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 Arguments
Applicant's arguments filed 10/30/2025 have been fully considered.
Regarding the amendment to the Specification, Applicant’s arguments are convincing. The amendment has been entered and overcomes the objection to the drawings.
Regarding the objection to claim 79, Applicant’s arguments are convincing. The amendment to the claim overcomes the objection and the objection is therefore withdrawn.
Regarding the 112 rejection, Applicant’s arguments are convincing. The amendments to the claims overcome the rejection and the rejection is therefore withdrawn.
Regarding the rejections over Dalton, Applicant’s arguments have been considered and are not convincing. Applicant argues that Dalton is silent in regards to the sharp tip section is configured to be substantially devoid of the biocompatible medical composition. This argument is not convincing. Dalton page 3, para. 0022 recites “it is preferred that the friable reservoir may be entirely held within such holes and thereby protected from breakage during puncture of the skin.” While this citation may not explicitly contain the words “the tip section is configured to be substantially devoid of the biocompatible medical composition”, it is clear that this is what is being described when Dalton states that the reservoir is entirely held within the holes as that would require the reservoir not being elsewhere on the needle, including the tip. It is noted that Dalton uses the term reservoir to refer to the drug containing medium. Additionally, Dalton states that the drug entirely held within the hole prevents breakage of the reservoir during puncture of the skin, which further implies that the puncture tip is free of the drug.
Applicant further argues that Dalton teaches away from keeping the sharp tip section devoid of the biocompatible medical composition as Dalton discloses that the reservoir medium is coated onto the skin piercing portion. The examiner agrees that there are embodiments disclosed by Dalton that include the sharp tip coated in the drug as can be seen in fig. 2. However, disclosure of alternate embodiments does not constitute a teaching away. And further, as noted above Dalton explicitly discloses that the drug may be entirely contained in the hole and the reason for doing so is to prevent breakage of the drug on the tip during insertion. Further, while Dalton does not show the drug coating in fig. 4, Dalton does show and embodiment in fig. 6 where the sharp tip is devoid of the drug coating. Therefore, the examiner does not find any reason why Dalton would teach away from the claimed configuration.
Applicant argues that Dalton describes the lyophilized formulation contained in the hole while the rest of the skin piercing member is coated. The examiner does not agree with this characterization of Dalton. The lyophilized formulation IS the drug. There is no suggestion that the needle include a first drug reservoir in the hole, and a second drug reservoir coating the needle. Again, Dalton explicitly states that the reservoir is entirely held within the holes. The term “reservoir” refers to the drug containing medium, and therefore the reservoir held entirely within the holes means just that, the drug held entirely within the hole.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 78, 81-85, 88-93 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dalton et al (US 2004/0049150).
Regarding claim 78, Dalton discloses a microneedle (fig. 4) configured for administration of a biocompatible medical composition to a predetermined treatment area of a subject (pages 1-2; para. 0010), the microneedle is characterized by comprising a rigid rod having at least one open cavity which is open from one face of the rod to at least one other face (fig. 4; page 3, para. 0022), wherein the cavity is configured to temporarily accommodate a biocompatible medical composition therein and when placed in the dermis and/or hypodermis, to promote its separation, via all open faces (pages 1-2; para. 0010; page 3, para. 0022), a rigid sharp tip at one end of the rod configured to allow penetration of the rod to at least the dermis of a subject (fig. 4; page 10, claim 9), wherein the sharp tip section is configured to be substantially devoid of the biocompatible medical composition (page 3, para. 0022: the drug is entirely held within the hole and therefore not coated on the tip), wherein a distal end of the sharp tip is located in line with a face of the rod having no cavities (see fig. 4 annotated below).
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Regarding claim 81, Dalton shows that the shape of the cross sectional area of the rod is rectangular (fig. 4).
Regarding claim 82, Dalton shows that the shape of the cross sectional area of the rod is rectangular (fig. 4).
Regarding claim 83, Dalton discloses that the cavity comprises the biocompatible medical composition (col. 3, para. 0022), wherein the biocompatible medical composition is solid at room temperature (page 2, para. 0011; page 3, para. 0023: friable lyophilized formulation) and is absorbable upon contact with liquid in the dermis layer and/or hypodermis layer, and wherein the biocompatible medical composition is configured to at least partially separate from eh cavity and the microneedle, when in the dermis and/or hypodermis environment (page 3, para. 0028).
Regarding claim 84, Dalton discloses that the biocompatible medical composition include botulinum composition (page 5, para. 45, bottom of left column).
Regarding claim 85, Dalton discloses that the biocompatible medical composition comprises botulinum material (page 5, para. 45, bottom of left column) and a dispersant material (page 3, para. 0024).
Regarding claim 88, Dalton discloses that that microneedle comprises a rigid base section comprising a length of 1µm to 1mm (page 2, para. 0017) to ensure delivery of the composition in the exact required histological and devoid of the upper/superficial level (page 2, para. 0017; the composition is located in the hole and therefore only delivered at the depth of the hole and not the upper/superficial location).
Regarding claim 89, Dalton discloses that the composition is carried in the hole (page 3, para. 0022) and therefore the base is devoir do the composition.
Regarding claim 90, Dalton discloses that the base is connected to a substrate (fig. 1).
Regarding claim 91, Dalton discloses a device configured for administration of a biocompatible composition to a dermis layer and/or hypodermis layer of a subject (pages 1-2; para. 0010), the device comprising a substrate (page 2, para. 0016: patch; fig. 1), configured to be attached to the subject’s skin, a plurality of microneedles (fig. 1) each according to claim 78 (see claim 78 above), connected to the substrate, such that when the substrate is attached to the skin, the microneedles penetrate the dermis and/or hypodermis layer (page 2, para. 0016).
Regarding claim 92, Dalton shows that the plurality of microneedle sis arranged in at least one row (fig. 1).
Claim 93 calls for the microneedle or device for use in filling an undesired fold, wrinkle, line or depressed area in the dermis layer of hypodermis layer of facial or neck skin. This is interpreted to be an intended use limitation. The microneedle and device disclosed by Dalton above is capable of being applied to any skin surface including a fold, wrinkle, line or depressed area and filling the area with the pharmaceutical composition.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dalton.
Claim 79 calls for the cavity of the rigid rod to be configured to accommodate a volume of the biocompatible medical composition that is at least 40% of the microneedle’s volume. Dalton does not specifically disclose this feature, but discloses that the configuration of microneedle having holes may be loaded with relatively high amounts of the pharmaceutical agent (page 4, para. 0042, 0044). It is understood that the amount of agent received in the hole is limited by the size of the hole. Applicant has not provided criticality to this limitation. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the size of the hole of Dalton so that it can accommodate the desired dosage of the agent, the dosage being relatively large compared to the size of the microneedle, thereby resulting in the claimed invention.
Claim(s) 80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dalton as applied to claim 79 above, and further in view of Chan et al (2007/0293815).
Claim 80 calls for the rigid rod to have at least two cavities, such that at least one support section is provided between the cavities. Chan teaches a microneedle having a through hole for carrying a pharmaceutical agent (fig. 6) and further discloses that the needle may have multiple holes (page 6, para. 0056: microblade can have multiple depressions, the depression can be through holes) to achieve the desired dosage on the microneedle. The area between the two holes necessarily forms a support section. 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 microneedle of Dalton to include two cavities as taught by Chan so that the needle can accommodate a larger dosage of medicament as needed.
Claim(s) 86, 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dalton in view of Amir (2018/0209563).
Regarding claim 86, Dalton discloses a dispersant material, but fails to disclose the specific material. Amir teaches a microneedle having a cavity carrying a therapeutic composition, the composition including a dispersant material configured to promote diffusion and/or solubility that may be PEG, magnesium sulfate, and/ or a salt (page 3, para. 0043). 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 dispersant of Dalton to include PEG, magnesium sulfate, and/ or a salt as taught by Amir as these material assist the delivery of the drug into the tissue.
Claim 87 calls for the biocompatible material composition to comprise between 60% and 65% augmenting material and accordingly between 40% and 35% dispersant material. Dalton in view of Amir does not specifically teach this composition. However, the instant disclosure fails to provide criticality for these percentages, and discloses a variety of suitable composition percentages (specification pages 13-15, paras. 0070-0076). The instant disclosure also discloses commercially available compositions that are suitable for use in the claimed microneedles such as Zyderm, Zyplast, Cosmoderm, Cosmoplast, Autologen, Hylaform, Restylane, etc. (spec, page 47, para. 0242). Amir teaches that similar materials can be used in the microneedles (page 10, para. 0133). Therefore, it would have been a matter of routine experimentation to arrive at the claimed composition percentages because Applicant has not provided any criticality for these percentages, and Amir teaches that the device is used with the same commercially available materials that Applicant uses.
Conclusion
THIS ACTION IS MADE FINAL. 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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783