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
This Office Action is in response to Applicant’s Arguments and Amendment filed, 11/25/2025, wherein the Amendment amended claims 9-10, cancelled claims 11 and 14, and added claims 17-18.
Claims 9-10, 12-13, and 15-18 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of
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, 2-methyl-2-thiazoline, as the species of the compound, in the reply filed on 06/24/2025, is acknowledged.
Claims 13 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
Claims 9-10, 12, 15, and 17-18 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Specification Objections
Applicant’s amendment to the specification is sufficient to overcome this objection.
35 U.S.C. § 112(d)
Applicant’s amendment to claim 10 is sufficient to overcome this rejection.
35 U.S.C. § 112(a)
Applicant’s amendment to independent claims 9 and 10 that limits ring A to “thiazoline, thiazole. . .or tetrahydrofuran,” and limits the definitions of R1-R5, such that the definitions of compounds of formula (I) and (II) are within the scope of the instant examples, are sufficient to overcome this rejection. Moreover, Applicant persuasively argues on pgs. 8-9, Remarks, that a person of ordinary skill in the art would understand that increasing specific immune cells would result in enhancing immunity, to overcome this rejection.
Double Patenting
Applicant’s amendment to independent claims 9 and 10 that modifies the patient population is sufficient to overcome the rejections over US Patent No. 11,590,141, US Patent No. 12,076,325, and Application No. 18/785,986 since ‘141,‘325, and ‘986 teach its methods as suppressing the immune response (Col. 5, lines 7-16; Col. 5, lines 22-30; and [0012], respectively).
NEW & MODIFIED REJECTIONS
The amendment to the claims amends the scope of instant compounds (I) and (II), and modifies the patient population to “a mammal in need thereof.” In view of these amendments, the prior art rejections have been modified or are new. Wagle continues to be relied upon as the primary reference.
Claim Objections
(New) Claims 9 and 10 are objected to because of the following informalities: in lines 3, the phrase “kind of” should be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(Modified) Claims 9-10, 12, 15, and 17-18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2002/0183317 to Wagle (published 2002, PTO-892 of 08/27/2025).
Wagle teaches a method of treating or ameliorating an indication of the invention in an animal, including a human, comprising administering an effective amount of a compound of formula I or IA:
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(pg. 16, claim 1).
Wagle exemplifies 2-methyl-2-thiazoline, the instant elected species, as a compound of formula (I) ([0149], [0182]). Wagle teaches 2-methyl-2-thiazoline as decreasing intraocular pressure ([0181]).
Wagle further exemplifies:
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, 2, 4, 5-trimethylthiazole ([0140]; pg. 17, claim 6) as a compound of formula (I), which meets the limitations of instant formula (I) when:
A is a thiazole,
R1-R3 are a C1 alkyl group, and
n is 0.
Wagle also teaches thiazole and 2-isobutylthiazole, which are also compounds of instant formula (I) ([0128]; [0148]; pg. 17, claim 6).
Applicant is reminded that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02.
Regarding claims 9-10, while Wagle does not explicitly teach “enhancing immunity in an animal in need thereof” or “enhancing immunity and suppressing inflammation in an animal in need thereof,” it teaches the same step of administering an effective amount of a compound of formula (I), i.e., 2-methyl-2-thiazoline, thiazole and 2-isobutylthiazole, to an animal; the instant specification teaches an effective amount as 1pg/kg to 5,000mg/kg ([0058]), and Wagle teaches an effective amount as 0.1mg/kg-4mg/kg and about 0.7mg/kg to about 280mg/kg ([0052], [0198]). The instant specification does not define a mammal in need of enhanced immunity. Since all mammals benefit from enhanced immunity, i.e., protection from viruses, protection from bacteria, and protection from the growth of cancerous cells, for example, the patient population of Wagle meets the limitation of “a patient in need of enhanced immunity,” as instantly claimed. See also MPEP 2112.02.
Further regarding claim 10, Wagle teaches its compounds as inhibiting the formation of inflammatory mediators to treat diseases/disorders ([0003]). As such, the patient population of Wagle is in need of the suppression of inflammation, and thus in need of enhanced immunity.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
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 (i.e., changing from AIA to pre-AIA ) 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, 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 factual inquiries 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.
(New) Claims 9-10, 12, 15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0183317 to Wagle (published 2002, PTO-892 of 08/27/2025) in view of Meneghin (Infectious disease, the innate immune response, and fibrosis, The Jn of Clinical Investigation, published 2007, PTO-892).
Wagle is applied as discussed above and incorporated herein.
Regarding claims 9-10, Wagle differs from that of the instant claims in that it does not explicitly teach a mammal in need of enhanced immunity or a mammal in need of enhanced immunity and suppression of inflammation.
Wagle teaches its compounds for the treatment of, prevention of, reduction of, or amelioration of fibrotic diseases ([0037]-[0045]).
Meneghin teaches that the unrelenting and destructive progression of most fibrotic responses in the pulmonary, cardiovascular, integumentary, and alimentary systems remains a major medical challenge for which therapies are desperately needed (abstract).
Meneghin teaches that persistent infectious stimuli initiate and sustain the fibrotic process. Pathogens such as bacteria, viruses, fungi, and multicellular parasites represent major tissue injurious signals. The resulting fibrotic response facilitates the persistence of pathogens and their byproducts, thereby allowing the vicious cycle of chronic inflammation leading to fibrosis (pg. 531, Fig. 1). In chronic pulmonary fibrosis, the fibrotic response to pathogens is exacerbated by secondary and repeated pathogen insults, wherein viral byproducts are particularly important in perpetuating fibrosis (pg. 534, Fig. 2).
Meneghin additionally teaches fibrosis as characterized by an inflammatory response (abstract; pg. 530, Col. 2 “Important cellular culprits of fibrosis”; pg. 532, “From pathogens to the chronic inflammatory response and pathological tissue fibrosis”; pg. 535 “Summary and clinical therapeutic considerations”).
In summary, Meneghin teaches that the persistence of pathogens and chronic inflammation, leads to debilitating tissue fibrosis (pgs. 535-536, “Summary and clinical therapeutic considerations”).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the animal of Wagle, which includes humans (abstract), as those in need of enhanced immunity or enhanced immunity and suppression of inflammation, to arrive at instant claims 9-10. One of ordinary skill in the art would have been motivated to make such selections, with a reasonable expectation of success, because:
-Wagle teaches its methods for the treatment of, prevention of, reduction of, or amelioration of fibrotic diseases, and
- Meneghin teaches that the persistence of pathogens leads to debilitating tissue fibrosis and inflammation, and teaches fibrosis as characterized by an inflammatory response.
As such, an ordinary skilled artisan would predictably expect that the patient population of Wagle would be in need of enhanced immunity or enhanced immunity and suppression of inflammation, to a) decrease infection by or mediate the infection of pathogens, that would lead to debilitating tissue fibrosis and inflammation, and b) decrease inflammation, which characterizes fibrosis.
Response to Arguments
On pg. 10, Remarks, Applicant argues that Wagle does not teach “a mammal in need of enhancing immunity or suppressing inflammation.”
This argument has been fully considered, but is not found persuasive.
While Wagle does not explicitly teach “enhancing immunity in an mammal in need thereof,” or “enhancing immunity and suppressing inflammation in a mammal in need thereof,” it teaches the same step of administering an effective amount of a compound of formula (I), i.e., 2-methyl-2-thiazoline, thiazole and 2-isobutylthiazole, to an animal; the instant specification teaches an effective amount as 1pg/kg to 5,000mg/kg ([0058]), and Wagle teaches an effective amount as 0.1mg/kg-4mg/kg and about 0.7mg/kg to about 280mg/kg ([0052], [0198]). The instant specification does not specifically define a mammal in need of enhanced immunity or suppression of inflammation. Since all mammals benefit from enhanced immunity, i.e., protection from viruses, protection from bacterium, and protection from cancerous cells, for example, the patient population of Wagle meets the limitation of “a patient in need of enhanced immunity,” as instantly claimed. See also MPEP 2112.02.
Further regarding claim 10, Wagle teaches its compounds as inhibiting the formation of inflammatory mediators ([0003]). As such, the patient population taught by Wagle is in need of the suppression of inflammation, and thus are in need of enhanced immunity; since the methods of Wagle inhibit the formation of inflammatory mediators, patients’ immunity is enhanced by the methods of Wagle.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Modified) Claims 9-10, 12, 15 and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-18 of copending Application No. 18/040,569 (claim set dated 02/03/2023, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘569 claims a method for preventing or treating a psychiatric disorder in a mammal, comprising administering an effective amount of a compound of instant formula (I) or (II) (claims 13, 15-16).
‘569 claims ring A as thiazoline, thiazole, thiazolidine, thiomorpholine and others (claim 14).
While ‘569 does not explicitly recite an animal in need of “enhancing immunity,” or “enhancing immunity and suppressing inflammation,” [0004] of ‘569 teaches inflammation as leading to psychiatric disorders, wherein inflammation is a response that is necessary for immune cells to destroy exogenous substances, and that when inflammation progresses excessively, immune cells destroy not only exogenous substances, but also normal cells.” As such, it is reasonable to assume that the patient population of ‘569 are in need of “enhanced immunity” and “enhanced immunity and suppressed inflammation.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
On pg. 11, Remarks, Applicant argues that ‘569 does not teach an animal in need of enhancing immunity or in need of enhancing immunity and suppressing inflammation.
This argument has been fully considered, but is not found persuasive. [0004] of ‘569 teaches inflammation as leading to psychiatric disorders, wherein inflammation is a response that is necessary for immune cells to destroy exogenous substances, and that when inflammation progresses excessively, immune cells destroy not only exogenous substances, but also normal cells.” As such, in view of this teaching, it is reasonable to assume that the patient population of ‘569 is in need of “enhanced immunity” and “enhanced immunity and suppressed inflammation.”
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 LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622