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
Request for Continued Examination
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 20th 2026 has been entered.
Status of the Claims
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Claims 1, 19-21, 28, 31-34, and 44-45 are pending and are examined on their merits.
35 U.S.C. § 112(a) New Matter Rejections Maintained
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.
Applicant’s amendment of claim 21 in the response filed on January 20th 2026 is acknowledged. Applicant has removed the term “operably,” from the claim and argues that this amendment is sufficient to overcome the 112(a) amendment over claim 21. However, the specification still fails to recite said limitation wherein “the compound is coupled to an opioid receptor agonist…” The 112(a) new matter rejection over claim 21 is thereby maintained.
35 U.S.C. § 112(a) Rejection Over Claim 21 Reiterated
Claim 21 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 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites the limitation, “wherein the compound is operably coupled to an opioid receptor agonist…” This limitation is not recited in the specification and is considered as new matter.
35 U.S.C. § 112(b) Rejections for Claims 1 and 28 Overcome by Amendment
Applicant’s amendment of claims 1 and 28 in the response filed on January 20th 2026 is acknowledged. Applicant has amended claim 1 to remove the phrase “wherein the formula is configured to act as a kappa ligand.” As this phrase was the basis for the 112(b) rejection over claims 1 and 28, said 112(b) rejections are withdrawn.
35 U.S.C. § 112(b) Rejections Maintained
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejections of claims 19-21 and 31-33 under 35 U.S.C. § 112(b) are maintained.
35 U.S.C. § 112(b) Rejections for Claim 21 Maintained
Applicant’s amendment to claim 21 in the response filed on January 20th 2026 is acknowledged. Applicant has removed the phrase “operably.” Claim 21 now reads “The compound of claim 1, wherein the compound is coupled to an opioid receptor agonist selected from the group…”
It is noted that the preamble, “the compound of claim 1,” necessarily describes a single compound. Thus, the compound of claim 1 wherein the compound is operably coupled to another compound is descriptive of a composition containing the compound and not further limiting to the compound itself. The 112(b) rejection of claim 21 is thereby maintained.
Previous Arguments for 35 U.S.C. § 112(b) Rejection for Claim 21 Reiterated
Applicant’s amendment to claim 21 in the response filed on June 19th 2025 is acknowledged. Applicant has removed the phrase “further comprises,” upon which the previous 112(b) rejection was based.
Claim 21 now reads “The compound of claim 1, wherein the compound is operably coupled to an opioid receptor agonist is selected from the group…” As a preliminary matter, the typographical error described in the previous rejection has not been fixed:
“wherein the compound is operably coupled to an opioid receptor agonist is selected from the group…”
It is unclear how this phrase further limits the compound of claim 1. The preamble, “the compound of claim 1,” necessarily describes a single compound. Thus, the compound of claim 1 wherein the compound is operably coupled to another compound is descriptive of a composition containing the compound and not further limiting to the compound itself.
Claim 21 is further indefinite for the phrase “wherein the compound is operably coupled to an opioid receptor agonist,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim from this phrase. Specifically, it is unclear what distinguishes a molecule as being “operably coupled to” another molecule. The guidance provided by applicant in paragraphs [00060]-[00082] does not clarify this phrase, but describes compositions containing the compound.
35 U.S.C. § 112(b) Rejections for Claims 19-20, 31-33 Maintained
Applicant’s amendments to claims 19, 20, 31, and 32 in the response filed on January 26th 2025 are acknowledged. The claims now recite:
Claim 19: “The compound of claim 1, wherein the formula inhibits the kappa opioid receptor.”
Claim 20: “The compound of claim 1, wherein the formula blocks or reduces the tolerance of a human to a kappa opioid receptor agonist.”
Claim 31: “The method of claim 28, wherein said administered compound inhibits the kappa opioid receptor.”
Claim 32: “The method of claim 28, wherein the compound blocks or reduces the tolerance of said human to a kappa opioid receptor agonist.”
Applicant argues that the claims are definite because the activity described in each claim is grounded in the particular R-groups of the compound. However, as stated in the final rejection filed on June 19th 2025, the extent that such a structural-activity relationship defines the R groups of the compound is found in paragraphs [00011]-[00012] of the application, which define R groups in the same manner as claims 1 and 28. That is, one of ordinary skill in the art could not reasonably distinguish between “the compound of claim 1” and “the compound of claim 1 wherein the formula inhibits the kappa opioid receptor.”
Such a limitation merely recites a property of the compound or an intended result of the method, and while such a property may be grounded in the particular R groups attached to the compound, without further guidance it is unclear how such R groups would be further limited to achieve the described activity.
35 U.S.C. § 112(b) Rejections for Claims 19-20, 31-33 Reiterated
Applicant’s arguments in the response filed on June 19th 2025 are acknowledged. Applicant argues that claims 19-20, and 31-33 are definite, because the functional limitations in these claims are directly tied to the properties of the structurally defined compounds. Applicant further states that “The claims do not require predicting the exact biochemical mechanism of action, only that the defined compounds exhibit the recited properties—something well within the understanding of those skilled in the art.” i.e. Applicant argues that the functional limitations described in these claims are grounded in structural definitions and particular definitions of R-groups along the structure.
Applicant’s arguments are found not persuasive. Examiner does not dispute that the functional limitations described are entirely dependent on the structural aspects of the compound, as demonstrated in the previous 112(b) rejections. The indefiniteness of these claims arises in that one of ordinary skill in the art could not determine which structural modifications to Formulas (I)-(IV) are required in order to achieve said activity. The extent that such a structural-activity relationship defines the R groups of the compound is found in paragraphs [00011]-[00012] of the application, which define R groups in the same manner as claims 1 and 28 (defined as a broader genus than claim 1 and 28 as of the amendment filed on June 19th 2025).
35 U.S.C. § 112(b) Rejections for Claims 19-20, 31-33 Reiterated
Claims 19 and 20 previously recited the compound of claim 1 “wherein said compound is capable of inhibition of the kappa opioid receptor” (claim 19) and “wherein said compound is further effective to block or reduce the tolerance of said human to a kappa opioid receptor agonist” (claim 20). The language of the two claims has been amended to recite the compound of claim 1, “wherein the formula is configured to” accomplish such activity. At no point in the specification is the guidance required to accomplish this “configuration” given. The metes and bounds of the compound of claim 1 are entirely structural. One of ordinary skill in the art could not reasonably determine how the structure of the compound of claim 1 would need to be further limited in order to accomplish the activity described in claims 19 and 20. Claims 19 and 20 are therefore indefinite.
Claims 31-33 are similarly indefinite. In each case, the claim language is amended to recite that the compound used in claim 28 “is configured” to have the particular described activity. However, there is no indication as to how the structural metes and bounds of the compound used are further limited to accomplish this configuration. Claims 31-33 are therefore still indefinite.
35 U.S.C. § 112(b) Rejections for Claims 19-20, 31-33 Reiterated (Previous Non-Final Rejection)
Claims 19-20, and 31-33 are indefinite for the following functional descriptive limitations:
“wherein said compound is capable of inhibition of the kappa opioid receptor” (claim 19)
“wherein said compound is further effective to block or reduce the tolerance of said human to a kappa opioid receptor agonist” (claim 20)
One of ordinary skill in the art could not reasonably determine how each of these phrases further limits the compound of claim 1. Each of these claims place a further limit on the structure of the compound, but these structural limitations are each directed solely towards the compound’s function. As one of ordinary skill in the art could not reasonably determine the structural metes and bounds as they relate to any of the functional limitations of claims 19-20, the claims are indefinite.
“wherein administering a therapeutically effective amount of said compound is capable of having at least 50% of the administered amount cross the blood-brain barrier of a patient” (claim 30)
“wherein said administered compound is capable of inhibition of the kappa opioid receptor” (claim 31)
“wherein said compound is further effective to block or reduce the tolerance of said human to a kappa opioid receptor agonist” (claim 32)
“wherein the kappa opioid receptor agonist is…” (claim 33)
One of ordinary skill in the art could not reasonably determine how each of these phrases further limits the compound administered in claim 28. Each of these claims place a further limit on the structure of the compound administered in the method of claim 28, but these structural limitations are each directed solely towards the compound’s function. As one of ordinary skill in the art could not reasonably determine the structural metes and bounds as they relate to any of the functional limitations of claims 30-33, the claims are indefinite.
35 U.S.C. § 102(a)(1) Rejections Maintained
The rejection of claims 1, 19-21, 28, 31-34, and 42-45 under 35 U.S.C. 102(a)(1) as being anticipated by Mickle (US 2007/0042955 A1 published on February 22nd 2007) is maintained.
Applicant’s arguments in the response filed on January 20th 2026 are acknowledged. Applicant argues that:
Mickle does not disclose compounds with the claimed scaffolds or R groups and therefore does not disclose “each and every element” of the claimed compound.
The compounds of Mickle are designed to modulate amphetamine’s bioavailability to reduce its abuse potential, a different therapeutic and mechanistic target than applicant’s compounds.
Mickle’s compounds require significantly different structural requirements for the desired activity.
Regarding argument 2, a compound’s intended purpose does not change the anticipatory nature of its structure. Furthermore, as stated in the below 102 rejections for claims 44 and 45, Mickle’s compounds are used for much of the same purpose as applicant’s compounds.
Regarding arguments 1 and 3, see the 102 rejection of claim 1 below. Mickle discloses serine-amphetamine. The species is equivalent to applicant’s formula III wherein R1 is H, R2 is H, R3 is H, R4 is H, R5 is CH3, and R6 is H. Mickle thereby anticipates claim 1. See MPEP 2131.02:
"A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989) (Gosteli claimed a genus of 21 specific chemical species of bicyclic thia-aza compounds in Markush claims. The prior art reference applied against the claims disclosed two of the chemical species. The parties agreed that the prior art species would anticipate the claims unless applicant was entitled to his foreign priority date.).
Applicant further states “Applicant’s prior efforts to provide limitation to the phrase “configured to act as a kappa ligand,” and which this context is not as a vague intention, but as a reference to established structure-activity relationships (SARs) widely known in the field of medicinal chemistry, and which further distinguishes completely from the other compounds taught by Mickle. Applicant would welcome the opportunity to revisit how to incorporate such a limitation in a manner that does not trigger Examiner’s 112(b) concerns and in a manner that presents clear metes and bounds of the claims.”
Examiner’s recommendation to establish definite structural requirements while distinguishing the compound genus from Mickle would be to amend the structural metes and bounds (i.e. the scope of the R groups) to further limit applicant’s compounds in a manner that does not encompass Mickle’s compounds.
35 U.S.C. § 102(a)(1) Previous Arguments Reiterated
Applicant argues that the compounds disclosed in Mickle are not within the scope of claim 1, which recites core scaffold structures bearing defined R-group substituents, and that Mickle teaches neither the scaffolds, nor compounds with the particular R-groups claimed.
However, as stated in the previous rejections, Mickle teaches serine-amphetamine (Mickle, specification, pg. 30, Table 6, S-Amp),
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This structure corresponds to applicant’s formula III,
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wherein R1 is H, R2 is H, R3 is H, R4 is H, R5 is CH3, and R6 is H. As each of these falls into the genus described of claim 1,
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Mickle’s serine-amphetamine anticipates applicant’s compound genus.
Regarding applicant’s argument that the phrase ‘“configured to act as a kappa ligand” is not a recitation of an inherent property, but rather a structural-functional characterization grounded in the claimed R-group combinations and formulas,” the extent that such R-group combinations are defined by the applicant is found in claim 1, and are interpreted as such.
35 U.S.C. § 102(a)(1) Rejections Reiterated—Previous Final Rejection
Claims 1, 16-21, 28-34, and 42-45 are currently rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mickle (US 2007/0042955 A1 published on February 22nd 2007). Mickle recites serine-amphetamine, which certainly falls into the genus of the compounds of claims 1 and 28, as well as its pharmacological activity.
Applicant argues that the 102 rejection is invalid because the claim language now states that the ‘formula is configured to act as a kappa ligand.’ It is not clear, however, how this phrase further limits the structure of the compound. The phrase recites particular activity of the compound that would be inherent in the compound’s structure, but does not provide any guidance as to how the structure itself is further limited by the phrase. No guidance is provided anywhere in the specification as to how the formula of the compound of claims 1 or 28 must be ‘configured’ in order to achieve the described activity. For this reason, the ‘configuration’ of the compound is equivalent to an intended use and is not more limiting to the compound itself. The 102(a)(1) rejections for claims 1, 16-21, 28-34, and 42-45 are thus maintained.
35 U.S.C. § 102(a)(1) Rejections Reiterated—Previous Non-Final Rejection
Claims 1, 16-21, 28-34, and 42-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mickle (US 2007/0042955 A1 published on February 22nd 2007).
The instant claims are directed to a compound of the generic structure,
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as well as a method of treating neurological disorders via administration of the compound.
Mickle teaches serine-amphetamine (Mickle, specification, pg. 30, Table 6, S-Amp),
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corresponding to the instant structure wherein R1 is H, R2 is H, R3 is H, R4 is H, R5 is CH3, and R6 is absent. As it is unclear how claims 17-21 further limit the generic structure of claim 1 (see the above 112B rejection), they are each anticipated by the serine-amphetamine structure. Mickle teaches a pharmaceutical composition of this compound (Mickle, pg. 40, claim 41), anticipating claim 16.
Mickle additionally teaches the treatment of several neurological disorders with the compound, including multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, and nicotine addiction (Mickle, specification, pg. 7, paragraph [0124]) (relevant to instant claims 28, 44, 45), as well as oral administration of the compound (Mickle, specification, pg. 30, Table 6, S-Amp) (relevant to instant claims 34). As it is unclear how claims 29-33 and 42-43 further limit the method of claim 28 (see the above 112B rejection), they are each anticipated by Mickle.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET 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, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629