DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
1. Formal Matters
Claims 1, 3-6, 10, 12, 13, 15-18, 21, 22, 25 and 30-35 are pending and are the subject of this Office Action.
2. Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors, embedded hyperlinks, or improperly referenced trademarks. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
3. Claim Objections
Claim 18 is objected to since “dazodalibep” should not be capitalized.
4. Claim Rejections - 35 USC § 112(a) – scope of enablement
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 13 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for reducing or inhibiting binding of CD40L to CD40, does not reasonably provide enablement for preventing binding. 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 the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The Examiner has interpreted “preventing” as a condition will not occur 100% of the time. While the Examiner will consider arguments, the issue lies in the fact that no amount of Tn3 scaffold can completely stop binding of all CD40L to CD40, as no dose-response curve would be expected to show complete blockage (i.e. 0% bound). Applicants provide no guidance or working examples of achieving preventing as defined in this manner, nor is it predictable to one of ordinary skill in the art how to prevent 100% of the binding.
It is suggested, without adding new matter, that terms such as “reduces” or “inhibits” be used in place of “prevents”. Again, however, arguments will be considered. Applicants may, without adding new matter, consider using a limitation such as “reducing the likelihood”, or a similar phrase.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
5. 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.
A. Claims 1, 3-6, 10, 12, 13, 18, 21, 22, 25, 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Karnell et al. (reference 184 on the IDS filed 4/24/24).
The claims are essentially drawn to a method of treating RA using VIB4920 (dazodalibep). Karnell teaches this treatment and uses the same/overlapping doses as the instant claims, See Table 1 which teaches 1500 mg. Furthermore, under “PK and PD after intravenous administration of VIB4920”, Karnell states that “[t]he PK profile of VIB4920 in both healthy volunteers and patients with RA was linear with increasing exposure in a dose-proportional manner (Fig. 3, A and B). After a single intravenous dose of 3 to 3000 mg…”
Furthermore, under the section “VIB4920 reduces disease activity as well as immunological and inflammatory biomarkers in patients with RA”, Karnell states “[i]n addition to safety and tolerability, evidence of clinical benefit with VIB4920 in patients with RA was also evaluated. Key end points in the MAD study in RA measured at week 12 included change in disease activity (DAS28-CRP) and biomarkers such as RF autoantibodies, serum CRP, and Vectra DA score”.
Finally, under “Phase 1b patients and study design”, Karnell teaches “[p]atients were treated with placebo (0.9% saline, n = 15) or VIB4920 (75 mg, n = 8; 500 mg, n = 10; 1000 mg, n = 12; or 1500 mg, n = 12) given by intravenous infusion every other week for 12 weeks, followed by 12 weeks of posttreatment observation”.
Therefore, regarding claims 1, 2, 4, 10, 13, 21, 22, 25, 30 and 31, the only substantial difference is the dosing schedule, with slight variation in dosing (e.g. claims 21 and 22). However, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955). Furthermore, "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and, therefore, obvious) and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018) (“it is not inventive to discover the optimum or workable ranges by routine experimentation.”).
Regarding claims 5 and 6, under “Phase 1b patients and study design”, Karnell teaches “[p]atients received MTX at a dose of 7.5 to 25 mg/week or, in case of MTX intolerance, a different conventional disease-modifying antirheumatic drugs…”.
Regarding claim 12, see “Isolation and optimization of CD40L-specific Tn3 proteins”, which states “[t]o explore the impact of bivalency on the potency of CD40L-specific Tn3 proteins, we linked two copies of identical Tn3 modules (309-309) via a flexible Gly4Ser-containing spacer to form a tandem bivalent fusion protein”.
B. Claims 15-17 and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Karnell et al. in view of Coyle et al. (U.S. Patent No. 10,000,553) teaches SEQ ID NO:133 is identical to instant SEQ ID NO:4 and also teach the sequences in claims 32-35 (patent SEQ ID NO:22 and 25 comprise those in claim 32). HSA is generally used to increase the half-life of circulating proteins.
SEQ ID NO:4
ALIGNMENT:
Query Match 100.0%; Score 3098; Length 585;
Best Local Similarity 100.0%;
Matches 585; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DAHKSEVAHRFKDLGEENFKALVLIAFAQYLQQSPFEDHVKLVNEVTEFAKTCVADESAE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DAHKSEVAHRFKDLGEENFKALVLIAFAQYLQQSPFEDHVKLVNEVTEFAKTCVADESAE 60
Qy 61 NCDKSLHTLFGDKLCTVATLRETYGEMADCCAKQEPERNECFLQHKDDNPNLPRLVRPEV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NCDKSLHTLFGDKLCTVATLRETYGEMADCCAKQEPERNECFLQHKDDNPNLPRLVRPEV 120
Qy 121 DVMCTAFHDNEETFLKKYLYEIARRHPYFYAPELLFFAKRYKAAFTECCQAADKAACLLP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 DVMCTAFHDNEETFLKKYLYEIARRHPYFYAPELLFFAKRYKAAFTECCQAADKAACLLP 180
Qy 181 KLDELRDEGKASSAKQRLKCASLQKFGERAFKAWAVARLSQRFPKAEFAEVSKLVTDLTK 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 KLDELRDEGKASSAKQRLKCASLQKFGERAFKAWAVARLSQRFPKAEFAEVSKLVTDLTK 240
Qy 241 VHTECCHGDLLECADDRADLAKYICENQDSISSKLKECCEKPLLEKSHCIAEVENDEMPA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VHTECCHGDLLECADDRADLAKYICENQDSISSKLKECCEKPLLEKSHCIAEVENDEMPA 300
Qy 301 DLPSLAADFVESKDVCKNYAEAKDVFLGMFLYEYARRHPDYSVVLLLRLAKTYETTLEKC 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 DLPSLAADFVESKDVCKNYAEAKDVFLGMFLYEYARRHPDYSVVLLLRLAKTYETTLEKC 360
Qy 361 CAAADPHECYAKVFDEFKPLVEEPQNLIKQNCELFEQLGEYKFQNALLVRYTKKVPQVST 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 CAAADPHECYAKVFDEFKPLVEEPQNLIKQNCELFEQLGEYKFQNALLVRYTKKVPQVST 420
Qy 421 PTLVEVSRNLGKVGSKCCKHPEAKRMPCAEDYLSVVLNQLCVLHEKTPVSDRVTKCCTES 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 PTLVEVSRNLGKVGSKCCKHPEAKRMPCAEDYLSVVLNQLCVLHEKTPVSDRVTKCCTES 480
Qy 481 LVNRRPCFSALEVDETYVPKEFNAETFTFHADICTLSEKERQIKKQTALVELVKHKPKAT 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 LVNRRPCFSALEVDETYVPKEFNAETFTFHADICTLSEKERQIKKQTALVELVKHKPKAT 540
Qy 541 KEQLKAVMDDFAAFVEKCCKADDKETCFAEEGKKLVAASQAALGL 585
|||||||||||||||||||||||||||||||||||||||||||||
Db 541 KEQLKAVMDDFAAFVEKCCKADDKETCFAEEGKKLVAASQAALGL 585
SEQ ID NO:1
SEQ ID NO 145
LENGTH: 785
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic construct
Query Match 100.0%; Score 4210; Length 785;
Best Local Similarity 100.0%;
Matches 785; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SQIEVKDVTDTTALITWSDDFGEYVWCELTYGIKDVPGDRTTIDLWYHHAHYSIGNLKPD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 SQIEVKDVTDTTALITWSDDFGEYVWCELTYGIKDVPGDRTTIDLWYHHAHYSIGNLKPD 60
Qy 61 TEYEVSLICRSGDMSSNPAKETFTTGGGGGGGGGGGGGGGRLDAPSQIEVKDVTDTTALI 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TEYEVSLICRSGDMSSNPAKETFTTGGGGGGGGGGGGGGGRLDAPSQIEVKDVTDTTALI 120
Qy 121 TWSDDFGEYVWCELTYGIKDVPGDRTTIDLWYHHAHYSIGNLKPDTEYEVSLICRSGDMS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TWSDDFGEYVWCELTYGIKDVPGDRTTIDLWYHHAHYSIGNLKPDTEYEVSLICRSGDMS 180
Qy 181 SNPAKETFTTGGGGGGGGGGDAHKSEVAHRFKDLGEENFKALVLIAFAQYLQQSPFEDHV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SNPAKETFTTGGGGGGGGGGDAHKSEVAHRFKDLGEENFKALVLIAFAQYLQQSPFEDHV 240
Qy 241 KLVNEVTEFAKTCVADESAENCDKSLHTLFGDKLCTVATLRETYGEMADCCAKQEPERNE 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 KLVNEVTEFAKTCVADESAENCDKSLHTLFGDKLCTVATLRETYGEMADCCAKQEPERNE 300
Qy 301 CFLQHKDDNPNLPRLVRPEVDVMCTAFHDNEETFLKKYLYEIARRHPYFYAPELLFFAKR 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 CFLQHKDDNPNLPRLVRPEVDVMCTAFHDNEETFLKKYLYEIARRHPYFYAPELLFFAKR 360
Qy 361 YKAAFTECCQAADKAACLLPKLDELRDEGKASSAKQRLKCASLQKFGERAFKAWAVARLS 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 YKAAFTECCQAADKAACLLPKLDELRDEGKASSAKQRLKCASLQKFGERAFKAWAVARLS 420
Qy 421 QRFPKAEFAEVSKLVTDLTKVHTECCHGDLLECADDRADLAKYICENQDSISSKLKECCE 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 QRFPKAEFAEVSKLVTDLTKVHTECCHGDLLECADDRADLAKYICENQDSISSKLKECCE 480
Qy 481 KPLLEKSHCIAEVENDEMPADLPSLAADFVESKDVCKNYAEAKDVFLGMFLYEYARRHPD 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 KPLLEKSHCIAEVENDEMPADLPSLAADFVESKDVCKNYAEAKDVFLGMFLYEYARRHPD 540
Qy 541 YSVVLLLRLAKTYETTLEKCCAAADPHECYAKVFDEFKPLVEEPQNLIKQNCELFEQLGE 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 YSVVLLLRLAKTYETTLEKCCAAADPHECYAKVFDEFKPLVEEPQNLIKQNCELFEQLGE 600
Qy 601 YKFQNALLVRYTKKVPQVSTPTLVEVSRNLGKVGSKCCKHPEAKRMPCAEDYLSVVLNQL 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 YKFQNALLVRYTKKVPQVSTPTLVEVSRNLGKVGSKCCKHPEAKRMPCAEDYLSVVLNQL 660
Qy 661 CVLHEKTPVSDRVTKCCTESLVNRRPCFSALEVDETYVPKEFNAETFTFHADICTLSEKE 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 CVLHEKTPVSDRVTKCCTESLVNRRPCFSALEVDETYVPKEFNAETFTFHADICTLSEKE 720
Qy 721 RQIKKQTALVELVKHKPKATKEQLKAVMDDFAAFVEKCCKADDKETCFAEEGKKLVAASQ 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 RQIKKQTALVELVKHKPKATKEQLKAVMDDFAAFVEKCCKADDKETCFAEEGKKLVAASQ 780
Qy 781 AALGL 785
|||||
Db 781 AALGL 785
SEQ ID NO:22
Patent No. 10000553
GENERAL INFORMATION
APPLICANT: MedImmune LLC
TITLE OF INVENTION: CD40L-SPECIFIC TN3-DERIVED SCAFFOLDS AND METHODS OF USE THEREOF
FILE REFERENCE: CD40L-101WO1
CURRENT APPLICATION NUMBER: US/14/347,016
CURRENT FILING DATE: 2014-03-25
NUMBER OF SEQ ID NOS: 210
SEQ ID NO 209
LENGTH: 190
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic construct
Query Match 100.0%; Score 468; Length 190;
Best Local Similarity 100.0%;
Matches 85; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SQIEVKDVTDTTALITWSDDFGEYVWCELTYGIKDVPGDRTTIDLWYHHAHYSIGNLKPD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 106 SQIEVKDVTDTTALITWSDDFGEYVWCELTYGIKDVPGDRTTIDLWYHHAHYSIGNLKPD 165
Qy 61 TEYEVSLICRSGDMSSNPAKETFTT 85
|||||||||||||||||||||||||
Db 166 TEYEVSLICRSGDMSSNPAKETFTT 190
SEQ ID NO:25
SEQ ID NO 209
LENGTH: 190
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: synthetic construct
Query Match 100.0%; Score 494; Length 190;
Best Local Similarity 100.0%;
Matches 90; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RLDAPSQIEVKDVTDTTALITWSDDFGEYVWCELTYGIKDVPGDRTTIDLWYHHAHYSIG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 101 RLDAPSQIEVKDVTDTTALITWSDDFGEYVWCELTYGIKDVPGDRTTIDLWYHHAHYSIG 160
Qy 61 NLKPDTEYEVSLICRSGDMSSNPAKETFTT 90
||||||||||||||||||||||||||||||
Db 161 NLKPDTEYEVSLICRSGDMSSNPAKETFTT 190
6. Nonstatutory 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, 3 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35 and 36 of copending Application No. 19/168,641 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘641 claims recite that the subject being treated has RA, which would be treated by the method of treating SS.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. Conclusion
No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
Prosecution Insights