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 .
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) 1-5, 7, 9-10 and 12 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 previously provided) and US Pre-Grant Publication 2017/0035765 to Roberts et al. (Roberts).
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. Krulevitch also does not teach a 6-month dose of paliperidone palmitate (PP6M). Roberts teaches 6-month doses of paliperidone palmitate (see e.g. paragraphs 43-44). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide the syringes of Krulevitch as PP6M in order to extend the length of treatment.
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 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 9-10, 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.
Regarding claim 12, it has been held by the courts that where the difference between the prior art and the claimed invention is a recitation of relative dimensions and there is no difference in performance, the claimed device is not patentably distinct (see MPEP 2144.04 IV A). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a syringe with the claimed dimensions as it differs from the syringe of Krulevitch in at most 4 dimensions and does not propose any difference in performance.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krulevitch in view of Saito and Roberts as applied to claim 1 above, and further in view of US Pre-Grant Publication 2005/0233398 to Chu et al (Chu).
Regarding claim 13, the previously applied references do not teach a 312 mg/ml concentration of PP6M. Chu teaches that concentration is a known result effective variable of many medical compositions (paragraph 2). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to adjust the concentration of the PP6M compound in the syringe of Krulevitch to attain a specific effectiveness.
Response to Arguments
Applicant’s arguments, see page 4, filed 24 April 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 103 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 in view of Roberts as set forth above.
With respect to the drawings, the objection is withdrawn.
With respect to the argument that the combined references do not teach the claimed syringe because the shipping method is not disclosed, the examiner is not persuaded. Applicant argues that the evidence in the specification indicates that the physical nature of the product is affected (page 6). The examiner does not dispute this allegation. However, the evidence of record relates to shaking by hand, rather than by a dedicated machine as proposed by Saito. Accordingly, the evidence is silent to the proposed combination and does not weigh against the conclusion of obviousness herein. Similarly, the applicant has not provided evidence sufficient to suggest that their alleged advantages (i.e. lower residual product and injection forces) are not obtainable by the Saito apparatus. The examiner holds that applicant has not met the burden of proof necessary to overcome the rejection and therefore maintains that the claimed invention is obvious.
Conclusion
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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, 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 17 June 2026
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