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 less than 50 words. 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).
Claim Objections
Claims 17, 23, 28 and 30 are objected to because of the following informalities:
Claim 17 recites the limitation “the proximal end” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 23, line 5, the recitation “it” appears to be amended to be recited with the intended feature being referred.
Regarding claim 28, line 1, the recitation “main portion” appears to be amended to recite “the main portion” in order to refer to “main portion” recited in claim 27.
Claim 30 recites the limitation “the shoulder wall portion” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 31 is 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 31, line 2, the recitation “for example” renders the claim indefinite because the claim is unclear if “a spring” is positively claimed as a part of the claimed invention. Thus, the claim does not clearly indicate if “a spring” is used as an example to provide biasing or if the spring is positively claimed as being a part of the claimed invention to provide biasing. Therefore, the claim fails to provide metes and bounds of the claim. For examination purposes, examiner construes “a spring” as being positively recited as a part of the claimed invention.
Claim Rejections - 35 USC § 102
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.
Claims 17-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Zolt et al. (US 2020/0139054 A1).
Regarding claim 17, De Zolt teaches a subassembly 1 (figure 2) of a medicament delivery device (paragraph 0037, “injector pen”) for expelling medicament from a medicament container (paragraph 0037), the subassembly 1 comprising:
a housing 4 having a proximal end (end of element 4 closest to the target site when in use) and a distal end (end of element 4 closest to element 2); and
a cover structure 55 configured to surround a medicament delivery member 15 at a proximal end (end of “injector pen” closest to element 2) of the medicament delivery device (paragraph 0037), the cover structure 55 is movable inside the housing 4 (paragraph 0052, lines 1-4) in an axial direction of the housing 4 between a retracted position (position where element 15 is exposed) in which the medicament delivery member 15 is exposed at the proximal end (end of element 55 closest to the site of delivery when in use) of the cover structure 55, and an extended position (position shown in figure 2 or figure 4) in which the medicament delivery member 15 is covered by the cover structure 55,
the cover structure 55 comprising a slot 63, 64 in a surface (surface of element 55 comprising element 38) facing radially outwards towards the housing 4,
the housing 4 comprising a slot 38 in a surface (surface of element 4 comprising element 38) facing radially inwards towards the cover structure 55,
the subassembly 1 further comprising a guiding member 68 arranged between the cover structure 55 and the housing 4 in the slot 38 of the housing and in the slot 63, 64 of the cover structure 55,
wherein the slot 38 of the housing 4 and the slot 63, 64 of the cover structure 55 are adapted so that, when the cover structure 55 is moved towards the retracted position, the guiding member 68 slides in the slot of the cover structure, and along a first path 39, 40 in the slot of the housing from a first position to a second position (paragraph 0052), and
when the cover structure 55 is moved from the retracted position towards the extended position (position shown in figure 4), the guiding member 68 slides in the slot of the cover structure 55, and along a second path 42 in the slot of the housing from the second position to a locking position (position where element 78 enters into element 42),
the slot of the housing and the slot of the cover structure are adapted so that, once in the locking position, if the cover structure is again attempted to be moved towards the retracted position, the guiding member maintains the relative positions of the slot of the housing and the slot of the cover structure thereby preventing the cover structure from moving axially to the retracted position (paragraph 0055, see figures 4 and 6 where due to deformation of the needle and the shape of the path, the cover structure is not able to move to the retracted position).
Regarding claim 18, De Zolt teaches wherein the guiding member 68 is a separate part (figure 5) adapted to fit in the slot 63, 64 of the cover structure 55 and in the slot 38 of the housing 4.
Regarding claim 19, De Zolt teaches wherein the guiding member 68 is held in place in the slot 63, 64 of the cover structure 55 and in the slot 38 of the housing by the proximity of the housing 4 and the cover structure 55 (no special other fastening mechanism used to place element 68 in place).
Regarding claim 20, De Zolt teaches wherein the guiding member 68 comprises a circular cross-section (see figure 5 where horizontal cross-section of element 68 is circular).
Regarding claim 21, De Zolt teaches wherein the guiding member 68 is moved in the slot of the housing 4 by a force (paragraph 0052) exerted on the guiding member 68 from sidewalls of the slot 63, 64 in the cover structure 55.
Regarding claim 22, De Zolt teaches wherein the slot 63, 64 of the cover structure 55 is arranged to extend along a circumference (element 63, 64 are extending along side surface of element 55) of the cover structure 55.
Regarding claim 23, De Zolt teaches wherein the first path 39, 40 of the slot 38 of the housing 4 comprises a first portion 40 and a second portion 39, where the second portion 39 is inclined with respect to the first portion 40 and arranged to extend at least partly along a circumference of a surface (see figure 5 where element 39 is extending along a circumference of a surface of element 4) of the housing 4, so that when the guiding member 68 slides in the second portion 39 it simultaneously moves in the slot of the cover structure in a first direction (paragraph 0052, lines 10-15, rotation of moving away from element 15).
Regarding claim 24, De Zolt teaches wherein the first portion 40 of the slot 38 of the housing 4 is arranged substantially parallel (element 40 is substantially parallel) with a longitudinal axis (axis along length of element 4) of the housing 4.
Regarding claim 25, De Zolt teaches where in the guiding member 68 is moved in the slot 63, 64 in the cover structure 55 by a force exerted on the guiding member 68 from side walls of the slot 38 in the housing in the second portion 39 (paragraph 0052, small rotation of movement of element 68 is bound to happen when element 68 is moving through element 39).
Regarding claim 26, De Zolt teaches wherein, the second path 42 of the slot 38 of the housing 4 comprises a shoulder wall portion 46, 45, 47 (figure 6) configured to prevent the guiding member from moving from the lock position towards the second position.
Regarding claim 27, De Zolt teaches wherein the second path 42 of the slot 38 of the housing 4 comprises a main portion (see “M” in figure 6 below) and a locking portion (see “L” in figure 6 below) connected by an intermediate portion (portion where element 49 is present), the intermediate portion 49 configured so that when the guiding member 68 moves in the intermediate portion the guiding member is simultaneously caused to move along the slot 63, 64 in the cover structure until the guiding member reaches the locking portion which includes the locking position (position shown in figure 6).
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Regarding claim 28, De Zolt teaches wherein the main portion (see “M” in figure 6 above) extends parallel with axial direction (portion of element “M” extends parallel with axial direction) of the medicament delivery device, the intermediate portion 49 is inclined with respect to the main portion, and the locking portion (see “L” in figure 6 above is parallel with “M” in figure 6 above) is parallel with the main portion (see “M” in figure 6 above).
Regarding claim 29, De Zolt teaches wherein the slots 63, 64, 38 are configured so that when the guiding member 68 moves in the slot 38 of the housing 4 from the first position to the second position the guiding member 68 moves in the slot of the cover structure 55 in a first direction (paragraph 0052, lines 10-15, rotation of moving away from element 15), and when the guiding member 68 moves in the slot 38 of the housing 4 from the second position to the locking position the guiding member 68 moves in the slot of the cover structure 55 in a second direction (paragraph 0053, lines 7-16, direction of moving towards element 15 is construed as being opposite direction to the first direction) being opposite to the first direction.
Regarding claim 30, De Zolt teaches wherein, in the locking position (position where element 78 enters element 42), the guiding member 68 abuts the shoulder wall portion 46 (figure 6) and a corresponding side wall (side wall of element 63, 64) of the slot 63, 64 in the cover structure 55 being parallel (portion of side walls of elements 63, 64 and element 46 would be parallel when viewing along a plane that coincides the portion of side walls of elements 63, 64 and element 46 such that they both appear parallel. The claim does not set any reference point for the parallel except for having relative parallel between side walls of the cover structure and the shoulder wall portion) with the shoulder wall portion 46.
Regarding claim 31, De Zolt teaches wherein the cover structure 55 is biased towards the extended position, for example by a spring 50.
Regarding claim 32, De Zolt teaches a medicament delivery device (paragraph 0037, “injector pen”) comprising the subassembly 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fuke et al. (US 2015/0119815 A1): discloses a liquid administering device comprising the cover structure and the housing with a guiding member disposed between the cover structure and the housing.
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.
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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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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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