Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims Status
The remarks filed 08/19/2025 are acknowledged.
Claims 1-4, 6, 10-14, 16, 24, 26, 28, 39, 53-55, 57-59 and 61 are pending.
Claims 3-4, 6, 10-11, 13-14, 16, 24, 26, 28, 39, 53-55, 58-59, and 61 are amended.
Claims 5, 7-9, 15, 17-23, 25, 27, 29-38, 40-52, 56, 60, and 62 are canceled.
Applicants election without traverse of the following species in the reply filed on 08/19/2025 is acknowledged: an anti-CD79b antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 36 and a light chain comprising the amino acid sequence of SEQ ID NO: 35, polatuzumab vedotin-piiq for the immunoconjugate, and that the human is an adult.
Claims 59 and 61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/19/2025.
Claims 1-4, 6, 10-14, 16, 24, 26, 28, 39, 53-55, and 57-58 are under examination.
Priority
The instant application is a Continuation of 17/074,471 (Abandoned) and claims priority to provisional applications 62/923,359 and 63/036,929. Priority is given with the earliest effective filing date of 10/18/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/13/2024 and 08/19/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code (see paragraphs [0368] and [0750] of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01.
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.
Claims 10, 12, and 28 are 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.
Claims 10 and 12 recite the limitation “about”. Applicant has provided an explicit definition for “about” meaning “the usual error range for the respective value readily known to the skilled person in this technical field.” (see paragraph 223 of the instant specification). However, the metes and bounds for “about” are dependent on the interpretation of others for determining what is a “usual” error range. Given a single value, one person of ordinary skill in the art could determine that the value is acceptably in the error range. Yet, another person of ordinary skill in the art could determine that it is unacceptable, leading to two different interpretations on if the claim infringes with “about.” Therefore, these claims are indefinite.
Claims 28 recites option (j) “is an adult.” However, options (a) – (i) and (k) also read on “is an adult.” Therefore, this claim is indefinite because all options read on said “adult.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6, 10-14, 16, 24, 26, 28, 39, 53-55, and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Polson (US 20160082120) and further in view of NCT01670370 (2018; instant PTO-892).
Regarding claims 1, 6, 10-13, 16, and 57-58, Polson teaches a method for treating a B-cell proliferative disorder, in particular Diffuse Large B-cell Lymphoma (DLBCL), by administering to an individual an effective amount of an immunoconjugate comprising an anti-CD79b antibody linked to a cytotoxic agent and rituximab [0003, 0008-0009, Claims 1-2]. Polson also teaches that the formula of the immunoconjugate is [0016]:
PNG
media_image1.png
96
562
media_image1.png
Greyscale
This structure is 100% identical to the structure of the instant claim, and therefore, this structure is necessarily polatuzumab vedotin-piiq (as elected). Additionally, Polson teaches administering polatuzumab vedotin (anti-CD79b (huMA79b.v8)-MC-vc-PAB-MMAE), which has the same structure as polatuzumab vedotin-piiq, in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma [0422]. Polson further teaches that the antibody comprises (a) HVR-H1 comprising the amino acid sequence of SEQ ID NO:21; (b) HVR-H2 comprising the amino acid sequence of SEQ ID NO:22; (c) HVR-H3 comprising the amino acid sequence of SEQ ID NO:23; (d) HVRL1 comprising the amino acid sequence of SEQ ID NO:24; (e) HVR-L2 comprising the amino acid sequence of SEQ ID NO:25; and (f) HVR-L3 comprising the amino acid sequence of SEQ ID NO:26 [0019].
SEQ ID NOs: 21-26 have 100% sequence identity to SEQ ID NOs: 21-26 of the instant claim, respectively.
Polson further teaches that p ranges from 1-8 [0012] and that the anti-CD79b immunoconjugate demonstrated clear inhibition of tumor growth and the combination with rituximab resulted in significantly greater efficacy [0421]. Polson also teaches that the anti-CD79 immunoconjugate (polatuzumab vedotin-piiq) is administered at a dose of 1.8 mg/kg [0158], the rituximab is administered at a dose of 375 mg/m2 [0159], and that the anti-CD79b immunoconjugate (polatuzumab vedotin-piiq) and the additional therapeutic agent (rituximab) can be co-administered on the same day [0155]. Polson further teaches that polatuzumab vedotin (anti-CD79b immunoconjugate) is administered intravenously in combination with rituximab, and rituximab is administered on day 1 of cycle 1 and on day 1 of each subsequent cycle for up to 6 cycles [0424]. Polson also teaches polatuzumab vedotin 1.8 mg/kg is administered intravenously (IV) on day 1 of cycle 1-6 of each 21-day cycle [0457-0463]. Polson further teaches Rituximab may be administered up to nine 3- to 4- weeks-dosage-cycles [0159] and that the dosing regimens for administration of the combination therapy of the anti-CD79b immunoconjugate and rituximab are, but not limited to, every 3 weeks (21 day cycle) [0160]. This range overlaps with up to eight 21-day cycles. MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists”.
However, Polson does not specifically teach administering an effective amount of (c) gemcitabine, and (d) oxaliplatin in combination with (a) the immunoconjugate and (b) rituximab, or that gemcitabine is administered at a dose of 1000 mg/m2, the oxaliplatin is administered at a dose of 100 mg/m2, and that the immunoconjugate (polatuzumab vedotin-piiq), the rituximab, the gemcitabine, and the oxaliplatin are administered for at least one (i.e. one or more) 21-day cycles, and wherein the gemcitabine and oxaliplatin are administered intravenously on Day 2 of each 21-day cycle.
NCT01670370 teaches R-GemOx, a combination of Rituximab, Gemcitabine, and Oxaliplatin to treat DLBCL [page 3]. NCT01670370 further teaches that Rituximab is administered at 375 mg/m2 IV (intravenously) on day 1, Gemcitabine is administered at 1g/m2 (equivalent to 1000mg/m2) IV (intravenously) on day 2, and Oxaliplatin is administered at 100mg/m2 IV (intravenously) on day 2 [page 4]. NCT01670370 also teaches that R-GemOx achieved high efficacy with a low toxicity profile in relapsed and refractory DLBCL [page 4].
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have combined the anti-CD79b immunoconjugate (polatuzumab vedotin-piiq) and rituximab, as taught by Polson, with the gemcitabine, and oxaliplatin, as taught by NCT01670370. One would have been motivated to combine these therapies because all are known compositions to treat diffuse large B-cell lymphoma (DLBCL) and relapsed or refractory (R/R) DLBCL. MPEP 2144.06 states “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it would have been obvious to combine the separate, known compositions into one single composition for the same purpose of treating DLBCL and R/R DLBCL with a reasonable expectation of success.
It further would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to administer the Polatuzumab vedotin (immunoconjugate) at a dose of 1.8mg/kg, as taught by Polson, the rituximab at a dose of 375 mg/m2, as taught by Polson and NCT01670370, the gemcitabine at a dose of 1000 mg/m2, as taught by NCT01670370, and the oxaliplatin at a dose of 100mg/m2, as taught by NCT01670370, for one or more 21-day cycles, for up to 9 cycles, as taught by Polson, wherein the immunoconjugate and the rituximab are administered intravenously on Day 1, as taught by Polson, and the gemcitabine and the oxaliplatin are administered intravenously on Day 2, as taught by NCT01670370, because these are known values of known parameters in the art, and therefore would have a reasonable expectation of success.
Claim 2 is included in this rejection because Polson teaches that the
antibody comprises a VH comprising the amino acid sequence of SEQ ID NO: 19 and a VL sequence comprises the amino acid sequence of SEQ ID NO:20 [0020].
SEQ ID NO: 19 has 100% identity to SEQ ID NO: 19 of the instant claim and SEQ ID NO: 20 has 100% identity to SEQ ID NO: 20 of the instant claim.
Claim 3 is included in this rejection because Polson teaches that the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO:36 and a light chain comprising the amino acid sequence of SEQ ID NO:35 [0020].
SEQ ID NO: 36 has 100% identity to SEQ ID NO: 36 of the instant claim and SEQ ID NO: 35 has 100% identity to SEQ ID NO: 35 of the instant claim.
Claim 4 is included in this rejection because Polson teaches that p ranges from 1-8 [0012] and in some embodiments p ranges from 2-5 [0017]. MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists”.
Claim 14 is included in this rejection because Polson teaches that the anti-CD79b immunoconjugate and the additional therapeutic agents are co-administered either simultaneously or sequentially in either order and when both therapeutic agents are co-administered sequentially the dose can be administered in two separate administrations [0155]. Further, rearranging steps is not inventive. See MPEP 2144 (IV)(C) which cites In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) that states “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results.”
Claim 24 is included in this rejection because Polson teaches that the individual has received at least one prior therapy for DLBCL [0149].
Claim 26 is included in this rejection because Polson teaches that the B-cell proliferative disorder is a histologically confirmed DLBCL [0149] and the B-cell proliferative disorder is a relapsed or refractory B-cell proliferative disorder [0151].
Claim 28 is included in this rejection because NCT01670370 teaches that the inclusion criteria for patients is to be newly-diagnosed and untreated. Therefore, the human would not have (f) had prior therapy with a combination of gemcitabine and a platinum-based agent or (g) received a prior therapy with polatuzumab vedotin-piiq for DLBCL.
Claims 39 and 53 are included in this rejection because it merely recites effects or results of administering the immunoconjugate, the rituximab, the gemcitabine, and the oxaliplatin together. Because it would have been obvious to administer this combination as described above, a person of ordinary skill in the art would have reasonably expected these effects to occur, absent evidence to the contrary. Further (a) and (b) are properties of the combination of the immunoconjugate, the rituximab, the gemcitabine, and the oxaliplatin. Applicant is reminded that chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
Claims 54 and 55 are included in this rejection because Polson teaches an article of manufacture containing materials for the treatment of DLBCL, wherein the article of manufacture (kit) comprises a container and a label or package insert on or associated with the container, and wherein the container holds a composition which is by itself or container with another composition effective for treating , and that the composition is the immunoconjugate of the invention. Polson further teaches that the article of manufacture may comprise a first container with a composition contained therein, wherein the composition comprises the immunoconjugate and a second container with a composition contained therein, wherein the composition comprises a further cytotoxic or otherwise therapeutic agent [0415].
The limitation of “for use in combination with rituximab, gemcitabine, and oxaliplatin for treating a human in need thereof having diffuse large B-cell lymphoma (DLBCL) according to the method of claim 1” is a recitation of intended use. The recitation of the intended use does not result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. As taught above, the prior art structure (i.e. polatuzumab vedotin-piiq) is capable of performing the intended use, and thus, it meets the limitations of the instant claims.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. Mounier et al., 2013 (instant PTO-892)
- This is pertinent art to the instant application because Mounier teaches administering rituximab, gemcitabine, and oxaliplatin to patients with diffuse large B-cell lymphoma.
B. NCT02257567 (2018; instant PTO-892)
- This is pertinent art to the instant application because NCT02257567 teaches Polatuzumab administered in combination with rituximab in patients with DLBCL.
C. Fotin-Mileczek (WO 2017186928)
- This is pertinent art to the instant application because Fotin-Mileczak teaches SEQ ID NO 704, Polatuzmab_vedotin_HeavyChain, which is 100% identical to SEQ ID NO: 36 of the instant application and SEQ ID NO 705, Polatuzmab_vedotin_LightChain, which is 100% identical to SEQ ID NO: 35 of the instant application [page 83].
D. Kagedal et al., 2017 (instant PTO-892)
- This is pertinent art to the instant application because Kagedal teaches that conjugation through reduced inter-chain disulfide cysteine residues results in a heterogeneous mixture of conjugated antibodies, with a drug to antibody ratio (DAR) ranging from 0 to 8; and, with an average DAR of 3–4 for most vc-MMAE ADCs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675