DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/29/2026 has been entered.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
3. New claims 30-32 have been added. Claims 1, 3-5, 7, 15-19 and 21-32 are pending. Claims 2, 6, 8-14 and 20 are canceled. Claims 1, 16, 23 and 28 have been amended.
4. Claims 1, 3-5, 7, 15-19 and 21-32 are under examination.
Rejections Maintained
Claim Rejections - 35 USC § 102
5. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
6. Claims 1, 3-5, 15-19, 22-27 and 29 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Trial NCT03269669 (version 109, posted on 9/25/2018).
Regarding claims 1, 3-5, 16-19 and 23-27, NCT03269669 (v.109) discloses a method of treating patients with relapsed or refractory follicular lymphoma, comprising administering to the patients therapeutically amounts of obinutuzumab and chemotherapy comprising doxorubicin, vincristine sulfate and prednisone (see Study Description and Arm III), wherein the patients with relapsed or refractory follicular lymphoma included the patients who have failed to treatment comprising bendamustine obinutuzumab x 3 cycles (under Eligibility). Follicular lymphoma is a non-Hodgkin’s lymphoma, and is a B cell lymphoma characterized by CD20 positivity. Obinutuzumab and chemotherapy comprising doxorubicin, vincristine sulfate and prednisone would inherently enhance cell cycle arrest or cell death as recited in claim 23, and enhance cell cycle arrest in G0/G1 phase as recited in claim 26.
Regarding claims 15, 22 and 29, NCT03269669 (v.109) discloses that obinutuzumab is administered by IV, which meets the limitation that obinutuzumab is administered in a pharmaceutical composition.
Claim 28 is withdrawn from the rejection in view of applicant’s amendments.
Applicant’s Arguments
The response states that ClinicalTrial discloses that the patients have previously received a combination treatment comprising bendamustine and an anti-CD20 monoclonal antibody, wherein the anti-CD20 monoclonal antibody may include rituximab or obinutuzumab. Applicant respectfully submits that these teachings fail to anticipate the presently claimed invention, which is directed to methods of treating an obinutuzumab-tolerant cancer by administering a combination treatment comprising obinutuzumab (e.g., obinutuzumab in combination with one or more of prednisolone, prednisone, doxorubicin, vincristine, and salts thereof), which Applicant has found to be effective despite the obinutuzumab-tolerance in the subject. ClinicalTrial simply fails to disclose a method of treating an obinutuzumab-tolerant cancer specifically, i.e., administering obinutuzumab to treat a patient known to be obinutuzumab-tolerant. In particular, Applicant respectfully submits that the genus of anti-CD20 monoclonal antibody-tolerant cancers (including both type I and type II anti-CD20 antibodies) described by ClinicalTrial fails to anticipate the presently claimed species of obinutuzumab-tolerant cancers.
Second, Applicant respectfully submits that ClinicalTrial's disclosure of treating patients including those who had received bendamustine and obinutuzumab for three cycles also fails to anticipate the presently claimed invention, because there is no indication in ClinicalTrial regarding whether those patients were tolerant of bendamustine treatment, obinutuzumab treatment, or both. In particular, as stated in M.P.E.P. § 2112(IV), "'[a] prior art reference that discloses a genus still does not inherently disclose all species within that broad category' but must be examined to see if a disclosure of the claimed species has been made or whether the prior art reference merely invites further experimentation to find the species" and "[i]n relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art" (emphasis original). Because the Inclusion Criteria section of ClinicalTrial only states that (1) bendamustine and rituximab for 4 cycles; (2) bendamustine, bortezomib, and rituximab for 6 cycles followed by rituximab maintenance; and (3) bendamustine and obinutuzumab for three cycles are "examples of eligible 1st line treatment regimens", the patients in ClinicalTrial did not necessarily receive prior treatment with bendamustine and obinutuzumab for three cycles.
Further, even if, arguendo, there were patients who did receive prior treatment with bendamustine and obinutuzumab, which Applicant does not concede, because ClinicalTrial's disclosure is of a patient who had relapsed after receiving treatment with a combination of bendamustine and obinutuzumab for three cycles, i.e., were tolerant to the combination, ClinicalTrial simply cannot anticipate, inherently or otherwise, the presently claimed methods, which are directed to the treatment of obinutuzumab-tolerant patients.
In addition, Applicant notes that new claims 30-32 specify that the obinutuzumab-tolerance is an acquired tolerance from being administered a prior treatment with obinutuzumab. Applicant respectfully submits that with respect to new claims 30-32, ClinicalTrial is entirely silent with regard to whether the tolerance to obinutuzumab was an acquired tolerance from being administered a prior treatment with obinutuzumab, e.g., whether the obinutuzumab-tolerance is an intrinsic tolerance or an acquired tolerance. For this reason alone, new claims 30-32 are free from the present anticipation rejection.
Response to Arguments
Applicant’s arguments have been carefully considered but are not persuasive
Clinical Trial NCT03269669 (v.109) discloses a method of treating patients with relapsed or refractory follicular lymphoma, comprising administering to the patients therapeutically amounts of obinutuzumab and a chemotherapy comprising doxorubicin, vincristine sulfate and prednisone (see Study Description and Arm III), wherein the patients include those who have failed to bendamustine obinutuzumab x 3 cycles (under Eligibility, reproduced below, see last line).
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MPEP 2131.02 states: “A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990)”
In the instant case, Clinical Trial NCT03269669 (v.109) specifically discloses that the patients with relapsed or refractory follicular lymphoma included those who have failed to bendamustine obinutuzumab x 3 cycles (under Eligibility).
Furthermore, the patients who have failed to bendamustine obinutuzumab x 3 cycles would indicate that the patients were resistant to bendamustine, obinutuzumab, as well as the combination thereof. Because if patient was sensitive to obinutuzumab, the cancer would not be a relapsed or refractory cancer.
Applicant’s arguments regarding new claims 30-32 are not persuasive as these claims are not included in the rejection.
For the foregoing reasons, the rejection is deemed proper and is therefore maintained.
Claim Rejections - 35 USC § 103
7. 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.
8. Claims 1, 3-5, 7, 15-19, 21-29 and new claims 30-32 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03269669 (version 109, posted on 9/25/2018), in view of Cheson et al. (J Clin Oncol., Aug 2018, 36(22): 2259-2266).
The teachings of NCT03269669 (v.109) have been set forth above as they apply to claims 1, 3-5, 15-19, 22-27 and 29.
Regarding claims 7, 21 and 28, NCT03269669 (v.109) discloses that the patients must have relapsed within 2 years after completing first line bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), patients who additionally received any maintenance anti-CD-20 antibody based therapy or consolidative radioimmunotherapy within 2 years of the last dose of the bendamustine therapy are eligible, and the patients included those who have failed to bendamustine obinutuzumab x 3 cycles (under Eligibility).
NCT03269669 (v.109) does not specifically disclose that the anti-CD20-antibody in the maintenance therapy is obinutuzumab.
Cheson et al teaches that obinutuzumab was used in the maintenance therapy for patients who had follicular lymphoma and received obinutuzumab plus bendamustine induction (title and Table 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included in NCT03269669 (v.109) the patients who had received obinutuzumab plus bendamustine induction and obinutuzumab maintenance therapy in view of NCT03269669 (v.109) and Cheson. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because NCT03269669 (v.109) teaches treating patients who had received bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), such as bendamustine obinutuzumab, and additionally received any maintenance anti-CD-20 antibody based therapy, and Cheson et al teaches that obinutuzumab was used in the maintenance therapy for patients who had follicular lymphoma and received obinutuzumab plus bendamustine induction (title and Table 1).
Regarding new claims 30-32, the combined reference teaches treating the patients who have failed to a therapy comprising (i) bendamustine obinutuzumab x 3 cycles and (ii) obinutuzumab maintenance therapy. Maintenance therapy is used to preserve the effect of prior treatment and implies an initial therapeutic response to bendamustine obinutuzumab x 3 cycles. Therefore, a cancer relapsed after a therapy comprising (i) bendamustine obinutuzumab x 3 cycles and (ii) obinutuzumab maintenance therapy meets the limitation “the obinutuzumab-tolerance is an acquired tolerance from being administered a prior treatment with obinutuzumab”.
Applicant’s Arguments
The response states that Applicant's finding that a combination treatment comprising a type II anti-CD20 antibody (e.g., obinutuzumab) together with prednisolone, prednisone, doxorubicin, or vincristine, or salts thereof, was surprisingly effective at treating obinutuzumab-tolerant cancers and killing obinutuzumab-tolerant cancer cells because, as discussed supra, ClinicalTrial does not describe administering such treatment to any obinutuzumab-tolerant patients.
Cheson fails to remedy the deficiencies of ClinicalTrial, because Cheson is directed to rituximab-refractory indolent non-Hodgkin lymphoma (see title of Cheson), and is entirely silent with regard to any method of treating obinutuzumab-tolerant CD20-positive cancers. Hence, neither reference teaches treating obinutuzumab-tolerant CD20-positive cancer and, therefore, the combination of the cited references fails to teach a feature required by the present claims.
Furthermore, Example 1 of the specification as filed compared the efficacy of different combination treatments comprising obinutuzumab and different chemotherapeutic agents at targeting obinutuzumab-tolerant CD20-positive cancer cells, and found that although "the combined use of obinutuzumab with 4- hydroperoxycyclophosphamide exhibited approximately additive effects in all of the obinutuzumab-directed cell death-tolerant clones" (emphasis added), "the combined use of obinutuzumab with doxorubicin, prednisolone, or vincristine exhibited supra-additive effects" (emphasis added). See paragraph [0095] of the specification as filed. These supra-additive effects described in Example 1 are indicative of a surprising synergistic effect of the presently claimed combination treatments as compared to a combination treatment comprising obinutuzumab and an alternative chemotherapeutic agent (e.g., 4- hydroperoxycyclophosphamide), which further highlights the surprising efficacy of the presently claimed methods for treating obinutuzumab-tolerant cancers. These surprising and synergistic effects of the presently claimed combination treatment are certainly not described or suggested by the combination of ClinicalTrial and Cheson.
Response to Arguments
Applicant’s arguments have been carefully considered but are not persuasive for the reasons discussed in the 102(a)(1) rejection.
Applicant’s arguments of unexpected results (synergistic effects) have been carefully considered but are not persuasive. As discussed above, claims 1, 3-5, 15-19, 22-27 and 29 are rejected under 102(a)(1) as being anticipated by Clinical Trial. Any results observed by applicants for claims 1, 3-5, 15-19, and 22-29 are considered inherent property of the method of Clinical Trial.
Regarding claims 7, 21 and 28 being rejected under 103, applicant has not shown unexpected results specifically relating to claims 7, 21 and 28.
It appears that the working examples only demonstrate synergistic effects on cancer cells that have intrinsic tolerance to obinutuzumab, i.e. the tolerance is not an acquired tolerance. The specification disclose that the cell clones 1A2, 1D2 and 3A4 were established as obinutuzumab tolerant clones by randomly introduce gene mutations ([0092], Example 1). The tolerance to obinutuzumab is not an acquired tolerance as required by new claims 30-32.
MPEP 716.02(d) states “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”.
For the foregoing reasons, the rejection is maintained.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 1, 3, 5, 7, 15-17, 19, 21-24 and 26-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims are rejected because the specification does not adequately describe all the species encompassed by the genus of type II anti-CD20 antibodies.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members.
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention.
Lastly, even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision.
The claims recite “a type II anti-CD20 antibody”. According to the specification, the term “a type II anti-CD20 antibody” is defined solely by functions listed in Table 1 (page, 26), reproduced below:
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The specification discloses the following type II anti-CD20 antibodies: tositumomab (B1 IgG2a), a humanized B-Ly1 antibody IgG1, 11B8 IgG1 and AT80 IgG1 ([0028)]. Obinutuzumab is a humanized B-Ly1 antibody.
Meyer et al. (British J Haematology, 2018, 180: 808-820) teaches that the only described Type II mAbs are OBZ (obinutuzumab), B1 (parental antibody of tositumomab) and 11B8 (page 808, last paragraph). Meyer teaches that due to the limited number of CD20 mAbs, drawing conclusions about which properties determine the mechanisms of action (MOA) of CD20 mAbs has been difficult (page 809, column 1, last para). Upon chimerization of a subpanel of the CD20 mAbs, one mAb displayed type II properties (page 809, column 1, last para). The similar location of the epitope of OBZ and B1 is most likely an incomplete explanation, given that B-Ly1, the parental mAb of OBZ, does not display complete Type II characteristics before humanization. Additionally, the epitope of Type II mAb 11B8 does not overlap with the OBZ epitope, but is comprised of amino acids located on the small and larger extracellular loop, similar to the Type I mAbs 7D8 and OFA. Further, the recently suggested V11L mutation in the VH chain of OBZ, reversing the mAbs Type II characteristics, is not a universal explanation (page 816, column 1). The teachings of Meyer show that there is no correlation between structure and functions listed in Table 1 above. The number of the species disclosed in the specification and known in the art is very small and thus cannot be considered as representative number of the species for the genus. Meyer teaches that studying functional properties revealed that all of the new mouse CD20 mAbs exhibit type I characteristics as they induce CDC but not PCD (programmed cell death) (page 815, column 2, para 1). Without further testing, one of ordinary skilled in the art would not be able to envision type II anti-CD20 antibodies from known anti-CD20 antibodies.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members.
It is noted that, “[r]egardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
In the absence of a representative number of species for the genus, and absence of a correlation between a structure and function, one of ordinary skill in the art would not consider that applicant was in possession of the genus of type II anti-CD20 antibodies.
Claim Rejections - 35 USC § 102
11. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
12. Claims 1, 4-5, 15-16, 18-19, 22-26 and 29-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Trial NCT03467373 v. 6 (pub. date: 10/3/2018).
Regarding claims 1, 4-5, 16, 18-19, 24-25 and 30-32, NCT03467373 v. 6 teaches a method of treating patients having relapsed and refractory (r/r) non-Hodgkin’s lymphoma (NHL), the method comprising administering to the patients obinutuzumab (G), rituximab (R), plus cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP), wherein the NHL is histologically confirmed to express CD20 (title) , and has relapsed/progressed following at least one prior treatment regimen containing R or G (under Inclusion Criteria).
Obinutuzumab and chemotherapy comprising doxorubicin, vincristine sulfate and prednisone would inherently enhance cell cycle arrest or cell death as recited in claim 23, and enhance cell cycle arrest in G0/G1 phase as recited in claim 26.
Regarding claims 15, 22 and 29, NCT03467373 v. 6 discloses that obinutuzumab is administered by IV, which meets the limitation that obinutuzumab is administered in a pharmaceutical composition.
Claim Rejections - 35 USC § 103
13. 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.
14. Claims 1, 3-5, 7, 15-19 and 21-32 are rejected under 35 U.S.C. 103 as being unpatentable over Grigg et al (Haematologica 2017, 102(4):765-772, PTO-892 dated 4/14/2025), in view of Fujimura et al (HemaSphere, June 2020, 4(1): 622, abstract no. EP1329, IDS filed on 6/7/2022).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Grigg et al teaches that obinutuzumab was used in the maintenance therapy for patients who had follicular lymphoma and received obinutuzumab plus bendamustine induction, or obinutuzumab plus CHOP ((cyclophosphamide, doxorubicin, vincristine, and prednisone( abstract and page 765, page 766, column 1). Follicular lymphoma is B-cell non-Hodgkin’s lymphoma and expresses CD20.
Grigg et al does not teach treating patients who had failed to therapy comprising obinutuzumab plus bendamustine induction and obinutuzumab maintenance (obinutuzumab-resistant cancer) with obinutuzumab and CHOP.
Fujimura et al teaches that OBI (obinutuzumab) was shown to be effective for relapsed and refractory follicular lymphoma (rr FL) after rituximab (abstract). Fujimura et al. teaches retreatment of non-Hodgkin lymphoma resistant to OBI-induced direct cell death (abstract). Fujimura teaches that resistant clones were established by treating cells with OBI for 3 weeks (abstract). Fujimura teaches that OBI continued to be effective against cells resistant to OBI-induced direct cell death when combined with chemotherapeutic agents such as doxorubicin, vincristine and prednisolone (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated patients who had failed therapy comprising obinutuzumab plus bendamustine induction and obinutuzumab maintenance with obinutuzumab and chemotherapeutic agents such as doxorubicin, vincristine and prednisolone in view of Grigg and Fujimura. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Grigg et al teaches that obinutuzumab plus CHOP have been used in treating follicular lymphoma, and Fujimura et al teaches obinutuzumab was still effective against obinutuzumab-resistant cancer when combined with chemotherapeutic agents (abstract).
Obinutuzumab and chemotherapy comprising doxorubicin, vincristine sulfate and prednisone would enhance cell cycle arrest or cell death as recited in claim 23, and enhance cell cycle arrest in G0/G1 phase as recited in claim 26.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate.
15. Claims 1, 4-5, 15-16, 18-19, 22-26 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Khurana et al. (SAGE Open Med Case Rep., Jan 2019, 7: 1-3, IDS filed on 11/20/2023) and Dumontet e al. (US 2009/0246197A1, pub date: 10/1/2009, IDS filed on 6/7/2022).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Khurana et al. et al. teaches a method of treating a patient having chronic lymphocytic leukemia who had first achieved partial remission with obinutuzumab and eventually relapsed over a course of 2.5 year, the method comprising administering to the patient obinutuzumab (abstract). Khurana et al. teaches that after retreatment with obinutuzumab, the patient achieved a partial remission again within one cycle and continues to maintain the response status (abstract).
Khurana does not teach treating the patient with a chemotherapeutic agent selected from the group consisting of doxorubicin, vincristine, prednisolone and prednisone.
Dumontet et al. teaches a method of treating a CD20 expressing cancer including chronic lymphocytic leukemia in a patient, the method comprising administering to the patient a type II anti-CD20 antibody and a chemotherapeutic agent selected from cyclophosphamide, vincristine and doxorubicin ([0076] and claims), wherein the type II anti-CD20 antibody is a humanized B-Ly1 antibody. Dumontet discloses that obinutuzumab is in a pharmaceutical composition ([105]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Khurana to treat patients who had failed obinutuzumab with obinutuzumab and a chemotherapeutic agent selected from cyclophosphamide, vincristine and doxorubicin in view of Dumontet. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Dumontet et al. teaches a method of treating a CD20 expressing cancer including chronic lymphocytic leukemia in a patient, the method comprising administering to patient a type II anti-CD20 antibody such as a humanized B-Ly1 antibody. and a chemotherapeutic agent selected from cyclophosphamide, vincristine and doxorubicin ([0076] and claims), and obinutuzumab is a humanized B-Ly1 antibody.
Obinutuzumab and chemotherapy comprising doxorubicin, vincristine sulfate and prednisone would enhance cell cycle arrest or cell death as recited in claim 23, and enhance cell cycle arrest in G0/G1 phase as recited in claim 26.
Conclusion
16. No claims are allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1646