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
Response to Amendments
The amendments made to the claims 06/24/2026 have been entered.
In view of the amendments made, the 101 rejection, the 112(d) rejection, and the 102 and 103 rejections over Chengfeng (cited in prior office action) have been withdrawn.
In view of the amendments made, the claim objections over claims 1 and 2 have been withdrawn.
Withdrawn Objection
Claims 1 was objected to because of the following structure.
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The crossed-double bond is used to show that the C-N bond can rotate. The objection is hereby withdrawn.
Claim Rejection
Claim Rejections - 35 USC § 112(b) - Indefiniteness
Claim 1 is 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 states “Ar represents a substituted or unsubstituted aromatic ring, specifically a benzene ring or a pyridine ring…”. The broader genus “substituted or unsubstituted aromatic ring” follow by the narrower species listing “specifically a benzene ring or a pyridine ring” is indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 1 states “the aromatic ring is optionally substituted with substituent could be a C1-C8 alkyl group…”.
The use of “could be” is not definite as it implies that a substituent is either being claimed or is not being claimed. Claims may use the term “optionally” to definitively state that a compound and its substituted version are both being claimed.
Applicant appears to have made a bona fide attempt to amend the claim and simply forgot to cross out the claim language being removed. The rejection is maintained until it is clear that the claim language is being removed.
Similarly, claim 1 was rejected for the use of “the substituent” in l. 5 of claim 1 which lacks antecedent basis. Examiner acknowledges the attempt to amend the claim to overcome this rejection. However, the antecedent basis rejection is maintained.
Claim Interpretation
The claims contain the following limitation “eukaryotic tumor cell proliferation inhibitor”. The term “eukaryotic tumor cell” is not defined in the instant specification. Within the art, “eukaryotic tumor cells” embrace “mammalian tumor cells.” Therefore, the broadest reasonable interpretation of “eukaryotic tumor cell proliferation inhibitors” includes inhibiting mammalian tumor cell proliferation.
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.
Claim(s) 1, 3-5, 7 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Mingshan (CN106279343, published 2017, citations made to machine translation of description claims).
Mingshan in the sec. Detailed Description of the Embodiments discloses compounds of structures shown below.
Mingshan Compounds
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The compounds embrace the formula of claim 1.
Mingshan in section Summary of Invention states “Attempts herein to provide Abiraterone metabolite D4A prodrug, which is rapidly metabolized in vivo to D4A prodrug as a use for the treatment of androgen-dependent diseases, disorders and conditions, including, but not limited to, prostate cancer…”.
Mingshan in reference claim 13 states “The use of a compound according to claims 1-7 or a pharmaceutical composition of 8-10 in the treatment of androgen-dependent conditions, such as prostate cancer….acne….”.
Mingshan in reference claim 10 claims a composition comprising the compounds above and “one or more pharmaceutically acceptable [solvent].”
Response to Arguments
Applicant only addressed the rejections over Chengfeng. Applicant’s arguments did not address the Mingshan reference.
New Objections
Claim 1’s limitations inconsistently use “in”, “wherein”, and “wherein” (l. 3, 8, and 16 respectively). Additionally, claim 1’s language simply states the limitation of “Ar represents…”. Examiner suggests using one of either “where” or “wherein” and amending the claim to include either “where” or “wherein” at the beginning of any limitation that specifies a substituent.
Duplicate claims
Applicant is advised that should claim 6 be found allowable, claim 8 will be objected to, and vice versa, under 37 CFR 1.75 as being a substantial duplicate thereof. 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).
New Rejections
Claim Rejections - 35 USC § 112(a)
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 6 and 8 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.
Claims 6 and 8 were amended to include “and a pharmaceutically acceptable carrier.” However, within the specification, there is no discussion of the compounds in any pharmaceutically acceptable carrier. The only carriers discussed within the claims are found on p. 29 where the specification states “Appropriate amount of the test compound was weighed and added into a glass bottle, appropriate volume of solvent DMSO was added, be treated with vortex ultrasonication, then appropriate volumes of PEG400 and PG were added in turn, be vortex mixed to obtain a dosing formulation with a final concentration of 0.05 M.” Therefore, applicant does not have possession of the full scope of “pharmaceutically acceptable carrier” and the limitation is considered new matter.
Although the limitation is new matter, these claims are addressed in the 103 rejection below.
Claim Rejections - 35 USC § 112(b)
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 1-8 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 now states “where R is [moiety omitted], neither R1 nor R2 is an unsubstituted alkyl group….”. Applicant has amended out the conditional phrase “when”. The claim now has two conflicting definitions of R1 and R2. As claims 3-8 are dependent on claim 1, they are also rejected.
Claim 2 contains two copies of the same compound. See below.
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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 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 and 3-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mingshan (cited above) in view of Gibson (Drugs and the Pharmaceutical Sciences, Vol. 19, 2009).
Discussion of Mingshan from the 102 rejection above is incorporated here.
Mingshan does not explicitly teach the compounds above in either corn oil, PEG400, or PG. However, the claim simply states “pharmaceutically acceptable carrier” and the combination of a pharmaceutically acceptable carrier with a compound with pharmaceutical properties would be obvious to one of ordinary skill in the art in view of Gibson.
Gibson is drawn to pharmaceutical formulations and pre-formulations (title). Gibson on p. 295, sec. Excipient Selection teaches broadly to the selection of a pharmaceutically acceptable excipient. This teaching indicates that it would be obvious and well within the skillset of one of ordinary skill to implement the compounds of Mingshan into a pharmaceutically acceptable excipient and/or carrier to arrive at the instant claims.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have combined the compounds of Mingshan with a pharmaceutically acceptable carrier and/or excipient to arrive at the instant claims. One of ordinary skill would find motivation to make the combination to optimize drug delivery of the compound.
This new rejection has been necessitated by amendments made to the claims.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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