying an orthodontic appliance since unless the appliance is specified it cannot be manufactured. Wallshein ‘715 also discloses forming the arch member body and an arch member coupling integral with the arch member body by removing a portion of a sheet of material to form the arch member coupling (see column 3, lines 18-21 stating, “Said strip includes an elongated flat middle portion suitable for having portions removed therefrom to thereby form apertures engageable with the brackets.” Wallshein ‘715 does not specifically disclose forming the arch member body by removing a portion of a sheet of material; however, Wallshein ‘549 discloses an orthodontic elastic band that also includes notches (see Figs. 1, 2, 6 and 8). Additionally, the specification at column 8, lines 28-35 stating, “While the elastic bands of the type suggested in the Figures may be manufactured in continuous strips, such bands can also be formed from the bands disclosed in the parent application. When utilized in combination with or derived from symmetrical bands, discontinuities or notches can be added by suitably punching out the same in any conventional manner along one or the other of both edges of the band.” The “parent application” is in reference to the application resulting in the Wallshein ‘715 patent. Therefore, at the time of the filing of the invention, it would have been obvious to make both the band itself and the coupling by removing a portion of the sheet of material to form the arch member body and coupling since Wallshein ‘549 a continuation of Wallshein ‘715 discloses the same invention and further discloses cutting out the notches in the later patent.
Wallshein ‘715 in view of Wallshein ‘549 meet the claim limitations as described above but fails to include providing a first digital image representing a first dental arrangement; deriving a target digital image representing a target dental arrangement, wherein at least one tooth in the target dental arrangement is in a different position from the corresponding tooth in the first dental arrangement, and wherein the proposed specification of the orthodontic appliance is based in part on the target digital image. However, this methodology is well known in the orthodontic appliance art. Specifically, Miller in Fig. 3 discloses this exact methodology. First the initial tooth arrangement is digitized. Second, the final digital data set is generated corresponding toa desired final tooth arrangement. Third multiple intermediate data sets are generated corresponding to successive tooth arrangements and finally an appliance is produced based on at least in part the final digital data set.
At the time of filing, it would have been obvious to incorporate the digital imaging, repositioning and appliance manufacturing from a final digital data set as taught by Miller into the invention of Wallshein ‘715 in view of Wallshein ‘549. The motivation would have been based on extensive knowledge in the art that digital imaging of the teeth position and manipulation of the teeth position digitally thereby resulting in a final data set in order to manufacture an orthodontic appliance is a less time consuming process than manually making molds of the patient’s teeth; moving the teeth in the mold and using plaster to finalize the teeth position and provide a final mold for the generation of an appliance.
Regarding claim 2, Wallshein ‘715 teaches wherein the arch member comprises a self-ligating arch member. See column 5, lines 12-14, stating “The elastic band 20 may be made from any elastomeric material such as rubber or plastic.” See also Fig. 6 showing that once the band is in position, no other element is required to keep the band on the anchor.
Regarding claim 3, Wallshein ‘715 further comprising removing a portion of the arch member body to provide a thickness of the body that varies along a length of the body. See column 3, lines 6-14 stating, “According to other features of the present invention, the strip may be provided with elongated edge portions having enlarged cross-sections or middle portions having an enlarged cross-section compared with the thickness of the strip. A projection may extend from one of the sides of the middle portion, said projection being configurated to be received in a channel for preventing excessive advancement of the bracket in the direction of the strip.”
Regarding claim 4, Wallshein ‘715 discloses forming a portion of the arch member body into a selected shape (see Fig. 26).
Regarding claim 5, Wallshein ‘715 discloses wherein the selected shape comprises at least one of a hook, a twist, and a step. See Fig. 26.
Regarding claim 7, Wallshein ‘715 discloses removing a portion of the sheet of material comprises cutting (punching), stamping, or etching a flat section of the sheet of material. See column 8, lines 1-10.
Regarding claim 9, both Wallshein ‘715 and Wallshein ‘549 disclose wherein the sheet of material is a single sheet of material. See Figures.
Regarding claim 10, both Wallshein ‘715 and Wallshein ‘549 disclose wherein the arch member body and the arch member coupling are integrally formed. See Figures.
Claim(s) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallshein ‘715 in view of Wallshein ‘549 in view of Miller and in further view of US Pat. No. 5,711,666 to Hanson (hereinafter “Hansen”).
Wallshein ‘715 in view of Wallshein ‘549 in view of Miller meet the claim limitations as described above but fail to teach further comprising heat-setting the arch member body and wherein the sheet of material comprises at least one of nitinol, stainless steel, nickel titanium, or beta titanium.
However, Hansen discloses at column 10 lines 21-25 stating, “[a] new family of nickel-titanium alloys has been developed that are rapidly finding use in the fabrication of arch wires, ligating and traction springs, the most important characteristic of these alloys being their extraordinarily high elasticity with corresponding resistance to overstressing and permanent deformation, as compared to the stainless steels.”
At the time of filing, it would have been obvious to one skilled in the art to substitute the plastic material as taught by Wallshein ‘715 or Wallshein ‘549 with the nickel titanium alloy as taught by Hansen. All the references are analogous in the art of orthodontic appliances; therefore, a combination is proper. Additionally, the nickel-titanium alloy can be heat set to take on a different shape and be bent in shapes not possible with other materials. Therefore, one skilled in the art would have been motivated to substitute the materials in order to enhance the performance of the arch band to have a shape memory and take on shapes not possible with other materials.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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, Eileen Lillis can be reached at 571-272-6928. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CATHERINE S WILLIAMS/Reexamination Specialist, Art Unit 3993
Conferees:
/WILLIAM V GILBERT/Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993