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 .
DETAILED ACTION
Status of the Claims
1. Claims 1-103 are the original claims filed on 2/13/2023. In the Preliminary Amendment of 2/13/2023, Claims 1, 8, 9, 13, 62, 73, 75, 92, 95, and 97-102 are amended, and claims 2-7, 11-12, 14-61, 63-72, 77-91, 93-94, and 103 are cancelled, and new claim 104 is added. In the Reply of 7/2/2025, claims 101-102 are canceled. In the Response of 12/22/2025, Claims 1, 8, 95-100 and 104 are amended and claims 9-10, 13, 62, 73-76 and 92 are canceled.
Applicants comments in the Response of 12/22/2025 are incongruous for some of the amended and canceled claims:
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Claims 1, 8, 95-100, and 104 are pending.
The Office Action is final.
Priority
2. USAN 18/108,961, filed 02/13/2023, is a Continuation of 16/644,585, filed 03/05/2020, now abandoned, 16/644,585, is a National Stage entry of PCT/US2018/050073, International Filing Date: 09/07/2018, PCT/US2018/ 050073 Claims Priority from Provisional Application 62/566,824, filed 10/02/2017, PCT/US2018/050073 Claims Priority from Provisional Application 62/555,110, filed 09/07/2017.
Information Disclosure Statement
3. As of 2/24/2026, a total of six (6) IDS are filed: 2/28/2024; 2/28/2024; 9/18/2024; 9/18/2024; 7/2/2025; and 7/2/2025. The initialed and dated 1449 form is considered of record.
Withdrawal of Objections
Drawings
4. The objections to drawings for Figures 37-43 because they recite the term “TriNKET”, which is a trade name or a mark used in commerce, is withdrawn. The replacement drawing sheets of 12/22/2025 rectify the deficiencies.
Specification
5. The objection to the disclosure because of informalities is withdrawn. Both clean substitute and marked-up copies of the specification are filed on 12/22/2025.
a) The specification is amended to rectify the improper use of the term, e.g., Trinket, which is a trade name or a mark used in commerce.
b) The specification is amended to include a sequence identifier for those amino acid sequences > 4 amino acids in length at [0025, 0161].
Claim Objections
6. The objection to Claims 1, 8-10, 13, 62, 73-76, 92, 95-102, and 104 because of the informalities is moot for the canceled claims and withdrawn for the pending claims.
a) Claims 1, 8-10, 13, 62, 73-76, 92, 95-102, and 104 are amended for consistency to recite the phrase “according to claim_.”
b) Claims 1, 8-10, 13, 62, 73-76, 92, 95-102, and 104 are amended for consistency to recite the phrase “The multi-specific binding protein of”.
c) Claim 98 is amended to recite the human recombinant NKG2D in an ELISA assay.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
7. The rejection of Claims 1, 8-10, 13, 62, 73-76, 92, 95-102, and 104 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is moot for the canceled claims and withdrawn for the pending claims.
a) Claims 1, 8-10, 13, 62, 73-76, 92, 95-102, and 104 are amended to delete the phrase portion of the phrase “sufficient to bind.”
b) Claims 10 and 76 are canceled.
Written Description
8. The rejection of Claims 1 and 13 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 is moot for canceled claim 13 and withdrawn for pending claim 1. The pending claims are amended to recite a multi-specific binding protein comprising (a) a VH/VL Fab that binds and activates NKG2D, (b) a VH/VL scfv that binds Nectin4, and (c) a 1st and 2nd Fc domain that together bind CD16 and that differentiates the VH/VL domain paired structures from single domain antibodies.
Rejections Withdrawn-in-Part/ Maintained-in-Part
Claim Rejections - 35 USC § 112(a)
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.
Written Description
9. The rejection of Claims
Moot for canceled claims 9-10, 13, 62, 73-76 and 92 (response of 12/22/2025) and 101-102 (reply of 7/2/2025).
Withdrawn-in-part: the pending claims are amended to recite a multi-specific binding protein comprising (a) a VH/VL Fab that binds and activates NKG2D, (b) a VH/VL scfv that binds Nectin4, and (c) a 1st and 2nd Fc domain that together bind CD16 and that differentiates the VH/VL domain paired structures from single domain antibodies.
Maintained in part: the pending claims are not defined by a structure/function correlation that meets the requirement of simultaneous (a) binding to and activating of any species of NKGD2 protein, (b) specific binding to any Nectin4 protein, and (c) binding to any CD16 protein. Where element (a) is required to bind and activate the antigen, both elements (b) and (c) are effectorless as interpreted as not required to activate the respective antigen.
A) Applicants allege sequence information of an anti- NKG2D Fab and an anti- Nectin4 scfv “is not central to the invention” but it is the “combination of components (antigen binding sites)” and “an antibody Fc domain that binds…CD16.”
Response to Arguments
AS regards element (a) the functional properties for the anti-NKG2D Fab are specific binding to any NKG2D protein and activation (agonist activity) of any NKG2D protein (claim 1), binding human and non-human primate NKG2D (claim 8), and where the protein (elements (a)-(c)) binds to NKG2D with a KD of 10 nM or weaker affinity, as measured by binding to human recombinant NKG2D in an ELISA assay (claim 98).
NKG2D agonist antibodies face significant challenges, primarily leading to the chronic activation, exhaustion, and downregulation of NKG2D receptors on NK and T cells, which ultimately impairs, rather than boosts, anti-tumor immunity. They also risk inducing severe autoimmune-like inflammation due to the overactivation of immune cells against healthy tissues (Sheppard et al (Front. Immunol. 9:1808. 13 August 2018)). Applicants have not identified the class of agonist anti-NKG2D Fab that meet the requirements under the claim interpretation set forth above.
“The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability” (citing In re Marzocchi, 439 F.2d 220, 223-24, 169 USPQ 367, 369-70 (CCPA 1971)).
“In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.”
Applicants have not identified a reasonable number of working examples comprising the combination of elements (a)-(c) with just any agonist anti-NKG2D Fab much less that meet the requirements for claim 98. Binding affinity for one component of a multispecific antibody is associated with significant caveats, as the surrounding format—such as other binding arms or linkers—can alter its behavior compared to a monospecific antibody (Rhoden et al. (JBC VOL. 291, NO. 21, pp. 11337–11347, May 20, 2016).
MPEP 2163II(a)(3)(a)(ii):
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that “only describe[d] one type of structurally similar antibodies” that “are not representative of the full variety or scope of the genus.”). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.”
As regards element (b) the functional properties for the anti-Nectin4 scfv are specific binding to any Nectin4 protein (neither agonistic or antagonistic) (claim 1), and where the protein (elements (a)-(c)) binds to NKG2D with a KD of 10 nM or weaker affinity, as measured by binding to human recombinant NKG2D in an ELISA assay (claim 98). The claims are construed as the anti-Nectin4 scfv having no signal activating potential (neither agonistic nor antagonistic). Applicants have not identified by intrinsic (original specification) or extrinsic evidence an example of anti-Nectin4 scfv that is neutral insofar as the signaling capacity.
As regards element (c) the functional properties for the paired Fc domains are binding to CD16 (claim 1), and where the protein (elements (a)-(c)) binds to NKG2D with a KD of 10 nM or weaker affinity, as measured by binding to human recombinant NKG2D in an ELISA assay (claim 98). The claims are construed as the Fc domains having no signal activating potential (neither agonistic nor antagonistic). Applicants have not identified by intrinsic (original specification/drawings) or extrinsic evidence an example of an Fc domain pair that is neutral insofar as the signaling capacity.
AS regards claim 98 and the phrase “the protein binds to NKG2D with a KD of 10 nM or weaker affinity, as measured by binding to human recombinant NKG2D in an ELISA assay” is infinite in scope. The specification demonstrates those data from ELISA assays in the figures that support a weaker affinity that is of finite scope:
[0070] FIG. 3 are line graphs demonstrating the binding affinity of NKG2D-binding domains (listed as clones) to human recombinant NKG2D in an ELISA assay. [0071] FIG. 4 are line graphs demonstrating the binding affinity of NKG2D-binding domains (listed as clones) to cynomolgus recombinant NKG2D in an ELISA assay.
[0072] FIG. 5 are line graphs demonstrating the binding affinity of NKG2D-binding domains (listed as clones) to mouse recombinant NKG2D in an ELISA assay. [0073] FIG. 6 are bar graphs demonstrating the binding of NKG2D-binding domains (listed as clones) to EL4 cells expressing human NKG2D by flow cytometry showing mean fluorescence intensity (MFI) fold over background (FOB).
[0074] FIG. 7 are bar graphs demonstrating the binding of NKG2D-binding domains (listed as clones) to EL4 cells expressing mouse NKG2D by flow cytometry showing mean fluorescence intensity (MFI) fold over background (FOB).
[0075] FIG. 8 are line graphs demonstrating specific binding affinity of NKG2D-binding domains (listed as clones) to recombinant human NKG2D-Fc by competing with natural ligand ULBP-6.
[0076] FIG. 9 are line graphs demonstrating specific binding affinity of NKG2D-binding domains (listed as clones) to recombinant human NKG2D-Fc by competing with natural ligand MICA.
[0077] FIG. 10 are line graphs demonstrating specific binding affinity of NKG2D- binding domains (listed as clones) to recombinant mouse NKG2D-Fc by competing with natural ligand Rae-1 delta.
B) Applicants allege although the experiment in Figure 19 was not performed with a protein comprising the three binding sites recited in claim 1, the experiment provides evidence suggesting that a protein that binds NKG2D and CD16 would synergistically activate an NK cell by co-stimulating NKG2D and CD16. “Applicant asserts that experimental results shown in the specification can be expanded or generalized to a protein binding Nectin4.”
Response to Arguments
Applicant asserts that experimental results shown in the specification can be expanded or generalized to a protein binding to Nectin4.
Applicants rely on attorney arguments that are not substantiated by intrinsic or extrinsic evidence that equates with the full scope of the claimed invention. MPEP 716.01 and 2145 (The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)).
Applicants state on the record that central to the invention is the “combination of components (antigen binding sites)” and “an antibody Fc domain that binds…CD16.” Applicants assert the criticality of the combination of components as the invention but they have not demonstrated synergy with the claimed invention as a whole based on only a partial structure in Figure 19. Applicants arguments are incongruous for what is actually claimed compared to what is only a partial structure of what is claimed.
It is asserted that neither the specification nor the state of art at the time of filing disclosed structural features common to the members of the genus of NKG2D, Nectin4 and CD16-targeted TriNKET constructs for reliably assigning different antigen binding site structures having specifically defined functions much less in a structural conformation and based on two TriNKET clones, which would support the premise that the inventors possessed the full scope of the claimed invention.
The rejection is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
10. The rejection of Claims 1, 8, and 95-100 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al (US 20120321626A1; 20 December 2012; IDS 2/28/2024) in view of Lopez (WO 2017/067944; filed 10/19/2016; IDS 2/28/2024) is moot for the canceled claims and maintained for the pending claims.
A) Applicants allege Zhou does not teach or suggest a protein comprising binding sites for both NKG2D and CD16, Zhou does not teach Fc domain-containing proteins, Zhou does suggest combining a NKG2D binding domain with an Fc domain or a CD16 binding domain much less combining the two with a Nectin-4 binding domain.
Applicants allege Lopez does not provide a combination system using NKG2D-Nectin4-CD16.
Response to Arguments
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
If the prior art structure is capable of performing the intended use, then it meets the claim. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combined references teach multispecific antibodies comprising a NKG2D targeting domain and a choice of CD16 (Zhou) with a Nectin4 binding domain attached to an Fc comprising CD16 (Lopez). The combined references teach treating breast cancer. The combined references teach the antibody is a multispecific antibody comprising a first antigen binding site specific for Nectin-4 (Lopez) and at least one second antigen binding site (Lpoez and Zhoe). In some embodiments, the second antigen-binding site is used for recruiting a killing mechanism such as, for example, by binding an antigen on a human effector cell or by binding a cytotoxic agent or a second therapeutic agent. As used herein, the term "effector cell" refers to an immune cell which is involved in the effector phase of an immune response, as opposed to the cognitive and activation phases of an immune response.
Applicants admission on the record is that it is not only obvious but permissible to mix the target antigens as between NKG2D and/or Nectin4 with other antigens. Applicants statement on the record:
“Applicant asserts that experimental results shown in the specification can be expanded or generalized to a protein binding to Nectin4. Example 8 of the instant specification provides a working example showing that a protein that binds NKG2D, CD16, and EpCAM is capable of increased lysis of EpCAM-expressing cells as compared to an anti-EpCAM antibody alone. See also FIG. 40-42 of the instant application. Although the example used a EpCAM binding site rather than a Nectin4 binding site, Nectin4 as a targeted tumor-associated antigen is well supported. Thus, it would have been well within the level of skill in the art to use such Nectin4 antigen binding sites in place of the EpCAM binding site in Example 8…”
The POSA could reasonably conclude that Nectin4 and NKG2D are well known targeting antigens for breast cancer treatment and that based on Applicants own comments it would have been obvious to combine them with a CD16 binding component.
B) Applicants allege the rejection is based on hindsight reasoning.
Response to Arguments
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. 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 re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
11. The provisional rejection of Claims 17/058,335 (reference application US 20210214436; IDS 2/28/2024) is moot for the canceled claims and maintained for the pending claims.
Applicants allege the instant application is a continuation of 16/644,585 having an earlier non-provisional filing date than the reference non-provisional filing date.
Response to Arguments
The instant application does not share continuity nor a restriction/speciation with the reference application 17/058,335.
Further, Applicants do not assert a patentable distinction between the claim sets. The patent term is only one of two reasons why the Office requires filing a TD.
i) Patent term
If more than one patent could be obtained on the same invention, an inventor could extend the period of exclusivity beyond what the law intends (See In re Goodman, 11 F3d. 1046, 1053 (Fed. Cir. 1993); General Foods Corp v. Studiengesellschaft Kohle MbH, 972 F.2d 1271, 1279-80 (Fed. Cir. 1992) (“The basic concept of double patenting is that the same invention cannot be patented more than once, which, if happened, would result in a second patent which would expire some time after the original patent and extend the protection timewise”). For example, and as in the present case, an inventor could apply for one patent in 2005 and a second on the same invention in 2015, thereby obtaining the equivalent of a 30 year patent. To prevent this result, the previous examiner (and the instant examiner agrees) that where the subject matter is essentially duplicative to that of the ‘185 patent, the instant claims are unpatentable in the absence of a terminal disclaimer.
ii) One patent to each invention per inventor
TDs are also required to link two cases together so that two patents to the same or a similar invention cannot be sold separately. An inventor is entitled to one patent on one invention (see In re Leonardo, 119 F.3d 960, 965 (Fed. Cir. 1997).
The double patenting rejection may be obviated by filing a terminal disclaimer in accordance with 37 CFR 1.321(d). See MPEP § 804 and § 804.02. The rejection is maintained.
12. The rejection of Claims 16/967,218 (reference application US 20210079102; IDS 2/28/2024; USPN 12384847; claims 1-20) is moot for the canceled claims and maintained for the pending claims.
Applicants allege filing a terminal disclaimer is not necessary because there would be no unjustifiable extension of patent term resulting from any claim that would grant from the instant application and citing Ex parte Baurin.
Response to Arguments
The instant application does not share continuity nor a restriction/speciation with the reference application 16/967,218 (USPN 12384847; claims 1-20).
Further, Applicants do not assert a patentable distinction between the claim sets.
The patent term is only one of two reasons why the Office requires filing a TD.
i) Patent term
If more than one patent could be obtained on the same invention, an inventor could extend the period of exclusivity beyond what the law intends (See In re Goodman, 11 F3d. 1046, 1053 (Fed. Cir. 1993); General Foods Corp v. Studiengesellschaft Kohle MbH, 972 F.2d 1271, 1279-80 (Fed. Cir. 1992) (“The basic concept of double patenting is that the same invention cannot be patented more than once, which, if happened, would result in a second patent which would expire some time after the original patent and extend the protection timewise”). For example, and as in the present case, an inventor could apply for one patent in 2005 and a second on the same invention in 2015, thereby obtaining the equivalent of a 30 year patent. To prevent this result, the previous examiner (and the instant examiner agrees) that where the subject matter is essentially duplicative to that of the ‘185 patent, the instant claims are unpatentable in the absence of a terminal disclaimer.
ii) One patent to each invention per inventor
TDs are also required to link two cases together so that two patents to the same or a similar invention cannot be sold separately. An inventor is entitled to one patent on one invention (see In re Leonardo, 119 F.3d 960, 965 (Fed. Cir. 1997).
The double patenting rejection may be obviated by filing a terminal disclaimer in accordance with 37 CFR 1.321(d). See MPEP § 804 and § 804.02. The rejection is maintained.
Finally, Ex parte Baurin is not a precedential decision.
13. The rejection of Claims 11939384 or claims 1-8 of U.S. Patent No. 12129300 in view of claims 34, 122, 127-131, 133-136, 140-148 of copending Application No. 17/058,335 (reference application US 20210214436; IDS 2/28/2024) is moot for the canceled claims and maintained for the pending claims.
Applicants allege filing a terminal disclaimer is not necessary because there would be no unjustifiable extension of patent term resulting from any claim that would grant from the instant application and citing Ex parte Baurin.
Response to Arguments
The instant application does not share continuity nor a restriction/speciation with either of the reference patents.
Further, Applicants do not assert a patentable distinction between the claim sets of the patent references to those of the instant claims.
The patent term is only one of two reasons why the Office requires filing a TD.
i) Patent term
If more than one patent could be obtained on the same invention, an inventor could extend the period of exclusivity beyond what the law intends (See In re Goodman, 11 F3d. 1046, 1053 (Fed. Cir. 1993); General Foods Corp v. Studiengesellschaft Kohle MbH, 972 F.2d 1271, 1279-80 (Fed. Cir. 1992) (“The basic concept of double patenting is that the same invention cannot be patented more than once, which, if happened, would result in a second patent which would expire some time after the original patent and extend the protection timewise”). For example, and as in the present case, an inventor could apply for one patent in 2005 and a second on the same invention in 2015, thereby obtaining the equivalent of a 30 year patent. To prevent this result, the previous examiner (and the instant examiner agrees) that where the subject matter is essentially duplicative to that of the ‘185 patent, the instant claims are unpatentable in the absence of a terminal disclaimer.
ii) One patent to each invention per inventor
TDs are also required to link two cases together so that two patents to the same or a similar invention cannot be sold separately. An inventor is entitled to one patent on one invention (see In re Leonardo, 119 F.3d 960, 965 (Fed. Cir. 1997).
The double patenting rejection may be obviated by filing a terminal disclaimer in accordance with 37 CFR 1.321(d). See MPEP § 804 and § 804.02. The rejection is maintained.
Finally, Ex parte Baurin is a non-precedential decision for a single case that does not reflect a trend in decisions by PTAB.
14. The rejection of Claims 11834506 in view of claims 34, 122, 127-131, 133-136, 140-148 of copending Application No. 17/058,335 (reference application US 20210214436; IDS 2/28/2024) is moot for the canceled claims and maintained for the pending claims.
Applicants allege the ref claims are patentably distinguishable in covering a genus of multi-specific binding proteins that bind NKG2D and any tumor-associated antigen and the claims do not recite Fab or scfv binding domains.
Response to Arguments
The references are not afforded safe harbor under 35 USC 121 where there is no overlap or shared continuity nor a restriction/speciation with the instant application.
It is permissible to consult the ref specification on the scope and meaning of a claim under Sun Pharmaceuticals. As established, the ref patent teaches Nectin4 as well as Fab and scfv structures.
That the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. See MPEP 804 II(B)(1) stating in part:
The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. V. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. If claims to the compound’s use and the compound were subject to a restriction requirement, and the compound was elected, a nonstatutory double patenting rejection may not be appropriate in a divisional application claiming the restricted compound’s use. See MPEP § 804.01. However, subject matter disclosed in the reference patent or application that does not fall within the scope of a reference claim cannot be used to support a nonstatutory double patenting rejection as this would effectively be treating the reference patent or application as prior art.
15. The provisional rejection of Claims 18/482,629 (reference application US 20240166753) in view of claims 34, 122, 127-131, 133-136, 140-148 of copending Application No. 17/058,335 (reference application US 20210214436; IDS 2/28/2024) is mot for the canceled claims and maintained for the pending claims.
Applicants allege they will consider filing a terminal disclaimer upon the otherwise allowable subject matter. The response is incomplete.
Conclusion
16. No claims are allowed.
17. 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.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643