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 .
Claim status
Claims 1-2, 4, 6-9, 14-15, 21-22, 38, 43-44, 51-52, 55, 59-60 and 66 filed 08/30/2024 are pending in the application and are hereby examined on the merits.
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 1-2, 4, 6-9, 14-15, 21-22, 38, 43-44, 51-52, 55, 60 and 66 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.
Claim 1 recites that “R3 is C1-6 alkyl optionally substituted with one or more R9, cycloalkyl, aralkyl, or (carboxycly)alkyl”. It is unclear whether cycloalkyl, aralkyl, or (carboxycly)alkyl is the option for R3, or is the option of substituents for C1-6 alkyl. Given that claim 44 recites that R3 is cycloalkyl, the former interpretation is assumed. Appropriate correction is required.
Claim 1 recites that “each R9 is independently F, Br, I, C-carboxy, C-amido, cycloalkyl, OR10,cyano, amino, aminoalkyl, C1-C6 alkoxy, or C1-6 alkyl optionally substituted with one or more OR10, C1-C6 alkoxy, phenyl, or halogen. It is unclear whether “C1-C6 alkoxy, phenyl, or halogen” is the option for R9, or is the option of substituents for C1-6 alkyl. Given that a halogen (e.g., F, Br and I) is already recited as the option for R9, the latter interpretation is assumed.
Claims 2, 4, 6-9, 14-15, 21-22, 51-52, 55, 60 and 66 ultimately depend from claim 1 and therefore necessarily incorporate the indefinite subject matter therein. Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9 and 55 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9 depends from claim 8 and recites that R8 is an aryl optionally substituted with one or more R9. However, claim 1, from which claim 8 depends, requires that R8 is an aryl substituted with one or more R9. As such, claim 9 fails to include all the limitations of the claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 55 depends from claim 1 and recites that R5 is C1-6 alkyl optionally substituted with one or more R9. However, claim 1 requires that R5 is C1-6 alkyl substituted with one or more R9. As such, claim 55 fails to include all the limitations of the claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 2, 4, 7, 8, 9, 38, 51, 55, 60 and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prasit US Patent Application Publication No. 2004/0198982 A1 (hereinafter referred to as Prasit).
Regarding claims 1, 2, 4, 7, 8, 9, 38, 51 and 55, Prasit teaches a compound that is capable of treating and/or preventing cathepsin dependent conditions or diseases in a mammal, the compound being represented by the following formula (I) (0008):
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Specifically, Prasit teaches that the compound is 2-[4-(4-bromophenyl)-1-piperazinyl]-N-(cyanomethyl)-4-methylpentanamide ([0737]; page 54, right column, the 7th entry). It is found that this specific compound as disclosed by Prasit meets instant claims 1, 2, 4, 7, 8, 9, 38, 51 and 55, in particular, the compound is instant formula (I) or (Ia) when Z is NR8 in which R8 is an aryl (e.g., phenyl) that substituted with a -Br; R1 is hydrogen; R3 is a methyl that is substituted with a cyano group; R4 is hydrogen; R5 is a propyl that is substituted with a methyl; and n is 1.
Regarding claims 60 and 66, Prasit teaches combing the compound with a carrier such as a sweetener (e.g., sucrose, glucose and lactose) to form an ingestible composition (e.g., a pharmaceutical composition for oral use) ([0439-0440]).
The preamble language about “enhancing sweetness of a sweetener” recites the purpose of the claim 66, and the recited purpose does not result in a manipulative difference between the claim and prior art because Prasit teaches the step of combining a compound of instant formula (I) with a sweetener which is the same as the instant claim, which will necessarily provide the purpose in the preamble of claim 66.
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.
Claims 1-2, 4, 6-9, 14-15, 21-22, 38, 44, 51-52, 55, 60 and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Baker WO 00/08006 A2 (cited in the IDS submitted 11/21/2024, hereinafter referred to as Baker).
Regarding claims 1-2, 4, 6-9, 14-15, 21-22, 38, 44, 51-52 and 55, Baker teaches a pharmaceutical composition comprising a compound of the following formula (I):
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548
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in which X is N or C, where X is C it can be bonded to its adjacent carbon by either a single or a double bond; R1 and R2 are each independently H or C1-6 alkyl or C3-6 alkenyl or C3-10 cycloalkyl, R3 and R4 are each independently H or C1-6 alkyl or C3-10 cycloalkyl, R5 and R6 are each independently H or C1-6 alkyl, C1-6 alkoxy, carboxy, hydroxy, cyano, halo, amino, etc. (page 1, line 14- page 2, line 13).
It is found that the formula as disclosed by Baker as defined above includes a compound that is represented by instant claims 1-2, 4, 6-9, 14-15, 21-22, 38, 44, 51-52 and 55, therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have made the compound that is represented by the instant formula.
Regarding claims 60 and 66, Baker teaches that the pharmaceutical composition is for oral use (page 9, line 19) thus reading on the ingestible composition of claim 60; further, Baker teaches that a carrier is combined with the compound in the pharmaceutical composition, wherein the carrier is sucrose, lactose, dextrose, sorbitol, mannitol etc. (page 10, line 14-15; page 9, line 13-15) which reads on the limitation about a sweetener as recited in claims 60 and 66.
The preamble language about “enhancing sweetness of a sweetener” recites the purpose of the claim 66, and the recited purpose does not result in a manipulative difference between the claim and prior art because Baker teaches the step of combining a compound of instant formula (I) with a sweetener which is the same as the instant claim, which will necessarily provide the purpose in the preamble of claim 66.
Allowable Subject Matter
Claim 59 is allowed, since no art teaches the compounds therein.
Claim 43 is free from prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGQING LI whose telephone number is (571)272-2334. The examiner can normally be reached 9:00-5:00.
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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