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 .
Applicant’s remarks filed 1-28-26 are acknowledged.
Claims 87, 89, 90, 92-94, 96-109 are pending.
Claims 87, 89, 90, 92-94, 96-105, 107 and 108 are under examination as they read on treating or ameliorating the species of disease which is “cancer,” and the sub-species of cancer which is “lymphoma;” and as they read on the species of administered polypeptide comprising a:
“a first anti-TCR ISV comprising the CDRs of SEQ ID NOs: 123, 153 and 170”; “a second ISV that binds a tumor associated antigen, wherein the sub-species of second ISV that binds a TAA “binds CD20” or “binds GPC3” or “binds HGF;”
and “a fourth ISV that binds serum albumin.”
Claims 106 and 109 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group or species of invention, there being no allowable generic or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. Election was made without traverse in the reply filed on 9-11-23.
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 87, 89, 92, 104 and 107 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27 and 28 of U.S. Patent No. 11932702, essentially for the reasons of record set forth in the Non-Final Office Action mailed 10-28-25.
Claims 87, 89, 92, 93, 104 and 107 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 and 19 of copending Application No. 18267257 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims, essentially for the reasons of record set forth in the Non-Final Office Action mailed 10-28-25.
Claims 87, 89, 90, 92, 94, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105 and 107 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27 and 28 of U.S. Patent No. 11932702 as applied to claims 87, 89, 92, 104 and 107 above, and further in view of Kolkman et al. (WO2013110531) as evidenced by Zhang et al. (Tumor Biol. (2016) 37:7741–7748, published online 22 December 2015), essentially for the reasons of record set forth in the Non-Final Office Action mailed 10-28-25.
Applicant argues the rejections should be withdrawn for various reasons.
In part A, applicant continues to assert that “the material facts of the instant case are the same as those at issue in Ex parte Baurin et al., in which the Board held that the asserted references were not proper nonstatutory double patenting (NSDP) References and overturned the asserted NSDP rejections in view of these references.”
Applicant newly asserts that “On December 18, 2025, the Board issued a Decision on Request for Rehearing with respect to Ex parte Baurin et al. in which the Board denied the Request for Rehearing by Examiner. See Ex parte Baurin et al., Decision on Request for Rehearing, pages 23-24,” and describes how “The Board reaffirmed that the asserted references were not proper NSDP References and that the asserted NSDP rejections were improper. See id.”
Applicant also points to the Board decision of Ex parte Mates et al., Appeal 2025-001500 (P.T.A.B. Dec. 23, 2025) “…which further supports that these rejections should be reversed. In Ex parte Mates et al., the Board held that the asserted references were not proper NSDP References and overturned the asserted NSDP rejections in view of these references.”
With respect to the decision of Ex parte Mates et al., applicant asserts:
“The Board in Ex parte Mates et al. found that each of the asserted references is a later filed application/patent (i.e., has a later patent term filing date relative to the application at issue)…”;
“The Board held that the asserted references were not proper NSDP References based on the comparisons of patent-term filing dates (and rough expiration dates based on the patent-term filing dates) and overturned the asserted NSDP rejections in view of these references.”;
“In the instant case, each of the asserted references (i.e., the '702 Patent and the '257 Application) has a later patent-term filing date relative to the application at issue.”; therefore,
“…the asserted references [in this case] are not proper NSDP References.”
Applicant’s arguments are acknowledged; however the cases that applicant points to (Ex parte Baurin; Ex parte Mates) were not precedential Board decisions and therefore are not binding. As set forth in the prior Office Action, the undersigned receives his guidance from the MPEP (see page 3-4 bridging paragraph of the prior Office Action) and maintains that the MPEP continues to advise that the fact pattern of this case wherein a reference patent / a reference patent application, each having patent term filing dates subsequent to the patent term filing date of instant application, and each reciting reference claims which anticipate one or more of the instant claims, is a situation where nonstatutory double patenting rejection is appropriate.
In part B, with respect to the guidance set forth in the MPEP § 804 applicant argues that the first step in examiner should follow is a “threshold inquiry”:
“M.P.E.P. guidance makes clear that a threshold inquiry of whether a reference qualifies
as a NSDP Reference must be made, and if the reference does not qualify as a NSDP Reference,
the inquiry ends. For example, M.P.E.P. § 804 states that:
Some commonality of inventorship or (deemed) ownership must exist between two or more patents or applications before consideration can be given to the issue of double patenting ... Alternatively, the patents or applications may have a common applicant, and/or be commonly assigned/owned or non-commonly assigned/owned but subject to a joint research agreement as set forth in 35 U.S.C. 102(c) or in pre-AIA 35 U.S.C. 103(c)(2) and (3).
(Emphasis added). Comparing inventorship, ownership, and applicants is one aspect of
determining whether a reference qualifies as a NSDP reference. M.P.E.P. § 804.01 also makes
clear that proper divisional applications (and corresponding patents) do not qualify as NSDP
References (i.e., the patentable distinctiveness of the claims at issue need not be determined).
Moreover, M.P.E.P. § 804 states that "[when] the inventor/applicant/patent owner has already
secured the issuance of a first patent, the examiner must determine whether the grant of a second
patent would give rise to an unjustified extension of the rights granted in the first patent."
(Emphasis added). Although M.P.E.P. § 804 does not expressly state that this determination relates to an analysis of whether a reference qualifies as an NSDP Reference, what other purpose
could such a determination serve?....”
Applicant then goes on to discuss “the Decision on Request for Rehearing in Ex parte Baurin et al., the Board stated that ‘[t]he Federal Circuit has made clear that in making a rejection based on ODP, not only must a determination of whether claims are patentably indistinct be made, but a determination of whether the reference claims are 'proper ODP reference' claims needs to also be made.’ (citing to Allergan, 111 F.4th, at 1369)). See page 11. The Board also emphasized that ‘our reviewing court in Allergan made clear that both effective filing dates and expiration dates are to be considered in determining whether claims are proper reference patents.’ Id., page 3.”
Applicant’s arguments are acknowledged; however, as stated above the Ex parte Baurin decision was not precedential and therefore is not binding in this case. With respect to applicant’s speculation that because “M.P.E.P. § 804 does not expressly state that this determination ["[when] the inventor/applicant/patent owner has already secured the issuance of a first patent, the examiner must determine whether the grant of a second patent would give rise to an unjustified extension of the rights granted in the first patent."] relates to an analysis of whether a reference qualifies as an NSDP Reference, what other purpose could such a determination serve?,” the undersigned disagrees with applicant’s reading of this section of the MPEP.
Section of the MPEP § 804(I)(A) reads as follows (emphasis added):
“Double patenting may exist between an issued patent and an application which share the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee. See In re Hubbell, 709 F.3d 1140, 1146-47, 106 USPQ2d 1032, 1037-38 (Fed. Cir. 2013) (in the context of an application and a patent that had two common joint inventors, but different inventive entities and no common owners or assignees, the court held that complete identity of ownership or inventive entities is not a prerequisite to a nonstatutory double patenting rejection). Double patenting may also exist where the inventions claimed in a patent and an application were made as a result of activities undertaken within the scope of a joint research agreement as defined in 35 U.S.C. 102(c) or pre-AIA 35 U.S.C. 103(c)(2) and (3). Since the inventor/applicant/patent owner has already secured the issuance of a first patent, the examiner must determine whether the grant of a second patent would give rise to an unjustified extension of the rights granted in the first patent.”
It is unclear to the undersigned what exactly is meant by the phrase highlighted above. The MPEP does not provide any further explanation for what exactly is meant by this sentence, e.g., was it written to explain something about how to interpret double patenting issues that may arise between issued patent(s) and an application in the instance where the issued patent includes a joint research agreement that establishes a contract, grant, or cooperative agreement between the issued patent and the application under consideration? (which is not the case here).
In part C, applicant argues “In Allergan, the Federal Circuit made clear that the fundamental purpose of the NSDP doctrine "is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter…. The Federal Circuit did not state or suggest that the standard in Allergan - for
determining whether a reference qualifies as an NSDP Reference - is so limited as asserted by
the Examiner. Indeed, there is no reason why the fundamental purpose of the NSDP doctrine
would serve as the guiding principle for determining whether a reference qualifies as an NSDP
Reference only in the factual context of Allergan…. As such, the Examiner's assertion that Allergan's standard for determining whether a reference qualifies as an NSDP Reference is not applicable to the instant case is unsupported."
The undersigned disagrees with applicant’s argument for the reasons of record and notes that the Decision set forth in the “DECISION ON REQUEST FOR REHEARING” posted to 17135529 (the application of Baurin et al. which was considered in Ex Parte Baurin) was not a precedential opinion.
In part D, applicant argues “Applicant previously explained that the references cited in (1)-(3) (i.e., the '702 Patent and the '257 Application) do not qualify as NSDP References to the instant application because each reference has a later patent term filing date compared to the instant application.” The undersigned disagrees with applicant’s argument for the reasons of record at set forth in the Non-Final rejection of 10-28-25 at page 3-4 bridging paragraph – page 5. Likewise, in parts E, F, G and H applicant appears to repeat various arguments that were “previously explained” and the undersigned disagrees with applicant’s argument for the reasons of record at set forth in the Non-Final rejection of 10-28-25.
Claim 108 is allowed.
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, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644