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 species election of “tumor tissue” and “microsatellite instability” without traverse in the reply filed on 5/13/26 is acknowledged.
2. The Restriction Requirement is deemed proper and is therefore made FINAL.
3. Claims 25, 28, 38, 41, 51, 54, 64, 67, 70, and 73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/13/26.
4. Currently claims 23, 24, 26-27, 29-34, 36, 37, 39, 40, 42-47, 49, 50, 52, 53, 55-60, 62, 63, 65, 66, 68, 69, 71, 72, and 75-82 are under consideration.
Information Disclosure Statement
5. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." For example, see the specification page 24-25 and 34-40. Therefore, unless the Examiner on form PTO-892 or Applicant on form PTO-1449 has cited the references they have not been considered.
6. The information disclosure statements filed 9/22/23, 8/16/24, 7/3/25, and 5/11/26 have been considered as to the merits before First Action.
Priority
7. The application has a priority date of November 13, 2024. This application is a continuation of U.S. Application No. 17/952,919, filed September 26, 2022, now U.S. Patent No. 11,753,468, issued September 12, 2023, which is a continuation of U.S. Application No. 17/354,656, filed June 22, 2021, now U.S. Patent No. 11,629,187, issued April 18, 2023, which is a continuation of U.S. Application No. 17/131,339, filed December 22, 2020, now U.S. Patent No. 11,325,975, issued May 10, 2022, which is a continuation of U.S. Application No. 16/144,549, filed September 27, 2018, now U.S. Patent No. 10,934,356, issued March 2, 2021, which is a continuation of U.S. Application No. 15/523,451, filed May 1, 2017, now abandoned, which is a National Stage application under 35 U.S.C. § 371 of International Application No. PCT/US2015/060331, having an International Filing Date of November 12, 2015, which claims the benefit of priority of U.S. Provisional Application No. 62/190,977, filed July 10, 2015 and U.S. Provisional Application No. 62/079,357, filed November 13, 2014, each of which are incorporated herein by reference in their entirety.
Specification
8. The first line of the specification-section 01 should be updated to include “U.S. Patent No. 11,753,468 issued 9/12/23”. Appropriate correction is required.
9. The use of the term TRITON (0389, 0391, 0387), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
10. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Please see sections 0003, 0300, and 0304 of the disclosure.
Double Patenting
11. 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.
See 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); and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
12. Claims 23, 26, 27, 29, 30, 31, 49, 53, 56, 57, 75, 76, 79, and 80 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-28 of US Patent #10,934,356.
The instant invention and US Patent #10,934,356 are drawn to methods for treating cancer in a patient in need thereof, wherein the patient has been determined to have a tumor that exhibits a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status, comprising administering an effective amount of an anti-PD-1 antibody or pembrolizumab to the patient; wherein the patient exhibits an outcome that is improved as compared to a corresponding outcome that would be observed in a reference patient that has been administered the anti-PD-1 antibody or pembrolizumab, wherein the reference patient has a tumor that does not exhibit a MSI-high or a MMR deficiency status; and wherein the patient has received a prior cancer therapy drug.
The claims in US Patent #10,934,356 specifically recite that the patient is administered an effective amount of pembrolizumab while the instant claims administer an effective amount of pembrolizumab or an anti-PD-1 antibody.
However, the specification in application number 18/224,156 discloses pembrolizumab as an anti-PD-1 antibody (see section 48). “Pembrolizumab is a humanized monoclonal anti-PD-1 antibody of the IgG4/kappa isotype that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.”
Therefore the claims of US Patent No. 10,934,356 read on the same sample population, administer the same anti-PD1-antibody compositions, and measure the same effect. Accordingly, the instant method is encompassed by the claims in US Patent #10,934,356. The methods are not patentably distinct.
Although the instant claims recite a negative limitations regarding the non- treatment of patients without a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status, this limitation is deemed obvious to the claimed method and the intended patient population.
13. Claims 23, 26, 27, 29, 30, 31, 49, 53, 56, 57, 75, 76, 79, and 80 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-7 of US Patent #11,325,974.
The instant invention and US Patent #11,325,974 are drawn to methods for treating cancer in a patient in need thereof, wherein the patient has been determined to have a tumor that exhibits a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status, comprising administering an effective amount of an anti-PD-1 antibody or pembrolizumab to the patient; wherein the patient exhibits an outcome that is improved as compared to a corresponding outcome that would be observed in a reference patient that has been administered the anti-PD-1 antibody or pembrolizumab, wherein the reference patient has a tumor that does not exhibit a MSI-high or a MMR deficiency status; and wherein the patient has received a prior cancer therapy drug.
The claims in US Patent #11,325,974 specifically recite that the patient is administered an effective amount of pembrolizumab while the instant claims administer an effective amount of pembrolizumab.
The specification in application number 18/224,156 discloses pembrolizumab as an anti-PD-1 antibody (see section 48). “Pembrolizumab is a humanized monoclonal anti-PD-1 antibody of the IgG4/kappa isotype that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.”
Therefore the claims of US Patent No. 11,325,974 read on the same sample population, administer the same anti-PD1-antibody compositions, and measure the same effect. Accordingly, the instant method is encompassed by the claims in US Patent #11,325,974. The methods are not patentably distinct.
Although the instant claims recite a negative limitations regarding the non- treatment of patients without a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status, this limitation is deemed obvious to the claimed method and the intended patient population.
14. Claims 23, 26, 27, 29, 30, 31, 49, 53, 56, 57, 75, 76, 79, and 80 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-15 of US Patent #11,325,975.
The instant invention and US Patent #11,325,975 are drawn to methods for treating cancer in a patient in need thereof, wherein the patient has been determined to have a tumor that exhibits a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status, comprising administering an effective amount of an anti-PD-1 antibody or pembrolizumab to the patient; wherein the patient exhibits an outcome that is improved as compared to a corresponding outcome that would be observed in a reference patient that has been administered the anti-PD-1 antibody or pembrolizumab, wherein the reference patient has a tumor that does not exhibit a MSI-high or a MMR deficiency status; and wherein the patient has received a prior cancer therapy drug.
The claims in US Patent #11,325,975 specifically recites that the patient is administered an effective amount of an anti-PD-1 antibody while the instant claims administer an effective amount of pembrolizumab or anti-PD-1 antibody.
However, the specification in application number 18/224,156 discloses pembrolizumab as an anti-PD-1 antibody (see section 48). “Pembrolizumab is a humanized monoclonal anti-PD-1 antibody of the IgG4/kappa isotype that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.”
Therefore the claims of US Patent No. 11,325,975 read on the same sample population, administer the same anti-PD1-antibody compositions, and measure the same effect. Accordingly, the instant method is encompassed by the claims in US Patent #11,325,975. The methods are not patentably distinct.
Although the instant claims recite a negative limitations regarding the non- treatment of patients without a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status, this limitation is deemed obvious to the claimed method and the intended patient population.
15. Claims 23, 26, 27, 29, 30, 31, 49, 53, 56, 57, 75, 76, 79, and 80 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-8 of US Patent #11,339,219.
The instant invention and US Patent #11,339,219 are drawn to methods for treating cancer in a patient in need thereof, wherein the patient has been determined to have a tumor that exhibits a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status, comprising administering an effective amount of an anti-PD-1 antibody or pembrolizumab to the patient; wherein the patient exhibits an outcome that is improved as compared to a corresponding outcome that would be observed in a reference patient that has been administered the anti-PD-1 antibody or pembrolizumab, wherein the reference patient has a tumor that does not exhibit a MSI-high or a MMR deficiency status; and wherein the patient has received a prior cancer therapy drug.
The claims in US Patent #11,339,219 specifically recite that the patient is administered an effective amount of pembrolizumab while the instant claims administer an effective amount of pembrolizumab.
The specification in application number 18/224,156 discloses pembrolizumab as an anti-PD-1 antibody (see section 48).
“Pembrolizumab is a humanized monoclonal anti-PD-1 antibody of the IgG4/kappa isotype that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.”
Therefore the claims of US Patent No. 11,339,219 read on the same sample population, administer the same anti-PD1-antibody or pembrolizumab compositions, and measure the same effect. Accordingly, the instant method is encompassed by the claims in US Patent #11,339,219. The methods are not patentably distinct.
Although the instant claims recite a negative limitations regarding the non- treatment of patients without a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status, this limitation is deemed obvious to the claimed method and the intended patient population.
16. Claims 23, 24, 26, 27, 29-34, 36, 37, 39, 40, 42-47, 49, 50, 52, 53, 55-60, 62, 63, 65, 66, 68, 69, 71, 72, and 75-82 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-36 of US Patent #11,649,287.
The instant invention and US Patent #11,649,287 are drawn to methods for treating colorectal cancer in a patient in need thereof and methods for reducing the risk of progression of colorectal cancer, wherein the patient has been determined to have a tumor that exhibits a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status, comprising administering an effective amount of an anti-PD-1 antibody or pembrolizumab to the patient; wherein the patient exhibits an outcome that is improved as compared to a corresponding outcome that would be observed in a reference patient that has been administered the anti-PD-1 antibody or pembrolizumab, wherein the reference patient has a tumor that does not exhibit a MSI-high or a MMR deficiency status; and wherein the patient has received a prior cancer therapy drug.
The claims in US Patent #11,649,287 specifically recite that the patient is administered an effective amount of pembrolizumab while the instant claims administer an effective amount of pembrolizumab or an anti-PD-1 antibody.
However, the specification in application number 18/224,156 discloses pembrolizumab as an anti-PD-1 antibody (see section 48). “Pembrolizumab is a humanized monoclonal anti-PD-1 antibody of the IgG4/kappa isotype that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.”
Therefore the claims of US Patent No. 11,649,287 read on the same sample population, administer the same anti-PD1-antibody compositions, and measure the same effect. Accordingly, the instant method is encompassed by the claims in US Patent #11,649,287. The methods are not patentably distinct.
Although the instant claims recite a negative limitations regarding the non- treatment of patients without a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status, this limitation is deemed obvious to the claimed method and the intended patient population.
17. For reasons aforementioned, no claims are allowed.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Cook whose telephone number is 571-272-0816. The examiner works a flexible Part-Time schedule but can normally be reached on Monday, Thursday, and Friday from 9am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lisa V. Cook
Art Unit 1641
Remsen - Hoteling
571-272-0816
7/23/26
/LISA V COOK/Primary Examiner, Art Unit 1641
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