DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed 08/08/25 has been entered. Claim 1 has been amended. Claims 2-15 and 19-20 are in the original/previously presented form. Claims 16-18 are cancelled. Claim 21 is newly presented. Thus, claims 1-15 and 19-21 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 03/10/25.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 1-2, 5, 8-15, and 19-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siegel et al. (U.S. PGPUB No. 2008/0305140), hereinafter Siegel, in view of Cima et al. (U.S. PGPUB No. 2009/0149833), hereinafter Cima.
Regarding claim 1, Siegel discloses a method for treating a patient suffering from schizophrenia (see [0099]), comprising:
subcutaneously (see [0115], [0120], [0160] & [0193]: rod implant implanted subcutaneously through 4mm hole) implanting in the patient a device comprising a formulation (see [0122], [0126], [0162], [0170], [0186]: a rod shaped implant with a formulation contained within),
wherein the formulation comprises a sparingly water-soluble drug (see [0009], [0114]: risperidone, FIG.3 & [0013]: release profile showing total mass of Risperidone released. If only some mass of the total is released, there must be some mass of the total still contained within the implant and therefore the formulation is sparingly water-soluble.) having a soluble form and an insoluble form (see [0127]: risperidone is controllably released as a flowable composition where the initial state of the drug is insoluble. Thus, the released mass==soluble form and the initial state and mass that is not yet released from implant==insoluble. See also FIG. 3 and [0013]) and a solubility-modifying excipient that generates acidic groups (see [0114]: formulation includes risperidone and copolymer PLGA, which would generate acidic groups and aligns with Applicant’s disclosure of solubility-modifying excipient that generates acidic groups in at least the current Application’s PGPUB [0036], [0081], [0089], and [0092]: PLGA generates acidic groups) for a period of between about 2-12 months following implantation in the patient (see [0079], [0111], [0121], [0155], [0165]: 6 months or more),
wherein the formulation provides a concentration of drug freely diffusing out of the device thereby delivering for the period a dose of the drug effective for treating schizophrenia (see [0155]: risperidone provided can deliver .05ng/day over 285 days or [0159]: 50mg implant provided for 40days).
Lastly, Siegel discloses the implant can be formed as an implantable osmotic pump (see [0130]: drug can be provided as implantable osmotic pump to provide controlled dosage release).
Siegel is silent to the device “comprising a membrane, a reservoir and a formulation contained in the reservoir,” “wherein the formulation “when hydrated” provides a concentration of drug in the soluble form freely diffuses out of the device “across the membrane, and a concentration of drug in the insoluble form is retained in the device by the membrane,” and “wherein the membrane separates the reservoir from an external medium into which the soluble form of drug is delivered.”
However, Cima teaches a method for treating a patient suffering from a condition (see [0022]: i.e.: interstitial cystitis or [0105]: non-bladder body cavity sites requiring therapy), the method comprising implanting in the patient a device (see FIG. 1 and [0002], [0015], [0022-0024]) comprising a membrane (30, see FIG. 3B), a reservoir (32, see [0068]) and a formulation (34) contained in (see [0067]: formulation drug core housed in reservoir and [0068]: a drug rod 34 in reservoir 32) the reservoir (32), wherein the formulation (34) comprises a sparingly water-soluble drug having a soluble form and an insoluble form (see [0069]: water permeable tube allows liquid to enter to solubilize portion of drug and [0097]: drug provided as solid drug rod. Therefore, the amount of solid drug left is the insoluble form while the dissolved/solubilized portion as in [0069] is the soluble form), wherein the formulation when hydrated (see [0069]: water permeable tube allows water/ other liquid to enter device to solubilize the drug) provides a concentration of drug in the soluble form freely diffusing out of the device across the membrane (see [0069-0070]: drug can be released via apertures or by diffusion through the tube/membrane wall), and a concentration of drug in the insoluble form retained in the device by the membrane (see [0097]), and wherein the membrane (30) separates the reservoir (34) from an external medium into which the soluble form of drug is delivered (i.e. the bladder, see [0058]: device implanted in bladder or other implanted sites as noted in [0105]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have combined the method for treating a patient suffering from schizophrenia including subcutaneously implanting a rod-shaped device containing a drug formulation for the treatment of schizophrenia disclosed in Siegel with the method for treating a patient including implanting a device with a membrane, reservoir, and a sparingly water-soluble formulation contained within the reservoir taught in Cima.
A person of ordinary skill in the art could have combined the elements (Siegel: subcutaneously implanting a device with a formulation and dosage specific to the treatment of schizophrenia and Cima: implanting a device comprising a membrane and sparingly water-soluble formulation disposed in a reservoir to release a formulation according to a specific release profile appropriate for treating a number of conditions) as claimed by known methods (Siegel discloses a rod implant containing the formulation for treating schizophrenia and Cima teaches a drug rod reservoir within the implantable device comprising a membrane.) with no change to the respective functions (both Siegel and Cima are intended to release a drug according to a release profile appropriate for treating a condition). Further, the combination would yield nothing more than predictable results (an implanted device having a drug formulation in the form of a rod reservoir for delivering the formulation in accordance with a drug release profile appropriate for treating a condition) to one of ordinary skill in the art, thus achieving the device “comprising a membrane, a reservoir and a formulation contained in the reservoir,” wherein the formulation “when hydrated” provides a concentration of drug in the soluble form freely diffuses out of the device “across the membrane, and a concentration of drug in the insoluble form is retained in the device by the membrane,” and “wherein the membrane separates the reservoir from an external medium into which the soluble form of drug is delivered.”
Regarding claim 2, the modified method of Siegel teaches the method according to claim 1, and Siegel further discloses wherein the sparingly water-soluble drug (see FIG.3 & [0013]: release profile showing total mass of Risperidone released. If only some mass of the total is released, there must be some mass of the total still contained within the implant and therefore the formulation is sparingly water-soluble. see [0127]: risperidone is controllably released as a flowable composition where the initial state of the drug is insoluble. Thus, the released mass==soluble form and the initial state and mass that is not yet released from implant==insoluble.) is a neuroleptic agent (see at least [0009] & [0114]: 9-OH risperidone is the drug released, aligning with Applicant’s definition of neuroleptic in at least [0014]).
Regarding claim 5, the modified method of Siegel teaches the method according to claim 2, and Siegel further discloses wherein the total amount of said neuroleptic agent loaded in said reservoir is greater than 100 mg (see Example 7 including [0165]: Siegel discloses a 600mg implant for a 50kg human patient for long-term delivery of 1 year).
Regarding claim 8, the modified method of Siegel teaches the method according to claim 2, and Siegel further discloses wherein the neuroleptic agent is risperidone, 9-hydroxyrisperidone or a pharmaceutically acceptable salt thereof (see [0009]: risperidone or 9-OH-Risperidone and [0114]: risperidone or 9-OH-Risperidone).
Regarding claim 9, the modified method of Siegel teaches the method according to claim 2, and Siegel further discloses wherein the neuroleptic agent is olanzapine, paliperidone, asenapine, haloperidol or aripiprazole or a pharmaceutically acceptable salt thereof (see [0087]: risperidone, 9-OH-risperidone, haloperidol, olanzapine, aripiprazole, or combination thereof).
Regarding claim 10, the modified method of Siegel teaches the method according to claim 1, but Siegel is silent to “wherein the device comprises a non-erodible, non-porous housing member.”
However, Cima teaches a method for treating a disorder comprising implanting a device (10, see FIG. 1 and [0010], [0015], [0021-0023]: implantation) with a reservoir (32, see FIG. 3B) for delivering a drug formulation (see [0058] & [0067]), wherein the device comprising a non-erodible, non-porous housing member (14, see [0065]: housing of device may be formed of stainless steel).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the implantable device disclosed in Siegel with a non-erodible, non-porous housing member as taught by Cima for the purpose of forming non-resorbable pieces of the device for extraction from a patient when treatment is complete (see [0065]), thus achieving “wherein the device comprises a non-erodible, non-porous housing member.”
Regarding claim 11, the modified method of Siegel teaches the method according to claim 10, but Siegel is silent to “wherein the housing member is a metal.”
However, Cima teaches a method for treating a disorder comprising implanting a device (10, see FIG. 1 and [0010], [0015], [0021-0023]: implantation) with a reservoir (32, see FIG. 3B) for delivering a drug formulation (see [0058] & [0067]), wherein the device comprising a non-erodible, non-porous housing member (14, see [0065]: housing of device may be formed of stainless steel), wherein the housing member is a metal (see [0065]: stainless steel).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the implantable device disclosed in Siegel with a non-erodible, non-porous housing member formed of a metal as taught by Cima for the purpose of forming non-resorbable pieces of the device for extraction from a patient when treatment is complete (see [0065]), thus achieving “wherein the housing member is a metal.”
Regarding claim 12, the modified method of Siegel teaches the method according to claim 1, but Siegel is silent to “wherein the membrane is selected from a polymer membrane, a sintered metallic membrane, and a ceramic membrane.”
However, Cima teaches a method for treating a patient suffering from a condition (see [0022]: i.e.: interstitial cystitis or [0105]: non-bladder body cavity sites requiring therapy), the method comprising implanting in the patient a device (see FIG. 1 and [0002], [0015], [0022-0024]) comprising a membrane (30, see FIG. 3B and [0068]: elastomeric tube 30), wherein the membrane is selected from a polymer membrane, a sintered metallic membrane, and a ceramic membrane (see [0014]: elastomeric tube can be water permeable material such as silicone == a polymer membrane).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the membrane used in the method taught by Siegel in view of Cima to be a polymer membrane as taught by Cima for the purpose of forming the membrane as a water permeable material such that water permeates the membrane to aid in delivery of the drug (see [0069]), thus achieving “wherein the membrane is selected from a polymer membrane, a sintered metallic membrane, and a ceramic membrane.”
Regarding claim 13, the modified method of Siegel teaches the method according to claim 1, and Siegel further discloses wherein the solubility-modifying excipient is a biocompatible, bioerodible polymer (see [0114]: solubility-modifying excipient is copolymer PLGA).
Regarding claim 14, the modified method of Siegel teaches the method according to claim 1, and Siegel further discloses wherein the polymer is selected from the group of polylactides, polyglycolides, and copolymers thereof (see [0114]: copolymer PLGA).
Regarding claim 15, the modified method of Siegel teaches the method according to claim 14, and Siegel further discloses wherein the polymer is a co- polymer of polylactic acid and polyglycolic acid monomeric units (see [0114]: PLGA), wherein the polylactic acid content is between about 50% to 100% (see [0114]: ratio of poly(lactide/glycolide) is 50:50, thus discloses a content at 50% within the claimed range).
Regarding claim 19, the modified method of Siegel teaches the method of claim 1, and Siegel discloses the implant can be formed as an implantable osmotic pump (see [0130]: drug can be provided as implantable osmotic pump to provide controlled dosage release), but Siegel is silent to “wherein the formulation when hydrated has a continuous aqueous phase comprising the soluble form of the drug and the insoluble form of the drug.”
However, Cima teaches a method for treating a patient suffering from a condition (see [0022]: i.e.: interstitial cystitis or [0105]: non-bladder body cavity sites requiring therapy), the method comprising implanting in the patient a device (see FIG. 1 and [0002], [0015], [0022-0024]) comprising a membrane (30, see FIG. 3B), a reservoir (32, see [0068]) and a formulation (34) contained in (see [0067]: formulation drug core housed in reservoir and [0068]: a drug rod 34 in reservoir 32) the reservoir (32). Cima further teaches the device formed as an osmotic pump wherein the formulation when hydrated has a continuous aqueous phase comprising the soluble form of the drug and the insoluble form of the drug (see [0068-0069]: drug reservoir operates as osmotic pump and solubilized drug is dispensed at controlled rate-- dependent on the device design and parameters—when the device contacts water==when hydrated. Osmotic pump delivering a solubilized drug inherently has continuous aqueous phase in order to enable operation of osmotic pump operation).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Siegel in view of Cima to include the formulation as an osmotic pump such that the formulation when hydrated has a continuous aqueous phase comprising the soluble form of the drug and the insoluble form of the drug as taught by Cima for the purpose of allowing water within the body to activate and aid in drug delivery (see [0069]), thus achieving “wherein the formulation when hydrated has a continuous aqueous phase comprising the soluble form of the drug and the insoluble form of the drug.”
Regarding claim 20, the modified method of Siegel teaches the method of claim 1, but Siegel is silent to “wherein the device comprises a single membrane through which drug is delivered to the patient.”
However, Cima teaches a method for treating a patient suffering from a condition (see [0022]: i.e.: interstitial cystitis or [0105]: non-bladder body cavity sites requiring therapy), the method comprising implanting in the patient a device (see FIG. 1 and [0002], [0015], [0022-0024]) comprising a membrane (30, see FIG. 3B), a reservoir (32, see [0068]) and a formulation (34) contained in (see [0067]: formulation drug core housed in reservoir and [0068]: a drug rod 34 in reservoir 32) the reservoir (32). Cima further teaches wherein the device comprises a single membrane (30, see FIG.3B) through which drug is delivered to the patient (see [0068-0069]: permeation of membrane provides drug delivery via osmotic pump).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Siegel in view of Cima to include the formulation as an osmotic pump such that the device comprises a single membrane through which drug is delivered as taught by Cima for the purpose of allowing water within the body to activate and aid in drug delivery (see [0069]) and for allowing the surface area of the single membrane to modify the delivery rate (see [0069]), thus achieving “wherein the device comprises a single membrane through which drug is delivered to the patient.”
Claims 3-4 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siegel in view of Cima as applied to claim 2 above, and further in view of DeGraaff et al. (U.S. PGPUB No. 2010/0203104), hereinafter DeGraaff.
Regarding claim 3, the modified method of Siegel teaches the method according to claim 2, and Siegel further discloses wherein the neuroleptic agent is provided at a dose (There are several examples of different release profiles depending on the composition. See [0186]: the risperidone rod implant has a designed release profile over a 2-month period. The release profile may be altered by varying the monomer ratio, initial drug loading, and fabrication procedures. See also [0185]: design for 12-14 month release dose and [0200]: release profile designed to achieved therapeutic levels from 3 weeks to 6-8 months after implantation.), but Siegel is silent to the dose “of about 0.5 mg/day to about 3 mg/day”.
However, DeGraaff teaches a method for treating a patient suffering from schizophrenia (see [0001-0004]) comprising delivering a drug comprising a neuroleptic agent (see [0023]: risperidone), wherein the neuroleptic agent is provided at a dose of about 0.5mg/day to about 3mg/day (see [0023]: delivering risperidone at 0.5 to 10mg/day, therefore disclosing the claimed range).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the release profile of the neuroleptic agent dose disclosed in Siegel to specifically be about 0.5mg/day to about 3mg/day as taught by DeGraaff for the purpose of providing the neuroleptic agent for extended release while avoiding dose-dumping (see [0012-0013] & [0081]: in rod form, the device provided the same safety against dose-dumping as in the ring form), thus achieving the dose of about 0.5 mg/day to about 3 mg/day
Regarding claim 4, the modified method of Siegel teaches the method according to claim 3, and Siegel further discloses wherein the neuroleptic agent is provided for a period of about 2 months to about 6 months (There are several examples of different release profiles depending on the composition. See [0186]: the risperidone rod implant has a designed release profile over a 2-month period. The release profile may be altered by varying the monomer ratio, initial drug loading, and fabrication procedures. See also [0079]: 3-10 months or 14days to 6 months, [0111]: 3-6 months, or [0165]: 6 months or more).
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siegel in view of Cima as applied to claim 2 above, and further in view of Gieling et al. (U.S. PGPUB No. 2004/0266791), hereinafter Gieling.
Regarding claim 6, the modified method of Siegel discloses the method according to claim 2, and Siegel further discloses wherein the neuroleptic agent is present in soluble and insoluble forms at 100 mg/mL (see [0064]: the drug is soluble at greater than 100mg/mL. and see [0127]: risperidone is controllably released as a flowable composition and thus has soluble and insoluble form. Therefore, if the drug is present in soluble form as disclosed in [0127], the drug must be provided in an amount of at least 100mg/mL to enable soluble form as disclosed).
Siegel is silent to the soluble and insoluble forms “in a total amount of greater than 100 mg/mL.”
However, Gieling teaches a method for treating a patient suffering from schizophrenia (see [0003], [0057]: risperidone formulations intended to treat disorders such as schizophrenia) providing administering a neuroleptic agent to the patient (see [0057]: administering to patient and [0023]: neuroleptic agent is prepared as a hydrate), wherein the neuroleptic agent is present in soluble and insoluble forms (see [0004]: risperidone sparingly water-soluble and this is present in soluble and insoluble forms) in a total amount of greater than 100mg/mL (see [0009]: solubility up to 200mg/mL and see solubility table in [0020] showing solubility of risperidone mesylate of Gieling as in [0019] greater than 160mg/mL--therefore, risperidone MUST be present in a soluble/ insoluble form within the solution greater than 100 mg/mL).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the formulation containing the risperidone neuroleptic agent disclosed by Siegel to include the risperidone mesylate salt and corresponding solubility taught by Gieling for the purpose of using a risperidone salt that is especially designed for use most preferably in an aqueous solution delivery method (see [0046]), thus achieving wherein the neuroleptic agent is present in soluble and insoluble forms “in a total amount of greater than 100 mg/mL”.
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siegel in view of Cima and Gieling as applied to claim 6 above, and further in view of DeGraaff (U.S. PGPUB No. 2010/0203104).
Regarding claim 7, the modified method of Siegel teaches the method according to claim 6, and Siegel further discloses methods for modifying the drug solubility (see [0076]: how to increase solubility and [0137]: composition influence on solubility), but Siegel is silent to “wherein the soluble fraction of drug is less than 1% of the total.”
However, DeGraaff teaches a method for treating a patient suffering from schizophrenia (see [0001-0004]) comprising delivering a drug comprising a neuroleptic agent (see [0015]: risperidone), wherein the soluble fraction of drug is less than 1% of the total (see 0015]: risperidone in the copolymer has solubility of 0.1 wt%, thus discloses a soluble fraction less than 1% of the total).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug solubility of the drug delivered by the method disclosed in Siegel to be a soluble fraction less than 1% of the total as taught by DeGraaff for the purpose of achieving a specific drug release rate dependent on the solubility of risperidone (see [0033]: release rate, such as 0.5 to 10mg/day is result of many factors including the dissolution rate of risperidone which is determined by risperidone solubility), thus achieving “wherein the soluble fraction of drug is less than 1% of the total.”
Claim 21 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siegel in view of Cima and Gieling as applied to claim 1 above, and further in view of Peery et al. (U.S. Patent No. 5,728,396), hereinafter Peery.
Regarding claim 21, the modified method of Siegel teaches the method of claim 1, and Siegel discloses subcutaneously implanting the device (see [0115], [0120], [0160] & [0193]: rod implant implanted subcutaneously through 4mm hole), but Siegel is silent to “wherein subcutaneously implanting the device comprises placing the device in a trocar and inserting the trocar loaded with the device through an incision in the patient's skin.”
However, Peery teaches a method for treating a patient suffering from a condition (see col. 1 lines 20-52: subcutaneous implantable devices and col. 10 line 64 – col. 11 line 51: device includes active agent for specific treatment), the method comprising subcutaneously implanting a device in the patient (see col. 11 lines 52-59: device can comprise any subcutaneous position or body cavity, wherein subcutaneously implanting the device comprises placing the device in a trocar and inserting the trocar loaded with the device through an incision in the patient's skin (see col. 13 lines 17-38: ‘Example 2’: an incision is made in the skin, the trocar is inserted into the incision and the obturator delivers the drug under the skin).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method including subcutaneous implantation of a drug delivery device disclosed in Siegel to include subcutaneous implantation via a trocar inserted through a skin incision as taught by Peery for the purpose of implanting the device using a procedure known in the art to provide sterile implantation of drug delivery devices (see col. 13 lines 20-25), thus achieving ““wherein subcutaneously implanting the device comprises placing the device in a trocar and inserting the trocar loaded with the device through an incision in the patient's skin.”
Response to Arguments
Applicant's arguments filed 08/08/25 have been fully considered but they are not persuasive.
On page 7 of Applicant Remarks, Applicant indicates that Siegel fails to disclose subcutaneous implantation. However, the examiner disagrees as set forth in the citations in the rejection of at least claim 1 above (see at least [0160]: “implant fabrication was modified to produce rod-shaped implants that can be inserted through a 4 mm hole. Rigid PLGA implants obviate the need for a tool to guide the implants under the skin, to ensure subcutaneous, rather than intramuscular insertion”. [0160] is cited in the evidence of the rejection of claim 1). Therefore the examiner was not persuaded by this argument and maintained the rejection of claim 1, now including the subject matter of previously presented and now cancelled claim 18, under Siegel in view of Cima.
All other previous arguments in the remarks filed 08/08/25 were directed to prior art combinations that are no longer used in the current rejection due to the amendment to independent claim1. Therefore, the arguments of pages 5-6 are rendered moot.
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 KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/LOAN B JIMENEZ/Supervisory Patent Examiner, Art Unit 3784