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
Pending claims 2, 5-6, 8-12, 24, 27-37 have been examined on the merits.
Withdrawn Rejections
The rejection of claims 2, 6 are rejected under 35 u.s.c. 102(a)(l) as being anticipated by chien et al., j agric food chem. 2008 aug 27;56(16):7017-22 is withdrawn in view of the amendments.
The rejection claims 5, 8-12, 24, 27 and 29 under 35 U.S.C. 103 as being unpatentable over Chien, as applied to claims 2 and 6 in view of Shimura et al. US 2007/0248705A1 is withdrawn in view of the amendments.
The rejection claim 2 under 35 U.S.C. 112(a) regarding lack of representative for R3 and R4, is withdrawn in view of Applicant’s Rule 132 Declaration.
New Grounds of Rejection due to the Applicant’s Claim Amendments and New Claims
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2, 5-6, 8-12, 24, 27-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2, regarding a method for treating inflammation and cancer, the instant claim broadly encompassed all inflammatory and cancer disease, including Ankylosing Spondylitis, Antiphospholipid Antibody Syndrome, Autoimmune Encephalitis, Chronic Recurrent Multifocal Osteomyelitis, Gout, melanoma, bladder cancer, kidney cancer, pancreatic cancer, thyroid cancer and leukemia. However, the specification's disclosure is clearly limited to influenza A respiratory inflammation, as an example. The specification does not demonstrate possession of treating full genus of any “inflammation and cancer” therefore the limited data does not commensurate in scope to support the entire claim. Given a inflammation and cancer encompasses a vast of heterogenous group of diseases, each with unique biological characteristic and therapeutic response, thus, it would not be obvious to a person of ordinary skill in the art (POSIT A) to assume that the limited results on influenza A infection in dTHP1/A549 cells and coronavirus 229E in endothelial cells would apply to all medication condition. This further demonstrates that the specification lacks adequate written description of the claimed subject.
Similarly, claims 5 and 8, recites “a disease of the lung” and “chronic inflammation.” The claims broadly encompass all acute inflammatory lung disease (e.g., asthma, COPD cystic fibrosis and bronchitis). The specification, however, provides examples only for influenza A virus (H1N1 PR8N) infection in A549 lung epithelial cells, reducing progeny virions (Figure 7). While certain, but not all, antiviral drugs (e.g., Baloxavir) used for influenza A also work against influenza B, C, and D. However, the specification fails to indicate whether the claimed compounds are also effective against influenza variant B, C, and D. Furthermore, the claim breadth far exceeds the single example of acute viral model, this is because influenza is an acute viral respiratory infection and is considered an acute inflammatory illness and not chronic. This further demonstrates that the specification lacks adequate written description of the claimed subject, chronic inflammation and any lung infection.
Claim 9 recites “a viral infection.” The claims broadly encompass any viral infection (e.g., coronaviruses, RSV, HIV, herpes, and rhinoviruses). The specification presents only two specific acute respiratory RNA viruses: influenza A viruses and human coronavirus 229E (Figure 1-3, 7 and 10), which represent a small subset of the broad genus recited in the instant claim. The instant claim evidence is based on host-directed modulation of inflammation pathways (e.g., ACOD1 inhibition, Nrf2, as an example), which are not uniform across all viruses; because such pathway varying significantly based on the virus type, the host cell, and the stage of infection. It would not be obvious to a person of ordinary skill in the art (POSITA) to assume that influenza A and human coronavirus 229E herein, would apply to all types of viruses or viral infection. Thus, the limited disclosure does not provide adequate support for the full scope of the claimed genus. This further demonstrates that the specification lacks adequate written description of the claimed subject.
Claim 24 recites “wherein the viral infection is an influenza virus, zika virus or coronavirus infection.” The claims broadly encompass any viral infection influenza virus, zika virus or coronavirus infection. The specification, however, provides examples only for influenza A virus (H1N1 PR8N) infection in A549 lung epithelial cells, and human coronavirus 229E in endothelial cells (Figure 7). Regarding zika virus, the specification contains no data, experiments, models, discussion, or rational linking citraconic or derivative to zika infection. The specification does not demonstrate possession of full genus of any “any viral infection” therefore the limited data on influenza A virus, and human coronavirus 229E do not commensurate in scope to support the entire claim. This further demonstrates that the specification lacks adequate written description of the claimed subject.
Claims 29, 31, 33-34, and 36-37 recites “medical condition is cancer.” The claims broadly encompass any cancer. The prediction is mainly based on ACOD1 overexpression and activity (specification page 11, line 13-15):
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The specification, however, fails to disclose any data, and working examples showing that the claimed compounds treat cancer. The specification (page 6, lines 32-36) further underscores this deficiency, due to the presumptive or prophetic statement without supporting evidence:
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Furthermore, the lack of any approved drug acting as ACOD-1inhibitor, further indicate that robust data are needed to support the asserted therapeutic effect across any cancer.
The specification’s failures to disclose a proper representative number of species across the claimed genus, thereof supports the conclusion that the specification lacks adequate written description of the claimed subject matter. Thus, a POSITA would conclude that Applicant was not in possession of the entirety of the claimed genus at the time of filling of the instant application in view of the disclosure of the application as filed.
New Grounds of Rejection due to the Applicant’s Claim Amendments and New Claims
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 2, 6 are rejected under 35 U.S.C. 102(a)(l) as being anticipated by
Al-Jaderi et al., Front Immunol. 2016 Jul 22;7:278.
Regarding claims 2, 5, 8, 12 and 29, Al-Jaderi (page 1) teaches Dimethyl fumarate (DMF) might be useful for treating psoriasis, asthma, aggressive breast cancers, hematopoeitic tumors, inflammatory bowel disease, intracerebral hemorrhage, osteoarthritis, chronic pancreatitis, and retinal ischemia. Al-Jaderi (page 1) discloses DMF having the following structure wherein R3 and R4 = O; R1 and R2 = CH3; R5 and R6 = hydrogen.
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Al-Jaderi (page 3) discloses Psoriasis is a type-1 cytokine-mediated chronic autoimmune skin disease aided by the infiltration of Th1/Th17 cells into the skin. DMF is utilized to treat psoriasis in European countries for more than 30 years.
Therefore, claims 2, 5, 8, 12 and 29 are anticipated.
New Grounds of Rejection due to the Applicant’s Claim Amendments and New Claims
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 non-obviousness.
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 6, 8-12, 24, 27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Jaderi, as applied to claims 2, 5, 8, 12 and 29 in view of Shimura et al. US 2007/0248705A1.
Al-Jaderi (page 1-2), as applied to claims 2, 5, 8, 12 and 29 above, discloses DMF possesses anti-inflammatory property and activates nuclear factor erythroid 2-related factor (Nrf2). Al-Jaderi (page 5) teaches DMF ameliorated inflammation through Nrf2 activation and suppression of cytokines. Thus, a POSITA would reasonably understand this general anti-inflammatory teachings might encompass acute inflammation and would have been motivated to administer such compound to patient with acute inflation. This is further supported by Shimura (abstract; page 1, [0003]; page 6, [0066] and [0067]) teaches activation of transcription factors or Nrf2 and methods of using Nrf2-activating compounds to treat inflammatory and oxidative stress-related disease, including but not limited to chronic inflammatory disease and cancer. It is important to highlight that the specification (page 6, line 15-18, page 30 and 32) teaches citraconic acid, a compound of formula VII, as an Nrf2 activator. Given that Chien teaches compounds that structurally encompassed by the instant claim, thus, a person of ordinary skill in the art (POSITA) would have reasonably expected the compounds disclosed by Chien to exhibit similar biological activity as citraconic acid, including activation of the Nrf2 signaling pathway. Consequently, it would have also been obvious to a POSITA to combine the teachings of Chien and Shimura to arrive at the claimed invention, since Shimura teaches the use of Nrf2-activating compound to treat or prevent disease, including but not limited to inflammatory disorder (e.g., rheumatoid arthritis) and cancer.
Subject Matter Free of the Art of Record
The subject matter of claims 28, 30-37 are free of the art of record. The closest prior art is the Al-Jaderi et al., Front Immunol. 2016 Jul 22;7:278. While Chien teaches a compound 6, dimethyl 2-(4-hydroxyphenyl)-3-isobutylmaleate, with anti-inflammatory property. However, there is no motivation for a POSITA to modify the teachings of Chien to arrive at the claimed compound. These claims are not allowable until the 112, 102 and 103 are resolved or overcome.
Response to Argument
Written Description
Applicant argues that the amendment addresses the 112 issue by clarifying the claimed subject matter to include inflammation and cancer. Applicant also argues “ACOD 1 activity was clearly established at the time of the invention as central to both cancer and inflammatory disease.” Applicant further argues “ACOD I inhibition is an established therapeutic target of research and indicates therapeutic relevance in inflammatory disease and cancer.” Applicant’s argument is not persuasive, because the cited publication establishes at most that ACOD1 inhibition was being investigated in connection with certain inflammatory diseases and cancers. However, they do not demonstrate that ACOD1 inhibition would be therapeutically effective across the full scope of the claimed “inflammatory and cancer disease” which encompasses substantially all diseases within those broad genera. Therefore, the cited publication do not provide sufficient evidence that Applicant possessed the claimed genus as a whole.
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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