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 .
Response to Amendment
This office action is responsive to the claim amendments filed on 1/16/2026. As directed by the amendment: claims 2-3, 17, and 19-20 have been amended; and no claims have been added. Thus, claims 1-21 are presently pending in this application.
Applicants amendments to claims 2-3 have overcome Examiner’s rejection under 35 USC § 112(a) and is therefore withdrawn.
Response to Arguments
Applicant's arguments filed 1/16/2026, pg. 7 line 17 to pg. 10 line 1, with regard to claim rejections under 35 USC § 112(b) of claims 9-14 and 18-21 are found persuasive. Examiners previous rejections under 35 USC § 112(b) are hereby withdraw. See Examiner’s interpretation below in light of Applicant’s argument and cited examples.
Applicant’s arguments with regard to rejection of claims 1-3 beginning pg. 11 line 4 are not found persuasive. Applicant’s argument appears directed to using a combination of anti-CTLA-4 therapy and anti-PD-1 together. Examiner’s rejection copied here for clarity. Non-Final Office Action mailed 7/16/2025 pg. 9 section 24 “to modify the pharmaceutical to be delivered as taught by Kwon Sunkuk to be an anti-PD-1 as taught by Gu” with regard to claim 1. See also pg. 11 section 28 with regard to claim 2 and pg 12 section 32 with respect to claim 3. It is noted in these rejections the modification is replacing the anti-CTLA-4 with anti-PD-1. Therefore Applicant’s argument is not found persuasive.
Claim Interpretation
Claims 9-14 and 18-21 considered to be comparison of claimed values of the same drug delivered by the different delivery methods as claimed. Interpretation made in light of Applicant’s specification and Applicants arguments dated 1/16/2026, specifically pg. 7 line 17 to pg. 10 line 1 including corresponding specification Examples cited.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Nanotopography-based lymphatic delivery for improved anti-tumor responses to checkpoint blockade immunotherapy” to Kwon Sunkuk et al. in view of WO 2017/161032 A1 to Gu et al.
In regard to claim 1:
Kwon Sunkuk teaches, a method of treating cancer in a patient (Page 8332 results “lymphatic infusion results in more effective tumor growth inhibition, arrest of metastases, increased tumor infiltrating lymphocytes and complete responses when compared to conventional systemic administration”), comprising: placing a device comprising a plurality of microneedles on the skin of the patient proximate to a first position under the skin of the patient (Pg 8333 col 2 last paragraph “In this contribution, we show that the anti-tumor responses of anti-CTLA-4 are significantly improved in a preclinical model when delivered with SOFUS™, a nanotopography-based lymphatic delivery system described previously by us and others [10,11]” (emphasis added) considered to be recitation of microneedles.), wherein the first position is proximate to lymph vessels and/or lymph capillaries in the patient's lymphatic system (pg. 8333 col 2 last paragraph “SOFUSA™ lymphatic infusion device”), and wherein the microneedles have a surface comprising nanotopography (pg 8333 “a nanotopography-based lymphatic delivery system described previously by us and others [10,11]”); inserting the plurality of microneedles into the patient to a depth whereby at least the epidermis is penetrated and an end of at least one of the microneedles is proximate to the first position (Pg 8333 col 2 last paragraph “In this contribution, we show that the anti-tumor responses of anti-CTLA-4 are significantly improved in a preclinical model when delivered with SOFUS™, a nanotopography-based lymphatic delivery system described previously by us and others [10,11]” references indicated dated as 2015 and 2017 respectively);
Gu teaches using anti-PD-1, and administering via the plurality of microneedles to the first position an effective amount of an anti-PD-1 therapeutic agent or an effective amount of an anti-PD-L1 therapeutic agent to treat cancer in a patient (page. 4 lines 25-35 “the immunotherapeutic agent is selected from an anti-OPD1 antibody”, pg 22 lines 25-30 “nivolumab”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the pharmaceutical to be delivered as taught by Kwon Sunkuk to be an anti-PD-1 as taught by Gu. This would have been motivated by Gu pg 26 lines 15-35 “controlled release of loaded anti-PD1 antibody … …can enhance the anti-cancer activity of a variety of cancer treatments”.
In regard to claim 2:
Kwon Sunkuk teaches, a method of reducing cancer metastasis in a patient (Page 8332 results “lymphatic infusion results in more effective tumor growth inhibition, arrest of metastases, increased tumor infiltrating lymphocytes and complete responses when compared to conventional systemic administration”), comprising: locating at least one lymph node in the patient that intervenes in the lymphatic system between a solid cancer tumor and a draining duct; placing a device comprising a plurality of microneedles on the skin of the patient proximate to a first position under the skin of the patient located between the intervening lymph node and the solid cancer tumor (Pg 8333 col 2 last paragraph “In this contribution, we show that the anti-tumor responses of anti-CTLA-4 are significantly improved in a preclinical model when delivered with SOFUS™, a nanotopography-based lymphatic delivery system described previously by us and others [10,11]” (emphasis added) considered to be recitation of microneedles.), wherein the first position is proximate to lymph vessels and/or lymph capillaries in the patient's lymphatic system (pg. 8333 col 2 last paragraph “SOFUSA™ lymphatic infusion device”), and wherein the microneedles have a surface comprising nanotopography (pg 8333 “a nanotopography-based lymphatic delivery system described previously by us and others [10,11]”); inserting the plurality of microneedles into the patient to a depth whereby at least the epidermis is penetrated and an end of at least one of the microneedles is proximate to the first position (Pg 8333 col 2 last paragraph “In this contribution, we show that the anti-tumor responses of anti-CTLA-4 are significantly improved in a preclinical model when delivered with SOFUS™, a nanotopography-based lymphatic delivery system described previously by us and others [10,11]” references indicated dated as 2015 and 2017 respectively);;
Gu teaches using anti-PD-1, and administering via the plurality of microneedles to the first position a therapeutically effective amount of an anti-PD-1 therapeutic agent or an anti-PD-L1 therapeutic agent that is effective for reducing cancer metastasis in the patient (page. 4 lines 25-35 “the immunotherapeutic agent is selected from an anti-OPD1 antibody”, pg 22 lines 25-30 “nivolumab”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the pharmaceutical to be delivered as taught by Kwon Sunkuk to be an anti-PD-1 as taught by Gu. This would have been motivated by Gu pg 26 lines 15-35 “controlled release of loaded anti-PD1 antibody … …can enhance the anti-cancer activity of a variety of cancer treatments”.
In regard to claim 3:
Kwon Sunkuk teaches, a method of reducing cancer metastasis in a patient (Page 8332 results “lymphatic infusion results in more effective tumor growth inhibition, arrest of metastases, increased tumor infiltrating lymphocytes and complete responses when compared to conventional systemic administration”), comprising: locating a solid cancer tumor in the patient; locating at least one lymph node in the patient that intervenes in the lymphatic system between the solid cancer tumor and a draining duct; placing a device that comprises a plurality of microneedles on the skin of the patient at a first location on the skin of the patient that is proximate to lymph capillaries and/or lymph vessels that flow into the intervening lymph node (Pg 8333 col 2 last paragraph “In this contribution, we show that the anti-tumor responses of anti-CTLA-4 are significantly improved in a preclinical model when delivered with SOFUS™, a nanotopography-based lymphatic delivery system described previously by us and others [10,11]” (emphasis added) considered to be recitation of microneedles.), wherein the microneedles have a surface comprising nanotopography (pg 8333 “a nanotopography-based lymphatic delivery system described previously by us and others [10,11]”); inserting the plurality of microneedles into the patient to a depth whereby at least the epidermis is penetrated (Pg 8333 col 2 last paragraph “In this contribution, we show that the anti-tumor responses of anti-CTLA-4 are significantly improved in a preclinical model when delivered with SOFUS™, a nanotopography-based lymphatic delivery system described previously by us and others [10,11]” references indicated dated as 2015 and 2017 respectively);
Gu teaches and administering via the plurality of microneedles to the lymph capillaries and/or lymph vessels that flow into the intervening lymph node a therapeutically effective amount of an anti-PD-1 therapeutic agent or an anti-PD-L1 therapeutic agent that is effective in reducing cancer metastasis in the patient (page. 4 lines 25-35 “the immunotherapeutic agent is selected from an anti-OPD1 antibody”, pg 22 lines 25-30 “nivolumab”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the pharmaceutical to be delivered as taught by Kwon Sunkuk to be an anti-PD-1 as taught by Gu. This would have been motivated by Gu pg 26 lines 15-35 “controlled release of loaded anti-PD1 antibody … …can enhance the anti-cancer activity of a variety of cancer treatments”.
In regard to claim 4:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk teaches, wherein the cancer comprises a tumor (pg. 8332-8333 “standard immune therapy for patients with advanced cancers. CTLA-4 is expressed on T-cell surfaces and interacts with tumor antigen”).
In regard to claim 5:
The method of claim 2, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk teaches, wherein the lymph node is a tumor draining lymph node (pg 8334 Fig. 1).
In regard to claim 6:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Gu teaches, wherein the cancer is a cancer susceptible to treatment with an anti-PD-1 therapeutic agent or anti- PD-L1 therapeutic agent (pg 26 lines 15-35. “controlled release of loaded anti-PD1 antibody … …can enhance the anti-cancer activity of a variety of cancer treatments” considered teaching that cancer is susceptible to treatment with anti-PD-1).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the pharmaceutical to be delivered as taught by Kwon Sunkuk to be an anti-PD-1 as taught by Gu. This would have been motivated by Gu pg 26 lines 15-35 “controlled release of loaded anti-PD1 antibody … …can enhance the anti-cancer activity of a variety of cancer treatments”.
In regard to claim 7:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein bioavailability of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent is up to 10%, 15% 20%, 25%, 30%, 35%, 40%, 45%, or 50%. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to have a bioavailability of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent is up to 10% since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed bioavailability and function appropriately having the claimed bioavailability. Further, applicant places no criticality on the range claimed, indicating simply that the bioavailability “may” be within the claimed ranges (specification page. 3 lines 17-20 “bioavailibility of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent may be up to 10%,15% 20%, 25%, 30%, 35%, 40%, 45%, or 50%.”).
In regard to claim 8:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein a serum Tmax of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent is from 10 to 100 hours. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to wherein a serum Tmax of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent is from 10 to 100 hours since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed serum Tmax and function appropriately having the claimed serum Tmax. Further, applicant places no criticality on the range claimed, indicating simply that the serum Tmax “may” be within the claimed ranges (specification page. 3 lines 18-22 “a serum Tmax of the anti-PD-1 therapeutic agent or the anti-PD-L 1 therapeutic agent may be from 10 to 100 hours.”)
In regard to claim 9:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein a serum Cmax of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent is decreased up to 1.5-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, or 4-fold, as compared to a serum Cmax following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to wherein a serum Cmax of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent is decreased up to 1.5-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, or 4-fold, as compared to a serum Cmax following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed serum Cmax and function appropriately having the claimed serum Cmax. Further, applicant places no criticality on the range claimed, indicating simply that the serum Cmax “may” be within the claimed ranges (specification page. 3 lines 20-25)
In regard to claim 10:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein a serum AUCo-t of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent is decreased up to 1.5-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, or 4-fold as compared to a serum AUCo-t following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to wherein a serum AUCo-t of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent is decreased up to 1.5-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, or 4-fold as compared to a serum AUCo-t following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed serum AUCo-t and function appropriately having the claimed serum AUCo-t. Further, applicant places no criticality on the range claimed, indicating simply that the serum AUCo-t “may” be within the claimed ranges (specification page. 3 lines 25-30)
In regard to claim 11:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein delivery of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent to one or more lymph nodes is increased up to 1.5-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, or 4-fold as compared to delivery to one or more lymph nodes of a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to wherein delivery of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent to one or more lymph nodes is increased up to 1.5-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, or 4-fold as compared to delivery to one or more lymph nodes of a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed increased delivery amount and function appropriately having the claimed increased delivery amount. Further, applicant places no criticality on the range claimed, indicating simply that the increased delivery amount “may” be within the claimed ranges (specification page. 3 lines 29-page 4 line 4).
In regard to claim 12:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein levels of the anti-PD-1 therapeutic agent or anti-PD-L1 therapeutic agent in one or more systemic organs is decreased 10-75% over a period of time as compared to levels in one or more systemic organs following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route over a same period of time. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to wherein levels of the anti-PD-1 therapeutic agent or anti-PD-L1 therapeutic agent in one or more systemic organs is decreased 10-75% over a period of time as compared to levels in one or more systemic organs following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route over a same period of time since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed level of anti-PD-1 therapeutic agent and function appropriately having the claimed level of anti-PD-1 therapeutic agent. Further, applicant places no criticality on the range claimed, indicating simply that the level of anti-PD-1 therapeutic agent “may” be within the claimed ranges (specification page 4 lines 3-10).
In regard to claim 13:
The method of claim 12, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Gu teaches, wherein the one or more systemic organs is a liver or a kidney (pg. 19:10-35 “liver and bile duct carcinoma”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the target organs taught by Kwon Sunkuk to include the liver as taught by Gu. This would have been motivated by Gu teaching treating many different organics for cancer Pg. 19 10-30 thus increasing the potential uses of and treatment options with the invention.
In regard to claim 14:
The method of claim 12, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein the period of time is up to 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, or 72 hours. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to have the period of time is up to 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, or 72 hours since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed period of time and function appropriately having the claimed period of time. Further, applicant places no criticality on the range claimed, indicating simply that the period of time “may” be within the claimed ranges (specification page 4 lines 9-10).
In regard to claim 15:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent is at least 90%, 95%,99%, or 99.9% cleared from the patient's serum by 28 days after administration. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to have the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent is at least 90%, 95%,99%, or 99.9% cleared from the patient's serum by 28 days after administration since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed clearance level and function appropriately having the claimed clearance level. Further, applicant places no criticality on the range claimed, indicating simply that the clearance level “may” be within the claimed ranges (specification page 4 lines 11-12).
In regard to claim 16:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk teaches, wherein the administering results in an undetectable primary tumor and/or an undetectable secondary tumor (considered intended use limitation to which the device taught by Kwon Sunkuk is considered fully capable of resulting in an undetectable primary tumor. Pg 8335 col 1 2nd paragraph a complete response as determined by undetectable primary tumor volume by caliper measurement”).
In regard to claim 17:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk teaches, wherein an incidence or probability of an undetectable primary tumor and/or an undetectable secondary tumor is at least 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 99% (considered intended use limitation to which the device taught by Kwon Sunkuk is considered fully capable of resulting in an undetectable primary tumor. Pg 8335 col 1 2nd paragraph a complete response as determined by undetectable primary tumor volume by caliper measurement”).
In regard to claim 18:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein exposure of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent to T-cells in the patient's lymphatic system is increased up to 1.5-fold, 2-fold, or 2.5- fold, as compared to exposure to T-cells in the patient's lymphatic system following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD- L1 therapeutic agent administered by an intravenous delivery route. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to have exposure of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent to T-cells in the patient's lymphatic system is increased up to 1.5-fold, 2-fold, or 2.5- fold, as compared to exposure to T-cells in the patient's lymphatic system following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD- L1 therapeutic agent administered by an intravenous delivery route since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed exposure and function appropriately having the claimed exposure. Further, applicant places no criticality on the range claimed, indicating simply that the exposure “may” be within the claimed ranges (specification page. 4 lines 17-23).
In regard to claim 19:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein the administering results in an incidence or probability of up to 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or 75% fewer metastases. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to have wherein the administering results in an incidence or probability of up to 20%, 25%, 30%, 35%, 40%,, 45%, 50%, 55%, 60%, 65%, 70%, or 75% fewer metastases since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed exposure and function appropriately having the claimed exposure. Further, applicant places no criticality on the range claimed, indicating simply that the exposure “may” be within the claimed ranges (specification page. 4 lines 15-17).
In regard to claim 20:
The method of claim 2, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk in view of Gu discloses the invention essentially as claimed except for, wherein tumor-infiltrating lymphocytes are increased up to 1.5-fold, 2-fold, or 2.5-fold as compared to tumor-infiltrating lymphocytes following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kwon Sunkuk in view of Gu to have tumor-infiltrating lymphocytes are increased up to 1.5-fold, 2-fold, or 2.5-fold as compared to tumor-infiltrating lymphocytes following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kwon Sunkuk would not operate differently with the claimed increase in tumor-infiltrating lymphocytes and function appropriately having the claimed increase in tumor-infiltrating lymphocytes. Further, applicant places no criticality on the range claimed, indicating simply that the increase in tumor-infiltrating lymphocytes “may” be within the claimed ranges (specification page. 4 lines 29-32).
In regard to claim 21:
The method of claim 1, as taught by Kwon Sunkuk in view of Gu as described in parent claim rejection above.
Kwon Sunkuk teaches, wherein incidence or severity of one or more immune-related Adverse Events is reduced as compared to one or more immune-related Adverse Events following a therapeutically equivalent amount of the anti-PD-1 therapeutic agent or the anti-PD-L1 therapeutic agent administered by an intravenous delivery route (pg. 8335 first column 2nd paragraph to 2nd col “there were statistically significant less animals with distant metastases in SOFUSA™ infused animals”).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark A Igel whose telephone number is (571)272-7015. The examiner can normally be reached Monday through Thursday 11 am to 5 pm 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, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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