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
Status of Claims
The amendments and arguments filed on 02/18/2026 are acknowledged and have been fully considered. Claims 1 and 3-20 are now pending. Claim 2 is canceled; claims 1, 3-4, 6-7, and 10 are amended; claims 11-14 are withdrawn; claims 15-20 are new.
Claims 1, 3-10, and 15-20 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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 4 and 16-19 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.
As written, claim 4 recites various disease associated antigens or dependency causing substances, however the data presented is shown only for fentanyl. Specifically, it is taught in the specification as filed in paragraph 0103 and figure 9 that the fentanyl VSG3 had unexpected results, however the limitations of the claim are much broader. One with ordinary skill in the art would not be able to understand the metes and bounds of the claim as the data presented is not commensurate in scope with the data provided.
Regarding claim 18, the claim recite “fentanyl related compounds”, what are those related compounds? The examiner suggests to either delete the term “related compounds” or recite “carfentanyl” that was previously recited by claim 4 and disclosed by paragraph [0045] of the published application.
Claims 16-19 are indefinite as they depend from an indefinite claim.
Response to Arguments
Claim Rejections - 35 USC § 112
Applicant’s arguments, see pages 1-2, filed 02/18/2026, with respect to the rejection(s) of claims 1-10 under 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as necessitated by amendment as discussed above.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pages 7-9, filed 02/18/2026, with respect to claims 1-10 have been fully considered and are persuasive. The rejection of claims 1 and 3-10 has been withdrawn (as claim 2 has been cancelled).
Double Patenting
Applicant’s arguments, see page 9-11, filed 02/18/2026, with respect to double patenting have been fully considered and are persuasive. The provisional rejections of the claims have been withdrawn.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The amendment of claim 1, specifically the addition of the limitation of the antigenic particle being derived from a UV-crosslinking-inactivated trypanosome, said trypanosome being an enzyme glycophosphatidylinositol phospholipase C-negative trypanosome, seems to be free of the art. However due to the indefiniteness of claims 4 and 16-19 as discussed above, the claims are not in allowable form. As indicated in the examiner interview summary attached, it was suggested that applicant cancel claims 4 and 16-19 and add the limitation of “wherein the antigenic compound is fentanyl” to claim 1 in order for the claims to be commensurate with the data provided.
Conclusion
No claims 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 AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
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