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 .
Election/Restrictions
Applicant’s election without traverse of Species I (Figure 1) in the reply filed on January 2, 2026, is acknowledged.
Applicant identified claims 1-20 as readable on elected Species I (Figure 1). Examiner disagrees:
Claim 8 recites: wherein the active ingredient reservoir is connected to an outlet of the conveying device. Figure 1 does not show this claim feature. Figure 1 instead shows the active ingredient reservoir 16 is connected an inlet 20 of the conveying device 14. Thus, Examiner withdraws claim 8 from examination as not readable on elected Species I (Figure 1).
Claim 9 recites: wherein the conveying device comprises two pumps, and wherein the active ingredient reservoir is arranged between the two pumps. Figure 1 does not show this claim feature. Figure 1 instead shows the conveying device comprises one pump 14. Thus, Examiner withdraws claim 9 from examination as not readable on elected Species I (Figure 1).
Claim 12 recites: wherein the active ingredient reservoir is integrated into the delivery device, and wherein the active ingredient is provided in the needles of the delivery device. Figure 1 does not show this claim feature. Figure 1 instead shows the active ingredient reservoir 16 is separate from the delivery device 26. Thus, Examiner withdraws claim 12 from examination as not readable on elected Species I (Figure 1).
Claim 14 recites: wherein the active ingredient reservoir forms the mixing chamber. Figure 1 does not show this claim feature. Figure 1 instead shows the conveying device 14 or the area where channels 12/18 merge to form the mixing chamber. Thus, Examiner withdraws claim 14 from examination as not readable on elected Species I (Figure 1).
Claim 18 recites: wherein the active ingredient reservoir is connected to the at least one outlet of the conveying device pump. Figure 1 does not show this claim feature. Figure 1 instead shows the active ingredient reservoir 16 is connected an inlet 20 of the conveying device pump 14. Thus, Examiner withdraws claim 18 from examination as not readable on elected Species I (Figure 1).
Currently, claims 1-7, 10-11, 13, 15-17, and 19-20 are under examination as readable on elected Species I (Figure 1).
Information Disclosure Statement
The information disclosure statement filed June 24, 2025, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
The provided copy of CN 101970030 is missing pages, such as Drawings
The provided copy of WO 2020/148741 is missing pages, such as Specification and Drawings
Specification
The abstract of the disclosure is objected to because:
In line 2, “a several hollow needles” should be changed to “several hollow needles”
In lines 5-6, “an interstitial liquid” should be changed to “the interstitial liquid”
In line 6, “active ingredient” should be changed to “an active ingredient”
In line 7, “the liquid mixture” should be changed to “the interstitial liquid comprising the active ingredient”
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).
Claim Objections
Claims 5, 13, and 20 are objected to because of the following informalities:
In regards to claim 5, line 2, “an active ingredient” should be changed to “the active ingredient”.
In regards to claim 13, lines 2-3, “interstitial liquid” should be changed to “the interstitial liquid”.
In regards to claim 13, line 3, “active ingredient” should be changed to “the active ingredient”.
In regards to claim 20, lines 3-4, “the conveying device pump” should be changed to “the pump”.
Appropriate correction is required.
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 3, 6-7, 11, and 17 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 regards to claim 3, line 2 recites “two microarrays”. Claim 3 depends upon claim 2. Claim 2, line 3 recites “a microarray”. It is unclear whether the two terms are the same components or different components.
In regards to claim 6, line 2 recites “the liquid active ingredient”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 6 depends upon claim 1. Claim 1, line 9 recites “an active ingredient”. It is unclear whether the two terms are the same component or different components. Claim 7 is rejected by virtue of being dependent upon claim 6.
In regards to claim 7, line 4 recites “the active substance”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 7 depends upon claim 6. Claim 6, line 2 recites “the liquid active ingredient”. Claim 6 depends upon claim 1. Claim 1, line 9 recites “an active ingredient”. It is unclear whether the three terms are the same component or different components.
In regards to claim 7, line 4 recites “the initial liquid”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 7 depends upon claim 6, which depends upon claim 1. Claim 1, line 3 recites “an interstitial liquid”. It is unclear whether the two terms are the same component or different components.
In regards to claim 11, line 2 recites “the outlet”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 17, line 2 recites “two microarrays”. Claim 17 depends upon claim 16. Claim 16, line 2 recites “a microarray”. It is unclear whether the two terms are the same components or different components.
Claim Rejections - 35 USC § 102
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, 4-7, 11, 13, 15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yodfat et al (US 2008/0281290).
In regards to claim 1, Yodfat et al teaches an intradermal active ingredient delivery system (Figure 25a) comprising:
an extraction device (166) for extracting interstitial liquid
a conveying device (4/17) fluidically connected to the extraction device for conveying liquid
an active ingredient reservoir (3) fluidically connected to the conveying device
a delivery device (16) fluidically connected to the conveying device for intradermal delivery of the interstitial liquid comprising an active ingredient
In regards to claim 4, Yodfat et al teaches wherein the conveying device comprises at least one pump (4).
In regards to claim 5, Yodfat et al teaches wherein an active ingredient in liquid form is stored in the active ingredient reservoir (paragraph [0141]: analyte-free perfused fluid stored in the reservoir 3).
In regards to claim 6, Yodfat et al teaches wherein the active ingredient reservoir containing the liquid active ingredient and the extraction device are connected to an inlet of the conveying device (Figure 25a).
In regards to claim 7, Yodfat et al teaches wherein the active ingredient reservoir and the extraction device are connected to the inlet of the conveying device in such a way that the active substance and the initial liquid are drawn in simultaneously (Figure 25a).
In regards to claim 11, Yodfat et al teaches wherein the delivery device is connected to the outlet of the conveying device (Figure 25a).
In regards to claim 13, Yodfat et al teaches a mixing chamber (3/17) for mixing interstitial liquid and active ingredient.
In regards to claim 15, Yodfat et al teaches wherein the mixing chamber (17) is integrated into the conveying device.
In regards to claim 20, Yodfat et al teaches wherein the conveying device comprises a pump (4/17), wherein the pump has at least one inlet and at least one outlet, and wherein the delivery device is connected to the at least one outlet of the conveying device pump (Figure 25a).
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.
Claims 2-3 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al, as applied to claim 1 above, and further in view of Kwiatkowski et al (US 2006/0058602).
In regards to claim 2, Yodfat et al teaches wherein the extraction device comprises microneedles provided by a microarray (paragraph [0084]: micro-needle array); however, Yodfat et al is silent about the microarray having at least 4 needles/cm2. Kwiatkowski et al teaches an intradermal system (Figure 1) wherein an extraction device comprises microneedles (12) provided by a microarray (11) having at least 4 needles/cm2 (paragraph [0041]: the density of the microprojections in the array is between about 5 microprojections per cm2 and about 1000 microprojections per cm2. More preferably, the density of the microprojections is between about 50 microprojections per cm2 and about 500 microprojections per cm2). 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 the microarray, of the system of Yodfat et al, to have between about 5 needles per cm2 and about 1000 needles per cm2 or between about 50 needles per cm2 and about 500 needles per cm2, as taught by Kwiatlowski et al, which is at least 4 needles/cm2, as an obvious matter of design choice of the density of needles of the microarray selectable by a person having ordinary skill in the art in order to sufficiently collect the necessary volume of interstitial liquid.
In regards to claim 3, in the modified system of Yodfat et al and Kwiatkowski et al, Yodfat et al teaches wherein the extraction device comprises a microarray (paragraph [0084]: micro-needle array); however, Yodfat et al is silent about wherein the extraction device comprises two microarrays each having at least 4 needles/cm2. Kwiatkowski et al teaches wherein the extraction device comprises two microarrays (11) each having at least 4 needles/cm2 (paragraph [0041]: the density of the microprojections in the array is between about 5 microprojections per cm2 and about 1000 microprojections per cm2. More preferably, the density of the microprojections is between about 50 microprojections per cm2 and about 500 microprojections per cm2). 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 the microarray, of the modified system of Yodfat et al and Kwiatkowski et al, to comprise two microarrays each having between about 5 needles per cm2 and about 1000 needles per cm2 or between about 50 needles per cm2 and about 500 needles per cm2, as taught by Kwiatlowski et al, which is at least 4 needles/cm2, as an obvious matter of design choice of the number of microarrays and the density of needles of the microarrays selectable by a person having ordinary skill in the art in order to sufficiently collect the necessary volume of interstitial liquid.
In regards to claim 16, Yodfat et al teaches wherein the extraction device comprises microneedles provided by a microarray (paragraph [0084]: micro-needle array); however, Yodfat et al is silent about the microarray having at least 50 needles/cm2. Kwiatkowski et al teaches an intradermal system (Figure 1) wherein an extraction device comprises microneedles (12) provided by a microarray (11) having at least 50 needles/cm2 (paragraph [0041]: the density of the microprojections is between about 50 microprojections per cm2 and about 500 microprojections per cm2). 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 the microarray, of the system of Yodfat et al, to have between about 50 needles per cm2 and about 500 needles per cm2, as taught by Kwiatlowski et al, which is at least 50 needles/cm2, as an obvious matter of design choice of the density of needles of the microarray selectable by a person having ordinary skill in the art in order to sufficiently collect the necessary volume of interstitial liquid.
In regards to claim 17, in the modified system of Yodfat et al and Kwiatkowski et al, Yodfat et al teaches wherein the extraction device comprises a microarray (paragraph [0084]: micro-needle array); however, Yodfat et al is silent about wherein the extraction device comprises two microarrays each having at least 50 needles/cm2. Kwiatkowski et al teaches wherein the extraction device comprises two microarrays (11) each having at least 50 needles/cm2 (paragraph [0041]: the density of the microprojections is between about 50 microprojections per cm2 and about 500 microprojections per cm2). 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 the microarray, of the modified system of Yodfat et al and Kwiatkowski et al, to comprise two microarrays each having between about 50 needles per cm2 and about 500 needles per cm2, as taught by Kwiatlowski et al, which is at least 50 needles/cm2, as an obvious matter of design choice of the number of microarrays and the density of needles of the microarrays selectable by a person having ordinary skill in the art in order to sufficiently collect the necessary volume of interstitial liquid.
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al, as applied to claim 1 above, and further in view of Etheredge et al (US 2007/0066934).
In regards to claim 10, Yodfat et al teaches wherein the delivery device comprises microneedles provided by a microarray (paragraph [0084]: micro-needle array); however, Yodfat et al is silent about the microarray having at least 4 needles/cm2. Etheredge et al teaches an intradermal active ingredient delivery system (Figure 1) wherein a delivery device comprises microneedles (14) provided by a microarray (Figure 1) having at least 4 needles/cm2 (paragraph [0027]: micro-needles 14 have a density… preferably in a range of about 150-250 needles per cm2). 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 the microarray, of the system of Yodfat et al, to have about 150-250 needles per cm2, as taught by Kwiatlowski et al, which is at least 4 needles/cm2, as an obvious matter of design choice of the density of needles of the microarray selectable by a person having ordinary skill in the art in order to sufficiently deliver the necessary volume of interstitial liquid and active agent.
In regards to claim 19, Yodfat et al teaches wherein the delivery device comprises microneedles provided by a microarray (paragraph [0084]: micro-needle array); however, Yodfat et al is silent about the microarray having at least 50 needles/cm2. Etheredge et al teaches an intradermal active ingredient delivery system (Figure 1) wherein a delivery device comprises microneedles (14) provided by a microarray (Figure 1) having at least 50 needles/cm2 (paragraph [0027]: micro-needles 14 have a density… preferably in a range of about 150-250 needles per cm2). 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 the microarray, of the system of Yodfat et al, to have about 150-250 needles per cm2, as taught by Kwiatlowski et al, which is at least 50 needles/cm2, as an obvious matter of design choice of the density of needles of the microarray selectable by a person having ordinary skill in the art in order to sufficiently deliver the necessary volume of interstitial liquid and active agent.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783