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 .
Status of the Claims
Currently, claims 20-38 are pending in the instant application and under consideration herein.
Response to Remarks and Amendments
Applicant’s arguments and amendments filed November 3, 2025 have been fully considered and entered into the application. All rejections and objections not explicitly maintained herein are withdrawn. The rejections recited below represent the full set being applied to the instant claims.
With regard to the rejection of claims 35-38 under 35 USC 112(b), Applicant traverses the rejection on the grounds that “the precursor compound can be any compound that can be used early in a synthetic method” and that “the precursor compound literally can be any compound that a creative abuser could use in a synthetic pathway then to make an illicit drug.” The arguments were not found to be persuasive. In order to determine the precise metes and bounds, i.e. what falls inside and outside the scope of the instant claims, a person of ordinary skill in the art must first make the determination of what constitutes “a drug that is susceptible to abuse.” The claims fail the test for whether the metes and bounds are clear at this first prong because functional language (i.e. whether or not a substance is susceptible to abuse) is used to define a chemical compound in the claim. There is no teaching, whether set forth in the claims or the specification, to determine what metric is used to decisively determine what renders a substance susceptible to abuse. While examples are provided (SPEC paragraph [0012]), these are explicitly described as not limiting.
Thus, the test provided in MPEP 2173.05(g) and described in the original rejection is not considered met by the claims because (1) there is not a clear cut indication of the scope of the subject matter covered by the claim; (2) the language does not set forth well-defined boundaries of the invention because it only states a problem solved or a result obtained; and (3) one of ordinary skill in the art would not know from the claim terms whether a particular structure is encompassed by the claim.
Similarly, even if the claim recitation of “drug susceptible to abuse” was found to be definite (which the examiner contends that it is not), the recitation of “a precursor compound that can be used in a chemical synthesis of a drug that is susceptible to abuse” also fails to meet the three prongs described above. There is no clearly described synthetic pathway towards the undefined “drug susceptible to abuse,” which requires a person of ordinary skill to imagine and envision every possible chemical synthesis resulting in the production of any drug susceptible to abuse. Thus again, as above, (1) there is not a clear cut indication of the scope of the subject matter covered by the claim because it is not possible to envision every possible synthetic pathway to arrive at a still unnamed scope of drugs; (2) the language does not set forth well-defined boundaries of the invention because it only states a problem solved or a result obtained; and (3) one of ordinary skill in the art would not know from the claim terms whether a particular structure is encompassed by the claim.
Accordingly, the rejection is maintained herein.
With regard to the rejection of claims 20-38 for nonstatutory double patenting over claims 1-19 of US Patent 9,757,466, claims 1-7 of US Patent 8,901,113, claims 1-29 of US Patent 10,155,044, clams 1-19 of US Patent 10,004,699, claims 1-19 of US Patent No. 10,610,497, and claims 1-18 and 20-25 of US Patent 11,723,885, the terminal disclaimer filed on November 24, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 9,757,466; US 8,901,112; US 10,155,044; US 10,004,699; US 10,610,497 and US 11,723,885 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 112
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.
Claims 35-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each rejected claim recites a limitation requiring a compound (i.e. “a precursor compound” to be included as a component of the composition to be administered as well as “a drug that is susceptible to abuse”) which must be claimed in a way that clearly sets forth all structural limitations of the compound. As a result of the definition of the structural limitation (i.e. the particular structure of the claimed precursor compound or “drug”) with functional language (i.e. the compound being usable in a chemical synthesis reaction of a drug which is further defined only by the functional language “susceptible to abuse” rather than any shared structural or identifying feature of the drug), the metes and bounds of the claims cannot be fully ascertained.
MPEP 2173.05(g) provides that, while there are permissible instances for the use of functional language to define a claim, “A functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used.” Further, “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. These factors are examples of points to be considered when determining whether language is ambiguous and are not intended to be all inclusive or limiting. Other factors may be more relevant for particular arts. The primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise.”
In the present case, it is unclear precisely what structures are intended for the claimed compounds, at least because the functional language used leaves room for ambiguity. For example, there is no recitation of how the precursor compound may be used to chemically synthesized unnamed compounds. Without clear direction as to which the compound is prepared or reacted, the product of any resulting synthesis is completely structurally undefined because the claim gives no context as to what manipulations are made to the disclosed structure to arrive at the claimed “drug” (or what, structurally speaking, a “drug that is susceptible to abuse” requires). For this reason, the metes and bounds of the claims cannot be determined.
Conclusion
Claims 20-34 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
THIS ACTION IS MADE FINAL. 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.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699