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 .
Response to Amendment
The amendment filed on 12/19/2025 has been entered. Claims 1, 3, 5-13, and 15-22 are pending in the application. Claims 2, 4, and 14 are cancelled. Claim 22 is new. The amendments to the claims, specification, and drawings overcome each and every objection, 112(b) rejection, and 112(d) rejection previously set forth in the Non-Final Office Action mailed on 8/19/2025.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. At least pages 6, 16, 19, and 26 of the Specification contain references which are not listed on an IDS and thus have not been considered by the Examiner.
Drawings
The drawings were received on 12/19/2025. These drawings are acceptable.
Claim Objections
Claims 1, 6-8, 10, and 18-19 are objected to because of the following informalities:
-Claim 1, line 10: please correct “one chamber” to “one chamber of the plurality of modular or replaceable chambers”
-Claim 1, line 11: please correct “another chamber” to “another chamber of the plurality of modular or replaceable chambers”
-Claim 1, line 12: please correct “one or more” to “the one or more”
-Claim 1, line 12: please correct “one chamber” to “the one chamber”
-Claim 1, line 13: please correct “another chamber” to “the another chamber”
-Claim 1, lines 18-19: please correct “of the composition into the skin” to “to the skin of the subject the composition”
-Claim 6, line 1: please correct “the microneedles” to “the microneedles each”
-Claim 6, line 2: please correct “the outer wall” to “an outer wall”
-Claim 6, line 2: please correct “the microneedle” to “each of the plurality of microneedles”
-Claim 6, lines 2-3: please correct “the single groove” to “each of the single grooves”
-Claim 6, lines 3-4: please correct “the microneedle” to “each of the plurality of microneedles”
-Claim 7, line 1: please correct “the microneedles” to “the plurality of microneedles each”
-Claim 8, line 1: please correct “the microneedles” to “the plurality of microneedles each”
-Claim 10, line 1: please correct “the microneedles” to “the plurality of microneedles each”
-Claim 18, lines 1-2: please correct “the additional therapy” to “the one or more additional therapies”
-Claim 19, line 3: please correct “microchannel” to “microneedle drug”
-Claim 19, line 7: please correct “one chamber” to “one chamber of the plurality of modular or replaceable chambers”
-Claim 19, line 8: please correct “another chamber” to “another chamber of the plurality of modular or replaceable chambers”
-Claim 19, line 9: please correct “one or more” to “the one or more”
-Claim 19, line 9: please correct “one chamber” to “the one chamber”
-Claim 19, line 10: please correct “another chamber” to “the another chamber”
-Claim 19, line 16: please correct “a subject’s skin” to “skin of a subject”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 9, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sumida (US 2016/0114144 A1).
Regarding claim 1, Sumida discloses a method for treating a condition or a disease in a subject (see Figs. 1-3), comprising administering to skin of the subject a composition comprising an effective amount of one or more bioactive formulations (see Figs. 1-3, par. [0021], [0049], [0053]), wherein the composition is administered with a multi-chamber microchannel delivery device (see Figs. 1-3), wherein the multi-chamber microchannel delivery device (see Figs. 1-3) comprises
a plurality of modular or replaceable chambers (chambers of outer cylinder 10a and injection needle attachment protrusion connection hole 18a) (see Figs. 1-3, par. [0028], [0038], [0049]), wherein the plurality of modular or replaceable chambers (chambers of outer cylinder 10a and injection needle attachment protrusion connection hole 18a) can hold the one or more bioactive formulations (chambers of outer cylinder 10a and injection needle attachment protrusion connection hole 18a), wherein one chamber (chamber of outer cylinder 10a) contains a pin (injection needle attachment protrusion 10b) that punctures another chamber (chamber of injection needle attachment protrusion connection hole 18a) to allow flow of one or more bioactive formulations from one chamber (chamber of outer cylinder 10a) to another chamber (chamber of injection needle attachment protrusion connection hole 18a) (see Figs. 1-3, par. [0028], [0038], [0049]-[0050]);
a plurality of microneedles (plurality of hollow acicular bodies 14a), wherein the plurality of microneedles (plurality of hollow acicular bodies 14a) are hollow (see par. [0029], only one of “hollow or non-hollow” is required by the claim);
a reservoir (reservoir between bottom surface of injector supporting member 18, top surface of main body 14, and liquid-tight structure 20) that holds the one or more bioactive formulations to be delivered (see Figs. 1-3, par. [0043]-[0045], [0050]); and
a spring system that enables the administering of the composition into the skin (see par. [0063]-[0065]),
wherein the administering comprises pressing a distal end of an external push assembly (plunger 10d) to enable a repeated motion of penetrating the multi-chamber microchannel delivery device into the skin of the subject (see par. [0049]-[0052], [0063]-[0065]).
Regarding claim 5, Sumida discloses the method of claim 1, wherein the spring system (see par. [0063]-[0065]) comprises a plate (see par. [0064], drive member) and spring (see par. [0065], tension/compression spring) that allows the composition to flow only when the multi-chamber microchannel delivery device (see Figs. 1-3) is tapped into the skin (see par. [0063]-[0065]).
Regarding claim 9, Sumida discloses the method of claim 1, wherein the plurality of microneedles (plurality of hollow acicular bodies 14a) comprises an array of microneedles in a shape of a circle (see Figs. 1-3, par. [0035], [0051], main body supporting member 16 has a cylindrical shape with a circular end region CR and a circular opening 16a for accommodating a circular main body 14 where the microneedles are located).
Regarding claim 19, Sumida discloses a multi-chamber microneedle drug delivery device comprising a composition comprising an effective amount of one or more bioactive formulations (see Figs. 1-3, par. [0021], [0049], [0053]), wherein the multi-chamber microchannel delivery device (see Figs. 1-3) comprises
a plurality of modular or replaceable chambers (chambers of outer cylinder 10a and injection needle attachment protrusion connection hole 18a) (see Figs. 1-3, par. [0028], [0038], [0049]), wherein the plurality of modular or replaceable chambers (chambers of outer cylinder 10a and injection needle attachment protrusion connection hole 18a) can hold the one or more bioactive formulations (chambers of outer cylinder 10a and injection needle attachment protrusion connection hole 18a), wherein one chamber (chamber of outer cylinder 10a) contains a pin (injection needle attachment protrusion 10b) that punctures another chamber (chamber of injection needle attachment protrusion connection hole 18a) to allow flow of one or more bioactive formulations from one chamber (chamber of outer cylinder 10a) to another chamber (chamber of injection needle attachment protrusion connection hole 18a) (see Figs. 1-3, par. [0028], [0038], [0049]-[0050]);
a plurality of microneedles (plurality of hollow acicular bodies 14a), wherein the plurality of microneedles (plurality of hollow acicular bodies 14a) are hollow (see par. [0029], only one of “hollow or non-hollow” is required by the claim);
a reservoir (reservoir between bottom surface of injector supporting member 18, top surface of main body 14, and liquid-tight structure 20) that holds the one or more bioactive formulations to be delivered (see Figs. 1-3, par. [0043]-[0045], [0050]); and
a spring system that enables administering of the composition into a subject’s skin (see par. [0063]-[0065]).
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 3, 6-7, 17-18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sumida (US 2016/0114144 A1), as applied to claim 1 above, in view of Eum (US 2014/0066864 A1).
Regarding claim 3, Sumida discloses the method of claim 1. However, Sumida fails to state wherein the plurality of microneedles are non-hollow.
Eum teaches a method (see Figs. 6-9) comprising administering one or more bioactive formulations with a multi-chamber microchannel delivery device comprising a plurality of microneedles (see Figs. 6-9, par. [0002]), wherein the plurality of microneedles are non-hollow (see Figs. 6-7, par. [0067]-[0069]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida to include wherein the plurality of microneedles are non-hollow, as taught by Eum, in order to inject the bioactive formulation(s) more slowly, improve efficiency, and inhibit breakage of the microneedles (see Eum par. [0068]-[0069]).
Regarding claim 6, Sumida discloses the method of claim 1. However, Sumida fails to state wherein the microneedles have a single groove inset along the outer wall of the microneedle, wherein the single groove has a screw thread shape going clockwise or counterclockwise around the microneedle.
Eum teaches a method (see Figs. 6-9) comprising administering one or more bioactive formulations with a multi-chamber microchannel delivery device comprising a plurality of microneedles (see Figs. 6-9, par. [0002]), wherein the microneedles have a single groove (recess 36) inset along the outer wall of the microneedle (see Fig. 6, par. [0067]), wherein the single groove (recess 36) has a screw thread shape going clockwise or counterclockwise around the microneedle (see Figs. 6-7, par. [0067]-[0069]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida to include wherein the microneedles have a single groove inset along the outer wall of the microneedle, wherein the single groove has a screw thread shape going clockwise or counterclockwise around the microneedle, as taught by Eum, in order to inject the bioactive formulation(s) more slowly, improve efficiency, and inhibit breakage of the microneedles (see Eum par. [0068]-[0069]).
Regarding claim 7, Sumida discloses the method of claim 1. However, Sumida fails to state wherein the microneedles are from 0.1 mm to about 25 mm in length and from 0.01 mm to about 0.05 mm in diameter.
Eum teaches a method (see Figs. 17-18) comprising administering one or more bioactive formulations with a multi-chamber microchannel delivery device comprising a plurality of microneedles (see Figs. 17-18, par. [0002]), wherein the microneedles (micro needles A) are from 0.1 mm to about 25 mm in length (see par. [0113]) and from 0.01 mm to about 0.05 mm in diameter see par. [0112]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida to include wherein the microneedles are from 0.1 mm to about 25 mm in length and from 0.01 mm to about 0.05 mm in diameter, as taught by Eum, in order to reach the dermis of the skin without causing pain (see Eum par. [0112]-[0113]).
Regarding claim 17, Sumida discloses the method of claim 1. However, Sumida fails to state further comprising administering to the subject one or more additional therapies.
Eum teaches a method comprising administering to the subject one or more additional therapies (see par. [0079] and [0085]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida to include administering to the subject one or more additional therapies, as taught by Eum, in order to increase the efficiency of transfer of the medication from the device into the skin, excite skin cells, remove environmental pollution, improve cosmetic effects, reduce inflammation, and improve blood circulation (see Eum par. [0079] and [0085]).
Regarding claim 18, Sumida discloses the method of claim 17. Modified Sumida further teaches wherein the additional therapy includes radiation (see Eum par. [0079] and [0085], see previous modifications in the rejection of claim 17 above, infrared rays are a type of electromagnetic radiation).
Regarding claim 22, Sumida discloses the method of claim 1. However, Sumida fails to state wherein one or multiple grooves are inset along an outer wall of each of the plurality of microneedles, wherein the composition is delivered into the skin by passing through the one or multiple grooves along the outer wall of each of the plurality of microneedles.
Eum teaches a method (see Figs. 6-9) comprising administering one or more bioactive formulations with a multi-chamber microchannel delivery device comprising a plurality of microneedles (see Figs. 6-9, par. [0002]), wherein one or multiple grooves (recess 36) are inset along an outer wall of each of the plurality of microneedles (see Fig. 6, par. [0067]), wherein the composition is delivered into the skin by passing through the one or multiple grooves (recess 36) along the outer wall of each of the plurality of microneedles (see Figs. 6-7, par. [0067]-[0069]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida to include wherein one or multiple grooves are inset along an outer wall of each of the plurality of microneedles, wherein the composition is delivered into the skin by passing through the one or multiple grooves along the outer wall of each of the plurality of microneedles, as taught by Eum, in order to inject the bioactive formulation(s) more slowly, improve efficiency, and inhibit breakage of the microneedles (see Eum par. [0068]-[0069]).
Claims 8, 10-11, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sumida (US 2016/0114144 A1), as applied to claim 1 above, in view of Chang et al. (US 2016/0175408 A1).
Regarding claim 8, Sumida discloses the method of claim 1. However, Sumida fails to expressly state wherein the microneedles are made from a substance comprising gold.
Chang teaches a method comprising administering a composition into the skin with a microchannel delivery device (see Figs. 1-10) comprising microneedles made from a substance comprising gold (see par. [0466]-[0467] and [0486]-[0488]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida such that the microneedles are made from a substance comprising gold, as taught by Chang, because Chang teaches that gold is a suitable material for drug-delivering microneedles (see Chang par. [0466]-[0467] and [0486]-[0488]).
Regarding claim 10, Sumida discloses the method of claim 1. However, Sumida fails to expressly state wherein the microneedles are made of 24-karat gold plated stainless steel and comprise an array of 20 microneedles.
Chang teaches a method comprising administering a composition into the skin with a microchannel delivery device (see Figs. 1-10) comprising microneedles which are made of 24-karat gold plated stainless steel and comprise an array of 20 microneedles (see par. [0466]-[0467] and [0486]-[0488], the table of par. [0488] shows that devices 1 and 2 have 20 microneedles made of 24-karat gold plated stainless steel).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida such that the microneedles are made of 24-karat gold plated stainless steel and comprise an array of 20 microneedles, as taught by Chang, because Chang teaches that 20 microneedles made of 24-karat gold plated stainless steel is a suitable for drug-delivery (see Chang par. [0466]-[0467] and [0486]-[0488]).
Regarding claim 11, Sumida discloses the method of claim 1. However, Sumida fails to expressly state wherein the one or more bioactive formulations are selected from the group consisting of hyaluronic acid, botulinum toxin, platelet-rich plasma, polylactic acid, cannabinoids, vitamins, minerals, bimatoprost, and minoxidil.
Chang teaches a method comprising administering a composition comprising one or more bioactive formulations selected from the group consisting of hyaluronic acid, botulinum toxin, platelet-rich plasma, polylactic acid, cannabinoids, vitamins, minerals, bimatoprost, and minoxidil (see par. [0057]-[0059]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida such that the one or more bioactive formulations are selected from the group consisting of hyaluronic acid, botulinum toxin, platelet-rich plasma, polylactic acid, cannabinoids, vitamins, minerals, bimatoprost, and minoxidil, as taught by Chang, in order to improve skin health and aesthetics in the subject (see Chang par. [0057]-[0059]).
Regarding claim 15, Sumida discloses the method of claim 1. However, Sumida fails to expressly state wherein the disease or the condition is selected from the group consisting of anorexia, emesis, sunburn, photodamaged skin, acne, psoriasis, atopic dermatitis, pain, inflammation, multiple sclerosis, neurodegenerative disorders (e.g. Parkinson's disease, Huntington's disease, Tourette's syndrome, Alzheimer's disease), epilepsy, glaucoma, osteoporosis, schizophrenia, cardiovascular disorders, cancer, actinic keratosis, obesity, and metabolic syndrome-related disorders.
Chang teaches a method for treating a condition or disease in a subject comprising administering to the subject's skin a composition, wherein the disease or condition is selected from the group consisting of anorexia, emesis, sunburn, photodamaged skin, acne, psoriasis, atopic dermatitis, pain, inflammation, multiple sclerosis, neurodegenerative disorders (e.g. Parkinson's disease, Huntington's disease, Tourette's syndrome, Alzheimer's disease), epilepsy, glaucoma, osteoporosis, schizophrenia, cardiovascular disorders, cancer, actinic keratosis, obesity, and metabolic syndrome-related disorders (see par. [0005], [0084], [0120], [0148], [0150], [0152]-[0153], [0155], [0157], [0165], [0171], [0182], [0441], at least photodamaged skin, acne, psoriasis, dermatitis, pain, inflammation, Alzheimer's disease, glaucoma, osteoporosis, schizophrenia, cardiovascular disorders, and cancer are contemplated by Chang to be treatable with their method).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida such that the administered compound treats a disease or condition selected from the group consisting of anorexia, emesis, sunburn, photodamaged skin, acne, psoriasis, atopic dermatitis, pain, inflammation, multiple sclerosis, neurodegenerative disorders (e.g. Parkinson's disease, Huntington's disease, Tourette's syndrome, Alzheimer's disease), epilepsy, glaucoma, osteoporosis, schizophrenia, cardiovascular disorders, cancer, actinic keratosis, obesity, and metabolic syndrome-related disorders, as taught by Chang, in order to provide therapeutic effects targeted to patients having these specific diseases/conditions (see Chang par. [0005], [0084], [0120], [0148], [0150], [0152]-[0153], [0155], [0157], [0165], [0171], [0182], [0441]).
Regarding claim 16, Sumida discloses the method of claim 1. However, Sumida fails to expressly state wherein the disease or condition is selected from cervical dystonia, glabellar lines, forehead lines, lateral canthal lines (Crow's feet), upper limb spasticity, lower limb spasticity, blepharospasms, strabismus, sialorrhea, hemifacial spasm, axillary hyperhidrosis, chronic migraine, neurogenic detrusor overactivity, overactive bladder, urinary incontinence, Plantar Fasciitis , cerebral palsy, acquired nystagmus, anal fissures, headache, tardive dyskinesia, achalasia, eyelid convulsion, muscle spasticity, dynamic equinus foot deformity, Raynaud phenomenon, and psychological conditions such as depression.
Chang teaches a method for treating a condition or disease in a subject comprising administering to the subject's skin a composition, wherein the disease or condition is selected from cervical dystonia, glabellar lines, forehead lines, lateral canthal lines (Crow's feet), upper limb spasticity, lower limb spasticity, blepharospasms, strabismus, sialorrhea, hemifacial spasm, axillary hyperhidrosis, chronic migraine, neurogenic detrusor overactivity, overactive bladder, urinary incontinence, Plantar Fasciitis , cerebral palsy, acquired nystagmus, anal fissures, headache, tardive dyskinesia, achalasia, eyelid convulsion, muscle spasticity, dynamic equinus foot deformity, Raynaud phenomenon, and psychological conditions such as depression. (see par. [0007], [0043], [0147], [0154], [0177], [0225], at least cervical dystonia, forehead lines, lateral canthal lines (Crow's feet), axillary hyperhidrosis, chronic migraine, overactive bladder, urinary incontinence, headache, tardive dyskinesia, and psychological conditions such as depression are contemplated by Chang to be treatable with their method).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida such that the administered compound treats a disease or condition selected from cervical dystonia, glabellar lines, forehead lines, lateral canthal lines (Crow's feet), upper limb spasticity, lower limb spasticity, blepharospasms, strabismus, sialorrhea, hemifacial spasm, axillary hyperhidrosis, chronic migraine, neurogenic detrusor overactivity, overactive bladder, urinary incontinence, Plantar Fasciitis, cerebral palsy, acquired nystagmus, anal fissures, headache, tardive dyskinesia, achalasia, eyelid convulsion, muscle spasticity, dynamic equinus foot deformity, Raynaud phenomenon, and psychological conditions such as depression, as taught by Chang, in order to provide therapeutic effects targeted to patients having these specific diseases/conditions (see Chang par. [0007], [0043], [0147], [0154], [0177], [0225]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Sumida (US 2016/0114144 A1), as applied to claim 1 above, in view of Santini, Jr. et al. (US 2008/0015494 A1).
Regarding claim 12, Sumida discloses the method of claim 1. However, Sumida fails to expressly state wherein the one or more bioactive formulations are administered with an effective amount of an antineoplastic agent.
Santini, Jr. teaches a method comprising administering one or more bioactive formulations with an effective amount of an antineoplastic agent (see par. [0101]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sumida such that the one or more bioactive formulations are administered with an effective amount of an antineoplastic agent, as taught by Santini, Jr., in order to provide additional therapeutic effects from the antineoplastic agent (see Santini, Jr. par. [0101]).
Regarding claim 13, modified Sumida teaches the method of claim 12 substantially as claimed. Modified Sumida further teaches wherein the antineoplastic agent is selected from the group consisting of alkylating agents, platinum compounds (e.g., cisplatin, carboplatin, oxaliplatin, mechlorethamine, cyclophosphamide, chlorambucil, ifosfamide), antimetabolic agents (e.g., purine and pyrimidine analogues, antifolates), anthracyclines (doxorubicin, daunorubicin, valrubicin, idarubicin, epirubicin), cytotoxic antibiotics (actinomycin, bleomycin, plicamycin, mitomycin), monoclonal antibodies (e.g., Alemtuzumab, Bevacizumab, Cetuximab, Gemtuzumab, Ibritumomab, Panitumumab, Rituximab, Tositumomab, and Trastuzumab), kinase inhibitors (e.g., imatinib, erlotinib, gefitinib), plant alkaloids and terpenoids, topoisomerase inhibitors (e.g., camptothecins, irinotecan, topotecan, amsacrine, etoposide, etoposide phosphate, teniposide), vinca alkaloids (e.g., vincristine, vinblastine, vinorelbine, vindesine), taxanes (e.g., paclitaxel, taxol, docetaxel), podophyllotoxins, epipodophyllotoxins and combinations thereof (see previous modifications in rejection of claim 12 above; see Santini, Jr. par. [0101], at least doxorubicin and paclitaxel are disclosed by Santini, Jr.).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sumida (US 2016/0114144 A1), as applied to claim 19 above, in view of Egeland et al. (US 2018/0001028 A1).
Regarding claim 20, Sumida discloses the multi-chamber microneedle drug delivery device of claim 19. However, Sumida fails to state wherein the one or more bioactive formulations are in lyophilized or powder form.
Egeland teaches a multi-chamber microneedle drug delivery device (see Figs. 1-10, par. [0051]-[0052], [0110], [0115]), wherein the one or more bioactive formulations are in lyophilized or powder form (see Figs. 1-10, par. [0052], [0110]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sumida to include wherein the one or more bioactive formulations are in lyophilized or powder form, in order to allow mixing of two different formulations within a single device and prevent premature mixing and loss of efficiency of the formulations (see Egeland par. [0110]).
Regarding claim 21, Sumida discloses the multi-chamber microneedle drug delivery device of claim 19. However, Sumida fails to state wherein the one or more bioactive formulations are auto-reconstituted.
Egeland teaches a multi-chamber microneedle drug delivery device (see Figs. 1-10, par. [0051]-[0052], [0110], [0115]), wherein the one or more bioactive formulations are auto-reconstituted (see Figs. 1-10, par. [0052], [0110]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sumida to include wherein the one or more bioactive formulations are auto-reconstituted, in order to allow mixing of two different formulations within a single device and prevent premature mixing and loss of efficiency of the formulations (see Egeland par. [0110]).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 19 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783