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 .1
Status of Claims
Claims 64-83 are pending.
Election/Restrictions
Claim 81 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 12, 2026.
Applicant’s election without traverse of the species sarin and compound of formula II, ((3R,5R,8R,9R,10S,13S,14S,17S)-3-hydroxy-3, 13-dimethylhexadecahydro-
1Hcyclopenta[a]phenanthren-17-yl)(phenyl)methanone in the reply filed on June 12, 2026 is acknowledged.
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Claims 64-80 and 82-83 are directed to the elected species.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 15/531,313, filed on 05/26/2017.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 10/04/2024 and 06/12/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
The specification number its paragraphs up to paragraph 86, starting on page 30 and then stops until page 58, where it restarts with paragraph 87. Clarification by Applicant is requested if Applicant intends the multiple paragraphs between pages 30-58 are all part of paragraph 86.
Claim Interpretation
In terms of claim interpretation, claims 64 and 65 limitation of “warfare agent” is broadly and reasonably interpreted as including not only chemical warfare agents such elected species sarin, as well as other nerve agents and neurotoxins, but also other non-nerve agents, such as mustard gas2, and even explosive warfare agents causing blast injuries (artillery, grenades, etc.). The common usage of the term warfare agents reasonably includes these non-neurotoxic chemical agents and explosives, as Applicant’s specification particularly carves out the category of chemical warfare agents from its definition of warfare agents (see page 56, lines 4-11). Further, the specification notes a subcategory of chemical nerve warfare agents and toxins from the category of chemical warfare agents. See page 57, lines 3-8.
The carve out of the narrower terms from the broader term of warfare agents clearly demonstrates that warfare agents, chemical warfare agents and in particular those chemical warfare agents that are nerve agents and neurotoxins are not intended to be interchangeable amongst each other.
The use of the broader term “warfare agent” broadly and reasonably demonstrates the claims are intended to include all warfare agents, beyond the chemical nerve agents genus (including sarin), which are specifically claimed by claims 78-81.
With regard to the claimed GABA modulators of examined claims 64-83, as per the specification, they are recognized to be neuroactive steroids. See paragraph 11. The specification only discloses neuronal activity of these GABA modulator neuroactive steroids, as starting at paragraph 179, titled Assay Methods, experimental TBPS binding data of the claimed neuroactive steroids is demonstrated by Sprague-Dawley rats being sampled decapitated for their cortices for the TBPS assay. See data of Table 1, paragraph 183. See also Table 2 noting GABA data.
Claim Rejections - 35 USC § 112 (Scope of Enablement)
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 64-77 and 83 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of chemical warfare agents (nerve agents or toxins per claim 78), does not reasonably provide enablement for all warfare agents as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Claims 64-65 are directed to methods for treating a subject having an injury resulting from exposure to a warfare agent, comprising administering to the subject an effective amount of a compound of Formula (II) or Formula (I).
Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set eight forth factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The predictability or unpredictability of the art
The instant claimed invention is highly unpredictable since a person having ordinary skill in the art (PHOSITA) recognizes the unpredictability of treating the broad scope of injuries resulting from warfare agents beyond the scope of chemical warfare nerve agents and neurotoxins.
Warfare agents causing physical injuries such as explosives and chemical mustard gas, are known in the art to be treated physically. For example, treatment of exposure to mustard gas requires removing any clothing or items on the person, as well as cleaning and blotting of mustard gas form the subject’s body. See page 3 of 5 of CDC Mustard Gas webpage.
As detailed above in the claim interpretation section of the office action, the claimed compounds have a GABA modulation effect on a subject’s nerve system. There is no indication in the art that physical trauma to the limbs or torso of a subject would be treated by GABA modulation affecting a subject’s nerve system.
In fact, there is some indication that GABA receptor modulation can have both healing and detrimental effects in physical brain injury such as traumatic brain injury or stroke. See page 15, Summary section of Wu and Sun.3
Accordingly, the unpredictability in the art is Wands factor against enablement of the claims.
The breadth of the claims
The claims broadly includes all warfare agents, such as explosives and the chemical agent mustard gas. See Claim Interpretation section above. The broad scope is a Wands factors weighing against enablement of the claims.
The amount of direction or guidance presented, and the presence or absence of working examples
It has been established that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839 166 USPQ 18, 24 (CCPA 1970).
The claimed GABA modulators, as per the specification, are disclosed to be neuroactive steroids. See paragraph 11. The specification only demonstrates neuronal-type activity of its compounds, starting at paragraph 179 titled Assay Methods, where experimental TBPS binding data of the claimed steroids is demonstrated. In the example Assay Methods of paragraph 179, Sprague-Dawley rats were sampled by decapitation for their cortices for the TBPS assay. See data of Table 1, paragraph 183.
Also noted is Table 2 of the specification for its summary of GABA modulation data for claimed compounds. There is no working example, either in vivo or in vitro to enable the treatment of the full scope of warfare agents, such as treatment of physical injuries.
Therefore, in view of the Wands factors, Applicant fails to provide information sufficient to practice the full scope of the claimed invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 78 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 78 depends from claim 64 and recites the term “the chemical warfare agent.” Claim 64 recites “warfare agent” and NOT “chemical warfare agent.” Claim 78 fails to further properly further limit claim 64 because it introduces the term “the chemical” warfare agent, where claim 64 does not establish proper antecedent basis for claim 78.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 79-80 and 82 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.
Conclusion and Correspondence
In summary no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 CONTINUING DATA
This application is a CON of 17/959,592 10/04/2022 PAT 11945836
17/959,592 is a CON of 16/800,053 02/25/2020 ABN
16/800,053 is a CON of 15/531,313 05/26/2017 PAT 10774108
15/531,313 is a 371 of PCT/CN2015/095765 11/27/2015
FOREIGN APPLICATIONS
PCTCN2014092369 11/27/2014
2 See CDC webpage facts sheet for Mustard Gas, accessed Aug 8, 2026.
https://www.cdc.gov/chemical-emergencies/chemical-fact-sheets/mustard-gas.html
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3 Wu and Sun Excitatory Actions of GABA after Neuronal Trauma J Neurosci. 1996 Jul 1;16(13):4283–4292. doi: 10.1523/JNEUROSCI.16-13-04283.1996
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