Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
On 4/27/26, applicant amended claims 60, 76, and 81 and canceled claim 62. Claims 60, 61, and 63-83 are pending.
Claim Objections
The claims are objected to for two reasons. First, claims 76 and 81 were amended but are still marked only as “new.” (The term 106 is now 106 in each claim, so the claims are also “amended.”) Second, applicant did not supply an explanation for these changes. See 37 CFR 1.173(c).
Election/Restrictions
Applicant’s election of Group I, a recombinant antibody, and the species in claims 62-65 in the reply filed on 4/27/26 is acknowledged. Because claim 62 is canceled, the examiner interprets this election as being the antibody of claims 63-65. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 72-83 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 66-71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/27/26.
Examination on the merits thus commences on claims 60, 61, and 63-65.
Assignee’s Consent to Reissue
The 7/8/22 consent to reissue signed by Adriana Kuiper is defective because it was neither signed by a person with apparent authority as defined in MPEP 325(V) nor clearly signed by a person authorized to act on behalf of the assignee at the time of signing. MPEP 325(V) recognizes that persons with “apparent authority” to sign on behalf of an organization include officers of that organization, e.g., its chief executive officer, president, vice-president, secretary, or treasurer. Consenter Kuiper is none of these, being designated only as “Associate Vice President of Strategy, ASU Knowledge Institute, for Arizona Board of Regents, a Body Corporate of the State of Arizona, Acting for and on Behalf of Arizona State University.” An “associate vice president” is not clearly an officer of the ASU Knowledge Institute. It is also unclear based on the wording of the “title” whether consenter Kuiper was personally authorized to act on behalf of the assignee or whether the ASU Knowledge Institute in general has this power.
This matter would be overcome by submission of a replacement consent of the assignee signed by either a person authorized to act on behalf of the assignee; an officer of the assignee; or a patent practitioner already appointed power of attorney at the time of signing.
Reissue Declaration
Claims 60, 61, and 63-65 are rejected under 35 U.S.C. 251 for lack of a defect in the original patent and lack of any error in obtaining the original patent. See MPEP 1412.01, part (I).
The reissue oath/declaration filed with this application is defective because the implied error which is relied upon to support the reissue application is not an error upon which a reissue can be based. See 37 CFR 1.175 and MPEP § 1414.
Changes to patented claims in a reissue application are limited due to the original patent requirement of 35 USC 251, as indicated in MPEP 1412.01; see particularly MPEP 1412.01, part (I), “Failure to timely file a continuing application prior to issuance of original patent”:
Where 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). In this situation, the reissue claims should be rejected under 35 U.S.C. 251 for lack of any defect in the original patent and lack of any error in obtaining the original patent.
(Emphases added.) See also MPEP 1412.01, part (II), regarding overlooked aspects:
Even though claims drawn to overlooked aspects are not subject to recapture, the failure to present such claims may not be a proper error under 35 U.S.C. 251. Specifically, where 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. See subsection I above for more information.
(Emphases added.)
In underlying application 14/388,209, applicants did not claim an antibody per se. The claims were limited to a direct current insulating gradient dielectrophoresis (DC-iGDEP) device for separating a target protein in a biological sample (claims 1-4 and 6-9) and a method of using that device to separate a target species from a sample (claims 11-16, 18, 20, 21, and 22-26). (See 9/25/14 preliminary amendment.) The examiner imposed a species-election requirement on 7/15/16 instructing applicants to select from several genera including “the antibody configurations of claim 15 or claim 16.” (Page 4.) On 10/13/16, applicant elected (among other things) “the target species of claim 16 (nanobody).” (Reply at 2.) The examiner withdrew claims 6, 8, 13-16, and 24 and examined claims 1-4, 7, 9, 11, 12, 18, 20, 21, 23, 25, and 26. (1/30/17 Office action at 2.) Prosecution proceeded, and on 11/30/17, the examiner sent a notice of allowability rejoining the withdrawn claims and allowing claims 1-4, 6-9, 11-16, 18, 20, 21, and 23-26.
Claims 60, 61, and 63-65 are drawn to antibodies per se. These claims recite an invention that lacks inventive unity with the inventions originally presented in restricted application 14/388,209. See 37 CFR 1.475(d) (multiple products); MPEP 1893.03(d); MPEP 1850(II). Neither of the independent claims required an antibody, much less the specific sequences required in the newly presented claims. No continuation application was filed to claim the antibody. As such, failure to file a continuing application to claim the antibody is not an error correctable by reissue.
Claim Rejections—35 U.S.C. 251
Claims 60, 61, and 63-65 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 defect(s) in the declaration is set forth in the discussion above in this Office action.
Specification—Sequence Listing
The sequence listing filed 4/14/13 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: SEQ ID NOs: 29 and 33.
The underlying application was filed with SEQ ID NOs: 1-27, most notably with SEQ ID NOs: 2-6 and 15 defining various antibodies to amyloid-β (Aβ) and α-synuclein. (See Figure 2 and Table 1 at column 12.) Applicant contends in the 4/14/23 remarks that some of the newly submitted SEQ ID NOs: correspond to the six complementary-determining regions (CDRs) within those antibodies:
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(Remarks at 13.) A review of the originally submitted sequences in Figure 2 reveals that this is not the case. For example, antibody A4 (SEQ ID NO: 2) shows a VH-CDR2 sequence of AIQHTGAPTTYADSVKG:
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SEQ ID NO: 29, however, is AIQHTGAPTTYADVSKG.
Similarly, SEQ ID NO: 2 shows a VL-CDR3 sequence of QQRETGPKA:
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SEQ ID NO: 33, however, is QQRETGPIL.
See appendix to Office action for alignments. These discrepancies cause SEQ ID NOs: 29 and 33 to add new matter to the disclosure.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 60 and 61 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. This is a new matter rejection.
New claim 60 allows that VH-CDR2 may comprise SEQ ID NO: 29 and that VL-CDR3 may comprise SEQ ID NO: 33. Underlying utility application 14/388,209 was filed with only 27 sequences. As discussed above with respect to the specification, SEQ ID NOs: 29 and 33 are not merely subsequences within the originally disclosed SEQ ID NOs. They represent new matter not supported by the original disclosure of the underlying ’209 application.
Conclusion
No claims are allowed. Claims 60, 61, and 63-65 are rejected.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP 1415.01.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 9,938,330 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, 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 material to patentability of the claims under consideration in this reissue application.
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.
Correspondence Information
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 on 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:
/KSO/
Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
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