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 .
Priority
This application is a 371 of PCT/EP2022/071160 07/28/2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP-21188490.3, filed on 07/29/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Claims 1-15 are pending.
Election/Restrictions
Applicant’s election of Group I, corresponding to claims 1-7 and 9-10, and the compound A2
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(on pages 11 and 50 of the specification) in the reply filed on 5/8/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The elected species reads on claims 1-7, and 9-10.
Expansion of Election of Species Requirement
As indicated above, the elected species reads upon claims 1-7, and 9-10. The elected species has been searched and is deemed to be free of the prior art and non-obvious. Accordingly, the search has been expanded as called for under current Office Markush practice (M.P.E.P. § 803.02).
Examiner has searched the following species:
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wherein, in Formula (I), R1 – R6 is hydrogen, W1-W4 is CH,
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wherein, in Formula (I), R1 – R6 is hydrogen, W1 is N, W2 -W4 is CH,
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wherein, in Formula (I), R5 is Cl, R1 – R4, and R6 is hydrogen, W1 and W2 is C-Cl, W3 -W4 is CH.
Claims 8, and 11-15 remain withdrawn as they do not require the particulars of the expanded species examination.
Claims 1-7 and 9-10 are examined using the above species.
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 1-6, and 9-10 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. In claim 1, “a compound of formula (I)” is not defined in the specification with reasonable clarity as to what entities the applicant is intending to reference.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the “written description” inquiry, is “whatever is now claimed” (See page 1117).
A review of the language of the claim indicates that these claims are drawn to “a compound of formula (I)”. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention”. Hence, an adequate written description of the ingredients requires more than a mere statement that it is a compound of formula (I).
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984). Accordingly, reciting “a compound of formula (I)”, in the absence of knowledge as to what constitutes a compound of formula (I), is not a description. In the instant case, on page 3, lines 5-15, Applicant discloses “a compound of formula (I)”. However, other than the mere mention on page 3, lines 5-15 wherein Applicant simply states “a compound of formula (I)”, Applicant does not provide representative examples of a compound of formula (I).
There are select species of the claimed genus disclosed that is within the scope of the claimed genus, i.e., the listed compounds A1-E1 on pages 12- 17.
The disclosure of select species may provide an adequate written description of a genus when the species disclosed is representative of the genus. However, the present claim encompasses numerous species that are not further described. There is substantial potential for variability among the species.
One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus of what constitutes “a compound of formula (I)”. The specification does not clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed (see Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
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 1-7, and 9-10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of claims 1-6, and 8 are rendered uncertain by the phrases “denote” and “denotes” throughout claims 1-6, and 8, because it is not clear whether the Applicant intends denote to mean to consist or to comprise. For example, would there be a difference between “denote” or “denotes” and –defined as--?
The metes and bounds of claims 1, 5 and 6 are rendered uncertain by the phrase “denote independently from on another” in claim 1; lines 3 and 8, claim 5; line 2, and claim 6; line 4, because it is not clear what the Applicant intends as a required limitation of the claim by the introduction of “independently from one another”. Using claim 1 for example, would there be a difference between what the Applicant has instantly claimed, and the recitation --W1, W2, W3, W4, are each defined as N or CH--.
The metes and bounds of claims 1 and 4 are rendered uncertain by the phrase “together also denote”, in claim 1; line 7, and claim 4; line 3, because it is not clear what the Applicant intends as a required limitation of the claim by the introduction of “together also denote”. Using claim 1 for example, would there be a difference between what the Applicant has instantly claimed, and the recitation –R2, R3 are each defined as -(CY)2- or -(CR7)-(CY)2- --.
The metes and bounds of claim 1 are rendered uncertain by the phrase “in which 1-7 H atoms can be replaced independently from one another by Hal”, in claim 1, because it is not clear what the Applicant intends as a required limitation of the claim by the introduction of “independently from one another”. For example, would there be a difference between what the Applicant has instantly claimed, and the recitation --denotes unbranched or branched C1-C10 alkyl, optionally substituted with Hal--?
The metes and bounds of claim 6 are rendered uncertain by the phrase “have the meaning as defined in claim 1”, in claim 6; line 5, because it is not clear what the Applicant intends by this recitation. Using claim 6 for example, there would be no difference in scope if the Applicant were to omit this recitation altogether, as claim 1 already imparts the definitions of W3, R2, R3, R4, and A.
The metes and bounds of claims 9 and 10 are rendered uncertain by the phrase “at least one compound according to claim 1”, in claim 9; line 2, and claim 10; line 2, because it is not clear whether the Applicant intends to claim more than one of the compounds of claim 1, or the Applicant intends to claim one compound from claim 1, in combination with another compound independent of the compounds of claim 1.
The metes and bounds of claim 10 are rendered uncertain by the phrase “pharmaceutically tolerable excipients”, in claim 10; lines 2-3, because it is not clear what the Applicant is referring to as being pharmaceutically tolerable. What is considered to be tolerable?
The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
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)(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 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry Number 2304825-24-7 (Entered STN Registry on 4/18/2019).
CAS Registry Number 2304825-24-7 teaches the compound shown below on Page 2
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which teaches Applicant’s Formula (I) in claim 1, as shown below:
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Wherein, R1 – R6 is hydrogen, and W1-W4 is CH. As such, claims 1 and 4 are anticipated by the prior art.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry Number 881447-85-4 (Entered STN Registry on 4/21/2006).
CAS Registry Number 881447-85-4 teaches the Applicants Formula(I), wherein: R1 – R6 is hydrogen, W1 is N, and W2-W4 is CH
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As such, claims 1 and 2 is anticipated by the prior art.
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 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.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over CAS Registry Number 1883537-20-9 (Entered STN Registry on 3/15/2016), in view of Patani, G. (Bioisosterism: A Rational Approach in Drug Design), Chem.Rev., Vol. 96, pp. 3147-3176 (Year: 1996).
CAS Registry Number 1883537-20-9 teaches the following compound
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Which teaches a majority of the limitations of the Applicant’s compound of claim 5, wherein: R1 –R4, and R6 is hydrogen, R5 is Cl, and W3 -W4 is CH.
However, CAS Registry Number 1883537-20-9 teaches that W1-W2 is C-Cl, where there is a replacement of the hydrogen with chlorine.
Patani teaches that chlorine is a known substitution for hydrogen within an aromatic ring, as it prevents oxidation, through the following recitation:
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In the instant case, CAS Registry Number 1883537-20-9 and Patani provide adequate teaching, suggestion, or motivation to one having ordinary skill in the art, before the Applicant’s effective filing date, to replace hydrogen with chlorine, to arrive at the Applicant’s instant compound of claim 5.
CAS Registry Number 1883537-20-9 provides the majority of the compound and its limitations, while Patani provides teaching that, the replacement of hydrogen on an aromatic ring should result in decreased metabolism.
One having ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated and have had reasonable expectation of success to combine the teachings of CAS Registry Number 1883537-20-9 and Patani.
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to combine these teachings and arrive at the Applicant’s compound of claim 5.
Claims 1, 2, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over CAS Registry Number 881447-85-4 (Entered STN Registry on 4/21/2006), in view of Patani, G. (Bioisosterism: A Rational Approach in Drug Design), Chem.Rev., Vol. 96, pp. 3147-3176 (Year: 1996).
CAS Registry Number 881447-85-4 teaches the Applicants Formula(I), wherein: R1 – R6 is hydrogen, W1 is N, and W2-W4 is CH
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However, compound A1 in claim 7 includes a chlorine at the R5 position (shown below).
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Patani teaches that chlorine is a known substitution for hydrogen within an aromatic ring, as it prevents oxidation, through the following recitation:
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In the instant case, CAS Registry Number 881447-85-4 and Patani provide adequate teaching, suggestion, or motivation to one having ordinary skill in the art, before the Applicant’s effective filing date, to replace hydrogen with chlorine, to arrive at the Applicant’s instant compound of claim 5.
CAS Registry Number 881447-85-4 provides the majority of the compound and its limitations, while Patani provides teaching that, the replacement of hydrogen on an aromatic ring should result in decreased metabolism.
One having ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated and have had reasonable expectation of success to combine the teachings of CAS Registry Number 881447-85-4 and Patani.
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to combine these teachings and arrive at the Applicant’s compound A1 of claim 7.
Claim(s) 1, 4, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over CAS Registry Number 2304825-24-7 (Entered STN Registry on 4/18/2019), in view of Jiang, C., et. al. (Chinese Patent Publication No. CN111825619; Published 10/27/2020).
CAS Registry Number 2304825-24-7 teaches the following compound:
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However, CAS Registry Number 2304825-24-7 does not teach the compound in a composition for use as a treatment.
Jiang teaches the same compound (See Page 7 of Chinese document; Compound I-15), and that it is a α-glucosidase inhibitor capable of treating diabetes mellitus (See Summary of Invention on Page 2-3 of translated document). Jiang further teaches that the compound can be formulated in a composition with pharmaceutically acceptable salts, hydrates, solvates or prodrugs thereof and a pharmacy an acceptable carrier (See Page 5; Paragraph 5 of translated document).
In the instant case, CAS Registry Number 2304825-24-7 and Jiang provide adequate teaching, suggestion, and motivation to one having ordinary skill in the art, before the Applicant’s effective filing date, to arrive at the Applicant’s instant compound, and include it in a composition intended as a medicament, with pharmaceutically acceptable salts and excipients.
CAS Registry Number 2304825-24-7 teaches the Applicant’s compound and Jiang teaches that the compound has activity against diabetes mellitus.
One having ordinary skill in the art would have been motivated and have had reasonable expectation of success to combine the teachings of CAS Registry Number 2304825-24-7 and Jiang before the Applicant’s effective filing date.
Therefore, it would have been obvious to one having ordinary skill in the art, before the Applicant’s effective filing date, to combine these teachings and arrive at the Applicant’s instant composition and medicament.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OROD MOTEVALLI whose telephone number is (571)272-6026. The examiner can normally be reached Monday - Friday 10:00AM - 6:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OROD MOTEVALLI/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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