DETAILED ACTION
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 .
Status of Application/Election/Restrictions
Claims 1-13 submitted on 1/3/2023 are pending and are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application PRO 62/818,483 and CON of 16/820,269 filed on 3/14/2019 and 3/16/2020, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 3/14/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/3/2023 were received. The submissions were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim reads "an NUsc1 antibody or antibody fragment". One interpretation of this is that there are two choices: an NUsc1 antibody or, alternately, any arbitrary antibody fragment. However, this is not a reasonable interpretation in light of the specification. Rather, this should read "an NUsc1 antibody or antibody fragment thereof", clearly noting that the antibody fragment must still be a fragment of the NUsc1 antibody. Further, based on the specification, this should be "an NUsc1 antibody or antigen-binding fragment thereof", as the disclosure is generally directed to the ability of NUsc1 to act as a pharmaceutical by binding amyloid- beta oligomers (AβO), and not simply any arbitrary portion of the antibody sequence. Appropriate correction is required.
Claim Rejections - 35 USC § 112d
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.
Claim 7 is 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.
The only difference between claim 1 and claim 7 is the preamble: "pharmaceutical". However, when reading the preamble in the context of the entire claim, the recitation "pharmaceutical" does not distinguish the claim because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention's limitations. There is no definition of what makes a composition "pharmaceutical" versus one which is not.
Thus, the preamble of the claim(s) is not considered to provide an additional limitation and therefore claim 7 fails to comply with the statute. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
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 § 112b
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.
Claims 6 is 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 the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 6 requires an ScFv to bind the same epitope as "an antibody of SEQ ID NO: 3". However,
SEQ ID NO: 3 is not an antibody, but a polynucleotide sequence (see claim 4). The polynucleotide sequence is not disclosed as binding anything in particular and so it is unclear how one would ascertain that an antibody binds the same epitope as a polynucleotide sequence which does not bind an epitope at all.
Claim 6 is further deficient for its use of the term "same epitope". As defined in the instant specification, an "epitope" is "any polypeptide determinant capable of specifically binding to an immunoglobulin or a T-cell or B-cell receptor" (specification, pg 9), while "the same" is evaluated as when "a particular antibody specifically binds both epitopes" (specification, pg 9). Antibodies are known to cross-react, whereby an antibody binds not only the intended target but also a different antigen. Under Applicant's definition, two wholly unrelated sequences from different proteins, such as with cross-reactivity, are still "the same epitope" because a single antibody binds both. This does not, in itself, create indefiniteness, as Applicant is allowed to be their own lexicographer so long as the new definition is explicit, which it is here. The issue arises in that the specification does not disclose the identity of this reference epitope. While NUsc1 binds AB oligomers, the protein itself is not the "epitope", as the specification clearly defines the epitope as the polypeptide determinant that binds, not the polypeptide itself. This is further supported by the examples of epitopes in the specification, such as "amino acids, sugar side chains, phosphoryl, or sulfonyl groups". Thus, it would be improper to interpret the epitope as " AβO", as this does not define the specific amino acids binding or the particular sugars, charge, or three-dimensional characteristics that define an epitope. Thus, to clearly define the metes and bounds of the claim, others must be fairly warned of the identity of the epitope, yet the specification fails to describe this epitope in any detail.
Therefore, claim 6 is indefinite.
Claims 1-2 and 7-13 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 the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The AAV of independent claim 1 encodes "an NUsc1 antibody or an antibody fragment".
However, "NUsc1" is not a protein nor target and does not describe any particular structure or property of an antibody. NUsc1 appears to be an administrative label with no implicit or explicit limitations, making the term indefinite. The specification uses NUsc1 to refer to SEQ ID NO: 4, but the claims are clearly not limited to this sequence as NUsc1 may be any possible scFv that "binds the same epitope as an antibody of SEQ ID NO: 3". Setting aside that SEQ ID NO: 3 is not an antibody, the term "NUsc1" is clearly meant to encompass wholly unrelated antibodies so long as they bind the same epitope. As this limitation is found in claim 6, independent claim 1 must be even broader (35 USC §112(d)). Thus, there is simply no actual limitation for the antibody in claim 1 save that it must be "an antibody or antibody fragment" and then provided the name "NUsc1". This does not fairly warn others as to what actually constitutes infringement of "an NUsc1 antibody" and therefore the claims are indefinite.
Therefore, claims 1-2 and 7-13 are indefinite.
Claim Rejections - 35 USC § 112a, Written Description
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.
Claims 1-13 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is supported by Kussie et al. "A single engineered amino acid substitution changes antibody fine specificity." Journal of immunology (Baltimore, Md.: 1950) 152.1 (1994): 146-152 (hereinafter Kussie) and Chen et al. "Enhancement and destruction of antibody function by somatic mutation: unequal occurrence is controlled by V gene combinatorial associations." The EMBO journal 14.12 (1995): 2784-2794 (hereinafter Chen).
Claim 1 is directed to a nucleic acid vector which encodes an NUsc1 antibody. As such, the claim is directed to an antibody defined entirely by function, as there is no particular structure for the nucleic acid and the only requirement is that the antibody being encoded is a "NUsc1 antibody", where NUsc1 appears to be merely an administrative label and not indicative of any target, property, or structure of the antibody. However, based on the disclosure, a NUsc1 antibody must bind AβO. See MPEP §2163(I)(A)
which states:
"The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence."
The structure/function correlation between nucleic acid codons and the amino acids they encode
is well established and there exists no deficiency here. However, the structure of the nucleic acid-the primary sequence of the polynucleotide-is solely dependent on the structure of the antibody being encoded, as that amino acid sequence will dictate the polynucleotide sequence. Thus, in order to meet the written description requirement for the polynucleotide as claimed, the claims must meet the written description requirement for the antibody, which they do not.
Antibodies generally share certain characteristics such as Fc regions or hinge regions. However,
these structures are not correlated with the binding function of the antibody. The hyper variable regions (HVRs), i.e., complementarity determining regions (CDRs) of an antibody, are well established in the art as the portion of the binding region which imparts the specificity of an antibody. However, there is no way to a priori look at an antigen sequence (NUsc1) and envisage the combination of six CDRs that will bind that antigen. First, even highly related CDRs may not bind the same target. For example, Kussie demonstrates that even a single amino acid change in the heavy chain of an antibody which binds p-axophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the
functionality of binding the structurally related p-azophenylsulfonate (Kussie, abstract). Second, even when provided with several related antibodies that bind the desired target, this does not represent potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (p.7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor's antibodies which bound the same target but shared only 50% sequence similarity.
Thus, the art recognizes that the CDRs define the binding properties of an antibody and that even
single amino acid changes to this region can completely abrogate the binding specificity of an antibody. Another example is provided in Chen who demonstrates that a single amino acid change in the VH CDR2 sequence can increase binding, decrease binding, destroy binding, or have no effect on binding when compared to the wild-type antibody (Chen, abstract).
Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and
the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable
expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would
still possess the required functions.
The specification discloses a single antibody (SEQ ID NO: 4). However, as discussed above, without any way to determine how broad the genus of such antibodies are, there is no way to determine if this antibody represents the full breadth of what is claimed. The disclosure of this specific antibody would not convey to the artisan that Applicant was in possession of the full genus of all antibodies which possess the required functions nor does it allow the skilled artisan to envisage the specific structure of such antibodies.
Further note the decision in Amgen v. Sanofi 2017, where the Court supported previous decisions
(Centocor 2011; Abbvie 2014) that defining an antibody solely by what it binds does not satisfy the written
description requirement, stating that this would allow patentees to "claim antibodies by describing something that is not the invention, i.e., the antigen". This decision has precipitated guidance to the Office
instructing that the portion of MPEP 2163 regarding the "newly characterized antigen test" (indicating a
well-characterized antigen is sufficient to satisfy written description for antibodies which bind that antigen) should no longer be used and that contrary materials should not be relied upon as reflecting the current state of the law.
It is appreciated that certain claims do include a partial structure, e.g., claims 3 and 4 requires at
least 70% identity with a reference sequence. However, as above, arbitrarily altering any amino acid in the CDR of an antibody is unpredictable and the specification does not convey possession of any CDRs other than those of the disclosed antibodies, while these claims allow 30% of the antibody (about 80 amino acids) to be altered. As all six CDRs add up to around 60 amino acids, such a claim encompasses wholly changing each and every CDR to one which is structurally unrelated, whereas the art recognizes that even a single mutation is unpredictable (above).
One could not envisage which portions of the CDRs are necessary to impart the claimed binding
properties or which could be mutated without affecting such properties, nor does the instant specification
provide guidance to this effect. As such, the disclosure of one antibody sequence does not convey possession of other antibodies with the same binding properties; possession of the precisely defined sequence of six CDRs is required.
Further, the specification notes that "antibody" explicitly includes chimeric, humanized, and human antibodies unless specified otherwise (specification, pg 7). Thus, the broadest reasonable interpretation of the claimed antibody includes such antibodies. However, chimeric/humanized antibodies contain non-human CDRs, while a human antibody contains human CDRs. As the specification only describes a single set of six CDRs, the disclosed antibody cannot possibly be both human and humanized, as a human sequence does not inform regarding a sequence from another species, nor does a sequence from a non-human species inform regarding the human sequence. Thus, while one of these categories is likely appropriate, all of these categories cannot be. Thus, such claims must fail the written description requirement on these grounds.
Therefore, claims 1-13 do not meet the written description requirement.
Claim 6 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The term "epitope" is discussed above and incorporated herein. As noted above, the specification
fails to identify any structural or physical characteristics of the epitope. Rather, an epitope need not have
anything in common with a second epitope, yet still might be considered "the same" if two antibodies "compete for specific binding to that epitope" (specification, pg 9). Thus, claim 6 encompasses antibodies that bind "the same epitope", but does not convey to the skilled artisan any information regarding the structure of those antibodies correlated to binding nor even the identity of the epitope itself. Rather, Applicant lays claim to all such antibodies while requiring others to make and test the range of all possible scFv antibodies to determine for themselves if the antibody possesses this functional property.
Laying claim to a genus of antibodies whilst providing no more than a suggestion to discover the
antibodies within that genus fails to convey to the skilled artisan that Applicant was in possession of that
genus.
Therefore, claim 6 does not meet the written description requirement.
Claim Rejections - 35 USC§ 112a, Scope of Enablement
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.
Claims 1-4 and 6-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the antibody of claim 5, does not reasonably provide enablement for any other antibody. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the
invention commensurate in scope with these claims.
There are many factors considered when determining if the disclosure satisfies the enablement
requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: 1) nature of the invention, 2) breadth of claims, 3) amount of direction or guidance by the inventor, 4) relative skill of those in the art, 5) level of predictability in the art, 6) state of the prior art, 7) existence of working examples, and 8) quantity of the experimentation needed to make or use the invention. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The nature of the invention is a NUsc1 antibody, which is an antibody with no clear requirements in claim 1 (see above). Dependent claims, however, introduce defining features, such as a partial structural identity (claims 3-4) or functional requirements (claims 6, 8). The direction and guidance in the specification is the disclosure of one such antibody, while the breadth of the claims encompasses any and all potential antibodies with a certain function (claims 6, 8), or structure (claim 3-4), where that partial structure is not correlated to any function (see written description rejection as it pertains to altering CDRs above). While skill in the art is high, the art of record establishes that predictability is low. The claims encompass an unknowable number of antibodies while requiring others to make and test those antibodies to determine if unrelated CDRs can still bind the target and even requiring others to determine the identity of the epitope being bound.
See the decision in Rasmusson v. SmithK/ine 413 F.3d 1318, 1325 (Fed. Cir. 2005) which stated: "Thus, at the end of the day, the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient. [Citation omitted.] 'If mere plausibility were the test for enablement under §112, applicants could obtain patent rights to "inventions" consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the "inventor" would be rewarded the spoils instead of the party who demonstrated that the method actually worked."
The standard of an enabling disclosure is not the ability to make and test if the invention worked
but one of the ability to make and use with a reasonable expectation of success.
"[T]o be enabling, the specification... , must teach those skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation."' Wright, 999 F.2d at 1561, 27 USPQ2d at 1513 (emphasis added), quoted in Genentech, Inc. v. Novo Nordisk, NS, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997). Thus, "there must be sufficient disclosure, either through illustrative examples or terminology, to teach those of ordinary skill how to make and how to use the invention as broadly as it is claimed." In re Vaeck, 947 F.2d 488,496 & n. 23, 20 USPQ2d 1438, 1445 & n. 23 (Fed. Cir. 1991), quoted in Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1372, 52 USPQ2d 1129, 1138 (Fed. Cir. 1999).
"Patent protection is granted in return for an enabling disclosure ... , not for vague intimations of
general ideas that may or may not be workable." Genentech, 108 F.3d at 1365, 42 USPQ2d at 1005. "Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public [skilled in the art] to understand and carry out the invention." Id. at 1366, 42 USPQ2d at 1005 (emphasis added).
Here, a mere germ of an idea is set forth: that antibodies which have the same function as NUsc1 would be desirable. However, Applicant then leaves it to others to determine if such antibodies exist, while laying claims to those antibodies that would be discovered by others. This is wholly inadequate to meet the requirements of enablement.
Therefore, claims 1-4 and 6-13 are not enabled for their full scope.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 7-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sebollela et al. "A human scFv antibody that targets and neutralizes high molecular weight pathogenic amyloid‐β oligomers." Journal of neurochemistry 142.6 (2017): 934-947 (hereinafter Sebolla, cited in applicants IDS) in view of Wilson et al. US 2018/0339065, published 11/29/2018 (hereinafter Wilson).
Claim 1: Sebollela teaches a human ScFv antibody named NUsc1. Sebollela teaches this antibody binds to AβOs and is an "effective tool for AD diagnostics and therapeutics" (Sebollela, pg 2). Sebollela uses an art recognized model of Alzheimer's to demonstrate the antibody clears AD-associated pathogenic Aβ and is neuroprotective (Sebollela, pg 10-11). Sebollela does not teach expression of NUsc1 in AAV.
Nevertheless, one of ordinary skill in the art at the time of filing would have found it obvious that
the NUsc1 antibody of Sebollela could be encoded in an AAV. Wilson is concerned with a similar
problem, using an antibody which is therapeutic for Alzheimer's. Wilson teaches using an AAV vector
comprising a sequence which encodes an immunoglobulin construct (antibody) and a pharmaceutical carrier (Wilson, abstract and claim 1).
Each element claimed existed in the prior art, though not in a single document. However, using AAV to encode antibodies was a well-established technique which one of ordinary skill in the art could have implemented in a predictable manner. The method of using AAV to encode and deliver an antibody is taught in Wilson and differs only in the antibody being encoded, which one of ordinary skill in the art would have recognized was substitutable because the AAV technology is not designed solely for the expression of the polynucleotides of Wilson, but for any polynucleotide.
As noted by the United States Supreme Court, if a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one method (i.e. Wilsons method of using AAV to improve delivery of an antibody to treat AD), and a person of ordinary skill would recognize that it would improve similar methods (i.e., delivery of the scFv antibody of Sebollela to treat AD) in the same way, using the technique is obvious unless its actual application is beyond his or her skill. KSR, 127 S. Ct. at 1740.
Claim 2: Sebollela teaches a human ScFv antibody named NUsc1 (Sebollela, title and abstract).
Claim 7: Since there is no special definition for a pharmaceutical and so this composition would have been obvious for the same reasons as claim 1. Moreover, it would have been obvious to formulate the composition as a pharmaceutical as Sebollela teaches the utility of the antibody as a therapeutic and Wilson teaches, e.g., including pharmaceutical carriers (paragraph 75; claim 10).
Claim 8: One of ordinary skill in the art would have been motivated to make the composition above and then to administer that composition to a subject to treat Alzheimer's disease with a reasonable expectation of success. This is because the antibody of Sebollela was used in an art recognized model of AD and was demonstrated to have beneficial effects, such as reducing the pathogenic species of AB oligomers. Further, Wilson teaches that such an antibody can be encoded in an AAV, delivered to a subject, and can treat AD.
Claim 9: Wilson makes obvious treating AD in humans by teaching treatment of AD where the subject is human (Wilson, para 75).
Claim 10: Wilson teaches a method of treating AD in a subject. In order to treat AD in a
subject, that subject must have AD.
Claim 13: Wilson teaches ICV injection is an effective method to deliver the therapeutic
AAV (Wilson, para 28).
Therefore, clams 1-2, 7-10, and 13 would have been obvious.
Nonstatutory 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 Langi, 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 706.02(1)(1) - 706.02(1)(3) 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.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US 11,541,085. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims would anticipate the instant claims if they were available as prior art.
Claims 1-2 and 7: The patented claims describe a composition comprising an engineered AAV comprising a nucleic acid vector (claim 1). The antibody described in claim 1 reads on the NUsc1 antibody or antibody fragment described in the instant claims as evidenced by dependent claim 5.
Claim 3: The patented claims describe a ScFV which comprises at least 70% sequence identity with SEQ ID NO: 4.
Claim 5: The patented claims describe an AAV vector encoding an antigen-binding region comprising a heavy chain variable region.
Claims 4 and 6: The patented claims describe a polynucleotide comprising 70% sequence identity with SEQ ID NO: 3.
Claims 8-12: The patented claims describe treating AD in human subjects which have early-stage AD and co-administering additional therapeutic agents.
Claim 13: The patented claims describe treating AD comprising administering the composition by intracerebroventricular injection.
The patented claims would anticipate the instantly claimed invention, which is drawn to a similar AAV composition encoding a NUsc1 antibody and method of treating AD. The claim sets are patentable indistinct therefore.
Conclusion
No claims allowed.
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Alexander Nicol
Patent Examiner
Art Unit 1633
/ALEXANDER W NICOL/Examiner, Art Unit 1634