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 .
DETAILED ACTION
Claims 1-2 and 4-27 are currently pending in the instant application.
Election/Restrictions
Applicant’s election of Group I, drawn to claims 1-2, 4-21, 23-25 and 27 with election of species
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in the reply filed on 09/20/2024 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)).
Claims 22 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/20/2024.
In accordance with the MPEP, 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 and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). 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 reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Applicant's elected species appears allowable over the prior art of record. Therefore, the search of the Markush-type claim has been extended to the non-elected species of
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.
As prior art has been found which anticipates the above identified nonelected species, the Markush-type claims are rejected as follows and the subject matter of the claims drawn to nonelected species held withdrawn from consideration. Claims 1-2, 4-9, 16-21, 23-25 and 27 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since art was found on the nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
The remaining subject matter of claims 10-15 that are not drawn to the above elected invention stand withdrawn under 37 CFR 1.142(b) as being non-elected subject matter. The remaining compounds which are not within the elected invention are independent and distinct from the elected invention as they differ in structure and composition. Therefore the compounds, which are withdrawn, have been restricted as the withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference, which anticipates one group, would not render obvious the other. Thus all claims containing compounds falling outside the search strategy of the elected compound and structure shown above are heretofore directed to non-elected subject matter and are withdrawn from consideration under 35 U.S.C. § 121 and 37 C.FR. § 1.142(b). A complete reply to the non-final rejection must include cancellation of non-elected claims include cancellation of non-elected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b). If one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statements filed on 09/20/2021, 11/11/2021, 10/11/2022, 01/17/2023, 04/26/2023 and 07/03/2024 have been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Claim 3 is entirely missing. Thus, misnumbered claim 4 should be renumbered as claim 3, while misnumbered claim 5 should be renumbered as claim 4, etc.
Claim 1 is objected to because of the following informalities: Under the definition for R, there are groups that are repeated twice. For example, R is recited as
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twice in claim 1. Appropriate correction is required.
Further X is defined as
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twice in claim 1 – once under R5 and also in the 5th line of the claim. Appropriate correction is required.
Under the definition of R1, there are also duplicate definitions found. For example, R1 is recited to be
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(see end of p. 6) and again at the top of p. 11. The entries for R1 on p. 11-15 appear to be repeats of entries for R1 found on p. 7-10 of the claims. Appropriate correction is required.
Claim 23 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 20. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 20 is the structural depiction of the named compounds of claim 23 so both claims cover the same subject matter. Claims 20 and 23 could be combined into one claim so that both the structure and name of each compound could be found in a single claim.
Similarly, claim 27 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 24 as claim 24 is the structural depiction of the named compounds of claim 27 so both claims cover the same subject matter.
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, 4-9, 16-19, 21 and 25 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 several instances of n with different definitions. For example, under the definition of
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, n is recited to be 0, 1, 2, or 3. Under the definition of R, n is recited to be 1 to 11. Under the definition of Q, n is recited to be n is 1, 2, 3 (see beg. of p. 16). The multiple definitions for variable n are confusing and make the scope of the claim 1 unclear. Claims 3-9 do not correct the problem so they have been rejected as well.
Further claim 16 also recites multiple instances of n having different definitions. Claim 16 states that n is 0, 1, 2 or 3 after the definition of Z. Then after the definition of R, n is 1 to 11. Further in the same claim, n is recited to be 1, 2 or 3 under the definition of Q. Thus, it is confusing what n can actually be and the metes and bounds of the definition for n make the claim unclear. Claims 17-19 do not fix the issue and have been rejected as well.
Further claims 1, 6 and 16-17 recite “A compound” or “the compound” comprising or comprises Formula(). However, MPEP 2111.03, Section I states that “the transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004)”. Thus, the preamble of the claim is drawn to a compound that can comprise an additional component in addition to Formula (I) or Formula (II) in claim 1. However, it is unclear what the additional component besides the compound of formula (I) can be as claim 1 is drawn to a compound, which is a singular compound. Similarly, for claim 6, it states the compound of claim 1, wherein the compound comprises Formula (I). Claim 16 states a compound comprising formulae (VII)-(XVIII) while claim 17 states wherein the compound comprises Formulae (VII), (XI), or (XIII). Thus, it appears the claims appear to be claiming additional components to the compound of Formula () but it is unclear what the additional component could be since the claim itself is drawn to a compound. It is suggested the preamble of the claim be changed to read “A compound or a pharmaceutically acceptable salt hereof of Formula (I) or (II)” for claim 1 while claim 6 could read “The compound of claim 1 wherein the compound is of Formula (I)” and similar changes be made to claims 16-17 in order to overcome this rejection.
Claim 21 is drawn to a pharmaceutical composition comprising one of more of compounds D1-D48. However, it is unclear what compounds D1-D48 are as claim 21 is an independent claim and thus one could not know compounds D1-D48 are by reading the claim itself. Claims must, under modern claim practice, stand alone to define an invention, and incorporation into claims by express reference to the specification is not permitted. See Ex parte Fressola, 27 USPQ 2d 1608 (1993).
Claim 25 is drawn to a pharmaceutical composition comprising one of more of compounds D49-D197, D199-202. However, it is unclear what compounds D49-D197, D199-202 are as claim 25 is an independent claim and thus one could not know compounds D49-D197, D199-202 are by reading the claim itself. Claims must, under modern claim practice, stand alone to define an invention, and incorporation into claims by express reference to the specification is not permitted. See Ex parte Fressola, 27 USPQ 2d 1608 (1993).
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)(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.
Claim(s) 1-2, 4-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by XU (see US Pat No. 9850244, issued 12/26/2017). XU teaches compound
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(see col. 7-8). This
corresponds to a compound of formula (I)
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wherein A is Me,
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is
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, X and Y are N, R is
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, R1 is
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X is N and R3 is H.
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.
Claim(s) 1, 6 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over XU (see US Pat No. 9850244, issued 12/26/2017). XU teaches compound
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(see col. 7-8) as described in the above 102(a)(1) rejection. The compound of XU corresponds to those of the instant claims except that XU has A is Me rather than H (aka none) as found in claims 6, 8-9. However the compound of XU is analogous art because compounds of the same structural formula that differ only by the replacement of a methyl for a hydrogen atom would be obvious. As stated in re Wood, 199 USPQ 137, hydrogen and methyl are deemed obvious variants, and substitution of a hydrogen for the methyl (i.e. substitution of H for CH3) in the compound of XU would give rise to the compounds of the instant claims.
One would be motivated to synthesize a compound wherein A is H rather than Me to find further compounds that function as cyclin-dependent kinase inhibitors. The motivation to make the claimed compound derives from the expectation that structurally similar compounds are generally expected to have similar properties and similar utilities. Further, there is close structural similarity of the instantly claimed compounds to the prior art compounds and the common utility shared among the compounds. There is an expectation among those of ordinary skill in the art that similar structural compounds will have similar properties and that modification of a known structure is mere experimentation within the means of a skilled artisan. See MPEP 2144.09(I).
Allowable Subject Matter
Claim 7 would be allowable over the prior art of record if rewritten to overcome all the 112 issues and objections.
Further claims 16-20, 23-24 and 27 would be allowable over the prior art of record if rewritten to overcome all the 112 issues and objections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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, Joseph McKane can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626