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 with traverse of Species A, figures 1A-1E, and subspecies 1B, 1D 1E, 2A-2F, 3 and 9A, claims 1-14, and 20-25 in the reply filed on 12/23/2025 is acknowledged. The traversal is on the ground(s) that a) there is no showing that the electroporation devices identified as species A-C are patentably distinct species, b) applicant acknowledges removal of figure 8C from species, but erroneously states that figure 8C is prior art, and c) Applicant's traversal is based upon the absence of a showing that the sub-species (i)-(xiii) identified by the Examiner are patentably distinct species. For example, the Examiner has not identified any mutually exclusive characteristics among sub-species (i)-(xiii). Furthermore, Applicant submits that at least claim 1 is generic to at least sub-species (i) (figures 1B, ID, 1E, 2A-2F, 3, 9A), sub-species (vi) (figures 7A-B), sub-species (viii) (figure 8B), and sub-species (xiii)(figure 9F).
This is not found persuasive because
Argument a) the Office action filed on 10/07/2025 (page 3) already provided reasons why Species A-C were patentably distinct species.
Argument b) the examiner acknowledges applicant’s remarks. It is noted figure 8C is considered prior art in US Pubs 2019/0009084 is because the Publication is invented by another and it is outside one year of publication. See MPEP 2152 and 2152.02.
Argument c) the reasons for insisting upon election of one species are the facts relied upon for the conclusion that there are claims restricted respectively to two or more patentably different species that are disclosed in the application. The breath of a single disclosed species does not necessitate the examination of the other disclosed species and their concomitant features. The examination of other species would include a determination of the patentability of the species additional features in combination with the subcombination common to all species, which determination amounts to an examination of multiple inventions. For clarification purposes about the election of species of the subspecies, the examiner provides the differences between the subspecies herein below:
In view of election of species C):
a) figures 30a-30b- electroporation needles arranged in a 5x2 matrix and injection channels for receiving injection needles interspersed between the electroporation needles, according to an embodiment of the present disclosure [0057];
b) figures 31a-31b- an array having electroporation needles arranged in a 6x4 matrix and injection channels for receiving injection needles interspersed between the electroporation needles, according to an embodiment of the present disclosure [0060];
c) figure 33a a modular array having electroporation needles arranged in a 6x4 matrix and injection channels for receiving injection needles interspersed between the electroporation needles, according to an embodiment of the present disclosure [0067];
d) figures 36a-36b- an electroporation array assembly having electroporation needles arranged in a 3x2 matrix and injection channels that are eccentrically offset from the electroporation needles, according to an embodiment of the present disclosure [0076]; and
e) figures 38a-38b- an electroporation array assembly having electroporation needles arranged in a 3x2 matrix and injection channels that are in-line with the rows of electroporation needles, according to an embodiment of the present disclosure [0081].
In view of election from A - C, or upon election of Species C with one respective matrix from a-e;
i) figures 1B, 1D, 1E, 2A-2F, 3, 9A- an electrode array of the electroporation system with a side-port injection needle showing an array of side-ports having elongated geometries and specific angle;
iii) figures 4A-4B- a side-port injection needle having a single, laterally elongated side-port. A single side-port 24 that is elongated along a direction that is offset from the longitudinal direction X;
iv) figures 5A-5B- an injection needle can have a single side-port 124, which, in this example, has a circular shape. The side-port 124 can extend from the lumen 22 (i.e., from the interior surface 84) along a port axis 85 that is oriented at an oblique angle A4 with respect to the central axis 27 of the injection needle 20;
v) figure 6- an injection needle 20 can have a port array 25 that includes multiple groups 100 of side-ports 124, such that the side-ports 124 in each group 100 are aligned in a manner generally approximating the elongated, slot-type side-ports 24;
vi) figures 7A-7B- an injection needle 20 can have a port array 25 with elongate, slot-like side-ports 24, similar to the port arrays 25 described above with reference to Figs. 1A-2F. However, in the present embodiment, the port array 25 can span less than an entire circumference of the injection needle 20;
vii) figures 8A- another example of a directed-array injection needle 20 has a port array 25 that includes a plurality of side-ports 124 that are arranged in a single series, such that all of the side-ports 124 are longitudinally aligned with each other. The side-ports 124 of the present embodiment can be circular side-ports 124;
viii) figures 8B- another example of a side-portion injection needle 20 can be configured for use with a drug cartridge, such as a single-dose injection cartridge, by way of a non-limiting example. In such embodiments, a proximal end 57 of the injection needle 20 can define a penetrating formation, such as a proximal bevel 115, configured to penetrate a distal septum of the drug cartridge, thereby placing the lumen 22 of the injection needle 20 in fluid communication with the injectate contained within the drug cartridge. The side-port injection needle 20 can also be configured for use with a retractable shroud configured to retract in a manner exposing the side-port injection needle, such as during injection, and further configured to extend and lock in place in a manner covering the injection needle 20 after use, such as after a single use injection;
ix) figures 9B- an example port array 25 includes circular side-ports 124 arranged in a total of twelve (12) groups 100, each group 100 having three (3) ports 124. Each port 124 has a radius of about 0.05 mm. The groups 100 are arranged into three (3) rows 70 having four (4) groups per row 70 (i.e., a 3x4x3 array having a total of thirty-six (36) side-ports). This port array 25 provides an angular span of 360 degrees. Each row 70 has spacing angles Al of about 90 degrees, and the middle row 70 is angularly offset at an angle A2 of about 45 degrees. The array 25 has an infusion length L2 of about 5.8 mm and provides a total infusion area of about 144.05 mm2 and a combined total port area of about 0.283 mm2;
x) figures 9C- an example port array 25 includes circular side-ports 124 arranged in thirty-one (31) rows 70 with four (4) ports per row 70 (i.e., a 31x4 array having a total of 124 side-ports) that provides an angular span of 360 degrees. Each port 124 has a radius of about 0.03 mm. Adjacent rows are spaced from each other at inter-row distances L8 of about 0.2 mm. Each row 70 has spacing angles Al of about 90 degrees, and adjacent rows are angularly offset from each other at an angle A2 of about 45 degrees. The port array 25 has an infusion length L2 of about 6.06 mm and provides a total infusion area of about 143.98 mm2 and a combined total port area of about 0.350 mm2;
xi) figures 9D- an example port array 25 includes circular side-ports 124 arranged in seven (7) rows 70 with four (4) ports per row 70 (i.e., a 7x4 array having a total of 28 side-ports) that provides an angular span of 360 degrees. Each port 124 has a radius of about 0.06 mm. Adjacent rows are spaced from each other at inter-row distances L8 of about 0.2 mm. Each row 70 has spacing angles Al of about 90 degrees, and adjacent rows are angularly offset from each other at an angle A2 of about 45 degrees. The port array 25 has an infusion length L2 of about 6.12 mm and provides a total infusion area of about 144.01 mm2 and a combined total port area of about 0.317 mm2;
xii) figures 9E- an example port array 25 includes circular side-ports 124 arranged in two (2) rows 70 with three (3) ports per row 70 (i.e., a 2x3 array having a total of six (6) side-ports) that provides an angular span of 360 degrees. Each port 124 has a radius of about 0.10 mm. Each row 70 has spacing angles Al of about 120 degrees, and the rows are angularly aligned with each other. The port array 25 has an infusion length L2 of about 6.0 mm and provides a total infusion area of about 144.14 mm2 and a combined port area of about 0.188 mm2; and
xiii) figures 9F- an example port array 25 includes elongated side-ports 24 arranged in fourteen (14) rows 70 with four (4) ports per row 70 (i.e., a 14x4 array having a total of fifty-six (56) side-ports) that provides an angular span of 360 degrees. Each row 70 has spacing angles Al of about 90 degrees, and adjacent rows are angularly offset from each other at an angle A2 of about 45 degrees. Each side-port 24 has a length L9 of about 0.3 mm and a width W1 of about 0.02 mm. The port array 25 has an infusion length L2 of about 6.15 mm and provides a total infusion area of about 144.0 mm2 and a combined port area of about 0.336 mm2.
In view of the mutually exclusive characteristics for the distinct species set forth above, the examiner maintained the election of species set forth in 10/07/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-19, 26-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/23/2025.
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.
Claims 1-6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20060084938 A1) in view of Sällberg et al. (US 20160235928 A1).
Regarding claim 1, Zhang discloses an injection device (figs 1 and 9) for in vivo delivery of an agent (abstract), comprising:
a tubular body 910 (fig 9) defining a lumen that extends along a central axis oriented along a longitudinal direction [0029], the tubular body 910 defining at least one side-port (fig 9) extending from the lumen to an outer surface of the tubular body.
Zhag fails to disclose a distal end of the lumen of the tubular body is occluded, and the at least one side-port is elongated along the outer surface of the tubular body.
Sällberg teaches an injection device (figs 1f,8a) for in vivo delivery of an agent including a tubular body defining a lumen [0008] where a distal end of the lumen of the tubular body is occluded ([0008] closed end), and the at least one side-port is elongated along the outer surface of the tubular body ([0010] oval, slit, ovoid shape).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang’s side ports shape with the ones taught by Sällberg (elongated shape) in order to improve and/or control the distribution and flow of agent at the tissue.
Regarding claims 2-4, Zhang discloses the at least one side-port has a length and a width each measured along the outer surface, but fails to disclose wherein the length is greater than the width by a factor in a range of about 2 to about 80; (claim 3), wherein the factor is in a range of about 15 to about 50; and (claim 4) wherein the factor is in a range of about 35 to about 45.
Sällberg further teaches in [0022, 0088] that side ports can be any size and shape, and in order to be elongated the length has to be greater than the width. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang’s side ports length and width with the claimed features since such modification is deemed matter of design choice, and recognized by Sällberg, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results in order to improve and/or control the distribution and flow of agent at the tissue.
Regarding claim 5, Zhang discloses the at least one side-port comprises a plurality of side-ports (fig 9).
Regarding claim 6, Zhang discloses wherein the plurality of side-ports are arranged into distinct rows spaced from each other along the longitudinal direction (figs 7 and 9).
Regarding claim 14, Zhang discloses wherein the injection device 910 is an injection needle [0029].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20060084938 A1) in view of Sällberg et al. (US 20160235928 A1), and further in view of Kjeken et al. (US 20110009807 A1).
Regarding claim 7, Zhang discloses at least a first one of the rows comprises four side-ports of the plurality of side-ports (fig 9). Sällberg teaches in [0010] that the side apertures can be evenly or unevenly spaced along the length of the tubular body (needle), but both fail to disclose that the four side-ports are evenly angularly spaced from each other about a circumference of the tubular body.
Kjeken teaches, (in figures 11a-11b and [0040]), that the apertures are spaced along the needle length (FIG. 11A) and at 90 degrees with respect to one another around the circumference of the needle shaft (FIG. 11B) for uniform distribution of the injected substance into the tissues [0011]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang/ Sällberg side ports by providing them with the teachings of Kjeken since such modification would enhance the flow and distribution of agent at the tissue.
Claims 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20060084938 A1) in view of Sällberg et al. (US 20160235928 A1), and further in view of Kjeken et al. (US 20110009807 A1), and further in view of Chomas et al. (US 10548659 B2).
Regarding claim 8, Zhang/ Sällberg/ Kjeken discloses at least a second one of the rows comprises four additional side-ports of the plurality of side-ports and the four additional side-ports being evenly angularly spaced from each other about a circumference of the tubular body. However, they do not disclose the four additional side-ports are angularly offset from the four side-ports of the at least first one of the rows by an offset angle of about 45 degrees about the central axis.
Chomas teaches in figure 2c the second one of the rows of the additional side ports are angularly offset from the four side-ports of the at least first one of the rows by an offset angle of about 45 degrees about the central axis.
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Given the teaching, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang/ Sällberg/ Kjeken with Chomas teaching since such modification as taught old and well known in the art, and it is deemed matter of design choice, and recognized by Sällberg/ Kjeken/Chomas, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results in order to improve and/or control the distribution and flow of agent at the tissue.
Regarding claim 9, Sällberg teaches the four side-ports and the four additional side-ports are each elongated along the longitudinal direction [0010,0022, 0088].
Regarding claim 10, Sällberg teaches wherein the four side-ports and the four additional side-ports are each rectangular [0010,0022, 0088].
Regarding claim 11, Zhang/ Sällberg/ Kjeken/Chomas fail to disclose at least a third one of the rows comprises four yet additional side-ports of the plurality of side-ports, the four yet additional side- ports being evenly angularly spaced from each other about a circumference of the tubular body, and wherein the four yet additional side-ports are angularly aligned from the four side-ports of the at least first one of the rows.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Zhang/ Sällberg/ Kjeken/Chomas with the claimed limitations since such modification would have been a mere duplication of essential working parts of the tubular body in order to complete the side ports around the circumference of the tubular body (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claims 12-13, Kjeken teaches in ([0011] .1 to 1.5cm falling the range) the plurality of side-ports are bounded within a region of the tubular body, and wherein the region has a length in a range of about 3.0 mm to about 12.0 mm (3cm to about 1.2cm); and (claim 13) wherein the length of the region is in a range of about 4.0 mm to about 6.0 mm (.4cm to about .6cm).
Claims 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over Draghia-Akli et al. (US 20040167458 A1) in view of Sällberg et al. (US 20160235928 A1).
Regarding claim 20, Draghia-Akli discloses an assembly for in vivo delivery of an agent [0061], comprising:
an electroporation device (figs 3-4) having an electrode array that includes a plurality of needle electrodes 3 configured for delivering one or more electroporation pulses to tissue;
at least one injection needle 2 attachable to the electroporation device [0021] so as to extend substantially parallel with at least one of the plurality of needle electrodes, the at least one injection needle 2 defining a lumen that extends along a central axis oriented along a longitudinal direction.
Draghia-Akli fails to disclose a distal end of the lumen is occluded, the at least one injection needle 2 defining at least one side-port extending from the lumen to an outer surface of the at least one injection needle, wherein the at least one side-port is elongated along the outer surface of the injection needle.
Sällberg teaches an injection device (figs 1f,8a) for in vivo delivery of an agent including a tubular body defining a lumen [0008] where a distal end of the lumen of the tubular body is occluded ([0008] closed end), and side ports where the at least one side-port is elongated along the outer surface of the tubular body ([0010] oval, slit, ovoid shape).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Draghia-Akli’s injection needle with a closed end, side ports, and side ports shape taught by Sällberg (elongated shape) since such modification would have enhanced the distribution and flow of agent at the tissue.
Regarding claims 21-22, Draghia-Akli/ Sällberg discloses wherein the at least one side-port comprises a plurality of side-ports, and the plurality of side-ports are configured to disperse injectate through muscle tissue (Draghia-Akli); and wherein the plurality of side-ports are configured to disperse injectate through both muscle tissue and adipose tissue (Sällberg).
Regarding claim 23, Draghia-Akli discloses the at least one injection needle is located intermediate the plurality of needle electrodes (fig 3), and Draghia-Akli /Sällberg teaches the at least one side-port is configured to eject fluid from the lumen into tissue intermediate the plurality of needle electrodes.
Regarding claim 24, Draghia-Akli discloses the plurality of needle electrodes are carried by a support member (figs 3-4) that also defines at least one injection channel for receiving the at least one injection needle.
Regarding claim 25, Draghia-Akli discloses wherein the plurality of needle electrodes are arranged in a circular pattern, and the at least one injection needle is centrally disposed in the circular pattern when attached to the electroporation device (figs 3 and 5).
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- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. 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