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 .
Priority- Foreign
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a)-(d) and (f) or under 35 U.S.C. 120, 121, 365(a) or (b), or 386(a) is acknowledged. The present application is drawn from PCT/KR2022/001498, filed 1/27/2022; and claims benefit under 35 U.S.C. (119(a)-(d) to foreign application KR-10-2021-0011845, filed 1/27/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Claims 34-54 are pending and are being examined on the merits.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiency #1 – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
The specifications describe antibody clone H6 antibody (GTC 110-04) on page 44, Table 4. Table 4 of the specifications list the amino acid sequences of the heavy and light chains of GTC 110-04, but do not identify these sequences with an appropriate sequence identifier (i.e. SEQ ID NO).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency #2- This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in the specifications on page 44, Table 4. The sequences of Table 4 are not provided in the Sequence Listing part of the disclosure.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Claim Rejections - 35 USC § 112(b)
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.
Claims 34-54 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.
Claims 34-35, 40, 46 and 50 recite a binding molecule comprising a domain “consisting of an amino acid sequence represented by SEQ ID NO:”. Claims 38-39 recite a binding molecule comprising a domain “consisting of an amino acid sequence selected from a group consisting of SEQ ID NOs:”. Use of the terminology “an amino acid sequence” reads on as little as 2-3 amino acids of any of the claimed sequences. That is, the claims do not require the full length sequence identifiers, it is not close-ended and defined by the recited SEQ ID NOs; rather, that any 2-3 consecutive amino acid residues constitute “an amino acid sequence of”. Thus, for example in claim 34, where the claim recites a heavy chain CDR1 consisting of an amino acid sequence represented by SEQ ID NO: 5, it is unclear which amino acid residues of SEQ ID NO: 5 are required, as all that is claimed is an amino acid sequence of SEQ ID NO: 5. This is repeated for the HCDRs 1-3 and LCDRs 1-3 of claims 34, 46 and 50; such that it is unclear what amino acid residues are required from the listed SEQ ID NOs. Further, the claims recite wherein the chosen sequence is “represented by” SEQ ID NO. This is not definitive language as it is unclear what being “represented by” means. Is this close-ended, and thus requires the exact sequence being represented; or is this open ended, whereby being “represented” by, for example SEQ ID NO: 5, means that SEQ ID NO: 5 is a base sequence that may then be modified? That is, it is unclear how one sequence is “represented” by another; and neither the claims nor specifications provide a definition of, or guidance, as to how one sequence is “represented” by another. As the structure of the binding molecule (claim 34), the VH/VL (claim 35), the heavy and light chain constant region (claims 38-39), the heavy chain and light chain (claim 40), the ADC (claim 46), and/or the CAR (claim 50) are limited by the recited amino acid sequences, and the claim language is unclear with regard to how the required amino acid sequences are defined, the metes and bounds of the claims are unclear, and claims 34-35, 38-40, 46 and 50 are rendered indefinite. Therefore claims 34-35, 38-40, 46 and 50 are rejected for indefiniteness. As claims 36-37, 41-45, 47-49 and 51-54 depend from rejected claims 34, 46 and/or 50, but fail to rectify the indefiniteness issues, claims 36-37, 41-45, 47-49 and 51-54 are also rejected. It is suggested that applicants use definitive language such as “consisting of the amino acid sequence of SEQ ID NO”, when referencing the required amino acid sequences that encode the domains of the claimed product.
Claim 42 contains the trademark/trade name "unibody". Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a generic antibody fragment and, accordingly, the identification/description is indefinite.
Claim 41 recites the binding molecule of claim 34, wherein the binding molecule is an antibody or a fragment thereof. Claim 42 recites the binding molecule of claim 41, wherein the binding molecule may be of various formats (i.e. chimeric, humanized, bispecific, diabody, etc.); however, claim 42 also recites “or a fragment thereof”. Claims 41-42 depend from the binding molecule of claim 34; claim 34 recites a binding molecule comprising a heavy and light chain with 3 HCDRs and 3 LCDRs. Thus, the binding molecule of claim 34 requires 6 CDRs of the antigen binding domain. Any “fragment thereof” of an antibody or the binding molecule encompasses fragments that may not comprises all 6 CDRs. For example a fragment may be only the VH domain, whereby it is coupled to alternative molecules in various formats. Thus it is unclear what the metes and bounds of the claims are when any fragment thereof may be used in alternative formats, while all 6 CDRs of the antigen binding domain of the molecule of claim 34 are necessary to impart its functionality, and/or patentability. It is suggested that applicants amend claims 41-42 to recite “or the antigen-binding fragment thereof”, so that it is clear that any fragment of the molecule used in various recited formats requires at least all 6 CDRs, which define the antigen binding domain, of the anti-Lrig binding molecule of claim 34.
Claims 47-49 and 51 are rejected under 35 U.S.C. 112(b), because claim 47 is a “use” claim. According to MPEP 2173.05(q), “[a]ttempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which reads: ‘[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon’ was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).” Claim 47 recites a pharmaceutical composition for [use] preventing or treating a brain and nervous system disease comprising the binding molecule of claim 34. However, the claim does not recite any active, positive steps defining how this use is actually practiced and is therefore rejected under 35 U.S.C. 112(b). Claim 48 depends from claim 47 and further limits the “use” of the composition, i.e. wherein the brain and nervous system disease is a neurodegenerative or neuroinflammatory disease. Claim 49 depends from claim 48 and further limits the neurodegenerative or neuroinflammatory disease to a group of alternate species. However, claim 47-49 are drawn to a product (i.e., a pharmaceutical composition) whereby the limitations should (further) define the structure of the product; and are not methods claims whereby the active steps of the method are defined, and wherein the methods are further limited to their “use” across different diseases. Thus, as claims 48-49 depend from claim 47 and do not rectify the indefinite issue of “use”, claims 47-49 are rejected under 35 U.S.C. 112(b).
Similarly, the diagnostic composition of claim 51 is interpreted to be a product (i.e. composition) for use in a method of diagnosing, comprising measuring an expression level of Lrig-1 protein in a sample. However, the limitation of “measuring an expression level of Lrig-1” does not describe the structural limitations of the claimed composition (product); or even how the composition is used in a method of diagnosing (i.e., administering the composition or contacting a sample with the composition). Thus, as the claim is drawn to a product, and it does not recite any active, positive steps defining how the “use” is actually practiced in a method, it is therefore rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 52-54 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Claims 52-54 are drawn to a method for preventing or treating a brain and nervous system disease comprising administering the anti-Lrig binding molecule of claim 34, the ADC of claim 46 or the CAR of claim 50. Although the specification is enabled for treating, the specification does not reasonably provide enablement for "preventing" Alzheimer's disease or treating "any" brain and nervous system disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include but are not limited to:
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The breadth of the claims;
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The nature of the invention;
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The state of the prior art;
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The level of one of ordinary skill;
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The level of predictability in the art;
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The amount of direction provided by the inventor;
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The existence of working examples; and
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The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The factors most relevant to this rejection are 1) the amount of direction provided by the inventor and 2) the existence of working examples. In the instant case, the amount of direction provided by the inventor and existence of working examples disclosed in the specification, as filed, would not be sufficient to enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue experimentation.
(1) The amount of direction provided by the inventor - The amount of guidance or direction needed to enable an invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). Due to the high level of unpredictability in the area of disease prevention, particularly brain and nervous system diseases, the skilled artisan would need significant guidance in preventing Alzheimer’s disease, or any other brain and nervous system disease, by practicing the claimed method. The term “preventing” is generally defined as keeping something from happening or arising. The specifications extend the scope of preventing to further include blocking, suppressing or delaying symptoms of the disease (Specs., pg. 20, last paragraph). The skilled artisan recognizes that the nature of preventing Alzheimer’s disease is complex and that keeping individuals free of Alzheimer’s disease indefinitely is an intractable proposition, if not now wholly impossible, given, for example, that the root causes of Alzheimer’s disease are not known, with a heterogeneous mix of potential pathologies and etiologies, which are multifactorial and as of yet are only partially characterized and poorly understood. It is generally recognized that a disease cannot be prevented unless and until it’s causes are fully appreciated and understood to a degree that it becomes possible to intercede effectively to block its onset or development by any cause. Further, regarding the blocking, suppressing or delaying of symptoms, it is clear that by administering the treatment for said symptoms, the underlying disease which causes the symptoms is already present, and therefore the disease is not prevented.
(2) The existence of working examples – The examples of the specification demonstrate methods that may be used to treat Alzheimer’s disease by administering a composition comprising the anti-Lrig1 binding molecule, or an ADC or a CAR expressing the anti-Lrig1 binding domain, into a subject. However, there is no showing in the specification of any means by which one skilled in the art could prevent Alzheimer’s disease by administering a composition comprising the anti-Lrig1 binding molecule to a subject in need thereof. For example, the specifications teach Examples 6 and 7 to show the therapeutic ability of an antibody of the present invention. In each example, the subject population was 5xFAD mice with induced Alzheimer’s disease (pg. 44, para. 2) or 6xTg mice with induced Alzheimer’s disease (pg. 48, para. 1). In each case, the subject of the treatments already had induced Alzheimer’s disease, and the treatment was effective in reducing the symptoms of the already present underlying pathology. Thus, the examples enable treatment, but not prevention of Alzheimer’s disease; and no examples were provided which teach a skilled artisan how to use the invention to prevent Alzheimer’s disease. Therefore one skilled in the art would be subject to undue experimentation to practice the instant invention as it is currently claimed.
Further, regarding the treatment of any brain and nervous system disease, the specifications do not enable the full scope of using the invention to treat any alternative neurological disease beyond Alzheimer’s disease. For example, Rett syndrome, meningitis, or even addiction, have distinct pathologies from Alzheimer’s disease. The specifications describe the mechanism of the treatment only so far as to highlight that T regulatory cells (Tregs) express the Lrig-1 molecule and that its expression increases when the Tregs are activated. Such that the anti-Lrig1 binding molecule of the instant claims, which is presumed to be agonistic to the Lrig-1 expressed on T cells, would promote the innate suppressive activity of Tregs, and thus results in therapeutic benefits. While it may be true that generally enhancing the body’s innate immune system would have a range of benefits (and potential side effects), when targeting a specific brain and nervous system disease, the pathology of the specific disease and the mechanism by which the invention targets and treats the pathology should be described, in order to determine the scope of diseases for which the treatment is enabled. What is the target of the modified/activated Tregs in treating Alzheimer’s disease, and would the Tregs also target, for example, the genetic mutations that underlie Rett syndrome? When comparing Alzheimer’s disease to Parkinson’s disease (PD), would the invention target the α-synuclein aggregates of PD? Example 6 of the specifications (pg. 45) describe that treatment reduced the Amyloid-β plaques in an Alzheimer’s disease mouse model, but it is unclear if Amyloid-β plaques are the target of the Tregs, or a downstream consequence to enhanced Treg activity on neurons; thus it is unclear if the same treatment would be suitable for treating PD, which is characterized by α-synuclein aggregates in dopamine neurons, specifically. Thus, the examples enable treatment of Alzheimer’s disease, but no examples were provided which teach a skilled artisan how to use the invention to treat any brain and nervous system disease; and no guidance is provided as to the mechanisms by which the Tregs work to treat Alzheimer’s disease, through which a skilled artisan can contemplate using the invention for alternative brain and nervous system diseases.
In conclusion upon careful consideration of the Wands factors that are used to determine whether undue experimentation is required to practice an invention, the amount of direction provided by the inventor and the working examples provided, as filed, is not deemed sufficient to enable the skilled artisan to make and/or use the invention commensurate in scope with the instant claims at the time the application was filed without undue experimentation.
Applicant is informed that this rejection may be overcome by amending claims 52-54 to remove the recitation of “preventing” and by limiting the scope of the brain and nervous system diseases to those that share a common pathological feature for which the invention is intended to target and treat.
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 34-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-10, 14-15 and 17-32 of copending Application No. 19/163,703 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of application '703 anticipates that of the instant claims.
Application ‘703 claims a binding molecule (claim 6) wherein the binding molecule has the HCDRs 1-3 of SEQ ID NOs: 7-9, respectively, and the LCDRs 1-3 of SEQ ID NOs: 10-12, respectively (claim 17); with a VH of SEQ ID NO: 13 and a VL of SEQ ID NO: 14 (claim 18); with a HC of SEQ ID NOs: 15 or 17 and a LC of SEQ ID NOs: 16 or 18 (claim 19).
The binding molecule of ‘703 is identical to that of the instant claims. Specifically, application ‘703 CDRs of SEQ ID NOs: 7-12 are 100% identical to the CDRs of instant SEQ ID NOs: 5-10, respectively. The VH and VL of application ‘703 SEQ ID NOs: 13 and 14 are 100% identical to the VH and VL of instant SEQ ID NOs: 11 and 12, respectively. The HCs of application ‘703 SEQ ID NOs: 15 and 17 are 100% identical to the HCs of instant SEQ ID NOs: 37 and 38, respectively; and the LCs of application ‘703 SEQ ID NOs: 16 and 18 are 100% identical to the LCs of instant SEQ ID NOs: 39 and 40, respectively. Thus, the binding molecule of application ‘703 anticipates the instant binding molecule with 100% structural similarity.
Application ‘703 also claims wherein the binding molecule is an antibody (claim 7), is a chimeric antibody (claim 8), is a CAR (claim 9), or an ADC (claim 10). Application ‘703 claims a method for screening using the binding molecule (claims 14-15), a method for treating a brain nervous system disease (claims 20-22 and 28-32); as well as nucleic acids encoding the binding molecule (claims 23-25), expression vectors (claim 26), and host cells (claim 27).
As application ‘703 claims the identical binding domain, ADCs, CARs, associated nucleic acids, vectors and host cells, and methods for treating, application ‘703 anticipates instant claims 34-35, 39-46, 50 and 52-54. Further, as the limitations of instant claims 36-39 are incorporated into the embodiments of claim 40, which are anticipated by application ‘703, instant claims 36-39 are also anticipated. Instant claims 47-49 and 51, drawn to pharmaceutical compositions comprising the identical binding molecule are made obvious by application ‘703 claim 20 which is drawn to a method of administering the binding molecule.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R. MELCHIOR whose telephone number is (703)756-4761. The examiner can normally be reached M-F 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES RYLAND MELCHIOR/Examiner, Art Unit 1644
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642