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 .
Acknowledgments
In the reply, filed on April 22, 2026, Applicant amended claims 2, 5-7, 11, 13, 16, and 20.
In the non-final rejection of February 10, 2026, Examiner noted that the information disclosure statement filed June 24, 2025, fails to comply with 37 CFR 1.98(a)(2). Applicant resubmitted copies of the indicated references. Concern is withdrawn.
Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 5, 13, and 20. Applicant amended claims 5, 13, and 20. Objection is withdrawn.
Examiner rejected claims 3, 6-7, 11, and 17 under 35 U.S.C. 112(b). Applicant amended claims 6-7 and 11; however, Applicant did not address all of the rejections. Rejection is maintained.
Currently, claims 1-7, 10-11, 13, 15-17, and 19-20 are under examination.
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 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, lines 2-3 recite “at least one microarray”. It is unclear whether the two terms are the same components or different components.
In regards to claim 17, line 2 recites “two microarrays”. Claim 17 depends upon claim 16. Claim 16, lines 2-3 recite “at least one 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 the 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 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 ingredient and the interstitial liquid are drawn in simultaneously (Figure 25a).
In regards to claim 11, Yodfat et al teaches wherein the delivery device is connected to an outlet of the conveying device (Figure 25a).
In regards to claim 13, Yodfat et al teaches a mixing chamber (3/17) for mixing the interstitial liquid and the 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 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 at least one microarray (paragraph [0084]: micro-needle array); however, Yodfat et al is silent about the at least one 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 at least one 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 at least one 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 Kwiatkowski et al, which is at least 4 needles/cm2, as an obvious matter of design choice of the density of needles of the at least one 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 Kwiatkowski 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 at least one microarray (paragraph [0084]: micro-needle array); however, Yodfat et al is silent about the at least one 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 at least one 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 at least one 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 Kwiatkowski et al, which is at least 50 needles/cm2, as an obvious matter of design choice of the density of needles of the at least one 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 Kwiatkowski 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 Kwiatkowski 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 Kwiatkowski 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.
Response to Arguments
Applicant's arguments filed April 22, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: Given the above, one of skill in the art would recognize that sensing arm (166) of Yodfat does not extract interstitial liquid. Rather, as discussed in Yodfat in Paragraphs [0139] and [0140] detailed above, cannula (6) is configured as a bifurcated element, consisting of a dispensing arm (16) and a sensing arm (166), wherein sensing arm (166) is used for analyte sensing. Given this, as is further noted in Yodfat in Paragraphs [0139] and [0140], the fluid, which is stored in reservoir (3) is pumped through dispensing arm (16) and a common arm (666) into the body, while simultaneously being pumped backwards through sensing arm (166) to sensing element (2000), as seen in Fig. 25a. Due to this, Yodfat requires that during the passage of the fluid through the sensing arm (166), analyte diffusion occurs between the ISF (interstitial fluid) analyte outside the cannula (6) and the fluid within the sensing arm (166). Thus, for at least this reason, it is clear that Yodfat fails to disclose the required element of claim 1 where an extraction device for extracting interstitial liquid is provided in an intradermal active ingredient delivery system as it is clear that element (166) of Yodfat does not extract interstitial flu id /liquid. Rather, as is clear from Yodfat, sensing arm (166) enables an equilibrium of the analyte concentration between the surrounding ISF and the fluid inside sensing arm (166) (emphasis supplied) (Remarks, pages 10-11). Examiner disagrees. Yodfat et al teaches an extraction device (166) for extracting interstitial liquid. Paragraph [0141] of Yodfat et al states: FIG. 25a shows an example implementation of a bifurcated cannula. After analyte sensing by the sensing element 2000, the fluid joins the analyte-free perfused fluid stored in the reservoir 3 and another reciprocating cycle begins. FIG. 25b shows another implementation in which a check valve, reverse flow restrictor, or other comparable regulation means 30, located at the reservoir outlet port 333, is provided. Thus, the analyte-rich perfused fluid, after passing through the sensing element 2000, is prevented from entering the reservoir 3 as it bypasses the reservoir 3 and instead enters the delivery tube 17.
Conclusion
THIS ACTION IS MADE FINAL. 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 SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm 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, Kevin C Sirmons can be reached at (571) 272-4965. 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.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
Prosecution Insights