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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 17, 2025 has been entered.
Status of Application
Receipt of the Amended Claims and Applicant’s Remarks filed on November 17, 2025 is acknowledged.
Claims 1, 3-4, 7-12, and 15-21 remain pending in this application.
Claims 2, 5-6 and 13-14 have been cancelled.
Claims 9-12 are withdrawn per the restriction by original presentation dated November 29, 2024.
Claims 1, 8, and 17-21 have been amended.
Claims 1, 3-4, 7-8, 15-21 are under examination in this application.
Withdrawn Objections/Rejections
Claim Objections
The objection to claims 9-12 because they have been withdrawn by original presentation has been withdrawn in view of the amendment to the claims to incorporate the claim language back into the claim listing.
Maintained and New Objections/Rejections
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.
Claim 17 is 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.
Regarding claim 17, the claim depends from claim 8, which requires sonication of a liquid monomer to evenly distribute instances of template molecule that corresponds to an analyte of interest throughout the liquid monomer to form a matrix of the template molecule. However, in claim 17, the tablet is divided into zones in which different the template molecule voids are limited to. It is unclear how a single tablet prepared by the method of claim 8 could have multiple zones for different template molecules.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues:
*Applicant has amended claim 17 to depend from claim 1. Claim 1 has been amended to be open to a tablet having a single zone for an analyte of interest of two zones for two different analytes of interest.
Claim 17 has not been amended to change the dependency from claim 8 to claim 1. Additionally, claim 1 has not been amended to recite different “zones”. The claim merely cites one or more matrix voids to hold one or more analytes. There is no claim language to recite the voids are in different zones.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-4, 7-8, 15-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kristensen et al. (US 2009/0104277) in view of Murray et al. (WO 01/77672).
Kristensen discloses molecular imprinted polymer particles (MIPs). It is noted that MIP’s are molecular imprinted compositions (MICs) made with a polymer matrix.
The MIPs bind particular target molecules in the gastrointestinal tract (paragraph 0001). The MIPs have a void or cavity with suitable binding ability to a selected template (paragraph 0028).
The MIPs may be formulated according to standard methods known to the person skilled in the art, especially formulated for oral use, where it is expected that MIPs will be administered in the form of powders, emulsions, encapsulated emulsions, pills and tablets, but also as ingredients in foodstuffs, where the MIPs can appear dispersed in virtually any food or foodstuff (paragraph 0161).
Regarding claim 3, Kristensen discloses the formulations can be in the form of tablets, however, does not explicitly recite a short cylinder. Applicant’s attention is directed to MPEP 2144.04 IV B.
Regarding claim 4, the MIPs have an average diameter of less than 20 mm (paragraph 0037).
Regarding claim 8 (in part), a method of preparing a composition comprising molecular imprinted polymers (MIPs) having high binding capacity and specificity for a target molecule, said method comprising:
a) obtaining a suspension of insoluble MIPs, which bind the target molecule, and which have been prepared using the target molecule or a mimic thereof as template molecule,
b) subjecting the suspended MIPs to an affinity purification procedure, wherein the template molecule or a fragment thereof or a mimic thereof is used as capture agent,
c) recovering the MIPs that bind the capture agent in the affinity purification procedure while substantially excluding the capture agent and MIPs that do not bind the capture agent from the recovered product, and
d) combining the MIPs recovered and optionally a carrier, vehicle or diluent to obtain said composition (such carriers, vehicle and diluents are typically selected amongst those that are pharmaceutically acceptable and known to the person skilled in preparation of pharmaceutical compositions comprising solid small-size particles).
Kristensen does not recite the analyte is methadone or amphetamine or the use of sonication in the preparation of the tablets.
Murray discloses methods of preparing molecularly imprinted polymers (abstract).
The molecularly imprinted polymers can selectively bind narcotics (abstract).
Regarding claims 7 and 16, the narcotics include methadone (claim 20).
Regarding claims 8 (in part) and 15, the monomer solutions, including the catalysts, were sonicated for 2-4 hours at 60 ˚C. Sonication is believed to help maintain homogeneity in the polymer, after polymer formation, the material was placed in an oil bath at 60 ˚C and allowed to cure overnight. The imprinted ion was then removed. (Example 2).
It would have been obvious to one of ordinary skill in the art to have created a polymer template for methadone in order to accurately test for its presence in a fluid in order to develop narcotics detection devices at extremely low concentration, minimally affected by interfering substances, rugged and completely user friendly (paragraph 0009).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have prepared the tablet as disclosed by Kristensen since it is disclosed MIP’s are commonly formulated for use as tablets in order to increase their feasibility to capture agents in the gastrointestinal tract and use the MIP’s in diagnostic, analytical, and therapeutic purposes (abstract) according utilizing the sonication step of Murray since it is discloses sonication helps maintain homogeneity in the polymer solution.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kristensen et al. (US 2009/0104277) and Murray et al. (WO 01/77672) as applied to claims 1, 3-4, 7-8, 15-16, and 18 above, and further in view of Singh et al. (US 6,582,971).
Kristensen and Murray are discussed above.
The combination does not disclose the polymer of the matrix is polyethylene.
Singh disclosed molecular imprinting polymers. Examples include polyethylene (column 6, lines 39-60).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have to substitute the polymers disclosed by Kristensen with any of the polymers disclosed by Singh since they are disclosed to be functional equivalents.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kristensen et al. (US 2009/0104277) and Murray et al. (WO 01/77672) as applied to claims 1, 3-4, 7-8, 15-16, and 18 above, and further in view of Sellergren et al. (US 6,759,488).
Kristensen and Murray are discussed above.
The combination does not disclose different zones having different template molecules.
Sellergren discloses molecularly imprinted polymers (MIPs) grafted on solid supports (abstract).
Regarding claim 19, Sellergren discloses additional layers of MIPs having different templates (column 5, lines 7-12).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have included additionally layers (zones) as taught by Sellergren in the tablets of Kristensen and Murray in order to target additional analytes.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues:
*Claims 1, 8, and 18 have been amended in similar manner to recite “inserting the tablet into a patient’s mouth and removing the tablet from the patient’s mouth after the tablet has had time to acquire a testable amount of a molecule that matches the template molecule; and providing the testable amount of the molecule for injection to an analysis machine to determine if the analyte of interest is present in the patient’s mouth”
Applicant submits none of the cited references disclose said features.
The claims are drawn to a solid dosage form and a method of making said form. Applicant has amended the claims to recite methods of use limitations, which do not further limit the instant claims. The intended function/use of a composition is not given patentable weight.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615