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 .
Drawings
The drawings filed on 3/29/24 are objected to because color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 1, 2, 5, 7, 9, 15, 19, 23, 25, 27-31, 33, 34, 36, 46, 49, 53, and 57 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.
The claims are directed to a nucleic acid comprising a nucleotide sequence encoding a full-length rod-derived cone viability factor (RdCVF-long) protein and a human IgK signal sequence comprising an amino acid sequence with at least 95% identity to SEQ ID NO: 7.
At the outset, it is noted that the claims do not recite a specific RdCVF-long nucleotide sequence by SEQ ID NO, but rather refer to the broad genus of RdCVF-long sequences.
As demonstrated by claim 2, recitation of RdCVF-long in claim 1 is not directed to any specific sequence and encompasses a genus of RdCVF1L and RDCVF2L sequences at a minimum, which is a genus that has not been adequately described by the specification.
The specification discloses that each of RdCVF1L and RDCVF2L encode two products via alternate splicing. The specification does not adequately describe the genus of RdCVF-long sequences in a definitive manner such that one would be readily able to envision the genus.
The species of the specification are not representative of the entire claimed genus. The claims are directed to any RdCVFL sequence of any length (instant claim 1) that comprises a sequence of any length that is at least 95% identical to SEQ ID NO: 3 or 15 (instant claim 9).
The specification discloses: As used herein the transitional term "comprising" is open-ended. A claim utilizing this term can contain elements in addition to those recited in such claim. Thus, for example, the claims can read on methods that also include other steps not specifically recited therein, as long as the recited elements or their equivalent are present.
Claim 5 requires for the sequence to be recoded. The specification does not adequately describe what level or quantity of alteration from what original sequence can be tolerated to function as required.
Claim 33 requires for the cell to be capable of secreting the RdCVFL protein. The specification does not adequately describe which cells necessarily have the structure to achieve the required function of being capable of secreting the RdCVFL protein.
Claim 34 requires for the cell to be cultured “under conditions that allow for expression and secretion of the RdCVFL protein”, which are conditions that are not adequately described in the specification. Without further description of the specific conditions required, one would not be able to readily envision which conditions are necessary for the recited method.
Claim 36 requires for the administration to be “under conditions permitting expression and secretion of RdCVFL”, which are conditions that are not adequately described in the specification. Without further description of the specific conditions required, one would not be able to readily envision which conditions are necessary for the recited method.
Claim 53 requires for the mammal to suffer from a disease associated with retinal pigmented epithelial cells. The specification does not adequately describe which diseases have any possible association to retinal pigmented epithelial cells.
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing.
Thus, having analyzed the claims with regard to the Written Description guidelines, it is clear that the specification does not disclose a representative number of species for RdCVF-long sequences within the instant enormous genus that function as claimed. Thus, one skilled in the art would be led to conclude that Applicant was not in possession of the claimed invention at the time the application was filed.
Claims 34, 36, 47, 49, 53, and 57 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 a method of expressing RdCVF-long via direct delivery of
to the cell, does not reasonably provide enablement for a method of preserving ocular rod and cone cells in the eye of any mammal with any of the recited conditions; or a method of treating any CNS disease. 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/or use the invention commensurate in scope with these claims.
Factors to be considered in a determination of lack of enablement include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) 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 claims are directed to a method of producing RdCVFL protein, secreting RdCVFL protein, preserving ocular rod and cone cells in the eye of any mammal with any of the recited conditions, and a method of treating any CNS disease via delivery of any RdCVF-long sequence and the recited IgK sequence.
The specification does not draw an adequate nexus between delivery of any possible RdCVFL sequence and each of the recited outcomes. The expression of two specific RdCVFL sequences in combination with a specific Igk sequence via an AAV virus and direct delivery of the eye is not enabling for delivery of any possible RdCVFL sequence via any mode of administration and each of the recited predictable outcomes.
The claims are directed to any RdCVFL sequence of any length (instant claim 1) that comprises a sequence of any length that is at least 95% identical to SEQ ID NO: 3 or 15 (instant claim 9).
The specification discloses: As used herein the transitional term "comprising" is open-ended. A claim utilizing this term can contain elements in addition to those recited in such claim. Thus, for example, the claims can read on methods that also include other steps not specifically recited therein, as long as the recited elements or their equivalent are present.
It is noted that claim 47 requires direct delivery to the eye, but the specification is not enabling for the recited outcome in any patient having any of the recited conditions because the specification does not draw an adequate nexus between delivery of the instantly recited genus of sequences and each of the recited outcomes.
Claim 57 is directed to a method of treating any CNS disease via broad systemic delivery of any RdCVFL sequence, although the specification does not draw an adequate nexus between delivery of the instant genus of sequences or even delivery of the two exemplified sequences of the specification and the predictable outcome of treatment of any possible CNS disease, which encompasses an enormous possible genus of diseases that have not been shown to be reliant upon RdCVFL expression alone.
Additionally, these claims do not require the addition of the AAV vector that was utilized for successful delivery of the two sequences of the specification and therefore the delivery conditions are not the same.
The specification demonstrates that AAV2-RdCVF1L (specific sequence that is not recited) vectors were injected into the subretinal space (not recited) of one eye with resultant protection against β-amyloid induced toxicity in specific neuron cells, which is not commensurate in scope with the predictable preservation of ocular rod and con cells in the eye of any mammal or with the treatment of any possible CNS disease.
The scope of the claims in view of the specification as filed together do not reconcile the unpredictability in the art to enable one of skill in the art to make and/or use the claimed invention, namely a broad method of mediating the instant methods via broad systemic delivery of an undefined genus of agents encompassing in vivo effects.
MPEP 2164.01
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.
Also, MPEP 2164.01(a)
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Given the teachings of the specification as discussed above, one skilled in the art could not predict a priori whether introduction of any possible RdCVF-long sequence in combination with IgK in vivo by the broadly disclosed methodologies of the instantly claimed invention, would result in each of the instantly recited outcomes. To practice the claimed invention, one of skill in the art would have to de novo determine; the stability of the molecule in vivo, delivery of the molecule to the whole organism, specificity to the target tissue in vivo, dosage and toxicity in vivo, and entry of the molecule into the cell in vivo and the effective action therein. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation (see MPEP 2164.01(a)).
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 5, 7, 9, 15, 19, 23, 25, 27-31, 33, 34, 36, 46, 49, 53, and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luo (WO 2013/063383 A2), in view of Stephens et al. (WO 2022/026775 A1), and Luo (US 2014/0328821 A1).
Luo et al. teach: The present invention relates to nucleic acids coding for and capable of expressing a rod-derived cone viability factor (RdCVF) and viral vectors containing these nucleic acids. The invention also relates to compositions and pharmaceutical preparations comprising these nucleic acids or vectors, methods of producing or secreting an RdCVF, and methods of treatment (abstract) (instant claim 1).
Luo et al. teach that the RdCVF1-long is RdCVF1L or 2L (page 3) (instant claim 2).
Luo et al. teach: The present invention relates, in part, to nucleic acids encoding RdCVF, RdCVF expression constructs, RdCVF vectors, methods of expressing RdCVF, methods of slowing, preventing or inhibiting photoreceptor cell (e.g., cone and/or rod cells) death, treating eye diseases, such as retinal dystrophies, and treating neurodegenerative diseases such as Alzheimer's disease, Huntington's disease, Parkinson's disease or an olfactory disease (page 2)(instant claims 36, 47, 53, and 57).
Luo et al. teach: Some embodiments of the invention provide nucleic acids comprising a nucleotide sequence encoding a coding sequence for an RdCVF protein, wherein the RdCVF coding sequence comprises a recoded nucleotide sequence. The invention also includes viral vectors comprising a nucleic acid, wherein the nucleic acid comprises a nucleotide sequence encoding a coding sequence for an RdCVF protein, wherein the RdCVF coding sequence comprises a recoded nucleotide sequence (page 2) (instant claim 5).
Luo et al. teach: Some embodiments of the invention relate to an isolated cell comprising a nucleic acid of the invention (page 2) (instant claim 33).
Luo et al. teach: Included in the invention are also pharmaceutical preparations comprising (i) a pharmaceutically acceptable carrier and (ii) a nucleic acid of the invention, a viral vector of the invention, an RdCVF protein of the invention or a combination thereof (page 2) (instant claim 46).
Luo et al. teach: Methods for producing an RdCVF protein comprising culturing a cell of the invention under conditions that allow for expression and secretion of the RdCVF protein and isolating the RdCVF protein from the cell culture are also provided (page 2)(instant claim 34).
Luo et al. teach: Some embodiments of the invention relate to methods of preserving ocular rod cells comprising administering to the eye of a mammal a nucleic acid of the invention, a viral vector of the invention, an RdCVF protein of the invention or a combination thereof (page 2) (instant claim 47).
Luo et al. teach: The invention also provides methods of treating diseases such as retinal dystrophy, Stargardt's disease, retinitis pigmentosa, dry age-related macular degeneration (dry AMD), geographic atrophy (advanced stage of dry AMD), wet age-related macular degeneration (wet AMD), glaucoma with or without ocular hypertension, diabetic retinopathy, Bardet-Biedel syndrome, Bassen-Kornzweig syndrome, Best disease, choroidema, gyrate atrophy, congenital amaurosis, refsun syndrome, Usher syndrome, thyroid related eye disease, Grave's disease, a disease associated with retinal pigmented epithelial cells, anterior segment disease, lens disease/cataracts, an eye cup disorder, uveitis, Alzheimer's disease, Huntington's disease, Parkinson's disease or an olfactory disease (pages 2 and 3) (instant claim 53).
Luo et al. teach: Some embodiments of the invention relate to methods of preserving ocular rod cells comprising administering to the eye of a mammal the nucleic acid and/or viral vector of the invention, wherein the nucleic acid and/or the viral vector is administered by subretinal injection and the rod cells are preserved at a site different from the site of the subretinal injection (page 3) (instant claim 47).
Luo et al. teach: Figure 9 shows the annotated nucleotide sequence of rAAV-RdCVF lL (page 5).
Luo et al. teach: Figure 10A: rAAV-RdCVFlL delivery improves retinal function in the rdlO mice. The ERGs were performed at approximately 5 wks after injection of rAAV-RdCVFlL. Measurements of ERG responses from all 8 mice we tested show that the mean b-wave amplitudes from treated eyes were about 3 times greater than those of untreated fellow eyes, which was statistically significant (p=0.025) (page 5).
Luo et al. teach: The invention also provides methods of treating a disease in a subject where the disease is mediated by or associated with a change in RdCVF 1 or RdCVF2 gene expression (e.g., a decrease in the presence of RDCVF 1 or RDCVF2 polypeptide in the eye) by the administration of a therapeutically effective amount of a nucleic acid or vector encoding an RDCVF 1 or RDCVF2 protein or a related protein or a fragment or portion thereof to a subject.
Luo et al. teach: Signal sequences are translated in frame as a peptide attached, typically, to the amino- terminal end of a polypeptide of choice. A secretory signal sequence will cause the secretion of the polypeptide from the cell by interacting with the machinery of the host cell. As part of the secretory process, this secretory signal sequence will typically be cleaved off or at least partially cleaved off. The term "signal sequence" also refers to a nucleic acid sequence encoding the signal peptide. In some embodiments, a signal sequence is heterologous as compared to a particular RdCVF (page 10) (instant claim 7).
Luo et al. teach: In some embodiments, the signal peptide is from an immunoglobulin such as an IgK (page 11) (instant claim 1).
Luo et al. teach: A signal sequence can be a mammalian, murine or human signal sequence (page 11).
Luo et al. teach: In some embodiments of the invention, a signal peptide sequence is encoded for the N-terminal or C-terminal of an RdCVF (page 11).
Luo et al. teach: In some embodiments, an RdCVF protein of the invention is initially translated from a nucleotide coding sequence with a signal peptide and in some cases all or part of the amino acids of the signal peptide are retained on an expressed and/or secreted RdCVF protein of the invention.
Luo et al. teach: Nucleic acids of the invention will typically comprise a promoter sequence operatively linked to an RdCVF coding sequence(page 13).
Luo et al. teach: In some embodiments, a vector or nucleic acid of the invention comprises an intron, operatively linked to a coding sequence for an RdCVF protein. An intron can be from an RdCVF gene or be a heterologous intron. Heterologous introns are known and non-limiting examples include a human β-globin gene intron and a beta-actin intron (page 14) (instant claims 19 and 23).
Luo et al. teach: The invention includes viral vectors comprising an RdCVF coding region of the invention. Examples of viral vectors useful in the present invention are described in PCT Publication No. WO08/106644 and U.S. Patent Publication No. US20100120665. In some embodiments, the invention is not limited to a particular viral vector. Viral vectors include, but are not limited to, retroviral vectors, lentiviral vectors, adenoviral vectors (see, for example, U.S. Pat. No. 7,045,344), AAV vectors (e.g., see U.S. Pat. No. 7, 105,345), Herpes viral vectors (e.g., see U.S. Pat. Nos. 5,830,727 and 6,040, 172), hepatitis (e.g., hepatitis D) viral vectors (e.g., see U.S. Pat. No. 5,225,347), SV40 vectors, EBV vectors (e.g., see U.S. Pat. No. 6,521,449) and Newcastle disease virus vectors (e.g., see U.S. Pat. Nos. 6, 146,642, 7,442,379, 7,332,169 and 6,719,979). In some embodiments, a lentiviral vector is an HIV, EIAV, SIV, FIV or BIV vector. In some embodiments, a vector is selected from an AAV vector or an adenoviral vector. The invention also provides a cell that produces a viral vector of the invention (page 15) (instant claims 25, 27, and 28).
Luo et al. teach: In some embodiments of the invention, an AAV1, AAV2, AAV3, AAV4, AAV5, AAV6, AAV7, AAV8 or AAV9 serotype may be used (page 16) (instant claims 29-31).
Luo et al. teach: Nucleic acids and viral vectors of the invention can be used to express, produce and/or secrete an RdCVF from a cell. This expression, production and/or secretion can occur in vitro, in vivo or ex vivo. Some embodiments of the invention provide methods of secreting an RdCVF protein from a cell comprising administering to the cell a nucleic acid and/or a viral vector of the invention. In some embodiments, the cell can be a mammalian cell, a human cell, an ocular cell, a retinal pigment epithelial (RPE) cell, a rod cell or a cone cell (instant claims 34 and 36).
Luo et al. teach: In some embodiments, compositions of the invention can be administered locally or systemically. Useful routes of administration are described herein and known in the art. Methods of introduction or administration include, but are not limited to, intradermal, intramuscular, intraperitoneal, intravenous, subcutaneous, intranasal, intratracheal, topical, inhaled, transdermal, rectal, parenteral routes, epidural, intracranial, into the brain, intraventricular, subdural, intraarticular, intrathecal, intracardiac, intracoronary, intravitreal, subretinal, intraanterior chamber of the eye, locally on the cornea, subconjunctival, subtenon injection, by applying eyedrops, oral routes, via balloon catheter, via stent or any combinations thereof. Systemic administration may be, but is not limited to, by intravenous or intra-arterial injection or by transmucosal, subcutaneous, transdermal and/or intraperitoneal delivery (page 18) (instant claims 47 and 49).
Luo et al. teach: In some embodiments, an RdCVF protein is administered by subretinal injection or intravitreal injection of an AAV vector that encodes RdCVF. In some embodiments, about 5xl0.sup.8 to about lxlO.sup.9; about 5xl0.sup.8 to about 7.5xl0.sup.8; about 7.5xl0.sup.8 to about lxlO.sup.9; about 6xl0.sup.8 to about 9xl0.sup.8; about 7xl0.sup.8 to about 8xl0.sup.8; about 5xl0.sup.8; about 6xl0.sup.8; about 7xl0.sup.8; about 8xl0.sup.8; about 9xl0.sup.8; or about lxlO.sup.9 vector genome copy (GC) number of an AAV vector is administered by subretinal injection. In some embodiments, about 5xl0.sup.8 to about lxlO.sup.10; about 5xl0.sup.8 to about 5xl0.sup.9; about 5xl0.sup.8 to about 2xl0.sup.9; about 2xl0.sup.9 to about 5xl0.sup.9; about 5xl0.sup.9 to about lxlO.sup.10; about 5xl0.sup.8 to about lxlO.sup.9; about lxlO.sup.9 to about 3xl0.sup.9; about 3xl0.sup.9 to about 6xl0.sup.9; about 6xl0.sup.9 to about lxlO.sup.10; about lxlO.sup.9 to about lxlO.sup.10; about lxlO.sup.10 to about lxlO.sup.11; or lxlO.sup.11 to about lxlO.sup.12 GC of an AAV vector is administered by intravitreal injection (page 23) (instant claim 49).
Luo et al. teach: The invention includes methods of treating a disease comprising administering to a mammal a nucleic acid of the invention, a viral vector of the invention, an RdCVF protein of the invention, a pharmaceutical composition of the invention or a combination thereof, wherein the disease is selected from the group consisting of Alzheimer's disease, Huntington's disease, Parkinson's disease and an olfactory disease. In some embodiments, the viral vector of this invention is an AAV vector (page 24) (instant claim 57).
Luo et al. teach that the IGK sequence can be human but do not disclose the sequence. However, Stephens et al. teaches an IGK sequence comprising instant SEQ ID NO: 7 and therefore comprises an amino acid sequence that is 100% identical to SEQ ID NO: 7 at positions 1-23 of SEQ ID NO: 5340 (Table 8, page 342). Therefore, it would have been obvious to utilize this known sequence as a matter of design choice.
See result #3 of the PE2E search file titled “us-18-622-513-7.align450.rag” as follows:
RESULT 3
BKQ67451
ID BKQ67451 standard; protein; 89 AA.
AC BKQ67451;
DT 07-JUL-2022 (revised)
DT 24-MAR-2022 (first entry)
DE mAb IGK light chain, SEQ ID 5340.
KW antibody therapy; antimicrobial-gen.; coronavirus infection;
KW immunoglobulin kappa; infectious disease; light chain;
KW monoclonal antibody; respiratory-gen.; sars coronavirus infection;
KW spike protein; therapeutic; virucide.
OS Homo sapiens.
CC PN WO2022026775-A1.
CC PD 03-FEB-2022.
CC PF 29-JUL-2021; 2021WO-US043799.
PR 30-JUL-2020; 2020US-0058907P.
CC PA (PREL-) PRELLIS BIOLOGICS INC.
CC PI Stephens E, Matheu MP;
DR WPI; 2022-185086/014.
CC PT Formulation useful for treating an infectious disease e.g. coronavirus
CC PT disease 2019 comprises an antibody or its fragment comprising a peptide or a polypeptide.
CC PS Claim 31; SEQ ID NO 5340; 482pp; English.
CC The present invention relates to a novel formulation, useful for treating
CC infectious disease in a subject. The formulation comprises a
CC therapeutically effective amount of an antibody or an active fragment of
CC SEQ ID NOs: 1-935 (see BKQ62112-BKQ63046), where the antibody comprises:
CC (a) a heavy chain (HC) variable region (VH); (b) a light chain (LC)
CC variable region (VL); (c) a heavy chain constant region (CH); (d) a light
CC chain constant region (CL); (e) complementarity determining regions
CC (CDRs); and (f) framework regions (FRs). The invention further relates
CC to: (1) a nucleic acid molecule encoding the antibody; (2) a vector
CC comprising the nucleic acid; (3) a pharmaceutical composition comprising
CC the antibody; amd (4) a method for treating a subject having or suspected
CC of having coronavirus disease. The novel formulation of the invention can
CC be used for treating infectious disease such as coronavirus disease 2019
CC (COVID-19). Note: SEQ ID NOs: 6329 and 7418 are mentioned in Claim 31 and
CC Claim 41, but their corresponding sequences are not shown in the
CC specification.
CC Revised record issued on 07-JUL-2022 : Addition of DWPI-enhanced title
CC (PT field).
SQ Sequence 89 AA;
Query Match 100.0%; Score 120; Length 89;
Best Local Similarity 100.0%;
Matches 23; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MDMRVPAQLLGLLLLWLSGARCD 23
Db 1 MDMRVPAQLLGLLLLWLSGARCD 23
Additionally. Luo (US20140328821A1) teach a sequence that comprises a sequence fragment that is 100% identical to instant SEQ ID NO: 3 and disclosed as recoded RdCVF1L with Igk signal peptide sequence (-Met). Therefore, this would have been an obvious selection of a sequence for the method of Luo et al. as a matter of design choice.
See result #4 of the PE2E sequence search file titled “us-18-622-513-3.align450.rapbm” as follows:
RESULT 4
US-14-354-415-2
Sequence 2, US/14354415
Publication No. US20140328821A1
GENERAL INFORMATION
APPLICANT: Wellstat Ophthalmics Corporation
APPLICANT: Luo, Tianci
TITLE OF INVENTION: VECTORS ENCODING ROD-DERIVED CONE VIABILITY FACTOR
FILE REFERENCE: WOC-018PCT
CURRENT APPLICATION NUMBER: US/14/354,415
CURRENT FILING DATE: 2014-04-25
PRIOR APPLICATION NUMBER: PCT/US2012/062106
PRIOR FILING DATE: 2012-10-26
PRIOR APPLICATION NUMBER: US 61/552,155
PRIOR FILING DATE: 2011-10-27
NUMBER OF SEQ ID NOS: 15
SEQ ID NO 2
LENGTH: 246
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: recoded RdCVF1L with Igk signal peptide sequence (-Met)
Query Match 92.1%; Score 1119; Length 246;
Best Local Similarity 89.4%;
Matches 220; Conservative 3; Mismatches 9; Indels 14; Gaps 1;
Qy 3 MRVPAQLLGLLLLWLSGARCD--------------ASLFSGRILIRNNSDQDELDTEAEV 48
| || :||||: |: | |||||||||||||||||||||||||
Db 1 METDTLLLWVLLLWVPGSTGDAAQPARRAVRSLVPASLFSGRILIRNNSDQDELDTEAEV 60
Qy 49 SRRLENRLVLLFFGAGACPQCQAFVPILKDFFVRLTDEFYVLRAAQLALVYVSQDSTEEQ 108
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SRRLENRLVLLFFGAGACPQCQAFVPILKDFFVRLTDEFYVLRAAQLALVYVSQDSTEEQ 120
y 109 QDLFLKDMPKKWLFLPFEDDLRRDLGRQFSVERLPAVVVLKPDGDVLTRDGADEIQRLGT 168
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 QDLFLKDMPKKWLFLPFEDDLRRDLGRQFSVERLPAVVVLKPDGDVLTRDGADEIQRLGT 180
Qy 169 ACFANWQEAAEVLDRNFQLPEDLEDQEPRSLTECLRRHKYRVEKAARGGRDPGGGGGEEG 228
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 ACFANWQEAAEVLDRNFQLPEDLEDQEPRSLTECLRRHKYRVEKAARGGRDPGGGGGEEG 240
Qy 229 GAGGLF 234
||||||
Db 241 GAGGLF 246
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 1, 2, 5, 7, 9, 15, 19, 23, 25, 27-31, 33, 34, 36, 46, 49, 53, and 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 35, 72, 81-83, 86, 89, 90, 128, 134, 143-145, 148, and 151 of copending Application No. 19/339,969 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of application ‘969 are directed to a fusion protein comprising an N-terminal signal peptide, more specifically a IgK (claim 5, instant claim 1) and two short RdCVF peptides, whereas the instant claims require the same IgK and a RdCVF long. The short peptides together meet the limitation of a long. The remainder of the claims recite the same vectors, cells, methods of delivery and methods of producing the protein. The claims are obvious variations of each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636
Prosecution Insights