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 Claims
Claims 1, 3, 6-7, 9, 11-12, 15, 18, 22, 30, 34, 38-40, 44-46, and 53-54 are pending.
Priority
Instant application 18/270,450, filed 06/29/2023 claims priority as follows:
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Information Disclosure Statement
All references from IDS(s) received 06/29/2023 and 01/21/2025 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3, 6-7, 9, 11-12, 15, 18, 22, 30, 34, 38-40, 44, and 45 in the reply filed on 12/10/2025 is acknowledged. Additionally, applicant’s election without traverse of the species compound:
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,
is acknowledged.
Examination will begin with the elected species. In accordance with MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and applicable art was not identified. The search was therefore extended to the specific compounds recited in claims 38 and 44 and applicable art was not identified. The search was therefore extended again and the following compound was identified:
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The instant specification states that “alkyl” is generally used to refer to both unsubstituted alkyl groups and substituted alkyl groups (page 16, [0041]). The instant specification also states that the term “substituted” is contemplated to include all permissible substituents of organic compounds (page 15, [0037]). Accordingly, the above compound is being interpreted to read on the formula:
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wherein Ar1 is phenyl; n is 1; m is 1; q is 1; X is N-R10; R10 is C1 alkyl; R1a and R1b are each independently hydrogen; R3a is H; R3b is substituted C1 alkyl; R4a is H; and R4b is substituted C1 alkyl.
The elected or expanded species read on claims 1, 3, 6, 15, 22, 34, 38-40, and 44-45. The entire scope of the claims has not yet been examined in accordance with Markush search practice. See MPEP 803.02.
Claims 7, 9, 11-12, 18, 30, 46, and 53-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025.
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, 3, 6, 15, 22, 34, 39-40, and 45 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a
claim contrary to its ordinary meaning, the written description must clearly redefine the claim
term and set forth the uncommon definition so as to put one reasonably skilled in the art on
notice that the applicant intended to so redefine that claim term. Process Control Corp. v.
HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
The instant specification sets forth that the term “alkyl” is generally used to refer to both unsubstituted alkyl groups and substituted alkyl groups (page 16, [0041]). The instant specification (page 15, [0037]) also states that the term “substituted” is contemplated to include all permissible substituents of organic compounds; and states “It is also contemplated that, in certain aspects, unless expressly indicated to the contrary, individual substituents can be further optionally substituted (i.e., further substituted or unsubstituted).”
Accordingly, the term “alkyl” recited in the claim appears to refer to an alkyl group which is either unsubstituted, or is substituted in an essentially unlimited fashion. The only limitation on the “substituted” alkyl group is that it must be a “permissible substituent of organic compounds”. The boundaries of the claims (specifically, the boundaries on claims reciting the term “alkyl”) are not clearly delineated and therefore the claims are indefinite.
The rationale above also applies to the term “cycloalkyl”, which is defined in para. [0042]) as referring to both unsubstituted and substituted cycloalkyl moieties; and the term “alkenyl” which is defined in para. [0046] as optionally substituted. Claims 1, 3, 6, 15, 22, 34, 39-40, and 45 either recite the terms “alkyl”, “cycloalkyl”, or “alkenyl” or depend from a claim which recite the terms without resolving the issues identified above. Therefore, these claims are rejected.
In the interest of compact prosecution, the examiner recommends that applicant amend the claims to replace the terms “alkyl”, “cycloalkyl”, and “alkenyl” with the phrases “unsubstituted alkyl”, “unsubstituted cycloalkyl”, and “unsubstituted alkenyl” in order to avoid the aforementioned issues. Alternatively, if protection for substituted “alkyl”, “cycloalkyl”, and “alkenyl” groups is sought, the claims should be amended to indicate (i) the number of substituents and (ii) the particular kinds of substituents, provided that support exists in the specification.
Please also note that substituents recited in the claims such as “aryl”, “heteroaryl”, “haloalkyl”, “cyanoalkyl”, “hydroxyalkyl”, “haloalkoxy”, “alkoxy”, “alkylamino”, “dialkylamino”, and “aminoalkyl” are being interpreted as unsubstituted unless explicitly stated otherwise. For example, claim 1 explicitly states that Ar1 is selected from C6-C14 aryl and C2-C10 heteroaryl, and is substituted with 0, 1, 2, or 3 groups independently selected from those particularly recited in the claim (halogen, -CN, -NH2, etc.).
Claim 45 recites a pharmaceutical composition comprising an “effective amount” of the compound of claim 1, and a pharmaceutically acceptable carrier. The term “effective amount” is indefinite and one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed invention.
The specification provides an ambiguous description of the term “effective amount” in para. [0029]:
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Please note that the phrase “effective amount” has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. See MPEP 2173.05(c). In the instant case, the effects implied from the specification are numerous and extend to any “desired result” or any “effect on an undesired condition”. Claim 45 is therefore indefinite because it does not clearly state the effect to be achieved. It is unclear what amount(s) of the compound should be in the composition to render it “effective” because it is unclear which effect(s) the claims are directed to.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 3, 6, 15, 22, 39-40, and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pimenta et al. (Biological Chemistry, vol. 383, no. 5, May 2002, pp. 853–857; previously cited).
Pimenta et al. discloses a compound having the formula (page 13, Table 1, No. XII):
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The instant specification states that “alkyl” is generally used to refer to both unsubstituted alkyl groups and substituted alkyl groups (page 16, [0041]). The instant specification also states that the term “substituted” is contemplated to include all permissible substituents of organic compounds (page 15, [0037]). Accordingly, Pimenta’s compound is being interpreted to read on the formula:
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wherein Ar1 is phenyl; n is 1; m is 1; q is 1; X is N-R10; R10 is C1 alkyl; R1a and R1b are each independently hydrogen; R3a is H; R3b is substituted C1 alkyl; R4a is H; and R4b is substituted C1 alkyl.
The above compound anticipates claims 1, 3, 6, 15, 22, 39, 40.
With respect to claim 45, Pimenta discloses testing the above compound for its inhibitory activity against human tissue kallikrein (page 5-7 and page 13, Table 1). Pimenta therefore discloses a pharmaceutical composition comprising an effective amount (wherein the “effect” is inhibition of kallikerin) of the above compound and a pharmaceutically acceptable carrier. Accordingly, claim 45 is also anticipated.
Allowable Subject Matter
Claims 38 and 44 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 3, 6, 15, 22, 34, 39-40, and 45 are rejected. Claims 38 and 44 are objected to. Claims 7, 9, 11-12, 18, 30, 46, and 53-54 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621