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Examiner have withdrawn all claim objections and 103 rejections on file.
New 103 rejections are made due to Markush search extension.
Applicant provide compliant species election as follows:
species of formula I:
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Additional compound/ therapy: immune checkpoint inhibitors.
Disease and condition: initiation of tumor formation
Examiner did not find prior art on applicant elected species (compound X6632). The compound X6632 is free of prior art. Therefore claim 3 and its depended claim 21-26 are rejoined.
Since claim 10 was not examined in previous office this office action is made non-final.
Markush search was extended to the species
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of (Ia), where Re is hydroxybenzyl, and n is 0.
Examiner found prior art for compound
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with the species of disease/ condition of initiation of tumor formation (examiner interpret this as cancer). Species reads on claims 2, 6-7 and 10-11.
Claims 2-3, 6-11 and 21-26 are examined in this office action.
Priority
The claim find support in EPO 19183945.5 therefore the effective filing date is 07/02/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 09/23/2024 and 03/24/2022. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Current Status of 17/623,556
This Office Action is in response to the amended claims of 10/24/2025.
Claims 2-3, 6-11 and 21-26 are examined in this office action.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of 10/24/2025. Examiner have reviewed these remarks and amendments.
Regarding claim objection, applicant
Deleted the structure (Ib), (Ic) and (Id)
Redrew structure ((Ia) to make the structure clear.
Thus objection to claim 2 is withdrawn.
Regarding 103 rejections, applicant amended claim 2 by deleting the structure (Ib).
Applicant’s argues:
Rempel failed to teach compound (Ib) to prevent or treat disease or condition associated with cell expressing Id1
Regarding prior art of McAllister et.al, cannabidiol (CBD) is structurally different then compound of (Ib). Applicant assert that CBD is structurally and mechanistically distinct from compound of formula (Ib) thus and CBD activity cannot be extrapolated to structurally unrelated compounds.
Regarding prior art of Lou et.al., applicant argues Lous is disconnect to the mechanism of action of the claimed inventions.
Applicant claims Formula 1 (a) shows surprising and unexpected efficacy in modulating ld1 and/or ld3 expression and treating associated conditions, whereas CB1, CB2 and GPR55 signaling pathways do not regulate ld1 or ld3 activity.
Examiner’s response:
Examiner’s disagrees with applicant’s assertions, Rempel teaches compound of (Ib) and (Ia) (abstract Muller et. al (J. Med. Chem. 2012, 55, 7967−7977) see new rejections below) as CB1 and CB2 agnostic. Prior art of McAllister et.al teaches cannabidiol (CBD), agonists of CB1 and CB2 receptor protein, inhibit ID-1 protein expression in cancer cells (examiner interpreting this as tumor initiation function). McAllister further teaches analogs of CBD could be created to be more active in inhibiting Id-1(McAllister, page 9). Therefore, there is a correlation between CB1 and CB2 agnostic and inhibition of Id1 protein. since both CBD and compound of formula Ib and Ia are CB1 and CB2 agnostic, it would be expected that compound of (Ib) and (Ia) will also inhibit Id1 protein.
Prior art of Lou et.al teaches method of use for immunocheckpoint inhibitor that can be used in combination with compound of claim 2 to teach claim 11. Examiner is not claiming immunocheckpoint inhibitor have same mechanism of action as Id1 protein inhibitor.
Applicant did not provide surprising and unexpected result as claimed by the applicant. Applicant did not provide evidence compounds as claimed does not inhibit CB1 and CB2 protein. The experimental evidence show inhibition of Id1 and Id3 in (Figure 1) with compound of formula(Ia).
103 rejection on record is moot due applicant amendment to the claim 2. Therefore 103 rejections are withdrawn.
Response to Amendment
Claim Objections
Claim 3 is objected to because the claim is directed to a compound “X6632” . Previously, the compound and structure were present, but now it is lined-through and is only in the spec. The claims should be complete in themselves. The name does not add anything to the claim.
Applicant is advised to end the claim at “and n is 1.”
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 2-3, 6-11 and 21-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment does not reasonably provide enablement for prevention. Furthermore, the specification and art, while being enabling for melanoma, do not reasonably provide enablement for the scope of treating all “diseases associated with cells expressing Id1 and/or ID3” as is instantly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include:
(a) Breadth of the claims:
(b) Nature of the invention;
(c) State of the prior art;
(d) Level of one of ordinary skill;
(e) level of predictability art
(f) amount of direction provided by the inventor;
(g) existence of working examples;
(h) and Quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth and nature of the claims and Nature of the Invention
Claims 2-3, 6-11 and 21-26 are directed to intended use limitations drawn to prevention or treatment of condition or disease that is associated with cells expressing Id1 and /or Id3. Claims 6-9 and 21-25 lists numerous diseases that are difficult to treat or prevent and each disease would require different prevention/treatment regimens.
State of the prior art:
The conditions/disease associated with cell expressing Id1 and/or Id3 are numerous as stated in claims 6-9 and 21-25. There are no one method that can prevent or treat all the diseases associated with cells expressing Id1 and/or Id3. For example, atherosclerotic plaque is caused by numerous factor (Wayne TF Jr. Int J Angiol. 2011 Dec;20(4):213-22.) and cannot be attributed only to cells expressing Id 1 and/or Id3. While regression of atherosclerotic plaque is known, for example by statin and exercise but there is no known method of prevention for atherosclerotic plaque formation.
Similarly, Gorham syndrome is a disease that presents idiopathic osteolysis of a bone or closely contiguous area. The etiology is unknown and difficult to diagnose (Lech O. et.al. GORHAM-STOUT SYNDROME: PHANTOM BONE DISEASE. Rev Bras Ortop. 2015 Nov 16;45(6):618-22). There is no known treatment, therefore it would be difficult to prevent or treat the disease.
Level of one of ordinary skill/ Level of predictability art
A person of ordinary skill in the art is an artisan who is a medicinal chemist and or oncologist that has experience treating cancer and other diseases associated with cell expressing Id1/Id3 and have to navigate various way for preventing or treating diseases associated with cells expressing Id1 and/or Id3 as stated in claims 6-9 and 21-25. For example, Gorham syndrome have no known method of treatment or/and preventions as state above (paragraph [25]), therefore an artisan skilled in the art would not be able to determine the course of treating or preventing such diseases.
A person skilled in the art would not be able to envision treating or preventing all the diseases associated with Id1/Id3 with the experiments disclosed in the specification (Wands factor (d)) because the specification does not provide guidance for method of preventing or treating diseases in claims 6-9 and 21-25 with compound of formula Ia (wand faction (e)). Moreover, preventions of diseases are unpredictable because no one compound can prevent all the diseases/conditions associated with cells expressing Id1 and/or Id3 (wand factor (e)).
Amount of direction provided by the inventor:
Although the specification teaches a method of treating melanoma, there is no working example that shows prevention of melanoma, in the specification The specification does not disclose a method of treating or preventing all diseases in claims 6-9 and 21-26. Moreover, prevention of diseases/condition are unpredictable because no one method can prevent a disease/condition from occurring.
It would require undue experimentation and be undue burden to practice the claimed method of treating and/or prevention for disease associated with cell expressing Id1/Id3. Since no one method can treat or prevent all the diseases stated in claims 6-9 and 21-26. Moreover, some of the diseases are rare and difficult to diagnose.
Therefore, method claims 2-3, 6-11 and 21-26 are rejected for lacking scope of enablement for treating and prevention all diseases associated with cell expressing Id1/Id3.
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.
Claim(s) 2 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over
Muller et. al (J. Med. Chem. 2012, 55, 7967−7977)
In view of
McAllister et al (Breast Cancer Res Treat. 2011 August ; 129(1): 37-47).
In further view of
Lou et al. (Journal of Hematology & Oncology (2018) 11:39)
1. Determining the scope and contents of the prior art.
Muller teaches the compound
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of (Ia), where Re is hydroxybenzyl, and n is 0 and compound as antagonists for GPR55, CB1 and CB2 (abstract and table 1 compound 27b) partially teaching claim 2.
McAllister et al. teaches, cannabidiol (CBD), agonists of CB1 and CB2 receptor protein, inhibit ID-1 protein expression in cancer cells (examiner interpreting this as tumor initiation function). McAllister further teaches analogs of CBD could be created to be more active in inhibiting Id-1(page 9). Partially teaching claims 2 and 6-9.
Lou et. al teaches the use of immune checkpoint inhibitor for treating cancer by to inhibit the nascent anti-tumor immune response. Immune checkpoint therapies act by blocking or stimulating these pathways and enhance the body’s immunological activity against tumors (abstract).
2. Ascertaining the differences between the prior art and the claims at issue.
Muller does not teach the use of the compound
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to prevent or treat a condition or diseases associated with cell expressing Id1.
McAllister et. al does not teach the of the compound
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to prevent or treat a condition or diseases associated with cell expressing Id1.
Lou does not teach combination of immune check point inhibitor with of the compound
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to prevent or treat a condition or diseases associated with cell expressing Id1 protein.
3. Resolving the level of ordinary skill in the pertinent art.
The leveling of ordinary skill in the art is an artisan who have sufficient background in developing therapeutics prevent or treat condition or diseases with cell expressing Id-1.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to develop compound
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Antagonists for GPR55, CB1 and CB2 (Muller et. al., abstract and table 1 compound 27b) and combine with the teaching of McAllister which teaches CB1 and CB2 antagonist induces reduction of Id-1 protein as a results slow the progression of cancer cell (McAllister page 9). It is expected
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an CB1 and CB2 antagonists will be effective in reduction of ID-protein in cancer cells (teaching all the elements of claims 2, 6-9).
Regarding claim 10, according to claim constructions, limitation recited in claim 10 are treating by compound of (Ia) because the conditions is a result of cell expressing Id1 and /or Id3, it would be obvious for a person skilled in the art to use the compound (Ia) to target the conditions stated in claim 10. Thus teaching claim 10.
It is therefore prima facia obvious to combine the teaching of Muller l et. al, McAllister et.al. and Lou et.al. to teach all the limitation of claims 2, and 6-10.
Claim(s) 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over
Muller et. al (J. Med. Chem. 2012, 55, 7967−7977)
In view of
McAllister et al (Breast Cancer Res Treat. 2011 August; 129(1): 37-47).
In further view of
Lou et al. (Journal of Hematology & Oncology (2018) 11:39)
1. Determining the scope and contents of the prior art.
Muller teaches the compound
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of (Ia), where Re is hydroxybenzyl, and n is 0 and compound as antagonists for GPR55, CB1 and CB2 (abstract and table 1 compound 27b) partially teaching claim 2.
McAllister et al. teaches, cannabidiol (CBD), agonists of CB1 and CB2 receptor protein, inhibit ID-1 protein expression in cancer cells (examiner interpreting this as tumor initiation function). McAllister further teaches analogs of CBD could be created to be more active in inhibiting Id-1(page 9). Partially teaching claims 2.
Lou et. al teaches the use of immune checkpoint inhibitor for treating cancer by to inhibit the nascent anti-tumor immune response. Immune checkpoint therapies act by blocking or stimulating these pathways and enhance the body’s immunological activity against tumors (abstract) partially teaching claim 11.
2. Ascertaining the differences between the prior art and the claims at issue.
Muller does not teach the use of the compound
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to prevent or treat a condition or diseases associated with cell expressing Id1.
McAllister et. al does not teach the of the compound
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to prevent or treat a condition or diseases associated with cell expressing Id1.
Lou does not teach combination of immune check point inhibitor with of the compound
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to prevent or treat a condition or diseases associated with cell expressing Id1 protein.
3. Resolving the level of ordinary skill in the pertinent art.
The leveling of ordinary skill in the art is an artisan who have sufficient background in developing therapeutics to treat condition or diseases with cell expressing Id-1.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to develop compound
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Antagonists for GPR55, CB1 and CB2 (Muller et. al., abstract and table 1 compound 27b) and combine with the teaching of McAllister which teaches CB1 and CB2 antagonist induces reduction of Id-1 protein, results in slow progression of cancer cell (McAllister page 9). It is expected
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an CB1 and CB2 antagonists will be effective in reduction of Id-protein in cancer cells (teaching all the elements of claims 2, 6-9).
A person skilled in the art would be motivated to administer an immune check point inhibitor (applicant’s elected species) (Lou, et. al. abstract) to suppress immune response in cancer cell with CB1 and CB2 inhibitor like the compound
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(combined teaching of McAllister and Rempel). Since compound would be expected to be more effective in reducing the production of Id-1 protein when administered with immune checkpoint inhibitor because immune checkpoint inhibitor enhances body’s own immune system (Lou. et. al. abstract) in treating and preventing cancer cell growth, teaching claim 11.
It is therefore prima facia obvious to combine the teaching of Muller l et. al, McAllister et.al. and Lou et.al. to teach all the limitation of claims 2, and 11
Conclusion
No claims are allowed as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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