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 Objections
Claims 1, 3, 6, 7 are objected to because of the following informalities:
Claim 1 recites “an self-administration injection device”. The article “an” is grammatically incorrect before a word beginning a consonant sound. It should likely read “a self-administration injection device.” Clarification is required.
Claim 1 recites “drug reservoir”. It should read “a drug reservoir” Clarification is required.
Claim 1, lines 4, recites “vehicle”. It should read “a vehicle”. Clarification is required.
Claim 3 recites “wherein said device provided as kit comprising container comprising said composition and instructions for use”. The claim most likely should read “wherein said device provided is a kit comprising a container comprising said composition and instructions for use.”. Clarification is required.
Claim 6 recites “wherein the risperidone microspheres suspended in triglycerides such as medium chain triglycerides” and should likely read “wherein the risperidone microspheres are suspended in triglycerides such as medium chain triglycerides.” Clarification is required
Claim 7 recites “wherein said composition has a viscosity is less than 100 cps.” The phrase contains a grammatical error and is incomplete. It should likely read “wherein said composition has a viscosity of less than 100 cps.”. Clarification is required.
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 1-3 and 7-10 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.
The limitation "said injection device" in line 5 of claim 1 and the limitation “said device” in line 1 of claim 3 and in line 1 of claim 9 all lack sufficient antecedent basis.
For the purposes of examination of claims 1, 3 and 9, “injection device” and “said device” are being interpreted as “self-administration injection device.”
The limitation “said injection” in line 6 of claim 1 lack sufficient antecedent basis.
For the purposes of examination of claim 1, “injection” is being interpreted as “liquid injectable composition.”
The limitation “the composition” in line 1 of claim 2 and line 1 of claim 10 as well as the limitation “said composition” in line 2 of claim 3 and line 1 of claim 7 all lack sufficient antecedent basis.
For purposes of examination of claims 2, 3, 7 and 10, “the composition” and “said composition” are both being interpreted as “liquid injectable composition.”
The limitation “the volume of injection” in lines 1-2 of claim 8 lacks sufficient antecedent basis.
For purposes of examination of claim 8, “the volume of injection” is being interpreted as a new limitation that requires the injection delivered by the self-administration injection device to have a volume of less than 5 mL, less than 3 mL, less than 2 mL, or less than 1mL.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 4-6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Krulevitch (WO Publication No. 2021/095003), hereinafter, Krulevitch, in view of Lai (CN Patent No. 106963746), hereinafter, Lai.
Regarding claim 1, Krulevitch discloses a self-administration injection device (Krulevitch: drug delivery device 12 is an autoinjector configured to deliver a drug 14 in fig. 1; para [0090]), comprising:
drug reservoir of liquid injectable composition (Krulevitch: drug delivery device 12 is an autoinjector configured to inject the drug 14 from a container 16 in fig. 1; para [0090]),
wherein the said injection device is auto-injector for single dose (Krulevitch: drug delivery device 12 is an autoinjector configured to deliver a drug 14 in fig. 1; para [0090]).
Krulevitch does not, however, disclose that the drug reservoir of liquid injectable composition comprises (i) risperidone microspheres, (ii) vehicle, and wherein said injection in long-acting.
Lai teaches that the drug reservoir of liquid injectable composition comprises (i) risperidone microspheres (Lai: sustained-release composition comprising risperidone microspheres as shown in examples 31-33, 36-38, 41, 45-50, and 52, which prepare and combine risperidone PLGA microspheres; pages 18-22), (ii) vehicle (Lai: microspheres can be formulated as a liquid injectable composition by dispersing them in a vehicle such as medium-chain triglycerides; page 9, para [1]); and wherein said injection is long-acting (Lai: PLGA microsphere can be prepared as long-acting formulation of carriers administered by means of intramuscular or subcutaneous injection; page 2, para [1]; has good slow-release performance, and can be several weeks of time in maintaining effective blood concentration; page 2, para[3]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device of Krulevitch to contain a long-acting, liquid injectable composition comprising risperidone microspheres and a vehicle, as taught by Lai, in order to provide a long-acting risperidone formulation suitable for convenient self-administration with improved patient compliance.
Regarding claim 2, modified Krulevitch discloses the self-administration injection device as claimed in claim 1, wherein the composition is present in a form suitable for subcutaneous administration (Lai: PLGA microspheres can be prepared as long-acting formulation of carriers, the human or animal is administered by means of intramuscular or subcutaneous injection; page 2, para [1]).
Regarding claim 4, modified Krulevitch discloses the self-administration injection device as claimed in claim 1, wherein the vehicle is non-aqueous (Lai: microspheres can be formulated as a liquid injectable composition by dispersing them in a vehicle such as medium-chain triglycerides, which is non-aqueous; page 9, para [1]).
Regarding claim 5, modified Krulevitch discloses the self-administration injection device as claimed in claim 4, wherein the non-aqueous vehicle comprises of triglycerides (Lai: microspheres can be formulated as a liquid injectable composition by dispersing them in a vehicle such as medium-chain triglycerides, which is non-aqueous; page 9, para [1]).
Regarding claim 6, modified Krulevitch discloses the self-administration injection device as claimed in claim 1, wherein the risperidone microspheres suspended in triglycerides such as medium chain triglycerides (Lai: microspheres can be formulated as a liquid injectable composition by dispersing them in a vehicle such as medium-chain triglycerides, to obtain suspension; page 9, para [1]).
Regarding claim 9, modified Krulevitch discloses the self-administration injection device as claimed in claim 1, wherein said device is digitally configured (Krulevitch: drug delivery device 12, including autoinjectors, are digitally configured with sensing module capable of collecting data and detecting and transmitting information with external devices in figs. 1-3; para [0090-0100]).
Claims 3, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Krulevitch in view of Lai, as applied to claim 1 above, and further in view of (Risperdal Consta® (risperidone) Long-Acting Injection, Full Prescribing Information (FDA label, 2021), available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021346s061lbl.pdf), hereinafter, Risperdal Consta®.
Regarding claim 3, modified Krulevitch discloses the self-administration injection device as claimed in claim 1, but fails to disclose that the device provided as kit comprising container comprising said composition and instructions for use.
Risperdal Consta® teaches a kit comprising a container comprising said composition (Risperdal Consta®: vial kits; page 1, “Dosage Forms and Strengths”; kit supplied with required components for single-use injection including a pre-filled syringe that contains 2 mL of diluent for reconstitution of composition of risperidone for treatment of schizophrenia or maintenance treatment of Bipolar I Disorder; page 52, section 16, “How Supplied/Storage and Handling) and instructions for use (Risperdal Consta®: page 8, section 2.8, “Instructions for Use”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the self-administration injection device of modified Krulevitch containing the liquid injectable composition to be provided as a kit comprising a container comprising the composition and instructions for use, as taught by Risperdal Consta®, in order to supply the device and composition in a convenient, ready-to-use package with proper administration instructions, as is conventional for long-acting injectable risperidone products.
Regarding claim 8, modified Krulevitch, as modified in the rejection of claim 3 above, discloses the self-administration injection device as claimed in claim 1, wherein the volume of injection at least less than 5ml, less than 3ml, less than 2ml or less than 1ml (Risperdal Consta®: pre-filled syringe contains 2 mL of diluent, the entirety of which is used for reconstitution and dose administration, and supports an injection volume based on 2 mL, less than 5 mL and less than 3 mL; page 15, section 3, “Dosage Forms and Strengths”).
Regarding claim 10, modified Krulevitch, as modified in the rejection of claim 3 above, discloses the self-administration injection device as claimed in claim 1, wherein the composition is used for treating risperidone sensitive diseases or disorders in mammals (Risperdal Consta®: for treatment of schizophrenia or maintenance treatment of Bipolar I Disorder; page 1, “Indications and Usage”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Krulevitch in view of Lai, as applied to claim 1 above, and further in view of Lallemand (CA Patent No. 2809460), hereinafter, Lallemand.
Regarding claim 7, modified Krulevitch discloses the self-administration injection device as claimed in claim 1, but fails to disclose that said composition has a viscosity is less than 100 cps.
Lallemand teaches that the said composition has a viscosity is less than 100 cps (Lallemand: injectable oil-based (including MCT) compositions having ranges of viscosity, one example presented a range from 27 to 33 mPa·s, or less than 100 cPs, and; page 11, lines 11-13; other embodiments range from 5 to 100 mPa·s, preferably 5 to 50 mPa·s, more preferably 5 to 20 mPa·s, or less than 100 cPs; page 11, lines 18-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the liquid injectable composition of modified Krulevitch to have a viscosity of less than 100 cPs, as taught by Lallemand, in order to provide a composition that is readily injectable through a needle or autoinjector while maintaining the benefits of an oil-based sustained-release formulation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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