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 .
Claims 55-72 are under consideration in the instant Office Action.
Examiner attempted to contact applicant to discuss claim amendments and TDs to place in condition for allowance on 8/27/2025. Examiner did not receive a response.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 57-59 and 61-64 are objected to because of the following informalities: the claims contain multiple periods within each claim. For example, "a.". Please change format to "a)". Applicant's attention is directed to MPEP 608.01(m) that deals with claim format. In particular, MPEP 608.01(m) discloses that each claim begins with a capital letter and ends with a period. In addition, it is disclosed that periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 58-59 and 63-64 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 58-59. the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The terms “binds disease relevant, pathological forms of a-synuclein” and “reduces free unbound a-synuclein” in claim 63 are relative terms which renders the claim indefinite. The terms “binds disease relevant, pathological forms of a-synuclein” and “reduces free unbound a-synuclein” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what is encompassed by term “binds disease relevant, pathological forms of a-synuclein”. What are relevant pathological forms? This terminology leaves it open to any interpretation and does not help determine what antibody would be binding. This is the same issue for the term “reduces free unbound a-synuclein”. Again the antibody is supposed to reduce the free and unbound protein but is unclear exactly what this entails.
Claim 64 uses ‘having” as a transitional phrases. Using the appropriate claim language would benefit from the transitional phrases as set forth in MPEP 2111.03 The transitional phrases "comprising", "consisting essentially of" and "consisting of" define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim. Using the correct transitional phrase would clarify exactly what the limitations are requiring as limitation or what is explicitly excluded.
Claim Rejections - 35 USC § 112
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 55-72 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.
Independent claim 55 and dependent claims 56-72 are directed an antibody that binds human -synuclein wherein there is L234F/L235E/P331S triple mutation in the Fc region (claim 55); the antibody specifically binds the region between amino acid 102 and amino acid 130 within the C-terminal region of human a-synuclein (claim 56); claims 57-59 and 61-63 describe the characteristics of the antibody but no specific structure; wherein at least one of the CDRs of the claimed antibody may differ from the instant sequences by 1-5 amino acids by single amino acid deletions, substitutions, or insertions or a sequence that maintains at least 80%, at least 85%, at least 90%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98% and up to 99% sequence identity thereto (claim 64). Claim 60 is also towards a human antibody that is not disclosed in the instant specification. As such, the claims are directed to an antibody that is claimed only by function or that includes unknown mutations, deletions or substitution that have not been taught or disclosed by the instant specification.
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.”
In this case, antibodies with unknown specific structure changes in their CDRs 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 or the general target protein and envisage or describe the structural combination of six CDRs that will bind that antigen/general target protein or what antibody will specifically meet all functional limitations of instant claims 55-59 and 61-63. First, even highly related CDRs may not bind the same target. See for example Kussie et al., 1994 (NPL25, IDS 6/9/2023) who demonstrates that 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 (e.g., abstract). Second, even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and 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 (see table on page 11 of Abbvie decision).
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 or alter the binding specificity of an antibody. As a further example, see Chen et al., 1995 (NPL9, IDS 6/9/2023) which demonstrates single amino acid changes 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. 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. As the specification does not provide sufficient guidance to the skilled artisan to allow such a reasonable expectation of success, it would require undue experimentation on the part of the skilled artisan to make and test each combination of CDRs and mutations to determine for themselves which antibodies meet the claim limitations.
The specification discloses specific antibodies but fails to specifically teach the claimed potential differentiations in the instantly claimed CDRs. The disclosure of specific antibodies would not convey to the artisan that Applicant was in possession of the full genus of all antibodies which possess the required functions with the required modifications. The instant specification also indicated that the possible antibody may be modifies in the CDR regions (see page 31 of the instant specification) without any specific guidance except requiring that these changes do not affect the binding with high affinity. There is no specific guidance regarding how the CDRs may be “altered” to preserve the function given the known sensitivity of CDRs to such alterations. As discussed above, one cannot predict how an alteration will affect binding affinity and antibodies may compete while not binding any common residues, such as through steric hindrance when binding spatially proximate epitopes of a protein. The specification does not convey possession of such antibodies, besides the ones claimed by the specific CDR sequences, nor does it allow the skilled artisan to envisage the specific structure of such modified antibodies. 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. Further, it is well-known in the art that specificity of an antibody stems from the interaction of at least three (in the case of single-domain antibodies) and usually six (for single-chain and full antibodies) CDRs.
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”.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Vas-Cath, Inc., v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. 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. An antibody described only by functional characteristics is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995). In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure of the antibody and its capability of binding -synuclein and preventing any neurodegenerative disease to demonstrate possession of the breadth of the genus of -synuclein antibodies encompassed by the instant claims, especially in view of the unpredictability of such an endeavor. The prior art as evidenced by Edwards et al., 2003 (NPL13, IDS 6/9/2023) teaches there is a substantially huge antibody diversity produced to one single antigen target. Edwards provides evidence that over 1000 antibodies, all different amino acid sequences, were generated towards one single protein antigen target (see abstract). Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The instant invention is claiming an antibody that binds to a-synuclein to treat a a-synucleinopathy disease. Dependent claim 60 encompasses a human antibody. There is no description of the structure of any antibody let alone human antibodies. Thus to the extent that the claims encompass human antibodies, they fail to meet the written description rejection.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Vas-Cath, Inc., v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116.
In the instant case, there is no corresponding progression exists with respect to making a fully-human antibody (comparing the process of constructing a chimeric antibody from a mouse antibody with the process of making a human antibody). One of skill in the art cannot look at a mouse variable region and know how to turn it into a human variable region with the same affinity and activity as the mouse antibody.
Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of a-synuclein antibodies or human antibodies. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004).
Without this guidance or direction the skilled artisan would not consider applicant to be in possession of the claimed genus of antibodies because the skilled artisan recognizes that even seemingly minor changes made without guidance or direction as to the relationship between the particular amino acid sequence of the instantly claimed antibody and its ability to bind antigen, can dramatically affect antigen-antibody binding.
Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of an antibody that binds -synuclein. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed 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 the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. 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.
To provide adequate written description and evidence of possession of the claimed genus, the specification must provide sufficient distinguishing identifying 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. In the instant case, the only factors present in the claims are a recitation of one broad genus with limited number of examples that encompassed a diverse and huge number of possible antibodies that bind -synuclein. The specification does not provide a consistent structure for all of the possible antibodies and fails to provide a representative number of species for the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly 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 is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed.” (See Vas-Cath at page 1116).
With the exception of specifically disclosed antibodies with specific CDRs, the skilled artisan cannot envision the detailed chemical structure of all of the encompassed antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. 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).
Therefore, claims 55-72 do not meet the written description requirement.
Claims 65-72 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 treating a -synucleinopathy disease with the antibody with SEQ ID NOs: 5, 15, 16, 20, 10 and 21 for their CDRs, does not reasonably provide enablement for a-synucleinopathy disease in the central nervous system in a patient with an antibody that binds to human a-synuclein, wherein the antibody comprises a L234F/L235E/P331S triple mutation in the Fe region. The enablement issue is complicated since specification is not enables to treat a-synucleinopathy disease with any a-synuclein antibody with undisclosed modifications and no specific structure requirement. 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.
The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and, (8) the breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The instant claims call for a method of treating a a-synucleinopathy disease in a patient using any antibody as disclosed in instant claim 55 that requires no specific structure and the dependent claims that describe the antibody or call for undisclosed modifications to the disclosed structure does not alleviate the burden on unpredictability on how to perform this method successfully. The dependent claims call for undisclosed modifications or differentiations in 1-5 amino acids in any of the CDRs of the claimed antibody. The patient population includes Parkinson’s disease subjects and subjects multiple system atrophy (MSA). The instant claims are broad and generic while what is enabled is narrow and specific. The instant specification only provides examples of reducing -synuclein spreading in the in vivo model of -synucleinopathy (see Example 12, page 63 of instant specification). This treatment is targeted towards someone with synucleinopathy like PD and MSA. While the treatment provides a benefit in the animal models, it still fails to prevent these diseases from occurring and therefore does not provide evidence that any neurodegenerative condition, let alone that PD or MSA is prevented or treated with non-specific antibodies. The instant specification does not provide any examples or evidence that this type of treatment would provide a benefit PD or MSA let alone any neurodegenerative disease in the CNS with unknown and undisclosed antibodies. Further, the instant specification fails to teach any other possible antibodies that have the instantly claimed function and able to treat or prevent any CNS disease in a patient population. There is no support provided in the instant specification or in the prior or instant art that teaches or supports the ability treat any CNS disease let alone PD or MSA.
The term “preventing” is generally understood in the art to encompass a total protection form disease or injury. Thus, given the high level of required effect, a high level of evidence showing prevention is also required. As noted above, however, there are no working examples in the instant specification demonstrating any therapy using the claimed antibody, nor any examples directed to the palliative, preventative, or curative treatment of Parkinson’s disease. Therefore, the instant specification does not provide evidence or substantial guidance commensurate in scope with the broadly claimed method in how to use the method to prevent Parkinson’s disease.
Both at the time of filing and now, effective therapy for the treatment and prevention of -synucleinopathies like PD or MSA, have eluded researchers. The instant specification itself does not teach any method or treatment that would treat any CNS disease, let alone PD or MSA. The prior art by Mandler et al., 2015 (NPL35 IDS 6/9/2023) indicates that there is no approved treatment for -synucleinopathy or MSA with a proven disease-modifying effect (see abstract and page 2 of 15, 1st column, 2nd paragraph). Mandler also observes that clinical trial has produced an effect of clearing -syn aggregates as a treatment but not as a prevention of the disease or cure (see page 2-15, 1st column). Thus, the relevant art recognizes the unpredictability of methods directed to treating CNS diseases like -synucleinopathies. The disclosure is not considered fully enabling for the claimed invention, since the state of the art teaches that effective treatment of PD, MSA or any non-specific neurodegenerative disease with any agent is not currently possible.
Claim 65 encompasses an antibody with unknown modifications to prevent any a-synucleinopathy disease of the CNS. The nature of the invention is clinical medicine comprising physiological modulation with an antibody for a disorder of the central nervous system (CNS), and is therefore of the highest complexity due to the complex nature of the nervous system. The art does not provide compensatory teachings. The art teaches a limited amount of possible treatments to produce the limited result of treating Parkinson’s disease but does not teach the prevention of these diseases or any other neurodegenerative disease. Therefore, the prior art does not compensate for the failing of the instant specification. This speaks to the fact that while the art has observed possible antibodies that match the functional criteria of instant claim 55 that they have not yet identified all of the possible antibodies that read on the instant claims. There is still a lot of unknown in the art of what are all the possible antibodies that are functionally capable of meeting the functional imitations of the instant claims and would still require undue experimentation to determine what these antibodies are to prevent any neurodegenerative disease. One of ordinary skill would also have to take into account what type of a-synucleinopathy disease this antibody is being administered to, to be able to determine if the antibody meets the required function of the instantly claimed antibody and prevent a-synucleinopathy disease. This would require undue experimentation. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without such guidance, the changes which can be made and still maintain activity/utility is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Int. 1986).
As set forth above, inadequate guidance is presented in the specification to overcome the obstacles in practicing the claimed invention in its full scope. The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. Given the tremendous breath of scope involving the instant claims, it would require undue experimentation for one of skill in the art to practice the claimed invention in its full scope. Therefore, the specification fails to provide enough guidance for one skilled in the art on how to practice the full scope of the instantly claimed method, thereby requiring trial and error experimentation to identify compounds meeting the functional limitations of the claims. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. One of skill in the art would neither expect nor predict the appropriate methods of treating all neurodegenerative conditions in the manner claimed. Therefore, in view of the lack of guidance in the specification and in view of the discussion above, undue experimentation would indeed be required to make and use the invention commensurate with the scope of the claims.
The scope of the claims must bear a reasonable correlation with the scope of enablement. In re Fisher, 166 USPQ 18(CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
Undue experimentation would be required to produce the invention commensurate with the breadth of the claims based on the disclosure of the instant specification and the knowledge in the art. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. In view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breadth of the claims, it would take undue trial and error to practice full scope of the claimed invention.
In conclusion, the instant claims encompass an invention of tremendous breadth, and essentially call for trial and error by the skilled artisan to begin discovering how to make the claimed invention without assisting the skilled artisan in such an endeavor, which amounts to undue experimentation and is therefore insufficient to constitute adequate enablement.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 55-72 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-18 of copending Application No. 19/025,554. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 55-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,160,800. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘800 claims the same a-synuclein antibodies with the same CDR sequences and the same methods of treating an α-synucleinopathy disease.
Claims 55-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,889,639. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘639 claims the same a-synuclein antibodies with the same CDR sequences and the same methods of treating an α-synucleinopathy disease.
Claims 55-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 10, 12, 15, 19-20, 41-55 and 57 of copending Application No. 18/398,531. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘531 claims a method of treating synucleinopathies using the same claimed a-synuclein antibodies. Therefore, “531 claims the same antibodies and methods as the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675