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
Claims 1-12 were previously objected for typographical errors and have been amended. The previous objections to claims 1-12 are thus withdrawn.
Claims 1-12 were previously rejected under 35 U.S.C. §112(b) and have been amended to overcome the previous rejections; Examiner accordingly withdraws the prior rejections under 35 U.S.C. §112(b).
Claim 4 has been canceled and claims 13-15 have been added. No new matter has been entered.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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(s) 1-3 and 5-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baek (US 20170368321, henceforth Baek) in view of Falo et al. (US 20110098651, henceforth Falo).
Regarding claim 1, Baek discloses a microstructure comprising: a base film (base 4 which is shown to be a film in fig. 3); and a plurality of microneedles (see fig. 3, there are a plurality of protrusions which are each considered to be microneedles which extend from base 4; while Baek discloses these as multiple tips for a microneedle, they can also be considered to be a plurality of individual microneedles) disposed on one surface of the base film (see fig. 3, the microneedle protrusions are on the top surface of base 4), wherein each of the plurality of microneedles comprises: a needle body (see annotated fig. 2 provided below, the needle body is the portion of the protrusion which extends from base 4 to the pointed tip within the bounds called out in the annotated figure as defined by the edge bounds of guide groove 3) having: a first region (see second annotated fig. 1 calling out the first region) coupled to the base film (see fig. 3, the bottom of the protrusion called out to be the first region is coupled directly to base 4); a second region (see second annotated fig. 1, the second region is called out as the portion of the needle body which is longitudinally between the first region and the top of groove 3 which delineates the support wings) extending from the first region (see second annotated fig. 1, the called out second region extends upwards from the called out first region as shown); and a third region (see second annotated fig. 1 and the called out third region) extending from the second region (see second annotated fig. 1, the third region extends upwards from the second region) and gradually decreasing in width (see second annotated fig. 1, width W1 is greater than width W2 because the width gradually decreases as claimed) as a distance from the second region increases (see second annotated fig. 1, the end of the third region is called out and movement away from the second region is the direction which the width decreases along as claimed); and a plurality of support wings (see annotated fig. 2 below, the support wings are the portion of the protrusion which extend from base 4 towards the pointed tip outside of the bounds of guide groove 3 as called out in annotated fig. 2) disposed around the needle body (see annotated fig. 2, the support wings are pictured around the called out needle body), and connecting an outer surface of the needle body and the base film (see annotated fig. 2, the support wings provide an interface between the needle body and the base and thus are considered to connect the structures as claimed), and wherein each of the plurality of support wings is coupled to the needle body (see annotated fig. 2 and second annotated fig. 2, each of the support wings is directly connected to the needle body as shown) between the first region and the second region (see second annotated fig. 2, the support wings are coupled to the needle body at the location between the first region and the second region as shown), and has a thickness (see thickness TS1 as called out in annotated fig. 2 below) thinner than a thickness of the needle body (see thickness TN1 as called out in annotated fig. 2 below, thickness TS1 is less than TN1 and thus the support wing has a thickness thinner than that of the needle body as claimed).
Baek does not disclose the microstructure wherein the needle body has a second region gradually increasing in width as a distance from the first region increases. Falo teaches the use of multiple sections of a microneedle body (see fig. 21), comprising a first filleted region which joins the microneedle to a base (see figs. 21 and 22, the bottom of the needle to the end of the filleted curve is a first region), a second region extending from the first region and gradually increasing in width as a distance from the first region increases (see fig. 21, the cross-sectional width of the microneedle increases as the distance from the filleted region towards the pointed tip increases due to the bevel angle), and a third region extending from the second region and gradually decreasing in width as it goes to an end thereof (see fig. 21, the third region is above the beveled angle point and tapers to a point as it gradually decreases in width as it moves toward the tapered point).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a beveled angle to the otherwise vertical groove walls of Baek as in Falo such as to yield the second region gradually increasing in width as a distance from the first region increases as in Falo as Falo teaches that use of a beveled angle along vertical walls provides a beneficial increase in retention of microneedles in tissue to increase amount of bioactive material to be delivered and thus increase efficacy ([0116]). This could be achieved by first molding the shape of Baek and then applying micro-milling as this is the same procedure as what is taught in Falo ([0115]).
PNG
media_image1.png
326
411
media_image1.png
Greyscale
Annotated fig. 2 from Baek calling out a needle body and support wings
PNG
media_image2.png
598
503
media_image2.png
Greyscale
Annotated fig. 1 from Baek further calling out the needle body and support wings in another view
PNG
media_image3.png
559
379
media_image3.png
Greyscale
Second annotated fig. 1 from Baek further calling out the claimed regions
Regarding claim 2, Baek discloses the microstructure of claim 1 wherein the plurality of support wings are disposed symmetrically about a longitudinal axis passing through a center of the needle body (see annotated fig. 2, the called out support wings are shown as being symmetric about the center of the needle body shown as the intersection of the edges).
Regarding claim 3, Baek discloses the microstructure of claim 1 wherein each of the plurality of support wings gradually decreases in thickness in a direction extending radially away from a center of the needle body (see annotated fig. 2, thickness TS2 is further away from the center of the called out needle body shown in the annotated fig. 2 and is shown as being shorter than thickness TS1 because of the gradual decreasing as claimed).
Regarding claim 5, Baek as modified discloses the microstructure of claim 1 wherein a connection region at which each of the plurality of support wings and the base film are connected (see fig. 3, the region where the support wings and base 4 are connected is the bottom surface of the support wings which provides an interface between the base and support wing) has a radial end located radially inward of a maximum radius region of the second region in a plan view (in the modified device, micro milling is applied to grooves 3 such that the grooves provide a beveled angle inwards from the top of the groove and the maximum radius of the second region; the support wings still extend radially outward from the needle body, but since the grooves are deeper into the needle body in the modified device, there would be a radius measured from the center of the needle body to the region where the support wings and base 4 interface with each other which is considered to be a radial end as it is a position measured radially which extends from the center of the needle body and each of the support wings which is less than the radius at the top of the second region where the beveled angle has not caused the radius to decrease yet – this radius at the top of the second region would be the maximum radius region as claimed).
Regarding claim 6, Baek as modified discloses the microstructure of claim 1 wherein a connection region at which each of the plurality of support wings and the base film are connected (see fig. 3, the region where the support wings and base 4 are connected is the bottom surface of the support wings which provides an interface between the base and support wing) has a radial end located at a position corresponding to a maximum radius region of the second region in a plan view (in the modified device, micro milling is applied to grooves 3 such that the grooves provide a beveled angle inwards from the top of the groove and the maximum radius of the second region; the support wings still extend radially outward from the needle body, but since the grooves are deeper into the needle body in the modified device, there would be a radius measured from the center of the needle body to the region where the support wings and base 4 interface with each other which is considered to be a radial end as it is a position measured radially which extends from the center of the needle body and each of the support wings which is equal to the radius at the top of the second region where the beveled angle has not caused the radius to decrease yet – this radius at the top of the second region would be the maximum radius region as claimed – because the support wings extend from a radius which is less than the maximum radius region to a radius which is more than the maximum radius region and extend over all radii therebetween).
Regarding claim 7, Baek as modified discloses the microstructure of claim 1 wherein a connection region at which each of the plurality of support wings and the base film are connected (see fig. 3, the region where the support wings and base 4 are connected is the bottom surface of the support wings which provides an interface between the base and support wing) has a radial end located radially outward of a maximum radius region of the second region in a plan view (in the modified device, micro milling is applied to grooves 3 such that the grooves provide a beveled angle inwards from the top of the groove and the maximum radius of the second region; the support wings still extend radially outward from the needle body, but since the grooves are deeper into the needle body in the modified device, there would be a radius measured from the center of the needle body to the region where the support wings and base 4 interface with each other which is considered to be a radial end as it is a position measured radially which extends from the center of the needle body and each of the support wings which is more than the radius at the top of the second region where the beveled angle has not caused the radius to decrease yet – this radius at the top of the second region would be the maximum radius region as claimed – and since the radius of the support wings is greater than that of the maximum radius region, the radial end is considered to protrude radially outward as claimed).
Regarding claim 15, Baek as modified discloses the microstructure of claim 7 wherein a height of the second region (see height H2 in second annotated fig. 1) is equivalent to a height of the third region (see height H3 in second annotated fig. 2 which appears to be the same height as H2 and thus they are equivalent), and a distal end of each of the plurality of support wings coupled to the needle body is positioned between the first region and a maximum radius region of the second region (in the modified device, since the micro milling of Falo is applied to grooves 3 of Baek, the distal end of each of the plurality of support wings just distal to the interface between the second region and the third region would be radially and longitudinally between the radially smallest first region and the maximum radius region of the second region at the distal most end of the second region).
Regarding claim 8, Baek as modified discloses the microstructure of claim 1 wherein the needle body further comprises a fillet (the interface between the second region and the third region in the modified device is considered to be a fillet as claimed where it is a strip that gives a rounded appearance to a concave junction where to surfaces meet – which is the definition from Merriam Webster of a fillet – where the rounding is due to the micro milling from Falo applied to the grooves 3 to curve the interface between the second and third regions) at an intersection (this is the interface between the groove and non-grooved portion shown in fig. 1) between the second region and the third region (see second annotated fig. 1) to connect the second region and the third region (see second annotated fig. 1, it is the connection and interface between the second region and the third region as shown), the fillet having a curved outer circumferential surface (this is the edge at the top of groove 3 in the modified device) provided as a curved surface (see fig. 6 at the leftmost picture, the edges are shown as being rounded and not sharp when they are manufactured, and thus they are considered to be curved as claimed).
Regarding claim 9, Baek discloses the microstructure of claim 1 wherein each of the plurality of support wings extends downward from a distal end of the third region (see annotated fig. 2, each of the plurality of support wings extends downwards, or proximally, from the pointed tip at the distal most end of the third region as shown) toward the base film (see annotated fig. 1) and is connected to the base film (see annotated fig. 1 and see fig. 3).
Regarding claim 10, Baek as modified discloses the microstructure of claim 9 wherein a connection region at which each of the plurality of support wings and the base film are connected (see fig. 3, the region where the support wings and base 4 are connected is the bottom surface of the support wings which provides an interface between the base and support wing) is larger than a maximum radius of the second region (in the modified device, micro milling is applied to grooves 3 such that they provide a beveled angle inwards from the top of the groove; there would be a radius measured from the center of the needle body to the region where the support wings and base 4 interface with each other which is greater than the radius at the top of the second region where the beveled angle has not caused the radius to decrease yet – this radius at the top of the second region would be the second region as claimed – because the support wings extend radially outward from the top of the grooves 3 as shown in fig. 2).
Regarding claim 14, Baek as modified discloses the microstructure of claim 10 wherein a first height of each of the plurality of support wings (height H2 in second annotated fig. 2, which is a height of each of the support wings since the support wings extend along height H2) is equivalent to a second height of the needle body (height H2 in second annotated fig. 2, which is a height of the needle body since the needle body extends along height H2; since the height H2 is the same for both elements, it is equivalent for both as claimed).
Regarding claim 11, Baek discloses the microstructure of claim 1 wherein the plurality of support wings includes: a first support wing (this is the support wing where TS1 is called out in annotated fig. 2) located on a first lateral side of the needle body (see annotated fig. 2, the first support wing is in the bottom left side of the needle body); and a second support wing (this is the support wing where TS2 is called out in annotated fig. 2) located on a second lateral side of the needle body, the second lateral side being opposite the first lateral side (see annotated fig. 2, the second support wing is opposite the first support wing relative to the center of the needle body where it is on the top right side of the needle body), wherein the first support wing and the second support wing have different thicknesses (TS1 and TS2 are different thicknesses as shown in annotated fig. 1).
Regarding claim 12, Baek discloses the microstructure of claim 1 wherein each of the plurality of support wings gradually increases in thickness (see annotated fig. 2, thickness TS3 is measured at the called out point at the uppermost end of the support wing as shown further in annotated fig. 1) in a direction from a distal end coupled to the needle body (see measurement point of thickness TS3 in annotated fig. 1) toward a radial end (see annotated figs. 1 and 2, thickness TS4 is measured at the lowermost end of the support wing and is a longer thickness measurement than thickness TS3 because the thickness gradually increases as claimed) directly adjacent to the base film (see fig. 3, the lowermost end of the support wing is directly adjacent to the base 4).
Regarding claim 13, Baek discloses the microstructure of claim 1 wherein the third region gradually decreases in width to taper into a sharp tip at a distal end thereof (see annotated fig. 1).
Response to Arguments
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive.
Applicant has argued that Baek as modified by Falo does not disclose the claimed invention, particularly where the claimed support wings are coupled to the needle body between the first and second regions as newly claimed. The support wings of Bark as modified connect to the base film, which is the proximal most extension point of the first region, and extend distally to the distal most point of the second region, and the support wings are coupled to the needle body at each longitudinal location between these two points. Thus, the support wings are coupled to the needle body longitudinally between the first and second region as claimed. Further, in the modified device, the micro milling applied to the grooves of Baek from Falo involves the beveling of the second region. This means that the first region of the needle body of Baek as modified has a smaller maximum radius than a maximum radius of the second region measured at its distal most point. Since the support wings are coupled to the needle body over the entire extension of the needle body from the proximal most point of the first region to the distal most point of the second region and there is a continuous line of maximum radii of the needle body at every coupling point, the support wings are also coupled to the needle body radially between the first region and second region. Thus, this argument is found unpersuasive.
Applicant additionally has argued that the support wings and the needle body in Baek as modified are not separate structures as in the instant application; there is no claim limitation specifically and structurally calling out differences which would negate the support wings and needle body of Baek as modified from anticipating the claimed support wings and needle body, and thus the interpretation applied above could be said to have separate structures of a needle body and support wings as argued (but not claimed).
Applicant has further argued regarding claim 8 that Baek as modified would not disclose a fillet as newly claimed. Examiner respectfully disagrees. The interface between the second region and the third region in the modified device is considered to be a fillet as claimed where it is a strip that gives a rounded appearance to a concave junction where to surfaces meet – which is the definition from Merriam Webster of a fillet – where the rounding is due to the micro milling from Falo applied to the grooves 3 to curve the interface between the second and third regions at the grooves, particularly where the rounding of the microneedle from the grooves in the distal direction to a sharp, pointed tip would make a rounded strip which is a fillet.
Regarding claim 14, the claim does not tie any specific structures to the newly required heights in the claim, and thus the called out heights provided in the rejection above apply.
Regarding claim 15, the claim does not tie any specific structures to the newly required heights in the claim, and thus the called out heights provided in the rejection above apply. Additionally, the distal end of each of the support wings as called out in the rejection above is considered to be a distal end where it is in the distal half of the support wings; the claim does not require that the distal end is the most distal end point.
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects all claims as indicated in the rejection above.
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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p 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.
/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights