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 .
Status of Claims
Applicant’s election of Group III (Figs. 9A-9E) and claims 23-37 and 39-41, without traverse, is acknowledged.
Claim 38 is withdrawn from further consideration.
Claims 23-37 and 39-41 are pending.
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 33 and 35 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.
Claim 33 recites the limitation "the device member is a member different from the housing" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether “a member” is referring to the previously recited “device member” introduced in claim 23 or a new element.
Claim 35 recites “wherein at least one of the device member is a needle shroud or the needle is axially fixed relative to the housing.” The phrase “at least one of the device member” is grammatically incomplete. It is unclear whether the claim requires the device member to be a needle shroud, the needle to be axially fixed relative to the housing, or both.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 23-25, 27, 35-37 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Limaye et al. (US Patent No. 10,688,256), hereinafter Limaye.
Regarding claim 23, Limaye discloses a drug delivery arrangement (syringe 10 with distal assembly that sets penetration depth in fig. 1; col. 1, lines 10-16; col. 2, lines 1-14; col. 3, lines 21-22), comprising:
a drug delivery device (syringe 10 in fig. 1) comprising a device member (hub 16 in fig. 1) and a housing (barrel 14 in fig. 1) adapted to receive a needle (needle 13 received by hub 16 that is attached to barrel 14 in figs. 1, 3; col. 3, lines 12-14), the needle being configured to pierce a skin (needle 13 is for subcutaneous injection; col. 3, lines 2-5 and lines 51-53);
an injection depth adjusting member (collar 20 in fig.1; col. 3, lines 19-22) that is connectable to or connected to the device member of the drug delivery device (collar 20 fits over hub 16 in figs. 1, 3-4; col. 3, lines 19-21);
wherein the injection depth adjusting member is configured to provide an adjuster bearing surface (distal end wall of collar 20 which has opening through which needle 13 protrudes in figs. 1-3; col. 3, lines 19-21) with which the drug delivery arrangement bears on the skin during use when the injection depth adjusting member is connected to the device member (collar 20 adjusted to axially move needle 13 penetration depth; col. 3, lines 51-53); and
wherein when the injection depth adjusting member is connected to the device member (collar 20 fits over hub 16 in figs. 1, 3-4; col. 3, lines 19-21), the injection depth adjusting member is configured to define an injection depth by which the needle can penetrate the skin (collar 20 adjusted to axially move needle 13 penetration depth; col. 3, lines 51-53).
Regarding claim 24, Limaye discloses the drug delivery arrangement of claim 23, wherein when the drug delivery device (syringe 10 in fig. 1) is operated to perform a drug delivery operation (adjustment of needle penetration depth to 4mm is appropriate for an insulin injection; col. 3, lines 51-53), the device member is arranged to provide a member bearing surface with which the drug delivery device can bear on the skin (hub 16 at the distal, injection end of syringe 10, carrying needle 13 in figs. 1-4; col. 3, lines 12-16).
Regarding claim 25, Limaye discloses the drug delivery arrangement of claim 23, wherein the injection depth adjusting member is releasably connected to the device member (collar 20 fits over hub 16 in figs. 1, 3-4; col. 3, lines 19-21).
Regarding claim 27, Limaye discloses the drug delivery arrangement of claim 23, wherein the injection depth adjusting member (collar 20 in fig.1; col. 3, lines 19-22) is configured to be disconnected from the drug delivery device (syringe 10 in fig. 1) and connected to the device member (collar 20 fits over hub 16 and tab 65 out of slots 29 in figs. 1, 3-5; col. 3, lines 19-21 and lines 36-51).
Regarding claim 35, Limaye discloses the drug delivery arrangement of claim 23, wherein at least one of the device member is a needle shroud or the needle (needle 13 in figs. 1, 3) is axially fixed relative to the housing (hub 16 is attached to barrel 14 and not moved during ordinary use; col 3, lines 12-16 and lines 32-35).
Regarding claim 36, Limaye discloses the drug delivery arrangement of claim 23, wherein the drug delivery device comprises a medicament container holding a medicament (medication compartment within the syringe barrel 14 to pressurize the compartment and eject medication out of needle 13; col. 3, lines 10-13; col. 5, lines 51-55).
Regarding claim 37, Limaye discloses the drug delivery arrangement of claim 23, wherein when the injection depth adjusting member (collar 20 in fig.1; col. 3, lines 19-22) is connected to the device member (hub 16 in fig. 1), the injection depth adjusting member is rigidly connected to the device member (once tab 65 is in a slot, collar 20 cannot slide on hub 16 until the user rotates it out in figs. 4-5; col. 3, lines 19-21 and lines 36-51).
Regarding claim 39, Limaye discloses the drug delivery arrangement of claim 23, comprising a selection mechanism (tab 65 in slots 29 at specified increments; col. 3, lines 36-58), which is operable to select a desired injection depth from a plurality of possible injection depths (tab 65 in slots 29 at specified increments; col. 3, lines 36-58);
wherein the selection mechanism comprises a selection member (tab 65 in fig. 5) which is rotatable (tab 65 formed on the interior wall of collar 20 can be rotated; col. 3, lines 38-43) from a first position (tab 65 in 8mm position slot in fig. 2) to a second position (tab 65 in 4mm position slot in fig. 3); and
wherein the first position is a position for a first injection depth (8mm injection depth is suitable for filling the syringe from a vial; col. 3, lines 27-29) and the second position is a position for a second injection depth (4mm injection depth appropriate for insulin injection; col. 3, lines 51-53).
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 26 and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Limaye in view of Wyrick (US Publication No. 2006/0173408), hereinafter Wyrick.
Regarding claim 26, Limaye discloses the drug delivery arrangement of claim 25, wherein the drug delivery arrangement comprises an injection depth adjusting member that is releasably connected to the device member (collar 20 fits over hub 16 in figs. 1, 3-4; col. 3, lines 19-21).
Limaye fails, however, to disclose a plurality of injection depth adjusting members.
Wyrick teaches a plurality of injection depth adjusting members (Wyrick: sleeves 70 are selected from a group having varying axial dimensions to effect different needle penetration depths; para [0095]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single injection depth adjusting member of Limaye to a plurality of injection depth adjusting members of different axial lengths, as taught by Wyrick, in order to allow the user to select among different needle penetration depths by connecting a chosen member to the device member.
Regarding claim 28, modified Limaye discloses the drug delivery arrangement of claim 27, comprising a plurality of injection depth adjusting members (Wyrick: sleeves 70 are selected from a group having varying axial dimensions to effect different needle penetration depths; para [0095]) that are configured to provide different injection depths when connected to the device member (collar 20 fits over hub 16 in figs. 1, 3-4; col. 3, lines 19-21).
Regarding claim 29, modified Limaye discloses the drug delivery arrangement of claim 28, wherein the plurality of injection depth adjusting members (Wyrick: sleeves 70 are selected from a group having varying axial dimensions to effect different needle penetration depths; para [0095]) form an injection depth adjusting member assembly that is connectable to or connected to the device member of the drug delivery device (Wyrick: sleeve 70 chosen and installed on nose 45; Limaye: collar 20 fitted over hub 16 to form assembly; figs. 1, 3-4; col. 3, lines 19-21).
Regarding claim 30, modified Limaye discloses the drug delivery arrangement of claim 29, wherein when the injection depth adjusting member assembly is connected to the device member (Wyrick: sleeve 70 chosen and installed on nose 45 to form assembly), the plurality of injection depth adjusting members is configured to define the injection depth by which the needle can penetrate the skin (Wyrick: sleeves 70 are selected from a group having varying axial dimensions to effect different needle penetration depths; para [0095]; Limaye: 4 mm / 6 mm / 8 mm; col. 5, lines 13-14).
Regarding claim 31, modified Limaye discloses the drug delivery arrangement of claim 29, wherein each injection depth adjusting member of the injection depth adjusting member assembly (Wyrick: sleeves 70 are selected from a group having varying axial dimensions to effect different needle penetration depths; para [0095]) is configured to provide an adjuster bearing surface with which the drug delivery arrangement bears on the skin during use when the respective injection depth adjusting member is exposed (collar 20 adjusted to axially move needle 13 penetration depth; col. 3, lines 51-53; col. 6, lines 47-52).
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Limaye in view of Giambattista (US Patent No. 10,881,795), hereinafter Giambattista.
Regarding claim 33, Limaye discloses the drug delivery arrangement of claim 23, wherein the device member (hub 16 in fig. 1) is a member different from the housing (barrel 14 in fig. 1).
Limaye fails, however, to disclose that the device member is movable relative to the housing.
Giambattista teaches a device member movable relative to the housing (Giambattista: shield 320 movable longitudinally within front assembly shell 300 between an extended position and a retracted position; col. 5, lines 40-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device member of Limaye to be a member different from the housing and movable relative to the housing, as taught by Giambattista, in order to cover the needle before and after injection while still presenting a distal, patient-facing member on which Limaye’s depth-adjusting collar can be mounted.
Regarding claim 34, modified Limaye discloses the drug delivery arrangement of claim 33, wherein the drug delivery device (syringe 10 in fig. 1) comprises a removable safety member (Giambattista: cap 110 is connected to shield 320 while cap 110 in figs. 1-3, 5-7; col. 2, lines 58-60) that is operatively connected to the device member to prevent movement of the device member relative to the housing when the safety member is connected to the device member (Giambattista: cap 110 and, when connected, prevents shield 320 and shell 300 from moving relative to each other; col. 2, lines 58-60).
Allowable Subject Matter
Claims 32, 40 and 41 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 32 requires a selection member configured to selectively detach one or more injection depth adjusting members simultaneously with removal of the selection member depending on rotational orientation of the selection member relative to those adjusting members, such that one or more of the adjusting members of the assembly remain after the selection member is removed.
Claim 40 requires a selection member that is removable from the drug delivery device, wherein in a first position the injection depth adjusting member is removed from the device member together with the selection member, and wherein in a second position the selection member is decoupled from the injection depth adjusting member so that the selection member is removed and the injection depth adjusting member stays connected to the device member.
The closest prior art cited above (Limaye, Wyrick, and Giambattista) fails to disclose a selection member that, depending on its rotational orientation, is removed together with one or more injection depth adjusting members in one position and is removed while those members stay connected to the device member in another position, as required by claims 32 and 40.
Claim 41 depends from claim 32 and would be allowable for the same reasons if claim 32 is rewritten in independent form including all limitations of the base claim and intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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