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 17/802,872
Claims 1-15 and 45-49 are currently pending.
Priority
Instant application 17/802,872, filed 8/26/2022, claims priority as follows:
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The provisional application 62/983,538 contains support for the instant claims, and thus the effective filing date of claims 1-15 and 45-49 is 2/28/2020.
Information Disclosure Statement
All references from the IDS’s submitted on 11/21/2022 and 7/14/2025 have been considered unless marked with a strikethrough.
Objection to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Specifically, hyperlinks are present on pages 9, 17, 18, and 35. 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.
Objection to Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figures 4A, 4B, 4C, 4D, 4E, 4F, 4G, 4H, 4I, and 5 are not able to be interpreted as they are pixelated and illegible. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Election/Restriction
Applicant’s election of Group I, claims 1-15, drawn to methods of administering a therapeutically effective amount of an HLA binding molecule to a subject in the reply filed 7/14/2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP § 818.01(a). Applicant’s election of abacavir as the species of HLA binding molecule and skin cancer as the species of cancer in the reply filed 9/30/2025, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 102 rejection below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1-3, 6, and 9-15 read on the elected species. Claims 4-5, 7-8, and 45-49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Interpretation
Claim 1 recites the limitation, “therapeutically effective amount”, with respect to the amount of HLA binding molecule administered to a subject. The instant disclosure does not explicitly define the term “therapeutically effective amount”, but does describe the term, “effective amount”, as an amount capable of producing a desirable result (page 20, last paragraph). However, the desirable result will depend upon the active agent being administered. Further, the “effective amount” may be an amount of the compound that is capable of inducing a response in a host organ, tissue, or cell (page 20, last paragraph). The “desirable result” and “response” in the disclosure are not clear, and the claim does not recite that the compound is treating a receptor or disease. Thus, there is no way to determine how much would be effective and the limitation “therapeutically effective amount” is currently being interpreted as any amount administered to a subject.
Claims 12 and 13 also recite the limitation, “therapeutically effective amount” in reference to the amount of HLA binding molecule administered to a subject, wherein the subject has been diagnosed as having cancer. With the “therapeutically effective amount” treating a specific disease, and the “desirable result” of the treatment of said disease being slowing the development, growth, or spread of cancer as recited in claim 12 or the killing of one or more cancer cells as recited in claim 13, the “therapeutically effective amount” is currently being interpreted in these claims is defined as an amount to induce the stated effects.
Claim Objections
Claim 3 is objected to because of the following minor informalities: abacavir and allopurinol are generic pharmaceutical names and do not need to be capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 applicant regards as his invention.
Claims 1-3, 6, and 9-15 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 1 recites the limitation, “therapeutically effective amount”, with respect to the amount of HLA binding molecule administered to a subject. As stated above, the instant disclosure does not explicitly define the term “therapeutically effective amount”, but does describe the term, “effective amount”, as an amount capable of producing a desirable result (page 20, last paragraph). However, the desirable result will depend upon the active agent being administered. Further, the “effective amount” may be an amount of the compound that is capable of inducing a response in a host organ, tissue, or cell (page 20, last paragraph). The “desirable result” and “response” in the disclosure are not clear, and the claim does not recite that the compound is treating a receptor or disease. Thus, there is no way to determine how much would be effective and the limitation “therapeutically effective amount” is currently being interpreted as any amount administered to a subject. Dependent claims 2-3, 6, and 9 do not overcome this issue by claiming a disease or defining the “desirable result” or “response”. Appropriate correction is required.
Claims 1 and 2 recite references to table and figures in the claim, found in the specification and drawings of the application. According to MPEP § 2173.05(s), claims should be complete and should not incorporate figures or tables by reference unless absolutely necessary. Incorporation by reference is a necessity doctrine, not a convenience for the Applicant. Dependent claims 3, 6, and 9-15 do not resolve this issue by incorporating the tables and figures and are thus also rejected. Appropriate correction is required.
Claim 15 recites the limitation, “cancer specific antigen”, which is not explicitly defined in the instant disclosure and is not known to one of ordinary skill in the art. For example, the difference between a tumor specific antigen and a cancer specific antigen is unclear. Because the phrase is unknown, it is unclear what is being administered and the metes and bounds of the claim cannot be properly determined. For art purposes, the Examiner is interpreting an anti-cancer vaccine as meeting the requirements of this claim based on the example of page 25, lines 4-6 of the specification, which states, “In some embodiments, an anti-cancer vaccine is a composition comprising an antigen in association with an effective amount of at least one immunomodulator chemotherapeutic adjuvant eliciting an immune response in a patient and a pharmaceutically acceptable carrier.” Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, and 9-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kyoto University (US 2016/0000796 A1, cited in the IDS of 11/21/2022, herein after “Kyoto”). The instant claims are drawn to a method of administering at therapeutically effective amount of abacavir to a subject.
The reference Kyoto discloses methods of treating cancer with the nucleoside analogue reverse transcriptase inhibitor abacavir (abstract). Specifically, with respect to claims 1-3 and 6, Kyoto discloses the administration of 100 μM of abacavir to an adult t-cell leukemia/lymphoma (ATL) cell line to induce apoptosis (page 6, para [0099]-[0101] and Figure 11). The Examiner notes that the instant independent claim 1 does not identify a specific disease of which to treat, and thus any method comprising an administration of a therapeutically effective amount of abacavir to any disease fulfills this limitation. Further, the limitation of 100 μM of abacavir satisfies the limitation of therapeutically effective amount as per the claim interpretation above, and that the “subject” can be interpreted as cells taken from a subject (page 10, first paragraph).
With respect to claim 9, the subject, the cancer cell line is a human cell line.
Regarding claim 10, the subject, the cancer cell line is diagnosed as having cancer.
With respect to claim 11, Kyoto discloses that the pharmaceutical compositions of the present invention can be used for a cancer whose DNA repair system is impaired, and an example of a cancer whose DNA repair system is impaired is skin cancer.
Regarding claims 12 and 13, Kyoto discloses the killing of cancer cells in Figure 11, which slows the development, growth, and spread of cancer.
With respect to claim 14, Kyoto discloses that the pharmaceutical composition may be used in combination with a different therapeutic agent for cancer, and is preferably, but not limited to, a chemotherapeutic agent, immunotherapeutic agent, hormone therapy agent, or radiation therapy (page 3, para [0056]). Given the small number of examples provided by Kyoto, a skilled artisan could at once envisage the combination. Thus, Kyoto anticipates claims 1-3, 6, and 9-14.
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.
Claims 1 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kyoto University (US 2016/0000796 A1, cited in the IDS of 11/21/2022, herein after “Kyoto”).
Determining the scope and contents of the prior art
The reference Kyoto teaches as disclosed above, and at least those teachings are incorporated herein.
Ascertaining the differences between the prior art and the claims at issue
Kyoto fails to teach a working example of a method of administering a therapeutically effective amount of abacavir with one or more addition anti-cancer drugs to the subject.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of administration of abacavir. An artisan possess the technical knowledge necessary to make adjustments to the methods to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said methods of administration of abacavir and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Above, the Examiner took the position that a skilled artisan could at once envisage the combination in the method given the small number of examples found in Kyoto. In the alternative, applying KSR prong (A), it would have been prima facie obvious for one of ordinary skill in the art to combine abacavir and an additional anti-cancer drug such as a chemotherapeutic agent, immunotherapeutic agent, hormone therapy agent, or radiation therapy because Kyoto teaches a small number of additional anti-cancer drug examples, and one of ordinary skill in the art would expect the combination of drugs to be successful in treating cancer. The artisan would be motivated before the effective filing date of the claimed invention to test combinations of compounds for the same purpose to improve the overall activity of the compositions and would have readily predicted success in light of the teachings of Kyoto.
Claims 1 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kyoto University (US 2016/0000796 A1, cited in the IDS of 11/21/2022, herein after “Kyoto”) in view of Suehiro (Suehiro, Y., et. al. British Journal of Haematology, 2015, 169, 356-367.)
Determining the scope and contents of the prior art
The reference Kyoto teaches as disclosed above, and at least those teachings are incorporated herein.
Suehiro teaches the administration of a vaccine to augment an immune response implicated in anti-Adult T cell leukemia/lymphoma (ATL) effects (abstract). Specifically, Suehiro teaches the administration of the Tax peptide-pulsed DC vaccine (page 361, first paragraph), which in turn decreased the number of ATL cells in peripheral blood (page 361, Figure 2A).
Ascertaining the differences between the prior art and the claims at issue
Kyoto fails to teach an example of a method of administering abacavir and a cancer specific antigen to a subject.
Suehiro fails to teach a method of administering a therapeutically effective amount of abacavir to a subject.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of administration of abacavir. An artisan possess the technical knowledge necessary to make adjustments to the methods to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said methods of administration of abacavir and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious for one of ordinary skill in the art to combine the methods of administration of abacavir found in Kyoto and the methods of administration of the anti-cancer vaccine found in Suehiro because one skilled in the art would expect the combination of pharmaceuticals known to treat the same diseases to maximize the effectiveness of treatment of said diseases. The artisan would be motivated before the effective filing date of the claimed invention to test combinations of pharmaceuticals taught for the same purpose to improve the overall activity of the compositions and would have readily predicted success in light of the teachings of Kyoto and Suehiro.
Conclusion
Claims 1-3, 6, and 9-15 are rejected. Claims 4-5, 7-8, and 45-49 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621