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
Figures 1 and 2 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Page 12, lines 20 – 24 of the Specification dated 11 April 2024 discloses that Figures 1 and 2 are a perspective view and an exploded view of the medicament delivery device or drug delivery device in EP 2890434 B1. Therefore, Figures 1 and 2 should be designated as prior art.
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
22 as mentioned on at least page 13, lines 6 – 14 and page 17 of the Specification dated 11 April 2024.
23 as mentioned on at least page 13, lines 6 – 14 and page 17 of the Specification dated 11 April 2024.
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. 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.
The drawings are objected to because of the following:
Figure 1 includes reference numeral “1” twice. The Examiner believes one of these reference numerals to be an error.
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 content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is not within the range of 50 to 150 words in length. 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 16, 22, 27, 28, and 30 are objected to because of the following informalities:
Claim 16 is suggested to be amended to remove the extra space between the word “protrusion” and the comma to clarify the claim language
Claim 22 is suggested to be amended to recite “The disposable drug delivery device [[of any]] of claim 19” to clarify the preamble of Claim 22.
Claim 22 is suggested to be amended to remove the reference numeral “(20)”.
Claim 27 is suggested to be amended to remove the extra space between the word “label” and the comma to clarify the claim language.
Claim 28 is suggested to be amended to recite “between a proximal portion and a distal portion [[which]] wherein the distal portion has a smaller inner diameter” to clarify the claim language and provide the proper antecedent basis.
Claim 30 is suggested to be amended to recite “The disposable drug delivery device [[of any]] of claim 16” to clarify the preamble of Claim 30.
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 22 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.
Claim 22 recites “a distally facing substantially cylindrical engagement portion of the inner housing.” It is unclear if this “distally facing substantially cylindrical engagement portion of the inner housing” is referring to the previously recited “distally facing substantially cylindrical engagement portion” recited in Claim 18 upon which Claim 22 depends.
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.
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.
Claim(s) 16, 17, 30, and 32 – 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre (US 2019/0307966 A1) and Gillespie, III et al. (US 8,048,029 B2) (hereinafter referred to as “Gillespie”).
With regards to claim 16, Plumptre discloses a disposable drug delivery device (1) (see ([0124] and [0137]) for selecting and dispensing a number of doses of a medicament (see abstract), the disposable drug delivery device comprising:
an outer housing (10) defining a central axis extending between a distal end and a proximal end (see Fig. 2 and [0124]);
an inner housing (20) (see Fig. 2 and [0124]);
a cartridge holder (11) (see [0125]) for retaining a cartridge (80) containing the medicament (see [0135] and abstract);
a piston rod (30) displaceable relative to the cartridge holder (see [0146]),
a driver (40) (see [0125]) coupled to the piston rod;
a display member (60) for indicating a set dose and being coupled to the inner housing and to the driver (see [0130], [0131], and abstract); and
a button (70) coupled to the display member and to the driver (see [0132], [0133], and Abstract).
However Plumptre is silent with regards to wherein the inner housing is axially retained in the outer housing by an interface comprising at least one radially deflectable arm with a lateral protrusion, at least one recess adapted for engagement with the lateral protrusion and at least one locking member adapted for hindering disengagement of the lateral protrusion from the at least one recess.
Nonetheless Gillespie, which is within the analogous art of injector apparatuses (see abstract and title), teaches the inner housing (117, 132) (see Col. 10, lines 61 – 67 “The distal housing 117 includes a tubular sleeve 132”) is axially retained in the outer housing (115) (see Col. 10, lines 61 – 67 “a proximal end of the tubular sleeve 132 partially overlaps with the distal end of the proximal housing 115 (FIG. 16)”) by an interface (132a, 113b) comprising at least one radially deflectable arm (132a) with a lateral protrusion (132b) (see Col. 10, lines 31 – 44 “The distal end includes an aperture 113b (FIG. 13) that receives and allows for a radially outwardly extending protrusion 132b of a deflectable member 132a (FIG. 15) to protrude therefrom, as further described below.”), at least one recess (113b) adapted for engagement with the lateral protrusion and at least one locking member (132c) adapted for hindering disengagement of the lateral protrusion from the at least one recess (see Fig. 19A, Col. 11, lines 7 – 22, Col. 12, lines 6 – 34 “the radially inward protrusion 132c resides on the rib 136d (FIG. 19), such that the deflectable member 132a is biased radially outwardly through the aperture 113b,” and Col. 12, lines 35 – 58 “Preferably, in the biased outward position, the radially inward protrusion 132c contacts a radially protruding rib 136d on the exterior surface of the syringe guide 136 to prevent the elongated body 132d from deflecting inwardly.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the inner and outer housings of the drug delivery device of Plumptre in view of a teaching of Gillespie such that the inner housing is axially retained in the outer housing by an interface comprising at least one radially deflectable arm with a lateral protrusion, at least one recess adapted for engagement with the lateral protrusion and at least one locking member adapted for hindering disengagement of the lateral protrusion from the at least one recess. One of ordinary skill in the art would have been motivated to make this modification because Plumptre is silent with regards to how the outer housing 10 and inner housing 20 are coupled together. See [0126] of Plumptre. A person of ordinary skill in the art would rely on a teaching of Gillespie to determine a structure to couple the inner and outer housings together. The interface of Gillespie teaches a structure that provides a tamper evidence means to determine whether or not the injector has been tampered with or previously used. See abstract and Col. 13, lines 40 – 51 of Gillespie. Therefore a person having ordinary skill in the art would be motivated to couple the inner and outer housings of Plumptre together using the interface of Gillespie so that the tamper evidence means can be incorporated within the drug delivery device.
The drug delivery device of Plumptre modified in view of a teaching of Gillespie will hereinafter be referred to as the drug delivery device of Plumptre and Gillespie.
With regards to claim 17, the drug delivery device of Plumptre and Gillespie teaches the claimed invention of claim 16, however Plumptre is silent with regards to wherein the inner housing comprises the at least one radially deflectable arm, wherein the lateral protrusion is directed radially outwards, and wherein the outer housing comprises the at least one recess.
Nonetheless Gillespie, which is within the analogous art of injector apparatuses (see abstract and title), further teaches the inner housing (117, 132) comprises the at least one radially deflectable arm (132a), wherein the lateral protrusion (132b) is directed radially outwards (see Fig. 19A), and wherein the outer housing (115) comprises the at least one recess (113b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery device of Plumptre and Gillespie in view of a further teaching of Gillespie such that the inner housing comprises the at least one radially deflectable arm, wherein the lateral protrusion is directed radially outwards, and wherein the outer housing comprises the at least one recess. One of ordinary skill in the art would have been motivated to make this modification because Plumptre is silent with regards to how the outer housing 10 and inner housing 20 are coupled together. See [0126] of Plumptre. A person of ordinary skill in the art would rely on a teaching of Gillespie to determine a structure to couple the inner and outer housings together. The interface of Gillespie teaches a structure that provides a tamper evidence means to determine whether or not the injector has been tampered with or previously used. See abstract and Col. 13, lines 40 – 51 of Gillespie. Therefore a person having ordinary skill in the art would be motivated to couple the inner and outer housings of Plumptre together using the interface of Gillespie so that the tamper evidence means can be incorporated within the drug delivery device.
With regards to claim 30, the drug delivery device of Plumptre and Gillespie teaches the claimed invention of claim 16, and Plumptre further teaches wherein the cartridge holder (11) (see [0125]) is a one-piece component with the outer housing (10) (see [0011] and [0125]).
With regards to claim 32, the drug delivery device of Plumptre and Gillespie teaches the claimed invention of claim 16, and Plumptre further teaches the drug delivery device further comprising a cartridge (80) containing a medicament (see abstract and [0135]).
With regards to claim 33, the drug delivery device of Plumptre and Gillespie teaches the claimed invention of claim 16, and Plumptre further teaches the drug delivery device further comprising a clutch (see [0133] “A clutch is provided…”) between the display member (60) and the button (70), the clutch comprising teeth (64, 74) rotationally locking the display member and the button (see [0133]), the clutch being releasable by axially shifting the button with respect to the display member (see [0133]).
With regards to claim 34, the drug delivery device of Plumptre and Gillespie teaches the claimed invention of claim 16, and Plumptre further teaches wherein the display member (60) comprises a series of numbers on an outer surface of the display member (see [0130]).
With regards to claim 35, he drug delivery device of Plumptre and Gillespie teaches the claimed invention of claim 34, and Plumptre further teaches wherein the series of numbers are arranged on a helical line on the outer surface of the display member (see [0130]).
Claim(s) 18, 19, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre and Gillespie as applied to claim 17 above, and further in view of Cowe (US 8,652,100 B1).
With regards to claim 18, the drug delivery device of Plumptre and Gillespie teaches the claimed invention of claim 17, and Plumptre teaches wherein the inner housing (20) comprises a distally facing substantially cylindrical engagement portion (see Fig. 16c at the label of 20).
However Plumptre is silent with regards to wherein the at least one radially deflectable arm is integrally formed in the engagement portion.
Nonetheless Cowe, which is within the analogous art of injector devices (see abstract and title), teaches the at least one radially deflectable arm (155) (see Col. 10, lines 1 – 11) is integrally formed in the engagement portion (see Examiner annotated Fig. 3 below hereinafter referred to as “Fig. A”).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the at least one radially deflectable arm of the drug delivery device of Plumptre and Gillespie in view of a teaching of Cowe such that the at least one radially deflectable arm is integrally formed in the engagement portion. One of ordinary skill in the art would have been motivated to make this modification because it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. See in re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965); MPEP 2144.04(V)(B). Additionally forming the at least one radially deflectable arm such that it is integral with the distally facing substantially cylindrical engagement portion reduces the number of separate parts within the drug delivery device thereby simplifying the device.
The drug delivery device of Plumptre and Gillespie modified in view of a teaching of Cowe will hereinafter be referred to as the drug delivery device of Plumptre, Gillespie, and Cowe.
With regards to claim 19, the drug delivery device of Plumptre, Gillespie, and Cowe teaches the claimed invention of claim 18, however, Plumptre is silent with regards to the at least one recess is a radial aperture in the outer housing.
Nonetheless Gillespie, which is within the analogous art of injector apparatuses (see abstract and title), further teaches the at least one recess (113b) is a radial aperture (see Figs. 19 and 19A) in the outer housing (115).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the at least one recess of the drug delivery device of Plumptre, Gillespie, and Cowe in view of a further teaching of Gillespie such that the at least one recess is a radial aperture in the outer housing. One of ordinary skill in the art would have been motivated to make this modification because Plumptre is silent with regards to how the outer housing 10 and inner housing 20 are coupled together. See [0126] of Plumptre. A person of ordinary skill in the art would rely on a teaching of Gillespie to determine a structure to couple the inner and outer housings together. The interface of Gillespie teaches a structure that provides a tamper evidence means to determine whether or not the injector has been tampered with or previously used. See abstract and Col. 13, lines 40 – 51 of Gillespie. Therefore a person having ordinary skill in the art would be motivated to couple the inner and outer housings of Plumptre together using the interface of Gillespie so that the tamper evidence means can be incorporated within the drug delivery device.
With regards to claim 21, the drug delivery device of Plumptre, Gillespie, and Cowe teaches the claimed invention of claim 19, however, Plumptre is silent with regards to wherein the at least one locking member is a pin provided on a radially inwardly facing side of the at least one radially deflectable arm.
Nonetheless Gillespie, which is within the analogous art of injector apparatuses (see abstract and title), teaches wherein the at least one locking member (132c) is a pin provided on a radially inwardly facing side of the at least one radially deflectable arm (132a) (see Fig. 19, Fig. 19A, Col. 11, lines 7 – 22, Col. 12, lines 6 – 34 “the radially inward protrusion 132c resides on the rib 136d (FIG. 19), such that the deflectable member 132a is biased radially outwardly through the aperture 113b,” and Col. 12, lines 35 – 58 “Preferably, in the biased outward position, the radially inward protrusion 132c contacts a radially protruding rib 136d on the exterior surface of the syringe guide 136 to prevent the elongated body 132d from deflecting inwardly.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the at least one locking member of the drug delivery device of Plumptre and Gillespie in view of a further teaching of Gillespie such that the at least one locking member is a pin provided on a radially inwardly facing side of the at least one radially deflectable arm. One of ordinary skill in the art would have been motivated to make this modification because Plumptre is silent with regards to how the outer housing 10 and inner housing 20 are coupled together. See [0126] of Plumptre. A person of ordinary skill in the art would rely on a teaching of Gillespie to determine a structure to couple the inner and outer housings together. The interface of Gillespie teaches a structure that provides a tamper evidence means to determine whether or not the injector has been tampered with or previously used. See abstract and Col. 13, lines 40 – 51 of Gillespie. Therefore a person having ordinary skill in the art would be motivated to couple the inner and outer housings of Plumptre together using the interface of Gillespie so that the tamper evidence means can be incorporated within the drug delivery device.
With regards to claim 22, the drug delivery device of Plumptre, Gillespie, and Cowe teaches the claimed invention of claim 19, and Plumptre further teaches wherein at least a proximal end (see at 82 in Fig. 2) of the cartridge (80) is retained in the inner housing (20) by a distally facing substantially cylindrical engagement portion (see Examiner annotated Fig. 16c below hereinafter referred to as Fig. B) of the inner housing.
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Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre, Gillespie, and Cowe as applied to claim 19 above, and further in view of Oakley et al. (US 2016/0166773 A1) (hereinafter referred to as “Oakley”).
With regards to claim 20, the drug delivery device of Plumptre, Gillespie, and Cowe teaches the claimed invention of claim 19, however Plumptre is silent with regards to wherein the radial aperture in the outer housing is covered by a label, shield and/or sleeve provided on an outer surface of the outer housing.
Nonetheless Oakley, which is within the analogous art of delivery devices (see abstract and title), teaches wherein the radial aperture (103) in the outer housing is covered by a label, shield and/or sleeve provided on an outer surface of the outer housing (see [0085] “It may be desired in some applications to cover the window 103 in the housing to prevent debris from entering the opening and either looking unsightly or interfering with the operation of the dose indicator mechanism. Means to prevent this include covering the opening with a transparent label.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery device of Plumptre, Gillespie, and Cowe in view of a teaching of Oakley such that the radial aperture in the outer housing is covered by a label, shield and/or sleeve provided on an outer surface of the outer housing. One of ordinary skill in the art would have been motivated to make this modification because Oakley teaches that the transparent label prevents debris from entering the opening and interfering with the operation of the device. See [0085] of Oakley.
Claim(s) 28 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre and Gillespie in further view of Urbanek et al. (US 2020/0376203 A1) (hereinafter referred to as “Urbanek”).
With regards to claim 28, the drug delivery device of Plumptre and Gillespie teaches the claimed invention of claim 16, however Plumptre is silent with regards to wherein the outer housing comprises an inner shoulder between a proximal portion and distal portion which distal portion has a smaller inner diameter than the proximal portion.
Nonetheless Urbanek, which is within the analogous art of connection mechanisms for medical devices (see abstract and title), teaches the outer housing (2) (see [0093]) comprises an inner shoulder (see Examiner annotated Fig. 3 below hereinafter referred to as “Fig. C”) between a proximal portion (see Fig. C below) and distal portion (see Fig. C below) which distal portion has a smaller inner diameter than the proximal portion (see Fig. C below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape of the outer housing of the drug delivery device of Plumptre and Gillespie in view of a teaching of Urbanek such that the outer housing comprises an inner shoulder between a proximal portion and distal portion which distal portion has a smaller inner diameter than the proximal portion. One of ordinary skill in the art would have been motivated to make this modification because Urbanek teaches that the shoulder of the outer housing prevents the inner housing from being removed from the outer housing. See [0096], [0102], [0109], [0135] and Fig. 3 of Urbanek. Furthermore it has been held to be an obvious matter of design choice to modify the shape of the outer housing such that the outer housing comprises an inner shoulder between a proximal portion and distal portion which distal portion has a smaller inner diameter than the proximal portion, since such a modification would have involved a mere change in the form of shape of a component. See in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP 2144.04(IV)(B).
The drug delivery device of Plumptre and Gillespie modified in view of a teaching of Urbanek will hereinafter be referred to as the drug delivery device of Plumptre, Gillespie, and Urbanek.
With regards to claim 29, the drug delivery device of Plumptre, Gillespie, and Urbanek teaches the claimed invention of claim 28, however, Plumptre is silent with regards to wherein a distal end face of the inner housing rests against the inner shoulder of the outer housing.
Nonetheless Urbanek, which is within the analogous art of connection mechanisms for medical devices (see abstract and title), teaches a distal end face (see at the annotated “inner shoulder” in Fig. C above) of the inner housing (40) rests against the inner shoulder (see Fig. C above) of the outer housing (20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the inner and outer housing of the drug delivery device of Plumptre, Gillespie, and Urbanek in view of a further teaching of Urbanek such that wherein a distal end face of the inner housing rests against the inner shoulder of the outer housing. One of ordinary skill in the art would have been motivated to make this modification because Urbanek teaches that the shoulder of the outer housing prevents the inner housing from being removed from the outer housing. See [0096], [0102], [0109], [0135] and Fig. 3 of Urbanek. Furthermore it has been held to be an obvious matter of design choice to modify the shape of the outer housing such that the outer housing comprises an inner shoulder between a proximal portion and distal portion which distal portion has a smaller inner diameter than the proximal portion, since such a modification would have involved a mere change in the form of shape of a component. See in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP 2144.04(IV)(B).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre and Gillespie in view of McWethy et al. (US 2002/0169421 A1) (hereinafter referred to as “McWethy”).
With regards to claim 31, the drug delivery device of Plumptre and Gillespie teaches the claimed invention of claim 16, however, Plumptre is silent with regards to wherein the interface further comprises at least one axially extending rib and at least one corresponding axially extending groove for rotationally securing the inner housing in the outer housing.
Nonetheless McWethy, which is within the analogous art of medical devices (see abstract), teaches the interface further comprises at least one axially extending rib (46) and at least one corresponding axially extending groove (22) for rotationally securing the inner housing (40) in the outer housing (20) (see [0032] and [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the interface of the drug delivery device of Plumptre and Gillespie in view of a teaching of McWethy such that the interface further comprises at least one axially extending rib and at least one corresponding axially extending groove for rotationally securing the inner housing in the outer housing. One of ordinary skill in the art would have been motivated to make this modification because McWethy teaches this configuration prevents rotation of the inner housing relative to the outer housing. See [0032] and [0040] of McWethy.
Claim(s) 16, 23 – 27, 30, and 32 – 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre in view of Avery et al. (US 2013/0184651 A1) (hereinafter referred to as “Avery”).
With regards to claim 16, Plumptre discloses a disposable drug delivery device (1) (see ([0124] and [0137]) for selecting and dispensing a number of doses of a medicament (see abstract), the disposable drug delivery device comprising:
an outer housing (10) defining a central axis extending between a distal end and a proximal end (see Fig. 2 and [0124]);
an inner housing (20) (see Fig. 2 and [0124]);
a cartridge holder (11) (see [0125]) for retaining a cartridge (80) containing the medicament (see [0135] and abstract);
a piston rod (30) displaceable relative to the cartridge holder (see [0146]),
a driver (40) (see [0125]) coupled to the piston rod;
a display member (60) for indicating a set dose and being coupled to the inner housing and to the driver (see [0130], [0131], and abstract); and
a button (70) coupled to the display member and to the driver (see [0132], [0133], and Abstract).
However Plumptre is silent with regards to wherein the inner housing is axially retained in the outer housing by an interface comprising at least one radially deflectable arm with a lateral protrusion, at least one recess adapted for engagement with the lateral protrusion and at least one locking member adapted for hindering disengagement of the lateral protrusion from the at least one recess.
Nonetheless Avery, which is within the analogous art of flexible fasteners for drug delivery devices (see abstract and title), teaches (see Figs. 8 – 11) the inner housing (520) (see [0160]) is axially retained in the outer housing (532)(see [0159]) by an interface (533, 528) comprising at least one radially deflectable arm (533)(see [0163]) with a lateral protrusion (see at 533 in Figs. 10 - 11), at least one recess (528)(see [0160]) adapted for engagement with the lateral protrusion (see Figs. 10 – 11 and [0163]) and at least one locking member (530) (see [0159]) adapted for hindering disengagement of the lateral protrusion from the at least one recess (see [0163]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the inner and outer housings of the drug delivery device of Plumptre in view of a teaching of Avery such that the inner housing is axially retained in the outer housing by an interface comprising at least one radially deflectable arm with a lateral protrusion, at least one recess adapted for engagement with the lateral protrusion and at least one locking member adapted for hindering disengagement of the lateral protrusion from the at least one recess. One of ordinary skill in the art would have been motivated to make this modification because Plumptre is silent with regards to how the outer housing 10 and inner housing 20 are coupled together. See [0126] of Plumptre. A person of ordinary skill in the art would rely on a teaching of Avery to determine a structure to couple the inner and outer housings together. The interface of Avery teaches a structure that provides a coupling mechanism that is difficult to tamper with so that the reservoir is not compromised. See [0002], [0010], and [0152] of Avery. Therefore a person having ordinary skill in the art would be motivated to couple the inner and outer housings of Plumptre together using the interface of Avery so that the inner and outer housings are difficult to tamper with.
The drug delivery device of Plumptre modified in view of a teaching of Avery will hereinafter be referred to as the drug delivery device of Plumptre and Avery.
With regards to claim 23, the drug delivery device of Plumptre and Avery teaches the claimed invention of claim 16, however, Plumptre is silent with regards to wherein the outer housing comprises the at least one radially deflectable arm, wherein the lateral protrusion is directed radially inwards, and wherein the inner housing comprises the at least one recess.
Nonetheless Avery, which is within the analogous art of flexible fasteners for drug delivery devices (see abstract and title), further teaches (see Figs. 8 – 11) the outer housing (532)(see [0159]) comprises the at least one radially deflectable arm (533) (see [0163]), wherein the lateral protrusion is directed radially inwards (see Figs. 8 and 10), and wherein the inner housing (520) (see [0160]) comprises the at least one recess (528)(see [0160]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery device of Plumptre and Avery in view of a further teaching of Avery such that the outer housing comprises the at least one radially deflectable arm, wherein the lateral protrusion is directed radially inwards, and wherein the inner housing comprises the at least one recess. One of ordinary skill in the art would have been motivated to make this modification because Plumptre is silent with regards to how the outer housing 10 and inner housing 20 are coupled together. See [0126] of Plumptre. A person of ordinary skill in the art would rely on a teaching of Avery to determine a structure to couple the inner and outer housings together. The interface of Avery teaches a structure that provides a coupling mechanism that is difficult to tamper with so that the reservoir is not compromised. See [0002], [0010], and [0152] of Avery. Therefore a person having ordinary skill in the art would be motivated to couple the inner and outer housings of Plumptre together using the interface of Avery so that the inner and outer housings are difficult to tamper with.
With regards to claim 24, the drug delivery device of Plumptre and Avery teaches the claimed invention of claim 23, however, Plumptre is silent with regards to wherein the outer housing comprises a substantially cylindrical engagement portion and wherein the at least one radially deflectable arm is integrally formed in the engagement portion.
Nonetheless Avery, which is within the analogous art of flexible fasteners for drug delivery devices (see abstract and title), further teaches (see Figs. 8 – 11) the outer housing (532)(see [0159]) comprises a substantially cylindrical engagement portion (531) (see [0162]) and wherein the at least one radially deflectable arm (533) (see [0163]) is integrally formed in the engagement portion (see Fig. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery device of Plumptre and Avery in view of a further teaching of Avery such that the outer housing comprises a substantially cylindrical engagement portion and wherein the at least one radially deflectable arm is integrally formed in the engagement portion. One of ordinary skill in the art would have been motivated to make this modification because Plumptre is silent with regards to how the outer housing 10 and inner housing 20 are coupled together. See [0126] of Plumptre. A person of ordinary skill in the art would rely on a teaching of Avery to determine a structure to couple the inner and outer housings together. The interface of Avery teaches a structure that provides a coupling mechanism that is difficult to tamper with so that the reservoir is not compromised. See [0002], [0010], and [0152] of Avery. Therefore a person having ordinary skill in the art would be motivated to couple the inner and outer housings of Plumptre together using the interface of Avery so that the inner and outer housings are difficult to tamper with.
With regards to claim 25, the drug delivery device of Plumptre and Avery teaches the claimed invention of claim 23, however, Plumptre is silent with regards to wherein the at least one recess is a radial aperture in the inner housing.
Nonetheless Avery, which is within the analogous art of flexible fasteners for drug delivery devices (see abstract and title), further teaches (see Figs. 8 – 11) the at least one recess (528)(see [0160]) is a radial aperture in the inner housing (520) (see [0160]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery device of Plumptre and Avery in view of a further teaching of Avery such that the at least one recess is a radial aperture in the inner housing. One of ordinary skill in the art would have been motivated to make this modification because Plumptre is silent with regards to how the outer housing 10 and inner housing 20 are coupled together. See [0126] of Plumptre. A person of ordinary skill in the art would rely on a teaching of Avery to determine a structure to couple the inner and outer housings together. The interface of Avery teaches a structure that provides a coupling mechanism that is difficult to tamper with so that the reservoir is not compromised. See [0002], [0010], and [0152] of Avery. Therefore a person having ordinary skill in the art would be motivated to couple the inner and outer housings of Plumptre together using the interface of Avery so that the inner and outer housings are difficult to tamper with.
With regards to claim 26, the drug delivery device of Plumptre and Avery teaches the claimed invention of claim 23, however, Plumptre is silent with regards to wherein the at least one radially deflectable arm of the outer housing is covered by a label, a shield and/or a sleeve provided on an outer surface of the outer housing.
Nonetheless Avery, which is within the analogous art of flexible fasteners for drug delivery devices (see abstract and title), further teaches (see Figs. 8 – 11) the at least one radially deflectable arm (533) (see [0163]) of the outer housing (532)(see [0159]) is covered by a label, a shield and/or a sleeve (530) (see [0159]) provided on an outer surface of the outer housing (see Figs. 8 – 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery device of Plumptre and Avery in view of a further teaching of Avery such that the at least one radially deflectable arm of the outer housing is covered by a label, a shield and/or a sleeve provided on an outer surface of the outer housing. One of ordinary skill in the art would have been motivated to make this modification because Plumptre is silent with regards to how the outer housing 10 and inner housing 20 are coupled together. See [0126] of Plumptre. A person of ordinary skill in the art would rely on a teaching of Avery to determine a structure to couple the inner and outer housings together. The interface of Avery teaches a structure that provides a coupling mechanism that is difficult to tamper with so that the reservoir is not compromised. See [0002], [0010], and [0152] of Avery. Therefore a person having ordinary skill in the art would be motivated to couple the inner and outer housings of Plumptre together using the interface of Avery so that the inner and outer housings are difficult to tamper with.
With regards to claim 27, the drug delivery device of Plumptre and Avery teaches the claimed invention of claim 26, however, Plumptre is silent with regards to wherein the at least one locking member is formed by the label, the shield and/or the sleeve.
Nonetheless Avery, which is within the analogous art of flexible fasteners for drug delivery devices (see abstract and title), further teaches (see Figs. 8 – 11) the at least one locking member (530) (see [0159]) is formed by the label, the shield and/or the sleeve (see [0163]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery device of Plumptre and Avery in view of a further teaching of Avery such that the at least one locking member is formed by the label, the shield and/or the sleeve. One of ordinary skill in the art would have been motivated to make this modification because Plumptre is silent with regards to how the outer housing 10 and inner housing 20 are coupled together. See [0126] of Plumptre. A person of ordinary skill in the art would rely on a teaching of Avery to determine a structure to couple the inner and outer housings together. The interface of Avery teaches a structure that provides a coupling mechanism that is difficult to tamper with so that the reservoir is not compromised. See [0002], [0010], and [0152] of Avery. Therefore a person having ordinary skill in the art would be motivated to couple the inner and outer housings of Plumptre together using the interface of Avery so that the inner and outer housings are difficult to tamper with.
With regards to claim 30, the drug delivery device of Plumptre and Avery teaches the claimed invention of claim 16, and Plumptre further teaches wherein the cartridge holder (11) (see [0125]) is a one-piece component with the outer housing (10) (see [0011] and [0125]).
With regards to claim 32, the drug delivery device of Plumptre and Avery teaches the claimed invention of claim 16, and Plumptre further teaches the drug delivery device further comprising a cartridge (80) containing a medicament (see abstract and [0135]).
With regards to claim 33, the drug delivery device of Plumptre and Avery teaches the claimed invention of claim 16, and Plumptre further teaches the drug delivery device further comprising a clutch (see [0133] “A clutch is provided…”) between the display member (60) and the button (70), the clutch comprising teeth (64, 74) rotationally locking the display member and the button (see [0133]), the clutch being releasable by axially shifting the button with respect to the display member (see [0133]).
With regards to claim 34, the drug delivery device of Plumptre and Avery teaches the claimed invention of claim 16, and Plumptre further teaches wherein the display member (60) comprises a series of numbers on an outer surface of the display member (see [0130]).
With regards to claim 35, he drug delivery device of Plumptre and Avery teaches the claimed invention of claim 34, and Plumptre further teaches wherein the series of numbers are arranged on a helical line on the outer surface of the display member (see [0130]).
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/15/2026
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