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 .
Response to Amendment
This office action is responsive to the amendments filed 12 September 2025. As directed by the amendments: claim 3 is cancelled, therefore, claims 1-2 and 4 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 12 September 2025 have been fully considered but they are not persuasive.
Applicant argues on pages 4-7 that the device of Lilley and Fukushima does not teach, “wherein the side surface, the inclined surface and the target region define a space”. As discussed below in the updated rejection of claim 1, the device of Lilley and Fukushima not only defines a space, but would be capable of defining a space regardless due to the nature of the inclined or tapered structure and the natural formation that would occur if said surface is applied to a material that allows for flexibility or elastic deformation.
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.
Claim(s) 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Lilley et al. (US 5,919,159) in view of Fukushima et al. (US 2019/0125973).
Regarding claim 1, Lilley discloses a needleless injector (needless injector 10) that ejects an intended injection substance to a target region without using an injection needle, the needleless injector comprising:
a housing part (Fig. 1, 22) including an accommodating space (Fig. 1, 26) in which the intended injection substance is accommodated the housing part defining a flow path (where there is path through 20 to 24) to allow the intended injection substance to be ejected to the target region through an ejection port (Fig. 1, 24);
a driving part (Fig. 1, 40) that imparts ejection energy for ejecting the intended injection substance (Col. 14, lines 25-67);
a pressurizing unit (Fig. 1, 30) that pressurizes the intended injection substance accommodated in the accommodating space, upon being imparted with the ejection energy (Col. 11, lines 32-63); and
an injector enclosure (Fig. 1, 200) to which the housing part (Fig. 1, 22), the driving part (Fig. 1, 40), and the pressurizing unit (Fig. 1, 30) are attached to form the needleless injector (Fig. 1, 10), wherein the housing part includes:
a housing part main body (Fig. 1, 20) incorporating the accommodating space (Fig. 1, 26);
a protrusion provided on a distal end side of the housing part (see annotated figure below, 28, where the protrusion is on the distal end of the device), the protrusion having a side surface that extends towards a distal end surface in which the ejection port is formed (see annotated figure below, 28, where 24 is located on the end of the annotated protrusion), the protrusion having an outer diameter that is smaller than an outer diameter of the housing part main body (see annotated figure below, 28, where the protrusion is a smaller portion on the end of the device), the distal end surface having at least a part defined by a first straight line (Fig. 1, see annotated figure below, 28, where the distal end has at least a straight line because the device has a horizontal axis that defines a straight plane) and at least a part of the side surface being defined by a second straight line in a cross section taken along the axial direction of the housing part (where the side of the device has a straight line and the part 28 is attached to the main housing), and
a connection part (Fig. 1, where the connection part is included in 22 as 20 is connected to the protrusion and 22) connecting the protrusion (see annotated figure 1, 28) and the housing part main body (Fig. 1, 20) to each other, and having an outer surface forming an annular inclined surface that is inclined with respect to a center axis of the housing part and continues from an end portion of the protrusion to an end portion of the housing part main body (Fig. 1, where 20 has an angled and inclined portion),
the flow path is formed in the protrusion (see annotated figure 1 above, where there is path through 20 to 24) and the connection part (Fig. 1, where the connection part is included in 22 as 20 is connected to the protrusion and 22) to communicate the ejection port (Fig. 1, 24) and the accommodating space (Fig. 1, 26) to each other, and
in a state where the housing part is attached to the injector enclosure (Fig. 1, 200), the distal end surface and the inclined surface of the connection part are exposed from the injector enclosure and are configured to make a direct contact with the target region (Fig. 1 & 17, where the protrusion and inclined portion of 20 make direct contact when using an ampule, when making an injection the protrusion and inclined surface will contact a target area).
wherein the housing part (Fig. 1, 22) is formed to enable, in a state where the distal end surface is in contact with the target region, a part of the target region, in a periphery of a portion to be in contact with the distal end surface, to be also in contact with the inclined surface (Fig. 17, where the protrusion caused by 28 and the inclined surface make contact with an ampule which is the target area).
Lilley does not specifically teach the distal end surface having an outer circumference edge represented by an intersection point between the first straight line and the second straight line (Fig. 17, where there is a circumference present between a straight line of the surface and a horizontal axis of the device which can be seen by the resting of the device); or the outer circumference edge of the distal end surface where the distal end surface and the side surface intersect is formed as a corner part. However, it is noted that the device of Lilley does have two separate surfaces that have an opening between them. These two surfaces do have at least two axes that intersect at a point and form what would be considered a corner as a corner is defined as the intersection of two surfaces or lines at a point. In the interest of compact prosecution, Fukushima is relied upon and teaches a surface that has two straight lines that intersect at a point of the distal end and form a corner part (Fig. 27, see annotated figure below).
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The rounded side of the device of Lilley is still a corner in its own right, however, modifying the device to have a flat surface and a squared corner would not change the functionality of the device of Lilley and would ultimately be a traditional change in shape that does not have an effect on the device as a whole when operational.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Lilley to have two straight lines that intersect to form a squared corner (Fig. 27, annotated figure above from Fukushima).
The combined device of Lilley and Fukushima teaches wherein the side surface, the inclined surface and the target region define a space (Fig. 17 where the contact region of the device forms a space within 140 and a space can be formed considering the tapered feature of the device from Lilley, see annotated figure below). The corner created by the combination of Lilley and Fukushima as shown above would apply to the device and would still form a space due to the angled or inclined surface that extends towards the contact region.
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Regarding claim 2, Lilley discloses a first and second straight line (where the rounded end of the device lies on two axes and has vertical and horizonal parts that meet).
Lilley and Fukushima do not specifically disclose wherein an angle formed between the first straight line and the second straight line is approximately 90 degrees in the cross section taken along the axial direction of the housing part.
Although Fukushima does not specifically disclose a 90 degree angle formed between a first and second straight line, the angle formed by the lines present in the disclosure appear to make a right angle on the distal surface and the claim language of “approximately 90 degrees” does not make the angle specific to exactly 90 degrees.
Additionally, there is no evidence of record that establishes that specifying the angle of the intersection between the first and second straight lines in Lilley would result in a difference in function of the Lilley and Fukushima device. Further, a person having ordinary skill in the art, being faced with modifying the protrusion of Lilley, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angle. Lastly, applicant has not disclosed that the claimed angle solves any stated problem, indicating that the angle “may” be “approximately 90 degrees”, and offering other acceptable ranges (¶[0016]) and therefore there appears to be no criticality placed on the angle as claimed such that it produces an unexpected result.
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 the protruding probe of Lilley using Fukushima to have a 90 degree angle formed by a first and second straight line as an obvious matter of design choice within the skill of the art.
Regarding claim 4, Lilley discloses wherein the inclined surface is defined by a third straight line in the cross section taken along the axial direction of the housing part (Fig. 1, where the inclined portion can be defined by a multitude of straight lines that cross horizontally across 20).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783