Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s amendments and remarks filed 11-26-25 are acknowledged.
Claims 1, 2, 5-13, 16-18, 28, 29, 34 and 35 are pending.
Claims 1, 2, 5-11, 18 and 35 are under examination as they read on the species of bispecific single chain antibody comprising the species of anti-CD3 having the CDRs of SEQ ID NOs: 171-176; the species of anti-EGFR having the CDRs of SEQ ID NOs: 441-446; the species of anti-CD3 having VL set forth in SEQ ID NO: 179 and VH set forth in SEQ ID NO: 177; the species of anti-EGFR having VH set forth in SEQ ID NO: 381 and VL set forth in SEQ ID NO: 383; and the species of full length bispecific single chain antibody comprising SEQ ID NO: 451 = “EGFR1 HL x I2C HL.”
Additionally, claims 1, 2, 5-11, 18 and 35 are further under examination as they read on the species of bispecific single chain antibody under examination has been extended to include the species of bispecific antibody comprising the anti-CD3 having the CDRs of SEQ ID NOs: 153-158; and the species of bispecific antibody comprising the anti-CD3 having the VH set forth in SEQ ID NO: 159 and the VL set forth in SEQ ID NO: 161.
Note that the scFv of SEQ ID NO: 185, which comprises the VH and VL of SEQ ID NOs: 177 and 179 (in this order) is contained within SEQ ID NO: 451.
Note further that the anti-EGFR VH and VL of SEQ ID NOs: 381 and 383 are contained within SEQ ID NO: 451.
Claims 12, 13, 16, 17, 28, 29 and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group or species of invention, there being no allowable generic or linking claim.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The prior ODP rejections over copending Application No. 18066972 have been withdrawn in view of the valid terminal disclaimer filed by applicant.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 5-9 and 18 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11753475 (of record).
Claim 35 stands rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11753475 (of record) as applied to claims 1, 2, 5-9 and 18 above, and further in view of Zuk et al. (4,281,061), Papadopoulos et al. (US 20060099582) and Marks et al. (5,977,322)(all cited on an IDS).
Applicant argues the following at page 9-10 bridging paragraph – page 10, 5th full paragraph, emphasis in the original:
“…U.S. Patent No. 11,753,475 is a later-filed, later-expiring, patent which is not a proper reference for nonstatutory double patenting rejection of the present application. The present application could not issue as a "second, later expiring patent" within the meaning of the Federal Circuit's decision in Allergan USA v. MSN Labs. Private, 111 F.4th 1358, 1369 (Fed. Cir. 2024), and thus U.S. Patent No. 11,753,475 cannot be a "first patent" that could serve as a proper reference for a nonstatutory double patenting rejection. See also Ex Parte Baurin et al., No. APPEAL 2024-002920, 2024 WL 4921198, at *5 (P.T.A.B. Nov. 6, 2024), which found that claims from a second, later-filed patent from a separate family, which were later expiring than the claims of the application at issue, could not serve as reference claims in nonstatutory double patenting against the claims of that application.
The present application does not share a priority claim with U.S. Patent No. 11,753,475, which is from a different patent family, and which has a filing date of March 13,2014, and an expiration date of March 13, 20341.
The filing date of the present application is April 3, 2008, and the 20-year patent term of a patent issuing from the present application is estimated to be April 3, 20282. U.S. Patent No. 11,753,475 is therefore a later-filed and later-expiring patent relative to the patent that would issue from the present application. In Ex Parte Baurin, the Board found that a nonstatutory double patenting rejection could not properly be based upon later-filed, earlier-issued, later-expiring patents-the same timing arrangement as the cited patent in the present case:
... here, the Examiner is applying, as the reference claims for the
nonstatutory double patenting rejection, claims from a second, later-filed
application that was earlier-issued, but would be later expiring than claims
that would issue from the application on appeal before us.
Id. at *8.
Thus, according to the holding of Ex Parte Baurin, claims 1-3 of U.S. Patent No.
11,753,475 cannot serve as reference claims in a nonstatutory double patenting rejection against the pending claims.
Thus, both rejections on the ground of nonstatutory double patenting over claims 1-3 of U.S. Patent No. 11,753,475, and over claims 1-3 of U.S. Patent No. 11,753,475 as applied to claims 1, 2, 5-9 and 18 above, and further in view of Zuk, Papadopoulos, and Marks are overcome.”
Applicant’s argument has been considered but has not been found convincing.
In essence applicant is arguing that the claims of the ‘475 patent cannot be used as the basis for a nonstatutory double patenting rejection of the present claims because if the instant claims were to issue as a patent then said patent would be “estimated” to expire around April 3, 2028, which is prior to the expiration date of the reference ‘475 patent (March 13, 2034), and according to applicant such a fact pattern would be contrary to the Board decision of Ex Parte Baurin et al., No. APPEAL 2024-002920, 2024 WL 4921198, at *5 (P.T.A.B. Nov. 6, 2024).
Stated another way, applicant asserts that because the ‘475 patent is a later-filed and later-expiring patent relative to the patent that would issue from the present application3, the claims of the ‘475 patent are not being properly applied as a basis for a nonstatutory double patenting rejection of the present claims.
Applicant’s argument is not found convincing for several reasons set forth below.
As preliminary matter note that, in general, patent examiners must follow the guidance set forth in the MPEP as laid out in the MPEP’s Forward, “…the Manual contains instructions to examiners, and other material in the nature of information and interpretation, and outlines the current procedures which the examiners are required or authorized to follow in appropriate cases in the normal examination of a patent application and during other Office proceedings.”
In this regard, as set forth in MPEP § 804(II)(B)(emphasis added), “A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate…”
For the reasons set forth in the prior Office Action the undersigned maintains that the instant claims 1, 2, 5-9 and 18 are unpatentable over claims 1-3 of U.S. Patent No. 11753475 on the ground of nonstatutory double patenting (as is also true for claim 35 wherein claims 1-3 of the ‘475 are considered further in view of Zuk et al., Papadopoulos et al. and Marks et al.).
Furthermore, with respect to applicant’s assertion that “the 20-year patent term of a patent issuing from the present application is estimated to be April 3, 2028,” the Office cannot predict the expiration date of any patent that may issue from an application because both patent term adjustment (PTA) and patent term extension (PTE) must be calculated after issuance.
In this regard, applicant is reminded that section 1701 of the MPEP expressly indicates that Office personnel may not express an opinion regarding the expiration date of any patent. Thus, even if “the present application is not estimated to have accrued any days of patent term adjustment” as applicant asserts, the office cannot know and further will not speculate on the expiration date of a patent which may issue from the instant application, said prospective patent which may or may not expire prior to the March 13, 2034 expiration date of the ‘475 reference patent.
With respect to the applicant’s assertion that “In Ex Parte Baurin, the Board found that a nonstatutory double patenting rejection could not properly be based upon later-filed, earlier-issued, later-expiring patents- the same timing arrangement as the cited patent in the present case….Thus, according to the holding of Ex Parte Baurin, claims 1-3 of U.S. Patent No.
11,753,475 cannot serve as reference claims in a nonstatutory double patenting rejection against the pending claims” (applicant’s emphasis shown),
and further with respect to applicant’s comment regarding “the Federal Circuit’s decision in Allergan USA v. MSN Labs. Private, 111 F.4th 1358, 1369 (Fed. Cir. 2024),”
applicant is directed to the “REQUEST FOR REHEARING BY EXAMINER UNDER MPEP 1214.04,” 13 pages, which was filed 1-3-25 in U.S. Application No. 17135529 and which is publicly available at www.patentcenter.uspto.gov; hereinafter “RFR.”
The RFR was filed in response to the decision of the Patent Trial and Appeal Board which applicant points to above (“Ex Parte Baurin et al., Appeal 2024-002920, P.T.A.B. Nov. 6, 2024”), hereinafter “Ex Parte Baurin.”
Starting at page 2 and continuing through page 5, the RFR describes in detail why certain aspects of Allergan do not apply to the 17135529 application (where 17135529 is the application of Baurin et al. which was considered in Ex Parte Baurin).
For example, at page 4-5 bridging paragraph, the RFR describes how the ‘529 application and the 10882922 patent (referred to as “the ‘922” in the RFR) do not have a “common priority date” and thus, “[b]ecause a shield under Allergan applies only when a challenged patent and a reference patent have a ‘common priority date,’ Allergan does not shield the claims of the instant application from the claims of the ’922 patent.”
Similarly, the instant application and the ‘475 patent have different priority dates and by the same reasoning Allergan does not shield the claims of the instant application from the claims of the ‘475 patent.
Additionally, as described in the RFR at pages 9-12 even if a pending application is already terminally disclaimed with respect to another patent, the policy rationale for the necessity of a terminal disclaimer based on the risk of separate ownership remains and must still be addressed.
At page 9 of the RFR it is stated that, “…MPEP § 804.02(IV) indicates that a terminal disclaimer is required for ‘[e]ach one of the commonly owned conflicting nonstatutory double patenting references ... to avoid the problem of dual ownership of patents to patentably indistinct inventions in the event that the patent issuing from the application being examined ceases to be commonly owned with any one of the double patenting references that have issued or may issue as a patent.’ Based on this guidance, an applicant may not overcome multiple nonstatutory double patenting rejections by filing a terminal disclaimer over the earliest-expiring reference and then argue that no further terminal disclaimers are needed for the other reference patents or applications.”
Additionally at page 11-12 bridging paragraph the RFR states:
“With respect to USPTO guidance, MPEP 804.02(VI) explains that the enforcement provision in a terminal disclaimer filed under 37 CFR l.32l(c) is intended to address the risk of separate ownership.35 Based on this guidance, it is appropriate for an examiner to require a terminal disclaimer that will address the risk of separate ownership even where it is possible that there would be no unjustified timewise extension of the right to exclude. Therefore, even if a pending application is already terminally disclaimed with respect to another patent and thus an improper timewise extension of the patent term is unlikely, the policy rationale for the necessity of the terminal disclaimer based on the risk of separate ownership remains. The way that an examiner requires a terminal disclaimer to address the risk of separate ownership is by making a double
patenting rejection that may be overcome by filing a terminal disclaimer with the enforcement language required by 37 CFR l.32l(c)(3),”
wherein footnote 35 reads: “MPEP 804.02(VI) (explaining that the common ownership language of 37 CFR l.32l(c)(3) serves "to avoid the potential for harassment of an accused infringer by multiple parties with patents covering the same patentable invention".
In conclusion, the rejections of record over claims 1-3 of the ‘475 patent will be maintained for the reasons set forth above, including especially the reasoning of the RFR that such a rejection is necessary to avoid the problem of dual ownership of patents to patentably indistinct inventions.
No claims are allowed. However, claims 10 and 11 stand objected to as being dependent upon a rejected base claim, but would be allowable if amended to (i) an independent form including all of the limitations of the base claim and any intervening claims, and (ii) to include only the species of bispecific single chain antibody molecule currently under examination, i.e., SEQ ID NO: 451.
THIS ACTION IS MADE FINAL. 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 ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
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, Daniel E Kolker can be reached at 571-272-3181. 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.
/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
1 This expiration date takes into account the terminal disclaimer filed over the later filed, later issuing patent application, US 17,697,632, filed March 17, 2022.
2 For completeness, as of November 26, 2025, the present application is not estimated to have accrued any days of patent term adjustment.
3 In particular applicant points to an alleged conclusion in Ex Parte Baurin: “…the Board found that a nonstatutory double patenting rejection could not properly be based upon later-filed, earlier-issued, later-expiring patents-the same timing arrangement as the cited patent in the present case….”