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 .
Status of the Claims
Examiner notes claim 3 appears to be amended even though an amended status has not been denotated as the “s” is shown with a strikethrough in the term “impacts”. For examination purposes the amendment is entered and the term “impact
Examiner notes claim 9 appears to be amended even though an amended status has not been denotated as the “s” is shown with a strikethrough in the term “drives”. For examination purposes the amendment is entered and the term “drive
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/16/2024, 9/16/2024, 2/24/2025, 5/28/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The abstract of the disclosure is objected to because:
Line 1 recites “the skin”. As the skin has not been previously introduced, Examiner suggests replacing “the skin” with “skin” to put the abstract in clearer form.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
This application is a continuation of application 17241927 filed 4/27/2021, which is now patent 12090295, which is a continuation of application 15762913 filed 3/23/2018, which is a 371 of PCT/AU2016/050907 filed 9/28/2016 which claims priority to provisional application 62/233,607 filed 9/28/2015. This continuity data should be included under the heading “Cross-References to Related Applications” under the title.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
Line 1 recites “the skin”. There is insufficient antecedent basis for the limitation in this claim. Appropriate correction is required. Examiner suggests replacing “the skin” in line 1 of claim 1 with “skin” to put the claim in clearer form.
Line 7 recites “the mass of the microprojection array”. As the mass of the microprojection array has not been previously introduced, Examiner suggests replacing “the mass of the microprojection array” in line 7 of claim 1 with with “a mass of the microprojection array”.
Claim 5 is objected to because of the following informalities:
Line 1 recites “the microprojections”. Claim 5 depends on claim 1. Claim 1 states “a plurality of microprojections”. Examiner suggests replacing “the microprojections” in line 1 of claim 5 with “the plurality of microprojections” in order to put the claim in clearer form and clearly refer to the plurality of microprojections of claim 1.
Claim 6 is objected to because of the following informalities:
Line 1 recites “the microprojections”. Claim 6 depends on claim 1. Claim 1 states “a plurality of microprojections”. Examiner suggests replacing “the microprojections” in line 1 of claim 6 with “the plurality of microprojections” in order to put the claim in clearer form and clearly refer to the plurality of microprojections of claim 1.
Claim 7 is objected to because of the following informalities:
Line 1 recites “the microprojections”. Claim 7 depends on claim 6 and claim 1. Claim 1 states “a plurality of microprojections”. Examiner suggests replacing “the microprojections” in line 1 of claim 7 with “the plurality of microprojections” in order to put the claim in clearer form and clearly refer to the plurality of microprojections of claim 1.
Claim 8 is objected to because of the following informalities:
Line 1 recites “the microprojections”. Claim 8 depends on claim 1. Claim 1 states “a plurality of microprojections”. Examiner suggests replacing “the microprojections” in line 1 of claim 8 with “the plurality of microprojections” in order to put the claim in clearer form and clearly refer to the plurality of microprojections of claim 1
Claim 9 is objected to because of the following informalities:
Line 4 recites “the microprojections”. Claim 9 depends on claim 1. Claim 1 states “a plurality of microprojections”. Examiner suggests replacing “the microprojections” in line 4 of claim 9 with “the plurality of microprojections” in order to put the claim in clearer form and clearly refer to the plurality of microprojections of claim 1.
Claim 10 is objected to because of the following informalities:
Line 1-2 recites “to configured to thereby release”. This is grammatically incorrect. Examiner suggests replacing “to configured to thereby release” with “which is configured to thereby release”.
Claim 13 is objected to because of the following informalities:
Line 1-2 recites “a retracted to an extended position”. Examiner suggests replacing “a retracted to an extended position” in line 1-2 of claim 13 with “a retracted position to an extended position” to put the claim in clearer form and clearly introduce the retracted position.
Claim 16 is objected to because of the following informalities:
Line 2 recites “and piston chamber”. Examiner suggests replacing “and piston chamber” with “and a piston chamber” to put the claim in clearer form as a piston chamber has not been previously introduced.
Claim 17 is objected to because of the following informalities:
Line 1-2 recites “is configured to impacts”. This is grammatically incorrect. Examiner suggests replacing “is configured to impacts” with “is configured to impact”.
Claim 18 is objected to because of the following informalities:
Line 1 recites “wherein at least tips of the microprojections are coated”. Claim 18 depends on claim 1. Claim 1 introduces a plurality of microprojections. Examiner suggests replacing “wherein at least tips of the microprojections are coated” with “wherein at least a tip of each microprojection of the plurality of microprojections are coated” to put the claim in clearer form and clearly refer to the plurality of microprojections of claim 1 and as each microprojection has a single tip.
Claim 19 is objected to because of the following informalities:
Line 1 recites “The apparatus of claim 1 wherein”. Examiner suggests adding a comma between “1” and “wherein” to put the claim in clearer form.
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 2, 11-12, 16-17, and 20 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.
In regard to claim 2,
Line 1-2 recites “wherein the microprojection array has a mass between 0.001 g and 0.05 g”. Claim 2 is dependent on claim 1. Claim 1 states “wherein the mass is the mass of the microprojection array”. It is unclear if the mass of the microprojection array of claim 2 is intended to be the same as the mass of the microprojection array of claim 1 or intended to be an additional mass of the microprojection array. Appropriate correction is required. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “wherein the microprojection array has a mass between 0.001 g and 0.05 g” in line 1-2 of claim 2 with “wherein the mass of the microprojection array is between 0.001 g and 0.05 g”.
In regard to claim 11,
Line 1 recites “the stop”. There is insufficient antecedent basis for the limitation in this claim. Claim 11 depends on claim 9. Claim 10 states “a stop”. Appropriate correction is required. Examiner suggests replacing “the stop” in line 1 of claim 11 with “a stop” or amending claim 11 to be dependent on claim 10.
In regard to claim 12,
Line 4 recites “the stop”. There is insufficient antecedent basis for the limitation in this claim. Claim 12 depends on claim 9. Claim 10 states “a stop”. Appropriate correction is required. Examiner suggests replacing “the stop” in line 4 of claim 12 with “a stop” or amending claim 12 to be dependent on claim 10.
In regard to claim 16,
Line 2 recites “a piston”. Claim 16 depends on claim 14. Claim 14 recites “a piston”. It is unclear if the piston of claim 16 is intended to be an additional piston to the piston of claim 14 or refer to the same piston as claim 14. For examination purposes Examiner construes them to be the same. Appropriate correction is required. Examiner suggests replacing “a piston” in line 2 of claim 16 with “the piston”.
In regard to claim 17,
Line 2 recites “a mass-to-velocity ratio”. Claim 17 depends on claim 1. Claim 1 recites “a mass-to-velocity ratio”. It is unclear if the mass-to-velocity ratio of claim 17 is intended to be the same or an additional mass-to-velocity ratio of claim 1. Appropriate correction is required. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a mass-to-velocity ratio” in line 2 of claim 17 with “the mass-to-velocity ratio”.
In regard to claim 20,
Line 2-3 recites “at which point the draught angle increases from 20 to 70 degrees”. It is unclear if the limitation is requiring the draught angle to be 20 degrees and then increase to 70 degrees at the transition point or if at the transition point the draught angle is/becomes 20 to 70 degrees. Appropriate correction is required. For examination purposes Examiner construes the draught angle at the transition point to be 20 to 70 degrees.
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 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.
Claims 1, 3, 5, 9, 13-14, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a first interpretation of Arami (U.S. PG publication 20150057604).
In regard to claim 1,
Arami discloses an apparatus (figure 5a, item 1) for delivering an active ingredient into the skin of an animal at a defined depth (paragraph [0010]; Examiner notes “for delivering an active ingredient into the skin of an animal at a defined depth” is functional limitation. The apparatus is fully capable of the recited function due to its structure and further as supported by paragraph [0010]), the apparatus including:
a) a microprojection array (figure 5a, item 30) including a plurality of microprojections (figure 7, item 32) having a density of 2000 projections per cm2 to 5000 projections per cm2 (5,000 projections per cm2 as supported by paragraph [0069]); and,
b) an applicator (figure 5a, item 20) for driving the microprojection array towards the skin in use (paragraph [0134]; Examiner notes “for driving the microprojection array towards the skin in use” is functional limitation. The applicator is fully capable of the recited function due to its structure) so that the microprojection array impacts on the skin with a mass-to-velocity ratio of between 0.005 g/m/s and 0.5 g/m/s (Examiner notes the velocity is construed as 10 m/s as supported by paragraph [0135] and the mass of the microprojection array is .1 g as shown in figure 11; therefore .1 g / 10 m/s = .01 g/m/s which satisfies the claimed mass-to-velocity ratio) wherein the mass is the mass of the microprojection array (see figure 11 wherein the mass is the mass of the microprojection array which is .1 g).
In regard to claim 3,
Arami discloses the apparatus of claim 1, wherein the microprojection array is configured to impact the skin at velocities between 10 m/s and 50 m/s (10 m/s; see analysis of claim 1 above and paragraph [0135]).
In regard to claim 5,
Arami discloses the apparatus of claim 1, wherein the microprojections are solid (see figure 7 which shows solid microprojections 32; paragraph [0070]).
In regard to claim 9,
Arami discloses the apparatus of claim 1, wherein the applicator includes a driver (figure 5a, item 20) configured to drive the microprojection array towards the skin (paragraph [0134]; Examiner notes “configured to drive the microprojection array towards the skin” is a functional limitation. The applicator is fully capable of the recited function due to its structure and as supported by paragraph [0134]) and wherein the microprojection array is releasably mounted to the driver (paragraph [0124]: wherein the microprojection array is releasably mounted to the driver via projections 31b) so that the microprojection array is configured to be released from the driver prior to the microprojections contacting the skin (Examiner notes “configured to be released from the driver prior to the microprojections contacting the skin” is a functional limitation; paragraph [0124]: the array is released from the driver prior to the microprojections contacting the skin since the microprojections are formed separately and do not contact the skin and then are attached to the driver thus resulting in the microprojections configured to be released from the driver prior to the microprojections contacting the skin).
In regard to claim 13,
Arami discloses the apparatus of claim 9, wherein the driver is configured to be urged from a retracted (position shown in figure 5a) to an extended position (position shown in figure 5b) using a biasing mechanism (figure 5a and 5b, item 40), and wherein the biasing mechanism and engagement between the driver and a housing (figure 5a, item 10) define a driver velocity in use (paragraph [0015], [0061] and [0134]; Examiner notes the spring biasing force and engagement between the driver and housing (how the driver is engaged/moves through the housing once released) defines a driver velocity).
In regard to claim 14,
Arami discloses the apparatus of claim 13, wherein the driver is a piston (figure 5a, item 20; paragraph [0047]).
In regard to claim 16,
[AltContent: textbox (Piston chamber)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Figure 5b)]
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Arami discloses the apparatus of claim 14, wherein the engagement is frictional engagement between a piston (figure 5a, item 20) and piston chamber (see figure 5b above) within the housing (see position of piston 20 in figure 5a to 5b where the piston 20 moves through the piston chamber; paragraph [0134]).
In regard to claim 17,
Arami discloses the apparatus of claim 1, wherein the microprojection array is configured to impacts on the skin with a mass-to-velocity ratio sufficiently high to dissipate inertia so as to avoid mechanical stress on body parts underlying the skin and cause a controlled amount of mechanical stress for immune-enhancing inflammation (see analysis of claim 1 above and 35. U.S.C. 112 rejection for claim interpretation; Examiner notes “configured to impacts on the skin with a mass-to-velocity ratio sufficiently high to dissipate inertia so as to avoid mechanical stress on body parts underlying the skin and cause a controlled amount of mechanical stress for immune-enhancing inflammation” is a functional limitation. The array is fully capable of the functional limitation since Arami teaches the claimed mass-to-velocity ratio in claim 1. Therefore, the mass-to-velocity ratio is construed as sufficiently high to dissipate inertia so as to avoid mechanical stress on body parts underlying the skin and cause a controlled amount of mechanical stress for immune-enhancing inflammation).
In regard to claim 18,
Arami discloses the apparatus of claim 1, wherein at least tips of the microprojections are coated (paragraph [0137]; see figure 7, item C).
In regard to claim 19,
Arami discloses the apparatus of claim 1 wherein the active ingredient is one or more vaccine antigens (paragraph [0084] and [0085]).
Claims 1, 3, 5, 9-14, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a second interpretation of Arami (U.S. PG publication 20150057604). Examiner notes the second interpretation differs from the first interpretation in regard to the applicator.
In regard to claim 1,
Arami discloses an apparatus (figure 5a, item 1) for delivering an active ingredient into the skin of an animal at a defined depth (paragraph [0010]; Examiner notes “for delivering an active ingredient into the skin of an animal at a defined depth” is functional limitation. The apparatus is fully capable of the recited function due to its structure and further as supported by paragraph [0010]), the apparatus including:
a) a microprojection array (figure 5a, item 30) including a plurality of microprojections (figure 7, item 32) having a density of 2000 projections per cm2 to 5000 projections per cm2 (5,000 projections per cm2 as supported by paragraph [0069]); and,
b) an applicator (figure 5a, item 10, 11, 20, and 50) for driving the microprojection array towards the skin in use (paragraph [0134]; Examiner notes “for driving the microprojection array towards the skin in use” is a functional limitation. The applicator is fully capable of the recited function due to its structure) so that the microprojection array impacts on the skin with a mass-to-velocity ratio of between 0.005 g/m/s and 0.5 g/m/s (Examiner notes the velocity is construed as 10 m/s as supported by paragraph [0135] and the mass of the microprojection array is .1 g as shown in figure 11; therefore .1 g / 10 m/s = .01 g/m/s which satisfies the claimed mass-to-velocity ratio) wherein the mass is the mass of the microprojection array (see figure 11 wherein the mass is the mass of the microprojection array which is .1 g).
In regard to claim 3,
Arami discloses the apparatus of claim 1, wherein the microprojection array is configured to impact the skin at velocities between 10 m/s and 50 m/s (10 m/s; see analysis of claim 1 above and paragraph [0135]).
In regard to claim 5,
Arami discloses the apparatus of claim 1, wherein the microprojections are solid (see figure 7 which shows solid microprojections 32; paragraph [0070]).
In regard to claim 9,
Arami discloses the apparatus of claim 1, wherein the applicator includes a driver (figure 5a, item 50) configured to drive the microprojection array towards the skin (paragraph [0134]; Examiner notes “configured to drive the microprojection array towards the skin” is a functional limitation. The applicator is fully capable of the recited function due to its structure and as supported by paragraph [0134]) and wherein the microprojection array is releasably mounted to the driver (Examiner notes the microprojection array is releasably mounted to the driver via the fact that depression 52 of the driver is releasable from tips 22a; Examiner notes when the depression 52 is released from tips 22a, the microprojection array is released from the driver as shown in figure 5b) so that the microprojection array is configured to be released from the driver prior to the microprojections contacting the skin (paragraph [0134]; Examiner notes “so that the microprojection array is configured to be released from the driver prior to the microprojections contacting the skin” is a functional limitation. When released from the position shown in figure 5a, the microprojection array is released from the driver prior to the microprojections contacting the skin in the position shown in figure 5b).
In regard to claim 10,
Arami discloses the apparatus of claim 9, wherein the driver abuts against a stop (figure 5a and 5B, item 10c) to configured to thereby release the microprojection array from the driver (Examiner notes “configured to thereby release the microprojection array from the driver” is a functional limitation. The stop is fully capable of the recited function due to its structure; see position of microprojection array and driver in figure 5b; paragraph [0134]).
In regard to claim 11,
[AltContent: textbox (Annular shoulder)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Figure 5b)]
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Arami discloses the apparatus of claim 9, wherein the stop includes an annular shoulder (see figure 5b above).
In regard to claim 12,
[AltContent: textbox (Proximate direction)][AltContent: arrow][AltContent: textbox (Open end)][AltContent: ][AltContent: textbox (Figure 5a)]
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Arami discloses the apparatus of claim 9, wherein the applicator includes:
a) a housing (figure 5a, item 10) containing the driver (see position in figure 5a and 5b wherein the driver is within the housing 10); and,
b) a substantially tubular spacer (figure 5a, item 11) that in use is positioned with an open end (see figure 5a above) in contact with a surface of the skin (Examiner notes “in use is positioned with an open end in contact with a surface of the skin” is a functional limitation. The open end of the tubular spacer of Arami is fully capable of being in contact with a surface of the skin due to its structure) to thereby space the housing from the skin (see figure 5a: wherein the ring is fully capable of spacing the housing from the skin since the ring fully covers the end of the housing), the stop being provided proximate the open end of the spacer (see figure 5a above).
In regard to claim 13,
Arami discloses the apparatus of claim 9, wherein the driver is configured to be urged from a retracted (position shown in figure 5a) to an extended position (position shown in figure 5b) using a biasing mechanism (force applied by user; paragraph [0134]), and wherein the biasing mechanism and engagement between the driver and a housing (figure 5a, item 10) define a driver velocity in use (Examiner notes the biasing force and engagement between the driver and housing i.e how the driver moves through the housing once released defines a driver velocity; paragraph [0118]-[0119]; [0130]).
In regard to claim 14,
Arami discloses the apparatus of claim 13, wherein the driver is a piston (It is Examiner’s position that the driver 50 is a piston as it structurally and functionally meets all limitations required of the piston/driver).
In regard to claim 16,
Arami discloses the apparatus of claim 14, wherein the engagement is frictional engagement between a piston (figure 5a, item 50) and piston chamber (figure 5a, item v2) within the housing (see figure 5a wherein the piston 50 is within the housing; paragraph [0118]-[0119]; [0130]).
In regard to claim 17,
Arami discloses the apparatus of claim 1, wherein the microprojection array is configured to impacts on the skin with a mass-to-velocity ratio sufficiently high to dissipate inertia so as to avoid mechanical stress on body parts underlying the skin and cause a controlled amount of mechanical stress for immune-enhancing inflammation (see analysis of claim 1 above and 35. U.S.C. 112 rejection for claim interpretation; Examiner notes “configured to impacts on the skin with a mass-to-velocity ratio sufficiently high to dissipate inertia so as to avoid mechanical stress on body parts underlying the skin and cause a controlled amount of mechanical stress for immune-enhancing inflammation” is a functional limitation. The array is fully capable of the recited function since Arami teaches the claimed mass-to-velocity ratio. Therefore, the mass-to-velocity ratio is construed as sufficiently high to dissipate inertia so as to avoid mechanical stress on body parts underlying the skin and cause a controlled amount of mechanical stress for immune-enhancing inflammation).
In regard to claim 18,
Arami discloses the apparatus of claim 1, wherein at least tips of the microprojections are coated (paragraph [0137]; see figure 7, item C).
In regard to claim 19,
Arami discloses the apparatus of claim 1 wherein the active ingredient is one or more vaccine antigens (paragraph [0084] and [0085]).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Arami (U.S. PG publication 20150057604) further in view of Cantor (U.S. PG publication 20080114298). Examiner notes the rejection of claim 2 applies to both the first and second interpretation of Arami.
In regard to claim 2,
Arami discloses the apparatus of claim 1, wherein the mass of the microprojection array is 0.1 g (see figure 11).
Although Arami discloses that the mass is not limited to the examples in figure 11 (see paragraph [0154]) and that the mass of the piston body 20 and microprojection array 30 together may be as small as 0.1 g (see paragraph [0114]), Arami is silent as to wherein the mass of the microprojection array is between 0.001 g and 0.05 g. Examiner notes if the mass of the piston body 20 and microprojection array 30 together may be as small as 0.1 g, the microprojection array alone would be less than 0.1 g. However, it is unclear the actual mass of the microprojection array 30, as the mass given in paragraph [0114] of Arami is of two components.
Cantor teaches wherein the mass of the microprojection array (item 120) is between 0.001 g and 0.05 g (see paragraph [0045]: wherein the mass is 4 grams or less. Examiner notes since the mass is disclosed as 4 grams or less, a mass of .04 g, which is less than 4 grams, satisfies the limitation. Additionally, Cantor states that the velocity is 20 m/s and therefore the limitation of the mass-to-velocity ratio of between 0.0005 g/m/s and 0.005 g/m/s as required in claim 1 would still be satisfied as .04g / 20 m/s = 0.002 g/m/s).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Arami to include wherein the mass of the microprojection array is .04 g, therefore resulting in wherein the mass of the microprojection array is between 0.001 g and 0.05 g, as taught by Cantor, for the purpose of limiting pain (paragraph [0045] of Cantor) and since it has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists.
Examiner notes the mass range does not appear to be critical as paragraph [0069] of Applicants disclosure discusses several mass possibilities which include both 0.1 g and 0.05 g among several others.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Arami (U.S. PG publication 20150057604) further in view of Donovan (U.S. PG publication 20150080844). Examiner notes the rejection of claim 4 applies to both the first and second interpretation of Arami.
In regard to claim 4,
Arami discloses the apparatus of claim 1, wherein the microprojection array has an area (paragraph [0063]).
Arami fails to disclose wherein the microprojection array has an area between 10 mm2 and 40 mm2.
Donovan teaches wherein the microprojection array (figure 1, item 103) has an area between 10 mm2 and 40 mm2 (paragraph [0128]; Examiner notes an area of .3 cm2 which is 30 mm2 falls within the claimed range).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Arami to include wherein the microprojection array has an area between 10 mm2 and 40 mm2, as taught by Donovan, for the purpose of utilizing a desirable sized array (paragraph [0128] and [0006] of Donovan) and for the purpose of constructing an array with a desired small size that is easy to use (paragraph [0063] and [0008] of Arami). Further Arami supports that modifications can be made to the area of the microprojection array (see paragraph [0063] of Arami).
Claims 6-8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Arami (U.S. PG publication 20150057604) further in view of Bernstein (U.S. PG publication 20130158468). Examiner notes the rejection of claims 6-8 apply to both the first and second interpretation of Arami and the rejection of claim 15 applies only to the first interpretation of Arami.
In regard to claim 6,
Arami discloses the apparatus of claim 1, wherein the microprojections are tapered (paragraph [0067]; Examiner notes the microneedle 32 may be formed like a polygonal pyramid) and polygonal (paragraph [0067]; Examiner notes the microneedle 32 may be formed like a polygonal pyramid).
Arami is silent as to the type of polygon and therefore fails to disclose wherein the microprojections are hexagonal.
Bernstein teaches wherein the microprojections are hexagonal (paragraph [0049]: wherein the needles are solid and hexagonal) and that a polygonal and a hexagonal shaped microprojection could all be used to achieve the same result (paragraph [0049] of Bernstein) and thus were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a hexagonal shape in place of the polygonal shape of the pyramid of Arami since it has been held that substituting parts of an invention involves only routine skill in the art.
In regard to claim 7,
Arami in view of Bernstein teaches the apparatus of claim 6, wherein the microprojections have a length of between 200 µm and 300 µm (paragraph [0066] of Arami; Examiner notes the length is construed as 250 µm which falls within the claimed range; see also paragraph [0049] of Bernstein wherein the needles may be any suitable length).
In regard to claim 8,
Arami in view of Bernstein teaches the apparatus of claim 7, wherein the microprojections include: a) a base having a width and b) a tip having a width (see paragraph [0067]: the base is wider than the tip and figure 7 of Arami and paragraph [0049] of Bernstein which supports that any suitable width and size can be utilized)
Arami in view of Bernstein fails to disclose wherein the microprojections include: a) a base having a width of about 5 µm to about 50 µm and b) a tip having a width of 0.5 µm to 2 µm.
It would have been an obvious matter of design choice to modify Arami in view of Bernstein to include wherein the microprojections include: a) a base having a width of about 5 µm to about 50 µm and b) a tip having a width of 0.5 µm to 2 µm since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device.
In regard to claim 15,
Arami in view of Bernstein teaches the apparatus of claim 13, wherein the biasing mechanism is a spring (figure 5b, item 40).
Arami in view of Bernstein fails to disclose wherein the biasing mechanism is a pneumatic actuator.
Bernstein teaches wherein the biasing mechanism is a pneumatic actuator (paragraph [0051]) and that a spring and a pneumatic actuator could all be used to achieve the same result (paragraph [0051] of Bernstein) and thus were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a pneumatic actuator in place of the spring since it has been held that substituting parts of an invention involves only routine skill in the art.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Arami (U.S. PG publication 20150057604) in view of Bernstein (U.S. PG publication 20130158468) further in view of Wakamatsu (U.S. PG publication 20170057124). Examiner notes the rejection of claim 20 applies to both the first and second interpretation of Arami.
In regard to claim 20,
Arami in view of Bernstein teaches the apparatus of claim 8.
Arami in view of Bernstein is silent as to wherein the base has two substantially parallel sides with a draught angle of 1 to 20 degrees up to a transition point at which point the draught angle increases from 20 to 70 degrees.
Wakamatsu teaches wherein the base has two substantially parallel sides with a draught angle of 1 to 20 degrees up to a transition point at which point the draught angle increases from 20 to 70 degrees (paragraph [0066] and [0067]; see figure 2 and 3).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Arami in view of Bernstein to include wherein the base has two substantially parallel sides with a draught angle of 1 to 20 degrees up to a transition point at which point the draught angle increases from 20 to 70 degrees, as taught by Wakamatsu, for the purpose of forming a microprojection which is easily inserted into the skin (paragraph [0067] of Wakamatsu).
Conclusion
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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