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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 06/15/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claims 14-15, 17-18, 21, 26, 29, 31, 37, 41-42, 49, 55-59, 65, 70-88, 91-103 are pending and under examination.
Claims Objection
Claims 70-72 and 96-98 are objected for depending on rejected claim 1.
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 14-15, 17-18, 21, 26, 29, 31, 37, 41-42, 49, 55-59, 65, 73-88, 91-95, 99-103 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention.
While all of the factors have been considered, only those required for a prima facie case are set forth below.
The specification discloses a small subgenus of 38 compound from a compound of formula (2), liposome and pharmaceutical composition as well as a method of treating cancer.
The claims are drawn to a compound of formula (2), liposome and pharmaceutical composition as well as a method of treating cancer.
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 genus, i.e., a compound of formula (2), liposome and pharmaceutical composition as well as a method of treating cancer. There is only a small subgenus of 38 compound from a compound of formula (2), liposome and pharmaceutical composition as well as a method of treating cancer explicitly disclosed.
The disclosure of a small disclosed subgenus may provide an adequate written description of a genus when the species disclosed is representative of the genus. The present claim encompasses any compound of formula (2). There is substantial variability among the species of compounds encompassed within the scope of the claims because the list of 38 disclosed compounds is only very small subgenus amongst an entire class of molecules that can have widely differing structures and corresponding biological activities.
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). Consequently, the Examiner notes that the claimed invention which is drawn to a genus of drugs may be adequately described if there is a (1) sufficient description of a representative number of species, or (2) by disclosure of relevant, identifying characteristics sufficient to describe the claimed invention in such full, clear, concise and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. Here, the specification discloses only a small subgenus of 38 compounds with similar structure. For example, each of the subgenus of 38 compounds has R1=Cl or cyano; A =furan, pyrrolidine or piperidine ring with heteroatom directly linked to Y1b; Z1a or Y1a=C only, Z1b or Y1b=C or N; while compound of formula (2), R1 includes numerous other substituents including any 3-10 member ring; A is any other 3-10 member ring; Z1a or Y1a=C or N. Therefore, the small subgenus of 38 compounds only represents very small fraction of numerous claimed compounds of formula (2) and does not sufficiently describe a representative number of species of claimed invention. Since the claimed genus encompasses compounds yet to be discovered, the disclosed structural feature does not constitute a substantial portion of the claimed genus. Therefore, the disclosure of a subgenus of 38 compounds does not provide an adequate description of the claimed genus.
Weighing all the factors, the breadth of the claims reading on drugs yet to be discovered, the lack of correlation between structure and function of the drugs, level of knowledge and skill in the art, one of ordinary skill in the art would not recognize from the disclosure that the applicant was in possession of a compound of formula (2), liposome and pharmaceutical composition as well as a method of treating cancer. At best, it simply indicates that one should run tests on a wide spectrum of compounds in the hope that at least one of them will work. Neither the exemplary embodiments nor the specification’s general method appears to describe structural features, in structural terms, that are common to the genus. That is, the specification provides neither a representative number of drugs to describe the claimed genus, nor does it provide a description of structural features that are common to the drugs. In essence, the specification simply directs those skilled in the art to go figure out for themselves the structure of the claimed drug.
The written description requirement is not satisfied.
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 95 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 95 recite “type”. The addition of the word "type" to an otherwise definite expression (e.g., Friedel-Crafts catalyst) extends the scope of the expression so as to render it indefinite. Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955). MPEP 2173.05 III.E.
Claims 14-15, 17-18, 21, 26, 29, 31, 37, 41-42, 49, 55-59, 65, 73-88, 91-95, 99-103 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of a compound of formula (2) is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: although each compound of formula (2) has core structure -pyrazole-NH-pyrazine-, which is not substantial structural feature of compound of formula (2). Furthermore, there is no structure active relationship established that all compound having core structure -pyrazole-NH-pyrazine- would have common activity such as anticancer.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Response to Argument:
Applicants argue that formula (2) are sufficient to overcome 112(a) and improper Markush rejection. All related arguments are incorporated herein by reference.
In response to this argument: this is not persuasive. As discussed in the above 112(a0 and improper Markush rejection, compound of formula (2) are much broader than only 38 working examples, which fails to represent the whole broad scope of compound of formula (2). Regarding arguments that all 38 working examples having 8 bicycle structure, it is argued that those 8 bicycle structures are not cited in claim 14. If applicants amend the claim by reciting those 8 bicycle structures in claim, the examiner would reconsider the position of both rejections. Therefore, the 112(a) and improper Markush rejections are still proper.
Conclusion
THIS ACTION IS MADE FINAL. 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 JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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