DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-15 are pending upon entry of amendment filed on 2/28/23.
Claims 1-15 are under consideration in the instant application.
3. Applicant’s IDS filed on 62/28/23 and 10/25/24 have been acknowledged.
4. The oaths filed on 2/28/23 and 6/3/24 have been acknowledged.
5. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
6. 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.
7. Claim 2 is 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 2 recites the broad recitation of antibody concentration between 100mg/ml to about 225 mg/ml and the claim also recites 175-195mg/ml which is the narrower statement of the range/limitation.
8. 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.
9. Claims 1-15 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of treating an atypical hemolytic syndrome (aHUS) and renel condition of lupus nephritis comprising administering MASP antibody set forth in SEQ ID NO:2-5, 10-50mM of citrate or histidine, 200-300mM of arginine and surfactant of 0.01-0.1% polysorbate at pH 5-7 does not reasonably provide enablement for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would make and use MASP antibody formulation that treats all or any of MASP dependent complement associated disease or disorder set forth in claims 11-15 other than aHUS and lupus nephritis.
Although Examples 1-4 exhibit stability studies of MASP antibody comprising various excipients, other than aHUS and/or renal disorder, no treatment method or regimen comprising antibody are disclosed.
U.S. Pub. 2015/0166676 (IDS reference) discloses or suggests treatment of aHUS comprising MASP2 antibody or OMS646 antibody. As such, given that the stabilizing effect for the excipient cannot be extrapolated any of MASP dependent complement associated disease or disorder set forth in claims 11-15 other than aHUS and lupus nephritis encompassed by the claimed invention.
The specification fails to provide sufficient guidance to direct a person of skilled in the art to make and achieve the intended use of the claimed invention without undue experimentation. It is unpredictable to develop antibody formulation and one exemplary formulation disclosed in the example cannot be extrapolated to various formulations encompassed by the claimed invention.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention.
10. 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 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.
11. 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 of this title, 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.
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.
12. Claims 1-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2015/0166676 (IDS reference) in view of U.S. Pub. 2014/0341885 (IDS reference).
The ‘676 publication teaches methods of treat MASP-2 (mannan binding lectin associated serine protease-2) dependent complement associated disease or disorder comprising the MASP-2 antibody set forth in the claimed SEQ ID NO:2-5 ([0037, 112], Fig 53-57, p. 5-10, note SEQ ID NO:67 and 70). The claimed SEQ ID NO:2-3 is OMS646 and shares the identical sequences with SEQ ID Nos:67 and 70, respectively. The ‘676 publication also discloses that the pharmaceutical formulations are suitable for various routes of administrations including subcutaneous and the article of manufacture comprising the formulations and the treatment of IgA nephropathy, lupus nephritis, renal disorder and aHUS (p. 14, 26-30).
The disclosure of the ‘676 publication differs from the instant claimed invention in that it does not teach the use of citrate or histidine buffer, antibody concentrations of 50-250mg/ml and the formulation is being hypertonic as in claim 1 of the instant application and the limitations of the dependent claims thereof.
The ‘885 publication teaches the use of the sodium citrate or histidine buffer at 5-50mM ([0015-0017]) at pH 6-7 with the antibody concentrations of 150-200mg/ml as in claims 2, 8,11 and 26. Further, the ‘885 publication teaches addition of glutamate and/or arginine at about 175mM ([0012]) readable upon claims 18-24 and 27. The term “about” includes +/- 10% and readable upon about 200mM of claim 27 of the instant application.
Moreover, the ‘885 publication discloses addition of surfactant in forms of polysorbate or poloxamer ([0079, 0118]) as in claims 30-33 and the formulations are stable at least 1 year at 2-8oC ([0123]). Further, the ‘885 publication teaches that the viscosity can be lowered by the addition of histidine and arginine and the formulation is being hypertonic ([131-133]).
In addition, the ‘885 publication discloses formulation of the antibody in the pre-measured injector and the set volume of high concentration in less than 2ml ([164], [0141]) as in claims 60-66 and the packages of the antibody formulation may vary with the dose and the regimen ([141-143]). Claims 51, 52, 58 and 75 reciting specific concentrations of excipients are included in this rejection as the ‘885 publication discloses the antibody formulation comprises about 160mg/ml antibody, about 10-50mM citrate and/or histidine at pH 6, about 200mM amino acid readable upon glutamate or arginine and 0.1% of polysorbate ([0138-140]).
The antibody formulation of the ‘885 publication is suitable to co-formulate with various antibodies for various regimen and treatment purpose ([0169-0183]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use citrate/histidine buffer, glutamate and/or arginine in the presence of polysorbate at pH about 6 or other manufacturing conditions as set forth in claims 1-15 at the claimed concentration as taught by the ‘885 publication into the MASP-2 formulation taught by the ‘676 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because use of such buffer, excipients improve stability of antibody formulation by reducing formation of aggregates and improve viscosity. Further, using the packaging or delivery conditions already known for one antibody is easily applicable for another is convenient to serve.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
13. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
14. Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Pat.11525011, 11981749 and 12351648 each in view of U.S. Pub. 2014/0341885 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the above mentioned patents recite treatment of MASP-2 dependent complement associated diseases comprising the MASP-2 antibody set forth in SEQ ID NO:2-5 that is identical to the patented SEQ ID NO:67 and 70.
The claims of the patents differ from the claimed invention in that they do not teach the use of citrate or histidine buffer, antibody concentrations of 50-250mg/ml and the formulation is being hypertonic as in claim 1 of the instant application and the limitations of the dependent claims thereof.
The teachings of the ‘885 publication have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use citrate/histidine buffer, glutamate and/or arginine in the presence of polysorbate at pH about 6 or other manufacturing conditions as set forth in claims 1-15 at the claimed concentration as taught by the ‘885 publication into the MASP-2 formulation taught by the claims of the patents.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because use of such buffer, excipients improve stability of antibody formulation by reducing formation of aggregates and improve viscosity. Further, using the packaging or delivery conditions already known for one antibody is easily applicable for another is convenient to serve.
15. No claims are allowable.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
October 23, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641