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 .
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.
Claims 1, 2, 5, and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2003/0069548 to Connelly in view of U.S. Patent Publication No. 2008/0091226 to Yeshurun et al. (“Yeshurun”), and U.S. Patent Publication No. 2015/0306363 to MEYER et al. (“Meyer”) and alternatively further in view of U.S. Patent Publication No. 2015/0196707 to Moore.
Regarding claim 1, Connelly teaches microneedle (56, Fig. 8) provided on a substrate (62), comprising an elongated body extending along a longitudinal axis (Fig. 8, vertical axis of 56) from a proximal end (Fig. 8, proximal end of needles adjacent 62) of the elongated body on the substrate to a distal end (56) thereof with a bevel (Fig. 8, 56 is beveled), wherein the elongated body comprises a capillary bore (58) extending in a longitudinal direction thereof and defines a fluid path (58 is a fluid path), the proximal end is connected to the substrate (Fig. 8, opt of 58 is connected to 60) and the capillary bore is in fluid communication with a fluid channel (Fig. 8, horizontal portion of 52 above the microneedles or Fig. 7, 46) of the substrate, but does not teach the triangular cross-section and the claimed cross-sectional areas of the capillary bore.
Yeshurun teaches cross-sectional area of the capillary bore comprises a triangular cross-section (Figs. 11A & 11B) in a perpendicular direction relative the longitudinal direction of the microneedle (Fig. 8C) and wherein the triangular cross-section of the capillary bore comprises a convex base connected to straight sections of the capillary bore via two rounded corners (Figs. 13A and 13B, the corners in the figures are considered “rounded” given the broadest reasonable interpretation and in light of Applicant’s broad definitions of what is considered a “triangle”). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the circular capillary bore of Connelly with the triangular bore of Yeshurun in order to maximize the area while keeping the bore as close to the microneedle tip as possible ([0080]).
Additionally regarding claim 1, in the event that Figs. 13A and 13B of Yeshurun do not teach two rounded corners, Yeshurun teaches the concept of alternatively using rounded corners in other embodiments. For example, Fig. 12A of Yeshurun teaches an angled corner (top corner) that can alternatively be rounded as shown in Fig. 18A (top corner). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the angled corners of the embodiment of Fig. 13A of Connelly, to be rounded as taught by Figs. 12A and Fig. 18A of Yeshurun, since such a modification would be considered a simple design variant to provide fluid flow through a bore. Additionally, unless a new and unexpected result is produced, a change in shape of the essential working parts of a device involves only routine skill in the art (see MPEP 2144.04(IV)(B)).
Meyer teaches an elongated body (22, Fig. 11) having a cross-sectional area of a capillary bore (51) in a distal end (52) is larger than the cross-sectional area of the capillary bore in the proximal end. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the cross-sectional area of the distal end of bore of Yeshurun larger as taught by Meyer to yield the predictable result of adjusting the flow of the fluid through the elongate body to optimize treatment depending on the particular needs of the patient which may vary depend on various factors such as the type of medicinal fluid, the length of treatment, the physiology of the patient, etc…
Additionally and/or in the alternative regarding claim 1, in the event that Figs. 13A and 13B of Yeshurun still do not teach two rounded corners, Moore teaches the use of rounded corners instead of sharp corners for fluid delivery ([0160]-[0161]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted round corners in the potentially not-round corners in the capillary bore of Yeshurun as taught by Moore, as avoiding sharp corners and edges reduces turbulence for better fluid flow ([0161]).
Regarding claim 2, Connelly, Yeshurun, Meyer, and alternatively Moore teach the microneedle according to claim 1 as shown above including the triangular cross-section of the capillary bore, Connelly further teaching at least one rounded corner (Figs. 13A and 13B).
Additionally and/or in the alternative regarding claim 1, in the event that Figs. 13A and 13B of Yeshurun do not teach two rounded corners, Moore teaches the use of rounded corners instead of sharp corners for fluid delivery ([0160]-[0161]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted round corners in the potentially not-round corners in the capillary bore of Yeshurun as taught by Moore, as avoiding sharp corners and edges reduces turbulence for better fluid flow ([0161]).
Regarding claim 5, Connelly, Yeshurun, Meyer, and alternatively Moore teach the microneedle according to claim 1 as shown above, wherein the fluid channel (46) of Connelly is capable of providing an under-pressure, relative the atmospheric pressure (this limitation pertaining to the “under-pressure” is an intended use and absent any additional structure, Connelly is capable of providing an “under-pressure”), to the capillary bore, whereby fluid flow through the capillary bore is promoted (as claimed, the term “promoted” does not have any inherent numerical value or specific affect upon the fluid flow, therefore any type of fluid flow can be considered “promoted” given the broadest reasonable interpretation).
Regarding claim 7, Connelly teaches a chip (Fig. 8), comprising a plurality of microneedles (56) integrally formed on a substrate (62), each microneedle comprising an elongated body extending along a longitudinal axis (Fig. 8, vertical axis of 56) from a proximal end (Fig. 8, proximal end of needles adjacent 62) of the elongated body on the substrate to a distal end (56) of the elongated body with a bevel (Fig. 8, 56 is beveled), wherein the elongated body comprises a capillary bore (58) extending in a longitudinal direction thereof and defining a fluid path (58 is a fluid path), and wherein the proximal end is integrally formed with the substrate (Fig. 8, 56 and 62 are integrally formed) and the first fluid path is in fluid communication with a fluid channel (Fig. 8, horizontal portion of 52 above microneedles and/or Fig. 7, 46) of the substrate, but does not teach the triangular cross-section.
Yeshurun teaches cross-sectional area of the capillary bore comprises a triangular cross-section (Figs. 11A & 11B) in a perpendicular direction relative the longitudinal direction of the microneedle (Fig. 8C) and wherein the triangular cross-section of the capillary bore comprises a convex base connected to straight sections of the capillary bore via two rounded corners (Figs. 13A and 13B, the corners in the figures are considered “rounded” given the broadest reasonable interpretation and in light of Applicant’s broad definitions of what is considered a “triangle”). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the circular capillary bore of Connelly with the triangular bore of Yeshurun in order to maximize the area while keeping the bore as close to the microneedle tip as possible ([0080]).
Additionally regarding claim 1, in the event that Figs. 13A and 13B of Yeshurun do not teach two rounded corners, Yeshurun teaches the concept of alternatively using rounded corners in other embodiments. For example, Fig. 12A of Yeshurun teaches an angled corner (top corner) that can alternatively be rounded as shown in Fig. 18A (top corner). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the angled corners of the embodiment of Fig. 13A of Connelly, to be rounded as taught by Figs. 12A and Fig. 18A of Yeshurun, since such a modification would be considered a simple design variant to provide fluid flow through a bore. Additionally, unless a new and unexpected result is produced, a change in shape of the essential working parts of a device involves only routine skill in the art (see MPEP 2144.04(IV)(B)).
Meyer teaches an elongated body (22, Fig. 11) having a cross-sectional area of a capillary bore (51) in a distal end (52) is larger than the cross-sectional area of the capillary bore in the proximal end. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the cross-sectional area of the distal end of bore of Yeshurun larger as taught by Meyer to yield the predictable result of adjusting the flow of the fluid through the elongate body to optimize treatment depending on the particular needs of the patient which may vary depend on various factors such as the type of medicinal fluid, the length of treatment, the physiology of the patient, etc…
Additionally and/or in the alternative regarding claim 1, in the event that Figs. 13A and 13B of Yeshurun still do not teach two rounded corners, Moore teaches the use of rounded corners instead of sharp corners for fluid delivery ([0160]-[0161]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted round corners in the potentially not-round corners in the capillary bore of Yeshurun as taught by Moore, as avoiding sharp corners and edges reduces turbulence for better fluid flow ([0161]).
Regarding claim 8, Connelly, Yeshurun, Meyer, and alternatively Moore teach the chip according to claim 7 as shown above, Connelly further teaching the fluid channel (Fig. 8, horizontal portion of 52) having a width (horizontal “width,” approximate distance between two “44” reference numerals) larger than the depth (height of the horizontal portion of 52 above the microneedles) of the fluid channel.
Regarding claim 9, Connelly, Yeshurun, Meyer, and alternatively Moore teach the chip according to claim 7 as shown above, Connelly further teaching at least a part of a wall of the capillary bore (wall surrounding proximal portions of bore 58) forms a part of a wall of the fluid channel (46).
Regarding claim 10, Connelly, Yeshurun, Meyer, and alternatively Moore teach the chip according to claim 7, Connelly further teaches the fluid channel (46) comprising directional changes with an angle (Ɵ) smaller than 90 degrees (adhesive 64 forms a rounded corner as shown in Fig. 9, the direction in the channel changes from horizontal to an angle smaller than 90 degrees, as it moves up the rounded corner, for example, half-way up the rounded corner).
Regarding claim 11, Connelly, Yeshurun, Meyer, and alternatively Moore teach chip according to claim 7 as shown above, Connelly further teaching a base substrate (Fig. 8, 50 and/or Fig. 7, 18), which comprises a fluid port (vertical portion of 52) in fluid communication with the fluid channel (46), wherein the fluid port opens in the backside of the base substrate (Fig. 8, port 52 opens towards the backside).
Regarding claim 12, Connelly, Yeshurun, Meyer, and alternatively Moore teach a chip according to claim 11 as shown above, Connelly further teaching the fluid port (Fig. 7, 52) comprising an increasing area in the longitudinal direction of the port (Fig. 7, 52 expands towards the back of 18) towards the back of the base substrate (18).
Regarding claim 13, Connelly, Yeshurun, Meyer, and alternatively Moore teach the chip according to claim 7 as shown above, Connelly teaches [[the]] a base substrate (50) being operatively connected to the substrate (62) by means of bonding (although “bonding” could be considered a product-by-process limitation which would only require the base substrate and substrate to be “connected,” not the process of how they are connected, in any case Connelly teaches adhesive 64 in Fig. 9 which would provide “bonding”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Connelly, Yeshurun, Meyer, and alternatively Moore as applied to claim 7 above, and further in view of U.S. Patent Publication No. 2015/0202418 to Simon et al. (“Simon”).
Regarding claim 4, Connelly, Yeshurun, Meyer, and alternatively Moore teach the microneedle according to claim 1 as shown above, but do not teach the hydrophilic surface.
Simon teaches a capillary bore (Fig. 6, 52) comprising a hydrophilic surface (51) in a microneedle. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a hydrophilic surface in the capillary bore of the device of Connelly, Yeshurun, Meyer, and alternatively Moore as taught by Simon to maximize fluid flow by reducing the contact angle ([0163]) thereby overcoming issues commonly associated with microneedles without hydrophilic bore surfaces.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Connelly, Yeshurun, Meyer, and alternatively Moore as applied to claim 7 above, and further in view of U.S. Patent No. 6,440,096 to Lastovich et al. (“Lastovich”).
Regarding claim 14, Connelly, Yeshurun, Meyer, and alternatively Moore teach the chip according to claim 7 as shown above, but do not teach the edge.
In Fig. 11, Lastovich teaches a plurality of microneedles (86) being surrounded by an edge (94) which is in level with the distal end of the microneedles (Fig. 11). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate of Connelly with an edge as taught by Lastovich in order to aid in encircling a target area (column 7, lines 56-60) for greater treatment accuracy and more precise targeting to enhance patient treatment and avoiding unnecessary procedures having poor accuracy.
Response to Arguments
Applicant’s arguments and amendments with respect to the art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Connelly, Yeshurun, Meyer, and alternatively Moore as shown 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 BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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.
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.
/B.K./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights