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 .
This office action is in response to applicant’s communication of 11/3/2025. Currently elected claims 1-13, 18, 19, and 21-25 are rejected below.
Election/Restrictions
Applicant's election with traverse of Group I, Species K, Subspecies a and iii, in the reply filed on 11/3/2025 is acknowledged. Applicant elected claims 1-13, 18, 19, and 21-25.
The traversal is on the ground(s) that the restriction practice relates to claimed subject matter and applicant observes a review of the specification and drawings would fail to determine if the application claims subject matter which could be subject to restriction, there is no search burden and further the species/subspecies requirements failed to have been rendered based on a proper analysis of the pending claims. This is not found persuasive because examiner is of the position that the Restriction groups are distinct or independent inventions as they are directed to a method for delivery a medical agent and apparatus delivery device as claimed, and the claims do cover multiple identified embodiments disclosed in the specification that examiner is considering as unique species. Further concerning both the Restriction and Election of Species examiner is of the position that there would be a serious search burden to the examiner. Examiner is of the position that the listed groups and species fail in vastly different classifications, have separate status in the art, and require a different field of search. additionally non-prior art issues under 35 U.S.C. 101, pre-AIA 35 U.S.C. 112, first paragraph, and/or 35 U.S.C. 112(a) relevant to one invention that are not relevant to the other invention are present in the Restriction election requirement as made. Further the applicant has not provided any evidence of serious search and/or examination burden by appropriate showings or evidence. The Applicant provided argumentative and conclusory statements and not factual evidence on the search burdens required.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14-17, 20 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups and Species/subspecies; there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/3/20025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trautman et al. (US 2008/0183144 A1).
Trautman teaches a delivery device (as shown in figures 7c) with : a main body including a peripheral region (near 26 and 114 as in figure 3a for one example) and a central region (near 18) extending proud of the peripheral region and having a top surface and a base, the peripheral region including a number of bodies (each of 114 elements) spaced apart by slits (spaces between 114 elements) which extend from the periphery of the peripheral region toward the central region; an adhesive (see para [0042-0043]) coupled to at least a part of the main body; and an at least partially collapsible reservoir (87) coupled to the main body and to at least one delivery sharp (note holder 86 which holds microneedles).
The embodiment of Trautman in FIG. 7c discloses the claimed invention except for the lobed number of body structures and slits which extend from the periphery. Trautman figure 3a teaches that it is known to use the lobed structures and slits which extend from the periphery as set forth in figure 3a and elements 114 to provide a means to allow a slight variability in the pressure exerted on the skin by a microprojection array to aid in needle penetration to a patient . It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Trautman in FIG. 7c with the lobed number of body structures and slits which extend from the periphery as taught by Trautman figure 3a, since such a modification would provide the system with the lobed number of body structures and slits which extend from the periphery for providing a means to allow a slight variability in the pressure exerted on the skin by a microprojection array to aid in needle penetration to a patient. Further in the alternative, it is examiners position that although the use of a reservoir is not shown in the lobed embodiment of figures 3a-3c it is examiners position that the prior art teaches adding a collapsible reservoir as shown in figures 7a-7d as a means to provide fluid treatment to a patient. It is examiner’s position that a PHOSITA would know to have the obvious modification of using the reservoir taught on the lobed applicator structure of figures 3a-3c as a means to administer fluid to a patient, further see para [0061-0063].
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Concerning claim 2 and the main body has a first state (top of figure 4) and a second state (middle or lower part of figure 4), the main body including at least one partially invertible region (region near 34 to the center) which is in a first shape in the first state and in the second state is substantially inverted with respect to the first shape over at least a portion of the of the invertible region (see middle or lower portion of figure 4).
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Concerning claim 3 and the at least one partially invertible region includes at least a portion of the top surface (again note figure 4 and top surface that inverts).
Concerning claim 4 and the main body further comprises a static region which is substantially the same shape when the main body is in the first state and the second state (note edges regions or the top most centermost surface of figure 4).
Concerning claim 5 and the static region is included in the central region and extends from a periphery of the top surface to the base (again note the top most centermost surface of figure 4).
Concerning claim 6 and the main body is configured such that at least two of the bodies of the peripheral region spreadingly displace as the main body transitions from the first state to the second state (see figure 4 and note opposing peripheral region edges spread and displace).
Concerning claim 7 and top surface is convex in the first state (see top surface in figures 3a-3c).
Concerning claim 8 and the top surface is concave in the second state (see bottom of figure 4).
Claim(s) 9-13, 18, 19, and 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trautman et al. (US 2008/0183144 A1) in view of Baker et al. (US 2017/0120025 A1).
Trautman teaches a delivery device (as shown in figures 7c) with : a main body including a peripheral region (near 26 and 114 as in figure 3a for one example) and a central region (near 18) extending proud of the peripheral region and having a top surface and a base, the peripheral region including a number of bodies (each of 114 elements) spaced apart by slits (spaces between 114 elements) which extend from the periphery of the peripheral region toward the central region; an adhesive (see para [0042-0043]) coupled to at least a part of the main body; and an at least partially collapsible reservoir (87) coupled to the main body and to at least one delivery sharp (note holder 86 which holds microneedles).
The embodiment of Trautman in FIG. 7c discloses the claimed invention except for the lobed number of body structures and slits which extend from the periphery. Trautman figure 3a teaches that it is known to use the lobed structures and slits which extend from the periphery as set forth in figure 3a and elements 114 to provide a means to allow a slight variability in the pressure exerted on the skin by a microprojection array to aid in needle penetration to a patient . It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Trautman in FIG. 7c with the lobed number of body structures and slits which extend from the periphery as taught by Trautman figure 3a, since such a modification would provide the system with the lobed number of body structures and slits which extend from the periphery for providing a means to allow a slight variability in the pressure exerted on the skin by a microprojection array to aid in needle penetration to a patient.
Trautman discloses the claimed invention except for the reservoir is formed as an assembly including a rigid portion to which the at least one delivery sharp is coupled and a flexible portion coupled to the rigid portion, there being a sealed reservoir volume defined between a section of the rigid portion and a section of the flexible portion.. Baker teaches that it is known to use the reservoir (98) is formed as an assembly including a rigid portion (122) to which the at least one delivery sharp (92 or 24) is coupled and a flexible portion (116) coupled to the rigid portion, there being a sealed reservoir volume defined between a section of the rigid portion and a section of the flexible portion.as See figure 10 for one example set forth in paragraphs [0084]-[0085] to provide a known collapsable reservoir structure for transdermal drug delivery through a microneedle. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Trautman with the reservoir is formed as an assembly including a rigid portion to which the at least one delivery sharp is coupled and a flexible portion coupled to the rigid portion, there being a sealed reservoir volume defined between a section of the rigid portion and a section of the flexible portion.as taught by Baker, since such a modification would provide the system with the reservoir is formed as an assembly including a rigid portion to which the at least one delivery sharp is coupled and a flexible portion coupled to the rigid portion, there being a sealed reservoir volume defined between a section of the rigid portion and a section of the flexible portion. for providing a known collapsable reservoir structure for transdermal drug delivery through a microneedle.
Concerning claim 10 and delivery device (see Trautman) comprising: a main body including a central region and a peripheral region (near 26 and 114 as in figure 3a for one example) having a plurality of petal members (each of 114 elements) extending in an outward direction from the central region, the central region defining a receptacle (87) and having a top region and a base which are connected by a wall; a variable volume reservoir including at least one delivery sharp (note holder 86 which holds microneedles), the reservoir coupled to the main body and at least partially disposed within the receptacle; and an adhesive (see para [0042-0043]) disposed on at least a portion of the main body.
As discussed in the claims above, Trautman teaches a delivery device (as shown in figures 7c) with : a main body including a peripheral region (near 26 and 114 as in figure 3a for one example) and a central region (near 18) extending proud of the peripheral region and having a top surface and a base, the peripheral region including a number of bodies (each of 114 elements) spaced apart by slits (spaces between 114 elements) which extend from the periphery of the peripheral region toward the central region; an adhesive (see para [0042-0043]) coupled to at least a part of the main body; and an at least partially collapsible reservoir (87) coupled to the main body and to at least one delivery sharp (note holder 86 which holds microneedles).
The embodiment of Trautman in FIG. 7c discloses the claimed invention except for the lobed number of body structures and slits which extend from the periphery. Trautman figure 3a teaches that it is known to use the lobed structures and slits which extend from the periphery as set forth in figure 3a and elements 114 to provide a means to allow a slight variability in the pressure exerted on the skin by a microprojection array to aid in needle penetration to a patient . It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Trautman in FIG. 7c with the lobed number of body structures and slits which extend from the periphery as taught by Trautman figure 3a, since such a modification would provide the system with the lobed number of body structures and slits which extend from the periphery for providing a means to allow a slight variability in the pressure exerted on the skin by a microprojection array to aid in needle penetration to a patient.
Trautman discloses the claimed invention except for the reservoir is formed as an assembly including a rigid portion to which the at least one delivery sharp is coupled and a flexible portion coupled to the rigid portion (or a variable volume reservoir), there being a sealed reservoir volume defined between a section of the rigid portion and a section of the flexible portion. Baker teaches that it is known to use the reservoir (98) is formed as an assembly including a rigid portion (122) to which the at least one delivery sharp (92 or 24) is coupled and a flexible portion (116) coupled to the rigid portion, there being a sealed reservoir volume defined between a section of the rigid portion and a section of the flexible portion (or a variable volume reservoir).as See figure 10 for one example set forth in paragraphs [0084]-[0085] to provide a known collapsable reservoir structure for transdermal drug delivery through a microneedle. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Trautman with the reservoir is formed as an assembly including a rigid portion to which the at least one delivery sharp is coupled and a flexible portion coupled to the rigid portion, there being a sealed reservoir volume defined between a section of the rigid portion and a section of the flexible portion.as taught by Baker, since such a modification would provide the system with the reservoir (or a variable volume reservoir) is formed as an assembly including a rigid portion to which the at least one delivery sharp is coupled and a flexible portion coupled to the rigid portion, there being a sealed reservoir volume defined between a section of the rigid portion and a section of the flexible portion. for providing a known collapsable reservoir structure for transdermal drug delivery through a microneedle. It is examiner position that the teachings of Baker would teach this reservoir formed as a variable volume reservoir.
Concerning claim 11 and the reservoir comprises a rigid portion (Baker 122) and a flexible portion (Baker 116), a sealed interior reservoir volume (98) being defined between the rigid portion and the flexible portion, the at least one delivery sharp (92 or 24) being coupled to the rigid portion.
Concerning claim 12 and the rigid portion includes a first portion (Baker 16) and a stage projection (Baker 90), the at least one delivery sharp being coupled to the stage projection.
Concerning claim 13 and the main body includes a ridge adjacent the receptacle, the ridge forming a mounting surface for the reservoir (note ridge of Baker around 36).
Concerning claim 18 and the delivery device further comprises a bias member disposed within the receptacle between the top region and the reservoir (note Baker bias member 46 or 142).
Concerning claim 19 and the bias member is a conical spring examiner is of the position that change in the shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669,149 USPQ 47 (CCPA 1966). Baker teaches that the spring is formed on the inside of a frustoconical shape outer structure. It is examiners position that a PHOSITA would form the spring to match of fit within the interior of the device in any suitable shape such as coiled, cone, incline, sloped or tapered in order to provide resistance within the device. A PHOSITA would know to make the obvious choice to have the shape of the spring be conical in order to achieve an efficient and compact operation.
Concerning claim 21 and an interior volume of the reservoir is partitioned into a first portion and a second portion (see Baker 98 first portion and 100 second portion).
Concerning claim 22 and the first portion and second portion are in fluid communication via at least one flow restrictor (note Baker flow restrictor near upper portion of 100 and bottom of 98 as in figure 10).
Concerning claim 23 and the first and second portion are in fluid communication via at least one orifice in an orifice plate (Baker portion 96/124 between reservoirs as in figure 10) separating the first and second portion.
Concerning claim 24 and wherein the first portion has a variable interior volume (98 region of Baker) and the second portion has a substantially fixed interior volume (100 region), the second portion being adjacent the at least one delivery sharp (Baker 92 or 24).
Concerning claim 25 and the at least one delivery sharp includes a spaced array of microneedles (see Baker 24 or Trautman holder 86 which holds microneedles).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, 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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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783