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 .
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after NOA. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/02/2026 has been entered.
Status of the Application
Claims 85-98, 150-175 and 186-197 are pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 85-98, 150-175 and 186-197 and the elected species are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 7473687 B2), Clive (WO96/40727; as provided by applicant on IDS dated 03/05/2026), Carl (Journal of the American Chemical Society, 1953, Vol 75 (18), 4440-4442) and Richmond (Endocrine, 2014 (published online 09/2013), 45:3-8) in combination.
Determining the scope and contents of the prior art
Hoffman teaches a method of treating TBI and concussion in human child (under 18 years of age), adult (over 18 years of age) and in age groups of 55-95 or older comprising administering progesterone:
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or synthetic progestin (encompass elected species of the instant claims) with a dose of about 0.1-0.5 mg/Kg; 0.05-5mg/Kg etc. (meets limitation of all doses of the instant claims) (column 3-5, 11-14) in a pharmaceutical composition as solid, liquid, suspension comprising small molecule such as cyclodextrin or neuroprotective agent through any route of administration such as intranasal, IP, IV, IM etc. (column 3-5, 11-14 and claims). The cited prior art and further give clinical trial examples with humans suffering from moderate to severe TBI (columns 17-34).
Ascertaining the differences between the prior art and the claims at issue
Hoffman teaches a method of treating TBI and concussion in human comprising administering progesterone or synthetic progestin (encompass elected species of the instant claims) with same dose and route as in the instant claims. However, the cited prior art fails to teach profession of the human to be treated; example with mild TBI and example using the elected species.
Resolving the level of ordinary skill in the pertinent art
With regard to the difference of providing example of the elected species- Hoffmann teaching is broader in scope and includes progesterone or synthetic progestin which encompass elected species of the instant claims. Although Hoffman doesn’t provide specific examples of the elected species in the process of treatment, the invention teaches method with progesterone which is different from the elected species with respect to Me Vs H and stereochemistry.
Since examples of species or subgenus taught by the cited prior art are structurally similar to that claimed, it would have been obvious to a person of ordinary skill in the art to choose the claimed species or subgenus from the genus, based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.”
In addition, substitution of a methyl for a hydrogen is considered to be prima facie obvious. In re Woods 199 USPQ 137; further, see also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious). Since chemical structures that are closely similar are expected to have similar properties and utilities, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that a synthetic progestin such as the elected species closely similar to progesterone may be useful in the method of treating TBI or concussion.
This deficiency is further cured by Carl.
Carl teaches a synthetic progestin:
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(same chemical formula as the elected species) (page 4441, col 1 and 2). Carl further teaches that the compound is found to be more biologically active than the parent progesterone (page 4441, col 1 and 2). Thus, based on the guidance provided by Hoffman and Carl, it would have been prima facie obvious to a person of ordinary skill in the art that stereoisomers of 19-norprogesterone may be useful in treating TBI or concussion. This is because Hoffmann suggests using synthetic progestin in the method and Carl teaches that 19-norprogesterone possess similar biological activity as progesterone. Further, a person of ordinary skill in the art would have been motivated to try 19-norprogesterone in the method as Carl teaches that 19-norprogesterone is more biologically active than its natural progesterone form. Further, Hoffmann teaches that progesterone or genus (encompassing ent-19-norprogesterone) may be administered through route of administration such as intranasal, IP, IV, IM etc., therefore a person of ordinary skill in the art would have tried other routes of administration besides IV, such as intranasal.
This deficiency is further cured by Clive.
Clive teaches using 19-norprogesterone and its stereoisomer ent-19-norprogesterone (same compound as in the instant claims) by administering nasally in treating/improving hypothalamic function caused by any reason (entire application). As evidenced by Richmond, hypothalamic functions are known to be affected by TBI (entire article). Thus, based on the guidance provided by Hoffman, Carl, Clive and Richmond, it would have been prima facie obvious to a person of ordinary skill in the art that stereoisomers of 19-norprogesterone may be useful in treating TBI or concussion. This is because Hoffmann suggests using synthetic progestin in the method, Carl teaches that 19-norprogesterone possess similar biological activity as progesterone, Clive teaches using 19-norprogesterone and its stereoisomer ent-19-norprogesterone by administering nasally in treating/improving hypothalamic function caused by any reason and as evidenced by Richmond, hypothalamic functions are known to be affected by TBI. Further, a person of ordinary skill in the art would have been motivated to try 19-norprogesterone in the method as Carl teaches that 19-norprogesterone is more biologically active than its natural progesterone form and Clive teaches using 19-norprogesterone and its stereoisomer ent-19-norprogesterone in treating/improving hypothalamic function (which is affected in TBI as evidenced by Richmond).
With regard to the difference of profession of the human being treated-Hoffman teaches treating TBI and concussion in all humans of different age groups. Thus, with the guidance provided by Hoffmann it would have been prima facie obvious to a person of ordinary skill in the art that any human from any profession may be treated by the method taught by Hoffmann absent any evidence to the contrary.
With regard to the difference of example with mild TBI-Although Hoffman provides examples of treating moderate and severe TBI, Hoffman teaches treating any TBI of any severity and concussion in all humans. Thus, with the guidance provided by Hoffmann it would have been prima facie obvious to a person of ordinary skill in the art that any human with any severity of TBI may be treated by the method taught by Hoffmann. Since Hofmann provides specific examples of treating moderate and severe TBI, it would have been prima facie obvious to a person of ordinary skill in the art that mild TBI having less severe symptoms may also be benefited by the same treatment absent any evidence to the contrary.
Based on the above established facts, it appears that the combination of teachings of above cited prior art read applicants’ process.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Hoffman teaches a method of treating TBI and concussion in human comprising administering progesterone or synthetic progestin (encompass elected species of the instant claims) with same dose and route as in the instant claims, whereas Carl teaches a synthetic progestin:
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(same chemical formula as the elected species) and provides that 19-norprogesterone is more biologically active than the parent progesterone. Clive teaches using 19-norprogesterone and its stereoisomer ent-19-norprogesterone in treating/improving hypothalamic function (which is affected in TBI as evidenced by Richmond).
So, the combination of prior art read applicants claims.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. It is well within the skill of the organic chemist to recognize the fact that applicants claimed process is nothing but the combination of known individual chemical processes. Further, there is a reasonable expectation of success that synthetic progestin such as 19-norprogesterone may be useful in treating TBI and concussion by combination of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed process with a reasonable expectation of success.
Response to Arguments
Applicant’s remarks and amendment, filed on 04/01/2026 and 04/02/2026, have been fully considered but not found persuasive.
Applicant argument is moot in view of new rejection as set forth above.
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Conclusion
No Claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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