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 .
This is a Final Office Action.
Election/Restrictions
Applicant's election without traverse of Group I in the reply filed on August 5, 2025 is acknowledged. Group I, drawn to compounds of formulas I-A, II-A, III-A and IV-A, and compositions thereof, embraced by claims 1-9 and 15 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the different inventions. Thus, the requirement is deemed proper and is therefore made FINAL.
Applicant elected the following species:
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111
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and indicated claims 1-9 and 15 read on said species. The elected species was searched but no art was found. Therefore, the search was extended to the elected Markush group.
Claims 1, 4-10, 12, 13 and 15-24 are pending and claims 1, 4-9 and 15-20 are under examination. Claims 21-24 are new claims. Claims 10, 12, 13 and 21-24 are currently withdrawn from consideration.
Newly submitted claims 21-24 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims 21-24 are drawn to method claims which were restricted from the compound claims.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-24 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
The objection to claim 9 because a period is required at the end of the claim, is withdrawn based on the amendments.
Claim 19 is objected to because of the following informalities: said claim is the same in scope as claims 18. Appropriate correction is required.
Claims 4-9 and 15-20 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.
Claim Rejections
Claim 1 is rejected as each directed to an improper Markush group. These Markush claims are rejected under the judicially approved ‘‘improper Markush grouping’’ doctrine when the claim contains an improper grouping of alternatively useable species. In re Harnisch, 206 USPQ 300 (CCPA 1980). A Markush claim contains an ‘‘improper Markush grouping’’ if: (1) the species of the Markush group do not share a ‘‘single structural similarity,’’ or (2) the species do not share a common use. The species of the present claims do not share a ‘‘single structural similarity. Therefore, a rejection on the basis that the claims contain an ‘‘improper Markush grouping’’ is appropriate. The rejection of the claims will be maintained on the basis that the claims contain an ‘‘improper Markush grouping’’ until the claims are amended to include only species that share a single structural similarity and a common use, or the applicant presents a sufficient showing that the species in fact share a single structural similarity and a common use.
Under principles of compact prosecution, the applicant elected a single disclosed species for search and examination (i.e., an election of species). The prior art search did not find the elected species in the prior art, and the search has been extended to those additional species that fall within the scope of a permissible Markush claim. In other words, the search has been extended to the species that share a single structural similarity and a common use. Proper Markush claims will be examined for patentability over the prior art with respect to the elected species or group of indistinct species, as well as the species that share a single structural similarity and a common use with the elected species or group of indistinct species (i.e., the species that would fall within the scope of a proper Markush claim). Federal Register, Vol. 76, No. 27, 02-09-2011, page 7166.
Claim 1, directed to the nonelected species, are withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species. To overcome the rejection, the claims may be amended to the elected Markush group, the compounds of formula IV-A1, wherein ring A of the steroid core is aromatic and a double bond in ring C and not ring D.
Claim Rejections - 35 USC § 112
The rejection of claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the terms “C1-C14-alkyl or C1-C14-haloalkyl” is withdrawn based on the amendments.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 1 is 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.
This is a written description rejection.
The analysis for adequate written description considers the following:
(a) Actual reduction to practice;
(b) Disclosure of drawings or structural chemical formulas;
(c) Sufficient relevant identifying characteristics, such as (i) complete/partial structure, (ii) physical and/or chemical properties, and (iii) functional characteristics when coupled with known or disclosed correlation with structure; and
(d) Representative number of samples.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571,39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written bases for the scope of the compounds of formulas I-A, II-A, III-A and IV-A, which demonstrates possession as glucocorticoid receptor modulators. The mere fact that Applicant may have discovered several specific compounds of formulas I-A, II-A, III-A and IV-A, is not sufficient to claim the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
The rejection is made under 35 USC 112 (a), as written description is lacking.
To overcome the rejection, the claims may be amended to the elected Markush group, the compounds of formula IV-A1, wherein ring A of the steroid core is aromatic and a double bond in ring C and not ring D.
Conclusion
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 SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 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, Jeffrey Murray can be reached on 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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/SUSANNA MOORE/Primary Examiner, Art Unit 1624