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
Status of Claims
An action on the merits of claims 28-44 and 48-50 is contained herein.
Previous Objections/Rejections
Any rejections or objections stated of record in the office action mailed on 12/12/2025 that are not explicitly addressed herein below, are hereby withdrawn in light of applicant's arguments and/or amendments filed 9/15/2025.
Status of Rejections
35 USC § 112 (b)
The rejection of claims 28-44 and 48-50 is maintained.
Applicant’s arguments, see Remarks, filed 12/12/2025, with respect to the rejection set forth in the Non-Final Office Action mailed 9/15/2025, have been fully considered but are not found persuasive.
To reiterate the rejection, in the instant claim 28 and other dependent claims, the recitation “steroid material comprising a compound of formula (A-I)” is indefinite in regard to the specific structures that may fall within the scope of this limitation. The language “comprising” suggests that the material is open ended and other embodiments or structures of unknown structure may be included besides that of the recited formula. Thus the claim and claims dependent on it are rejected for indefiniteness. Correction is required.
Applicants suggest that the term “comprising” is permissible when directing to materials or compositions comprising compounds (referencing MPEP 2163(II)(A)(1)). The examiner does not argue with the latter but the rejection is in regard to the language “steroid material comprising a compound of formula (A-I)”. Claim 28 clearly recites the structure of the formula (A-1) which represents the steroid material. The latter is viewed as a compound of structural formula (A-1) and not a composition thereof. This specific structural formula (representative of a compound) is incorporated within the claimed articles as recited in claim 28. Thus, using language such as “comprising” for defining a chemical structure suggests that the compound is not limited in chemical structure of (A-1) but may include other embodiments of unknown structure. Thus the claim and claims dependent on it are rejected for indefiniteness. Correction is required. The examiner will assume all reasonable possibilities regarding this limitation in reference to applying prior art until the issue is addressed.
35 USC § 112 (a)
The rejection of claims 28-44 and 48-50 is maintained.
Applicant’s arguments, see Remarks, filed 12/12/2025, with respect to the rejection set forth in the Non-Final Office Action mailed 9/15/2025, have been fully considered but are not found persuasive.
To reiterate the rejection, The skilled artisan would not have adequate reason to believe that Applicant had possession of the claimed genus shown in claim 28 based on the information provided in the specification. The only working examples described in the specification that consist of a proper Markush grouping consist of the following:
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The claimed articles consist of various steroids and linkers that are not viewed as equivalents in the art. No where does the specification allude to other articles comprising the latter within a proper Markush claim. Thus, how would one skilled in the art expect that Applicant was indeed of possession of the claimed genus if only a few working embodiments were presented in the disclosure? Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p). Note also the following:
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 (see i)(A), above), reduction to drawings (see i)(B), above), 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 i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation.
The courts have applied this criteria in a more recent decision stating the following referencing genus claims drawn to chemical compounds:
“For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” see Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010).
Therefore, based on the lack of working examples, nature of the described genus, and indefiniteness of the claims (see rejections herein); Applicants are not in possession of the claimed genus.
Applicants argue that the working examples have different steroid radicals selected from 3 different steroids including dexamethasone which satisfies the written description requirement. Again the examiner states that this limited number of species is insufficient to show possession of the entire genus of articles claimed in particular with respect to formula A-I. The scope of the claims may encompass millions of different species comprising various steroids and linkers that are not viewed as equivalents in the art. For example the claims are not limited to these articles consisting of defined steroids but may embrace other chemical embodiments of unknown structure due to the claim language “e.g. comprising”. Additionally the linkers provided in the examples appear to consist of only one common linkage moiety comprising a carbonate moiety:
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There are no other working examples consisting of different linkers besides those mentioned above. Note that the claims also state that these linkers may be attached to various locations on these steroid radicals and not just in the manner as shown in the few working examples. Thus, how would one skilled in the art expect that Applicant was indeed of possession of the claimed genus if only a few working embodiments were presented in the disclosure? Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p). Note also the following:
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 (see i)(A), above), reduction to drawings (see i)(B), above), 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 i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Thus based on the limited number of working examples, indefiniteness of the claims, Applicants could not possibly be in possession of the claimed genus.
New Rejections
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 of this title, 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 28-44 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2011/120044-mentioned in IDS.
The instant claims are drawn to an article comprising the formula A-1 and a therapeutic agent where D1=D2 is a steroid radical and L is a linker. WO 2011/120044 teaches the following seen at claim 39, page 95:
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. The above formula wherein R is “therapeutic agent-neuroactive steroid” (a combination of the embodiments described above for R which may include more than one therapeutic agent)-linker-neuroactive steroid” may fall within the broadest reasonable scope of claim 28. This combination would presumably result in the language wherein the “therapeutic agent” resides within the “steroid material”. Thus the claims would have been considered obvious over the prior art document. Dependent claims reciting specific amounts of therapeutic agent, ratios of components, etc. would be considered routine optimization by one skilled in the art.
Generally, such will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally specific physical/chemical properties of the claimed articles would have been inherently possessed in the “articles” of the prior art document since they meet the structural limitations of the claimed subject matter.
Conclusion
No claims are 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 BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
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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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624