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 .
Non-Final Rejection
The Status of Claims:
Claims 1-11 are pending.
Claims 1-11 are rejected.
DETAILED ACTION
1. Claims 1-11 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/JP2023/001111 01/17/2023, which has a foreign priority of JAPAN JP2022-011064 01/27/2022 .
Drawings
3. The drawings filed on 7/23/24 were accepted by the examiner.
IDS
4. The IDS filed on 7/23/24 were reviewed by the examiner.
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 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.
Claim Rejections - 35 USC § 112
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 1-11 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 pre-AIA the applicant regards as the invention.
In claim 3 , the phrase ”a derivative thereof ” is recited. This expression is vague and indefinite because the claim does not define what is meant by the phrase ”a derivative thereof ” in the claim.
In claims 1-3, 6, and 8, the phrases “ a compound acting on a retinoid receptor” ,
, “a BRAF inhibitor”, “ a retinoid compound”, “an MEK inhibitor”, “a compound acting on an epidermal growth factor or an epidermal growth factor receptor” are recited. These terms “ a compound acting on a retinoid receptor” , “a BRAF inhibitor”, “ a retinoid compound”, “an MEK inhibitor”, “a compound acting on an epidermal growth factor or an epidermal growth factor receptor” can be vague and indefinite because the terms can be read on the reach-through claim. A functional definition of a chemical compound ("reach-through" claim) covers all compounds possessing the activity or effect specified in the claim. It would be an undue burden to isolate and characterize all potential compounds, without any effective pointer to their identity or to test every known compound and every conceivable and undiscovered future compound for this activity to see if it falls within the scope of the claims. In effect, the applicant is attempting to patent what has not yet been invented. Therefore, an appropriate correction is required.
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 1-9 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims set forth the therapeutic agent for cancer, generally comprising: a compound acting on a retinoid receptor; and a BRAF inhibitor.
However, there never has been a compound capable of treating cancer generally. There are compounds that treat a range of cancers, but no one has ever been able to figure out how to get a compound to be effective against cancer generally, or even a majority of cancers. Thus, the existence of such a “silver bullet” is contrary to our present understanding in oncology. Even the most broadly effective antitumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, such as viruses (e.g. EBV, HHV-8, and HTLV-1), exposure to chemicals such as tobacco tars, genetic disorders, ionizing radiation, and a wide variety of failures of the body’s cell growth regulatory mechanisms. Different types of cancers affect different organs and have different methods of growth and harm to the body, and different vulnerabilities. Thus, it is beyond the skill of oncologists today to get an agent to be effective against cancers generally, evidence that the level of skill in this art is low relative to the difficulty of such a task.
When the best efforts have failed to achieve a goal, it is reasonable for the PTO to require evidence that such a goal has been accomplished, In re Ferens, 163 USPQ 609. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs Novo Nordisk, 42 USPQ2nd 1001, 1006.
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1-2, 5-7, 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Marine et al (WO 2019/158579 A1).
Marine et al discloses tumor treatment, in particular to melanoma tumor treatment. In particular it relates to the use of retinoid X receptor antagonists for use in tumor treatment, in particular for use in reducing tumor cell heterogeneity during minimal residual disease (MRD), and thus for use in treating MRD. Even more in particular, the invention relates to the use of retinoid X receptor antagonists in combination with a combination of BRAF and MEK inhibitors, and optionally other anticancer agents.
It teaches that melanoma mice were treated with BRAF/MEK inhibitors (marked with *) and POX melanoma (MEL006) mice were treated with BRAF/MEK/RXR inhibitors (double therapy/dabrafenib+trametinib (see page 12, lines 15-17).
Also, tt was aimed at validating these predictions using genetic and pharmacological perturbation experiments. Knock-down experiments in the BRAF-mutant MEL006 melanoma cultures were exposed on BRAF and MEK-inhibitors (see page 81, lines 16-17). These are identical with the claims.
Conclusion
Claims 1-11 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 6/26/26
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