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 1-15 are pending.
Claims 1-15 are rejected.
DETAILED ACTION
1. Claims 1-15 are under consideration in this Office Action.
Priority
2. It is noted that this application has a priority date of 63400445 08/24/2022 ..
Drawings
3. None.
IDS
4. The IDS filed on 12/18/2023 were reviewed by the examiner.
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 1-13 and 15 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 1, the limitations” forming a compound according to Formula (Ia) from a compound according to Formula (Ia1), or the corresponding freebase or a different salt thereof, and a compound according to Formula (Ia2)” is recited. These are vague and indefinite because this does not explain clearly how the compound of formula (Ia) can be formed from a compound according to Formula (Ia1) and the compound according to Formula (Ia2) under any reaction conditions and steps (e.g. any temperature or pressure , or any reagent and etc..).
In claim 1, the limitation” forming a compound of Formula (Ib) from a compound of Formula (Ia)” is recited. This is vague and indefinite because this does not explain clearly how the compound of formula (Ib) can be formed from a compound according to Formula (Ia) under any reaction conditions and steps (e.g. any temperature or pressure , or any reagent and etc..).
In claim 1, the limitation” forming a compound of Formula (Ib) from a compound of Formula (Ia)” is recited. This is vague and indefinite because this does not explain clearly how the compound of formula (Ib) can be formed from a compound according to Formula (Ia) under any reaction conditions and steps (e.g. any temperature or pressure , or any reagent and etc..).
In claim 1, the limitation” forming a compound of Formula (Ic) from a compound of Formula (Ib)” is recited. This is vague and indefinite because this does not explain clearly how the compound of formula (Ic) can be formed from a compound of Formula (Ib) under any reaction conditions and steps (e.g. any temperature or pressure , or any reagent and etc..).
In claim 1, the limitation” forming a compound of Formula (Id) from a compound of Formula (Ic)” is recited. This is vague and indefinite because this does not explain clearly how the compound of formula (Id) can be formed from a compound of Formula (Ic) under any reaction conditions and steps (e.g. any temperature or pressure , or any reagent and etc..).
In claim 1, the limitation” forming a compound of Formula (Ie) from a compound of Formula (Id) )” is recited. This is vague and indefinite because this does not explain clearly how the compound of formula (Ie) can be formed from a compound of Formula (Id) under any reaction conditions and steps (e.g. any temperature or pressure , or any reagent and etc..).
In claim 1, the limitation” forming a compound of Formula (If) from a compound of Formula (Ie)” is recited. This is vague and indefinite because this does not explain clearly how the compound of formula (If) can be formed from a compound of Formula (Ie) under any reaction conditions and steps (e.g. any temperature or pressure , or any reagent and etc..).
In claim 1, the limitation” forming a compound of Formula (Ig) from a compound of Formula (If)” is recited. This is vague and indefinite because this does not explain clearly how the compound of formula (Ig) can be formed from a compound of Formula (If) under any reaction conditions and steps (e.g. any temperature or pressure , or any reagent and etc..).
In claim 1, the limitation” forming a compound of Formula (I) from a compound of Formula (Ig) is recited. This is vague and indefinite because this does not explain clearly how the compound of formula (I) can be formed from a compound of Formula (Ig) under any reaction conditions and steps (e.g. any temperature or pressure , or any reagent and etc..).
In claims 1 and 15, the abbreviated term” CSA” is recited.
This expression is vague and indefinite because the claim does not define what is meant by the term ” CSA”; it can have a different meaning in a different field of the art
The examiner recommends to put a specific name for the abbreviated term” CSA”.
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) 14 is rejected under 35 U.S.C. 102[(a)(2) as being anticipated clearly by Inghardt et al (US 2016/0152623 A1).
Inghardt et al discloses the following compound :
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1-(2-acetyl-4-chlorobenzyl)-2-thioxo-1,2,3,5-tetrahydro-4H-pyrrolo[3,2-d]pyrimidin-4-one(see page 15, a paragraph#0203)
This is identical with the claim.
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Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
5. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Inghardt et al (US 2016/0152623 A1) in view of Wikipedia (Camphorsulfonic acid, October 22, 2020, p. 1-3)
Applicants claim the following:
15. (Original) A compound having the structure:
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.
Determination of the scope and content of the prior art
Inghardt et al discloses 1-{ 2-[ (1 R)-1-Aminoethyl]-4-chlorobenzyl }-2-
thioxo-l ,2,3,5-tetrahydro-4H-pyrrolo[3,2-d]pyrimidin-4-one compound in the following:
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Or a pharmaceutically acceptable salt thereof (see page 15, a paragraph#0204; page 25, claim 7)
Furthermore, a compound according to claim 1, or a pharmaceutically acceptable salt thereof, is for use as a medicament (see page 25, claim 8) .
The current invention, however, differs from the prior art in that the (R)-CSA salt of the compound(Ig) is unspecified in the prior art.
Wikipedia teaches that camphorsulfonic acid, sometimes abbreviated CSA or 10-CSA is an organosulfur compound. Camphorsulfonic acid is used in some pharmaceutical formulations, where is it referred to as camsilate or camsylate(see pages 1-3).
Ascertainment of the difference between the prior art and the claims
1. The difference between the instant application and the applied Inghardt et al art is that the applied Inghardt et al art does not expressly teach the (R)-CSA salt of the claimed compound(Ig). The deficiency of the Inghardt et al is cured by Wikipedia.
2. The difference between the instant application and the applied Wikipedia art is that the applied Wikipedia art does not expressly teach the claimed compound(Ig). The deficiency of Wikipedia is cured by the Inghardt et al.
Resolving the level of ordinary skill in the pertinent art.
With respect to the (R)-CSA salt of the claimed compound(Ig), Wikipedia does teach that camphorsulfonic acid (CSA) ), which is known to have a R or S configuration, is used in some pharmaceutical formulations, where is it referred to as camsilate or camsylate,(see pages 1-3). Whereas Inghardt et al does disclose the claimed compound known as 1-{ 2-[ (1 R)-1-Aminoethyl]-4-chlorobenzyl }-2-thioxo-l ,2,3,5-tetrahydro-4H-pyrrolo[3,2-d]pyrimidin-4-one compound or a pharmaceutically acceptable salt thereof (see .page 25, claim 7). From these teachings, it is reasonable for the skilled artisan in the art to have assumed to form such a claimed compound(Ig) having (R)-CSA salt since the claimed compound and the claimed salt are well-known in the art.
So, if the skilled artisan in the art had desired to form 1-{ 2-[ (1 R)-1-Aminoethyl]-4-chlorobenzyl }-2-thioxo-l ,2,3,5-tetrahydro-4H-pyrrolo[3,2-d]pyrimidin-4-one having (R)-CSA salt. it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate the teaching of Wikipedia’s (R)-CSA salt.as an alternative into Inghardt’s et al compound.
This is because the skilled artisan in the art would expect to form such a combined salt form of the compound (Ig) to be successful and feasible as guidance shown in the prior art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Inghardt et al expressly discloses 1-{ 2-[ (1 R)-1-Aminoethyl]-4-chlorobenzyl }-2-
thioxo-l ,2,3,5-tetrahydro-4H-pyrrolo[3,2-d]pyrimidin-4-one compound in the following:
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Or a pharmaceutically acceptable salt thereof (see page 15, a paragraph#0204; page 25, claim 7). Furthermore, its pharmaceutically acceptable salt thereof, is for use as a medicament(see page 25, claim 8).
Although Inghardt et al does not teach specifically that the claimed compound(Ig) has (R)-CSA salt form, Wikipedia does mention that camphorsulfonic acid (CSA), which is known to have a R or S form, is used in some pharmaceutical formulations(see page 3).
So, if the skilled artisan in the art had desired to develop a pharmaceutical formulation containing 1-{ 2-[ (1 R)-1-Aminoethyl]-4-chlorobenzyl }-2-thioxo-l ,2,3,5-tetrahydro-4H-pyrrolo[3,2-d]pyrimidin-4-one having (R)-CSA salt. it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate the teaching of Wikipedia’s (R)-CSA salt.as an alternative into Inghardt’s et al compound.
This is because the skilled artisan in the art would expect to form such a combined salt form salt form of the compound (Ig) to be successful and feasible as guidance shown in the prior art.
Conclusion
Claims 1-15 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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/TAYLOR V OH/Primary Examiner, Art Unit 1625 3/3/2026