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
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 legal phraseology such as “said”. 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 “2” has been used to refer to “housing” on page 8, line 28 and “top body” on page 8, line 29. Examiner has identified a single instance but the specification contains plurality of such instances. Applicant is requested to identify and correct all the instances.
Appropriate correction is required.
Claim Objections
Claims 1, 7, 9 and 13 are objected to because of the following informalities:
Regarding claim 1, line 3, the reference character “A” needs to be put into parentheses so as to avoid confusion with other numbers or characters which may appear in the claims (see MPEP 608.01(m)).
Claim 1 recites the limitation “the distal direction” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, line 30, the recitation “activated position” appears to be amended to recite “the activated position” in order to refer to “activated position” recited previously in claim 1.
Regarding claim 1, the recitation “a plunger rod” on page 1, line 16 appears to be amended to recite “the plunger rod” in order to refer to “a plunger rod” recited on page 1, line 9.
Claim 7 recites the limitation “said proximal flange” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation “the end user” in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner acknowledges the usage of “a user” in claim 1 but not “an end user” therefore, applicant is requested to either amend claim 1 to recite “an end user” or amend claim 9 to recite “the user” to overcome the objection.
Claim 13 recites the limitation “the end user” in line 3. There is insufficient antecedent basis for this limitation in the claim. There is insufficient antecedent basis for this limitation in the claim. Examiner acknowledges the usage of “a user” in claim 1 but not “an end user” therefore, applicant is requested to either amend claim 1 to recite “an end user” or amend claim 9 to recite “the user” to overcome the objection.
Regarding claim 9, line 3, the limitation “activated position” appears to be amended to recite “the activated position” in order to refer to “activated position” recited in claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, line 4, the recitation “a medical product” renders the claim indefinite because the claim is unclear if “a medical product” refers to “a product” recited in claim 1 or additional. For examination purposes, examiner construes “a medical product” being same as “a product” recited in claim 1.
Regarding claim 1, the recitation “a corresponding storage and an activated position” on page 2, lines 4-5 renders the claim indefinite because the claim is unclear if “a corresponding storage and an activated position” refers to “a locking position” on page 1, line 26 and “a release position” on page 1, line 27 or additional. For examination purposes, examiner construes “a corresponding storage and an activated position” refers to respective locking and release position.
Claims 2-15 being dependent on claim 1 are also rejected.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wozencroft (US 2011/0202011 A1).
Regarding claim 1, Wozencroft teaches an autoinjector (figure 1), for automatic injection of a product into an injection site, said autoinjector (figure 1) comprising:
a housing 18 (and housing of element 12, hereinafter referred as “12, 18”) extending along a longitudinal axis A (line indicated by A-A in figure 2a) and configured to receive a medical container (integrated structure formed by elements 2, 4, 6 and 8) having a barrel 2 defining a reservoir (hollow portion inside element 2) for containing a medical product, said barrel 2 having a distal end (end of element 2 connected to element 6) provided with an injection needle 6 and an opened proximal end (end of element 2 which receives element 4) configured to receive a plunger rod 4 for pushing a stopper (see “S” in figure 5(b) below) arranged inside the barrel 2,
a needle cover 14 coupled to and axially movable with respect to said housing 12, 18 between a first extended position (position shown in figure 6(a)), in which the needle cover 14 at least partially shields the injection needle 6, a retracted position (paragraph 0044, lines 15-19, position where needle gets exposed out of element 14), in which the needle cover 14 moves proximally with respect to the housing 12, 18, and a second extended position (paragraph 0045, position where element 14 covers element 6) in which the needle cover moves back in the distal direction to shield the injection needle 6,
a plunger rod 4 axially movable inside the housing 12, 18 between a storage position (position shown in figure 6(a)) and an injection end position (position where element 4 moves distally to expel the drug out of element 2) distally located relative to the storage position, the plunger rod 4 being configured to push the stopper (see “S” in figure 5(b) below) in order to expel the medical product when moving from the storage position to the injection end position,
a retainer 92, movable with respect to the plunger rod 4 between a blocking position (paragraph 0044, lines 9-14, position before pivot of element 92), in which the retainer 92 blocks the plunger rod 4 in the storage position, and a release position (paragraph 0044, lines 9-14, position after pivot of element 92), in which the retainer 92 is moved away from the plunger rod 4 to allow axial displacement of the plunger rod 4 from the storage to the injection end position,
a locker (50 and 58 on element 16), movable with respect to the retainer 92 between a locking position (position where element 16 is not rotated), in which the locker locks the retainer in the blocking position (paragraphs 0039, 0044), and a release position (position after rotating element 16, paragraph 0044), in which the locker allows movement of the retainer to the release position, movement of the locker from the locking position to the release position being caused by the needle cover 14 moving from the first extended position to the retracted position,
a controller 16, movable (paragraph 0043) with respect to the housing 12, 18, between a storage position (position of element 16 in “locked”) which the controller prevents activation of the autoinjector and an activated position (position of element 16 in “unlocked”) allowing for activation of the autoinjector, said controller 16 comprising a grasping member (see “g” in figure 1 below) configured for allowing a user to move the controller from the storage position to the activated position, wherein the locker 50, 58 is connected to the controller 16 such that movement of the controller 16 with respect to the housing 12, 18 between the storage and activated position entails movement of the locker 50, 58 with respect to the housing (paragraphs 0039, 0044) between a corresponding storage and an activated position, and
the locker 50, 58 comprising a blocking member 50 configured for abutting against a stop 66 of the housing as long as the locker is in the storage position, such that the locker is prevented from moving to the release position with respect to the retainer, the blocking member of the locker being moved away from said stop of the housing when the locker is moved to the activated position, such that the locker can move to the release position with respect to the retainer (paragraphs 0039, 0044).
PNG
media_image1.png
280
690
media_image1.png
Greyscale
PNG
media_image2.png
572
696
media_image2.png
Greyscale
Claims 1, 2, 6, 10 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dasbach et al. (US 2014/0243757 A1).
Regarding claim 1, Dasbach teaches an autoinjector 1 (figure 1A), for automatic injection of a product into an injection site, said autoinjector 1 comprising:
a housing 12 extending along a longitudinal axis A (axis extending along the length of element 1) and configured to receive a medical container 3 having a barrel (structure of element 3 to hold element “M”) defining a reservoir (hollow portion inside element 3 for holding element “M”) for containing a medical product “M”, said barrel having a distal end (end of element 3 connected to element 4) provided with an injection needle 4 and an opened proximal end (end of element 3 closed by element 6) configured to receive a plunger rod 9 for pushing a stopper 6 arranged inside the barrel,
a needle cover 2 coupled to and axially movable with respect to said housing 12 between a first extended position (position of element 2 shown in figure 2A), in which the needle cover 2 at least partially shields the injection needle 4, a retracted position (position shown in figure 5A), in which the needle cover 2 moves proximally with respect to the housing 12, and a second extended position (position of element 2 shown in figure 10A) in which the needle cover 2 moves back in the distal direction to shield the injection needle 4,
a plunger rod 9 axially movable inside the housing 12 between a storage position (position of element 9 shown in figure 2A) and an injection end position (position of element 9 shown in figure 7A) distally located relative to the storage position, the plunger rod 9 being configured to push the stopper 6 in order to expel the medical product when moving from the storage position to the injection end position,
a retainer 14, movable with respect to the plunger rod 9 (paragraph 0072) between a blocking position (position shown in figure 15A), in which the retainer blocks the plunger rod 9 in the storage position, and a release position (position shown in figure 15B), in which the retainer 14 is moved away from the plunger rod 9 to allow axial displacement of the plunger rod 9 from the storage to the injection end position,
a locker 7, movable with respect to the retainer 14 between a locking position (a position before pressing element 2 on the patient’s skin), in which the locker 7 (element 7 is indirectly locking element 14 by preventing upward movement of element 13) locks the retainer 14 in the blocking position, and a release position (position where element 7 gets pressed enough for releasing element 13, paragraph 0082, lines 12-21), in which the locker 7 allows movement of the retainer 14 to the release position, movement of the locker from the locking position to the release position being caused by the needle cover 2 moving from the first extended position to the retracted position,
a controller 13, movable with respect to the housing 12, between a storage position (position shown in figure 1A) which the controller 13 prevents activation of the autoinjector and an activated position (position shown in figure 3A) allowing for activation of the autoinjector, said controller 13 comprising a grasping member (see “G” in figure 16A below, the claim does not require user to be able to hold by hand in order to move the controller) configured for allowing a user to move the controller 13 from the storage position to the activated position, wherein the locker 7 is connected to the controller such that movement of the controller 7 with respect to the housing 12 between the storage and activated position entails movement of the locker with respect to the housing between a corresponding storage and an activated position (paragraph 0082, lines 12-21), and
the locker 7 comprising a blocking member 7.1 (figure 11A) configured for abutting against a stop (paragraph 0082, lines 1-6, surface of element 12 preventing element 2.1, element 7.1 is indirectly abutting against a stop) of the housing 12 as long as the locker 7 is in the storage position, such that the locker 7 is prevented from moving to the release position with respect to the retainer 14, the blocking member of the locker being moved away from said stop of the housing (paragraph 0082, lines 1-6) when the locker is moved to the activated position, such that the locker (element 7 will be able to move due to movement of surface of element 12 away from element 2.1 thereby allowing deflection of element 2.1) can move to the release position with respect to the retainer.
PNG
media_image3.png
248
502
media_image3.png
Greyscale
Regarding claim 2, Dasbach teaches wherein the controller 13 comprises a distal flange (see “F” in figure 16A above) having a distal side (see “D” in figure 16A above) and a proximal side 13.2, and the housing 12 comprises a proximal bearing surface (surface of element 12 engaging with element “D” in figure 16A above) arranged for axially abutting against the distal side of said distal flange, and a distal bearing surface (surface of element 12 engaging with element 13.2) for axially abutting against the proximal side 13.2 of the distal flange (see “F” in figure 16A above).
Regarding claim 6, Dasbach teaches wherein the controller 13 comprises a proximal flange (see “PF” in figure 3A below) arranged for closing an opened proximal end (end where element 13 is present) of the housing 12, and the housing 12 comprises a proximal bearing surface (see “BS” in figure 3A below) configured for axially abutting against a distal side (side of “PF” in figure 3A below engaging with element “BS” in figure 3A below) of said proximal flange (see “PF” in figure 3A below).
PNG
media_image4.png
253
510
media_image4.png
Greyscale
Regarding claim 10, Dasbach teaches wherein the controller 13 comprises a resiliently deformable holder (see “F” in figure 16A above) configured to abut against the housing 12 in order to hold the controller 13 in the storage position before use of the autoinjector.
Regarding claim 15, Dasbach teaches wherein the retainer 14 and the controller 13 are made of a single piece (element 14 is a part of element 13 thereby making as a single piece, paragraph 0072, lines 3-8).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wozencroft (US 2011/0202011 A1).
Regarding claim 9, Wozencroft discloses the claimed invention substantially as claimed, as set forth above in claim 1. Wozencroft discloses wherein the housing 12, 18 comprises a tapered outer end 68 configured to point a first or second indicator 70 of the controller in the storage position or activated position. However, Wozencroft is silent regarding wherein the grasping member of the controller comprises a tapered outer end configured to point at a first or second indicator of the housing for indicating to the end user when the controller is in the storage position or activated position.
According to MPEP 2144.04 (VI)(A), it would be obvious to reverse the parts if reversal does not change the operation. In Wozendroft, reversing the placement of a tapered outer end to be placed on grasping portion of the controller and placing the first or second indicator on the housing will merely reverse the placement of the feature without changing the operation. Therefore, it would be obvious to one of ordinary skill in the art to reverse the placement of a tapered outer end to incorporate wherein the grasping member of the controller comprises a tapered outer end configured to point at a first or second indicator of the housing for indicating to the end user when the controller is in the storage position or activated position for the purpose of indicating the end user the status of the controller.
Allowable Subject Matter
Claims 3-5, 7, 8 and 11-14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The closest prior art of record, Dasbach et al. (US 2014/0243757 A1), is silent regarding wherein the proximal bearing surface is arranged at an axially extending indexation rib, said indexation rib comprising, axially opposite the proximal bearing surface, a distal end configured for engaging an axial slot of a bottom body of the housing in combination with other claimed limitations of claim 3.
The closest prior art of record, Dasbach et al. (US 2014/0243757 A1), is silent regarding wherein the proximal bearing surface is arranged at an axially extending blocking rib, said blocking rib comprising, axially opposite the proximal bearing surface, the distal stop configured for axially abutting against the locker in combination with other claimed limitations of claim 4.
The closest prior art of record, Dasbach et al. (US 2014/0243757 A1), is silent regarding wherein the proximal bearing surface is arranged at an axially extending mounting rib, said mounting rib comprising, axially opposite the proximal bearing surface, a distal end configured for axially abutting against a proximal end of a bottom body of the housing in combination with other claimed limitations of claim 5.
The closest prior art of record, Dasbach et al. (US 2014/0243757 A1), is silent regarding wherein the proximal bearing surface configured for axially abutting against a distal side of said proximal flange is arranged at a first axially extending rib of the housing, and a peripheral edge of the distal flange of the controller comprises a cutout for receiving the first axially extending rib through the distal flange in combination with other claimed limitations of claim 7.
The closest prior art of record, Dasbach et al. (US 2014/0243757 A1), is silent regarding wherein the controller comprises a rotation limiting member having a first lateral side configured for orthoradially abutting against the first axially extending rib of the housing when the controller is in the storage position, and a second lateral side configured for orthoradially abutting against a protrusion of the housing when the controller is in the activated position, and the rotation limiting member connects the distal flange to the proximal flange of the controller in combination with other claimed limitations of claim 8.
The closest prior art of record, Dasbach et al. (US 2014/0243757 A1), is silent regarding wherein the resiliently deformable holder is configured for abutting against a first side of a first axially extending rib of the housing and, opposite said first side, the first axially extending rib of the housing comprises an inclined surface, such as a chamfer, for allowing the resiliently deformable holder to deform so as to pass over the first axially extending rib during assembly of the controller within the housing in combination with other claimed limitations of claim 11.
The closest prior art of record, Dasbach et al. (US 2014/0243757 A1), is silent regarding wherein the retainer comprises an axially extending guiding leg configured for engaging an axially extending guiding groove of the locker, the axially guiding leg defining an orthoradial pushing surface configured for abutting against a lateral side of the guiding groove to rotate the locker to the activated position when the retainer is rotated to the activated position in combination with other claimed limitations of claim 12.
Claim 13 being dependent on claim 12 is also indicated allowable.
The closest prior art of record, Dasbach et al. (US 2014/0243757 A1), is silent regarding wherein the retainer comprises resiliently deformable blocking legs comprising a radially inward protrusion configured for engaging a distal abutment surface of the plunger rod when the retainer is in the blocking position, an opposite radially outward protrusion configured for engaging an axially extending locking groove of the locker such that the outward protrusion abuts against a lateral abutment surface of said locking groove when the locker is in the locking position, and wherein the outward protrusion further defines a proximal shoulder configured for axially abutting against a distal stop inwardly radially protruding from the locking groove in combination with other claimed limitations of claim 14.
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 design of an autoinjector comprising a drive means for expelling medicament after placing and pressing the autoinjector at the injection site.
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.
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.
/NILAY J SHAH/Primary Examiner, Art Unit 3783
Prosecution Insights