,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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 14, 2025 has been entered.
Claim 15 remains pending in the application. Claims 1-14 have been cancelled.
Claim Objections
Claim 15 is objected to because there is a lack of antecedent basis for “the entirety of the hypodermic injection device” in line 9-10 and “the receiving ends of the array of hypodermic needles” in line 12-13. Appropriate correction is required.
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over KR20090008983 in view of Ozawa et al. (US 2014/0128810) in view of Fretta et al. (US 2020/0188610) in further view of Prausnitz et al. (USPN 6743211).
Regarding claim 15, KR20090008983 discloses a hypodermic injection device (needle header 20; Figures 1 and 2) for injecting an injection fluid (noted “for injecting an injection fluid” is a functional limitation and a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The needle header 20 is capable of injecting an injection fluid.), the hypodermic injection device consisting solely and exclusively of two components:
a chamber (body portion 22) comprising a distal outer surface (see annotated Figure 2 below), a proximal outer surface (see annotated Figure 2 below), and a wall (see annotated Figure 2 below) connecting the distal outer surface to the proximal outer surface, wherein a hollow space (cavity 28) is formed inside the chamber (Figure 2); and
an array of hypodermic needles (needle 30) projecting outward from the distal outer surface of the chamber and perpendicular to the distal outer surface (Figure 2);
wherein: the chamber (body portion 22) and the array of hypodermic needles (needles 30) together form the entirety of the hypodermic injection device (needle header 20; Figure 2), and the hollow space inside the chamber provides an uninterrupted fluid pathway that allows the injection fluid to flow directly from a connector (syringe coupling portion 24) to the receiving ends of the array of hypodermic needles (see annoted in Figure 2 below) without passing through, contacting, or being obstructed by any intervening structure or material (see Figure 2 annotated below. Noted that the limitation “the hollow space inside the chamber allows the injection fluid to flow directly from a threaded Luer lock connector to the receiving ends of the array of hypodermic needles, without passing through, contacting, or being obstructed by any intervening structures or materials” is a functional limitation and a recitation of intended use. The cavity 28 shown in Figure 2 is capable of allowing fluid to flow directly from a Luer lock connector to the receiving ends of the array of hypodermic needles without passing through, contacting, or being obstructed by any intervening structure or material; and there are no “intervening structure or material” in the cavity 28 as shown in Figure 2);
the proximal outer surface is a flat or planar surface (Figures 1 and 2) and the connector (syringe coupling portion 24) is formed on the proximal outer surface of the chamber (Figure 2);
the chamber includes a compact configuration that occupies a volume (Figure 2);
the distal outer surface of the chamber is substantially flat or planar (Figures 1 and 2);
each of the hypodermic needles comprises a bore (see annotated Figure 2 below) extending from a receiving end of the hypodermic needle (at needle fitting portion 26) to a delivery end of the hypodermic needle along a longitudinal axis (see annotated Figure 2 below), wherein the bore at the receiving end of each of the hypodermic needles is in fluid communication with the hollow space (cavity 28) in the chamber (Figure 2);
wherein the distal outer surface, the proximal outer surface, and the wall are integrally formed and an inside of the chamber consists solely of the hollow space (cavity 28) that is defined by the distal outer surface, the proximal outer surface, and the wall (Figure 2);
wherein the hypodermic injection device is adapted to transition a flow of the injection fluid directly from the connector to the hollow space of the chamber and directly from the hollow space to the receiving end of each of the hypodermic needles (see Figure 2 annotated below. Noted that the limitation “wherein the hypodermic injection device is adapted to transition a flow of the injection fluid directly from the connector to the hollow space of the chamber and directly from the hollow space to the receiving end of each of the hypodermic needles” is a functional limitation and a recitation of intended use. The needle header 20 shown in Figure 2 is capable of transitioning flow of a fluid directly from the syringe coupling portion 24 to the cavity 28 and then directly to the receiving ends of the needles 30).
KR20090008983 fails to explicitly teach the connector is a threaded Luer lock connector formed on the proximal outer surface of the chamber; the chamber includes a compact configuration that occupies a volume ranging from 0.1 centimeters3 to 25 centimeters3, wherein the volume of the chamber is defined by: a thickness of the wall being in a range of 0.1 centimeter to 1 centimeter, the distal outer surface of the chamber is a square-shaped surface, and a length of each side of the distal outer surface being in a range of 1 centimeter to 5 centimeter, the proximal outer surface of the chamber being a square-shaped surface, and a length of each side of the proximal outer surface being in a range of 1 centimeter to 5 centimeter; a diameter of the bore of each of the hypodermic needles is about 27 gauge to about 32 gauge, and wherein a length of each hypodermic needle is about 1 mm to about 10 mm.
Ozawa teaches a hypodermic injection device (needle formation 1) for injecting an injection fluid (“a medical liquid in the syringe 6 enters a space portion 36 of the needle formation 1, and further, the medical liquid is pushed out from the discharge opening 13 of the needle 11 through each needle 11 of the needle formation 1.” [0065]), the hypodermic injection device comprising: a chamber (needle formation body 10 enclosing space portion 36) comprising a wall connecting a distal outer surface (surface from which needles 11 project; Figure 3) to a proximal outer surface (surface from which flange 12 projects; Figures 1 and 3); and an array of hypodermic needles (needles 11) projecting perpendicularly outward from the distal outer surface of the chamber (Figure 3), wherein a hollow space (space portion 36) inside the chamber allows the injection fluid to flow directly from a threaded Luer lock connector (flange 12; Figures 3 and 5, wherein flange 12 is threaded because it mates with the screw 23 of luer lock 20 as described in [0043] and [0064]) to receiving ends of the array of hypodermic needles without passing through, contacting or being obstructed by any intervening structure or material (Figure 3; “a medical liquid in the syringe 6 enters a space portion 36 of the needle formation 1, and further, the medical liquid is pushed out from the discharge opening 13 of the needle 11 through each needle 11 of the needle formation 1.” [0065]); wherein the threaded Luer lock connector (flange 12) formed on the proximal outer surface of the chamber (Figure 3), the chamber includes a compact configuration that occupies a volume (Figure 3), the distal outer surface of the chamber is a square-shaped surface that is substantially flat or planar (“The cross-sectional shape of the needle formation 1…may be a square” [0071]; Figure 3 showing that the distal surface is planar), the proximal outer surface of the chamber being a square-shaped surface (“The cross-sectional shape of the needle formation 1…may be a square” [0071]); each of the hypodermic needles comprises a bore extending from a receiving end of the hypodermic needle (proximal ends of needles 11 within space 36) to a delivery end of the hypodermic needle along a longitudinal axis, wherein the bore at the receiving end (discharge opening 13) of each of the hypodermic needles is in fluid communication with the hollow space (space portion 36) in the chamber (“the plunger 8 of the syringe 6 is pressed for operation, and a medical liquid in the syringe 6 enters a space portion 36 of the needle formation 1, and further, the medical liquid is pushed out from the discharge opening 13 of the needle 11 through each needle 11 of the needle formation 1.” [0065]); a diameter of the bore of each of the hypodermic needles is about 27 gauge to about 32 gauge (“the maximum outer diameter of the needle 11 is more preferably within the range of 0.1 mm to 0.6 mm, and, still more preferably, within the range of 0.1 mm to 0.4 mm.” [0052], wherein 27-32 gauge is equivalent to an outer diameter of 0.235 mm to 0.413 mm and 0.1- 0.4 mm is within the range of 28-34 gauge), and wherein a length of each hypodermic needle is about 1 mm to about 10 mm (“The projection dimension of the needle 11 projecting from the surface of the needle formation 1 is preferably equal to or less than 10 mm; and the projection dimension can be 5 mm or less, and in particular, 3 mm or less. Furthermore, the projection dimension of the needle 11 projecting from the surface of the needle formation 1 is more preferably within the range of 0.5 mm to 2.0 mm, and still more preferably, within the range of 0.5 mm to 1.5 mm.” [0052]); wherein the hypodermic injection device (needle formation 1) is adapted to transition a flow of the injection fluid directly from the threaded Luer lock connector (flange 12) to the hollow space (space portion 36) of the chamber and directly from the hollow space to the receiving end of each of the hypodermic needles (proximal ends of needles 11 within space 36; “the plunger S of the syringe 6 is pressed for operation, and a medical liquid in the syringe 6 enters a space portion 36 of the needle formation 1, and further, the medical liquid is pushed out from the discharge opening 13 of the needle 11 through each needle 11 of the needle formation 1.” [0065]; Figure 1, wherein the liquid flows through the flange 12 via the inner cylinder 22 directly into the space portion 36 and then directly into the needles 11).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the connector of the hypodermic injection device of KR20090008983 to be a threaded Luer lock connector based on the teachings of Ozawa to removably couple the hypodermic device to a source of fluid (Ozawa [0064]); to modify the hypodermic injection device of KR20090008983 to include the distal and proximal outer surfaces of the chamber to be square-shaped surfaces based on the teachings of Ozawa to provide the hypodermic device with the shape necessary to provide percutaneous access to the targeted portion of tissue (Ozawa [0071], [0073]); and to modify the hypodermic needles of the hypodermic device of KR20090008983 to have a diameter of the bore of each of the hypodermic needles to be about 27 gauge to about 32 gauge and a length of each hypodermic needle is about 1 mm to about 10 mm based on the teachings of Ozawa to adapt the hypodermic device for delivery of medical liquid into the subcutaneous layer in a manner that limits pain during injection (Ozawa [0009] and [0022]).
Modified KR20090008983 fails to explicitly teach the chamber includes a compact configuration that occupies a volume ranging from 0.1 centimeters3 to 25 centimeters3, wherein the volume of the chamber is defined by: a thickness of the wall being in a range of 0.1 centimeter to 1 centimeter, a length of each side of the distal outer surface being in a range of 1 centimeter to 5 centimeter, and a length of each side of the proximal outer surface being in a range of 1 centimeter to 5 centimeter.
Fretta teaches a needle device comprising a chamber (needle hub assembly 306) comprising a distal outer surface and a proximal outer surface (Figure 4); and a hollow space (hollow body 404) located within the chamber (Figure 4); the distal outer surface being a square-shaped surface (Figures 6 and 7; square platform 602/700), and the length of each side of the distal outer surface being in the range of 1 centimeter to 5 centimeter (“the length of each side of the platform 700 may be in a range from 0.4 to 0.9 inches.” [0053] 1.02 to 2.29 cm); the proximal outer surface being a square-shaped surface (Figure 6), and a length of each side of the proximal outer surface being in the range of 1 centimeter to 5 centimeter (“the length of each side of the platform 700 may be in a range from 0.4 to 0.9 inches.” [0053] 1.02 to 2.29 cm).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify square shaped surfaces of the distal and proximal outer surfaces of the hypodermic device of KR20090008983 in view of Ozawa to have sides having lengths in the range of 1 to 5 centimeters based on the teachings of Fretta to cover a larger area of skin during administration of the injection fluid (Fretta [0053]).
Modified KR20090008983 fails to explicitly teach the chamber includes a compact configuration that occupies a volume ranging from 0.1 centimeters3 to 25 centimeters3, wherein the volume of the chamber is defined by: a thickness of the wall being in a range of 0.1 centimeter to 1 centimeter.
Prausnitz teaches a needle device (device 10; Figure 9) comprising a chamber (upper portion 11) comprising a distal outer surface (surface of 11 having microneedles 12), a proximal outer surface (upper surface of 11 opposite of microneedles 12), and a hollow space (upper portion 11 “of the device can be…hollow” [Col 9, line 39]) inside the chamber (Figure 9); the chamber includes a compact configuration (Figure 9) that occupies a volume ranging from 0.1 centimeters3 to 25 centimeters3 (“The height of the upper portion 11 is between about 1 .mu.m and 1 cm, and the width of the upper portion is between about 1 mm and 10 cm.” [Col 9, lines 37-39], resulting in a volume in the range of 0.000001-100 cm3 wherein the chamber as disclosed by Ozawa is a rectangular prism. This range is can be further limited based on the disclosure of Fretta detailed above which limits the width to be between 1.02 to 2.29 cm resulting in a volume in the range of 0.000104-5.2441 cm3), wherein the volume of the chamber is defined by: a thickness of the wall being in a range of 0.1 centimeter to 1 centimeter (“The height of the upper portion 11 is between about 1 .mu.m and 1 cm” [Col 9, line 37] wherein “thickness of the wall” has been interpreted as the height of the wall between the distal and proximal outer surfaces, consistent with paragraph [0026] of the present disclosure), and the length of the distal and proximal outer surfaces being in the range of 1 centimeter to 5 centimeter (“the width of the upper portion is between about 1 mm and 10 cm.” [Col 9, line 38]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the hypodermic device of KR20090008983 in view of Ozawa and Fretta to include that the chamber includes a compact configuration that occupies a volume ranging from 0.1 centimeters3 to 25 centimeters3, wherein the volume of the chamber is defined by: a thickness of the wall being in a range of 0.1 centimeter to 1 centimeter based on the teachings of Prausnitz to ensure that the chamber is of an adequate size to act as a reservoir for the injectable fluid prior to distributing the injectable fluid through the bores of the hypodermic needles (Prausnitz [Col 9, line 37]).
Response to Arguments
Applicant's arguments filed October 14, 2025 have been fully considered but they are not persuasive. Regarding the argument that “newly added claim 15 is believed to be patentable over the prior art, including the combination of the foregoing references” (Remarks, page 5), the examiner respectfully disagrees. Newly added claim 15 recites limitations similar those previously presented in now canceled Claim 14, with the addition of “the chamber and the array of hypodermic needles together form the entirety of the hypodermic injection device, and the hollow space inside the chamber provides an uninterrupted fluid pathway that allows the injection fluid to flow directly from a threaded Luer lock connector to the receiving ends of the array of hypodermic needles, without passing through, contacting, or being obstructed by any intervening structures or material”. As detailed above, KR20090008983 discloses the chamber (22) and the array of hypodermic needles (30) together form the entirety of the hypodermic injection device (20; Figure 2), and the hollow space inside the chamber provides an uninterrupted fluid pathway that allows the injection fluid to flow directly from a connector (24) to the receiving ends of the array of hypodermic needles without passing through, contacting, or being obstructed by any intervening structure or material (see Figure 2 annotated above). This limitation is a functional limitation and a recitation of intended use. The cavity 28 shown in Figure 2 is capable of allowing fluid to flow directly from a Luer lock connector to the receiving ends of the array of hypodermic needles without passing through, contacting, or being obstructed by any intervening structure or material; and there are no “intervening structure or material” in the cavity 28 as shown in Figure 2.
Applicant's argument fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Therefore, it is maintained that the disclosures of KR20090008983, Ozawa et al. (US 2014/0128810), Fretta et al. (US 2020/0188610), and Prausnitz et al. (USPN 6743211) disclose the hypodermic device as claimed in claim 15 and detailed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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 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.
/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783