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 § 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 29, 31, 33-38, 41-44 121-122, 124 are 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.
Claim 29 is indefinite because it is not clear from preamble of the claim what applicant intends to say “a plurality of microprojections and a rear surface to which is attached a spigot to the skin of a mammal”, and then further perform paragraph c) since the spigot is attached to the skin of a mammal.
The examiner will interpret this claim as to the front surface of the microprojection array is being attached to the skin of a mammal.
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.
Claims 29, 33-38, and 121-122 are rejected under 35 U.S.C. 103 as being unpatentable over Colburn et al. (US 20140257187 A1) in view of Cantor et al (US 20080114298 A1).
Regarding claims 29 and 122, Colburn discloses a method for applying a microprojection array having a front surface comprising a plurality of microprojections 152 (to be attached to the skin of a mammal) and a rear surface 151 to which is attached a spigot (figs 3-7), the method comprising:
a) pre-loading a dome 130,330 with a loading force (111,120,130,112) (fig 3; [0045,0046,0048]),
b) placing the pre-loaded dome within a device (carrier assembly 150), wherein the device comprises a housing 150 having a collapsible trigger 140 and the microprojection array 151,152, wherein the plurality of microprojections of the microprojection array 152 are coated with a vaccine antigen [0081], and
c) triggering the pre-loaded dome by contacting the collapsible trigger 140 with a triggering force such that the dome is triggered (Fig 4; 0056,0059]) ; and thereby contacts the spigot (via actuator 120) such to enable guided travel of the microprojection array such that the microprojection array is accelerated through a space between the device and the skin of a mammal such that the microprojection array is releasably detached from the device [0060,0062,0085], wherein the microprojection array attains a velocity of greater than about 15 m/s [0046], thereby penetrating the skin of the mammal and delivering the vaccine antigen into the skin of the mammal (figures 4-5c).
Colburn fails to disclose the microprojection array having a mass of less than 0.8 grams or about 0.1 to 0.8 grams.
Cantor teaches a microneedle array that is 6 grams or less [0045] which falls within the claimed range. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Colburn’s microprojection array to have a mass from less than 0.8 grams or within 0.1-0.8 grams, since Cantor et al. expressly teaches that microneedle arrays (microprojections) generally have a mass of 6 grams or less in order to prevent nerve tissue damage as taught old and well known in the art.
Regarding claims 33-35, Colburn and Cantor teach that the microprojection array velocity claimed in the claims as a modification deemed matter of design choice well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Cantor discloses velocities of about 15 m/s and of about 20 m/s.
Regarding claims 36-38, Colburn discloses a microprojection array, but it is moot to the microprojection array being within the claimed ranges about 1000-20000 microprojections, about 2000-10000 microprojections, or about 3000-6000 microprojections. It would have been obvious to one having ordinary skill in the in the art before the effective filing date of the claimed invention to modify the Colburn by modifying the number of microprojections with any of the set forth ranges as an obvious design choice, well within the skill of ordinary artisan, obtained through routine experimentation in determining optimum results, in order to efficiently deliver the desire doses at specific delivery time.
Regarding claim 121, Colburn discloses the microprojections can have a length (height) in the range 250 to 700 um in length (less than 500 microns; [0040]).
Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Colburn et al. (US 20140257187 A1) in view of Cantor et al (US 20080114298 A1), further in view of Trautman et al (US 20080183144 A1).
Colburn, in [0007], discloses triggering force and the loading force can be modified to the user or stored energy device 130. Colburn disclose a triggering force applied to the dome to move the microprojections unto the skin, and a loading force (stored energy to 130). However, Colburn/Cantor fail to disclose the triggering force as set forth in claims 41-42.
Trautman teaches a device (applicator, Figs. 7A-7D) comprising a dome (dome 84) in an encasement (body 82, see Fig. 7B}, wherein the dome (dome 84) is pre-loaded with a force (paragraph 58). Trautman further discloses that a force required to triggering force is about 5 to about 50 newtons [0067] discloses that the threshold force required to make the applicator change configuration is between about 0.1 lbf (about 0.0449 N) and about 20 Ibf (about 89 N)}, which includes at least part of the recited range). Therefore, it would have been obvious to one having ordinary skill in the in the art before the effective filing date of the claimed invention to modify the Colburn/Cantor with Trautman’s teaching of the triggering force since such modification would be sufficient for penetration of the microprojections unto the skin.
Claims 31, 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Colburn et al. (US 20140257187 A1) in view of Cantor et al (US 20080114298 A1), further in view of Masaoka (US 20130296790 A1).
Colburn in [0007] discloses a loading force can be modified in stored energy device 130.
However, Colburn fails to disclose the ratio of the triggering force and loading force being 1:50 to about 1:5, the loading force specifically from about 100 to about 400 newtons or about 250 to about 350 Newtons.
Regarding claim 31, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the Colburn/Cantor’s device with a ratio of a triggering force and loading force of about 1:50 to about 1:5 since these parameters are deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results to prevent and/or reduce pain on the skin area.
Regarding claims 43-44, Masaoka et al. teaches a microneedle array application force in the range of 1 to 200 Newtons as this is an effective force range for inserting the microneedles of a microneedle array into the skin and is not too large of a force such that the patient feels pain from the application of the microneedles being pressed to the skin (paragraph 60). The disclosed range includes at least a portion of the claimed range of from about 100 to 400 Newtons and from about 250 to about 350 Newtons.
It would have been obvious to one of ordinary skill before the effective filing date of the present invention to have modified the Colburn/Cantor’s device so that the loading force on the dome is in the range from about 100 to about 400 Newtons or from about 250 to about
350 Newtons, as taught by Masaoka et al. by providing an effective force range for inserting the microneedles of a microneedle array into the skin and is not too large of a force such that the patient feels pain from the application of the microneedles being pressed to the skin ([0060] of Masaoka et al.
Claim 124 is rejected under 35 U.S.C. 103 as being unpatentable over Colburn et al. (US 20140257187 A1) in view of Cantor et al (US 20080114298 A1), further in view of Chen et al. (US 20140276378 A1).
Regarding claim 124, Colburn/Cantor discloses the invention substantially as claimed. However, they fail to disclose the device containing a desiccant.
Chen teaches that the packaged microstructure array may include a desiccant.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Colburn/Cantor’s device by incorporating Chen’s desiccant into the device to control humidity in the packaging.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because of the new ground of rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Mon-Thur 8am- 3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783