DETAILED ACTION
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 .
Claims 1-34 are pending and currently under consideration.
Claim Objections
Claim 7 is objected because of an apparent typographical issue. Claim 7 recites “…the bispecific antibody and the therapeutic agent is administered….” The “is” should be replaced by “are” because two things are being administered. Proper correction is required.
Claim 8 and 22-26 are objected to because of apparent typographical issues. It appears instances of “mg/m2” should be replaced by “mg/m2”. Proper correction is required.
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 11, 16-18, 20, and 31 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 11 recites “…wherein the gap between the first treatment session and the second treatment session is from….” There is insufficient antecedent basis for “the gap between the first treatment session and the second treatment session” in the claim.
Claims 16-18, 20, and 31 are rejected for each reciting “its derivative.” The metes-and-bounds of the claims are unclear because, for each instance of “its derivative”, it is unclear what is (or is not) “its derivative”.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 14-20, and 29-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gao et al (US 2017/0073418 A1; 3/16/17).
Gao et al teaches bispecific antibodies that bind a combination of EGFR family members, including EGFR and HER3 ([0037], claim 9, and Figure 3, in particular). Gao et al further names these antibodies 1X1, 1X2, 1X3, 1X4, 1X4.2, 1X5, 1X5.2, 1X6, and 1X6.4 (see [0055]) and provides the amino acid sequences of the antibodies in Table 1 (note the prefix “SI”, for SystImmune, Inc., prior to the antibody names in the table). Gao et al further teaches a method of treating cancer (including breast cancer and non-small lung cancer) expressing EGFR family members (including EGFR and HER3) comprising administering the bispecific antibodies in combination with a second therapeutic agent, such as cisplatin or erlotinib ([0050]-[0051] and claims 51-60, in particular). Gao et al further teaches the bispecific antibody that binds EGFR and HER3 “1X6” comprises SEQ ID NO:119, SEQ ID NO:120, SEQ ID NO:118, SEQ ID NO:114, and SEQ ID NO:113 (see Table 1, in particular). SEQ ID NO:119, SEQ ID NO:120, SEQ ID NO:118, SEQ ID NO:114, and SEQ ID NO:113 are 100% identical to instant SEQ ID NOs:1-5, respectively. Gao et al further teaches the bispecific antibody that binds EGFR and HER3 “1X6.4” comprises SEQ ID NO:137, SEQ ID NO:138, SEQ ID NO:136, SEQ ID NO:132, and SEQ ID NO:131 (see Table 1, in particular). SEQ ID NO:137, SEQ ID NO:138, SEQ ID NO:136, SEQ ID NO:132, and SEQ ID NO:131 are 100% identical to instant SEQ ID NOs:1-5, respectively. Gao et al further teaches weekly administration of 10 mg/Kg of 1X6 to subjects with tumors resulted in a reduction in tumor volume ([0091], in particular). At [0095], Gao et al further teaches persons skilled in the art have the ability to determine the effective amount or concentration of the antibodies disclosed therein to effectively treat a condition such as a cancer. Gao et al continues: doses of the antibody may be, without limitation, from about 0.1 to about 20, from about 1 to about 5 mg/Kg body weight and that example administration frequency could be, without limitation, once per day or three times per week.
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.
Claim(s) 1-12, 14-20, and 27-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al (US 2017/0073418 A1; 3/16/17) as applied to claim 1-5, 14-20, and 29-31 above, and for the reasons stated below.
Teachings of Gao et al are discussed above.
Gao et al does does not specifically demonstrate methods comprising administering the bispecific antibodies of Gao et al in combination with a second therapeutic agent of Gao et al or kits comprising such reagents.
However, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a method of treating subjects with EGFR+ and HER3+ cancers of Gao et al by sequentially and/or simultaneously administering a combination of a pharmaceutical formulations comprising the bispecific antibodies (anti-EGFR/anti-HER3) of Gao et al and pharmaceutical formulations comprising the second therapeutic agent of Gao et al wherein doses of the antibodies are administered at doses suggested by Gao et al (including 10mg/kg) and at dosing times suggested by Gao et al (including weekly) because Gao et al teaches the combination of antibodies and second therapeutic agent are to be therapeutically administered to subjects with cancer (including breast cancer and non-small lung cancer) expressing EGFR family members (including EGFR and HER3) ([0050]-[0051] and claims 51-60, in particular) and the bispecific antibodies target both EGFR and HER3. This is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143.
Further, generating a “kit” for a given method provides two services: 1) a variety of different reagents have been assembled and pre-mixed specifically for a defined set of experiments. Thus, one need not purchase gram quantities of numerous different reagents when each of which may be needed in only microgram amounts, when beginning a series of experiments. When one considers all of the unused chemicals that typically accumulate in weighing rooms, desiccators, and freezers, one quickly realizes that it is actually far more expensive for a small number of users to prepare most buffer solutions from the basic reagents. In actuality, a kit format saves money and resources for everyone by dramatically reducing waste. 2) The other service provided in a kit is quality control. Therefore, it would have been prima facie obvious to one having ordinary skill in the art to generate a kit with containers comprising doses of the antibodies, containers comprising doses of the second therapeutic, and instructions stating the antibodies and the second therapeutic are for use in treating a subject having cancer that tests positive for EGFR expression and HER3 expression since (i) a kit provides a quality control, saves money, and saves resources and (ii) the instructions provide the benefit of guidance for performing the method.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al (US 2017/0073418 A1; 3/16/17) as applied to claims 1-12, 14-20, and 27-34 above, and further in view of Rossi et al (Expert Opinion on Pharmacotherapy, 2017, 18(2): 151-163).
Teachings of Gao et al and methods rendered obvious by Gao et al are discussed above.
Gao et al does not specifically teach a “kit” or that recited doses of the second therapeutics or that the second therapeutic can be Osimertinib, carboplastin, pemetrexed, paclitaxel, or docetaxel. However, these deficiencies are made up in the teachings of Rossi et al.
In addition to cisplatin of Gao et al, Rossi et al further teaches the following other therapeutics to treat non-small lung cancer: Osimertinib, carboplatin, pemetrexed, paclitaxel, and docetaxel. Specifically, Rossi et al teaches treating non-small lung cancer by administering cisplatin at a dose of 75 mg/m2 cisplatin (right column on page 152, in particular). Rossi et al teaches treating non-small lung cancer by administering Osimertinib with doses up to 240mg/day and observed no dose-limiting toxic effects (left column on page 158, in particular). Rossi et al teaches treating non-small lung cancer by administering carboplatin at a dose of AUC 5 or 6 (right column on page 155, in particular). Rossi et al teaches treating non-small lung cancer by administering pemetrexed at a dose of 500 mg/m2 (right column on page 154, in particular). Rossi et al teaches treating non-small lung cancer by administering paclitaxel at a dose of 200 mg/m2 (right column on page 153, in particular). Rossi et al teaches treating non-small lung cancer by administering docetaxel at a dose of 75 mg/m2 on a three-week cycle (right column on page 152, in particular). Rossi et al further teaches administering numerous therapeutics to treat non-small lung cancer by administering the therapeutics on days 1 and 8 every three weeks (right columns on pages 152 and 155; both columns on page 156, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method comprising the method of treating non-small lung cancer rendered obvious by Gao et al wherein the second therapeutic is cisplatin, osimertinib, carboplastin, pemetrexed, paclitaxel, or docetaxel administered at doses and/or dosing regimens taught by Rossi et al because Rossi et al teaches cisplatin, osimertinib, carboplastin, pemetrexed, paclitaxel, and docetaxel as therapeutics to treat non-small lung cancer. This is an example of combining prior art elements according to known methods to yield predictable results. See MPEP 2143.
In regards to doses and dosing schedules passively recited by the instant claims, it would be conventional and routine for one to perform the combined method using various dosages and dosing schedules, including those encompassed by the claims, in order to optimized the combined method. “[W]here the general conditions of a claims 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 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “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.” In the instant case, given the known function of the reagents to treat non-small lung cancer, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination of administered therapeutics is expected to provide therapeutic cancer treatment.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
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 1-12, 14-20, and 27-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10919977 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims recite bispecific antibodies encompassed by the instant claims (note: SEQ ID NOs: 131, 132, and 136 of patent claim 1 comprise instant SEQ ID NOs:1-5), the patent claims treatment methods encompassed by the instant claims, and the patent discloses (see lines 44-58 of column 28) doses of the antibody may be, without limitation, from about 0.1 to about 20, from about 1 to about 5 mg/Kg body weight and that example administration frequency could be, without limitation, once per day or three times per week.
Claims 1-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1-29 of U.S. Patent No. 10919977 B2, as applied to claims 1-12, 14-20, and 27-34 above, and in further view of Rossi et al (Expert Opinion on Pharmacotherapy, 2017, 18(2): 151-163).
The patent claims do not specifically recite a “kit” or recite doses of the second therapeutics or that the second therapeutic can be Osimertinib, carboplastin, pemetrexed, paclitaxel, or docetaxel. However, these deficiencies are made up in the teachings of Rossi et al.
Teachings of Rossi et al are discussed above.
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method comprising the patent method of treating non-small lung cancer wherein the second therapeutic is cisplatin, osimertinib, carboplastin, pemetrexed, paclitaxel, or docetaxel administered at doses and/or dosing regimens taught by Rossi et al because Rossi et al teaches cisplatin, osimertinib, carboplastin, pemetrexed, paclitaxel, and docetaxel as therapeutics to treat non-small lung cancer. This is an example of combining prior art elements according to known methods to yield predictable results. See MPEP 2143.
In regards to doses and dosing schedules passively recited by the instant claims, it would be conventional and routine for one to perform the combined method using various dosages and dosing schedules, including those encompassed by the claims, in order to optimized the combined method. “[W]here the general conditions of a claims 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 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “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.” In the instant case, given the known function of the reagents to treat non-small lung cancer, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination of administered therapeutics is expected to provide therapeutic cancer treatment.
Claim 1-12, 14-20, and 27-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending Application No. 18/681827 (reference application) in view of Gao et al (US 2017/0073418 A1; 3/16/17). Although the claims at issue are not identical, they are not patentably distinct from each other because copending claims and the instant claims are both drawn to bispecific antibodies that binds EGFR and HER3 and methods of treating cancer comprising administering the bispecific antibodies in combination with other cancer therapeutics to the same population of subjects. While the copending claims do not recite antibodies with the same sequences as those recited in the instant claims, it would be obvious to use the antibody sequences of Gao et al as the antibody sequences of the bispecific antibodies that binds EGFR and HER3 of the copending claims because the antinbodies of bispecific antibodies that binds EGFR and HER3 of Gao et al are taught by Gao et al to be used to treat the same population of subjects alongside the same other cancer therapeutics.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending Application No. 18/681827 (reference application) in view of Gao et al (US 2017/0073418 A1; 3/16/17), as applied to claims 1-12, 14-20, and 27-34 above, and in further view of Rossi et al (Expert Opinion on Pharmacotherapy, 2017, 18(2): 151-163).
The copending claims do not specifically recite a “kit” or recite doses of the second therapeutics or that the second therapeutic can be Osimertinib, carboplastin, pemetrexed, paclitaxel, or docetaxel. However, these deficiencies are made up in the teachings of Rossi et al.
Teachings of Rossi et al are discussed above.
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method comprising the copending method of treating non-small lung cancer wherein the second therapeutic is cisplatin, osimertinib, carboplastin, pemetrexed, paclitaxel, or docetaxel administered at doses and/or dosing regimens taught by Rossi et al because Rossi et al teaches cisplatin, osimertinib, carboplastin, pemetrexed, paclitaxel, and docetaxel as therapeutics to treat non-small lung cancer. This is an example of combining prior art elements according to known methods to yield predictable results. See MPEP 2143.
In regards to doses and dosing schedules passively recited by the instant claims, it would be conventional and routine for one to perform the combined method using various dosages and dosing schedules, including those encompassed by the claims, in order to optimized the combined method. “[W]here the general conditions of a claims 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 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). MPEP 2144.05 states: “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.” In the instant case, given the known function of the reagents to treat non-small lung cancer, it is well within the level of the ordinary skilled artisan to adjust the dosages and timing of administration for optimal therapeutic efficacy and safety, and to arrive at the dosages and timing of administration instantly claimed, where the combination of administered therapeutics is expected to provide therapeutic cancer treatment.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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