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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-18, and 20-21 have an effective filing date of 10 MAR 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/15/2025 and 9/8/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Claims
Claims 1-18, and 20-21 are currently pending and presented for examination on the merits.
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 10-11 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.
Claim 10 recites the limitation "the curve 5 carboplatin" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
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 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.
Claims 1-9, 11-12, 14-17, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer et al (Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study, Gyn Onc 156, 523-529, 2020, IDS 9/8/2023), and further in view of Oza et al (Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial, Lancet Oncol 2015; 16: 928–36, IDS 9/8/2023).
With regards to claim 1, Brewer et al teaches a method of treating advanced ovarian cancer (Stage III/IV) comprising carboplatin, paclitaxel, and oregovomab (mAb-B43.13) [Abstract]. Brewer et al further teaches administering the treatment over six cycles [Abstract]. Brewer et al further teaches increase in progression free survival (PFS) and overall survival (OS) when compared to treating with just carboplatin and paclitaxel [Abstract]. Brewer et al further teaches enhanced activity that favored simultaneous day scheduling of administration [Left column, 3rd Paragraph, pg. 524]. Brewer et al further teaches that over the six cycles, oregovomab was administered four times, on cycles one, three, five and a maintenance infusion 12 weeks following [Left column, 5th Paragraph, pg. 524]. Brewer et al further teaches these results were compared to a patient with ovarian cancer, stages III-IV, receiving carboplatin and paclitaxel [Abstract].
Brewer et al does not specifically teach administering bevacizumab. However, this deficiency is made up in the teaching of Oza et al.
Oza et al teaches a method of treating ovarian cancer (stage III/IV) comprising carboplatin, paclitaxel, and bevacizumab [Summary]. Oza et al further teaches the bevacizumab was administering concurrently with the carboplatin and paclitaxel on six cycles [Summary]. Oza et al further teaches improved progression-free survival with the addition of bevacizumab to standard chemotherapy [Summary].
With regards to the order the treatments are administered, the order of administration is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal order to administer the treatments needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredients administration order would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
One of ordinary skill, before the effective filing date, would have been motivated to combine Brewer’s method of treating stage III/IV ovarian cancer comprising carboplatin, paclitaxel, and oregovomab, administered over six cycles and an oregovomab treatment administer 12 weeks later, with Oza’s method of treating stage III/IV ovarian cancer comprising administering concurrently carboplatin, paclitaxel, and bevacizumab on six cycles. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Brewer and Oza’s methods for a method of treating stage III/IV ovarian cancer comprising carboplatin, paclitaxel, bevacizumab, and oregovomab administered concurrently, with oregovomab administered on cycles 1, 3, 5, and an additional dose of oregovomab 10-14 weeks after the 5th cycles administration. Furthermore, to increase the patients likelihood of survival in comparison to the patient being treated with carboplatin and paclitaxel only, Brewer et al teaches increase in progression free survival (PFS) and overall survival (OS) when compared to treating with just carboplatin and paclitaxel, and Oza et al teaches the addition of bevacizumab to chemotherapy improved the progression-free survival compared to standard chemotherapy.
With regards to claims 2-3, Brewer et al teaches the time interval between each cycle is three weeks [Left column, 5th Paragraph, pg. 524].
With regards to claim 4, Brewer et al teaches administering a maintenance infusion 12 weeks following the 5th cycle [Left column, 5th Paragraph, pg. 524].
With regards to claims 5-6, Brewer et al teaches administering 2 mg of oregovomab [Left column, 5th Paragraph, pg. 524]. Furthermore, it is well within the level of one of ordinary skill in the art to determine optimum concentrations of reactants. See In re Kronig, 190 USPQ 425.
With regards to claim 7, Brewer et al teaches administering oregovomab infusion over 20 minutes [Left column, 5th Paragraph, pg. 524]. Furthermore, it is well within the level of one of ordinary skill in the art to determine optimum concentrations of reactants. See In re Kronig, 190 USPQ 425.
With regards to claim 8, Brewer et al further teaches administering paclitaxel 175 mg/m2 [Left column, 5th Paragraph, pg. 524].
With regards to claim 9, Brewer et al teaches paclitaxel is administered over 20 minutes [Left column, 5th Paragraph, pg. 524].
With regards to claim 11, carboplatin is administered over 20 minutes [Left column, 5th Paragraph, pg. 524].
With regards to claim 12, Brewer et al teaches administering antihistamine with the treatment [Right column, 1st Paragraph, pg. 527]. One of ordinary skill would recognize antihistamines act as an antiemetic medication.
With regards to claim 14, Oza et al teaches continuing bevacizumab for up to 12 further three weekly cycles [Summary].
With regards to claims 15-16, Oza et al teaches continuing bevacizumab, after carboplatin and paclitaxel treatments, for up to 12 further three weekly cycles [Summary].
With regards to claim 17, Oza et al teaches administering bevacizumab at 7.5 mg/kg of body weight [Summary]. Oza et al further teaches administering bevacizumab at 15 mg/kg every 3 weeks of maintenance cycle [Right column, 1st Paragraph, pg. 929].
With regards to claim 20, Brewer et al teaches administering carboplatin, paclitaxel, and oregovomab by infusions [Left column, 5th Paragraph, pg. 524]. Furthermore, Oza et al teaches administering carboplatin, paclitaxel, and bevacizumab by intravenous infusions [Summary].
With respect to claim 21, Brewer et al teach treatment methods that do not include maintenance therapy.
Claims 1-9, 11-17, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer et al (Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study, Gyn Onc 156, 523-529, 2020, IDS 9/8/2023) and Oza et al (Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial, Lancet Oncol 2015; 16: 928–36, IDS 9/8/2023) as applied to claims 1-9, 11-12, 14-17, and 20-21 above, and further in view of Duron et al (US 20150202186 A1).
The teachings of Brewer et al and Oza et al are discussed above.
Brewer et al does not specifically teach administering paclitaxel and carboplatin with a hypersensitivity medication. However, this deficiency is made up in the teachings of Duron et al.
With regards to claim 13, Duron et al teaches a method of treating hypersensitivity reactions in a patient after receiving carboplatin and paclitaxel with anti-hyperalgesics [0270]. Duron et al further teaches the chemotherapeutics agents carboplatin and paclitaxel is associated with the development of peripheral neuropathy and to treat with an anti-hyperalgesics to reduce signs of pain [0270].
One of ordinary skill, before the effective filing date, would have been motivated to combine Brewer’s method of treating stage III/IV ovarian cancer comprising carboplatin, paclitaxel, and oregovomab, administered over six cycles and an oregovomab treatment administer 12 weeks later, with Oza’s method of treating stage III/IV ovarian cancer comprising administering concurrently carboplatin, paclitaxel, and bevacizumab on six cycles, with Duron’s method of treating hypersensitivity reaction in patients treated with carboplatin and paclitaxel comprising anti-hyperalgesics. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Brewer, Oza, and Duron’s methods for a method of treating stage III/IV ovarian cancer comprising carboplatin, paclitaxel, bevacizumab, and oregovomab, and administering hypersensitivity medication with the carboplatin and paclitaxel, because Duron teaches treating hypersensitivity from carboplatin and paclitaxel with hypersensitivity medications.
Claims 1-9, 11-12, 14-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer et al (Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study, Gyn Onc 156, 523-529, 2020, IDS 9/8/2023) and Oza et al (Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial, Lancet Oncol 2015; 16: 928–36, IDS 9/8/2023) as applied to claims 1-9, 11-12, 14-17, and 20-21 above, and further in view of Zhang et al (US 20200253915 A1).
The teachings of Brewer et al and Oza et al are discussed above.
Brewer et al does not specifically teach administering bevacizumab over 30 to 90 minutes. However, this deficiency is made up in the teachings of Zhang et al.
With regards to claim 18, Zhang et al teaches administering bevacizumab injection over 60-90 minutes [Table 13, pg. 31].
One of ordinary skill, before the effective filing date, would have been motivated to combine Brewer’s method of treating stage III/IV ovarian cancer comprising carboplatin, paclitaxel, and oregovomab, administered over six cycles and an oregovomab treatment administer 12 weeks later, with Oza’s method of treating stage III/IV ovarian cancer comprising administering concurrently carboplatin, paclitaxel, and bevacizumab on six cycles, with Zhang’s method of administering bevacizumab over 60-90 minutes. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Brewer, Oza, and Zhang’s methods for a method of treating stage III/IV ovarian cancer comprising carboplatin, paclitaxel, bevacizumab, and oregovomab, and administering bevacizumab over 30-90 minutes, because Zhang teaches the administration of bevacizumab over 60-90 minutes.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer 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 terminal disclaimer 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 may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9, 11-18, and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10537636 B2 ('636) in view of Brewer et al (Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study, Gyn Onc 156, 523-529, 2020, IDS 9/8/2023), Oza et al (Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial, Lancet Oncol 2015; 16: 928–36, IDS 9/8/2023), Duron et al (US 20150202186 A1), and Zhang et al (US 20200253915 A1).
The teachings of Brewer et al, Oza et al, Duron et al, and Zhang et al are discussed above.
It is initially noted that the antibody mAb-B43-13 recited in the instant claims 1, 5-7, and 20-21 is oregovomab, see pg. 1 of Specification. The primary difference between the instant claims 1-4, 7, and 20, and conflicting claims 1-6 is that the instant claims recite the administration of carboplatin, bevacizumab, paclitaxel, and oregovomab.
Based on the teachings of Oza et al, one of ordinary skill in the art would have been motivated to modify the conflicting claim to recite the administration of bevacizumab. The invention of the conflicting claims and Oza et al meets the limitations of claims 1-4, 7, and 20.
With regards to claims 5-6, Brewer et al teaches administering 2 mg of oregovomab [Left column, 5th Paragraph, pg. 524]. Furthermore, it is well within the level of one of ordinary skill in the art to determine optimum concentrations of reactants. See In re Kronig, 190 USPQ 425.
With regards to claim 8, Brewer et al further teaches administering paclitaxel 175 mg/m2 [Left column, 5th Paragraph, pg. 524].
With regards to claim 9, Brewer et al teaches paclitaxel is administered over 20 minutes [Left column, 5th Paragraph, pg. 524].
With regards to claim 11, carboplatin is administered over 20 minutes [Left column, 5th Paragraph, pg. 524].
With regards to claim 12, Brewer et al teaches administering antihistamine with the treatment [Right column, 1st Paragraph, pg. 527]. One of ordinary skill would recognize antihistamines act as an antiemetic medication.
With regards to claim 13, Duron et al teaches a method of treating hypersensitivity reactions in a patient after receiving carboplatin and paclitaxel with anti-hyperalgesics [0270]. Duron et al further teaches the chemotherapeutics agents carboplatin and paclitaxel is associated with the development of peripheral neuropathy and to treat with an anti-hyperalgesics to reduce signs of pain [0270].
With regards to claim 14, Oza et al teaches continuing bevacizumab for up to 12 further three weekly cycles [Summary].
With regards to claims 15-16, Oza et al teaches continuing bevacizumab, after carboplatin and paclitaxel treatments, for up to 12 further three weekly cycles [Summary].
With regards to claim 17, Oza et al teaches administering bevacizumab at 7.5 mg/kg of body weight [Summary]. Oza et al further teaches administering bevacizumab at 15 mg/kg every 3 weeks of maintenance cycle [Right column, 1st Paragraph, pg. 929].
With regards to claim 18, Zhang et al teaches administering bevacizumab injection over 60-90 minutes [Table 13, pg. 31].
With regards to claim 20, Brewer et al teaches administering carboplatin, paclitaxel, and oregovomab by infusions [Left column, 5th Paragraph, pg. 524]. Furthermore, Oza et al teaches administering carboplatin, paclitaxel, and bevacizumab by intravenous infusions [Summary].
With respect to claim 21, Brewer et al teach treatment methods that do not include maintenance therapy.
Claims 1-9, 11-18, and 20-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11351255 ('255) in view of Brewer et al (Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study, Gyn Onc 156, 523-529, 2020, IDS 9/8/2023), Oza et al (Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial, Lancet Oncol 2015; 16: 928–36, IDS 9/8/2023), Duron et al (US 20150202186 A1), and Zhang et al (US 20200253915 A1).
The teachings of Brewer et al, Oza et al, Duron et al, and Zhang et al are discussed above.
It is initially noted that the antibody mAb-B43-13 recited in the instant claims 1, 5-7, and 20-21 is oregovomab, see pg. 1 of Specification. The primary difference between the instant claims 1-4, 7, and 20 and conflicting claims 1-10 is that the instant claims recite the administration of carboplatin, bevacizumab, paclitaxel, and oregovomab.
Based on the teachings of Oza et al, one of ordinary skill in the art would have been motivated to modify the conflicting claim to recite the administration of bevacizumab. The invention of the conflicting claims 1-10 and Oza et al meets the limitations of claims 1-4, 7, and 20.
With regards to claims 5-6, Brewer et al teaches administering 2 mg of oregovomab [Left column, 5th Paragraph, pg. 524]. Furthermore, it is well within the level of one of ordinary skill in the art to determine optimum concentrations of reactants. See In re Kronig, 190 USPQ 425.
With regards to claim 8, Brewer et al further teaches administering paclitaxel 175 mg/m2 [Left column, 5th Paragraph, pg. 524].
With regards to claim 9, Brewer et al teaches paclitaxel is administered over 20 minutes [Left column, 5th Paragraph, pg. 524].
With regards to claim 11, carboplatin is administered over 20 minutes [Left column, 5th Paragraph, pg. 524].
With regards to claim 12, Brewer et al teaches administering antihistamine with the treatment [Right column, 1st Paragraph, pg. 527]. One of ordinary skill would recognize antihistamines act as an antiemetic medication.
With regards to claim 13, Duron et al teaches a method of treating hypersensitivity reactions in a patient after receiving carboplatin and paclitaxel with anti-hyperalgesics [0270]. Duron et al further teaches the chemotherapeutics agents carboplatin and paclitaxel is associated with the development of peripheral neuropathy and to treat with an anti-hyperalgesics to reduce signs of pain [0270].
With regards to claim 14, Oza et al teaches continuing bevacizumab for up to 12 further three weekly cycles [Summary].
With regards to claims 15-16, Oza et al teaches continuing bevacizumab, after carboplatin and paclitaxel treatments, for up to 12 further three weekly cycles [Summary].
With regards to claim 17, Oza et al teaches administering bevacizumab at 7.5 mg/kg of body weight [Summary]. Oza et al further teaches administering bevacizumab at 15 mg/kg every 3 weeks of maintenance cycle [Right column, 1st Paragraph, pg. 929].
With regards to claim 18, Zhang et al teaches administering bevacizumab injection over 60-90 minutes [Table 13, pg. 31].
With regards to claim 20, Brewer et al teaches administering carboplatin, paclitaxel, and oregovomab by infusions [Left column, 5th Paragraph, pg. 524]. Furthermore, Oza et al teaches administering carboplatin, paclitaxel, and bevacizumab by intravenous infusions [Summary].
With respect to claim 21, Brewer et al teach treatment methods that do not include maintenance therapy.
Conclusion
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642