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 .
Priority
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: 15/269,248 and 15/204,542.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 15/269,248 and 15/204,542, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Neither application discloses any detail of a needle cap remover as detailed in claims 1-11. While 15269248 is completely silent regarding a needle cap remover, 15204542 merely discloses that a "cap remover" may protrude from the injector (¶0134 of the application specification). The instant application's disclosure of elastic arms, a rigid portion, and snaps/hooks are all new matter with respect to these two parent applications and are therefore not supported or enabled in the manner required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
Claim Objections
Claim 6 is objected to because of the following informalities: in line 1, “said needle cap remover” should be “said needle cap remover device”. 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist et al (US 2014/0343503) in view of Ambrose et al (US 4636201).
Regarding claim 1,
Holmqvist discloses:
A system for medicament delivery (Fig. 4), comprising: (a) a cartridge (seen in Fig. 4; ¶0002) containing a medicament and being in fluid communication with a needle (50), said needle (50) enveloped by a needle cap (52; Fig. 5a); (b) a housing (seen in Fig. 4 surrounding the cartridge) for containing said cartridge and having an orifice (open distal end) for allowing access to said needle cap (52) and its associated needle (50); and (c) a needle cap remover device (Fig. 1) comprising: (i) at least two elastic arms (18), said elastic arms (18) envelop at least a portion of said needle cap (52) (Fig. 5b).
Ambrose discloses:
A system for medicament delivery (Fig. 1), comprising: (a) a cartridge (10) containing a medicament and being in fluid communication with a needle (14), said needle enveloped by a needle cap (25); and (c) a needle cap remover device (30; Fig. 2) comprising: (i) at least two elastic arms (34; Fig. 4) coupled to define an unstressed width greater than the outside of a width of a top sill of the needle cap (25) (see Image 1 below), said elastic arms (34) envelop at least a portion of said needle cap (25), wherein a proximal end of said elastic arms (34) can be accessed through said orifice; (ii) a rigid portion (Fig. 3 – proximal half of body 31 near closed end 32), said at least two elastic arms (34) extending beyond said rigid portion towards a distal end of the needle cap remover device (30); and (iii) a distal end of each of said at least two elastic arms (34) including at least one snap (35), said snaps (35) defining an unstressed width smaller than the width of the top sill of the needle cap (25) (Col. 3:30-35 – the diameter of the snaps 35 is necessarily smaller than the width of the top sill in order to be able to remove the needle cap 25), wherein said at least two snaps (35; Fig. 4 – three snaps 35) overhang the top sill of the needle cap (25), and when said proximal end of said elastic arms (34) is pulled, said snaps (35) cause said needle cap (25) to pull with the needle cap remover device (30; Col. 3:30-35).
Image 1. Annotated portion of Fig. 2
PNG
media_image1.png
308
340
media_image1.png
Greyscale
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Holmqvist to incorporate the needle cap removal device of Ambrose as such a modification would be the result of a simple substitution of one known element (the removal device of Ambrose) for another known element (the removal device of Holmqvist) in order to obtain predictable results (removing a needle cap from an injection device).
Regarding claim 7, Holmqvist in view Ambrose discloses the system of claim 1 but is silent regarding “pulling said needle cap remover device together with the enveloped needle cap requires a force being no more than 1 kg at most.” However, there is no evidence of record that establishes that changing the force required to separate the needle cap would result in a difference in function of the Holmqvist device. Further, a person having ordinary skill in the art, being faced with modifying the needle of Holmqvist, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended with the claimed separation force. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the force may “alternately” be within the claimed range, and offering other acceptable ranges (e.g., 1.2 kg or 1.5 kg at most, instant ¶0065) and therefore there appears to be no criticality placed on the range 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 required force to remove the needle cap of Holmqvist to be up to 1 kg at most as an obvious matter of design choice within the skill of the art.
Allowable Subject Matter
Claims 2-6 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.
Claims 8-11 are allowed, with an effective filing date of 10/10/2016 based on PCT/US16/56247.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record, Ambrose et al (US 4636201), fails to disclose or make obvious a device as described in claim 8. Specifically, Ambrose fails to disclose or make obvious a method of assembling a needle cap remover onto a needle cap, in combination with the other elements of the claim, comprising steps of “aligning a longitudinal axis of the needle cap remover to be colinear with a longitudinal axis of the needle cap” and “inserting the distal end of the needle cap remover in the direction of a top portion of the needle cap while deflecting at least two elastic elements of said needle cap remover in a direction away from the central axis of the needle cap,” where “said deflecting is provided by a plurality of hooks coupled to a distal end of each of the at least two elastic elements and defining a smaller perimeter than a perimeter of the needle cap” and “said inserting is provided until said plurality of hooks extend beyond the top portion of the needle cap and snap inwardly towards the central axis of the needle cap, thereby overhanging the top portion of said needle cap, causing the elastic elements to snap from said deflecting towards the central axis of the needle cap.”
Ambrose teaches a needle cap remover device (30; Fig. 2) with at least two elastic arms (34; Fig. 4) comprising snaps (35) that envelope and overhang the top sill of the needle cap (25) when assembled with the needle cap (25) (Fig. 2) so that when said proximal end of said elastic arms (34) is pulled, said snaps (35) cause said needle cap (25) to pull with the needle cap remover device (30; Col. 3:30-35). The resulting structure has snaps (35) defining an unstressed width smaller than the width of the top sill of the needle cap (25) (Col. 3:30-35 – the diameter of the snaps 35 is necessarily smaller than the width of the top sill in order to be able to remove the needle cap 25). However, Ambrose fails to teach or make obvious “a plurality of hooks coupled to a distal end of each of the at least two elastic elements” as required by the claim. Although Holmqvist teaches structures that can be interpreted as hooks, these are not distinct from the elastic elements. In addition, it would not be obvious to modify a plurality of hooks to the structure of Ambrose as such a duplication has no motivation to a person of ordinary skill in the art without hindsight reasoning. As such, a prima facie case of obviousness or an anticipation rejection cannot be established with respect to the claimed combination of elements as set forth in claim 8. Claims 9-11 are allowed for incorporating the above limitations due to their respective dependencies on claim 8.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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, Bhisma Mehta can be reached at (571)272-3383. 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.
/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
Prosecution Insights