DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 7, 2026 has been entered.
Claim Amendment
3. The amendment filed May 7, 2026 has been entered. Claims 1-25, 32, 37 and 47 are cancelled. Claim 26 was amended. Claim 48 was newly added. Claims 26-31, 33-36, 38-46 and 48 are under consideration in this Office Action.
Withdrawn Grounds of Rejection
4. The rejection of claim 26 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of Applicants amendments and arguments.
5. The new matter rejection of claim 47 under 35 U77.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of Applicants amendments and arguments.
6. The rejection of claim 37 on the ground of non-statutory double patenting as being unpatentable over claims 1-19 and 21-26 of U.S. Patent No. 11,149,091 is withdrawn in view of Applicants amendments.
7. The rejection of claims 26-27, 29-31, 33-37, 39, 41, 44-45 and 47 under 35 U.S.C. 103 as being unpatentable over Gokarn et al; Brown et al., in view of Nozu et al., and Mossner et al., is withdrawn in view of Applicants amendments.
New Grounds of Rejection Necessitated By Applicants Amendment
Claim Rejections - 35 USC § 112
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.
8. Claim 43 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 26 now recites “…wherein the effective amount is about 1 gram of Obinutuzumab per dose…”. Thus claim 26 recites a larger limitation yet dependent claim 43 recites a lower limitation, an amount of 100 mg on day 1 and 900 mg on day 2
that falls within the below the limitation of 1000mg as recited by claim 26. Therefore, claim 43 is indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Claim 43 presents a question or doubt as to whether the amount introduced by claim 43 is (a) merely exemplary and therefore not required, or (b) a required feature of the claim.
For instance, 100mg is not about 1 gram, thus the metes and bounds for limiting the Obinutuzumab to about 1 gram per dose is inconsistent to the amount of 100 mg. Therefore, clarification is still required to overcome the rejection.
Maintained Grounds of Rejection
Double Patenting
9. The non-statutory 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 non-statutory 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 non-statutory 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 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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 26-31, 33-36 and 38-46 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-19 and 21-26 of U.S. Patent No. 11,149,091. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to:
A method for treating, or inhibiting or reducing severity relative to baseline of, lupus nephritis, nephrotic syndrome, or glomerulonephritis in a subject in need thereof, comprising: administering an effective amount of an anti-CD20 antibody over a period of no more than 21 days to the subject, said anti-CD20 antibody comprising Obinutuzumab, and abstaining from administering the anti-CD20 antibody for at least 12 months from the period of the anti-CD20 antibody administration.
The claims of U.S. Patent No. 11,149,091 recite:
A method of treating, inhibiting or reducing severity of nephrotic syndrome in a subject in need thereof consisting of: administering an effective amount of an anti-CD20 antibody, or a pharmaceutical composition consisting of the anti-CD20 antibody and a pharmaceutically acceptable excipient in two or more doses over a period of no more than 21 days to the subject, so as to treat, inhibit or reduce the severity of nephrotic syndrome in the subject wherein the anti-CD20 antibody comprises obinutuzumab. and the two or more doses have a first dose and a last dose that are 1-20 days apart: or administering an effective amount of the anti-CD20 antibody or the pharmaceutical composition in the two or more doses over a period of no more than 21 days and a standard-of-care treatment to the subject, so as to treat, inhibit or reduce the severity of nephrotic syndrome in the subject.
The claims of both application and patent are drawn to a method of treating, inhibiting or reducing severity of nephrotic syndrome, and glomerulonephritis, in a subject in need thereof. Both the application and patent administer Obinutuzumab in the same recited amounts and dosing schedules; thus they are not patentably distinct from each other. The instant application and patent do not recite patentably distinct subject matter.
Double Patenting
11. Claims 26-31, 33-36 and 38-46 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No 11,840,576. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to:
A method for treating, or inhibiting or reducing severity relative to baseline of, lupus nephritis, nephrotic syndrome, or glomerulonephritis in a subject in need thereof, comprising: administering an effective amount of an anti-CD20 antibody over a period of no more than 21 days to the subject, said anti-CD20 antibody comprising Obinutuzumab, and abstaining from administering the anti-CD20 antibody for at least 12 months from the period of the anti-CD20 antibody administration.
The claims of U.S. Patent No. 11,840,576 recite:
A method of treating, inhibiting or reducing severity of nephrotic syndrome or glomerulonephritis in a subject in need thereof, wherein the subject is a transplant recipient, the method consisting of: administering an effective amount of an anti-CD20 antibody, or a pharmaceutical composition consisting of the anti-CD20 antibody and a pharmaceutically acceptable excipient, in two or more doses over a period of no more than 21 days to the subject after transplantation, or administering an effective amount of the anti-CD20 antibody or the pharmaceutical composition in the two or more doses over a period of no more than 21 days and a standard-of-care treatment to the subject,
wherein the anti-CD20 antibody comprises Obinutuzumab, so as to treat, inhibit or reduce the severity of nephrotic syndrome or glomerulonephritis in the subject.
The claims of both application and patent are drawn to a method of treating, inhibiting or reducing severity of nephrotic syndrome, glomerulonephritis, and lupus nephritis in a subject in need thereof. Both the instant application and patent claims administer Obinutuzumab in the same recited amounts and the same dosing schedules; thus they are not patentably distinct from each other. The instant application and patent do not recite patentably distinct subject matter.
Response to Arguments
12. Applicant's arguments filed May 7, 2026 have been fully considered but they are not persuasive. Applicants requested the double patenting rejections be held in abeyance. However the rejection of non-statutory double patenting rejection as being unpatentable over claims 1-19 and 21-26 of U.S. Patent No. 11,149,091 is maintained. Additionally, the non-statutory double patenting rejection as being unpatentable over claims 1-20 of U.S. Patent No 11,840,576 is maintained.
It is noted that Applicants requested the rejections be held in abeyance. However, the rejection are maintained until the non-statutory double patenting rejections are addressed.
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.
13. Claims 26, 28-32, 34-36, 38-46 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Gokarn et al., Brown et al., and Moulin et al., in view of Brunetta et al., (US20090311255 published Dec 2009; priority to Aug 2008) and Mossner et al., (Blood. 2010 Mar 1;115(22):4393–4402).
The claims are drawn to a method for treating, or inhibiting or reducing severity of, lupus nephritis, nephrotic syndrome, or glomerulonephritis in a subject in need thereof, wherein the subject is diagnosed with the lupus nephritis, the nephrotic syndrome, or the glomerulonephritis, the method comprising: administering an effective amount of obinutuzumab in two or more doses over a period of no more than 21 days to the subject wherein the effective amount is about 1 gram of Obinutuzumab per dose; measuring, or obtaining a result of, serum creatinine level, urine protein-to-creatinine ratio, or both of the subject at one or more post-obinutuzumab time points selected from the group consisting of about 1 month, about 2 months, about 3 months, about 4 months, about 6 months, and about 12 months from the period of the obinutuzumab administration, wherein the serum creatinine level, the urine protein-to-creatinine ratio, or both at the one or more post-obinutuzumab time points is lower than before the obinutuzumab administration; and abstaining from administering an anti-CD20 antibody for at least 12 months from the period of the Obinutuzumab administration wherein the reduction of severity is compared to the subject before receiving the Obinutuzumab or compared to a subject who is diagnosed with the lupus nephritis the nephrotic syndrome or the glomerulonrphritis but not administered with the Obinutuzumab.
Gokarn et al., teach a method of treating a disease or disorder in a subject comprising administering the formulation to a subject in an amount effective to treat the disease or disorder [para 37]. Examples of disorders include inflammatory renal diseases, such as glomerulonephritis, especially mesangioproliferative glomerulonephritis, nephrotic syndrome, haemolytic uremic syndrome, diabetic nephropathy or hypertensive nephrosclerosis and diseases occurring after transplants including post-transplant lymphoproliferative disorder (PTLD) [para 97-98]. Thus teaching a method for treating, or inhibiting or reducing severity of nephritis, nephrotic syndrome, or glomerulonephritis, post kidney transplant disorders in a subject in need thereof as claimed in claims 26, 29-31 and 45. Additionally, Gokarn et al., teach treatment of chronic lymphocytic leukemia [para 38 and para 106].
The stable aqueous pharmaceutical formulation, the formulation comprising a monoclonal antibody, trehalose and a buffer [para 8]. Gokarn et al., describe the Obinutuzumab, formulations comprising Obinutuzumab, trehalose, sodium phosphate and polysorbate 20 [para 19, 23, and 34]. In one embodiment, the anti-CD20 antibody is obinutuzumab (recommended INN, WHO Drug Information, Vol. 26, No. 4, 2012, p. 453). As used herein, obinutuzumab is synonymous for GA101 or RO5072759 [para 88]. Example 2 teach the development and formulation of Obinutuzumab. The antibody is obinutuzumab.
The formulation for administration to a subject is for intravenous (IV) administration [para 16], thus teaching claim 41. The antibody is suitably administered to the patient over a series of treatments and may be administered to the patient at any time from diagnosis onwards. The antibody may be administered as the sole treatment or in conjunction with therapies useful in treating the condition in question [para 271]. The dose may be infusions administered as a single dose or as multiple doses (e.g., 2 or 3 doses) [para 272]; thus teaching a single dose for only 1 day as recited by claims 38-39. Thus teaching abstaining from administration for about 1 month as recited by claim 26.
The formulation may also contain more than one protein as necessary for the particular disorder being treated. For example, it may be combined with another agent such as a chemotherapeutic agent, and/or anti-neoplastic agent [para 267]. The “chemotherapeutic agent” is a chemical compound useful in the treatment of cancer. Examples of chemotherapeutic agents include mycophenolic acid [para 110]. Thus teaching claims 35-36. Therefore, Gokarn et al., teach a method for treating, or inhibiting or reducing severity of, lupus nephritis, nephrotic syndrome, glomerulonephritis and/or chronic lymphocytic leukemia in a subject in need thereof, wherein the subject is diagnosed with the lupus nephritis, the nephrotic syndrome, or the glomerulonephritis, the method comprising: administering an effective amount of obinutuzumab in two or more doses over a period of no more than 21 days to the subject. However, Gokarn et al., do not teach the doses in an amount of about 1000mg.
Brown teach human patients received treatment with Obinutuzumab was administered IV (900 mg and 1000 mg on a 15 day cycle 1; 1000 mg on day 1 of cycles 2-6) with either fludarabine and cyclophosphamide. Each cycle was 28 days [Treatment]. Thus teaching claim 43. To enroll, patients had to have adequate renal function (creatinine clearance >60 mL/min for G-FC) [Patient population]. Thus teaching measuring creatinine level at a time point as recited by claims 27 and 48. Brown et al., explored the safety and preliminary efficacy of obinutuzumab-bendamustine (G-B) or obinutuzumab fludarabine cyclophosphamide (G-FC) for the therapy [Abstract]. Thus teaching claims 34-35. Obinutuzumab is in combination with chemotherapy has an acceptable safety profile when administered to previously untreated fit patients. After the first infusion of obinutuzumab symptoms were easily handled with corticosteroid premedication and split dosing. Brown et al’s data demonstrate that obinutuzumab in combination with FC or B has promising activity when used in the therapy of patients.
Obinutuzumab (previously known as GA101) is a humanized immunoglobulin G1 antibody targeting CD20, which was developed as a type 2 antibody and glycoengineered for enhanced antibody-dependent cellular cytotoxicity and phagocytosis. Obinutuzumab does induce stronger homotypic aggregation of B cells, resulting in greater direct cell death. In addition, the Fc segment of obinutuzumab is glycoengineered and is more effective at eliciting antibody-dependent cellular cytotoxicity than rituximab.
Gokarn et al., and Brown et al., have been discussed above as teaching a method for treating, or inhibiting or reducing severity of, nephrotic syndrome, in a subject in need thereof, wherein the subject is diagnosed with nephrotic syndrome, the method comprising: administering an effective amount of Obinutuzumab in two or more doses over a period of no more than 21 days to the subject, and abstaining from administering an anti-CD20 antibody for at least 12 months from the period of the Obinutuzumab administration. However, none of the references teach the subject has been administered a standard-of-care treatment prior to the administration of the Obinutuzumab, and the subject does not respond to the standard-of-care treatment prior to the administration of the anti-CD20 antibody or the measurement of urine protein to creatinine ratio at about 3 months, 6 months or 12 months.
Moulin et al., analyzed clinical presentation, immunopathological data and renal outcome in 13 patients with glomerulonephritis (GN) and chronic lymphocytic leukemia (CLL) [abstract]. B-cell proliferation and glomerulopathy were simultaneously diagnosed in seven of the 13 patients. Nephrotic syndrome was observed in nine patients. Serum creatinine was elevated (greater than 120 mumol/liter) in 10 patients and exceeded 400 mumol/liter in three patients. A clear cut relationship between GN and hematologic disease could be established in nine cases: five patients had MPGN caused by type I or type II cryoglobulinemia; two had MPGN or mesangial hypertrophy with circulating and deposited noncryoprecipitating monoclonal IgG K and IgM K, respectively; in the two remaining patients, monotypic IgG K glomerular deposits exhibiting fibrillary organization were observed in association with MGN or MPGN, despite the absence of circulating M-component by immunofixation [abstract]. These overall data demonstrate that the occurrence of GN in B-CLL and related lymphoma is not fortuitous, and testify to the paraneoplastic nature of glomerular involvement mediated by deposition [abstract]. However, none of the references teach treating lupus nephritis, comprising administering an effective amount of obinutuzumab.
Brunetta et al., teach administration in an asymptomatic human subject at risk for experiencing one or more symptoms of the autoimmune disease, by administering a CD20 antibody to the subject in an amount to prevent the subject from experiencing one or more symptoms of the autoimmune disease [para 11]. Brunetta et al., teach treating autoimmune diseases including lupus, including lupus nephritis, lupus cerebritis, pediatric lupus, non-renal lupus, extra-renal lupus, discoid lupus and discoid lupus erythematosus, alopecia lupus, systemic lupus erythematosus (SLE) such as cutaneous SLE or subacute cutaneous SLE, neonatal lupus syndrome (NLE), and lupus erythematosus disseminatus, glomerulonephritis (GN) with and without nephrotic syndrome such as chronic or acute glomerulonephritis such as primary GN, immune-mediated GN, membranous GN (membranous nephropathy), idiopathic membranous GN or idiopathic membranous nephropathy, membrano- or membranous proliferative GN (MPGN), including Type I and Type II, and rapidly progressive GN, proliferative nephritis, immune complex nephritis, antibody-mediated nephritis, (IgA nephropathy), idiopathic IgA nephropathy, post-streptococcal nephritis, idiopathic nephritic syndrome, minimal change nephropathy, nephrosis, mixed connective tissue disease, nephrotic syndrome, nephrotic syndrome, focal or segmental or focal segmental glomerulosclerosis (FSGS), glomerulonephritides [para 23]. Thus teaching claims 28-31.
As a general proposition, the effective amount of the antibody administered parenterally per dose will be in the range of about 20 mg/m2 to about 10,000 mg/m2 of subject body, by one or more dosages [para 100]. Thus teaching claims 37. Exemplary IV dosage regimens for intact antibodies include 1000 mg×2 (e.g. on days 1 and 15); or 1 gram×3 [para 100]. Thus teaching claims 38, 40 and 42. Parenteral infusions include intravenous or intraarterial administration [para 102]. Thus teaching claim 41. One may administer other compounds [103]. The combined administration includes coadministration, using separate formulations or a single pharmaceutical formulation, and consecutive administration in either order, wherein preferably there is a time period while both (or all) active agents simultaneously exert their biological activities [para 103]. For example, glucocorticoid, low-dose prednisone, glucorticoids/prednisone/methylprednisone (glucocorticoids), cyclosporin A. The combined administration includes coadministration, using separate formulations or a single pharmaceutical formulation, and consecutive administration in either order, wherein preferably there is a time period while both (or all) active agents simultaneously exert their biological activities [para 103]. Thus teaching claims 34-36. Aside from the CD20 antibody, the subject may be treated with steroids, one or more immunosuppressants such as cyclosporine [para 235]. Thus teaching claims 34-36.
Mossner et al., teach CD20 is an important target for the treatment of B-cell malignancies, lymphoma as well as autoimmune disorders. B-cell depletion therapy using monoclonal antibodies against CD20, such as rituximab, has revolutionized the treatment of these disorders, greatly improving overall survival in patients. Here, Mossner et al., reported the development of GA101 as the first Fc-engineered, type II humanized IgG1 antibody against CD20 [abstract]. It is noted, that GA101 is also known as Obinutuzumab.
Relative to rituximab, GA101 has increased direct and immune effector cell-mediated cytotoxicity and exhibits superior activity in cellular assays and whole blood B-cell depletion assays [Discussion]. In human lymphoma xenograft models, GA101 exhibits superior antitumor activity, resulting in the induction of complete tumor remission and increased overall survival. In nonhuman primates, GA101 demonstrates superior B cell–depleting activity in lymphoid tissue, including in lymph nodes and spleen [Discussion]. Taken together, these results provide compelling evidence for the development of GA101 as a promising new therapy for the treatment of B-cell disorders [abstract]. Because of its superior B cell–depleting activity in lymphoid tissues, GA101 may provide an effective treatment alternative for autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythomatosus, or immune thrombocytic purpura, where rituximab has shown some benefit [Discussion]. Thus, Mossner et al., teach the motivation to exchange rituximab for obinutuzumab.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to treat lupus nephritis as taught by Brunetta et al., using the method of Gokarn et al., Brown and Moulin et al., already known to treat inflammatory renal diseases, such as systemic lupus erythematosus, lupus nephritis, and other B-cell diseases by administering obinutuzumab in conjunction with standard of care agents in order to have increased direct and immune effector cell-mediated cytotoxicity and exhibits superior activity. It is prima face obvious to substitute one anti-CD20 antibody rituximab
for another, obinutuzumab when the prior art proves the diseases are all B-cell disorder and the prior art shows that obinutuzumab performs better than rituximab as taught by Mossner et al.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to combine known methods which function in a predictable manner to yield a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
14. Applicant’s arguments and amendments filed October 23, 2025, with respect to the rejections of claims 26, 28-32, 34-39, 40-42 and 44-47 under 35 U.S.C. 103 as being unpatentable over Gokarn et al., Brown et al., Moulin et al., Brunetta et al., and Mossner et al., is maintained.
In response to Applicants arguments, the rejection of record clearly teach how Obinutuzumab will treat patients with subject is diagnosed with the lupus nephritis, the nephrotic syndrome, or the glomerulonephritis wherein the effective amount is about 1 gram. Brown et al., teach human patients received treatment with Obinutuzumab was administered at 900 mg and 1000 mg within a cycle or a different cycle of 1000 mg on day 1 of the cycle. Similarly, Brunetta teach the effective amount of the antibody administered parenterally per dose will be in the range of about 20 mg/m2 to about 10,000 mg/m2 of subject body, by one or more dosages [para 100]. Exemplary IV dosage regimens for intact antibodies include 1000 mg×2 (e.g. on days 1 and 15); or 1 gram×3 [para 100]. Therefore, both Brown and Brunetta both teach administrating about 1g or 1000mg for administration just as instantly claimed. Brown et al., teach patients having adequate renal function (creatinine clearance >60 mL/min for G-FC); thus teaching measuring creatinine level at a time point. Therefore, the prior art teach the newly recited limitations.
Gokarn et al., clearly teach a method for treating, or inhibiting or reducing severity of, lupus nephritis, nephrotic syndrome, or glomerulonephritis in a subject in need thereof, wherein the subject is diagnosed with the lupus nephritis, the nephrotic syndrome, or the glomerulonephritis, the method comprising: administering an effective amount of Obinutuzumab. Moreover, the prior art teaching of Gokarn et al., and Brown et al., teach the administration of an effective amount of Obinutuzumab. Inherently, serum creatinine and/or urine protein to creatinine ratio is reduced. See also MPEP 2112.01 "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Gokarn et al., teach administration of obinutuzumab. Brown teach human patients received treatment with Obinutuzumab at about 1 g and Mossner et al., teach Obinutuzumab demonstrates superior B cell–depleting activity in lymphoid tissue, when compared to rituximab. Therefore one of ordinary skill in the art would clearly be motivated to exchange one antiCD20 antibody for a superior anti-CD20 antibody, obinutuzumab. Additionally, Moulin et al., teach a clear cut relationship between CLL and glomerulonephritis (GN), glomerulopathy and nephrotic syndrome. Therefore, there is clear cut evidence for the use of the anti-CD20 monoclonal antibody obinutuzumab with a higher efficacy than rituximab in patients with comorbidities and poor renal functions.
Therefore, Applicants amendments and arguments do not overcome the instant rejection.
Pertinent Art
15. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. See WO2016183104 and WO2015116729.
Conclusion
16. No claims allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645
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