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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-9 and 11-13 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 7-8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 11-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: claim 11 refers to “an elongate arm at a free end of which the respective at least one microneedle is provided;” however, claim 12 which depends from claim 1 refers to “each arm defines an upper end opposite the lower end.” It is unclear if the lower end is the “free end” from claim 11.
Claim 12 recites the limitation "each arm" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the lower end" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the end" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-7, 10-11 and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2012/006677 to Kendall et al. (“Kendall”).
Regarding claim 1, Kendall discloses a microneedle based delivery system (800) comprising a body having a first section (803) and a second section (804) displaceable relative to one another; at least one first hollow microneedle (100/1351) provided on the first section and at least one second hollow microneedle (100/1351) provided on the second section (Figs. 8A-8F clearly show two patches and thereby microneedles 100 on each of the first 803 and second 804 sections), the first and second sections being displaceable relative to one another in order to transition the microneedles between a disengaged state and an engaged state (see Figs. 8A-8F); and a delivery manifold (1360 and Figs. 13E-13H) in fluid communication with the first and second hollow microneedles.
Regarding claim 2, Kendall teaches the microneedle based delivery system of claim 1 and also in which a longitudinal axis of the at least one first microneedle extends at a first oblique angle relative to the direction of displacement between the first and second sections, and a longitudinal axis of the at least one second microneedle extends at a second oblique angle relative to the direction of displacement between the first and second sections. See Figs. 8A-8F.
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Regarding claim 3, Kendall teaches the microneedle based delivery system of claim 2 and also in which the first oblique angle extends away from the second oblique angle. It is noted that “extends away” has no point of reference; therefore, any first angle that is not in the same point of space as another second angle extends away from the first angle.
Regarding claim 4, Kendall teaches the microneedle based delivery system of claim 3 and also in which the at least one first microneedle is transversely offset to the at least one second microneedle relative to the direction of displacement between the first and second sections. See dotted line the annotated Fig. 8E below.
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Regarding claim 5, Kendall teaches the microneedle based delivery system of claim 1 and also in which the first and the second sections are hingedly displaceable relative to one another. See Figs. 8A-8F.
Regarding claim 6, Kendall teaches the microneedle based delivery system of claim 1 and also in which the delivery manifold is captured between the first and second sections at least when the microneedles are in the engaged state. See the combination of Figs. 8E, 13B/D-H and annotated Fig. 13E below.
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Regarding claim 7, Kendall teaches the microneedle based delivery system of claim 6 and also in which the delivery manifold is clamped against the body when the microneedles are in the engaged state such as to establish a fluid tight seal between the delivery manifold and the body. See at least Figs. 13E-H.
Regarding claim 10, Kendall teaches the microneedle based delivery system of claim 1 and also in which the body defines an enclosure (841/842) at least partially surrounding the delivery manifold.
Regarding claim 11, Kendall teaches the microneedle based delivery system of claim 1 and also in which the first and second section of the body each define an elongate arm (803/804) at a free end of which the respective at least one microneedle (100/1351) is provided. See Figs. 8A-8F.
Regarding claim 16, Kendall teaches the microneedle based delivery system of claim 1 and also comprising a retention lock (831/832) operable to prevent the first and second sections from being separated from one another beyond the disengaged state.
Regarding claim 17, Kendall teaches the microneedle based delivery system of claim 1 and also comprising a pair of tissue contacting feet (811/812) each defining a tissue contacting surface which is substantially longitudinally aligned with the microneedles.
Regarding claim 18, Kendall teaches the microneedle based delivery system of claim 17 and also comprising interlocking elements (773) operable to prevent the first and second sections from being displaced from the disengaged to the engaged state when the elements are interlocked, and which are separable in response to downward pressure (on 763) and reactive forces applied to the feet by contacted tissue.
Claim(s) 1 and 6-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US2009/0270906 to Hossainy (“Hossainy”).
Regarding claim 1, Hossainy discloses a microneedle based delivery system (Fig. 4) comprising a body (420) having a first section and a second section (see annotated Fig. 4 below) displaceable relative to one another (inflation of the balloon displaces the microneedles relative to one another); at least one first hollow microneedle (442 and para. [0068]) provided on the first section and at least one second hollow microneedle provided on the second section (see annotated Fig. 4 below), the first and second sections being displaceable relative to one another (they are displaced relative to one another upon inflation of the balloon) in order to transition the microneedles between a disengaged (collapsed configuration not contacting the inner lumen of the vessel wall) state and an engaged state (imbedded in the epithelial surface or plaque of the inner luminal vessel wall); and a delivery manifold (424/415/430) in fluid communication with the first and second hollow microneedles (see para. 0068).
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Regarding claims 6-7, Hossainy teaches the microneedle based delivery system of claim 1 and also in which the delivery manifold (424) is captured between the first and second sections and clamped (by cuff 460) against the body (420) at least when the microneedles are in the engaged state such as to establish a fluid tight seal between the delivery manifold and the body. See Fig. 4.
Regarding claim 8, Hossainy discloses the microneedle based delivery system of claim 1 and also teaches in which the delivery manifold comprises an inlet (430) adapted for connection with a fluid reservoir and an outlet (415) engageable with the body (420) such that the inlet is in fluid communication with the hollow microneedles (at 446).
Regarding claim 9, Hossainy teaches the microneedle based delivery system of claim 8 and also in which the body defines a chamber (460) between the first and second sections in which the outlet of the delivery manifold (415) is captured and which chamber is arranged to bias the outlet into sealing engagement with the body (420) at least when the system is in the engaged state. See Fig. 4.
Regarding claim 10, Hossainy teaches the microneedle based delivery system of claim 1 and also in which the body (420) defines an enclosure (cuff 460) at least partially surrounding the delivery manifold.
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.
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) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kendall in view of US2019/0134370 to Sumida (“Sumida”).
Regarding claim 14, Kendall teaches the microneedle based delivery system of claim 1 but fails to disclose a release mechanism defined by a trigger on each of the first and second sections and arranged to facilitate manual displacement of the system into the disengaged state.
Regarding claim 15, Kendall teaches the microneedle based delivery system of claim 1 but fails to disclose a stop releasably engageable with the body to limit relative displacement between the first and section sections.
However, Sumida discloses a microneedle puncture instrument that includes a trigger or stop (41) on each of the first and second sections (11a and 11b) that is arranged to facilitate manual displacement of the system into the disengaged state and limit relative displacement between the first and second sections.
At the time of filing, it would have been obvious to one of ordinary skill in the art to incorporate the trigger/stop (41) of Sumida into the invention of Kendall. Both devices are analogous in the art of microneedle path applicators; therefore, a combination is proper. Additionally, the motivation for the incorporation would have been in order to provide the device of Kendall with a removable mechanism to prevent actuation of the device until the user was ready to apply the patch to the patient.
Allowable Subject Matter
Claims 12-13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO2013/090844; KR20070091115 and WO03/074102.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/Primary Examiner, Art Unit 3993