DETAILED ACTION
This action is in reply to papers filed 5/11/2016.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230226158A1, Published 7/20/2023.
Withdrawn Objections/Rejections
Unless otherwise indicated, previous objections/rejections that have been rendered moot in view of the amendment will not be reiterated. The arguments in the 5/11/2016 response will be addressed to the extent that they apply to current rejection(s).
Election by Original Presentation
Newly submitted claim 58 is directed to a method of treating or ameliorating inefficient neutrophilic extracellular trap hydrolysis in a subject afflicted with a bacterial or viral infection;
the method comprising administering to the subject a therapeutically effective amount of a polypeptide construct comprising: a human DNAseI domain, wherein the human DNAsel domain comprises a variant of a polypeptide of SEQ IDNO: 1, wherein the variant of a polypeptide of SEQ ID NO: I has substitutions that correspond to the substitutions Q3IR, N96K, and A136F in the polypeptide of SEQ ID NO: 1, and wherein the variant of a polypeptide of SEQ ID NO: I has DNAse activity; a half-life extending domain; and a linker connecting the human DNAsel domain and the half-life extending domain.
Pending claim 1 is drawn to the method comprising administering to the subject a therapeutically effective amount of a construct comprising a human DNAsel domain, wherein the human DNAsel domain comprises a variant of a polypeptide of SEQ ID NO: 1, wherein the variant of the polypeptide of SEQ ID NO: 1 has substitutions that correspond to the substitutions Q3IR, N96K, and A136F in the polypeptide of SEO ID NO: 1, and wherein the variant of the polypeptide of SEQ ID NO: I has DNAse activity; and a variant of the polypeptide of SEQ ID NO: 4, wherein the variant of the polypeptide of SEQ ID NO: 4 is an Fc domain comprising substitutions corresponding to substitutions M32Y, S34T, and T36E in the polypeptide of SEQ ID NO: 4.
The independent claims] are directed to related but distinct inventions. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are not capable of use together and have different designs. Note that the method of treating of claim 1 does not require a half-life extending domain and the invention of claim 58 does not require an Fc domain. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented
invention, this invention has been constructively elected by original presentation for
prosecution on the merits. Accordingly, claims 58 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Claims 1, 9, 18, 23, 27-28, 30-33, 26-42, 44-58 with claims 1, 9, 18, 23, 27-28, 30-33, and 26-42 examined herein.
Rejections Necessitated by Amendments
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.
Prior Art Rejection 1
Claim(s) 1, 9, 27, 30, 33, 36, and 42 are newly rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Romo et al. (Sci Transl Med. 2011;3:73ra20), Ledbetter et al. (PgPub US20140044711A1, Published 2/13/2014; Ref. 2 in IDS filed 10/2/2023), Posada et al. (PgPub US20190241878A1, Published 8/8/2019; Ref. 4 in IDS filed 10/2/2023) and Ulrichts et al. (PgPub US20150218239A1, Published 8/6/2015).
Regarding claim 1, in-part, Garcia-Romo et al. teach SLE is a chronic inflammatory disease caused by inefficient NETolyisis (Pg. 8, Col. 1) (as in claim 33). Garcia-Romo explains that SLE neutrophils readily release NETs in response to exogenous stimuli, such as bacterial infection (as further in claim 1), and that these NETs can then potently activate pDCs to release high levels of IFN which in turn primes neutrophils for additional NETosis. Garcia-Romo teaches this loop promotes the disease development and progression in SLE (Pg. 8, Col. 1, last paragraph).
However, Garcia-Romo fails to teach a method of treating comprising administering to the subject a therapeutically effective amount of a construct comprising, inter alia, a human DNAse1 domain (as further in claim 1).
Before the effective filing date of the claimed invention and with further regards to claim 1, in-part, Ledbetter et al. teach a hybrid nuclease molecule (i.e. a construct) comprising a human DNAseI (Pg. 3, para. 23) and a Fc domain of human IgG1 (Pg. 12, para. 138), wherein the first nuclease domain is operatively coupled to the Fc domain (as in claim 14a). Ledbetter teaches the hybrid nuclease molecule further includes a first linker domain, and the human DNAseI polypeptide is operatively coupled to the Fc domain of human IgG1 by the first linker domain (Pg. 1, para. 5). Ledbetter teaches the linker domains comprises 18 more amino acids in length (as in claim 9b) (Pg. 32, para. 313). In fact, Ledbetter teaches the linker includes an N-linked glycosylation site, which can be sensitive to protease cleavage in vivo. In some embodiments, an N-linked glycosylation site can protect the hybrid nuclease molecules from cleavage in the linker domain. Moreover, Ledbetter teaches an N-linked glycosylation site can assist in separating the folding of independent functional domains separated by the linker domain. (Pg. 10, para. 119).
Ledbetter teaches the invention also includes a vector capable of expressing the peptides in an appropriate host, such as a mammalian cell (as in claim 27) (Pg. 18, para. 189-191). Ledbetter teaches the hybrid nuclease can be delivered by implanting certain cells that have been genetically engineered, using methods such as those described herein, to express and secrete the polypeptides (Pg. 21, para. 219). Ledbetter teaches the DNAseI hybrid nuclease molecules can be active towards extracellular immune complexes containing DNA, e.g., either in soluble form (as in claim 30) or deposited as insoluble complexes (Pg. 10, para. 117). Ledbetter teaches the construct is administered orally (as further in claim 1 and as in claim 36) (Pg. 19, para. 208).Ledbetter teaches a human subject in need of treatment (as in claim 42) is selected or identified. The subject can be in need of, e.g., reducing a cause or symptom of systemic lupus erythematosus (SLE), as further in claim 1 (Pg. 4, para. 32; Pg. 33, para. 322).
However, neither Garcia-Romo et al. nor Ledbetter et al. teach the human DNAse1 domain comprises a variant of a polypeptide of SEQ ID NO: 1, wherein the variant of the polypeptide of SEO ID NO: I has substitutions that correspond to the substitutions Q3IR, N96K, and A136F in the polypeptide of SEO ID NO: 1, and wherein the variant of the polypeptide of SEO ID NO: 1 has DNAse activity (as further in claim 1).
Before the effective filing date of the claimed invention, Posada et al. teach methods of treating or preventing a condition associated with an abnormal immune response, including SLE (Abstract; Pg. 3-4, para. 36). In one embodiment, Posada teaches said method comprises administering optimized binuclease fusion proteins comprising two or more nuclease domains (e.g., RNase and DNase domain) operably coupled to an Fc domain (Abstract; Pg. 4,para. 52). Posada teaches the DNase is a Type I secreted DNase, preferably a human DNase.
The alignment between the human DNAse1 domain comprising a variant of a polypeptide of SEQ ID NO: 1 of instant claims (Qy) and the human DNAse1 domain taught by Posada et al. (Db, database) is provided below.
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As shown above, the human DNAse1 domain of Posada lacks residues 1-22 corresponding to SEQ ID NO: 1 (as in claim 18 and claim 23). Consequently, the substitutions at Q9R, N74K and A114F of Posada (Pg. 11,para. 124) correspond to Q31R, N96K, and A136F of SEQ ID NO: 1.
However, none of the aforementioned references teach a variant of the polypeptide of SEQ ID NO: 4, wherein the variant of the polypeptide of SEQ ID NO: 4 is an Fc domain comprising substitutions corresponding to substitutions M32Y, S34T, and T36E in the polypeptide of SEO ID NO: 4 (as further in claim 1).
Before the effective filing date of the claimed invention, Ulrichts et al. taught methods of treating autoimmune diseases, including SLE, using FcRn antagonist compositions, nucleic acids encoding the FcRn antagonist compositions, recombinant expression vectors and host cells for making the FcRn antagonist compositions, and pharmaceutical compositions comprising the FcRn antagonist compositions (Abstract; Pg. 2,para. 21).
The alignment between the Fc domain comprising a variant of a polypeptide of SEQ ID NO: 4 of instant claims (Qy) and the Fc domain taught by Ulrichts et al. (Db, database) is provided below. Ulrichts teaches SEQ ID NO: 2 in Table 1 on Pg. 5.
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Note the Fc domain of Ulrichts comprises substitutions corresponding to substitutions M32Y, S34T, and T36E in the polypeptide of SEO ID NO: 4 (as further in claim 1).
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. Before the effective filing date of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Garcia-Romo et al. who teaches SLE neutrophils readily release NETs when induced by bacterial infection with the teachings of Ledbetter et al. et al., wherein Ledbetter teaches a hybrid nuclease comprising a DNAse1 polypeptide and an Fc domain of human IgG1 for the purposes of treating SLE, with a reasonable expectation of arriving at the claimed invention. That is, one of ordinary skill in the art would have found it prima facie obvious to treat SLE patients afflicted with a bacterial infection with the construct of Ledbetter et al. because Garcia-Romo teaches bacteria induces NETosis in SLE patients. Moreover, the skilled artisan would have found it prima facie obvious to use the DNAseI polypeptide variant of Posada et al. and the Fc domain of Ulrichts et al. in the construct of Ledbetter et al. because both teach the usefulness of these elements in treating SLE.
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the claimed invention, as a whole, was clearly prima facie obvious.
Examiner’s Note: In ‘Prior Art Rejection 1’, the alignment comparison between Ulrichts et al. and instant application is made using the application of Ulrichts ending ‘346. However, note that the use of the ‘346 app here was solely due to the unavailability of the sequences of earlier filed application (App 14/580,771, PgPub US20150218239) in the sequence searching system of the Patent Office (ABSS). However, note that SEQ ID NO: 2 is provided in the ‘239 Publication at Table 1 on Pg. 5.
Prior Art Rejection 2
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Romo et al. (Sci Transl Med. 2011;3:73ra2;previoulsy cited), Ledbetter et al. (PgPub US20140044711A1, Published 2/13/2014; Ref. 2 in IDS filed 10/2/2023;previoulsy cited), Posada et al. (PgPub US20190241878A1, Published 8/8/2019; Ref. 4 in IDS filed 10/2/2023) and Ulrichts et al. (PgPub US20150218239A1, Published 8/6/2015) as applied to claims 1, 9, 27, 30, 33, 36, and 42 above, and further in view of Faridmoayer et al. (PgPub 20210332403, Filed 6/28/2018;previoulsy cited).
The teachings of Garcia-Romo et al., Ledbetter et al., Posada et al. and Ulrichts et al. are relied upon as detailed above. And although Ledbetter teach the construct is expressed in a mammalian cell, Ledbetter fails to teach the mammalian cell is stably transfected with ST6GAL1 (as further in claim 28a).
Before the effective filing date of the claimed invention, Faridmoayer et al. taught
methods for producing N-glycosylated target proteins. In one embodiment, Faridmoayer teaches a method of producing glycosylated target proteins in vivo, using a host cell described herein. In a specific embodiment, provided herein is a method for producing glycosylated target proteins, said method comprising (i) culturing a host cell provided herein under conditions suitable for protein production and (ii) isolating said target protein. In a specific embodiment, the host cell comprises (a) a recombinant nucleic acid encoding a target protein; and (b) a recombinant nucleic acid encoding a heterologous sialyltransferase (Pg. 28,para. 254-255), such as Beta-galactoside alpha-2,6-sialyltransferase 1 of Homo sapiens (as in claim 28a) (Pg. 25,para. 222).
When taken with the teachings of Garcia-Romo et al., Ledbetter et al., Posada et al. and Ulrichts et al., wherein the combination teaches a construct comprising a human DNAse1 polypeptide, an Fc domain of human IgG1, and an N-linked glycosylation site for the purposes of treating SLE, with the teachings of Faridmoayer, wherein Faridmoayer teaches a method for producing glycosylated target proteins in a host cell comprising a recombinant nucleic acid encoding a target protein and a recombinant nucleic acid encoding a heterologous sialyltransferase, such as Beta-galactoside alpha-2,6-sialyltransferase 1 of Homo sapiens, with a reasonable expectation of arriving at the claimed invention.
The skilled artisan would have found it prima facie obvious to modify the teachings of Garcia-Romo et al., Ledbetter et al., Posada et al. and Ulrichts et al. to include the teachings of Faridmoayer because Faridmoayer teaches inclusion of sialyltransferase aids in producing glycosylated proteins in vivo.
Thus, for the purposes of treating SLE in patients, the combination would have been prima facie obvious.
Prior Art Rejection 3
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Romo et al. (Sci Transl Med. 2011;3:73ra2;previoulsy cited), Ledbetter et al. (PgPub US20140044711A1, Published 2/13/2014; Ref. 2 in IDS filed 10/2/2023;previoulsy cited), Posada et al. (PgPub US20190241878A1, Published 8/8/2019; Ref. 4 in IDS filed 10/2/2023) and Ulrichts et al. (PgPub US20150218239A1, Published 8/6/2015) as applied to claims 1, 9, 27, 30, 33, 36, and 42 above, and further in view of Zuo et al. (JCI Insight. 2020 Jun 4;5(11):e138999).
The teachings of Garcia-Romo et al., Ledbetter et al., Posada et al. and Ulrichts et al. are relied upon as detailed above. However, none of the aforementioned references teach viral infection is caused by a coronavirus (as in claim 31).
Before the effective filing date of the claimed invention, Zuo et al. report elevated levels of serum NETs in many hospitalized patients with COVID-19 (as in claim 31). Zuo measured 3 markers commonly used to detect NET remnants in blood (cell-free DNA, MPO-DNA, and Cit-H3) and found significant elevations in all 3. Zuo also found that COVID-19 sera are potent stimulators of NETosis when added to control neutrophils. Taken together, Zuo teaches these data provide evidence that COVID-19, at least in hospitalized patients, is a pro-NETotic state (Abstract; Pg. 3, last paragraph).
When taken with the teachings of Garcia-Romo et al., Ledbetter et al., Posada et al. and Ulrichts et al., wherein the combination teaches a construct comprising a human DNAse1 polypeptide and an Fc domain of human IgG1, for the purposes of treating SLE, one ordinary skill in the art would have found it prima facie obvious to use the same construct to treat a viral infection caused by coronavirus. The skilled artisan would have found it prima facie obvious to do so because like Zuo teaches Covid-19 patients have elevated levels of serum NET and Garcia-Posada teaches SLE neutrophils readily release NETs in response to exogenous stimuli.
That is, one of ordinary skill in the art would have had a reasonable expectation of treating a viral infection caused by coronavirus because NET formation is common in both infections and the each of Ledbetter and Posada teach methods of treating NET formation using a construct comprising a human DNAse1 polypeptide and an Fc domain of human IgG1.
Thus, for the purposes of treating a viral infection caused by a coronavirus in patients, the combination would have been prima facie obvious.
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, 9, 18, 23, 27-28, 30-33, and 26-42 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 57-58, 60-70 and 73-75 of copending Application No. 17792101 (reference application). The rejection is maintained for reasons advanced in the previous office action and will not be reiterated herein.
Applicant’s Arguments/Response to Arguments
Applicant argues: The Office never points to language in the ‘101 application claims that discloses or provides reasonable motivation for arriving at a method of treating a subject afflicted with a bacterial or viral infection.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. The ‘101 application is drawn to a method of treating, ameliorating, or preventing diseases or disorders associated with inefficient NET hydrolysis (NETolysis). Instant claims are drawn to a method of treating or ameliorating, or preventing inefficient neutrophilic extracellular trap NET hydrolysis in a subject afflicted with a bacterial or viral infection.
Contrary to Applicant’s argument, the preamble of claim 1 does not require “treating a subject afflicted with a bacterial or viral infection”. Rather, the preamble requires treating or ameliorating inefficient neutrophilic extracellular trap NET hydrolysis in a subject having a bacterial or viral infection. Stated another way, all that is required by the preamble of claim 1 is to treat or ameliorate Netolysis. Thee is no requirement to treat the infections.
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TITILAYO MOLOYE whose telephone number is (571)270-1094. The examiner can normally be reached Working Hours: 5:30 a.m-3:00 p.m M-F. Off first friday of biweek..
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/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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