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 .
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 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iga et al (US 2020/0114083 is used for all annotations below and is considered a translation of WO/2019/004323 which was published Jan 3, 2019 in Japanese) in view of May (US 2,667,870).
Regarding claim 1, Iga discloses a needleless injector configured to eject an injection substance to a target region without using an injection needle, the needleless injector comprising: an injector main body 30; a housing part 42 including an accommodating space 43 in which the injection substance is accommodated, the housing part defining a flow path to enable the injection substance to be ejected to the target region through an ejection port (fig 1); an attachment part 41 configured to attach the housing part to the injector main body; a driving part 10 that is provided in the injector main body and imparts ejection energy for ejecting the injection substance (¶45); and a pressurizing unit 32/35 that is disposed to be movable in a direction toward the ejection port in a predetermined region that is provided to be located inside both the injector main body and the housing part, and pressurizes the injection substance accommodated in the accommodating space, upon being imparted with the ejection energy (fig 1, ¶37), wherein the attachment part attaches the housing part to the injector main body, with a distal end side outer surface of the housing part corresponding to an inner surface of the housing part on a distal end side (fig 1 at 46), where a communication portion where the flow path is in communication with the accommodating space is located, pressed in a direction opposite to a movement direction of the pressurizing unit toward the ejection port (fig 1, ¶39 – “sandwiched”).
While Iga substantially discloses the invention as claimed, it does not disclose wherein the housing part includes a base end portion where the attachment part is fastened to the housing part, the base end portion including a base end surface, a distal end portion including the distal end side outer surface, and a body portion that connects the base end portion and the distal end portion to each other, the attachment part is fastened to the housing part to make the attachment part be in contact with and press the distal end side outer surface of the distal end portion, and the housing part is attached to the injector main body with the attachment part to which the housing part is fastened being fastened to the injector main body.
May discloses the housing part 35 includes a base end portion (threaded portion) where the attachment part 34 is fastened to the housing part 35 (via threads, fig 5), the base end portion including a base end surface (fig 5), a distal end portion including the distal end side outer surface (rounded end with outlet 36), and a body portion that connects the base end portion and the distal end portion to each other (fig 5), and the housing part is attached to the injector main body with the attachment part to which the housing part is fastened being fastened to the injector main body (fig 5).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Iga such that the housing part includes a base end portion where the attachment part is fastened to the housing part, the base end portion including a base end surface, a distal end portion including the distal end side outer surface, and a body portion that connects the base end portion and the distal end portion to each other, and the housing part is attached to the injector main body with the attachment part to which the housing part is fastened being fastened to the injector main body as taught by May to more directly secure the parts together (as opposed to enclosing the housing such that it could move around if the sizes were not manufactured properly).
Such a combination also results in the attachment part being fastened to the housing part to make the attachment part be in contact with and press the distal end side outer surface of the distal end portion as Iga is already arranged in such a manner and only the connections on the proximal/base ends are being changed.
Regarding claim 2, wherein the housing part includes a base end portion radially expanded in a radial direction and including a base end surface (left side of 42 in fig 1), a distal end portion including the distal end side outer surface (right side of 42 in fig 1), and a body portion that connects the base end portion and the distal end portion to each other (fig 1), and the attachment part is fastened to the injector main body with the base end portion sandwiched between the attachment part and the injector main body, to attach the housing part to the injector main body with the base end surface of the housing part on a side opposite to a distal end surface of the housing part where the ejection port is provided, brought into contact with a predetermined end surface that is part of a surface of the injector main body intersecting the predetermined region, and with the distal end side outer surface of the housing part pressed (see attachment between 30 and 40 in fig 1).
Regarding claim 4, wherein the distal end portion includes a protruding portion that includes part of the flow path on a side of the ejection port; and a tapered portion that connects the protruding portion and the body portion to each other and includes the distal end side outer surface inclined with respect to a center axis along a longitudinal direction of the injector main body (see rightmost side of fig 1), and the attachment part has an opening formed, through which the protruding portion passes, to open the ejection port, and includes a contact portion that comes into contact with a region having a predetermined width from a connection portion where the tapered portion and the body portion are connected to each other in the distal end side outer surface (see rightmost side of fig 1).
Regarding claim 5, while Iga substantially discloses the invention as claimed, it does not disclose wherein a ratio of an area of the opening to a cross-sectional area of the body portion is from 0.10 to 0.74.
It requires routine skill in the art to determine an appropriate ratio to achieve desired delivery parameters.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Iga such that a ratio of an area of the opening to a cross-sectional area of the body portion is from 0.10 to 0.74 since it has been held that where the general conditions of a claim are disclosed in the prior art (needleless delivery with a similar device), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Regarding claim 6, while Iga substantially discloses the invention as claimed, it does not disclose wherein tensile strength of the attachment part is not lower than tensile strength of the housing part.
Iga discloses the material of the housing part is a resin material that can be used for injection molding (¶45).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to utilize the same material for the attachment part as that of the housing as taught by Iga itself to allow it to be manufactured via injection molding. Which also results in the tensile strength not being lower than that of the housing.
Response to Arguments
Applicant’s arguments are not persuasive. Applicant argues the housing part 35 is fastened to the attachment part 34 so that it is screwed in the direction of the distal end portion, while the screw of May is in the opposite direction. This allows for “the attachment part be in contact with and press the distal end side outer surface of the distal end portion”. References are not read in a vacuum but for what they teach one of ordinary skill in the art. Further, the combination itself must be addressed, not by attacking a reference individually. Applicant has drawn attention to the thread direction as the basis for their argument, aside from thread direction not being claimed, one of ordinary skill in the art would recognize that the threads are used to join the structures in liquid tight engagement. In fig 1 of Iga, one looking to add threads to between attachment part 41 and housing 42 would add said threads so that the housing and attachment part are screwed together as is consistent with both Iga and May wanting liquid tight connections, which is capable of being accomplished with threads towards the rear of the device.
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783