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 .
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.
Election/Restrictions
Examiner have withdrawn 102 rejection over Aoki and Chen et.al from previous non-final office action
Examiner have withdrawn 103 rejection from previous non-final office action.
Examiner made new 112, 102 and 103 rejection.
Applicant provide a compliant species of mTOR inhibitor or AKT phosphorylation inhibitor: Tenofovir.
Examiner did not find prior art of applicants elected species . Therefore Markush search was extended to prodrug of tenofovir. Examiner found prior art on prodrug of tenofovir. Therefore, Markush search is not extended to other species. Elected species reads on claim 8-27.
Election of species requirement is maintained.
Claims 8-27 are examined in this office action.
Priority
The effective filing date is 02/22/2019.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Current Status of 17/432,839
This Office Action is in response to the amended claims of 09/18/2025.
Claims 8-11 and 14-27 are previously presented; and claims 12-13 are currently amended.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of 09/18/2025.Examiner have reviewed these remarks and amendments.
Applicant submitted certified copy of foreign priority document therefore effective filing date is 02/22/2019.
Regarding 102(a)(1) rejection of claim 8 over Aoki.
Applicant claims the Aoki was not publicly available until, March 27, 2019 after the prior date of 02/22/2019.
Applicant provide evidence on pages 7-8 in the remarks of 09/18/2025.
Therefore 102(a)(1) rejection of claim 8 over Aoki is withdrawn.
Regarding 102(a)(1) rejections of claims 8-9,11-14, 16,18-19,21, 23-24 and 26-27 over Chen et. al. (Cancers 2019, 11, 930, page 1-17) publications date is July 3rd , 2019 after the effective filing date of 2/22/2019.
Applicant submitted foreign priority document that renders moot 102(a)(1) rejections over Chen et. al. Therefore 102(a)(1) rejections over Chen et. al is withdrawn.
Regarding 102(a)(1) rejections of claims 12, 14, 16 and 18 over Mylonas ((Invest New Drugs (2012) 30: 1389-1395):
Applicant amended claim 12 by incorporating “. . .thereof, wherein adefovir or tenofovir or a prodrug thereof, or a pharmaceutically acceptable salt thereof is not used in combination with another antitumor agent.”
Applicant amended claim 13 by incorporating “A method for treating a tumor and/or cancer comprising:administering a treatment effective amount/a therapeutically effective amount of adefovir or tenofovir or a prodrug thereof, or a pharmaceutically acceptable salt thereof to a subject in need thereof …”
Applicant argues:
Mylonas does not teach or suggest independent claim 12 as amended.
Mylonas does not suggest treating tumor and/or cancer with tenofovir alone.
Examiner’s response:
Amended claims 12 does not change the scope of independent claim 12, because the word “comprising” in claim 12 is interpreted as the composition may have other compounds in the composition including antiviral agent such as emtricitabine. Therefore, applicant argument is not convincing to overcome the 102(a)(1) rejections of claim 12, 14, 16 and 18.
Moreover, emtricitabine is an antiviral drug not another antitumor agent (Saag et.al Clinical Infectious Diseases, Volume 42, Issue 1, 1 January 2006, Pages 126–131, abstract).
Therefore 102(a)(1) rejections of claims 12, 14, 16 and 18 over Mylonas is maintained.
Regarding 103 rejections, effective filing date of 02/22/2019 is before the publication date of Aoki and Chen et.al thus rendering moot 103 rejection on record. Therefore 103 rejection is withdrawn.
Claim Rejections - 35 USC § 102(maintained with modification)
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.
Claims 12, 14, 16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mylonas et. al. (Invest New Drugs (2012) 30:1389–1395).
Mylonas et. al teaches combination of emtricitabine (anti-viral and also be anti-tumor or 18) and tenofovir (applicant’s elected species) induces cell death in human cancer cell (examiner interpret this as cancer not induced by hepatitis virus ) (Mylonas et. al page 1389, Summary) thus anticipating claims 12, 14, 16 and 18.
Response to Amendment
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 18 is 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.
Dependent claims 18 recites “adefovir or tenofovir or a prodrug thereof, or a pharmaceutically acceptable salt thereof is used in combination with another antitumor agent”, There is insufficient antecedent basis for ”adefovir or tenofovir or a prodrug thereof, or a pharmaceutically acceptable salt thereof is used in combination with another antitumor agent in claim 12 . The independent claim 12 recites “adefovir or tenofovir or a prodrug thereof, or a pharmaceutically acceptable salt thereof is not used in combination with another antitumor agent”. As drafted “adefovir or tenofovir or a prodrug thereof, or a pharmaceutically acceptable salt thereof is used in combination with another antitumor agent” in claim 18 renders mete and bounds of claim 18 undefined. Hence renders claim 18 indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 18 and 23 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.
Dependent claims 18 and 23 recites limitation “combination with another antitumor agent”, which fails to properly further limit independent claim 12, since claim 12 does not have limitations drawn to “combination with another antitumor agent’. Thus claims 18 and 23 rejected under 35 U.S.C. 112(d)
Claim Rejections - 35 USC § 102(new)
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.
Claims 8-10, 12-17, 19, 20-22 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wolf et. al. (American Journal of Hematology, Vol. 91, No. 4, April 2016).
Wolf et. al. in the abstract discloses TAK-228 (examiner interprets this as prodrug thereof of tenofovir) as mTOR inhibitor (claims 13) for treating patients with myeloma, non-Hodgkin lymphoma (examiner interpret this as patients not infected with hepatitis virus (claims 9, 16,21) or tumor caused by hepatitis (claims 14 and 19)) thus anticipating claims 8-9, 12-14, 16, 19, 21 and 24).
Since Examiner has proven “not infected with a hepatitis virus”, above, there is no need to further prove “wherein the patient is not infected with a hepatitis B virus”. This teaches claims 10, 15, 17, 20, 22.
Applicants must delete “prodrug” from the claims to render moot this rejection.
Claim Rejections - 35 USC § 103 (new)
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 8-27 are rejected under 35 U.S.C. 103 as being unpatentable over
Wolf et. al. (American Journal of Hematology, Vol. 91, No. 4, April 2016)
In view of
Bertacchini et. al. (Cell. Mol. Life Sci. (2015) 72:2337-2347).
In further view of
Thorgeirsson et.al (J Hepatol. 2014 April ; 60(4): 855–865).
1. Determining the scope and contents of the prior art.
Wolf et.al teaches claims 8-10, 12-17, 19, 20-22 and 24 as stated in 102 rejection above.
Bertacchini et. al. teaches mTor inhibitor have therapeutic effects in leukemia (hematopoietic cancers) (Bertacchini et. al. page 2337, abstract) partially teaching 24 and 25.
Thorgersson et.al teaches combination of therapy for treating hepatocellular carcinoma (HCC) (solid liver cancer) (claims 25-26) with Sorafenib (anti-tumor agent) (claims 11, 18, 23 and 27)and (Everolimus) mTor inhibitor (Table 1) partially teaching claims 11, 18, 23-27.
2. Ascertaining the differences between the prior art and the claims at issue.
Wolf does not teach combination of TDF analog with anti-tumor agent for treating hematopoietic solid cancer in patients.
Bertacchini does not teach TDF analog as mTor inhibitor for treating cancer/tumor in patients.
Thorgersson does not teach treating hepatocellular carcinoma (HCC) with tenofovir analog.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing cancer treatment and is interested in developing treatment for hematopoietic tumor with mTor inhibitor.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine the teaching of Wolf ( TAK-228 (examiner interprets this as prodrug thereof of tenofovir), a mTOR inhibitor (claims 13) for treating patients with myeloma, non-Hodgkin lymphoma (examiner interpret this as patients not infected with hepatitis virus (claims 9, 16,21) or tumor caused by hepatitis (claims 14 and 19)) thus anticipating claims 8-9, 12-14, 16, 19, 21); with the teaching of Bertacchini et. al. (mTor inhibitor have therapeutic effects in leukemia (hematopoietic cancers) (Bertacchini et. al. page 2337, abstract)) to develop a method of treating leukemia (hematopoietic cancers). Since TAK-228 (examiner interprets this as prodrug thereof of tenofovir) as a mtor inhibitor is expected to treat leukemia,thus teaching claim 24. It is expected TAK-228 (prodrug of tenofovir) will act as mTor inhibitor in treating patient with cancer, thereby teaching all the elements of independent claim 24.
Furthermore, artisan would be motivated use the teaching of Thorgersson et. al (Table 1), mTor inhibitor with anticancer agent for treating HCC, as discussed above, with the teaching of Wolf et.al which teach, TAK-228, tenofovir prodrug (mTor inhibitor) to develop a combination therapy (page 1, abstract), to treat liver cancer. A person skilled in the art would expect to replace Everolimus in Thorgersson et. al (Table 1), with TAK-228 since TAK-228, mTor inhibitor is expected to behave similar to everolimus also a mTor inhibitor for liver cancer, teaching claim 26.
Moreover, artisan would be motivated to use the combined teaching of Thorgersson et. al and Wolf et. al. (TDF as mTor inhibitor to treat cancer) as discussed above, with the teaching of Bertacchini et. al, therapeutic effect of mTor inhibitor to treat leukemia (Bertacchini et. al. page 2337, abstract), because a person skilled in the art would expect TAK-228 (prodrug of tenefovir) would treat leukemia same as any mTor inhibitor, thereby teaching claims 11, 18, 23-27.
Since Examiner has proven “not infected with a hepatitis virus”, above, there is no need to further prove “wherein the patient is not infected with a hepatitis B virus”. This teaches claims 10, 15, 17, 20, 22, 24, ad 26.
Conclusion
No claims are allowed as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625