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. Status of Claims The preliminary amendment filed on 1 2 / 0 7/2023 amended claims 4-12 15, 16, and 18-23. There are no claims added and no claims cancelled. Claims 1- 23 are pending and will be examined on the merits. Priority Provisional application 63/ 208 , 804 is acknowledged as disclosing the claimed invention and the effective filing date is 06/09/2021. Information Disclosure Statement The references cited in the PCT international search report by the FILLIN "Identify the office (e.g., JPO, EPO, etc.) that issued the international search report and the date it issued." \d "[ 1 ]" European Patent Office have been considered, but will not be listed on any patent resulting from this application because they were not provided on a separate list in compliance with 37 CFR 1.98(a)(1). In order to have the references printed on such resulting patent, a separate listing, preferably on a PTO/SB/08 form, must be filed within ONE (1) MONTH of the mailing date of this communication. NO EXTENSION OF TIME WILL BE GRANTED UNDER EITHER 37 CFR 1.136(a) OR (b) to comply with this requirement. 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 appl icant regards as his invention. Claim s FILLIN "Enter claim indentification information" \* MERGEFORMAT 5 , 9 and 10 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 FILLIN "Enter claim identification information" \* MERGEFORMAT 5 recites the limitation " FILLIN "Enter appropriate information" \* MERGEFORMAT the lymph node " in FILLIN "Enter appropriate information" \* MERGEFORMAT line 1 . There is insufficient antecedent basis for this limitation in the claim. Claim 5 depends on claim 1, which does not recite a lymph node. Claims 2 and 3 do recite “at least one lymph node”; Examiner recommends amending claim 5 to be dependent on claim 2 or claim 3. Claim 9 recite s “the method of claim 1, wherein a serum Cmax of the… therapeutic agent is decreased up to 1.5-fold, 2-fold, 2.5-fold, 3.5-fold, or 4-fold….” Claim 10 recites “the method of claim 1, wherein a serum AUC 0-t of the… therapeutic agent is decreased up to 1.5-fold, 2-fold, 2.5-fold, 3.5-fold, or 4-fold….” Depending on the relative values, a fold decrease of a number can result in a negative number, and a serum Cmax or a serum AUC 0-t cannot be negative. For example, if an arbitrary Cmax value is 100, a 1.5-fold decrease would be a decrease of 150, which is -50, which cannot exist. Appropriate correction is required. 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. Claim FILLIN "Pluralize \“Claim\” if necessary, insert \“is\” or \“are\” as appropriate, and insert the claim number(s) which are under rejection." 17 is 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. FILLIN "Insert an explanation of what is in the claim and why it does not constitute a further limitation." Claim 17 depends from claim 16, and does not further limit the scope of claim 16, but does expand it. Claim 16 recites that the treatment of claim 1 results in an undetectable tumor, indicating that 100% of patients treated with the method of claim 1 have an undetectable tumor. Claim 17 recites that the incidence or probability of an undetectable tumor is 30%, indicating that 70% of patients may have detectable tumors. This expands the scope of claim 16, and does not further limit it . 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. Claim(s) FILLIN "Insert the claim numbers which are under rejection." \d "[ 1 ]" 1-6 is/are rejected under 35 U.S.C. 102 FILLIN "Insert either \“(a)(1)\” or \“(a)(2)\” or both. If paragraph (a)(2) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.01.aia, 7.15.02.aia or 7.15.03.aia where applicable." \d "[ 2 ]" (a)(1) as being FILLIN "Insert either—clearly anticipated—or—anticipated—with an explanation at the end of the paragraph." \d "[ 3 ]" anticipated by FILLIN "Insert the prior art relied upon." \d "[ 4 ]" NCT04118868 . Claim 1 of the instant application recites a method of treating cancer in a patient comprising (i) placing a device comprising a plurality of microneedles on the skin of the patient in a proximity to the lymphatic system, (ii) inserting the plurality of microneedles into the patient so that at least the epidermis is penetrated, and (iii) administering, via the microneedles, an effective amount of an anti-PD1 or anti-PDL1 therapeutic agent. Claim 2 recites a method of preventing or reducing cancer metastasis in a patient comprising (i) locating at least one lymph node that intervenes in the lymphatic system between the cancer tumor and a draining duct, (ii) placing a device comprising a plurality of microneedles on the skin of the patient between the intervening lymph node and the tumor, (iii) inserting the plurality of microneedles into the patient so that at least the epidermis is penetrated, and (iv) administering, via the microneedles, an effective amount of an anti-PD1 or anti-PDL1 therapeutic agent. Claim 3 recites a method of preventing or reducing cancer metastasis in a patient comprising the same steps as claim 2, but with an additional first step of locating a solid cancer tumor in the patient. Claim 4 further modif ies the method of claim 1 and recites that the cancer comprises a tumor; claim 5 recites that the lymph node is a tumor draining lymph node, and claim 6 recites the cancer is susceptible to treatment with anti-PD1 or anti-PDL1 therapy. FILLIN "Insert the prior art relied upon." \d "[ 4 ]" NCT04118868 is a clinical trial titled “ Pembrolizumab Administered Via the Sofusa ® DoseConnect ™ in Patients With Relapsed/Refractory Cutaneous T-cell Lymphoma ”. The clinical trial was first reported on 10/7/2019, and was updated with arms and interventions, outcome measure, conditions, eligibility, and more on 3/17/2020 . The 3 / 17 /2020 version of the study record is presented. The detailed description of the study recites that patients will receive pembrolizumab administered intra-lymphatically using the Sofusa DoseConnect device with relapsed or refractory cutaneous T-cell lymphoma. This administration meets the limitations of instant claims 1-3. Moreover, t he specification of the instant application recites the Sofusa drug delivery platform as a device that can be used in the instant claims, on page 11. Moreover, pembrolizumab is a PD1 inhibitor, or an anti-PD1 therapeutic agent, as defined on page 1 of the instant specification. Page 30 of the instant specification identifies cutaneous T-cell lymphomas (CTCLs) as a cancer susceptible to treatment with an anti-PD1 therapeutic agent. Therefore, the clinical trial NCT04118868 anticipates instant claims 1-6. 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) FILLIN "Insert the claim numbers which are under rejection." \d "[ 1 ]" 1-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over FILLIN "Insert the prior art relied upon." \d "[ 2 ]" Kwon et al., Theranostics (2019); 9(26): 8332-8342 (hereinafter Kwon) in view of WO2017161032, Gu et al., 2017 (hereinafter known as Gu) . Kwon teaches administration of another immune checkpoint inhibitor, an anti-CTLA-4 therapeutic agent, via a SOFUSA device , a “ nanotopography -based lymphatic delivery system.” SOFUSA is described as an array of 100 microneedles (a plurality of microneedles, instant claim s 1 /2/3 ) with a film heat-formed over each microneedle to form nanotopographical features (wherein the microneedles have a surface comprising nanotopography , claim s 1 /2/3 ) on page 8333, right column, third paragraph. The microneedles are used to deliver the anti-CTLA-4 therapeutic agent (administering via the plurality of microneedles…[a] therapeutic agent, claims 1/2/3) into the sub-epidermal space (at least the epidermis is penetrated, claim 1 /2/3 ), as stated on page 8334, left column, first paragraph. The SOFUSA device was positioned between the tumor and the draining lymph nodes (position[ed] proximate to lymph vessels and/or lymph capillaries, claim 1; located between the intervening lymph node and the solid cancer tumor, claims 2/3), as recited on page 8334 right column second paragraph and page 8335 left column first paragraph. Kwon therefore meets the steps recited in instant claims 1-3. Moreover, the instant specification names, on page 11, the Sofusa drug delivery platform as a device that can be used in the instant methods , indicating the SOFUSA of Kwon is the same device recited in the instant examples. Kwon teaches the administration of treatment to tumor bearing mice ( pg 8334 right column, second paragraph), meeting the limitation of instant claim 4. This same paragraph in Kwon teaches that the targeted lymph node drains the mammary chain, where the tumor is located, and thus is a tumor draining lymph node, meeting the limitations of claim 5. The patients in Kwon are mice with mammary (or breast) cancer tumors; the specification, on page 30, lists breast cancer as a cancer susceptible to treatment with an anti-PD1 or anti-PDL1 therapeutic, and therefore Kwon meets the limitations of claim 6. Kwon shows arrested tumor growth and decreased metastasis to lymph nodes, bone, and lungs ( pg 8335, left column, second paragraph, and figure 3), meeting the limitations of claims 22 and 23. Kwon shows undetectable primary tumor in 4 mice, meeting the limitations of claim 16. As Kwon is capable of resulting in an undetectable primary tumor, the method of administration taught by Kwon is capable of meeting the intended use limitation of claim 17 as well. Kwon states the results are consistent with greater drug exposure to naïve T cells in tumor draining lymph nodes, more effective activation of T cells against tumor antigens, and a more robust systemic anti-tumor response (page 8335, left column), teaching claims 18 and 19. Kwon also shows more tumor infiltrating lymphocytes in the tumors compared to systemically administered treatment, meeting the limitations of claim 20. Kwon also uses SOFUSA to administer to lymph nodes in humans and shows no adverse events (page 8338, right column, first paragraph), meeting the limitations of claim 21. Kwon does not teach the administration of an anti-PD1 or anti-PDL1 therapeutic agent; Kwon teaches another known immune inhibitory checkpoint inhibitor, an anti-CTLA-4 therapeutic agent. Both the instant specification, on page 1, and Kwon, in the first sentence, equate treatment with anti-PD1, anti-PDL1, and anti-CTLA-4 therapeutic agents, reciting them as immune checkpoint inhibitors. Kwon also suggests, on page 8337, that lymphatic delivery of anti-PD1 would be advantageous. Kwon also does not teach the pharmacokinetics of claims 7-15, nor does Kwon report on the occurrence of immune-related adverse events, as in claim 21. However, the method taught by Kwon uses the same device and an analogous treatment, by admittance of both the instant application and Kwon, to achieve the results of the instant application, including increased tumor growth inhibition (claims 22 and 23), increased exposure of the drug to cells in the lymphatic system (claims 18 and 19), increased tumor infiltrating lymphocytes ( claim 20), and undetectable tumors at conclusion of treatment (claim 16 and 17), as explained above. As such, as the method of Kwon and the outcome of Kwon meet the limitations of the instant claims, it follows that all other such limitations that naturally flow from the administration of the method of claim 1, such as the pharmacokinetics of claims 7-15. Therefore, Kwon meets the limitations of instant claims 1-23. Gu teaches, in claim 30, a method for treating or preventing a disease (wherein the disease is a cancer, claim 37) comprising providing a microneedle patch comprising a plurality of microneedles to a subject, and inserting the microneedles into a biological barrier, wherein the immunotherapeutic is released into the subject, and wherein the immune therapeutic is an anti-PDL1 antibody (claim 31) or an anti-PD1 antibody (claim 32), and specifically, the anti-PD1 antibody nivolumab (claim 33) or pembrolizumab (claim 34). As Gu shows that an anti-PD1 or anti-PDL1 therapeutic agent can be administered via a plurality of microneedles to a subject with cancer in order to prevent or treat cancer, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the anti-PD1 and/or anti PDL1 antibody of Gu with the administration method of Kwon to arrive at the claimed invention. One would be motivated to use the anti-PD1 antibody of Gu over the anti-CTLA-4 antibody of Kwon because, as Kwon recites on page 8337, left column, second paragraph, “ PD-1 is expressed by T-cells in [Tumor Draining Lymph Nodes ( TDLN )] , and associates with its ligand, PD-L1 expressed on the lymphatic endothelium and on tumor cells to limit T cell effector function in the tumor microe n vironment. Lymphatic delivery of anti-PD-1 could selectively remove mechanisms for inducing tolerance to tumor [antigens] within the TDLN, but, since lymph ultimately empties in the blood circulation, lymphatic delivery could also restrict tolerance acquisition at peripheral and tumor sites. ” One would be motivated to use the intra-lymphatic administration of Kwon with the anti-PD1 or anti-PDL1 therapeutic of Gu because, as Gu recites on p age 37 , lines 28-30 , “[t] he sustained high concentrations of the drugs within tumor regions as well as in peripheral circulation would enhance the immune system capability to treat not only primary tumor but also metastatic tumors in the body .” Taken together, one of ordinary skill in the art would be motivated to combine Gu and Kwon in order to improve cancer treatment at the tumor, in the lymph nodes, and at sites of metastasis. One would have reasonable expectation of success, as Gu demonstrates that anti-PD1 and anti-PDL1 antibodies can be administered via microneedles, and Kwon demonstrates that the family of antibodies that includes both anti-CTLA-4 and anti-PD1/PDL1 antibodies, immune checkpoint inhibitors, are more effective when delivered lymphatically than systemically. Therefore, Kwon in view of Gu renders the instant invention obvious. Double Patenting A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claim FILLIN "Indicate the claim(s) of the present application." \d "[ 1 ]" s 1, 4, 6, 8-16, 18, and 21 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim FILLIN "Indicate the copending claim(s)." \d "[ 2 ]" s 1, 4, 6, 8-16, 18, and 21 of copending Application No. FILLIN "Insert the number of the copending application." \d "[ 3 ]" 17/781,672 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. ‘672 claim 1 recites a method of treating cancer in a patient comprising placing a device comprising a plurality of microneedles on the skin of the patient near the lymph vessels, inserting the microneedles into the skin so at least the epidermis is penetrated, and administering via said needles an anti-PD1 therapy, identical to instant claim 1. ‘672 claim 4 is identical to instant claim 4, reciting the cancer comprises a tumor, and ‘672 claim 6 is identical to instant claim 6, reciting the cancer is susceptible to treatment with an anti-PD1 therapeutic agent. ‘672 claim 8 recites the serum Tmax of the anti-PD1 therapy as 10-100 hours, ‘672 claims 9 and 10 recite the serum Cmax and the serum AUC, respectively, as decreased up to 1.5-4-fold as compared to the same agent delivered via an IV route, and ‘672 claim 11 recites the delivery of the therapy to lymph nodes is increased up to 1.5-4-fold as compared to the same agent delivered via an IV route; these claims are identical to instant claims 7-11, respectively. ‘672 claim 12 recites the levels of the anti-PD1 therapeutic in systemic organs is decreased 10-75% over a period of time as compared to IV administration, and ‘672 claim 13 specifies the organ is a liver or a kidney, while ‘672 claim 14 specifies the period of time to be up to 12-72 hours, which is identical to instant claims 12-14. ‘672 claim 15 recites the anti-PD1 therapy is at least 90% cleared from the patients serum by 28 days after administration, identical to instant claim 15. ‘672 claim 16 recites the administration of the method of claim 1 results in an undetectable primary or secondary tumor, identical to instant claims 16. ‘672 claim 18 recites the exposure of the anti-PD1 therapy to T cells in the lymphatic system as compared to IV administration of the same therapy, identical to instant claim 18. ‘672 claim 21 recites the incidence or severity of one or more immune-related Adverse Events is reduced as compared to IV administration, identical to instant claim 21. Therefore, claims 1, 4, 6, 8-16, 18, and 21 are rejected as unpatentable over claims 1, 4, 6, 8-16, 18, and 21 of ‘672. 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 . Claim FILLIN "Indicate the claim(s) of the present application." \d "[ 1 ]" s 2, 3, 5, 7, 17, 19, 20, 22, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim FILLIN "Indicate the claim(s) of the copending application." \d "[ 2 ]" s 1-21 of copending Application No. FILLIN "Insert the number of the reference application." \d "[ 3 ]" 17/781,672 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because FILLIN "Provide appropriate explanation for anticipation or rationale for obviousness of claims being rejected over the claims of the cited application." \d "[ 4 ]" they are drawn to the same inventive concept - a method of reducing cancer metastasis and/or treating cancer using the same method of delivery and therapeutic agent . ‘672 claim 1 recites a method of treating cancer in a patient comprising placing a device comprising a plurality of microneedles on the skin of the patient near the lymph vessels, inserting the microneedles into the skin so at least the epidermis is penetrated, and administering via said needles an anti-PD1 therapy identical to the limitations of instant claim 1. ‘672 claim 2 recites a method of reducing cancer metastasis in a patient comprising (i) locating at least one lymph node that intervenes in the lymphatic system between the cancer tumor and a draining duct, (ii) placing a device comprising a plurality of microneedles on the skin of the patient between the intervening lymph node and the tumor, (iii) inserting the plurality of microneedles into the patient so that at least the epidermis is penetrated, and (iv) administering, via the microneedles, an effective amount of an anti-PD1 or anti-PDL1 therapeutic agent. ‘672 claim 3 recites a method of reducing cancer metastasis in a patient comprising locating a solid tumor, locating at least one lymph node between the tumor and a draining duct, and placing the same device between the lymph node and the tumor, inserting the plurality of needles to at least the epidermis, and administering an anti-PD1 therapeutic. While instant claims 2 and 3 recite the same methods, respectively, the methods of instant claims 2 and 3 are drawn to preventing or reducing cancer metastasis. However, a method that will reduce metastasis will also prevent metastasis, and therefore, ‘672 claims 2 and 3 anticipate instant claims 2 and 3. ‘ 672 claim 5 is dependent on claim 2, and recites the lymph node is a tumor draining lymph node . While instant claim 5 recites the same limitation, it is dependent on claim 1. However, claim 1 recites no lymph node. Therefore, the method of claim 5 can be placed near any tumor draining lymph node, which includes the lymph nodes of ‘672 claims 2 and 5. Therefore, ‘672 claim 5 anticipates instant claim 5. ‘ 672 claim 7 recites the bioavailability of the anti-PD-1 therapy is up to 50% . Instant claim 7 recites that the serum bioavailability of the anti-PD-1 therapy is up to 70% . As “up to 70%” encompasses 50%, and as bioavailability can be considered as in the serum, as well as among other tissues, ‘672 claim 7 anticipates instant claim 7. ‘ 672 claim 17 is dependent on claim 1 and recites the probability of an undetectable tumor is at least 30% . I nstant claim 17 recites the same, but is dependent on claim 16, which is dependent on claim 1, and recites that the administering results in an undetectable tumor . While the dependency of ‘672 claim 17 is different, it still anticipates instant claim 17, as they both depend from identical methods and both recite that the incidence or probability of an undetectable tumor is at least 30-99%. ‘ 672 claim 1 8 recite s the increased exposure of the anti-PD1 therapy to T cells in the lymphatic system as compared to IV administration of the same therapy . Instant claim 19 recites the increased exposure of the anti-PD1 therapy to tumor cells in the lymphatic system as compared to IV administration of the same therapy. While not identical, if the T cells in the lymphatic system are being exposed to an increased amount of anti-PD1 therapy compared to IV administration, then all other cells, including tumor cells, in the lymphatic system would be exposed to the same increased levels of anti-PD1 therapy. As ‘672 claim 18 recites the same increase range of 1.5-2.5 fold as instant claim 19, ‘672 claim 18 anticipates instant claim 19 . ‘ 672 claim 20 is dependent on claim 2 and recites the tumor infiltrating lymphocytes are increased up to 1.5-2.5 fold as compared to IV administration . I nstant claim 20 recites the same limitation, but depends on claim 1. However, as the steps of instant claim 1 are identical to the steps of ‘672 claim 2, without the specific location of near a lymph node, the amount of therapeutic agent that would be delivered, and therefore bioavailable, would be the same. Furthermore, ‘672 claim 1 9 depends from ‘672 claim 2 and indicates that the administering results in fewer metastases, indicat ing that the method of claim ‘672 claim 2 has a positive effect on cancer treatment, similar to the method of ‘672 claim 1. As the treatment methods of instant claims 1 and 2 are the same as those of ‘672 claims 1 and 2, the end results would also be the same. Therefore, the limitation of instant claim 20, depending from the method of claim 1, is anticipated by ‘672 claim 20, even though it depends from ‘672 claim 2. Furthermore, a s the treatment methods of ‘ 672 anticipate those of the instant application, and the pharmacokinetics of the administration of the anti-PD1 therapy are the same in ‘ 672 and the instant application, as evidenced by claims 7-11 (see statutory double patenting above) , the limitations concerning tumor growth inhibition in instant claims 22 and 23 would naturally flow from the administration of the method of ‘ 672 claim 1. Therefore, claims 22 and 23 are anticipated by ‘ 672 . As such, claims 2, 3, 5, 7, 17, 19, 20, 22, and 23 are anticipated by ‘672 and are therefore rejected under nonstatutory double patenting as unpatentable over ‘672. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim FILLIN "Pluralize \“Claim\” if necessary, insert \“is\” or \“are\” as appropriate, and insert the claim number(s) which are under rejection." s 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim FILLIN "Pluralize \“Claim\” if necessary, insert \“is\” or \“are\” as appropriate, and insert the claim number(s) of the copending application.." s 1-17 of copending Application No. FILLIN "Insert the number of the reference copending application." 18/622,067 in view of FILLIN "Insert the secondary reference." WO2017161032, Gu et al., 2017 and Kwon et al., Theranostics (2019); 9(26): 8332-8342 . Claim 1 of ‘067 recites a method of treating a subject with a disease comprising one or more tumors by administering one or more bioactive agents to the one or more tumors comprising (a) applying one or more delivery devices having a plurality of delivery structures to one or more sites of a skin of a subject comprising blood any lymphatic vasculature, wherein the delivery device contacts one or more layers of the epidermis; (b) administering a liquid dosage of the one or more bioactive agents at a controlled administration flow rate through the delivery device to a depth within the epidermis, and the bioactive agent then moves or diffused deeper through the epidermis into at least the underlying portion of the dermis to achieve uptake of the bioactive agents by blood or lymphatic capillaries, and the bioactive agents circulate through the lymphatic system to the tumors, and the concentration of bioactive agents delivered to the tumors is greater as compared to intravenous delivery of the same agents. Claims 2-17 further limit the method of claim 1, with claim 12 reciting that the plurality of delivery structures comprise a nanostructured or nanotopography surface, and claim 13 reciting that the delivery structures comprise needles. Claim 15 recites that the concentration of the bioactive agents delivered with the method of claim 1 in the tumors is 1.25 to 50-fold more than compared to an intravenous administration route, and claim 16 recites the bioactive agent is useful for retarding progression of, or reducing symptoms of the disease comprising the tumors (i.e. cancer). Instant claim 1 is drawn to a method of treating cancer in a patient comprising placing a device comprising a plurality of microneedles on the skin of a patient proximal to lymph vessels and/or capillaries, wherein the microneedles have a surface comprising nanotopography , inserting the needs to a depth whereby at least the epidermis is penetrated, and administering via the device an anti-PD-1 therapeutic agent to treat the cancer in the patient. Instant claim 4 recites the cancer comprises a tumor. As ‘067 claims 12 and 13 recite the device of ‘067 claim 1 has a plurality of needles with a nanotopography surface, and ‘067 claim 1 is a method for treating cancer, the method of ‘067 and the instant method comprise the same steps with the same device. ‘067 does not disclose that the bioactive agent for treating cancer is an anti-PD-1 antibody; however, as Gu teaches demonstrates that anti-PD1 and anti-PDL1 antibodies can be administered via microneedles, and anti-PD1 antibodies are known in the art to be effective against cancer (see Gu for evidence), it would be obvious to one skilled in the art of treating cancer to administer the anti-PD1 antibody of Gu via the method claimed in ‘067 claim 1. One would be motivated to use the method of lymphatic administration of ‘067 with the anti-PD1 or anti-PDL1 therapeutic of Gu because, as Gu recites on page 37, lines 28-30, “[t]he sustained high concentrations of the drugs within tumor regions as well as in peripheral circulation would enhance the immune system capability to treat not only primary tumor but also metastatic tumors in the body.” Therefore, it would be obvious to one of ordinary skill in the art to combine the administration of ‘067 and Gu and arrive at the current invention of claim 1 and claim 4. Furthermore, ‘067 places no limitation on the type of tumor that may be treated via the method of claim 1, and thus the method can be used on an anti-PD1 susceptible tumor, meeting the limitations of instant claim 6. ‘067 claim 15 recites that the concentration of bioactive agent, or anti-PD1 antibody, in the tumor is at least 1.5-fold higher than administration via an intravenous route, meeting the limitation of claim 19, and ‘067 claim 16 recites that the treatment results in the slowing of progression of tumor development, meeting the limitations of instant claims 16, 17, 22, and 23. As the method of ‘067 provides an increase in treatment concentration in the tumor, and results disease improvement, it would logically flow that the remaining limitations 7-15, 18, 20, and 21 would also be met if the anti-PD1 antibody recited by Gu was administered through the method of ‘067. Finally, neither ‘067 nor Gu teach the positioning of the device in an intervening space between a lymph node and a tumor, as in instant claims 2 and 3. However, Kwon teaches the administration of another immune checkpoint inhibitor, an anti-CTLA-4 therapeutic agent, via a plurality of microneedles positioned between the tumor and the draining lymph nodes (see above rejection under paragraph 1 7 for further details), meeting all limitations of claims 2, 3, and 5. Kwon teaches that this administration results in “ more effective tumor growth inhibition, arrest of metastases, increased tumor infiltrating lymphocytes and complete responses when compared to conventional systemic administration ” (abstract), which provides motivation for the particular placement of the lymphatic administration. The anti-CTLA-4 therapeutic agent is in the same standard immunotherapy class as anti-PD1 antibodies, and Kwon indeed recites, on page 8337, left column, second paragraph, “ PD-1 is expressed by T-cells in [Tumor Draining Lymph Nodes ( TDLN )] , and associates with its ligand, PD-L1 expressed on the lymphatic endothelium and on tumor cells to limit T cell effector function in the tumor microe n vironment. Lymphatic delivery of anti-PD-1 could selectively remove mechanisms for inducing tolerance to tumor [antigens] within the TDLN, but, since lymph ultimately empties in the blood circulation, lymphatic delivery could also restrict tolerance acquisition at peripheral and tumor sites. ” Therefore, one of ordinary skill in the art of cancer treatment would be motivated to use the placement of Kwon and the intra-lymphatic administration of Kwon and ‘067 with the anti-PD1 or anti-PDL1 therapeutic of Gu, thereby rendering obvious instant claims 1-23. This is a provisional nonstatutory double patenting rejection. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Amelia C Stephens whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1006 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8-5 EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Daniel E Kolker can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-3181 . 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