Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/16/25 has been entered. Applicant should note that the examiner for this case has changed.
Applicant’s request for an interview has been noted. (Reply at 29.) The examiner cannot accommodate this request; see 37 CFR 1.4(c) as well as MPEP 714.03(a) regarding supplemental amendments that might be filed after a reply complying with 37 CFR 1.111(b) has been submitted. Applicant should contact the examiner to arrange a time for an interview and before submitting a response to this Office action. Applicant may wish to employ the Office’s Automated Interview Request (AIR) form at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form. Use of this form immediately notifies the examiner of an interview request.
Status of Claims
This application is a reissue of US Patent 8,598,121. Patent claims 1-14 have been canceled and new claims 15-98 are presented. Claim 42 was amended in the 9/16/25 claim listing.
Independent claims 15, 17, 35, 47, 57, and 72 recite methods of treating various bone related disorders or skeletal dysplasia with CNP variants.1 Independent claim 86 recites a kit comprising the CNP variants recited in the method claims.
Withdrawn Rejection
The 9/16/25 claim listing has overcome the rejection of record under 35 U.S.C. 112, fourth paragraph. That rejection is therefore withdrawn.
Specification
The 7/30/24 amendment to the specification is objected to because it shows material to be deleted in double brackets, not single brackets as required by 37 CFR 1.173(d)(1). See MPEP 1453(I). To avoid printing delays, applicant should supply a replacement specification amendment in response to this Office action.
Claim Objections
The 9/16/25 claim listing is objected to because claim 42’s status identifier is incorrect. This new claim has been amended relative to its first presentation, so it should be annotated as (New, Amended) to reflect that fact. See MPEP 1453(V)(D). A compliant replacement claim listing is required in response to this Office action.
Application Data Sheet
The 10/19/20 application data sheet (ADS) is objected to because it does not fully account for all of the benefit claims in this reissue application’s family. The term “Continuation Reissue of” on applicant’s ADS is insufficient. The ADS should reflect the following:
This application is a CON of 15/646,822
This application is a REI of 13/466,672
The ’822 application is a CON of 14/604,262
The ’822 application is a REI of 13/466,672
The ’262 application is a REI of 13/466,672
The ’672 application is a CON of 12/784,117
The ’117 application claims benefit of provisional 61/254,563
The ’117 application claims benefit of provisional 61/180,112
Each parent application should also be accompanied by its respective filing date and status (pending, patented, expired, etc.). The amended ADS should use strikethrough and underlining to show the changes relative to the originally filed one. See 37 CFR 1.76(c)(2). A form-fillable PDF version of form AIA /14 is available online at https://www.uspto.gov/patents/apply/applying-online/form-fillable-pdfs-available.
A corrected ADS should be filed with a request for a corrected filing receipt unless accompanied by a request to take some other action, such as a request under 37 CFR 1.48, a request under 37 CFR 1.46(c), or the submission of a power of attorney. See MPEP 601.05(a)(II).
Claim Rejections - 35 USC § 251
Claims 15-98 remain rejected under 35 U.S.C. 251 for lack of defect in the original patent and lack any error in obtaining the original patent. See MPEP 1412.01(I).
Independent claims 15, 17, 35, 47, 57, 72 and claims depending from these independent claims recite methods of treating various bone related disorders and skeletal dysplasias2 by administering to the subject a CNP variant selected from the group consisting of
(i) CNP 18-52 variants of SEQ ID Nos: 145, 146-160, 60, 161-178, 182, 186, 192, 75, 181, 191, 144, 183, 188, 193, 36, 184, 189, 194; CNP-37 variants of SEQ ID Nos: 182-191; CNP-27 variants of SEQ ID NO: 144, 183, 188, 193, 36, 184, 189, 194;
(ii) a macromolecule comprising a CNP variant of (i) and a synthetic polymeric group coupled to CNP variant through a hydrolysable linkage; or
(iii) a sustained CNP variant release formulation comprising a CNP variant of (i) coupled to a synthetic polymer group through a hydrolysable linkage.
Independent claim 86 recites a kit comprising a CNP variant as in claim 15.
During the prosecution3 of application 13/466,672, in view of restriction requirement applicants elected group I invention to a variant CNP (claims 1-4, 30, 45 and 46) and Pro-CNP-53 sequence of SEQ ID NO: 185 as species to examine in the application. The non-elected and withdrawn variants of CNP18-52 of SEQ ID Nos: 146-178, 60, 75, 144, 183, 188, 193, 184, 189 and 194, and the non-elected inventions of groups III (claim 9- a method of treating a vascular smooth muscle disorder) and group V (claims 39 and 41- a method of treating a CNP-responsive condition or disorder) were canceled (see Notice of Allowance mailed on 7/30/2013).
In the US 8,598,121 Patent, claims reciting the variants of CNP-53 of SEQ ID Nos: 179, 185, 190 and 180, and a method of treating a bone-related disorder or skeletal dysplasia by administering the CNP-53 variants were issued.
Pursuant to MPEP 1412.01.II, the failure to file a continuation application of 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.
In this reissue amended claims 15-98 include CNP-variants which correspond to the non-elected withdrawn CNP variant (species) sequences of SEQ ID Nos: 145-178, 60, 182, 186, 192, 75, 181, 191, 144, 183, 188, 193, 36, 184, 189 and 194 of the `672 application.
A review of the record indicates that Patentee failed to file a continuing application of the non-elected withdrawn invention in response to the restriction requirement issued in the `672 application. The failure to file a continuing application is not considered to be error causing a patent granted on the elected claims to be partially inoperative by claiming less than applicant had a right to claim. Accordingly, this is not correctable by reissue of the original patent under 35 U.S.C. 251 (See MPEP 1412.01 citing In re Orita, 550 F.2d 1277, 1280, 193 USPQ 145, 148 (C.C.P.A. 1977)). In this reissue the presentation of new claims 15-98 reciting the nonelected CNP variant (species) sequences of SEQ ID Nos: 145-178, 60, 182, 186, 192, 75, 181, 191, 144, 183, 188, 193, 36, 184, 189, and 194 is precluded under 35 USC 251. Thus, claims 15-98 are rejected under 35 USC 251.
Response to Arguments
Applicant contends that In re Doyle, 293 F.3d 1355 (Fed. Cir. 2002), not In re Orita, 550 F.2d 1277 (1977), controls this prosecution. According to applicant, In re Doyle permits reissue claims “if they are not substantially similar to the original claims.” (Reply at 30.) Applicant writes, “The Examiner continues to conflate the election of species with the actual election of invention during prosecution of the [underlying] application.” (Reply at 31.) Applicant submits that “[n]one of the [presently claimed] methods or kits were presented in the [underlying] restriction requirement in the manner in which they are claimed herein.” (Reply at 31.) Applicant alleges that “the pending claims were not asserted in and are not substantially similar to the original application” and contends that the examiner indicated that the claims “are within the scope of the previous method claims in the [underlying] ’121 patent.” (Reply at 32.) The arguments have been fully considered but are not convincing of error.
The facts of In re Doyle are inapposite to the facts here. In that case, reissue was requested on so-called “linking claims,” “claims broad enough to read on—or link—two or more groups subject to a restriction requirement.” Id. at 1358. Critical to the court’s analysis in that case, the reissue claims were “genus claims that read on, but are broader than, the species claims found in the issued . . . patent.” Id. Furthermore, the court relied on the fact that the reissue claims could have been prosecuted with the claims of the elected invention, unlike the situation in Orita. Id. at 1360.
Claims 15-98 are not linking claims because they do not contain any of the species recited in the underlying ’121 patent’s claims—SEQ ID NOs: 179, 180, 185, and 190. See MPEP 809 (linking claims); see also MPEP 1412.01(II) (describing the holding of Doyle with respect to linking claims in reissue). The reissue claims may be broader than the patent claims in the sense of reissue broadening, but they do not “read on” the patented species. MPEP 1412.03 instructs, “A claim of a reissue application enlarges the scope of the claims of the patent if it is broader in at least one respect, even though it may be narrower in other respects.” In contrast, a linking claim arises when
an application has claims to two or more properly divisible inventions, so that a requirement to restrict the claims of the application to one would be proper, but presented in the same case are one or more claims . . . which, if allowable, would require rejoinder of the otherwise divisible inventions.
MPEP 809; see also Doyle, 293 F.3d at 1360 (“[the reissue] claims are genus claims, whereas the nonelected claims are species that fall within the new genus claims”). The new claims are not linking claims, so Doyle does not apply.
Furthermore, claims 15-98 could also not have been prosecuted with the elected invention and species of the underlying ’121 patent because the provisions of 35 U.S.C. 121 applied with respect to both the group (invention) and species elections. Applicant elected both the invention and the species without traverse. (See 4/12/13 reply to restriction in application 13/466,672.) Applicant also agreed to cancel the nonelected inventions and species during the prosecution of the underlying application. (See 7/30/13 examiner’s amendment in ’672 application at pages 3-4.) At that point, applicant should have pursued the nonelected species and inventions in a divisional application.
Contrary to applicant’s suggestion otherwise, nonelected species are a type of nonelected invention. See MPEP 821 (referring to “nonelected inventions, including claims drawn to nonelected species or inventions that may be eligible for rejoinder”). As such, a species elected without traverse must be treated for reissue in the same way as an invention elected without traverse; applicant has provided no basis for distinguishing species election from invention election in the context of reissue. It is not disputed that new claims 15-98 recite species that are not those allowed in the underlying ’121 patent, so 35 U.S.C. 121 would have barred their presentation in the prosecution of that patent.
The facts within this reissue closely parallel those in In re Weiler, 790 F.2d 1576 (Fed. Cir. 1986). In that case, the reissue claims recited a separate invention from the issued claims or any nonelected claims. Id. at 1581 (discussed in Doyle, 293 F.3d at 1362-63). Here, the reissue claims recite separate species (which are a type of invention) from the issued ’121 claims. They were subject to the original restriction requirement, so applicants were required to submit them in a divisional application. See Doyle, 293 F.3d at 1362 (discussing Weiler). Consistent with the Orita court’s observation, permitting the presentation of non-elected inventions and species in this reissue would cause 35 U.S.C. 120’s copendency requirement to “become meaningless, for should an applicant fail to file a divisional application while maintaining copendency as required by section 120, he could simply revert to section 251 to cure his mistake.” See 550 F.2d at 1281. Applicant has not demonstrated that there was a mistake in the prosecution of the underlying patent, and reissue cannot cure a failure to file a divisional application on the nonelected species and inventions.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORA E BARNHART DRISCOLL, whose telephone number is (571)272-1928. The examiner can normally be reached M-F 7:00-4:00 p.m. 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, Patricia Engle, can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lora E Barnhart Driscoll/Patent Reexamination Specialist, Art Unit 3991
Conferees:
/Padmashri Ponnaluri/
Patent Reexamination Specialist, CRU 3991
/Patricia L Engle/SPRS, Art Unit 3991
1 Increasing growth velocity (claim 15), increasing or promoting endochondral bone ossification (claim 16), bone related disorder or skeletal dysplasia (claim 17), increasing long bone growth (claims 35, 47), increasing height (claim 57), increasing proliferation and differentiation of chondrocytes (claim 72).
2 The claimed methods of increasing growth velocity, increasing or promoting endochondral bone ossification, bone related disorder or skeletal dysplasia, increasing long bone growth, increasing height, increasing proliferation and differentiation of chondrocytes are all related to bone-related disorders and skeletal dysplasia (genetic disorder) (see col.2:44-63; col.81:49-col.82:14 of the `121 patent).
3 See prosecution history of 13/466,672 including the restriction requirement (2/13/2013), Applicants response (4/12/2013) with election of group I invention and Pro-CNP53 (SEQ ID NO: 185) as species without traverse, and Notice of Allowance (7/30/2013) including rejoinder of group II (a method of treating a bone-related disorder or skeletal dysplasia) with the allowable CNP-53 variants of SEQ ID Nos: 185, 179, 190 and 180; and cancellation of non-elected claims to other CNP variants); and Examiner’s amendment of claims 1, 10, and 30 to include only the elected species of CNP-53 variants.