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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07 August 2025 has been entered.
Claim Status
Claims 1-2 and 6-13 as filed on 06 November 2025 are pending and under examination.
Rejections Withdrawn
Rejection of claims 1-13 under 35 U.S.C. 103 over Clinical Trial# NCT02826486, https://clinicaltrials.gov/ct2/show/NCT02826486 (2017) (“Clinical Trial” IDS 02/20/2023), Feig et. al. PNAS. 110(50):20212-20217. (2013) (Of Record), and Blanchette (WO2017/034957) (IDS 02//20/2023) is withdrawn with applicant amendment to claims changing the combination therapy resulting in a new search and new rejections. Applicant arguments relate to claims with a different scope, different drugs administered to the patient population, and different combination of art.
Rejection of claims 1-13 under Double Patenting over U.S. Patents: 10,682,390 B2, 11,559,562 B2, 11,534,478 B2 all in view of in view Clinical Trial# NCT02826486, https://clinicaltrials.gov/ct2/show/NCT02826486 (2017) (“Clinical Trial” IDS 02/20/2023), Feig et. al. PNAS. 110(50):20212-20217. (2013) (Of Record), and Blanchette (WO2017/034957) (IDS 02//20/2023) are withdrawn with applicant amendment to claims changing the combination therapy resulting in a new search and new rejections. Applicant did not argue previous double patenting rejections.
New Rejections – Necessitated by Applicant Amendment to Claims
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.
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 1-2 and 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over “Hoffmann” NCT03193190 (Version Dated 08/29/2018) (PTO-892), “Western” NCT02331251 (Version Dated 07/02/2018) (PTO-892), “Clinical Trial” NCT02826486 (IDS), and Manji et. al. Clin Cancer Res. 23(7): 1670-1678. (2017) (PTO-892).
Instant SEQ ID NO: 1 is the peptide BL-8040.
Regarding claims 1, 6-7, and 9, Hoffmann teaches first line therapy of metastatic pancreatic adenocarcinoma administered at 1.25 mg/Kg subcutaneously in combination with the PD-L1 antibody that inhibits PD-1 pathway Atezolizumab (Experimental Cohort 2 page 18 in last row of table onto page 19). Hoffmann teaches the control arm will be patients receiving nab-paclitaxel and gemcitabine administered intravenously with the PD-L1 antibody that inhibits PD-1 pathway Atezolizumab (page 14 in Arms and Interventions onto page 15).
Hoffmann does not teach the use of the anti-PD-1 antibody pembrolizumab or the combination with gemcitabine and nab-paclitaxel. Hoffman does not teach the dose schedule of the claims of administration of a monotherapy on days 1-5 of treatment cycle followed by combination therapy of pembrolizumab plus gemcitabine and nab-paclitaxel.
These deficiencies are filled by Western, Clinical Trial, and Manji.
Western teaches the treatment of metastatic pancreatic adenocarcinoma with pembrolizumab plus gemcitabine and nab-paclitaxel. Western teaches the administration of all three drugs intravenously (page 6 in Study Design in Point 4 of list and page 9 Experimental Arm 3).
Western teaches the administration of pembrolizumab every three weeks and the administration of gemcitabine and nab-paclitaxel on day 1 and day 8 every three weeks (page 9 Experimental Arm 3).
Clinical Trial teaches a method of treating a subject with metastatic pancreatic adenocarcinoma with a combination therapy including BL-8040 (same as instant SEQ ID NO: 1) and the PD-1 antagonist, Pembrolizumab (Tabular View, section (Current Other Pre-specified Outcome Measures). Clinical Trial further teaches the administration of BL-8040 for a monotherapy period followed by combination with Pembrolizumab, and it also teaches combination treatment with Pembrolizumab every 3-weeks, and administration of peptide treatment on Day 10 (Descriptive Information, section (study arms) where combination therapy is initiated on Day 8 (Detailed Description).
Regarding claims 6-8, Clinical Trial, teaches the subcutaneous administration of BL-8040 at a dosage of 1.25mg/kg and IV Pembrolizumab administration at a dosage of 200mg (Descriptive Information, section (study arms).
Regarding claim 10, Clinical trial teaches the administration of monotherapy of BL-8040 followed by combination therapy of BL-8040 and pembrolizumab (Detailed description page 3 in par 1).
Regarding claim 12, Clinical Trial teaches the monotherapy period has BL-8040 administered daily on days 1-5 (Arms and Interventions).
Regarding claims 11 and 13, Clinical Trial teaches the administration of combination therapy comprising the anti-PD-1 antibody pembrolizumab once every three weeks for up to two years which would include 3 cycles of treatment (Page 3 in par 1-2).
Manji teaches targeted therapies for use in the treatment of pancreatic adenocarcinoma (abstract). Manji teaches a number of clinical trials for first line treatment of pancreatic adenocarcinoma (Table 1). Manji teaches BL-8040 is a CXCR4 antagonist and teaches the use of BL-8040 with pembrolizumab in metastatic adenocarcinoma. Manji teaches away from combination therapy not comprising chemotherapy in pancreatic adenocarcinoma and teaches towards combining CXCR4 based therapy with gemcitabine containing regimens. Manji further gemcitabine as an ideal choice when considering chemotherapy combinations (page 1673 in col 1 in par 1). Manji further teaches gemcitabine in combination with nab-paclitaxel had a marked improvement on gemcitabine alone with 2-month survival benefit (page 1671 in col 1 in par 2).
Thus Manji teaches towards the administration of BL-8040 with pembrolizumab and gemcitabine in the treatment of pancreatic adenocarcinoma and further teaches the combination of gemcitabine with nab-paclitaxel.
It would have been obvious at the time the application was filed to combine fist line method of treating metastatic pancreatic adenocarcinoma comprising BL-8040 with the method of treating metastatic pancreatic adenocarcinoma comprising pembrolizumab and the chemotherapeutics of gemcitabine with nab-paclitaxel.
First, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two modes of treatment, each of which is taught by the prior art to be useful for the same purpose in order to make a protocol that is to be used for the very same purpose since the idea of combining them flows logically from their having been individually taught in the prior art. Applying the same logic to the instantly claimed method of combining the CXCR4 inhibitor BL-8040 and inhibitor of PD-1/PD-L1 pembrolizumab known in the prior art to be successful for metastatic pancreatic cancer treatment, it would have been obvious to combine BL-8040 taught by Hoffmann and pembrolizumab with gemcitabine with nab-paclitaxel as taught by Western for improved first line therapeutic benefit in patients with metastatic pancreatic adenocarcinoma as taught the idea of doing so would have logically followed from their having been taught in the prior art to be useful for the same purpose, metastatic pancreatic adenocarcinoma therapy. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to perform the combined method of therapy instantly claimed based on the teachings of Hoffmann, Western, and Clinical Trial.
Second, one of skill in the art would have been further motivated by the teaching of Manji as Manji explicitly teaches the combination of BL-8040 with pembrolizumab and gemcitabine and further teaches the combination of gemcitabine with nab-paclitaxel for improved outcome. Manji explicitly teaches to use BL-8040 in combination with chemotherapeutics and teaches away from its use without further therapeutics. There would have been an expectation of success as Manji is teaching an expectation of improvement and Hoffmann, Western, and Clinical Trial teach the administration of these drugs to patients with pancreatic adenocarcinoma with Hoffmann and Western teaching it as a first line treatment.
Regarding claims 10 and 12, one of skill in the art would have been motivated to combine the combination of BL-8040 with pembrolizumab and chemotherapeutics taught by the combination of Hoffmann and Western in view of Manji with the dosing schedule taught in the art by Clinical trial wherein monotherapy on days 1-5 of BL-8040 followed by combination therapy of BL-8040 and pembrolizumab was used successfully to administer the same drugs to pancreatic adenocarcinoma. One of skill in the art would have been motivated to use known dosing for BL-8040 and pembrolizumab to reach the same compartment of the body of the pancreas for the treatment of cancer. There would have been a reasonable expectation of success as Clinical Trial is provided dosing schedules for the same therapeutics, BL-8040 and pembrolizumab, for use in pancreatic adenocarcinoma with Clinical Trial only differing in the method being for a second line treatment.
In regards to the specific dosage and interval amounts recited in the instant claims "[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), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This because, as is made clear from the prior art, the determination of the dosage regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered and optimal intervals to achieve target levels and therapeutically effective doses. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the prior art and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (i.e. dosage and intervals) optimization is obvious. Thus, administration every two weeks twice a week rather than every three weeks as required by claim 11 would be obvious absent unexpected results.
New Rejections – Necessitated by Applicant Amendment to Claims
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.
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Claims 1-2 and 6-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,682,390 B2 (‘390) (IDS 02/02/2023) in view of “Hoffmann” NCT03193190 (Version Dated 08/29/2018) (PTO-892), “Western” NCT02331251 (Version Dated 07/02/2018) (PTO-892), “Clinical Trial” NCT02826486 (IDS), and Manji et. al. Clin Cancer Res. 23(7): 1670-1678. (2017) (PTO-892).
Instant SEQ ID NO: 1 is the peptide BL-8040.
‘390 recites the treatment of cancer using SEQ ID NO: 1 (same as instant SEQ ID NO: 1) in combination with a PD1 antagonist in a therapeutically effective amount (claims 1 and 4). ‘390 further recites the treatment of pancreatic cancer using this method (claim 2). ‘390 recites the PD1 antagonist as an antibody (claim 3). The method of ‘390 is to a method of treating pancreatic cancer and does not specify if the treatment is first or second line. Taken broadly the claims are read to mean first or second line treatment of pancreatic cancer.
‘390 does not recite the specific therapy schedule or combination with chemotherapeutics. ‘390 does not specifically recite first line treatment of metastatic pancreatic adenocarcinoma.
These deficiencies are filled by Hoffmann, Western, Clinical Trial, and Manji.
The teachings of Hoffmann, Western, Clinical Trial, and Manji as described in the 103 rejection above are incorporated here in full.
It would have been obvious at the time the application was filed to substitute the genus of treating a pancreatic cancer, genus of chemotherapeutics, and genus of PD1 antagonists in the method of treatment recited by the patent with the specific first line treatment of metastatic pancreatic adenocarcinoma comprising the administration of BL-8040, pembrolizumab, and the chemotherapeutics of gemcitabine and nab-paclitaxel as taught by Hoffmann, Western, Clinical Trial, and Manji. One of skill in the art would know in view of Hoffmann, Western, and Clinical trial that pancreatic adenocarcinoma, gemcitabine and nab-paclitaxel, and pembrolizumab are species of pancreatic cancer, chemotherapeutics, and PD1 antagonist, respectively. One of skill in the art would have been motivated in view of Manji teaching towards the administration of BL-8040 with pembrolizumab and gemcitabine in the treatment of pancreatic adenocarcinoma and further teaches the combination of gemcitabine with nab-paclitaxel. Further, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two modes of treatment, each of which is taught by the prior art to be useful for the same purpose in order to make a protocol that is to be used for the very same purpose since the idea of combining them flows logically from their having been individually taught in the prior art. Applying the same logic to the instantly claimed method of combining the CXCR4 inhibitor BL-8040 and inhibitor of PD-1/PD-L1 pembrolizumab known in the prior art to be successful for metastatic pancreatic cancer treatment, it would have been obvious to combine BL-8040 taught by the patent and Hoffmann and pembrolizumab with gemcitabine with nab-paclitaxel as taught by Western for improved first line therapeutic benefit in patients with metastatic pancreatic adenocarcinoma as taught the idea of doing so would have logically followed from their having been taught in the prior art to be useful for the same purpose, metastatic pancreatic adenocarcinoma therapy. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to perform the combined method of therapy instantly claimed based on the teachings of Hoffmann, Western, and Clinical Trial.
Claim 1-2 and 6-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,559,562 B2 (‘562) (IDS 05/20/2023) in view of “Hoffmann” NCT03193190 (Version Dated 08/29/2018) (PTO-892), “Western” NCT02331251 (Version Dated 07/02/2018) (PTO-892), “Clinical Trial” NCT02826486 (IDS), and Manji et. al. Clin Cancer Res. 23(7): 1670-1678. (2017) (PTO-892).
‘562 recites the treatment of cancer using SEQ ID NO: 1 which matches instant SEQ ID NO: 1 in combination with a PD1 antagonist in a therapeutically effective amount (claims 1 and 4). ‘562 further recites the treatment of pancreatic cancer using this method (claim 2). ‘562 recites the PD1 antagonist as an anti-PD-1 antibody (claim 3). The method of ‘562 is to a method of treating pancreatic cancer and does not specify if the treatment is first or second line. Taken broadly the claims are read to mean first or second line treatment of pancreatic cancer.
Claims of ‘562 are not directed to the combination with multiple chemotherapeutics or the specific claimed dose schedule or amounts.
These deficiencies are filled by Hoffmann, Western, Clinical Trial, and Manji.
The teachings of Hoffmann, Western, Clinical Trial, and Manji as described in the 103 rejection above are incorporated here in full.
It would have been obvious at the time the application was filed to substitute the genus of treating a pancreatic cancer, genus of chemotherapeutics, and genus of PD1 antagonists in the method of treatment recited by the patent with the specific first line treatment of metastatic pancreatic adenocarcinoma comprising the administration of BL-8040, pembrolizumab, and the chemotherapeutics of gemcitabine and nab-paclitaxel as taught by Hoffmann, Western, Clinical Trial, and Manji. One of skill in the art would know in view of Hoffmann, Western, and Clinical trial that pancreatic adenocarcinoma, gemcitabine and nab-paclitaxel, and pembrolizumab are species of pancreatic cancer, chemotherapeutics, and PD1 antagonist, respectively. One of skill in the art would have been motivated in view of Manji teaching towards the administration of BL-8040 with pembrolizumab and gemcitabine in the treatment of pancreatic adenocarcinoma and further teaches the combination of gemcitabine with nab-paclitaxel. Further, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two modes of treatment, each of which is taught by the prior art to be useful for the same purpose in order to make a protocol that is to be used for the very same purpose since the idea of combining them flows logically from their having been individually taught in the prior art. Applying the same logic to the instantly claimed method of combining the CXCR4 inhibitor BL-8040 and inhibitor of PD-1/PD-L1 pembrolizumab known in the prior art to be successful for metastatic pancreatic cancer treatment, it would have been obvious to combine BL-8040 taught by the patent and Hoffmann and pembrolizumab with gemcitabine with nab-paclitaxel as taught by Western for improved first line therapeutic benefit in patients with metastatic pancreatic adenocarcinoma as taught the idea of doing so would have logically followed from their having been taught in the prior art to be useful for the same purpose, metastatic pancreatic adenocarcinoma therapy. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to perform the combined method of therapy instantly claimed based on the teachings of Hoffmann, Western, and Clinical Trial.
Claim 1-2 and 6-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,534,478 B2 (‘478) (IDS 05/30/2023) in view of “Hoffmann” NCT03193190 (Version Dated 08/29/2018) (PTO-892), “Western” NCT02331251 (Version Dated 07/02/2018) (PTO-892), “Clinical Trial” NCT02826486 (IDS), and Manji et. al. Clin Cancer Res. 23(7): 1670-1678. (2017) (PTO-892).
‘478 recites the treatment of cancer using SEQ ID NO: 1 which matches instant SEQ ID NO: 1 in combination with a PD1 antagonist in a therapeutically effective amount (claims 1 and 4). ‘478 further recites the treatment of pancreatic cancer using this method (claim 2). ‘478 recites the PD1 antagonist as an antibody (claim 3). The method of ‘478 is to a method of treating pancreatic cancer and does not specify if the treatment is first or second line. Taken broadly the claims are read to mean first or second line treatment of pancreatic cancer.
‘478 does not recite the specific therapy schedule or combination with chemotherapeutics.
These deficiencies are filled by Hoffmann, Western, Clinical Trial, and Manji.
The teachings of Hoffmann, Western, Clinical Trial, and Manji as described in the 103 rejection above are incorporated here in full.
It would have been obvious at the time the application was filed to substitute the genus of treating a pancreatic cancer, genus of chemotherapeutics, and genus of PD1 antagonists in the method of treatment recited by the patent with the specific first line treatment of metastatic pancreatic adenocarcinoma comprising the administration of BL-8040, pembrolizumab, and the chemotherapeutics of gemcitabine and nab-paclitaxel as taught by Hoffmann, Western, Clinical Trial, and Manji. One of skill in the art would know in view of Hoffmann, Western, and Clinical trial that pancreatic adenocarcinoma, gemcitabine and nab-paclitaxel, and pembrolizumab are species of pancreatic cancer, chemotherapeutics, and PD1 antagonist, respectively. One of skill in the art would have been motivated in view of Manji teaching towards the administration of BL-8040 with pembrolizumab and gemcitabine in the treatment of pancreatic adenocarcinoma and further teaches the combination of gemcitabine with nab-paclitaxel. Further, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two modes of treatment, each of which is taught by the prior art to be useful for the same purpose in order to make a protocol that is to be used for the very same purpose since the idea of combining them flows logically from their having been individually taught in the prior art. Applying the same logic to the instantly claimed method of combining the CXCR4 inhibitor BL-8040 and inhibitor of PD-1/PD-L1 pembrolizumab known in the prior art to be successful for metastatic pancreatic cancer treatment, it would have been obvious to combine BL-8040 taught by the patent and Hoffmann and pembrolizumab with gemcitabine with nab-paclitaxel as taught by Western for improved first line therapeutic benefit in patients with metastatic pancreatic adenocarcinoma as taught the idea of doing so would have logically followed from their having been taught in the prior art to be useful for the same purpose, metastatic pancreatic adenocarcinoma therapy. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to perform the combined method of therapy instantly claimed based on the teachings of Hoffmann, Western, and Clinical Trial.
Conclusion
No Claims allowable.
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/F.E./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643