DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The response filed 3-2-2026 has been entered into the record. Claims 2-19 are pending.
Drawings
The drawings in this application have been accepted. No further action by Applicant is required.
Information Disclosure Statement
The information disclosure statements have been considered. Initialed copies are enclosed.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of all the prior-filed applications fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In the instant case, the prior applications provided claims defining antibodies or antigen binding fragments thereof (against 158P1D7) and separate conceptual embodiments in paragraphs 130-135 of the specification having:
the variable regions set forth in SEQ ID NO:7 or 8,
antibodies and antigen binding fragments have the complementary determining regions from the variable regions set forth in SEQ ID NO:7 and 8 or
amino acids sequence % homologous to the VH and VL sequences.
The embodiments 1-2 are set forth in the original claims and description of the parent (13/975,214). The as filed parent specification does not provide basis for claiming percent homologous variants of SEQ ID NO:7 or 8 (concept #3) in combination with other embodiment concepts (#1 or #2). Applicant herein presents new claims providing for combination of two different separate concepts/embodiments of the specification. Applicant has elected embodiment 2(i) that presents and antibody having a combination of two different concepts: 1- percent homology to a variable region and 2- the CDRs from the other variable region in a binding antibody or antibody fragment. Such a new combination is not found to have conception by way of written description support in the instant specification or in any parent specification or claims. Applicants are directed to Studiengesellschaft Khole m.b.H. v. Shell Oil Co. 42 USPQ2d 1674 CAFC, 1997 which states: "In order for patent application to receive benefit of earlier filing date from prior application pursuant to 35 USC 120, earlier-filed applicant must contain disclosure which complies with first paragraph of 35 USC 112 for each claim in newly filed application, claim therefore complies with section 120 and acquires earlier filing date only if it could have been added to earlier application without introducing new matter." It is noted that entitlement to a filing date does not extend to subject matter which is not disclosed but would be obvious over what is expressly disclosed. Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977). Novozymes A/S v. DuPont Nutrition Biosciences APS, 107 USPQ2d 1457 (Fed. Cir. 2013). While the original patent application describes each element of the claimed invention. However, the application does not particularly identify this particular combination claimed combination of limitations from different embodiments. Rather, the application lists multiple different embodiments. In considering whether the description was sufficient, the Federal Circuit considered the claimed invention "as a integrated whole" rather than merely element by element: while the application provides formal textual support for each individual limitation recited in the claims, it nowhere describes the actual functioning, variants that those limitations together define. Each claim must be taken as an integrated whole rather than as a collection of independent limitations. The court makes clear here that written description is not satisfied merely by ensuring that each individual claim limitation is disclosed in the original disclosure. Rather, the written description requires disclosure of the patented claim as a whole. Given these findings, it has been determined the elected and recited embodiment of claim 2(i) when viewed as a whole lacks conception by way of written description in the earlier patent applications. The dependent claims 3-13 likewise lack written description.
Consequently, the filing date assigned for prior art purposes is the instant filing date of 3-10-2023.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 2-13 MMAE conjugates where the species embodiment (i) and linker as valine-citrulline in the response filed 3-2-2026 is acknowledged. Claim 14 was place in both groups in an oversight. As claim 14 is drawn to a method of treatment it is correctly place in Group II. Claims 2-13 drawn to antibody MMAE conjugates are under examination.
Claims 14-19 are withdrawn from consideration.
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. See 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 2-13 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-10 and 24 of U.S. Patent No. 8,969,742. Although the conflicting claims are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims in view of patented claims IN particular claim 8 of the ‘742 patent meets the antibody structure of the antibody of instant claim 1 with a linker and claim 8 as depending therefrom has a valine-citrulline linker of the structure of instant claim 8 with the p values of 2-8. The fragments and variants of patented claim 8 are obvious in view of patented claims 4 and 5. The instantly claimed pharmaceutical compositions are prima facie obvious as it would be obvious to combine the patented anticipatory or obvious conjugates with a pharmaceutical carrier for treatment.
Claims 2-13 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-11 and 15-29 of U.S. Patent No. RE47,103 E. Although the conflicting claims are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims in view of patented claim 16 as encompassed by the instant claims. Additionally, claim 25 of the reissue patent has the antibody structure of the antibody of claim 15 with a linker valine-citrulline linker of the structure of instant claim 8 and it would be obvious to substitute the patented antibody claim 16 for that of claim 15 in the antibody conjugate of claim 25.
Claims 2-13 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-10 and 24 of U.S. Patent No. 9,926,376. Although the conflicting claims are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims. In particular claims 7 and 8 comprises the antibody, the val-cit linker and the MMAE drug as claimed along with a p value of 2-8 which encompasses that which is claimed. The instant claims are prima facie anticipated or obvious over the patented claims.
Claims 2-13 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-10 and 16-25 of U.S. Patent No.10,669,348 Although the conflicting claims are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims, see in particular claim 22.
Claim Rejections - 35 USC § 112
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 his invention.
The following is a quotation of 35 U.S.C. 112(d):
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for 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 claims recite a antibody or antigen binding fragment thereof which binds to a 158P1D7 protein where the heavy chain is defined by the three complementary determining regions of the variable region of the heavy chain of SEQ ID NO:7 and “a light chain variable region comprising an amino acid sequence at least 80% homologous to the light chain variable region amino acid sequence set forth in SEQ ID NO:8” The instant claim language defining the light chain variable region of the antibody encompasses substantial and unlimited combination of changes to the complementary determining regions CDRs in the light chain variable region. The specification does not disclose an antibody that has variations of the CDRs.
The structures of the polypeptides comprising antigen-binding domains which bind an 158P1D7 protein which are claimed are not adequately described. In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., Ill 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 states, “When a patent claims a genus using 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 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.” In the instant application, while an antibody that binds has been produced, only a single embodiment is disclosed. This antibody is Ha15-10ac12 (Figures 1-3 of the specification). This antibody has a heavy and light chain variable region of SEQ ID NO:7 and 8. This antibody also has 6 CDRs of as set forth in paragraph [0132] of the specification. This antibody has not been described in a way to support a generic claim to antibodies with variant CDR structure that bind to the 158P1D7 protein as currently claimed. The disclosure of a single species rarely is sufficient to provide support for a genus especially in light of a lack of disclosure of structure or disclosure of a correlation between structure and function.
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 specification and claims draw a fence around a perceived genus but the genus is not adequately described. The specification fails to exemplify s antibodies which differ from the disclosed antibody CDRs by any variation in amino acid sequence and only a single embodiment that binds to the recited protein is disclosed. The claims encompass variations in the disclosed heavy and light chain variable regions of up to 20%, but fail to describe even a single variation in the disclosed antibody that would still have the functionality of binding to 158P1D7 and provides no guidance of where the variation may occur such that functionality is preserved. While the art supports variation being permitted in the framework regions if the CDR amino acid sequence structure is preserved, the claims are not so limited. No reasonable structure-function correlation has been established that is commensurate in scope with the disclosure and the claims. The specification does not describe representative examples to support the full scope of the claims.
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). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
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.”
Thus, given the level of skill and knowledge and predictability in the art, those of skill in the art would not conclude that the applicant was in possession of the claimed genera of polypeptides and antigen-binding fragments which bind to FAP based on disclosures set forth above. "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." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). For 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. See, e.g., Eli Lilly. Further, it is not sufficient to define the genus solely by its principal biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. Per the Enzo court's example, (Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched "in terms of its function of lessening inflammation of tissues" which, the court stated, "fails to distinguish any steroid from others having the same activity or function" and the expression "an antibiotic penicillin" fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, the function of a protein to bind FAP as claimed does not distinguish a particular protein from any other protein and as such, fails to satisfy the written-description requirement. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. (Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406).
Applicant is 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).
Claims 11 and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As to claim 11, the claim recites mere intended use of the composition for treatment of cancer. The intended use does not structurally properly further limit the composition per se. As to claim 12, the claim recites that the composition Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2-13 are rejected under 35 U.S.C. 102(b) as being by Kendall et al (US 8,968742, 2015).
Kendall et al teaches a conjugation of monoclonal antibody Ha15-10ac12 (Figure 2) to conjugated to MMAE using a val-cit linker. The antibody is a human antibody. The conjugate is disclosed at Example 4, column 76-78. The structure of the conjugate is set forth in column 4 and has a p from 1-12 with a preferred p value of the antibody drug conjugate between 3.5 and 3.7 (see column 7, first paragraph). The conjugate was administered as a bolus in animal trials (i.e. pharmaceutical composition of conjugate and pharmaceutically acceptable carrier). This conjugate anticipates claims 2, 5, 6, 7, 8 and 9. Monoclonal antibody Ha15-10ac12 comprises the heavy chain having SEQ ID NO:7 and the light chain having SEQ ID NO:8. Kendall et al teach the pharmaceutical combination of the conjugate with a chemotherapeutic or anti-neoplastic agent and/or radiation therapy (see column 83, Example 8; column 71, lines 20-35). Kendall et al teach that the antibody can be an antigen-binding fragment (column 15, lines 19-48). Kendall et al teach therapeutic ADC formulations (column 68, lines 37-68) and routes of administration such as intravenous, intraperitoneal, intramuscular, intratumor, intradermal and the like and a dose rage of 0.1 to 25 mg/kg body weight (i.e. human unit dosage forms; column 71, lines 24-33). Kendall et al teach that the antibody can be a packaged in a unit dosage (see column 83, lines 44 to column 84 line 15) as such claims 10-13 are anticipated.
Status of the Claims
Claims 2-13 stand rejected. Claims 14-19 are withdrawn from consideration.
Conclusion
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/PATRICIA DUFFY/Primary Examiner, Art Unit 1645
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