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
The amendment filed on 01/19/26 has been entered in the case. Claims 1-4, 6-8, 12, 16-26 are pending for examination; claim 27 is withdrawn (see Election/Restriction below) and claims 5, 9-11, 13-15 are cancelled.
Election/Restrictions
Newly submitted claim 27 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The independent claim 27 requires that:
coupling means operably connecting the piston rod assembly to the drug cartridge holder assembly to impart rotation from the drive motor to the drug cartridge holder assembly to collapse the drug cartridge holder assembly from the extended configuration to the collapsed configuration; and
means for axially translating the piston rod assembly relative to the coupling means along an axial length of the elongated body of the proximal drive system to move the distal tip in the direction of the collapsed drug cartridge holder assembly.
These limitations above do not include in the independent claim 1.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 27 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
Claims 1-2 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Marcoz et al. (US 2021/0077723) in view of Lippe et al. (US 6,171,276).
Regarding claim 1, Marcoz discloses a handheld motor-driven drug comprising:
a proximal drive system 3 comprising:
an elongated body 56a/b having a substantially central longitudinal axis along said elongated body, and a bore extending along said longitudinal axis and within said body, the elongated body housing a controllable drive motor 67, and an axially drivable piston rod assembly 69 coupled to said motor located within said bore having a distal tip 71;
a distal drug cartridge holder assembly 2 having a collapsed configuration (Fig. 5) and an extended configuration (Fig. 13) along the central longitudinal axis configured to house a chamber drug cartridge 14; wherein the distal drug cartridge holder assembly 2 has a proximal extremity which is releasably attached to a distal zone of the proximal drive system, see Fig. 1, and a distal extremity configured to receive an injection needle 11;
an axially fixed coupling member 66 (or #72) operably connecting the piston rod assembly 69 to the drug cartridge holder assembly to impart rotation from the piston rod assembly 69 to the coupling member 66 (or #72) to collapse the drug cartridge holder assembly in a proximal direction (Fig. 5) toward the distal tip from the extended configuration (Fig. 13) along the central longitudinal axis, to the collapsed configuration along the central longitudinal axis to effect of an injectable product; and the piston rod assembly 69 being axially movable in a distal direction relative to and along an axial length of the coupling member 66 (or #72) to move the distal tip of the piston rod assembly 69 towards to the collapsed drug cartridge holder assembly 2 via operation of the drive motor 67.
Marcoz fails to disclose that the cartridge is a multiple chamber drug cartridge; a multiple chamber drug cartridge comprising at least a first substance stored in a first chamber, and at least a second substance stored in a respective second chamber, the first and second chambers being located in a nose to tail arrangement in substantial axial alignment with the central longitudinal axis. However, a person skilled in the art would recognize that the cartridge in Marcoz can be provided a multiple chamber for mixing drug.
Lippe discloses a handheld motor-driven drug reconstitution and auto-injector device comprising: a proximal drive system (including #6, #7, #15); a distal drug cartridge holder assembly 3 having a collapsed configuration (Figs. 1B-1C); and an extended configuration (Fig. 1A) along a central longitudinal axis configured to house a multiple chamber drug cartridge 3 comprising at least a first substance 3a stored in a first chamber 3a; and at least a second substance 3b stored in a second chamber 3b, the first and second chambers being located in a nose (distal end of the cartridge 3) to tail arrangement (in a proximal end of the cartridge 3) in substantial axial alignment with the central longitudinal axis.
Since Marcoz and Lippe are both from the same field of endeavor (e.g., a handheld motor-driven drug & an auto-injector device), the purpose disclosed by Lippe would have been recognized in the pertinent art of Marcoz.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the distal drug cartridge device of Marcoz with providing a multiple chamber drug cartridge including at least a first substance stored in a first chamber in , and at least a second substance stored in a respective second chamber, the first and second chambers being located in a nose to tail arrangement in substantial axial alignment with the central longitudinal axis, as taught by Lippe, in order to mixing two different drug components before injection or during injection.
Note: the modification of Marcoz’s device comprising: a cartridge 6 is as a multiple chamber drug cartridge (as modified by Lippe).
Thus, Marcoz in view of Lippe discloses that the axially fixed coupling member 66 (or #72) operably connecting the piston rod assembly to the drug cartridge holder assembly to impart rotation from the piston rod assembly to the coupling member to collapse the drug cartridge holder assembly in a proximal direction toward the distal tip from the extended configuration along the central longitudinal axis, to the collapsed configuration along the central longitudinal axis to effect reconstitution of an injectable product (mixing two different drug components 3a & 3b, as modified by Lippe) comprising the at least first and second substances located within only one of said at least first or second chambers after said reconstitution and the piston rod assembly 69 being axially movable in a distal direction relative to and along an axial length of the coupling member 66 (or #72) to move the distal tip of the piston rod assembly towards the collapsed drug cartridge holder assembly via operation of the drive motor 67.
Regarding claim 2, Marcoz in view of Lippe discloses all the claimed subject matter as required; wherein the drug cartridge assembly is further configured to be operated by the proximal drive system in a reversed relative movement (when the piston rod assembly moves backward direction) compare to a reconstitution movement (when the piston rod assembly moves forward direction) to move the drug cartridge holder assembly from the collapsed configuration to the extend configuration.
Regarding claim 16, it encompasses the same scope of the invention as to that of claims apparatus claim 1 except the claim 16 is drafted in method format instead of apparatus format. The claim 16 is therefore rejected for the same reason as set forth above.
It is noted that Examiner believes that claims 1 and 16 are not patentable distinguish from each other. In other words, if the device/apparatus claim (or method claim) is unpatentable and rejected over the prior art, the evidence or admission may be used in a rejection under method claim (or device/apparatus claim) as well. Therefore, claims 1 and 16 are examined together. However, if Applicant believes that the claims 1 and 16 are patentable distinguishable, then the claims would be subject to further Election/Restriction.
Allowable Subject Matter
Claims 3-4, 6-8, 12, 17-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2 & 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783