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 .
Drawings
The drawings are objected to because figure 2 shows few reference characters with numbers moving in axial direction therefore it is unclear if the reference character is a single digit or double digit. For example, the reference character “20” is unclear if the reference character is supposed to be “20” or “2” and “0”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract contains more than 150 words and contains the term “said U-bracket” which is a legal phraseology. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The reference character “17” has been used to refer to “the tubular operation member” in paragraph 0039 and “tubular rotator” in paragraph 0038.
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.
Claims 13-23 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 2018/0154083 A1) in view of Holland et al. (US 2017/0232201 A1).
Regarding claim 13, Stewart discloses a medicament delivery device 1 (figure 1), comprising:
a housing 3 having a proximal end (end of element 3 closest to the medication delivery site when the device is in use) and a distal end (end of element 3 furthest away from the medication delivery site when the device is in use);
a plunger rod 11 received by the housing 3 and axially displaceable from an initial position (position of element 11 prior to delivery of the medicament) to a final position (position of element 11 at the end of delivery of the medicament) relative to the housing 3 (paragraph 0034, lines 7-11),
a tubular extension member 5 received by the housing and arranged to receive the plunger rod 11,
a U-bracket 21 received by the tubular extension member 5, the plunger rod 11 being arranged (see figures 6a-6c) to be received by the U-bracket 21,
a first energy accumulation member 15 arranged to bias (paragraph 0037, lines 32-37, paragraph 0043, lines 1-3) the plunger rod 11 in a proximal direction (direction towards the delivery site) towards the proximal end and to bias the U-bracket 21 in a distal direction (direction opposite to the delivery site) which is opposite to the proximal direction; and
a medicament container 25 provided with a needle 25a, a plunger 13 being arranged to move into the medicament container 25 by linear displacement of the plunger rod 11 (paragraph 0034, lines 7-11), to thereby expel medicament through the needle 25a,
wherein said U-bracket 21 comprises a first longitudinally extending leg (one of the two sets of legs formed by elements 19 and 21a combined) and a second longitudinally extending leg (other of the two sets of legs formed by elements 19 and 21a combined),
a distal end (end of element 19 being connected to element 21d) of the first longitudinally extending leg being connected to a distal end of the second longitudinally extending leg by a transversal end portion 21d of the U-bracket,
a proximal end (end of element 21a connected to element 21b) of the first longitudinally extending leg being bent radially outward (bent outward at element 21a), thereby defining a first bent portion 21a,
the U-bracket 21 comprising a third longitudinally extending leg 21b (one of two elements 21b), a distal end (end of element 21b connected to element 21a) of the third longitudinally extending leg being attached to the first bent portion 21a, a proximal end (end of element 21b being connected to element 21c) of the third longitudinally extending leg comprising a radially extending portion 21c,
the radially extending portion 21c of the third longitudinally extending leg 21b defining a first radial foot 21c (one of two elements 21c) but is silent regarding the first radial foot supporting the medicament container by abutting a flange of the medicament container.
However, Holland teaches a design of an injection device (figure 1a) with feedback mechanism comprising the radial foot (see “F” in figure 1a below) supporting the medicament container 20 by abutting (see figure 1b) a flange (see “S” in figure 1a below) of the medicament container 20 for the purpose of pushing the medicament container or blocking the reverse movement of the medicament container when injecting the medicament to the patient (paragraph 0044).
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the first radial foot of Stewart to incorporate the first radial foot supporting the medicament container by abutting a flange of the medicament container as taught by Holand for the purpose of pushing the medicament container or blocking the reverse movement of the medicament container when injecting the medicament to the patient (paragraph 0044).
Regarding claim 14, Stewart discloses wherein a proximal end (end of element 21a connected to element 21b) of the second longitudinally extending leg (other of the two sets of legs formed by elements 19 and 21a combined) is bent radially outward, thereby defining a second bent portion 21a, the U-bracket comprising a fourth longitudinally extending leg (other of two elements 21b), a distal end (end of element 21b connected to element 21a) of the fourth longitudinally extending leg 21b being attached to the second bent portion 21a, wherein a proximal end (end of element 21b connected to element 21c) of the fourth longitudinally extending leg comprises a radially extending portion (other of two elements 21c), the radially extending portion 21c defining a second radial foot. Stewart is silent the second radial foot supporting the medicament container by abutting the flange of the medicament container.
However, Holland teaches a design of an injection device (figure 1a) with feedback mechanism comprising the radial foot (see “F” in figure 1a above) supporting the medicament container 20 by abutting (see figure 1b) a flange (see “S” in figure 1a above) of the medicament container 20 for the purpose of pushing the medicament container or blocking the reverse movement of the medicament container when injecting the medicament to the patient (paragraph 0044).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the second radial foot of Stewart to incorporate the second radial foot supporting the medicament container by abutting a flange of the medicament container as taught by Holand for the purpose of pushing the medicament container or blocking the reverse movement of the medicament container when injecting the medicament to the patient (paragraph 0044).
Regarding claim 15, Stewart discloses wherein the U-bracket 21 is made of metal (paragraph 0046, lines 1-3).
Regarding claim 16, Stewart discloses wherein the U-bracket 21 is made of sheet metal (paragraph 0046, lines 4-6, “metal strip”).
Regarding claim 17, Stewart discloses wherein the U-bracket 21 is made of wire (paragraph 0046, lines 4-6).
Regarding claim 18, Stewart discloses wherein the U-bracket 21 is made of plastic (paragraph 0046, lines 3-4).
Regarding claim 19, Stewart discloses wherein the first longitudinally extending leg 19, 21a is parallel to the second longitudinally extending leg 19, 21a.
Regarding claim 20, Stewart discloses wherein the distance between the distal end (end of element 19 connected to element 21d) of the first longitudinally extending leg 19, 21a and the distal end (end of element 19 connected to element 21d) of the second longitudinally extending leg 19, 21a is less than the distance between the proximal end (end of element 21a connected to element 21b) of the first longitudinally extending leg 19, 21a and the proximal end of the second longitudinally extending leg 19, 21a (the distance between the proximal end of the first and second longitudinally extending leg will be larger compared to distance between the distal ends of the first and second longitudinally extending legs because element 21a is extending radially outward and examiner construes elements 19, 21a together as longitudinally extending legs).
Regarding claim 21, Stewart discloses wherein the distal end (end of element 21b connected to element 21a) of the third longitudinally extending leg 21b is further (opposite ends of element 21b are located at different horizontal axis) from the axis than the proximal end (end of element 21b connected to element 21c) of the third longitudinally extending leg 21b.
Regarding claim 22, Stewart discloses wherein the U-bracket 21 is flexible (element 21b are flexible, see abstract).
Regarding claim 23, Stewart discloses wherein the medicament delivery device is a single use device (paragraph 0029, lines 1-4).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 2018/0154083 A1) in view of Holland et al. (US 2017/0232201 A1) and further in view of Cowe (US 2013/0338601 A1).
Regarding claim 24, Stewart/Holland (hereinafter referred as “modified Stewart”) discloses the claimed invention substantially as claimed, as set forth above in claim 13. While Stewart discloses “The medicament delivery device may be a regular medicament delivery device for medicament administration or a trainer device”, one can construe that Stewart is disclosing the medicament delivery device is a multiple use device. Alternatively, one can re-cock the device and either replace or refill the medicament container for reusing the medicament delivery device. However, modified Stewart does not explicitly recite the medicament delivery device being a multiple use device.
However, Cowe teaches a design of an injection device (figure 1) wherein the medicament delivery device is a multiple use device (paragraph 0030, lines 5-10) for the purpose of reusing the medicament delivery device for subsequent medical operations (paragraph 0030, lines 5-10).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the medicament delivery device of modified Stewart to incorporate the medicament delivery device is a multiple use device as taught by Cowe for the purpose of reusing the medicament delivery device for subsequent medical operations (paragraph 0030, lines 5-10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Daniel (US 2013/0035642 A1): discloses a medicament delivery device comprising U-bracket and a feedback signal to indicate the beginning of the dose delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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, 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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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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