DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
1) Acknowledgment is made of Applicants’ preliminary amendment filed 06/22/23.
Election
2) Acknowledgment is made of Applicants’ election filed 04/08/26 in response to the restriction and the species election requirement mailed 02/25/26. Applicants have elected, without traverse, invention I, and the CD40-specific 12E12 antibody species comprising SEQ ID NO: 3 as CDR1H, SEQ ID NO: 4 as CDR2H, SEQ ID NO: 5 as CDR3H, SEQ ID NO: 6 as CDR1L, SEQ ID NO: 7 as CDR2L, and SEQ ID NO: 8 as CDR3L, wherein the heavy chain of the antibody is fused or conjugated to the VS4 polypeptide and the light chain is not conjugated or fused; and the FlexV1 linker species.
Status of Claims
3) Claims 1-25 have been canceled via the preliminary amendment filed 06/22/23.
New claims 26-46 have been added via the preliminary amendment filed 06/22/23.
Claims 26-46 are pending.
Claims 36-38, 41-44 and 46 are withdrawn from consideration as being directed to a non-elected invention or species. See 37 CFR 1.142(b) and M.P.E.P § 821.03.
Claims 26-35, 39, 40 and 45 are examined on the merits.
Information Disclosure Statements
4) Acknowledgment is made of Applicants’ Information Disclosure Statements filed 10/16/23 and 01/08/26. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Sequence Listing
5) Acknowledgment is made of Applicants’ Sequence Listing which has been entered on 06/22/23.
Drawings
6) Acknowledgment is made of Applicants’ drawings filed 06/22/23.
Priority
7) The instant AIA application, filed 06/22/23, is the national stage application filed under 35 U.S.C § 371 of PCT/EP2021/087211 filed 12/22/2021, which claims priority to the European application 20306668.3 filed 12/23/2020. A certified copy of the foreign priority document is of record.
Oath/Declaration
8) The instant application has new claims filed with the application. The new claim 40 reciting “the cohesion” fusion protein contains new subject matter relative to the prior application(s) to which priority is claimed. A new oath or declaration along with the surcharge set forth in 37 CFR 1.16(f) re-designating the application as a continuation-in-part application is needed.
Objection(s) to Specification & Claim(s)
9) The specification is objected to for the following reason(s):
(a) MPEP 601.01 (g) states: "if the drawings show Figures 1A, 1B, and 1C and the brief description of the drawings refers only to Figure 1, this is an error in the specification which must be corrected."
Figure 1 has two panels 1A and 1B and Figure 3 has 3 panels 3A, 3B and 3C, yet these Figures are not properly referred to. The limitation “Figure-1” at the beginning of line 22 of page 28 should be replaced with --Figures 1A and 1B-- and the limitation at the beginning of line 32 of page 28 should be replaced with --Figures 3A, 3B and 1C--. References to these Figures throughout the specification should be amended accordingly.
(b) The section “FIGURES” at line 21 of page 28 of the specification should be replaced with ‘Brief Description of the Drawings’. See 37 C.F.R 1.74.
(c) 37 C.F.R 1.75(d)(1) provides, in part, that ‘the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.’ The term or limitation in new claim 40 “the cohesion” fusion protein lacks antecedent basis in the as-filed specification and/or in the original claims.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ), First Paragraph
10) The following is a quotation 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 35 U.S.C. § 112 (pre-AIA ), first paragraph:
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 the invention.
11) Claims 26-35, 39, 40 and 45 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The purpose of the written description requirement is “to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.” In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicant has demonstrated possession of the full scope of the claimed invention at the time of the invention. In the instant application, an analysis of the scope of the claims and of the antibody genus and the genus of VS4 polypeptide variants having at least 80% identity with the amino acid sequence that ranges from the amino acid residue at position 282 to the amino acid residue at position 358 in SEQ ID NO: 1 indicates the following.
Claim 26 is representative of the claimed invention. Claim 26 is drawn to an antibody directed against a surface antigen of an antigen-presenting cell, wherein the heavy chain is conjugated to or fused to a VS4 polypeptide having at least 80% identity with the amino acid sequence that ranges from the amino acid residue at position 282 to the amino acid residue at position 358 in SEQ ID NO: 1. The antibody is specific for CD40 as claimed in claim 30, The antibody is a CD40 agonist antibody as claimed in claim 33. The antibody claimed in claim 40 is required to comprise a heavy chain conjugated via a dockerin domain to “the cohesion” fusion protein, yet what precisely is “the cohesion” fusion protein, structure-wise and scope-wise, is not disclosed. The elected antibody species is the 12E12 antibody as claimed in lines 1-12 of claim 31 that is specific to CD40. The top of pages 17 and 18 of the as-filed specification refers to the mAb 6 as [12E12] comprising the SEQ ID NO: 30 VH amino acid sequence and the SEQ ID NO: 31 VL amino acid sequence. However, the broadly claimed antibody represents a very huge genus of antibodies encompassing limitless antibody species of variable structure or CDRs of variable structure, each directed against a huge genus of structurally divergent surface antigens of numerous structurally diverse antigen-presenting cells. Likewise, “a VS4 polypeptide ......” as claimed is a huge genus encompassing a very large number of VS4 polypeptide variant species having up to 20% non-identity with the amino acid sequence that ranges from the amino acid residue at position 282 to the amino acid residue at position 358 in SEQ ID NO: 1. The number and variety of antibody species and of VS4 polypeptide variant species encompassed within the scope of instant claims are huge. The antibody as claimed in claim 28 is a chimeric mouse/human antibody or a humanized antibody which is also a genus. Both the antibody genus and the VS4 polypeptide genus are the essential components of the claimed product. The claimed antibody genus wherein the heavy chain is conjugated or fused to the claimed VS4 polypeptide genus encompassing up to 20% non-identical variants is required to have CD40 immunospecificity and is required to be a “vaccine” composition. See claims 30 and 45. The ‘vaccine’ ‘must by definition trigger an immunoprotective response in the host vaccinated; a mere antigenic response is not enough’. In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). However, at the time of the invention, Applicants were not in possession of the full breadth of each of the variable genus identified supra and the full scope of the claimed invention.
Whether or not one of skill in the art would recognize that Applicant was in possession of the claimed invention as a whole at the time of invention is to be determined upon considering the actual reduction to practice, sufficient relevant identifying characteristics, disclosure of drawings or structural chemical formulas, method of making the claimed invention, level of skill and knowledge in the art, and predictability in the art. Under the written description provision of the 35 U.S.C § 112(a) or pre-AIA , first paragraph, the structure of a representative number and variety of the encompassed structurally highly variable antibody species of the claimed specificity and of the structurally variable VS4 polypeptide variant species, the fusion or conjugate of which species is required to be correlated with the requisite vaccine functions. The written description requirement can be met by describing the claimed subject matter to a person skilled in the art using sufficiently detailed, relevant identifying characteristics such as functional characteristics and correlating those functional characteristics with a disclosed structure. See Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964, 967, 968 (Fed. Cir. 2002). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention. See e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). In the instant application, the structure of a sufficient number and variety of species encompassed within each of the variable and structurally divergent genus has not been correlated with the requisite specific binding and the vaccine functions.
In the instant application, the specification does not disclose distinguishing and identifying features of a representative number and variety of members of the genus of CD-40-specific antibodies and CD40 agonist antibodies to which the claims are directed to along with a correlation of their structure to the requisite CD40-specificity, CD40 agonist function, and vaccine function such that a skilled artisan could immediately envision or recognize at least a substantial number and variety of members of the claimed genus of antibodies. The as-filed specification fails to disclose which specific combination of variable regions and framework regions are critical for specific binding to CD40, or which amino acid residues might be substituted, inserted or deleted such that the resultant species retain the CD40-binding specificity and the CD40 agonist function. Analogous analysis, lack of adequate description, and lack of structure-vaccine function correlation within the as-filed specification apply to the VS4 polypeptide variant genus that encompasses up to 20% non-identical variant species. This is important because ‘[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus’. 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 each genus as in the instant case, one must describe a sufficient variety of species to reflect the variation within the genus along with a concrete structure-function correlation. The Court in Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) stated that “[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”). The written description inquiry is case-specific and context-specific. It “depend[s] on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.” Ariad, 560 at 1372. A number of factors guide the inquiry, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.” Ariad, 560 at 1372 [Emphasis added]. MPEP 2163 states [Emphasis added]:
The description needed to satisfy the requirements of (pre-AIA ) 35 U.S.C § 112 “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art.
Evidence required to demonstrate possession of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable arts. The state of the art at the time of the invention documents unpredictability associated with amino acid modifications within a protein or polypeptide sequence. For example, Mikayama et al. Proc. NatI. Acad. Sci. USA, 90: 10056-10060, 1993, taught that the three-dimensional structure of molecules is important for their biological function and even a single amino acid difference may account for markedly different biological activities. See page 10060. Caldas et al. Mol. Immunol. 39: 941-952, 2003 teach an unexpected effect of substituting a framework residue on CD18 binding specificity during the humanization of an antibody. See for example the abstract. Skolnick et al. Trends in Biotechnology, 18: 34-39, 2000 teach that the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based on sequence homology is inaccurate, in part because of the multifunctional nature of proteins. See abstract and ‘Sequence-based approaches to function prediction’ on page 34. Skolnick et al. further teach that even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan's best guess as to function of the structurally related protein. See in particular abstract and Box 2. With regard to the structure-function relationship of an encoded amino acid sequence in general, Rudinger J. In: Peptide Hormones. (Ed) JA Parsons, University Park Press, pages 1-7, 1976 taught that ‘the significance of particular amino acid sequences for different aspects of biological activity cannot be predicted a priori but must be determined from case to case by painstaking experimental study’. See page 6 of Rudinger J. Rudinger J. further taught that ‘it is impossible to attach a unique significance to any residue in a sequence’ and that a ‘given amino acid will not by any means have the same significance in different peptide sequences, or even in different positions of the same sequence. See page 3 of Rudinger J. Furthermore, the art recognizes that defining epitopes is not easy and there is a confusing divergence between the textbook definition of epitope and the definition that is in use in published descriptions of experimental investigations and that epitopes must be empirically determined. See Greenspan et al. Nature Biotechnology 17: 936-937, 1999. Even with regard to conservative amino acid substitutions, Lazar et al. Mol. Cellular Biol. 8: 1247-1252, 1988 demonstrated that a substitution of the Leucine residue with a conservative amino acid residue such as, Isoleucine or Histidine, in the transforming growth factor (TGF) alpha led to a mutant protein with dramatically altered biological activities. Lazar et al. expressly stated that they ‘did not expect that a mutation of Leu to Ile (which have similar sizes and polarities) would cause such a strong effect’. See paragraph bridging left and right columns on page 1251; and third full paragraph on page 1251. In the instant application, with up to 20% sequence non-identity permitted within the multiple sequences that are comprised within the VS4 polypeptide variant genus comprised in the claimed vaccine composition, there is no predictability that the amino acid sequence variant species in the vaccine would retain the conformational integrity and the native VS4 polypeptide immunospecificity such that the encompassed various variant species in the vaccine composition would retain the requisite protective vaccine functions.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California V. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California V. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(1), the court states, "An adequate written description of a DNA requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention." Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117).
In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., III USPQ2d 1780 (Fed. Cir. 2014), AbbVie had claims to functionally claimed antibodies and Centocor presented evidence that the antibodies described in AbbVie ‘s patents were not representative of other members of the functionally claimed genus. The decision stated: “When a patent claims a genus using the functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus”. Id. at 1349. We have held that “a sufficient description of a genus ....... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus.” Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). Here, the claimed invention is a class of fully human antibodies that are defined by their high affinity and neutralizing activity to human IL-12, a known antigen. AbbVie's expert conceded that the '128 and '485 patents do not disclose structural features common to the members of the claimed genus." The AbbVie decision considers how large of a genus is involved and what species of the genus are described in the patent. With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and cover any compound later actually invented and determined to fall within the claim's functional boundaries."). In the instant application, the as-filed specification and claims draw a fence around a perceived genus but the genus is not adequately described. The claims are not limited to the particular elements described in the specification and variability for each of the genus encompassed by the claims is extremely large. The specification does not describe representative examples to support the full scope of the claims.
MPEP § 2163.02 states: ‘an objective standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. The courts have decided that the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Applicants should note that written description provision of 35 U.S.C § 112(a) or pre-AIA , first paragraph is severable from its enablement provision, and written description requires more than a mere statement that something is part of the invention and a reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. A mere idea or unsubstantiated function is insufficient for written description; characterization of a representative number of species within the huge variable genus as claimed, with their precise structure correlated with the requisite or intended functions is required. In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus. In the instant case, one of skill in the art would not recognize from the disclosure that the Applicants were in possession of each genus. The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. See Vas-Cath at page 1116. Applicants’ specification does not contain a written description sufficient to show that they had possession of the full breadth of the varied genus and the full scope of the claimed invention at the time the application was filed. Instant claims do not meet the written description provision of 35 U.S.C § 112(a) or pre-AIA , first paragraph. Applicants are reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ) Second Paragraph
12) The following is a quotation of 35 U.S.C § 112(b):
(B) CONCLUSION - The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
13) Claims 28, 31, 32, 34, 35 and 40 are rejected under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite, for failing to particularly point out and distinctly claim the subject matter which inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) The claim limitation “in particular” in claim 28 renders the claim indefinite because it is unclear whether the limitations following said limitation are part of the claimed invention. Said limitation renders the scope of the claim unascertainable. MPEP § 2173.05(d).
(b) Claim 31 is ambiguous and indefinite in the limitation “derives from ....” because it is unclear what is encompassed therein. It is not clear whether said limitation encompasses structural modification(s) within the 12E12 antibody, for example, in the framework regions. One of ordinary skill in the art cannot understand in an unambiguous way that which is being claimed.
(c) Claim 32 is ambiguous and indefinite in the limitation “as described in Table A”, because it fails to point out what is included or excluded by the claim language. According to M.P.E.P 2173.05(s), where possible, claims are to be complete in themselves. Incorporation by reference to Tables, Figures, or Examples as in this case, is a necessity doctrine, not for Applicants’ convenience. See Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
(d) Claims 34 and 35 are indefinite for having improper and/or confusing antecedence in the plural limitation “the VS4 polypeptides”. These claims depend from claim 26, which includes the recitation of the non-pleural limitation “a VS4 polypeptide”.
(e) Claims 34 and 35 are ambiguous and indefinite in the parenthetic limitations: “(i.e., the chain that is .............)” because it is unclear whether these features or limitations are a part of the claimed invention or are optional. Said limitations render the scope of the claims unascertainable. MPEP § 2173.05(d).
(f) Analogous rejection applies to claims 34 and 35 with regard to the parenthetic limitation “(SEQ ID NO: 2)”. For the purpose of particularly pointing out and distinctly claiming the subject matter, it is suggested that Applicants replace said limitation with --consisting of SEQ ID NO: 2--.
(g) Claim 35 is indefinite for having insufficient antecedence in the limitation “CD40L”. See lines 5 and 9 of the claim. Since the line 3 of the claim already includes this limitation, for proper antecedence, it is suggested that Applicants insert the limitation –the-- prior to each of the “CD40L” limitations.
(h) Claim 40 is ambiguous, confusing, indefinite and appears to have an antecedence issue in the limitations: The antibody of Claim 26 that comprises “a heavy chain ...... that is conjugated ...”. Is this heavy chain different from the one recited in the base claim 26 which heavy chain is already conjugated as recited therein. One of ordinary skill in the art cannot understand in an unambiguous way that which is being claimed.
(i) Claim 40 is indefinite for having insufficient antecedence in the limitation “CD40L”. See lines 5 and 9 of the claim. Since the line 3 of the claim already includes this limitation, for proper antecedence, it is suggested that Applicants insert the limitation –the-- prior to each of the “CD40L” limitations.
(j) Claim 40 is indefinite for having improper antecedence in the limitation “the cohesion” fusion protein. Claim 40 depends from claim 26, which does not recite any “cohesion: fusion protein.
Double Patenting Rejection(s)
14) 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 Web site contains terminal disclaimer forms which may be used. Please visit http://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.
15) Claims 26-35, 39, 40 and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42, 39, 40-44, 46, 47 and 52 of the co-pending application 18274848.
Although the conflicting claims are not identical, they are not patentably distinct from each other. Both sets of claims are drawn to or encompass an antibody such as 12E12 directed against or specific for a surface antigen of an antigen-presenting cell such as CD40, wherein the heavy chain is conjugated or fused to a VS4 polypeptide as recited via FlexV1 linker, and a vaccine comprising the same. The CD40-specific 12E12 antibody of the co-pending ‘848 application comprising a heavy chain comprising SEQ ID NOs: 13, 14 and 15 as CDRH1, CDR2H and CDR3H respectively and SEQ ID NOs: 16, 17 and 18 as CDR1L, CDR2L and CDR3L respectively is the instantly claimed CD40-specific 12E12 antibody comprising SEQ ID NOs: 3, 4 and 5 as CDRH1, CDR2H and CDR3H respectively and SEQ ID NOs: 6, 7 and 8 as CDR1L, CDR2L and CDR3L respectively that is conjugated to a VS4 polypeptide via the heavy chain. Furthermore, as in In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008), the specification of the co-pending ‘848 application, for example on page 24, discloses the heavy chain of the antibody being conjugated via a dockerin domain to the cohesin fusion protein indicating that said conjugating via a dockerin domain is intended to fall within the coverage and/or meaning of the claims. Note that ‘[The specification] may be used to learn the meaning of terms and in interpreting the coverage of a claim’ [Emphasis added]. In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
16) No claims are allowed.
Correspondence
17) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
18) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
June, 2026
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