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 .
Claims 1-24 are being examined in this Office Action.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 115, 159, 160, 185 and 186. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Claim Objections
Claims 1-24 are objected to because of the following informalities:
Claim 1 recites the limitation “a medicament delivery device” in line 2. Examiner recommends amending the limitation to read “the medicament delivery device”.
Claim 1 recites the limitation “a medicament container” in line 8. Examiner recommends amending the limitation to read “the medicament container”.
Claim 10 recites the limitation “a medicament delivery device” in line 2. Examiner recommends amending the limitation to read “the medicament delivery device”.
Claim 10 recites the limitation “a medicament container” in line 8. Examiner recommends amending the limitation to read “the medicament container”.
Claim 10 recites the limitation “the device” in line 12. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends amending the limitation to read “the medicament delivery device”.
Claim 10 recites the limitation “the delivery device” in line 13. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends amending the limitation to read “the medicament delivery device”.
Claim 12 recites the limitation “to provide a path for connection the medicament container with the fluid path”. This should read “to provide a path for connecting the medicament container with the fluid path”.
Claim 17 recites the limitation “a medicament delivery device” in line 2. Examiner recommends amending the limitation to read “the medicament delivery device”.
Claim 17 recites the limitation “a medicament container” in line 8. Examiner recommends amending the limitation to read “the medicament container”.
Claim 17 recites the limitation “moveable container sled” in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends amending the limitation to read “the moveable medicament container sled”.
Claim 17 recites the limitation “the device” in line 12. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends amending the limitation to read “the medicament delivery device”.
Claim 17 recites the limitation “the delivery device” in line 13. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends amending the limitation to read “the medicament delivery device”.
Claim 20 recites the limitation “to provide a path for connection the medicament container with the fluid path”. This should read “to provide a path for connecting the medicament container with the fluid path”.
All remaining claims are objected to by virtue of their dependence on an objected claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 recites the limitation “wherein the moveable medicament container sled is secured by a mechanical stop, and activating the medicament delivery device comprises causing the mechanical stop to be released from the moveable medicament container sled”. The only mention of a mechanical stop is in paragraph [0047] of the specification and is in relation to the drive mechanism 134 and not the medicament container sled 140.
As to the sled, the disclosure describes that the medicament container is retained within the medicament container sled via snap-fit or friction fit, Paragraph [0046], and that the drive mechanism moves the sled forward upon activation, Paragraph [0057]. No structure is described that secures the sled itself, or the release of the sled via such structure upon activation.
The drive release latch 133 and button sled 131 release the drive mechanism, not the medicament container sled, and therefore, do not provide support.
Claim 24 recites the limitation “wherein the moveable medicament container sled is secured by a mechanical stop, and activating the delivery device comprises causing the mechanical stop to be released from the moveable medicament container sled”. The only mention of a mechanical stop is in paragraph [0047] of the specification and is in relation to the drive mechanism 134 and not the medicament container sled 140.
As to the sled, the disclosure describes that the medicament container is retained within the medicament container sled via snap-fit or friction fit, Paragraph [0046], and that the drive mechanism moves the sled forward upon activation, Paragraph [0057]. No structure is described that secures the sled itself, or the release of the sled via such structure upon activation.
The drive release latch 133 and button sled 131 release the drive mechanism, not the medicament container sled, and therefore, do not provide support.
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 5, 6, 13, 14, 21, and 22 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 5 recites the limitation “a cap” in line 2. It is unclear if this refers to a new element, or the previously recited cap of claim 4. Examiner interprets “a cap” in claim 5 to be referencing the cap of claim 4.
Claim 6 recites the limitation “the sterile barrier” in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets the sterile barrier to mean the second barrier as recited in claim 5.
Claim 13 recites the limitation “a cap” in line 2. It is unclear if this refers to a new element, or the previously recited cap of claim 12. Examiner interprets “a cap” in claim 13 to be referencing the cap of claim 12.
Claim 14 recites the limitation “the sterile barrier” in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets the sterile barrier to mean the second barrier as recited in claim 13.
Claim 21 recites the limitation “a cap” in line 2. It is unclear if this refers to a new element, or the previously recited cap of claim 20. Examiner interprets “a cap” in claim 21 to be referencing the cap of claim 21.
Claim 22 recites the limitation “the first sterile barrier and second sterile barrier” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets the first sterile barrier to mean the first barrier and the second sterile barrier to mean the second barrier as recited in claim 21.
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.
Claim(s) 1, 2, 4-10, 12-18, and 20-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson et al. (Pub. No. US 20190022306 A1, herein Gibson).
Regarding Claim 1, Gibson discloses a method of operating a medicament delivery device (10, Paragraph [0016]), comprising: selecting a medicament delivery device (any one of 10, 910, 2010, 6000, or 8000), comprising:
an external housing (12) including a substantially rigid body (Examiner interprets that the housing is made of a rigid material as it is meant to provide protection to the interior components of the drug delivery device, Paragraph [0296]);
a moveable medicament container sled (300, Figs 2A and 2B);
a needle insertion mechanism (200, Fig 7A);
a fluid path (30) operable to connect a needle of the needle insertion mechanism with a medicament container (“Upon proper activation of the drug delivery device 10 by the patient, the fluid pathway connector 300 is connected to a drug container 50, thereby enabling fluid flow from the drug container (as may be forced by the drive mechanism 100), through the fluid pathway connector 300, the fluid conduit 30, the insertion mechanism 200 and into the body of the patient.” – Paragraph [0305]);
a medicament container (50) including a container body (58) and plunger (60), wherein the medicament container is secured in a portion of the moveable medicament container sled (via 20, Fig. 1B); and
a drive mechanism (100, Fig. 1B);
applying the medicament delivery device to a skin surface of a patient (“removably attaching the wearable drug delivery device to a patient's skin” – Paragraph [0016]); and
activating the medicament delivery device to cause the drive mechanism to apply pressure to the plunger of the medicament container to cause the moveable medicament container sled to move, thereby advancing the medicament container and causing the medicament container to become fluidly connected with the fluid path (Figs 4A and 4B, Paragraph [0305]).
Regarding Claim 2, Gibson discloses the method of claim 1, wherein activating the medicament delivery device comprises releasing a latch mechanism of the drive mechanism (Fig. 14A, “Initially, one or more locking mechanisms (not shown) may reside within the locking grooves 110A of piston 110. Directly or indirectly upon activation of the device by the patient, the locking mechanism may be removed from the locking grooves 110A of piston 110, to permit operation of the drive mechanism. Such a locking mechanism may function as a first retainer having: a first retainer retaining position, where the first retainer retains the drive biasing member 122 in the energized state; and a first retainer releasing position, where the first retainer allows the drive biasing member 122 to de-energize. The first retainer may be structurally and functionally similar to the clip 2115 illustrated in FIGS. 22 and 23A and described in more detail below” – Paragraph [0358]).
Regarding Claim 4, Gibson discloses the method of claim 1, wherein the medicament delivery device comprises an aseptic region between a cap (52) of the medicament container and the fluid path (Paragraph [0508]), and the method further includes disrupting at least one barrier of the aseptic region to provide a path for connecting the medicament container with the fluid path (“pierceable seal 56 has a seal barrier 56C that would be pierced to open the drug container to the fluid pathway. In an initial position, the distal end of the piercing member 330 may reside adjacent to, or in contact with, the seal barrier 56C of the pierceable seal 56 to, for example, minimize the distance of translation of the fluid pathway connector 300 to pierce the pierceable seal 56 and open the drug container to the fluid pathway.” – Paragraph [0309]).
Regarding Claim 5, Gibson discloses the method of claim 4, wherein the at least one barrier includes a first barrier covering a cap (52) of the medicament container (56 including seal barrier 56C, Paragraph [0309]) and a second barrier covering a portion of the fluid path (320 including 320B which may be a closed surface, Paragraph [0309], Fig. 4A).
Regarding Claim 6, Gibson discloses the method of claim 5, wherein the first barrier and the sterile barrier each comprise at least one of a cap, a foil, or a film (“the connection opening 320B may be a closed surface and function as a pierceable sealing membrane between the fluid pathway and the drug container. However, in at least a preferred embodiment of the present disclosure, pierceable seal 56 has a seal barrier 56C that would be pierced to open the drug container to the fluid pathway.” – Paragraph [0309]).
Regarding Claim 7, Gibson discloses the method of claim 1, wherein activating the medicament delivery device further comprises activating the needle insertion mechanism to cause the needle of the needle insertion mechanism to pierce the skin surface of the patient (“Prior to operation, sealing member 254 may be removed from bottom of base 252 and base 252 is placed in contact with the target injection site on the body of the patient. As lockout pin(s) 208 are displaced by the activation mechanism, as described above, and insertion biasing member 210 is permitted to expand axially in the distal direction (i.e., in the direction of the solid arrow in FIG. 11A), manifold ring guide 228 is forced by the decompression and/or de-energizing of the insertion biasing member 210 to translate axially in the distal direction to insert the needle 214 and cannula 234 into the body of the patient.” – Paragraph [0331]).
Regarding Claim 8, Gibson discloses the method of claim 1, wherein causing the medicament container to become fluidly connected with the fluid path includes causing a needle (330) in communication with the fluid path to pierce a cap portion (52) of the medicament container as the medicament container is advanced (Figs 4A and 4B, Paragraph [0313]).
Regarding Claim 9, Gibson discloses the method of claim 1, wherein the moveable medicament container sled is secured by a mechanical stop (locking mechanism disclosed in Paragraph [0358]), and activating the medicament delivery device comprises causing the mechanical stop to be released from the moveable medicament container sled (Fig. 14A, “Initially, one or more locking mechanisms (not shown) may reside within the locking grooves 110A of piston 110. Directly or indirectly upon activation of the device by the patient, the locking mechanism may be removed from the locking grooves 110A of piston 110, to permit operation of the drive mechanism. Such a locking mechanism may function as a first retainer having: a first retainer retaining position, where the first retainer retains the drive biasing member 122 in the energized state; and a first retainer releasing position, where the first retainer allows the drive biasing member 122 to de-energize. The first retainer may be structurally and functionally similar to the clip 2115 illustrated in FIGS. 22 and 23A and described in more detail below” – Paragraph [0358]).
Regarding Claim 10, Gibson discloses a method of operating a medicament delivery device (10, Paragraph [0016]), comprising:
selecting a medicament delivery device (any one of 10, 910, 2010, 6000, or 8000), comprising:
an external housing (12) including a substantially rigid body (Examiner interprets that the housing is made of a rigid material as it is meant to provide protection to the interior components of the drug delivery device, Paragraph [0296]);
a moveable medicament container sled (300, Figs 2A and 2B);
a needle insertion mechanism (200);
a fluid path (30) operable to connect a needle of the needle insertion mechanism with a medicament container (“Upon proper activation of the drug delivery device 10 by the patient, the fluid pathway connector 300 is connected to a drug container 50, thereby enabling fluid flow from the drug container (as may be forced by the drive mechanism 100), through the fluid pathway connector 300, the fluid conduit 30, the insertion mechanism 200 and into the body of the patient.” – Paragraph [0305]);
a medicament container (50) including a container body (58) and plunger (60), wherein the medicament container is secured in a portion of the moveable medicament container sled (via 20, Fig. 1B); and
a drive mechanism (100, Fig. 1B);
applying the device to a skin surface of a patient (“removably attaching the wearable drug delivery device to a patient's skin” – Paragraph [0016]);
activating the delivery device to cause the drive mechanism to apply pressure to the plunger of the medicament container (Figs 4A and 4B, Paragraph [0305]), wherein activating the medicament delivery device comprises releasing a latch mechanism of the drive mechanism (Fig. 14A, “Initially, one or more locking mechanisms (not shown) may reside within the locking grooves 110A of piston 110. Directly or indirectly upon activation of the device by the patient, the locking mechanism may be removed from the locking grooves 110A of piston 110, to permit operation of the drive mechanism. Such a locking mechanism may function as a first retainer having: a first retainer retaining position, where the first retainer retains the drive biasing member 122 in the energized state; and a first retainer releasing position, where the first retainer allows the drive biasing member 122 to de-energize. The first retainer may be structurally and functionally similar to the clip 2115 illustrated in FIGS. 22 and 23A and described in more detail below” – Paragraph [0358]).
Regarding Claim 12, Gibson discloses the method of claim 10, wherein the delivery device comprises an aseptic region between a cap (52) of the medicament container and the fluid path (Paragraph [0508]), and the method further includes disrupting at least one barrier of the aseptic region to provide a path for connection the medicament container with the fluid path (“pierceable seal 56 has a seal barrier 56C that would be pierced to open the drug container to the fluid pathway. In an initial position, the distal end of the piercing member 330 may reside adjacent to, or in contact with, the seal barrier 56C of the pierceable seal 56 to, for example, minimize the distance of translation of the fluid pathway connector 300 to pierce the pierceable seal 56 and open the drug container to the fluid pathway.” – Paragraph [0309]).
Regarding Claim 13, Gibson discloses the method of claim 12, wherein the at least one barrier includes a first barrier covering a cap (52) of the medicament container (56 including seal barrier 56C, Paragraph [0309] and a second barrier covering a portion of the fluid path (320 including 320B which may be a closed surface, Paragraph [0309], Fig. 4A).
Regarding Claim 14, Gibson discloses the method of claim 13, wherein the first barrier and the sterile barrier each comprise at least one of a cap, a foil, or a film (“the connection opening 320B may be a closed surface and function as a pierceable sealing membrane between the fluid pathway and the drug container. However, in at least a preferred embodiment of the present disclosure, pierceable seal 56 has a seal barrier 56C that would be pierced to open the drug container to the fluid pathway.” – Paragraph [0309]).
Regarding Claim 15, Gibson discloses the method of claim 10, wherein activating the medicament delivery device further comprises activating the needle insertion mechanism to cause the needle of the needle insertion mechanism to pierce the skin surface of the patient (“Prior to operation, sealing member 254 may be removed from bottom of base 252 and base 252 is placed in contact with the target injection site on the body of the patient. As lockout pin(s) 208 are displaced by the activation mechanism, as described above, and insertion biasing member 210 is permitted to expand axially in the distal direction (i.e., in the direction of the solid arrow in FIG. 11A), manifold ring guide 228 is forced by the decompression and/or de-energizing of the insertion biasing member 210 to translate axially in the distal direction to insert the needle 214 and cannula 234 into the body of the patient.” – Paragraph [0331]).
Regarding Claim 16, Gibson discloses the method of claim 10, wherein causing the medicament container to become fluidly connected with the fluid path includes causing a needle (330) in communication with the fluid path to pierce a cap portion (52) of the medicament container as the medicament container is advanced (Figs 4A and 4B, Paragraph [0313]).
Regarding Claim 17, Gibson discloses a method of operating a medicament delivery device (10, Paragraph [0016]), comprising:
selecting a medicament delivery device (any one of 10, 910, 2010, 6000, or 8000), comprising:
an external housing (12) including a substantially rigid body (Examiner interprets that the housing is made of a rigid material as it is meant to provide protection to the interior components of the drug delivery device, Paragraph [0296]);
a moveable medicament container sled (300, Figs 2A and 2B);
a needle insertion mechanism (200);
a fluid path (30) operable to connect a needle of the needle insertion mechanism with a medicament container (“Upon proper activation of the drug delivery device 10 by the patient, the fluid pathway connector 300 is connected to a drug container 50, thereby enabling fluid flow from the drug container (as may be forced by the drive mechanism 100), through the fluid pathway connector 300, the fluid conduit 30, the insertion mechanism 200 and into the body of the patient.” – Paragraph [0305];
a medicament container (50) including a container body (58) and plunger (60), wherein the medicament container is secured in a portion of the moveable container sled (via 20, Fig. 1B); and
a drive mechanism (100, Fig. 1B);
applying the device to a skin surface of a patient (“removably attaching the wearable drug delivery device to a patient's skin” – Paragraph [0016]);
activating the delivery device by substantially simultaneously:
activating the needle insertion mechanism to cause the needle of the needle insertion mechanism to pierce the skin surface of the patient (“Prior to operation, sealing member 254 may be removed from bottom of base 252 and base 252 is placed in contact with the target injection site on the body of the patient. As lockout pin(s) 208 are displaced by the activation mechanism, as described above, and insertion biasing member 210 is permitted to expand axially in the distal direction (i.e., in the direction of the solid arrow in FIG. 11A), manifold ring guide 228 is forced by the decompression and/or de-energizing of the insertion biasing member 210 to translate axially in the distal direction to insert the needle 214 and cannula 234 into the body of the patient.” – Paragraph [0331]); and
activating the drive mechanism to cause the drive mechanism to apply pressure to the plunger of the medicament container to cause the moveable medicament container sled to move, thereby advancing the medicament container and causing the medicament container to become fluidly connected with the fluid path (Figs 4A and 4B, Paragraph [0305]).
Regarding Claim 18, Gibson discloses the method of claim 17, wherein activating the medicament delivery device comprises releasing a latch mechanism of the drive mechanism (Fig. 14A, “Initially, one or more locking mechanisms (not shown) may reside within the locking grooves 110A of piston 110. Directly or indirectly upon activation of the device by the patient, the locking mechanism may be removed from the locking grooves 110A of piston 110, to permit operation of the drive mechanism. Such a locking mechanism may function as a first retainer having: a first retainer retaining position, where the first retainer retains the drive biasing member 122 in the energized state; and a first retainer releasing position, where the first retainer allows the drive biasing member 122 to de-energize. The first retainer may be structurally and functionally similar to the clip 2115 illustrated in FIGS. 22 and 23A and described in more detail below” – Paragraph [0358]).
Regarding Claim 20, Gibson discloses the method of claim 17, wherein the medicament delivery device comprises an aseptic region between a cap (52) of the medicament container and the fluid path (Paragraph [0508]), and the method further includes disrupting at least one barrier of the aseptic region to provide a path for connection the medicament container with the fluid path (“pierceable seal 56 has a seal barrier 56C that would be pierced to open the drug container to the fluid pathway. In an initial position, the distal end of the piercing member 330 may reside adjacent to, or in contact with, the seal barrier 56C of the pierceable seal 56 to, for example, minimize the distance of translation of the fluid pathway connector 300 to pierce the pierceable seal 56 and open the drug container to the fluid pathway.” – Paragraph [0309]).
Regarding Claim 21, Gibson discloses the method of claim 20, wherein the at least one barrier includes a first barrier covering a cap (52) of the medicament container (56 including seal barrier 56C, Paragraph [0309]) and a second barrier covering a portion of the fluid path (320 including 320B which may be a closed surface, Paragraph [0309], Fig. 4A).
Regarding Claim 22, Gibson discloses the method of claim 21, wherein the first sterile barrier and the second sterile barrier each comprise at least one of a cap, a foil, or a film (“the connection opening 320B may be a closed surface and function as a pierceable sealing membrane between the fluid pathway and the drug container. However, in at least a preferred embodiment of the present disclosure, pierceable seal 56 has a seal barrier 56C that would be pierced to open the drug container to the fluid pathway.” – Paragraph [0309]).
Regarding Claim 23, Gibson discloses the method of claim 17, wherein causing the medicament container to become fluidly connected with the fluid path includes causing a needle (330) in communication with the fluid path to pierce a cap portion (52) of the medicament container as the medicament container is advanced (Figs 4A and 4B, Paragraph [0313]).
Regarding Claim 24, Gibson discloses the method of claim 17, wherein the moveable medicament container sled is secured by a mechanical stop (locking mechanism disclosed in Paragraph [0358]), and activating the delivery device comprises causing the mechanical stop to be released from the moveable medicament container sled (Fig. 14A, “Initially, one or more locking mechanisms (not shown) may reside within the locking grooves 110A of piston 110. Directly or indirectly upon activation of the device by the patient, the locking mechanism may be removed from the locking grooves 110A of piston 110, to permit operation of the drive mechanism. Such a locking mechanism may function as a first retainer having: a first retainer retaining position, where the first retainer retains the drive biasing member 122 in the energized state; and a first retainer releasing position, where the first retainer allows the drive biasing member 122 to de-energize. The first retainer may be structurally and functionally similar to the clip 2115 illustrated in FIGS. 22 and 23A and described in more detail below” – Paragraph [0358]).
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.
Claim(s) 3, 11, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gibson.
Regarding Claim 3, Gibson discloses method of claim 2.
Gibson does not expressly disclose wherein releasing the latch mechanism comprises pushing a button on a side portion of the external housing to push the latch mechanism substantially orthogonally to an axis of the drive mechanism.
However, in an alternate embodiment (Figs 20A-24B), Gibson teaches of a clip (2115, Fig. 22) that is used to retain the piston (2110) in a retracted first position (Fig. 23A showing drive mechanism of alternate drug delivery device in retracted position, Paragraph [0382]). Upon activation by the patient by pressing the start button (similar to 14 in Fig. 1B), the activation mechanism (2014, Fig. 20A) causes the clip to be removed in a linear, perpendicular movement relative to the axis of the drug container (2050, Fig. 22, Paragraph [0382]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Gibson wherein releasing the latch mechanism comprises pushing a button on a side portion of the external housing to push the latch mechanism substantially orthogonally to an axis of the drive mechanism as taught by the differing embodiment so that a user is able to activate the piston to exert an axial dispensing force (Paragraph [0382]).
Regarding Claim 11, Gibson discloses method of claim 10.
Gibson does not expressly disclose wherein releasing the latch mechanism comprises pushing a button on a side portion of the external housing to push the latch mechanism substantially orthogonally to an axis of the drive mechanism.
However, in an alternate embodiment (Figs 20A-24B), Gibson teaches of a clip (2115, Fig. 22) that is used to retain the piston (2110) in a retracted first position (Fig. 23A showing drive mechanism of alternate drug delivery device in retracted position, Paragraph [0382]). Upon activation by the patient by pressing the start button (similar to 14 in Fig. 1B), the activation mechanism (2014, Fig. 20A) causes the clip to be removed in a linear, perpendicular movement relative to the axis of the drug container (2050, Fig. 22, Paragraph [0382]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Gibson wherein releasing the latch mechanism comprises pushing a button on a side portion of the external housing to push the latch mechanism substantially orthogonally to an axis of the drive mechanism as taught by the differing embodiment so that a user is able to activate the piston to exert an axial dispensing force (Paragraph [0382]).
Regarding Claim 19, Gibson discloses the method of claim 18.
Gibson does not expressly disclose wherein releasing the latch mechanism comprises pushing a button on a side portion of the external housing to push the latch mechanism substantially orthogonally to an axis of the drive mechanism.
However, in an alternate embodiment (Figs 20A-24B), Gibson teaches of a clip (2115, Fig. 22) that is used to retain the piston (2110) in a retracted first position (Fig. 23A showing drive mechanism of alternate drug delivery device in retracted position, Paragraph [0382]). Upon activation by the patient by pressing the start button (similar to 14 in Fig. 1B), the activation mechanism (2014, Fig. 20A) causes the clip to be removed in a linear, perpendicular movement relative to the axis of the drug container (2050, Fig. 22, Paragraph [0382]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Gibson wherein releasing the latch mechanism comprises pushing a button on a side portion of the external housing to push the latch mechanism substantially orthogonally to an axis of the drive mechanism as taught by the differing embodiment so that a user is able to activate the piston to exert an axial dispensing force (Paragraph [0382]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
