CTNF 18/651,535 CTNF 80005 DETAILED ACTION This is a first Office Action (“Action”) on the merits in this reissue application filed 4/30/2024 on underlying U.S. Patent No. 10,639,468 (“the ‘468 patent”). Claims 1-29 are pending with claims 1-9 being originally patented and indicated as withdrawn by Applicant, and claims 10-29 are newly presented. For the reasons explained below, claims 1-9 are elected by original presentation, despite being “withdrawn” by Applicant, and claims 10-29 are withdrawn from consideration as being drawn to a non-elected invention. In this Action, claims 1-9 are rejected as explained below. Notice of Pre-AIA or AIA Status The ‘468 patent has an effective filing date of Feb. 14, 2010 1 , which is prior to March 16, 2013, thus, examination of this reissue application will be conducted using the pre-AIA first to invent provisions. All references to sections 102 and 103 of U.S.C. title 35 in this Order are pre-AIA unless otherwise stated. While the examination of the current reissue application falls under the pre-AIA first to invent provisions due to the effective filing date of the ‘468 patent, the filing date of this reissue application is on or after September 16, 2012, which subjects this application to the reissue rule changes enacted under the Leahy-Smith American Invents Act (“AIA”). See Federal Register, Vol. 77, No. 157, pg. 48820, August 16, 2012. As a result, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.75, and 3.73 are to the current provisions enacted under the AIA. See id . Terminal Disclaimer and Reissue Applications Three terminal disclaimers were filed on April 30, 2024 that appear to be duplicates of the terminal disclaimers filed and approved during prosecution of the ‘468 patent. The terminal disclaimers filed in this reissue application were not approved, however, because they list the wrong application number. It should be noted that terminal disclaimers filed in an underlying patent follow through to the reissue application and any subsequently issued reissued patent, thus, copies of the approved terminal disclaimers from the ‘468 patent’s prosecution need not be filed in this reissue application. See MPEP § 1411. Application Data Sheet The Application Data Sheet (“ADS”) is objected to because the instant reissue application (18/651,535) is not listed as being a reissue of U.S. application no. 15/650,707, now the ‘468 patent. While this reissue is a divisional of the first reissue application no. 17/736,017, it is still a reissue of the ‘468 patent. As a result, similar to the first reissue application no. 17/736,017, there should be an entry added in the ADS indicating this application is a reissue of the ‘468 patent. The other entries of the ADS are correct and should remain the same. Election/ Restriction Section 1.176(b) of 37 CFR “permits the examiner to require restriction in a reissue application between claims newly added in a reissue application and the original patent claims, where the added claims are directed to an invention which is separate and distinct from the invention(s) defined by the original patent claims.” See MPEP § 1450. Additionally, even if an underlying patent was a national stage application under 35 U.S.C. § 371, and subject to lack of unity, a reissue application is filed under 35 U.S.C. § 251 and subject to U.S. restriction practice. See MPEP § 1450. During the prosecution of the ‘468 patent, a restriction requirement was made between myriad species of treating medical disorders as covered by new application claims 118-137 filed June 3, 2016. See ‘468 Pat, Pros. History, Restriction Requirement mailed Aug. 25, 2016. The listing of the species was presented as a Markush list of medical disorders. In response, Applicant elected the species directed to the treatment of Attention Deficit Disorder (“ADD”) and Attention Deficit Hyperactivity Disorder (“ADHD”), to which the examiner agreed, and amended the independent claims to remove all other medical disorders of the Markush group except ADD and ADHD. As such, in response to the Restriction Requirement, Applicant not only elected the ADD/ADHD species but also removed the other species from the claims via the amendment, and thus only those claims covering the treatment of ADD/ADHD were examined based upon Applicant’s election and amendment. See id. , Restriction Requirement Response filed Oct. 13, 2016. Newly submitted claims 10-29 have been broadened out and now cover the more generic treatment of “a medical disorder.” Additionally, claims 1-9 are directed to a “method” and claims 10-29 are directed to a “device.” Thus, only one invention of the following inventions is allowed to be examined under 35 U.S.C. § 121, and restriction is required. 08-11 AIA I . Claim s 1-9 , drawn to a surgical method , classified in A61N 1/00 . 08-11 AIA II. Cl ai ms 10-2 9 draw n to nerv e stimulation devices, clas sified in A61N 1/18. The i nventions are independent or distinct, each from the other, because Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed could be used to perform a materially different method or process, such as placement of the device behind the ear or in the ear canal, instead of on the forehead, and treating a different disorder than ADD or ADHD. As a result, both Inventions I and II are thus subject to restriction and will not be examined in this reissue application. Since the merits of the originally presented invention (Invention I) have already been examined during prosecution of the ‘468 patent, Invention I has been constructively elected by original presentation, even though Applicant has indicated claims 1-9 as “withdrawn.” Therefore, only claims 1-9 are elected and will be examined. Accordingly, claims 10-29 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.176 and MPEP § 1450. To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, Applicant must indicate which of the subsequently added claims are readable upon the elected invention. Should Applicant traverse on the ground that the inventions are not patentably distinct, Applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. The Unelected Species If a species in a Markush grouping is elected in response to a restriction requirement and then found allowable, the MPEP allows the examiner to continue examination of the other claimed species in the Markush group. See MPEP § 803.02, subsection (III)(C)(2). These additional unelected species must still be part of the claim in the Markush grouping to be further examined. However, during the prosecution of the ‘468 patent and in response to the Restriction Requirement, Applicant amended the claims to remove the other non-elected species. In other words, because of the amendments in the ‘468 patent in response to the Restriction Requirement, the invention of the ‘468 patent was limited to only those treatments of ADD and ADHD. Claims 10-29 attempt to broaden out the elected species to now cover all species encompassed by “a medical disorder,” as claimed. The problem is that such an attempt at broadening after a restriction requirement in the underlying patent is improper in a reissue application, which is filed under 35 U.S.C. § 251. Specifically, “[w]here a restriction (or an election of species) requirement was made in an application and Applicant permitted the elected invention to issue as a patent without filing a continuing application on the non-elected invention(s) or on non-claimed subject matter distinct from the elected invention, the non-elected invention(s) and non-claimed, distinct subject matter cannot be recovered by filing a reissue application. A reissue Applicant’s failure to timely file a continuing application is not considered to be error causing a patent granted on the elected claims to be partially inoperative by reason of claiming less than the Applicant had a right to claim. Accordingly, this is not correctable by reissue of the original patent under 35 U.S.C. 251. See In re Watkinson, 900 F.2d 230, 14 USPQ2d 1407 (Fed. Cir. 1990); In re Weiler, 790 F.2d 1576, 229 USPQ 673 (Fed. Cir. 1986); In re Orita, 550 F.2d 1277, 1280, 193 USPQ 145, 148 (CCPA 1977); see also In re Mead, 581 F.2d 251, 198 USPQ 412 (CCPA 1978).” See MPEP § 1412.01, subsection II. Thus, while not examined, if Applicant presents only claims 10-29 in any subsequent amendment or reissue application stemming from the ‘468 patent, these claims will likely be rejected under 35 U.S.C. § 251 for lack of any defect in the original patent that can be corrected in a reissue application since they cover inventions/species excluded by the previous restriction requirement, were amended out of the claims, and no continuation or divisional was filed to cover these additional inventions/species. Amending the claims of the ‘468 patent during prosecution to limit them to only the ADD and ADHD species, and failure to file a divisional of the ‘468 patent covering the other species during the pendency of the application that issued as the ‘468 patent, is not a correctable error under section 251. See MPEP § 1412.01, subsections II, III. Moreover, new claims 10-29 would likely not be considered claims directed to overlooked aspects because the genus (“medical disorder”) was covered by the claims during the original prosecution of the ‘468 patent, but removed by way of an amendment in response to the Restriction Requirement to only cover the more particular species of ADD and ADHD disorders. See MPEP § 1412.01, subsection III, “Claims to separate inventions/embodiments/species that were disclosed but never covered by the claims in the original application prosecution are claims to overlooked aspects.” (Emphasis added.) While claims 10-29 are not rejected under section 251 for the reasons above because they are withdrawn from consideration, the above comments on the limitations covered by claims 10-29 are to aid Applicant in any subsequently filed response. Objection – Reissue Oath/Declaration The reissue oath/declaration filed with this application is defective for the following reasons. See 37 CFR 1.175 and MPEP § 1414. The following assumes the error is that claims 1-9 are being broadened by the addition of new claims 10-29. Under this assumption, however, there is no correctable error since new claims 10-29 are withdrawn from consideration as being directed to a separate, non-elected invention than claims 1-9, thus, only claims 1-9 remain. Since claims 1-9 are not amended, there is no corrected error present. If Applicant wishes to broaden by the addition of new claims 10-29 in this reissue application, then originally patented claims 1-9 must be canceled and not simply marked as “withdrawn.” Additionally, and as explained above, any new claims should also be directed to the elected species of treatment for ADD and ADHD. The error statement is of such a small size and is blurry that it is not legible. Therefore, the reissue oath/declaration cannot be evaluated to determine if the error statement is adequate or not. In the Remarks submitted with the Preliminary Amendment on April 30, 2024, Applicant appears to discuss what might be the purported error on pages 10-11. However, it is unclear if this is the error statement or not. Applicant is reminded that a lengthy error statement in a broadening reissue is not needed, which would help keep the error text legible on the reissue oath/declaration form. Section 1414 of the MPEP outlines the requirements of an error statement in a broadening reissue. These include: (1) checking the box that states “by reason of the patentee claiming more or less than he had the right to claim in the patent”; (2) identifying at least one originally patented claim that is being broadened; and (3) “a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid.” See MPEP §§ 1414.01, 1444. This reissue application was filed after Sept. 16, 2012, so it is not necessary to include any history of how the error was discovered, any statement on deceptive intent, or the corresponding corrective action taken. See MPEP §§ 1414, subsection II, 1414.02, subsection I. For the reasons above, the reissue oath/declaration is objected to for failing the requirements of 37 CFR 1.175. A newly executed reissue oath/declaration is required to be submitted. Claim Rejections - 35 USC § 251 The following is a quotation of 35 U.S.C. 251 that form the basis for the rejections under this section made in this Office action: (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. (b) MULTIPLE REISSUED PATENTS.— The Director may issue several reissued patents for distinct and separate parts of the thing patented, upon demand of the applicant, and upon payment of the required fee for a reissue for each of such reissued patents. (c) APPLICABILITY OF THIS TITLE.— The provisions of this title relating to applications for patent shall be applicable to applications for reissue of a patent, except that application for reissue may be made and sworn to by the assignee of the entire interest if the application does not seek to enlarge the scope of the claims of the original patent or the application for the original patent was filed by the assignee of the entire interest. (d) REISSUE PATENT ENLARGING SCOPE OF CLAIMS.—No reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent. Claims 1-9 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175. The nature of the defects in the reissue declaration are set forth in the discussion above in this Action. Amendments in Reissue Applications Amendments made during examination of a reissue application are different than amendments made during examination of a standard utility application. See 37 CFR § 1.173; see also MPEP § 1453. A few notable, but by no means the only, differences are: Throughout examination of a reissue application, amendments are always with respect to the original patent regardless of any amendments that have already been filed. See 37 CFR § 1.173(g). Deleted limitations must be shown in single brackets while newly added limitations and the entirety of newly added claims are underlined, including number and status identifier. See 37 CFR § 1.173(d). Changes to the specification must mention where in the issued patent ( i.e. , column and lines numbers) the changes are to be made and the entirety of an amended paragraph must be presented, unless canceling the paragraph. See 37 CFR § 1.173(b)(1)(i); see also MPEP § 1453, subsection V.A., Example (1). Status identifiers, after the first amendment, must indicate how many times an original patent claim has been amended during examination of the reissue application ( e.g. , “Twice Amended”, etc.). See 37 CFR § 1.173(b)(2). When claims are amended, “there must also be supplied, on pages separate from the pages containing the changes, the status ( i.e. , pending or canceled), as of the date of the amendment, of all patent claims and of all added claims, and an explanation of the support in the disclosure of the patent for the changes made to the claims.” 37 CFR § 1.173(c). Applicant Obligations 14-11-01 Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 10,639,468 is or was involved. These proceedings would include interferences, reissues, reexaminations, post-grant proceedings before the Patent Trial and Appeal Board, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04. Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. In particular, the following prior art is considered relevant to the invention of new claims 10-29 even though they are withdrawn from consideration. Applicant is strongly advised to review these references prior to filing any subsequent amendment if the scope of the invention of claims 10-29 is sought. Additionally, as noted above, the effective filing date of any claimed invention is the first application in the family that has adequate section 112, first paragraph support. For the invention of claims 10-29 this is U.S. provisional application no. 61/445,505 with a filing date of Feb. 22, 2011 . The following references are pertinent to at least the invention covered by claims 10-29. U.S. Patent Application Publication no. 2010/0198282, to Lesco L. Rogers. For example, Figs. 1, 2, and 13 show an ear insert 11 attached to out portion 13 to provide nerve stimulation to treat various medical conditions. See e.g., id. , ¶¶24, 25, 79-80, 124, 139, 148-156. U.S. Patent Application Publication no. 2005/0102006, to Whitehurst et al., describes a skull mounted nerve stimulation device to treat various medical conditions, in particular various types of headaches. See e.g., id. , ¶59, Figs. 2, 3. U.S. Patent Application Publication nos. 2011/0106220, to DeGiorgio et al., no. 2014/0081353, to Cook et al., and no. 2014/0142669, to Cook et al., all of which have much of the same description as the ‘468 patent but different overall inventive entities. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA KADING whose telephone number is (571) 270-3413. The examiner can normally be reached Monday-Friday, 8:00 AM to 5:00 PM Eastern Time. 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. /JOSHUA KADING/ Reexamination Specialist, Art Unit 3993 Conferees: /WILLIAM V GILBERT/ Reexamination Specialist, Art Unit 3993 /EILEEN D LILLIS/ SPRS, Art Unit 3993 Application/Control Number: 18/651,535 Page 2 Art Unit: 3993 Application/Control Number: 18/651,535 Page 3 Art Unit: 3993 Application/Control Number: 18/651,535 Page 4 Art Unit: 3993 Application/Control Number: 18/651,535 Page 5 Art Unit: 3993 Application/Control Number: 18/651,535 Page 6 Art Unit: 3993 Application/Control Number: 18/651,535 Page 7 Art Unit: 3993 Application/Control Number: 18/651,535 Page 8 Art Unit: 3993 Application/Control Number: 18/651,535 Page 9 Art Unit: 3993 Application/Control Number: 18/651,535 Page 10 Art Unit: 3993 Application/Control Number: 18/651,535 Page 11 Art Unit: 3993 1 The ‘468 patent claims domestic benefit to U.S. non-provisional applications (one continuation and two continuation-in-parts), an international application, and several provisional patent applications. A claim is entitled to the benefit of any of the filing dates prior to the international application filing date if they are fully supported under 35 U.S.C. § 112, first paragraph. See MPEP § 2139.01. After review of all these applications, the effective filing date of claims 1-9 is determined to be Dec. 14, 2010, the filing date of U.S. provisional application no. 61/423,011, which first supports the claimed subject matter under the first paragraph of section 112.
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