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 .
Applicant’s amendment, filed on 3/27/2026, is acknowledged.
Claims 1-34 and 36-41 are cancelled.
Claims 35 and 42-46 are currently pending.
Claim 35 is the only independent claim.
Election/Restrictions
Applicants’ election without traverse of Group II, claims 35, and 42-46, directed to a pre-filled syringe comprising a sterile preparation of an anti-BDCA2 antibody, filed on 3/27/2026 is acknowledged.
Claims 35 and 42-46 are under examination as reading on the elected invention of a pre-filled syringe comprising a sterile preparation of an anti-BDCA2 antibody.
Priority
Applicant’s claim for the benefit of a prior-filed U.S. Provisional Appl. No. 63/121,194 filed December 3, 2020, is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/11/2023 and 3/27/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner in their entireties.
Claim Objections
Claim 44 is objected to because the claim currently recites (“…L-Arginine HCl…”) and should most likely recite “L-arginine HCl” to correct a minor typographical error.
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.
Claims 35 and 42-46 are rejected under 35 U.S.C. 103 as being unpatentable over Krebs et al. (WO2017189827) in view of Shah et al. (Pharma Bio World. 2016).
Claim 35 recites a pre-filled syringe or auto-injector comprising a sterile preparation of a, anti-BCDA2 antibody at a dose of 225mg, and wherein the antibody comprises the HCDR1-3 and LCDR1-3 of SEQ ID NO: 1-6, respectively.
Krebs et al. teaches anti-BDCA2 antibodies to treat lupus erythematosus and/or cytokine release syndrome (Abstract). Krebs et al. teaches the anti-BDCA2 antibody BIIB059 (Table 1) comprising the heavy chain sequence of SEQ ID NO: 9 and the light chain sequence of SEQ ID NO: 10 (pg. 25, lines 19-36). SEQ ID NO: 9 of Krebs et al. is 100% identical to instant SEQ ID NO: 9 (which contains the VH of SEQ ID NO: 7 and the HCDR1-3 of SEQ ID NO: 1-3, respectively):
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SEQ ID NO: 10 of Krebs et al. is 100% identical to instant SEQ ID NO: 10 (which contains the VH of SEQ ID NO: 8 and the LCDR1-3 of SEQ ID NO: 4-6, respectively):
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Krebs et al. further teaches therapeutically effective amounts of BIIB059 include fixed doses of 25, 50, 150, and 450mg (pg. 37, lines 1-20): “[t]he anti-BDCA2 antibody (e.g., BIIB059) or BCDA2-binding fragment thereof described above can be administered to a subject, e.g., a human subject, at different doses. The anti-BDCA2 antibody (e.g., BIIB059) or BCDA2-binding fragment thereof can be administered as a fixed dose…the dosage of the anti-BDCA2 antibody (e.g., BIIB059) or BCDA2-binding fragment thereof is a fixed dose of 25 mg…50 mg… 150 mg… 450 mg.”
Krebs et al. further teaches syringes or auto-injectors designed for subcutaneous administration comprising sterile compositions of BIIB059 at fixed doses (pg. 42, lines 25-31): “[t]his disclosure also provides a pump or syringe, or injector (e.g., autoinjector, subcutaneous large volume injector) comprising a sterile preparation of an anti-BDCA2 antibody (e.g., BIIB059) or BCDA2-binding fragment thereof. The syringe or pump can be adapted for subcutaneous administration of the pharmaceutical compositions comprising the anti-BDCA2 antibody or BDCA2-binding fragment thereof. In some instances, the syringe or pump delivers a fixed doses(s) (e.g., 18 mg, 22 mg, 28 mg, 40 mg, 50 mg, 56 mg, 80 mg, 150 mg, 450 mg) of the anti-BDCA2 antibody or BDCA2-binding fragment thereof.”
Krebs et al. additionally teaches compositions comprising the BIIB059 antibody at 150mg/mL (pg. 2, line 8), sucrose at a concentration of 3% (pg. 2, line 11), histidine (“L-histidine”) at 20mM (pg. 23-24), arginine (“L-Arginine”) HCl at 100mM (pg. 2, line 15), polysorbate 80 at a concentration of 0.05% (pg. 2, line 19), a pH of 5.7 (pg. 34, line 2), and glutathione at 0.4mM (pg. 34, lines 10 and 16). Krebs et al. teaches this composition can be made by dissolving all of the ingredients in an acceptable excipient such as sterile water (pg. 35, lines 6-12).
Krebs et al. further teaches arginine reduces viscosity (pg. 32, lines 15-16), sucrose reduces the formation of visible particulate (pg. 32, lines 30-32), polysorbate-80 reduces agitation-induced stress (pg. 33, lines 16-18), histidine acts as a buffer (pg. 33, lines 25-27), and glutathione acts as an antioxidant (pg. 34, lines 7-8).
Krebs et al. does not teach a pre-filled syringe or auto-injector comprising a sterile preparation of a fixed dose of 225mg of BIIB059 (i.e., the limitations of instant claim 35).
Shah et al., in the same field of endeavor, teaches that pre-filled syringes of therapeutics are useful to allow for self-administration of therapeutics, especially for chronic diseases, that help control healthcare costs (Title and Abstract): “[p]opulation demographics and efforts by managed care providers to control healthcare costs are driving the growth in drug self-administration, particularly for chronic conditions, introducing a new class of naive users to parenteral drug delivery. User-friendly syringe and injection device designs and the availability of an increasing number of drugs in pre-filled insertable and disposable cartridges are propelling the growth of prefilled syringes for self-administration.”
Shah et al. teaches general techniques to prepare pre-filled syringes, and gives examples of different pre-filled syringes currently on the market (Fig. 1 and “Preparation of Pre-filled Syringes” section). Shah et al. teaches advantages of pre-filled syringes, including less overfill, low risk of cross-contamination due to needle reuse, accurate dosage measurement, easier product identification, speed of use, shorter preparation time, and convenience (pg. 52, Col 1). Shah et al. further teaches that autoinjectors can be used with pre-filled syringes for subcutaneous injection of fixed doses with automatic needle retraction, which can provide a fast, easy, and safe pathway to injection (pg. 55, Col. 2 and Fig. 7).
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the instant application, to have modified the syringe of fixed doses of BIIB059 taught by Krebs et al. in view of Shah et al. to package fixed doses of BIIB059 into pre-filled syringes or autoinjectors with a reasonable expectation of success, as Shah et al. teaches methods to do so. One would have been motivated to make this change for the purposes of packaging pre-filled syringes/autoinjectors of fixed doses of sterile preparations of BIIB059 to allow for self-administration of the therapeutic, as well as reducing the amount of overfill, increasing speed of use, decreasing preparation time, and increasing convenience of use of the BIIB059 therapeutic.
Regarding the limitation “225mg”, Krebs et al., teaches fixed doses of BIIB059 for subcutaneous administration in the range of 18-450mg, and in absence of evidence to the contrary the dosage of 225mg can be achieved through routine optimization by one with ordinary skill in the art to achieve a “therapeutically effective” dose within the taught prior art dosage range conditions to treat lupus erythematosus in a subject in need. Also see MPEP 2144.05(II)(A).
Regarding claims 42 and 43, the BIIB059 antibody clone taught by Krebs et al. contains these heavy and light chain antibody sequences, meeting the claim limitations (see supra).
Regarding claim 44, Krebs et al. teaches pharmaceutical compositions can comprise 150mg/mL BIIB059, 3% sucrose, 20mM histidine, 100mM arginine HCl, 0.4mM glutathione, 0.05% polysorbate 80, and a pH of 5.7 (i.e., the limitations of instant claim 44; see supra). One with ordinary skill in the art would have used the teachings of Krebs et al. to make this formulation of antibody through routine optimization within these taught prior art conditions to generate this liquid pharmaceutical composition to achieve an antibody solution with optimal viscosity and clarity that is resistant to agitation-induced stress and oxidation.
Regarding claims 45 and 46, Shah et al. teaches that pre-filled syringes are created with USP (“United States Pharmacopeia”) type 1 clear borosilicate glass (pg. 52, first ¶): “[p]refilled syringes have traditionally been made of a glass body formed from USP type 1 borosilicate glass…”; as well as having a rubber stopper (pg. 54, Col. 3): “…separated by a rubber stopper…”, meeting the claims limitations.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 35 and 42-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of U.S. Patent No. 9,902,775 (Pat ‘775) in view of Krebs et al. (WO2017189827, supra) and Shah et al. (Pharma Bio World. 2016, supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘775 claims anti-BDCA2 antibodies comprising a heavy chain of SEQ ID NO: 4 and a light chain of SEQ ID NO: 3 (claims 1 and 7). SEQ ID NO: 4 of Pat ‘775 is 100% identical to instant SEQ ID NO: 9 (which contains the VH of SEQ ID NO: 7 and HCDR1-3 of SEQ ID NO: 1-3, respectively):
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SEQ ID NO: 3 of Pat ‘775 is 100% identical to instant SEQ ID NO: 10 (which contains the VH of SEQ ID NO: 8 and HCDR1-3 of SEQ ID NO: 4-6, respectively):
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Pat ‘775 claims pharmaceutical compositions comprising the antibody and an acceptable carrier (claim 18), as well as methods of treating lupus erythematosus in a subject comprising administration of the antibody (claims 25 and 26).
Pat ‘775 does not claim a pre-filled syringe or auto-injector comprising a sterile preparation of a fixed dose of 225mg of BIIB059 (i.e., the limitations of instant claim 35).
Krebs et al. teaches anti-BDCA2 antibodies to treat lupus erythematosus and/or cytokine release syndrome (Abstract). Krebs et al. teaches the anti-BDCA2 antibody BIIB059 (Table 1).
Krebs et al. further teaches therapeutically effective amounts of BIIB059 include fixed doses of 25, 50, 150, and 450mg (pg. 37, lines 1-20): “[t]he anti-BDCA2 antibody (e.g., BIIB059) or BCDA2-binding fragment thereof described above can be administered to a subject, e.g., a human subject, at different doses. The anti-BDCA2 antibody (e.g., BIIB059) or BCDA2-binding fragment thereof can be administered as a fixed dose…the dosage of the anti-BDCA2 antibody (e.g., BIIB059) or BCDA2-binding fragment thereof is a fixed dose of 25 mg…50 mg… 150 mg… 450 mg.”
Krebs et al. further teaches syringes or auto-injectors designed for subcutaneous administration comprising sterile compositions of BIIB059 at fixed doses (pg. 42, lines 25-31): “[t]his disclosure also provides a pump or syringe, or injector (e.g., autoinjector, subcutaneous large volume injector) comprising a sterile preparation of an anti-BDCA2 antibody (e.g., BIIB059) or BCDA2-binding fragment thereof. The syringe or pump can be adapted for subcutaneous administration of the pharmaceutical compositions comprising the anti-BDCA2 antibody or BDCA2-binding fragment thereof. In some instances, the syringe or pump delivers a fixed doses(s) (e.g., 18 mg, 22 mg, 28 mg, 40 mg, 50 mg, 56 mg, 80 mg, 150 mg, 450 mg) of the anti-BDCA2 antibody or BDCA2-binding fragment thereof.”
Krebs et al. additionally teaches compositions comprising the BIIB059 antibody at 150mg/mL (pg. 2, line 8), sucrose at a concentration of 3% (pg. 2, line 11), histidine (“L-histidine”) at 20mM (pg. 23-24), arginine (“L-Arginine”) HCl at 100mM (pg. 2, line 15), polysorbate 80 at a concentration of 0.05% (pg. 2, line 19), a pH of 5.7 (pg. 34, line 2), and glutathione at 0.4mM (pg. 34, lines 10 and 16). Krebs et al. teaches this composition can be made by dissolving all of the ingredients in an acceptable excipient such as sterile water (pg. 35, lines 6-12).
Krebs et al. further teaches arginine reduces viscosity (pg. 32, lines 15-16), sucrose reduces the formation of visible particulate (pg. 32, lines 30-32), polysorbate-80 reduces agitation-induced stress (pg. 33, lines 16-18), histidine acts as a buffer (pg. 33, lines 25-27), and glutathione acts as an antioxidant (pg. 34, lines 7-8).
Shah et al., in the same field of endeavor, teaches that pre-filled syringes of therapeutics are useful to allow for self-administration of therapeutics, especially for chronic diseases, that help control healthcare costs (Title and Abstract): “[p]opulation demographics and efforts by managed care providers to control healthcare costs are driving the growth in drug self-administration, particularly for chronic conditions, introducing a new class of naive users to parenteral drug delivery. User-friendly syringe and injection device designs and the availability of an increasing number of drugs in pre-filled insertable and disposable cartridges are propelling the growth of prefilled syringes for self-administration.”
Shah et al. teaches general techniques to prepare pre-filled syringes, and gives examples of different pre-filled syringes currently on the market (Fig. 1 and “Preparation of Pre-filled Syringes” section). Shah et al. teaches advantages of pre-filled syringes, including less overfill, low risk of cross-contamination due to needle reuse, accurate dosage measurement, easier product identification, speed of use, shorter preparation time, and convenience (pg. 52, Col 1). Shah et al. further teaches that autoinjectors can be used with pre-filled syringes for subcutaneous injection of fixed doses with automatic needle retraction, which can provide a fast, easy, and safe pathway to injection (pg. 55, Col. 2 and Fig. 7).
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the instant application, to have modified the BIIB059 pharmaceutical compositions claimed by Pat ‘775 in view of Krebs et al. and Shah et al. to package fixed doses of BIIB059 into pre-filled syringes or autoinjectors with a reasonable expectation of success, as Krebs et al. and Shah et al. teaches methods to do so. One would have been motivated to make this change for the purposes of packaging pre-filled syringes/autoinjectors of fixed doses of sterile preparations of BIIB059 to allow for self-administration of the therapeutic to treat diseases such as lupus erythematosus, as well as reducing the amount of overfill, increasing speed of use, decreasing preparation time, and increasing convenience of use of the BIIB059 therapeutic.
Regarding the limitation “225mg”, Krebs et al., teaches fixed doses of BIIB059 for subcutaneous administration in the range of 18-450mg, and in absence of evidence to the contrary the dosage of 225mg can be achieved through routine optimization by one with ordinary skill in the art to achieve a “therapeutically effective” dose within the taught prior art dosage range conditions to treat lupus erythematosus in a subject in need. Also see MPEP 2144.05(II)(A).
Regarding claims 42 and 43, the BIIB059 antibody clone taught by Krebs et al. contains these heavy and light chain antibody sequences, meeting the claim limitations (see supra).
Regarding claim 44, Krebs et al. teaches pharmaceutical compositions can comprise 150mg/mL BIIB059, 3% sucrose, 20mM histidine, 100mM arginine HCl, 0.4mM glutathione, 0.05% polysorbate 80, and a pH of 5.7 (i.e., the limitations of instant claim 44; see supra). One with ordinary skill in the art would have used the teachings of Krebs et al. to make this formulation of antibody through routine optimization within these taught prior art conditions to generate this liquid pharmaceutical composition to achieve an antibody solution with optimal viscosity and clarity that is resistant to agitation-induced stress and oxidation.
Regarding claims 45 and 46, Shah et al. teaches that pre-filled syringes are created with USP (“United States Pharmacopeia”) type 1 clear borosilicate glass (pg. 52, first ¶): “[p]refilled syringes have traditionally been made of a glass body formed from USP type 1 borosilicate glass…”; as well as having a rubber stopper (pg. 54, Col. 3): “…separated by a rubber stopper…”, meeting the claims limitations.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘775 in view of Krebs et al. and Shah et al., especially is absence of evidence to the contrary.
Claims 35 and 42-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39-56 of copending Application No. 19/037,765 (App ‘765) in view of Krebs et al. (supra) and Shah et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘765 claims nucleic acids encoding an anti-BDCA2 antibody with a heavy chain and light chain of SEQ ID NO: 4 and 3, respectively (claim 39 and 45). SEQ ID NO: 4 of App ‘765 is 100% identical to instant SEQ ID NO: 9 (which contains the VH of SEQ ID NO: 7 and HCDR1-3 of SEQ ID NO: 1-3, respectively):
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SEQ ID NO: 3 of App ‘765 is 100% identical to instant SEQ ID NO: 10 (which contains the VH of SEQ ID NO: 8 and HCDR1-3 of SEQ ID NO: 4-6, respectively):
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App ‘765 additionally claims methods of making the anti-BDCA2 antibody (claims 53 and 56). One with ordinary skill in the art would appreciate that the claimed nucleic acids and methods of producing an anti-BDCA2 antibody would necessarily lead to the isolated anti-BDCA2 antibody with the claimed amino acid sequences.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App’ 765 in view of Krebs et al. and Shah et al. for the same reasons discussed for Pat ‘775 supra. This is a provisional double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 35 and 42-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 8, 12, 16, 19, 21-27, 31, 39, 42, 53, 81, 82, 86, 91-95, 104, 107, 109, 114, 119, 124, 126, and 128 of copending Application No. 19/060,474 (App ‘474) in view of Shah et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘474 claims pharmaceutical compositions comprising an anti-BDCA2 antibody, sucrose, arginine HCl (i.e., “L-arginine”) at a pH of 5.0-6.5 (claim 1). App ‘474 additionally claims the anti-BDCA2 antibody comprising the heavy chain sequence of SEQ ID NO: 9 and the light chain sequence of SEQ ID NO: 10. SEQ ID NO: 9 of App ‘474 is 100% identical to instant SEQ ID NO: 9 (which contains the VH of SEQ ID NO: 7 and HCDR1-3 of SEQ ID NO: 1-3, respectively):
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SEQ ID NO: 10 of App ‘474 is 100% identical to instant SEQ ID NO: 10 (which contains the VH of SEQ ID NO: 8 and HCDR1-3 of SEQ ID NO: 4-6, respectively):
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App ‘474 additionally claims pharmaceutical compositions comprising the anti-BDCA2 antibody at a concentration of 150mg/mL, sucrose at a concentration of 3%, histidine (“L-histidine”) at a concentration of 20mM, arginine HCl at 100mM, polysorbate 80 at 0.05%, and a pH of 5.7 (i.e., the limitations of instant claim 44; App ‘474 claim 22).
App ‘474 additionally claims syringes or injectors comprising a sterile preparation of the anti-BDCA2 antibody at fixed dosages of 50, 150, and 450mg (claim 53).
App ‘474 does not claim a pre-filled syringe or auto-injector comprising a sterile preparation of a fixed dose of 225mg of BIIB059 (i.e., the limitations of instant claim 35).
The invention encompassed by the instant claims is a prima facie obvious variant of App ‘474 in view of Shah et al. for the same reasons discussed in the 35 U.S.C. § 103 rejection supra. This is a provisional double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEC JON PETERS whose telephone number is (703)756-5794. The examiner can normally be reached Monday-Friday 8:30am - 6:00pm EST.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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