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 .
Election/Restrictions
Applicant’s election of pembrolizumab, 395 mg administered subcutaneously, and Non-Small-Cell Lung Cancer in the reply filed on 04/17/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant states that claims 1-14, 44-46, and 78-138 read on the elected species of pembrolizumab. Examiner agrees. Applicant states that claims 1-14, 44-46, and 84, 87-138 read on the elected species of 395 mg administered subcutaneously. Examiner agrees, with the exception that claims 122-127 and 129-130 are also drawn to a non-elected species and will be withdrawn. Applicant states that claims 1-14, 44-46, and 78-102, 106, 110, 111, and 121-138 read on the elected species of pembrolizumab. Examiner agrees, with the exception of claim 110, as claim 110 is dependent on claim 109, which is also drawn to a non-elected species, and will be withdrawn.
Upon further consideration, claims 85, 105, and 129 have been rejoined.
Claims 78-83, 86, 103-104, 107-110, 112-120, 122-127, and 130 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 04/17/2026.
Status of Claims
Claims 15-43 and 47-77 were previously cancelled, in the amendment filed 10/06/2023. Claims 1-14, 44-46, and 78-138 are pending. Claims 78-83, 86, 103-104, 107-110, 112-120, 122-127, and 130 are withdrawn. Claims 1-14, 44-46, 84-85, 87-102, 105-106, 111, 121, 128-129, and 131-138 will be examined on the merits.
Priority
Provisional application 63/172,299 is acknowledged as disclosing the claimed invention and the effective filing date is 04/08/2021.
Information Disclosure Statement
The Information Disclosure Statements filed on 01/10/2024, 11/04/2024, 01/15/2025, and 04/17/2026 have been considered. Signed copies are enclosed.
The information disclosure statement filed 01/14/2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. All references except those lined through have been considered. There is no translation of foreign patent documents 3 or 6, and no copy of non-patent literature documents 75, 89, and 141.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 99 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 is dependent on claim 6. Claim 6 recites that the SC administration of the antibody results in a Ctrough that is the same as or greater than the Ctrough of the IV administration of a 200 mg dose of the same antibody. Claim 7 recites that the ratio of subcutaneous Ctrough to IV Ctrough is at least 1. However, if the Ctroughs are required to be "the same as or greater", as in claim 6, the ratio of the Ctroughs will inherently equal 1. Therefore, claim 7 does not further limit claim 6. Claim 99 has the same issue with respect to claim 98. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 10-14, 44, 87, 88, 91-93, 96, 97, 102, 105, 131, 132, and 135-136 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Akala and Jacobs, Keynote-555, AACR2021, 4/7/2021.
Akala and Jacobs disclose a method of treating cancer comprising subcutaneously administering, to a human patient, 285 mg of anti-PD-1 antibody (pembrolizumab) every three weeks, anticipating claims 1, 10-13, 44, and 93. Akala and Jacobs disclose that the bioavailability of the antibody is 66%, anticipating claims 3, 4, 96, and 97. They disclose that the antibody was administered in a formulation that contained 130 mg/ml of antibody and another formulation that contained 165 mg/ml of antibody, anticipating claims 87, 88, 91, and 92, and 131, 132, 135, and 136. Finally, the method was administered to patients with metastatic melanoma, anticipating claims 14, 102, and 105. Therefore, as Akala and Jacobs disclose a method of treating metastatic melanoma with pembrolizumab at the claimed concentration, dosage, and schedule, claims 1, 3, 4, 10-14, 44, 87, 88, 91-93, 96, 97, 102, 105, 131, 132, and 135-136 are anticipated by Akala and Jacobs.
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.
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.
Claim(s) 1-5, 10-14, 44-46, 84-85, 87-88, 91-97, 102, 105, 106, 111, 121, 128-129, 131, 132, and 135-138 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/160755 A1, Lala et al., published 8/22/2019, in view of NCT03665597, ClinicalTrials.gov, record date 2/25/2020, as evidenced by Akala and Jacobs, Keynote-555, AACR2021, 4/7/2021.
Claims 1 and 93 are drawn to a method of treating cancer comprising subcutaneously administering 280-450 mg of pembrolizumab every three weeks (Q3W). Dependent claims further limit the cancer, the dosage, the administration, and the pharmacokinetics of the antibody.
Lala et al. (hereinafter Lala) teaches a method of treating cancer comprising subcutaneously administering about 400 mg of pembrolizumab every approximately six weeks (see claims 1-5, 12, and 13), thereby teaching the dose of instant claims 1, 2, 5, 10-13, 44, 46, 85, 93-95, 121, and 129. Lala teaches that the antibody used in treatment may also be a pembrolizumab variant (see claims 1-4, page 33), teaching claim 45. Lala teaches that this method may be used as a treatment for many cancers (see Lala claim 11), including melanoma, in embodiment E2 (page 26), and NSCLC, in embodiment E3 (page 26). Embodiment E3-B discloses that the patient with NSCLC may have had disease progression during or following platinum-containing chemotherapy (page 26). Therefore, Lala teaches claims 14, 102, 105, 106, and 111. Lala teaches, on page 8, line 1, that the dose of about 400 mg may be 395 mg, thereby teaching claims 84 and 128. Finally, Lala teaches at kit comprising about 400 mg of pembrolizumab and instructions for administering in claims 19 and 20, and Lala discloses that the pembrolizumab may be in a syringe on page 39, line 14.
Lala does not disclose the administration of the antibody at a dose of 400 mg Q3W. Lala also does not teach the bioavailability of the antibody after administration, or the concentration at which the antibody is administered.
NCT03665597, a clinical trial for "Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma”, was published as early as 9/7/18 on clinicaltrials.gov, and was updated on 1/31/2020 with information about the arms and intervention. The version of the clinical trial record history from 2/25/2020 is included in this Office Action. NCT03665597 teaches the subcutaneous administration of pembrolizumab every three weeks (21 days) to patients with advanced melanoma. NCT03665597 does not disclose the dose administered; however, Akala and Jacobs present on this trial, recite a dose of 285 mg administered subcutaneously Q3W, teaching claims 1, 10-14, and 44. Akala and Jacobs teach that the bioavailability of the antibody after this administration routine is 66%, teaching claims 3, 4, 96, and 97. Akala and Jacobs also teach that the dose was administered from two compositions with concentrations of 130 mg/ml and 165 mg/ml, teaching claims 87, 88, 91, 92, 131, 132, 135, and 136.
It would be obvious to one of ordinary skill in the art of cancer treatment with antibodies to combine the dose of about 400 mg recited in Lala with the administration schedule of Q3W demonstrated in NCT03665597. Lala mentions that the dose may be administered via IV or SC routes; NCT03665597 requires SC administration. One of ordinary skill in the art would know that SC administration of antibodies requires higher doses administered more frequently, as recited in Bittner et al., 2018 (see page 431, right column, second paragraph). Moreover, as Bittner teaches, SC administration is generally preferred by patients and healthcare provides as compared to IV administration, and there is reduced drug delivery cost and resource use (see abstract). Therefore, one would be motivated to administer the dosing of Lala more frequently and via subcutaneous administration. One would have a reasonable expectation of success because both Lala and NCT03665597 use the same antibody, pembrolizumab, and Lala teaches that pembrolizumab can be administered subcutaneously.
Additionally, claim 137 recites that the antibody dose is administered as two 1.15 ml injections of a 165 mg/ml composition. While neither Lala nor NCT03665597 disclose this exact dosing regimen, it would be obvious for one of ordinary skill in the art of antibody treatment to optimize the dosing parameters of the antibody based on the properties of the antibody and the desired outcome. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), discloses that if a method is “obvious to try”, it is not patentable over the prior art. MPEP § 2144.05(II) recites that routine optimization is “obvious to try”, and therefore supported by said rational. Dosing parameters, such as how often a medication is administered, could be routinely optimized in light of other dosing protocols. Therefore, it would be obvious to routinely optimize the dosing protocol of Lala, NCT03665597, or any other antibody regimen for optimize pembrolizumab treatment and provide optimal reduction of symptoms. Thus, the combination of prior art references as combined provide a prima facie case of obviousness, absent convincing evidence to the contrary.
Therefore, claims 1-5, 10-14, 44-46, 84-85, 97-88, 91-97, 102, 105, 106, 111, 121, 128-129, 131-132, and 135-138 are obvious over Lala in view of NCT03665597.
Claim(s) 1-5, 10-14, 44-46, 84-85, 87-97, 102, 105, 106, 111, 121, 128-129, and 131-138 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/160755 A1, Lala et al., in view of NCT03665597, ClinicalTrials.gov, record date 2/25/2020 as applied to claims 1-5, 10-14, 44-46, 84-85, 87-88, 91-97, 102, 105, 106, 111, 121, 128-129, 131, 132, and 135-138 above, and further in view of Strickley et al., Journal of pharmaceutical sciences 110.7 (2021): 2590-2608.
Claims 1 and 93 are drawn to a method of treating cancer comprising subcutaneously administering 280-450 mg of pembrolizumab every three weeks (Q3W). Dependent claims further limit the cancer, the dosage, the administration, and the pharmacokinetics of the antibody. Claims 89, 90, 133, and 134 specify the formulation of the composition administered in claim 1 or claim 93 as 10mM L-methionine, 10 mM histidine, pH 5.5, 7% sucrose, and 0.02% polysorbate 80. Lala et al. disclose a composition comprising 10 mM histidine, pH 5.5, 7% sucrose, and 0.02% polysorbate 80 on page 38, line 6-7. Neither Lala nor NCT03665597 disclose a composition that comprises L-methionine.
Strickley et al. review commercially available formulations of antibodies, and disclose a formulation of 25 mg/mL pembrolizumab, 70 mg/mL sucrose, polysorbate 80 (0.2 mg/mL), and 0.01M histidine at a pH of 5.5 on page 2608.e22 in Appendix A. Moreover, Strickley et al. recite, on page 2605, right column, that antibodies often comprise methionine as an anti-oxidant. Strickley et al. disclose that methionine-containing solution formulations are most often for subcutaneous injection. Strickley et al. also disclose that antibody formulations can include up to 200 mg/mL of antibody, and that the highest concentrations of antibodies are often for subcutaneous administration, as the entire dose must be contained within a limited dose volume (see page 2598, right column). This dose volume is often less than 2 mL (page 2592, left column) but can be up to 15 mL (see abstract), and for that reason, subcutaneous antibodies normally have an antibody concentration of over 100 mg/ml (page 2592, left column). Strickley also mentions that prefilled syringes are most often used to administered SC antibodies, as this makes treatment more convenient and accessible to patients who need chronic treatments, like cancer patients (page 2592, left column).
It would be obvious to one of ordinary skill in the art, before the effective filing date, to modify the existing compositions of Lala and Strickey et al. by adding methionine to them. One would be motivated to do so in order to prevent oxidation and stabilize the antibody at higher concentrations. It would be obvious to increase the concentration of Strickley et al. to a dose of greater than 100 mg/ml in order to administer the subcutaneous antibody. Strickley et al. teach that these are routine and conventional modifications to make to antibody formulation, and so one would have a reasonable expectation of success. Additionally, one would be motivated to use prefilled syringes to administer the antibody, as they are routine and conventional in the art of SC antibody administration and provide increased convenience and accessibility. Therefore, it would be obvious to include a prefilled syringe in the kit of Lala, as in instant claim 138.
Taken together, claims 1-5, 10-14, 44-46, 84-85, 87-97, 102, 105, 106, 111, 121, 128-129, and 131-138 are obvious over Lala and NCT03665597 in view of Strickley et al.
Claim(s) 1-14, 44-46, 84-85, 87-88, 91-102, 105, 106, 111, 121, 128-129, 131, 132, and 135-138 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/160755 A1, Lala et al., in view of NCT03665597, ClinicalTrials.gov, record date 2/25/2020 as applied to claims 1-5, 10-14, 44-46, 84-85, 87-88, 91-97, 102, 105, 106, 111, 121, 128-129, 131, 132, and 135-138 above, and further in view of Johnson et al., JAMA oncology 5.7 (2019): 999-1007. and Bittner et al., BioDrugs 32, 425–440 (2018).
Claims 1 and 93 are drawn to a method of treating cancer comprising subcutaneously administering 280-450 mg of pembrolizumab every three weeks (Q3W). Dependent claims further limit the cancer, the dosage, the administration, and the pharmacokinetics of the antibody. Claims 6-9 and 98-101 specify the dosage of the antibody to be administered by the Ctrough, or Cmin, of the antibody as higher than that of an IV dose. Ctrough is interpreted to mean the concentration present in the blood before the next dose. Neither Lala nor NCT03665597 disclose the Ctrough of pembrolizumab administered via IV or SC administration.
Johnson et al. disclose the assessment of SC vs IV administration of a different anti PD-1 antibody. Johnson et al. disclose a Ctrough greater than or equal to that of IV administration for a 300 mg SC dosing vs that of a 1 or 3 mg/kg IV dosing (see figure 3). Bittner et al. review the state of the art regarding SC vs IV administration of antibodies. Page 434, right column, discloses the results of two studies in cancer patients where the Ctrough was greater after SC dosing than IV dosing, with ratios of 1.33 and 1.5 respectively. Taken together, it can be understood that, at the time of filing, the state of the art acknowledges that SC administration results in improved Ctrough as compared to IV administration of antibodies. Therefore, only routine optimization is needed to determine a dosing regimen that will result in the Ctrough ratio recited in instant claims 6-9 and 98-101. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), discloses that if a method is “obvious to try”, it is not patentable over the prior art. MPEP § 2144.05(II) recites that routine optimization is “obvious to try”, and therefore supported by said rational. Dosing parameters, such as dosing to obtain an improved Ctrough, could be routinely optimized in light of the state of the art and other dosing protocols. Therefore, it would be obvious to routinely optimize the dosing protocol of Lala, NCT03665597, Johnson et al., or any other antibody regimen for optimize pembrolizumab SC administration and provide optimal Ctrough values. Thus, the combination of prior art references as combined provide a prima facie case of obviousness, absent convincing evidence to the contrary.
Therefore, claims 1-14, 44-46, 84-85, 87-88, 91-102, 105, 106, 111, 121, 128-129, 131, 132, and 135-138 are obvious Lala and NCT03665597 in view of Johnson et al. and Bittner et al.
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 1-14, 44-46, 84-85, 87-102, 105-106, 111, 121, 128-129, and 131-138 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15-36, 43, 45-48, 52-55, and 58-77 of copending Application No. 17/482,650 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the formulation disclosed in '650 claim 1 is substantially identical to the antibody formulations of instant claims 87-90 and 131-134. The administration of this antibody formulation via subcutaneous injection would be substantially the same as the claimed method of instant claims 1 and 93.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-14, 44-46, 84-85, 87-102, 105-106, 111, 121, 128-129, and 131-138 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 18/182,097 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the formulation disclosed in '097 claim 1 and 14 is substantially identical to the antibody formulations of instant claims 87-90 and 131-134, respectively. Moreover, the methods of treating cancer in claims 29, 32, and 34 are substantially the same as that of instant claim 1 and instant claim 93, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-14, 44-46, 84-85, 87-102, 105-106, 111, 121, 128-129, and 131-138 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-65 of copending Application No. 18/182135 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the formulations disclosed in '135 claims 1,16, and 27 are substantially identical to the antibody formulations of instant claims 87-90 and 131-134. Moreover, the methods of treating cancer in claims 33 and 50 are substantially the same as that of instant claim 1 and instant claim 93, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/AMELIA STEPHENS/Examiner, Art Unit 1645
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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