DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s Response to Election/Restriction Filed, Amendment, and Arguments/Remarks, filed 25 June 2025, have been entered. Applicant canceled claims 10-11 and 25-26. Claims 1-9, 12-14, 16-24, 27, and 32 are currently pending. Claims 1 and 14 are independent claims. Applicant’s election of the following species:
Heavy chain amino acid sequences: a. SEQ ID NO: 2;
Light chain amino acid sequences: a. SEQ ID NO: 1;
Cell type: l. retinal pigment epithelial cells;
in a reply filed 25 June 2025 is acknowledged.
Claims 6-7 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Claims 1-5, 8-9, 12-14, 16-18, 21-24, 27, and 32 are currently pending in the application and under examination to which the following grounds of rejection are applicable. An action on the merits follows.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2020/047733, filed 25 August 2020, which claims priority to U.S. Provisional Application Nos. 62/891,799, filed 26 August 2019, 62/902,352, filed 18 September 2019, and 63/004,258, filed 02 April 2020.
Thus, the earliest possible priority for the instant application is 26 August 2019.
However, U.S. Provisional Application Nos. 62/891,799 and 62/902,352 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for one or more claims of this application. Claims 12-13 and 23-24 of the instant application recite an additional step to the method of treating a human subject diagnosed with DR of “monitoring the post ocular injection thermal profile of the injected material in the eye using an infrared thermal camera” (claims 12 and 23 lines 2-3 each) and “wherein the infrared thermal camera is a FLIR T530 infrared thermal camera” (claims 13 and 24, lines 1-2 each). The provisional applications 62/891,799 and 62/902,352, upon which the instant application claims priority, do not disclose any steps of monitoring the post ocular injection thermal profile of the injected material in the eye using an infrared thermal camera. Thus, the provisional applications 62/891,799 and 62/902,352 do not provide support for claims 12-13 nor 23-24 of the instant application.
Additionally, claim 27 recites, wherein (a) the method does not result in shedding of the expression vector; or (b) less than 1000, less than 500, less than 100, less than 50, or less than 10 expression vector gene copies/5 µl are detectable by qPCR in a biological fluid at any point after administration; or (c) 210 expression vector gene copies/5 µl or less are detectable by qPCR in a biological fluid at any point after administration; or (d) less than 1000, less than 500, less than 100, less than 50, or less than 10 vector gene copies/5 µl are detectable by qPCR in a biological fluid by 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 weeks after administration; or (e) no vector gene copies are detected in a biological fluid by week 14 after administration of the vector. Claim 32 further recites wherein the biological fluid is tears, serum, or urine. The provisional applications 62/891,799, 62/902,352, and 63/004,258 upon which the instant application claims priority, do not disclose any testing of biological fluids to measuring shedding of the expression vector, nor do they disclose any use of qPCR.
Accordingly, claims 12-13 and 23-24 are not entitled to the benefit of the prior applications 62/891,799 and 62/902,352 and thus have an effective filing date of 02 April 2020. Claims 17 and 32 are not entitled to the benefit of the prior applications 62/891,799, 62/902,352, and 63/004,258 and thus have an effective filing date of 25 August 2020. Claims 1-5, 8-9, 14, 16-18, and 21-22 are entitled to the benefit of the prior applications with an effective filing date of 26 August 2019.
Information Disclosure Statement
The information disclosure statements filed 25 August 2022 have been considered by the Examiner.
37 CFR 1.821-1.825
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2), see for example paragraph [0073] section (iv) on page 34 (e.g., EDTAVY94Y95 and EDFATY86), [00122] section (ii) on page 57 (e.g., TVSWN165SGAL, QSGN158SQE, and TFFQ100GT) and section (iv) on page 57 (e.g., EDTAVYY and EDFATY), [0193] (e.g., RKRR, RRRR, RRKR, RKKR), and Table 2 of the instant specification and Figures 1 and 3 of the instant drawings. However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below and on the Notice to Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures which is attached to this communication. Specifically, paragraph [0073] section (iv) on page 34 (e.g., EDTAVY94Y95 and EDFATY86), [00122] section (ii) on page 57 (e.g., TVSWN165SGAL, QSGN158SQE, and TFFQ100GT) and section (iv) on page 57 (e.g., EDTAVYY and EDFATY), [0193] (e.g., RKRR, RRRR, RRKR, RKKR), and Table 2 of the instant specification and Figures 1 and 3 of the instant drawings disclose amino acid and/or nucleotide sequences but do not include any sequence identifiers. If the unidentified sequences of paragraph [0073] section (iv) on page 34 (e.g., EDTAVY94Y95 and EDFATY86), [00122] section (ii) on page 57 (e.g., TVSWN165SGAL, QSGN158SQE, and TFFQ100GT) and section (iv) on page 57 (e.g., EDTAVYY and EDFATY), [0193] (e.g., RKRR, RRRR, RRKR, RKKR), and Table 2 of the instant specification and Figures 1 and 3 of the instant drawings are included in the submitted sequence listing, Applicant must amend the claims and specification and/or drawings to comply with the sequence identification requirements. Alternatively, if the unidentified sequences of paragraph [0073] section (iv) on page 34 (e.g., EDTAVY94Y95 and EDFATY86), [00122] section (ii) on page 57 (e.g., TVSWN165SGAL, QSGN158SQE, and TFFQ100GT) and section (iv) on page 57 (e.g., EDTAVYY and EDFATY), [0193] (e.g., RKRR, RRRR, RRKR, RKKR), and Table 2 of the instant specification and Figures 1 and 3 of the instant drawings are not included in the presently submitted sequence listing, Applicant must submit an updated sequence listing in compliance with 37 CFR 1.821(c)-(d) and 37 CFR 1.825(b). See also the attached Notice to Comply.
APPLICANT IS GIVEN A THREE MONTH EXTENDABLE PERIOD WITHIN WHICH TO COMPLY WITH THE SEQUENCE RULES, 37 CFR 1.821-1.825. Failure to comply with these requirements will result in ABANDONMENT of this application under 37 CFR 1.821 (g). Extension of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 CFR 1.136. In no case may an applicant extend the period for response beyond the six month statutory period. Applicant is requested to return a copy of the attached Notice to Comply with the response.
Specification
The disclosure is objected to because of the following informalities: the Brief Description of the Drawings does not include a description of each panel. Specifically, Figure 7 does not include individual descriptions of panels A, B, C, or D, and Figure 9 does not include individual descriptions of panels A and B. See MPEP 608.01(f), which states, “When there are drawings, there shall be a brief description of the several views of the drawings and the detailed description of the invention shall refer to the different views by specifying the numbers of the figures, and to the different parts by use of reference letters or numerals”. Further, MPEP 608.01(f) instructs Examiners such that “If the drawings show Figures 1A, 1B, and 1C and the brief description of the refers only to Figure 1, the examiner should object to the brief description, and require applicant to provide a brief description of Figures 1A, 1B, and 1C.” Appropriate correction is required.
Additionally, the brief description of Figure 10 includes and apparent typographical error reciting “FIG. 8B” [00110] which appears to refer to Figure 10B. Appropriate correction is required.
The use of the terms “MedOne”, “Dorc”, and “Visionisti” in [00246], “FLIR” in [00256-00257, 00350], and “ELISpot” in Table 8, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Note that the specification has not been inspected sufficiently to identify all uses of trade names and/or marks. It is Applicant’s responsibility to ensure complete compliance.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 3-5, 14, and 16-18 are objected to because of the following informalities: claims 1, 3-5, 14, and 16-18 each recite amendments to the claim wherein the inserted text is presented in bold type, which is not an acceptable format for claims. See MPEP 714 and 37 C.F.R. 1.121(c), which outlines the specific acceptable markings for amendments to the claims (e.g., underlining of inserted text) and does not indicate that bold text is an acceptable marking. Appropriate correction is required.
Additionally, claim 14 recites the abbreviation “DR” without first writing out the term for which “DR” is an abbreviation. Appropriate correction is required.
Claims 8 and 21 are objected to because of the following informalities: claims 8 and 21 recite the abbreviation “CB7” without first writing out the term for which “CB7” is an abbreviation. Appropriate correction is required.
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.
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 9, 12-13, and 22-24 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 9 and 22 each recite, “ wherein the expression vector is Construct II”, which is indefinite because it is unclear what is required to be comprised within “Construct II”. The claim does not define the scope of the term “Construct II” and the specification does not provide a limiting definition of “Construct II”. As such, the metes and bounds of the claims cannot be determined.
In the interest of compact prosecution, claims 9 and 22 have been interpreted to encompass any expression vector construct which meets the limitations of claims 1 and 8 or claims 14 and 21, upon which claims 9 and 22 depend.
Claims 12 and 23 recite, “a step of monitoring the post ocular injection thermal profile of the injected material in the eye using an infrared thermal camera” in lines 2-3 in each claim, which is indefinite because infrared thermal cameras for monitoring a thermal profile in the eye measure the thermal profile of the surface of the eye, and as such do not monitor the thermal profile of the subretinally injected material. Tan teaches that ocular IR thermography is unable to provide thermal information and description of anatomical features beneath the anterior eye and cannot provide description (or image) on the posterior segment of the eye (Tan et al. 2009, Infrared Physics & Technology, 52, 97-108, column 19 ¶ 6). As such, the metes and bounds of the claim cannot be determined. Claims 13 and 24 are included in this rejection due to their dependence on claims 12 and 23, respectively.
Claims 13 and 24 contains the trademark/trade name “FLIR T530”. 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 an infrared thermal camera and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 8-9, 14, 16-18, and 21-22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Simpson et al. (US20190127455A1), published 2 May 2019, filed 14 April 2017, with priority to U.S. Provisional Application No. 62/323,285, filed 15 April 2016, IDS.
Regarding claims 1 and 14, Simpson discloses a method of treating a human subject diagnosed with diabetic retinopathy (DR) [abstract, 0003, 0006, 0009, 0025, 0082], comprising administering to the subretinal space of the eye of said human subject [0025, 0082] an expression vector encoding an anti-human vascular endothelial growth factor (hVEGF) antigen-binding fragment/ antibody fragment [0025, 0082], wherein the anti-hVEGF antigen-binding fragment/antibody fragment comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 2, which is the same length as and has 100% sequence identity with instant SEQ ID NO: 2 [0082, 0223, Table 2, see alignment below] and a light chain comprising the amino acid sequence of SEQ ID NO: 1, which is the same length as and has 100% sequence identity with instant SEQ ID NO: 1 [0082, 0223, Table 2, see alignment below], and wherein the expression vector is an AAV8 vector [0045, 0072, 0082, 0188, 0194, 0223].
Alignment of instant SEQ ID NO: 2 with Simpson SEQ ID NO: 2:
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Alignment of instant SEQ ID NO: 1 with Simpson SEQ ID NO: 1:
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Regarding claim 2, Simpson discloses wherein the administering to the subretinal space of the eye of the human subject is by injecting the expression vector into the subretinal space using a subretinal drug delivery device (e.g., the delivery is automated via the vitrectomy machine to deliver 250 µl to the subretinal space with a 38 gauge subretinal cannula) [0314].
Regarding claims 3-5 and 16-18, Simpson teaches wherein the administering delivers a therapeutically effective amount of the anti-hVEGF antigen-binding fragment/ antibody fragment to the retina of said human subject [0048, 0111, 0237-0238], and wherein the therapeutically effective amount of the anti-hVEGF antigen biding fragment/antibody fragment is produced by human retinal cells of said human subject, including retinal epithelial cells [0048, 0111, 0239].
Regarding claims 8 and 21, Simpson discloses wherein the expression vector comprises the CB7 promoter [0184, 0205, 0270].
Regarding claims 9 and 22, Simpson teaches that the expression vector is an HuPTMFabVEGFi vector called “Vector 1”, which is a non-replicating AAV8 vector containing a gene cassette encoding a humanized mAb antigen-binding fragment that binds and inhibits human VEGF, flanked by AAV2 inverted terminal repeats (ITRs) such that expression of heavy and light chains in Vector 1 are controlled by the CB7 promoter consisting of the chicken β-actin promoter and CMV enhancer, and the vector also comprises a chicken β-actin intron, and a rabbit β-globin polyA signal, wherein the nucleic acid sequences coding for the heavy and light chains of anti-VEGF Fab are separated by a self-cleaving furin (F)/F2A linker [0269-0270]. As discussed above in the 112(b) rejection of claims 9 and 22, “Construct II” has not been defined by the claim nor is a limiting definition of “Construct II” provided within the specification. Therefore, by teaching an expression vector is a vector/construct meeting the limitations of claims 1 and 8 and 14 and 21, Simpson teaches that the expression vector is a vector which meets the limitations of claims 9 and 22 as written.
Accordingly, by teaching all of the limitations of claims 1-5, 8-9, 14, 16-18, and 21-22 as written, Simpson anticipates the instant invention as claimed.
Claim(s) 1-5, 8-9, 14, 16-18, 21-22, 27, and 32 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tretiakova & Wilson (US20190381194A1), published 19 December 2019, filed 14 April 2017, with priority to U.S. Provisional Application No. 62/323,184, filed 15 April 2016, IDS.
Regarding claims 1 and 14, Tretiakova teaches a method of treating a human subject diagnosed with diabetic retinopathy (DR) [0087-0088, 0092], comprising administering to the subretinal space of the eye of said human subject [0012, 0026, 0074, 0109] an expression vector encoding an anti-human vascular endothelial growth factor (hVEGF) antigen-binding fragment/ antibody fragment (Fab) [0029, 0109], wherein the anti-hVEGF antigen-binding fragment/antibody fragment (Fab) comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 1, which is the same length as and has 100% sequence identity with instant SEQ ID NO: 2 [0029, 0045] and a light chain comprising the amino acid sequence of SEQ ID NO: 2, which is the same length as and has 100% sequence identity with instant SEQ ID NO: 1 [0029, 0045], and wherein the expression vector is an AAV8 vector [0014, 0026, 0060, 0109].
Alignment of instant SEQ ID NO: 2 with Tretiakova SEQ ID NO: 1:
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Alignment of instant SEQ ID NO: 1 with Tretiakova SEQ ID NO: 2:
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Regarding claim 2, Tretiakova discloses wherein the administering to the subretinal space of the eye of the human subject is by injecting the expression vector into the subretinal space using a subretinal drug delivery device (e.g., the delivery is automated via the vitrectomy machine to deliver 250 µl to the subretinal space with a 38 gauge subretinal cannula) [0094, 0017].
Regarding claims 3-5 and 16-18, Tretiakova teaches wherein the administering delivers a therapeutically effective amount of the anti-hVEGF antigen-binding fragment/ antibody fragment (Fab) to the retina of said human subject [0014, 0093], and wherein the therapeutically effective amount of the anti-hVEGF antigen binding fragment/antibody fragment is produced by human retinal cells of said human subject, including retinal epithelial cells [0060, 0344].
Regarding claims 8 and 21, Tretiakova discloses wherein the expression vector comprises the CB7 promoter [0016-0017, 0052, 0113, Figure 1].
Regarding claims 9 and 22, Tretiakova teaches that the expression vector is an AAv8.CB7.aVEGF vector, which is an AAV8 vector genome containing a gene cassette flanked by the AAV2 inverted terminal repeats (ITRs) and expressing human anti-vascular endothelial growth factor (anti-VEGF) antigen binding antibody fragment (Fab) and comprises control elements including the CB7 promoter consisting of the chicken β-actin promoter and CMV enhancer, a chicken β-actin intron, and a rabbit β-globin polyA signal, wherein the nucleic acid sequences coding for the heavy and light chains of anti-VEGF Fab are separated by a self-cleaving furin (F)/F2A linker [0007, 0016, Figure 1]. As discussed above in the 112(b) rejection of claims 9 and 22, “Construct II” has not been defined by the claim nor is a limiting definition of “Construct II” provided within the specification. Therefore, by teaching an expression vector is a vector/construct meeting the limitations of claims 1 and 8 and 14 and 21, Tretiakova teaches that the expression vector is a vector which meets the limitations of claims 9 and 22 as written.
Regarding claims 27 and 32, Tretiakova teaches that clinical objectives are determined by measuring performing vector shedding analysis in serum and urine [0166, 0275, 0366]. Tretiakova also teaches that shedding of the AAV8.aVEGF test vector was determined by quantitative PCR (qPCR) analysis targeting transgene-specific sequences in samples of tears, nasal secretion, serum, saliva, urine, and feces, and that the AAV8.aVEGF test vector DNA was readily detectable in most samples collected from animal administered AAV8 [0318]. Tretiakova further teaches that the presence of AAV8.aVEGF DNA was dose-dependent, transient, and decreased over time [0318]. By teaching that only “most” samples had readily detectable vector DNA and that the presence of AAV8.aVEGF DNA was transient, Tretiakova teaches that the expression vector DNA was undetectable by qPCR at some point after administration.
Accordingly, by teaching all of the limitations of claims 1-5, 8-9, 14, 16-18, 21-22, 27, and 32 as written, Tretiakova anticipates the instant invention as claimed.
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 1-5, 8-9, 12-14, 16-18, 21-24, 27, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 24-34, and 38-63 of copending Application No. 16/971,215, hereafter referred to as the ‘215 application.
The ‘215 application claims recite a method for inhibiting human vascular endothelial growth factor (hVEGF) in an eye of a human patient comprising administering an rAAV comprising a vector genome and an AAV8 capsid to the eye, wherein the vector genome comprises AAV2 inverted terminal repeats and an expression cassette comprising an anti-hVEGF Fab with a heavy chain comprising the amino acid sequence of SEQ ID NO: 1 (which is the same length as and 100% identical to SEQ ID NO: 2 of the instant application) and a light chain comprises SEQ ID NO: 2 (which is the same length as and 100% identical to SEQ ID NO: 1 of the instant application), a self-cleaving furin (F)/F2A linker, a cytomegalovirus immediate early (CMV IE) enhancer, a chicken beta actin promoter, a chicken beta actin intron, and a rabbit beta globin polyA signal, wherein the administration maintains effective expression of the anti-hVEGF in the eye and is effective in treating a retinal disease associated with hVEGF (claim 54). The additional vector components recited by the ’215 application claim 54 are components taught by the instant specification to be comprises within Construct II, as recited in instant claims 9 and 22 (e.g., AAV2 inverted terminal repeats that flank the expression cassette, control elements including a chicken beta-actin intron, a rabbit beta-globin polyA signal, and a furin (F)/F2A linker [instant 0008, 00165, 00211, Figure 4]). The ‘215 application claims 55 and 62 recite wherein the retinal disease is diabetic retinopathy, and claim 56 recites wherein the administration is subretinal injection.
Alignment of instant SEQ ID NO: 2 with ‘215 application SEQ ID NO: 1:
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Alignment of instant SEQ ID NO: 1 with ‘215 application SEQ ID NO: 2:
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Therefore, by teaching the limitations of the instant claims, the ‘215 application claims encompass and render obvious the method of the instant application.
This is a provisional nonstatutory double patenting rejection.
Claims 1-5, 8-9, 12-14, 16-18, 21-24, 27, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-10, 15-18, 23-25, 34-38, and 41 of copending Application No. 17/600,377, hereafter referred to as the ‘377 application.
The ‘377 application claims recite a method of subretinal administration for treating a diabetic retinopathy comprising administering to the subretinal space a rAAV8 vector comprising an expression cassette encoding an anti-hVEGF antigen-binding fragment, wherein the expression cassette comprises a CB7 promoter, a heavy chain of the anti-hVEGF antigen-binding fragment comprising the amino acid sequence of SEQ ID NO: 2 (which is the same length as and 100% identical to SEQ ID NO: 2 of the instant application), and a light chain of the anti-hVEGF antigen-binding fragment comprising the amino acid sequence of SEQ ID NO: 1 (which is the same length as and 100% identical to SEQ ID NO: 1 of the instant application), wherein the anti-hVEGF is expressed and results in treatment of DR of the eye (claim 15). The ‘377 application claims teach all of the limitations of independent claims 1 and 14 of the instant application. The ’377 application claim 15 recites additional limitations regarding the components of the AAV8 vector genome which are components taught by the instant specification to be comprises within Construct II, as recited in instant claims 9 and 22 (e.g., AAV2 inverted terminal repeats that flank the expression cassette, control elements including a chicken beta-actin intron, a rabbit beta-globin polyA signal, and a furin (F)/F2A linker [instant 0008, 00165, 00211, Figure 4]). The ‘377 application claims also recite wherein the method further comprises, after administering, monitoring a thermal profile of the composition in the eye using an infrared thermal camera (claim 41), as recited in claims 12-13 and 23-24 of the instant application.
Alignment of instant SEQ ID NO: 1 with ‘377 application SEQ ID NO: 1:
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Alignment of instant SEQ ID NO: 2 with ‘377 application SEQ ID NO: 2:
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Therefore, by teaching the limitations of the instant application, the ‘377 application claims encompass and render obvious the method of the instant application.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. KATIE L PENNINGTON whose telephone number is (703)756-4622. The examiner can normally be reached M-Th 8:30 am - 5:30 pm, Friday 8:30 am - 12:30 pm CT.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634