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 .
Specification
The incorporation by reference of the European patent application EP 20315110.5 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 03/31/2021 see MPEP 1893.03(b). Therefore, the specification amendment of 01/25/2023 to include the incorporation by reference is new matter, per MPEP 608.01(p).
It is recommended to remove the “incorporation by reference” language from first paragraph of the Specification.
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 15, 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Dennis, Jr. et al (US 2017/0224926 A1) in view of Cowe (US 2017/0361025 A1).
Regarding claim 15, Dennis discloses an injector device comprising:
an elongate housing 23 having a proximal end, a proximal region, and a distal end, the housing configured to receive a container of medicament 50;
a plunger rod 62 moveable longitudinally within the housing between a primed position and a completed position, the plunger rod being configured to engage with a container of medicament that is received in the housing;
wherein the housing comprises an indicator located in the proximal region of the housing; the indicator comprising:
a display window 38 located in a side wall of the proximal region of the housing,
a projection 100 proximally extending from the plunger rod, wherein the projection is coupled to the plunger rod, the projection being visible through the display window in the primed position,
the projection being configured to move between a first indicating position and a second indicating position to provide a user with information associated with a progress of an injection process dependent upon a longitudinal position of the plunger rod. However, Dennis fails to disclose wherein the distal end of the housing is relatively closer to an injection site and the proximal end of the housing is relatively further away from the injection site.
Cowe teaches an injector device including the distal end of the housing 101 is relatively closer to an injection site and the proximal end of the housing is relatively further away from the injection site 102, and also teaches two display windows 124,133 at distal and proximal ends to indicate progress of the injection [0033, 0044, 0059, 0087-0088, 0090, 0110, 0111].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dennis by pointing out the distal and proximal direction of the injector device and the display window with Cowe’s display windows location teachings in relation to where display windows can be located at the distal and proximal regions to help user with the injection progress.
Regarding claim 27, Dennis discloses the injector device comprising a container of medicament received within the housing between the plunger rod and the distal end of the housing.
Regarding claim 28, Dennis discloses a method of using an injector device, the method comprising:
actuating the injector device such that a plunger rod moves longitudinally within a housing from a primed position to a completed position; and
moving a proximally extending projection with the plunger rod to provide
information associated with a longitudinal position of the plunger rod with an indicator. However, Dennis fails to disclose the injector device comprising an elongate housing having a proximal end and distal end, wherein the distal end of the housing is relatively closer to an injection site and the proximal end of the housing is relatively further away from the injection site.
Cowe teaches an injector device including the distal end of the housing 101 is relatively closer to an injection site and the proximal end of the housing is relatively further away from the injection site 102, and also teaches two display windows 124,133 at distal and proximal ends to indicate progress of the injection [0033, 0044, 0059, 0087-0088, 0090, 0110, 0111].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dennis by pointing out the distal and proximal direction of the injector device and the display window with Cowe’s display windows location teachings in relation to where display windows can be located at the distal and proximal regions to help user with the injection progress.
Allowable Subject Matter
Claims 16-26 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) have been considered but are moot because the new ground of rejection.
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 Monday-Thursday 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
Prosecution Insights