DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 11/25/25 has been entered in full.
Claims 1, 24 and 36-53 were pending.
Claims 1 and 53 are canceled. Claims 24, 36-37, 39, 43, 45, 47, 49 and 52 are amended. Claims 24 and 36-52 are pending.
Election/Restrictions
Applicants’ election of Group II, currently all pending claims, in the reply filed on 11/20/25 is acknowledged. There is no indication of whether the election is with or without traverse, but because the response did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The election of “antibody-mediated transplant rejection” as the species of complement-mediated disease or disorder is also acknowledged. Applicants indicate that claims 24, 36-44 and 46-51 correspond to the elected species. Claim 43 recites “transplant rejection” in the alternative, which encompasses the elected species. Claims 45 and 52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 24, 36-44 and 46-51 are under consideration, as they read upon the elected species.
Claim Objections
Claim 43 is objected to because of the following informalities:
In claim 43, line 25, the acronym “HuS” should be accompanied by the full terminology, e.g., “hemolytic uremic syndrome (HuS)”.
Appropriate correction is required.
Double Patenting
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(1) Claims 24, 36-44 and 46-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-12, 14-20 and 24-32 of U.S. Patent No. 10,729,767, issued 8/4/20 (cited on a 3/31/23 IDS), and which shares the same applicant and inventors with the instant application.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The instant application claims priority as a continuation to application 17/568,123 (now abandoned), which in turn claims priority as a continuation to application 16/898,908, which in turn claims priority as a divisional to application 15/564,904, from which the ‘767 patent issued.
Instant independent claim 24 encompasses a method having the intended use of reducing the level of a complement component cleavage product in an individual, and comprising a single step of administering to the individual an effective amount of a humanized antibody that specifically binds to complement component C1s, wherein the antibody comprises (a) a heavy chain variable (VH) region comprising the amino acid sequence of SEQ ID NO: 26 and (b) a light chain variable (VL) region comprising the amino acid sequence of SEQ ID NO: 27. Claim 7 of ‘767 is directed to a method with the same intended use, and comprising a single step of administering a composition of claim 5 in an amount effective to inhibit C1s and to reduce the level of the cleavage product. The composition of claim 5 comprises the humanized antibody of claim 1 and a pharmaceutically acceptable carrier, and the humanized antibody of claim 1 specifically binds C1s and comprises a VH region comprising SEQ ID NO: 26 and a VL region comprising SEQ ID NO: 27. Therefore, the method of claim 7 of ‘767 is directed to administration of this antibody, which is the same as recited in instant claim 24. As such, instant claim 24 is not patentably distinct from the claims of ‘767.
Instant independent claim 36 encompasses a method having the intended use of inhibiting C1s-mediated cleavage of a complement component in an individual, and comprising the same method step as claim 24. Claim 9 of ‘767 is directed to a method with the same intended use as instant claim 36, and comprising a single step of administering a composition of claim 5 in an amount effective to inhibit C1s and to reduce the level of the cleavage product. Therefore, the method of claim 9 of ‘767 is also directed to administration of the same antibody as in instant claim 36. As such, instant claim 36 is not patentably distinct from the claims of ‘767.
Instant independent claims 37, 43, 44 and 46 each encompass a method having the intended use of treating a complement-mediated disease or disorder in an individual, wherein the complement-mediated disease or disorder is antibody-mediated transplant rejection (the elected species under consideration) comprising the same method step as claim 24. Claims 10-11 and 19 each encompass a method of administering (and therefore treating) to a human having antibody-mediated transplant rejection a humanized antibody that specifically binds C1s and comprises a VH region comprising SEQ ID NO: 26 and a VL region comprising SEQ ID NO: 27. As such, the two sets of claims are not patentably distinct.
Instant claims 38 and 47 each encompass a method of claim 37 wherein the antibody comprises a VH region comprising the amino acid sequence of SEQ ID NO: 14 and the VL region comprising the amino acid sequence of SEQ ID NO: 22. The antibody of claim 1 of ‘767 encompasses such an antibody, as evidenced by dependent claim 2 of ‘767, which narrows the antibody to one selected from a group including a VH region comprising the amino acid sequence of SEQ ID NO: 14 and the VL region comprising the amino acid sequence of SEQ ID NO: 22. As such, the method of claims 10-11 and 19 of ‘767 each encompass use of such an embodiment. As such, instant claims 38 and 47 are not patentably distinct from the claims of ‘767.
Instant claim 39 encompasses a method of claim 37 wherein the antibody is a Fab fragment. The antibody of claim 1 of ‘767 encompasses such an antibody, as evidenced by dependent claim 3 of ‘767, which narrows the antibody to one selected from a group including a Fab fragment. As such, instant claim 39 is not patentably distinct from the claims of ‘767.
Instant claims 40 and 41 each encompass a method of claim 37 wherein the antibody comprises a heavy chain constant region of the isotype IgG4. The antibody of claim 1 of ‘767 encompasses such an antibody, as evidenced by dependent claim 4 of ‘767, which narrows the antibody to one comprising a heavy chain constant region selected from a group including an IgG4. As such, instant claims 40 and 41 are not patentably distinct from the claims of ‘767.
Instant claim 42 encompasses a method of claim 37 wherein the administering is intravenously administering. This corresponds to the further limitation of claim 12 of ‘767, depending from claim 10. As such, instant claim 42 is not patentably distinct from the claims of ‘767.
Instant claims 48-51 each depend from claims 37 and 47 and combine the limitations of claims 37, 47 and either 40 (claim 48), 39 (claim 49), 42 (claim 50) or 44 (claim 51) and therefore are not patentably distinct for the same reasons as above. As such, instant claims 48-51 are not patentably distinct from the claims of ‘767.
(2) Claims 24, 36-38, 40-41, 43 and 47-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,391,750, issued 8/19/25 (cited on a 11/20/25 IDS), and which shares the same applicant and inventors with the instant application.
The scope of the instant claims is as forth above.
The independent claims of the ‘750 patent, claims 1 and 8, are each directed to a method comprising the same step, which is administering to the subject a pharmaceutically effective amount of an antibody that specifically binds activated C1s and comprises a VL region comprising SEQ ID NO: 22 and VH region comprising SEQ ID NO: 14, and a heavy chain IgG4 constant region comprising 4 substitution mutations. The VL/VH sequences of SEQ ID NO: 22/14 of ‘750 are 100% identical to instant SEQ ID NO: 22/14, which are expressly recited in instant dependent claims 38 and 47 and encompassed by the antibody of each of instant independent claims 24, 36 and 37. The intended use of claim 1 of ‘750 patent is for “inhibiting a complement pathway in a subject having chronic inflammatory demyelinating polyneuropathy (CIDP)”, and the intended use of claim 8 is for “treating [CIDP] in a subject in need thereof”. CIDP is a type of autoimmune disease. As such, instant claims 24, 36-38, 43 and 47 each fully encompass the method of claims 1-16 of ‘750, and as such the two sets of claims are not patentably distinct. Furthermore, as the antibody of claim 1 of ‘750 also includes an IgG4 region, it also meets the further limitations of dependent claims 40-41 and 48.
Claims 39 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,391,750 issued 8/19/25 (cited on a 11/20/25 IDS), and which shares the same applicant and inventors with the instant application, and further in view of Sandhu, 1992. Critical Reviews in Biotechnology, 12(5/6):437-462.
Claims 39 and 49 further limit the method of claim 37 or 47 (which depends from claim 37) to one wherein the antibody is selected from a group including an scFv.
Sandhu teaches that the “The main advantages of scFv are the rapid clearance from human circulation and reduced toxic side effects” (page 450).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of claims 1-16 of the ‘750 patent and modify it such that the administered antibody is in an scFv format. The person of ordinary skill in the art would have been motivated to make this change in order to employ the advantages taught by Sandhu for scFv antibodies when administered, including rapid clearance from human circulation and reduced toxic side effects. The person of ordinary skill in the art would have had a reasonable expectation of success because the teachings of Sandhu are directed to scFv antibodies in general, and thus in absence of evidence to the contrary the skilled artisan would reasonably expect the advantages of the scFv format to be observed with the anti-C1s antibodies of the claims of the ‘750 patent. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claims 42 and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,391,750 issued 8/19/25 (cited on a 11/20/25 IDS), and which shares the same applicant and inventors with the instant application, and further in view of U.S. Patent Application Publication 2014/0140933, published 5/22/14.
Claims 42 and 50 further limit the method of claim 37 or 47 (which depends from claim 37) to one wherein the antibody is administered intravenously.
The ‘933 publication teaches that anti-C1s antibodies can be administered intravenously to treat a complement-mediated disease or disorder (¶ 34).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of claims 1-16 of the ‘750 patent and modify it to administered the antibody intravenously. The person of ordinary skill in the art would have been motivated to make this change because the claims of ‘750 are directed to administration of an anti-C1s antibody but are silent as to the route of administration, and the ‘933 publication supplies the missing information. The person of ordinary skill in the art would have had a reasonable expectation of success because the teachings of ‘933 are also directed to administration of an anti-C1s antibody, and thus in absence of evidence to the contrary the skilled artisan would reasonably expect that the teachings of ‘933 directed to anti-C1s antibodies would be applicable to administration of the specific anti-C1s antibodies of the claims of the ‘750 patent. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Notes on Patentability
(1) No prior art has been identified that teaches or renders obvious the amino acid sequences of the antibody of a humanized antibody comprising (a) a heavy chain variable (VH) region comprising the amino acid sequence of SEQ ID NO: 26 and (b) a light chain variable (VL) region comprising the amino acid sequence of SEQ ID NO: 27. As such, no prior art has been identified that teaches or renders obvious a method comprising administering said antibody to an individual.
(2) Instant independent claim 37 is limited to treating “a complement-mediated disease or disorder”, and the specification defines such as “a disorder characterized by an abnormal amount of complement C1s or an abnormal level of complement C1s proteolytic activity in a cell, a tissue, a fluid, or an organ of an individual” (¶ 176, published application). The specification teaches that the “complement system is a well-known effector mechanism of the immune response, providing not only protection against pathogens and other harmful agents but also recovery from injury” (page 1), and that C1s is a protease that is part of the C1 complex, which is the “first component” of the “classical complement pathway”, which is initiated by the protease activity of C1s.
With respect to the elected species of disease, antibody-mediated transplant rejection (AMTR), the prior art at the claimed priority date (4/6/15) recognized that in “AMR [antibody-mediated allograft rejection] causes graft failure through acute and/or chronic immunoglobulin and complement induced microvascular injury and remodeling that eventually leads to graft fibrosis” (page 1793 of Drachenberg et al, 2011. American Journal of Transplantation 2011: 1792-1802). Thus, the skilled artisan would have understood complement activity, including C1s activity, to be increased in AMTR, and that AMTR is thus a “complement-mediated disease or disorder” as recited in the claims, and would have reasonably expected the administered antibody to be effective in providing treatment for said condition.
In addition, the relevant prior art also recognized that “[c]omplement activation has been shown to occur in many pathological states, including renal, vascular, neurological, allergic, and infectious disease” (page 48 of Wagner et al, 2010. Nature Reviews. 9: 43-56). Box 2 of Wagner further details “Diseases in which complement is activated”, and includes approximately 45 different conditions, including lupus, Alzheimer’s disease, sepsis, stroke, allergy, asthma and more. Thus, the skilled artisan would have reasonably expected the administered antibody to be effective in providing treatment for the complement-mediated aspect of the diseases and disorders indicated as complement-associated by Wagner.
(3) Claim 10 of U.S. Patent No. 10,729,767 (cited on a 3/31/23 IDS), issuing from parent application 15/564,904, to which the instant application claims priority as a continuation, is directed to a method of administering an anti-C1s antibody to a subject having a disease or disorder selected from a group having the same scope as in instant dependent claim 43. This instant claims are subject to a double patenting rejection over the claims of the ‘767 patent (see above).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674