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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the storage and shipping orientations, shipping container, and residue amounts must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
As a general matter herein, the examiner notes that the broadest reasonable interpretation of an apparatus claim includes the structure thereof and not how it is used or made. In particular, the examiner directs attention to MPEP 2113 regarding Product-by-Process claims, stating that the “patentability of a product does not depend on its method of production.” Therefore, the examiner may establish anticipation or obviousness by referencing a “product which appears to be the same or similar” to the claimed invention. Upon such establishment, the burden of proof shifts to the applicant to establish a non-obvious difference.
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2018/0190153 to Krulevitch et al. (Krulevitch hereinafter) in view of JP 2015150113 to Saito et al. (Saito, copy and machine translation attached herewith).
Regarding claims 1 and 3, Krulevitch teaches at least one syringe containing paliperidone palmitate extended-release injectable suspension (see e.g. paragraph 205). Krulevitch further teaches manually mixing such a syringe prior to injection (see e.g. paragraph 1). Krulevitch does not teach the claimed shipping method. Saito teaches another pharmaceutical dose mixing device generally, and particularly teaches that optimal dissolution is provided by a custom oscillatory method (see discussion on page of translation beginning “six vial holders 49”). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use the apparatus taught by Saito to replace the manual mixing of Krulevitch in order to optimally mix the contents of the syringe prior to injection. Thus utilized, the examiner holds that the syringe so mixed is equivalent in structure to the syringes shipped as claimed. Additionally, the provision of a population of such syringes constitutes merely the duplication (see MPEP 2144.04 VI. B) of the previous syringe and therefore does not patentably distinguish over Krulevitch.
Regarding claim 2, the provision of more than 100 such syringes constitutes merely the duplication (see MPEP 2144.04 VI. B) of the previous syringe and therefore does not patentably distinguish over Krulevitch and Saito.
Regarding claim 4, there appears to be no functional relationship between the printed instructions and the functions of a container (MPEP 2111.05) and therefore the examiner holds that claim 4 does not patentably distinguish over Krulevitch and Saito.
Regarding claim 5, Krulevitch is silent to an amount of residue. However, optimization of the oscillatory motion of Saito will naturally minimize the amount of residue. One of ordinary skill in the art would appreciate the therapeutic benefits and cost reductions associated with such minimization and would therefore be led to use the apparatus of Saito to eliminate to any extent possible the un-suspended residue in the syringes of Krulevitch to a point falling within the claimed range.
Regarding claim 6, Krulevitch teaches 819 mg doses (see e.g. paragraph 219-220 and Table 1).
Regarding claim 7, Krulevitch does not explicitly teach the use of a 1092 or 1560 mg dose. However, the distinction between these doses and those taught by Krulevitch is merely the length of therapeutic effect and the dimensions of the syringe. Accordingly, it would have been obvious to use larger doses such as 1092 or 1560 mg in order to lengthen the therapeutic effect.
Regarding claims 8-11, as noted above, the examiner holds that there is no patentable difference in structure between a syringe stored and shipped in these configurations and one that is agitated by the apparatus of Saito. Accordingly, the invention of these claims is obvious by the analysis discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pre-Grant Publication 2017/0035765 teaches 6-month doses of paliperidone palmitate (see e.g. paragraphs 43-44). US Pre-Grant Publication 2016/0015457 teaches a horizontal shipping container for syringes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 18 December 2025