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 the Claims
Claims 1-4, 8, 11-21, 23 and 26-27 are pending. Claims 11, 19, 21 and 26 are rejected. Claims 1-4, 8, 12-18, 20, 23 and 27 are objected to.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/EP2022/053042, filed 02/08/2022, which claims priority under 35 U.S.C. 119(a-d) to UNITED KINGDOM 2101728.0, filed 02/08/2021. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) dated 08/04/2023 has been considered.
Claim Objections
Claims 1, 13 and 19-20 are objected to because of the following informalities:
Claim 1:
In the section beginning with “Z is selected from:” add “and” at the end of the second line and delete “and” at the end of the third line;
In the line beginning with R1 and R2”, change -OC(O)R13 to -OC(O)R13 and add “and” to the end of the line;
On page 3, lines 5, 8 and 10, change superscript text to regular where appropriate (example: “C2-6 alkynyl” should be “C2-6 alkynyl”);
Page 3, line 15, change “or” to “and”;
Page 3, line 19, change “or” to “and”;
Page 3, line 27, change “or” to “and”;
Page 3, lines 32-35, add necessary commas between items, for example, line 32 should read: “ethylamino, acetylamino, N-methylcarboamoyl, N-ethylcarboamoyl, N,N-diemthylcarbamoyl, N,N-”; and
Page 3, line 35, change “or” to “and”.
Claims 2-4, 8, 11-21, 23 and 26-27 are objected to because they refer to claim 1.
Claim 13: Amend the first line as follows:
“A compound as claimed in claim 1,”.
Claim 19 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP 608.01(n).
Claim 20: consider deleting the last line of the claim “wherein R1, R2, R6, n and Z are as defined in claim 1” since there is no n variable in Formula (2) and there are other variables in the formula that are not addressed. Moreover, it is already clear to a person having ordinary skill in the art that the definitions from claim 1 would apply.
Appropriate correction is required.
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.
Claim 26 is 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 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.
Present claim 26 is directed to a method of treating or preventing a disease, disorder or condition. The limitation “a disease, disorder or condition” is exceedingly broad, and a person having ordinary skill in the art would expect a wide variety of uses for the compound of claim 1. However, the specification only provides a description wherein a compound of the invention may be used to treat or prevent various cancers. See page 50, lines 1 through 50. Additionally, the specification states broad “genetic or biochemical markers are appropriate to the disease, disorder or condition under consideration” in lines 34-35 of page 49. Lastly, there are several examples provided wherein compounds of the claimed invention are tested in various cancer cell lines (see Examples 1 through 11 and 14, pages 74-82), but no examples of methods for the treatment or prevention of other diseases, disorders or conditions.
Therefore, the claims lack written description and are properly rejected under 35 U.S.C. 112(a). Applicant may amend claim 26 such that it is limited to a method of treating or preventing a cancer and cancel claim 27, as supported by the disclosure, to overcome this rejection.
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.
Claims 11, 19 and 21 are rejected under 35 U.S.C. 112(b) being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 11, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant may overcome the rejection by, for example, amending the claim to delete the phrase “for example 3 or 4”.
Regarding claim 19, the claim recites “wherein R1, R2, R6, n and Z are as defined in claims 1 to 18” which renders the metes and bounds of the claim indefinite since different claims have different definitions for the groups identified.
Additionally, claim 19 is rejected for indefiniteness because claims 5-7 from which it depends have been cancelled.
Applicant may overcome the rejections to claim 19 by, for example, amending the claim such that the variables are as defined in claim 1 only.
Claim 21 is rejected because it refers to Table A of the instant specification. A claim should particularly point out and distinctly claim the subject matter which the applicant regards as his invention and, under modern claim practice, stand alone to define the invention. MPEP 2173.05(s) states “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)”. Applicant may overcome the rejection by, for example, including the compounds of Table A directly in the claims.
Allowable Subject Matter
Claims 1-4, 8, 11-21, 23 and 26-27 are free of the prior art.
The closest prior art is from CN 1861590 A in view of Lazarevic-Pasti et al. in “Modulators of Acetylcholinesterase Activity: From Alzheimer’s Disease to Anti-Cancer Drugs” Current Medicinal Chemistry, 2017, 24, p. 3283-3309.
CN ‘590 teaches compounds Id-1, Id-2, Id-3 and Id-4,
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597
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(see page 24) which are nearly embraced by the instant formula (1),
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467
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, wherein:
R2 and R3 are each -O-C1 alkyl (per instant claims 2, 3, 19-20);
R1, R4, R5, R6, R7, R8, and R9 are each H (per instant claim 8, 19-20);
n is 1 (per instant claims 11, 12, 19-20); and
Z is: -N(CH3)(CH2CH3), -N(CH2CH3)2, pyrrolidine or piperidine.
CN ‘590 teaches that the above compounds are potent acetylcholinesterase (AChE) inhibitors as therapeutics for Alzheimer’s disease. See English Machine Translation, page 1, abstract and Table 1 above which displays inhibition of acetylcholinesterase activity (as translated on page 15 of the English Machine Translation).
Lazarevic-Pasti et al. teach that while AChE inhibitors are known to have an effect on neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease, they also teach the findings that a high expression of AChE has been found in different cancer types and that the enzyme serves as a potential target for developing new anti-cancer agents. See Abstract, Background section and page 3296, Section 4.2.1. AChE Inhibitors as Anticancer Agents. Lazarevic-Pasti et al. even highlight the flavonoids isoorientin and isovixetin (p. 3299, Fig. 5), as having moderate anticancer activity:
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120
387
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. See page 3298, right column, third paragraph.
However, the prior art reference CN ‘590 teaches compounds that are position isomers wherein R2 and R3 of the instant formula are -O-C1 alkyl groups, as opposed to R1 and R2 as described in the instant claims. This would require a person having ordinary skill in the art to either move two substituents or move one over the other. CN ‘590 does not suggest such a change for any of the compounds identified therein, and there is no motivation to make this change identified in the prior art. Since the compounds are found to be novel and nonobvious, any composition or method requiring their use are also considered novel and nonobvious.
Therefore, claims 1-4, 8, 11-21, 23 and 26-27 are novel and nonobvious.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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/J.H.F./Examiner, Art Unit 1626
/JOSEPH K MCKANE/Supervisory Patent Examiner, Art Unit 1626