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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/15/2026 has been entered.
Response to Amendment
The Amendment filed on 7/15/2026 has been entered. Claims 1-4, 9, 12-15, 31-37, 54, 57-60, 117-119, and 122-123 remain pending in the application.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Final Office Action mailed 3/19/2026.
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)(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 1-4, 9, 12-15, and 122-123 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dasbach (U.S. PG publication 20210162133).
In regard to claim 1,
Dasbach discloses a drug delivery device (see figure 1D, item 1 and figure 15A-15E, item 12 and paragraph [0128] wherein the drug delivery device 1 has the plunger release mechanism 12 shown in figure 15A) comprising:
a housing (figure 1D, item 2.1);
a drug storage container (figure 1D, item 3) fixed relative to the housing (paragraph [0102]) and including an interior surface (see figure 1D) and a stopper (figure 1D, item 6) slidable along the interior surface (paragraph [0083] and [0086]);
a biasing member (figure 1D, item 9);
a plunger (figure 1D, item 10) operably coupled to the biasing member (paragraph [0086]) and configured to:
selectively rotate (paragraph [0129]) from an initial rotational position (see position shown in figure 15B) to a second rotational position (see position shown in figure 15D) under a biasing force exerted by the biasing member (paragraph [0133] and [0135]), and
translate linearly (paragraph [0136]) in a distal direction to drive the stopper through the drug storage container after rotating from the initial rotational position to the second rotational position (paragraph [0136]); and
a plunger guide (figure 15A-15D, item 2.2) fixed relative to the housing (paragraph [0096]) and having an annular wall (see figure 15A-15D), the plunger being disposed at least partially within the plunger guide (see figure 15A-15D and 1D),
wherein the plunger comprises a cam follower (figure 15A-15D, item 10.2) and the plunger guide comprises a cam (figure 15A-15D, item 2.11) formed by a proximally facing surface of the annular wall (see figure 15A-15D), the proximally facing surface being sloped (see figure 15A-15D),
wherein the biasing force of the biasing member is configured to urge the cam follower to slide along the proximally facing surface to urge the plunger to rotate from the initial rotational position toward the second rotational position (paragraph [0135]), and
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wherein an opening (see figure 15C above) is formed in the annular wall distal to the proximally facing surface (see figure 15C above), the opening being configured to receive the cam follower after the plunger rotates to the second rotational position (see figure 15D; paragraph [0135]-[0136]) and allow the cam follower to translate linearly in the distal direction through the opening without further rotation of the plunger(paragraph [0135]-[0136]).
In regard to claim 2,
Dasbach discloses the drug delivery device of claim 1, the biasing member being disposed at least partially within the plunger (see figure 1D).
In regard to claim 3,
Dasbach discloses the drug delivery device of claim 2, the biasing member comprising a compression spring (see figure 1D and paragraph [0092]).
In regard to claim 4,
Dasbach discloses the drug delivery device of claim 3, wherein the plunger is configured to translate linearly in the distal direction while rotating from the initial rotational position to the second rotational position (item 10.2 translates along 2.11 in the distal direction while rotating from the initial rotational position to the second rotational position, see figure 15A-15D wherein item 2.11 is angled and enables movement of item 10.2 in the distal direction).
In regard to claim 9,
Dasbach discloses the drug delivery device of claim 1, wherein the cam follower is formed by at least one projection extending outwardly from the plunger (see figure 4).
In regard to claim 12,
Dasbach discloses the drug delivery device of claim 1, comprising:
a releaser member (see figure 9B below where the releaser member is construed as the portion of item 7 that is not labeled as the guard) operably coupled to the plunger (paragraph [0094]) and configured to selectively rotate relative to the housing (item 7.1. of the releaser member is configured to selectively rotate relative to the housing 2.1 as item 7.1 can deflect inward as discussed in paragraph [0089]), wherein each of the plunger and the plunger guide is disposed at least partially within the releaser member (see figure 1D); and
a guard (see figure 9B below) moveably positioned adjacent to an opening in the housing (see figure 1D) and operably coupled to the releaser member (see figure 9B below).
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In regard to claim 13,
Dasbach discloses the drug delivery device of claim 12, wherein the guard has an extended position wherein the guard extends at least partially through the opening in the housing (see figure 1D and paragraph [0106]; first extended position) and a retracted position wherein the guard is positioned away from the extended position toward the housing (paragraph [0106], retracted position).
In regard to claim 14,
Dasbach discloses the drug delivery device of claim 13, wherein the releaser member is prevented from rotating in at least one rotational direction when the guard is in the extended position (paragraph [0107]), and wherein the releaser member is allowed to rotate in the at least one rotational direction when the guard is in the retracted position (paragraph [0107]).
In regard to claim 15,
Dasbach discloses the drug delivery device of claim 14, wherein moving the guard from the extended position to the retracted position allows the releaser member and the plunger to rotate jointly when the plunger rotates from the initial rotational position toward the second rotational position under the biasing force exerted by the biasing member (paragraph [0107]; Examiner notes moving the guard from the extended position to the retracted position allows the plunger to rotate from the initial rotational position toward the second rotational position under the biasing force exerted by the biasing member; Examiner further notes the releaser member would also be allowed to rotate by the movement of the guard and force exerted by the biasing member).
In regard to claim 122,
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Dasbach discloses the drug delivery device of claim 1, wherein the plunger guide comprises a further opening formed in the annular wall (see figure 15C above), and wherein the proximally facing surface defines a portion of the periphery of the further opening (see figure 15C above).
In regard to claim 123,
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Dasbach discloses the drug delivery device of claim 1, wherein the opening comprises a longitudinal slot extending parallel to a longitudinal axis of the plunger guide (see figure 15C above).
Claims 31-37, 54, and 57-60 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Garson (U.S. PG publication 20200101230).
In regard to claim 31,
Garson discloses a drug delivery device (figure 1 and 2, item 100; paragraph [0029]: wherein a medicament is delivered) comprising:
a housing (figure 2, item 118) having an opening (see opening at distal end which item 124 and 122 are received in);
a drug storage container (figure 2, item 200) including a delivery member (see needle in figure 2) having an insertion end (end which pierces the skin) configured to extend at least partially through the opening (see figure 2; paragraph [0048]: “the syringe may be fixed in relation to the injection device 100 and the force applied by the user when pushing the auto-injector 100 onto the injection site may insert the needle into the injection site”);
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a guard (see figure 1 above) moveably positioned adjacent to the opening (paragraph [0047]);
a plunger (figure 1 and 3A, item 106) moveable in a distal direction to expel a drug from the drug storage container through the delivery member (paragraph [0049]);
a plunger biasing member (pip of the locking shroud 122; paragraph [0047] and [0049]; Examiner notes the plunger biasing member biases the plunger to rotate); and
a releaser member (figure 2, item 116 and 114) operably coupled to the guard and the plunger (paragraph [0031]), wherein the releaser member includes a recess (internal track of item 116 disclosed in paragraph [0049] which receives a lug of the plunger) configured to receive a projection extending radially outwardly from the plunger (lug of the plunger disclosed in paragraph [0049]; see also paragraph [0031]), and wherein the releaser member is configured to rotate from an initial rotational position (position before rotation occurs) to a second rotational position (position after rotation occurs) under a biasing force exerted by the plunger biasing member (paragraph [0047] and [0049]).
In regard to claim 32,
Garson discloses the drug delivery device of claim 31, wherein the guard has an extended position (see position shown in figure 2) wherein the guard extends at least partially through the opening in the housing (see figure 2) and a retracted position (position when item 122 has been at least initially retracted as described in paragraph [0047]) wherein the guard is positioned away from the extended position toward the housing (paragraph [0047]).
In regard to claim 33,
Garson discloses the drug delivery device of claim 32, wherein the releaser member is prevented from rotating from the initial rotational position toward the second rotational position when the guard is in the extended position (see paragraph [0033], and [0046]-[0047]; Examiner notes the releaser member cannot rotate when the guard is in the extended position. The cap 124 must be removed and the guard must be displaced before the releaser member can rotate), and wherein the releaser member is allowed to rotate from the initial rotational position toward the second rotational position when the guard is in the retracted position (paragraph [0046]-[0047]; Examiner notes the releaser member rotates when the guard has been initially retracted and continues to rotate until the guard is fully retracted).
In regard to claim 34,
Garson discloses the drug delivery device of claim 33, wherein moving the guard from the extended position to the retracted position allows the releaser member and the plunger to rotate jointly when the releaser member rotates from the initial rotational position to the second rotational position under the biasing force exerted by the plunger biasing member (paragraph [0047] and [0049]).
In regard to claim 35,
Garson discloses the drug delivery device of claim 34, comprising a guard extension (figure 2, item 110; Examiner notes item 110 is construed as a guard extension as it is an extension and functions to guard components as it surrounds components. Examiner notes item 110 also extends via other components from the guard), wherein the releaser member is disposed at least partially within the guard extension (see figure 2 and 3A).
In regard to claim 36,
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Garson discloses the drug delivery device of claim 35, comprising a first projection (figure 5, item 307) extending outwardly from the releaser member (see figure 5) and a second projection (see figure 5 above) extending inwardly from the guard extension (see figure 5; Examiner notes the guard extension is a 3D structure and extends inward), wherein the first projection and the second projection engage one another to retain the releaser member in the initial rotational position (see figure 5; paragraph [0042]).
In regard to claim 37,
Garson discloses the drug delivery device of claim 36, wherein the second projection slides out of engagement with the first projection to allow the releaser member to rotate away from the initial rotational position toward the second rotational position when the guard is in the retracted position (paragraph [0042] and [0054]).
In regard to claim 54,
Garson discloses a drug delivery device (figure 1 and 2, item 100; paragraph [0029]: wherein a medicament is delivered) comprising:
a housing (figure 2, item 118) having an opening (see opening at distal end which item 124 and 122 are received in);
a drug storage container (figure 2, item 200) including a delivery member (see needle in figure 2) having an insertion end (end which pierces the skin) configured to extend at least partially through the opening (see figure 2; paragraph [0048]: “the syringe may be fixed in relation to the injection device 100 and the force applied by the user when pushing the auto-injector 100 onto the injection site may insert the needle into the injection site”);
a plunger (figure 1 and 3A, item 106),
a plunger biasing member (figure 2, item 112) initially retained in an energized state (see figure 2; paragraph [0029]), wherein releasing the plunger biasing member is configured to drive the plunger in a distal direction to expel a drug from the drug storage container through the delivery member (paragraph [0029] and [0049]);
an indicator (figure 3a, item 114 which includes lug 307; paragraph [0040]) having an initial position (see position shown in figure 3A) wherein the indicator retains the plunger biasing member in the energized state (see figure 3A wherein the indicator functions to retain the plunger biasing member in the energized state as item 112 is coupled to an end of item 114. As item 112 is between item 114 and 106, the indicator and plunger retain the plunger biasing member in the energized state when in the initial position; Examiner notes the claim does not specify how the plunger biasing member is retained via the indicator or how/if the plunger biasing member is released from the energized state), and a second position (position where item 307 has moved rearward in channel 312 to produce an audible sound as disclosed in paragraph [0054]-[0055]) proximal to the initial position (see figure 5 when item 307 is more proximal to the initial position once it moves rearward) wherein the indicator generates an audible signal indicating an end of drug delivery (paragraph [0055]); and
a second biasing member (figure 2, item 120, 122, and 116) configured to bias the indicator in a proximal direction (paragraph [0047] and [0053]-[0054]; Examiner notes item 120, 122, and 116 collective form the second biasing member. Item 122 is pushed back against item 120 which causes item 116 to rotate and bias the indicator in a proximal direction).
In regard to claim 57,
Garson discloses the drug delivery device of claim 54, wherein the second biasing member includes a compression spring (figure 2, item 120).
In regard to claim 58,
Garson discloses the drug delivery device of claim 54, comprising a cam (figure 5, item 311) and a cam follower (figure 5, item 307), wherein the indicator includes the cam follower (see figure 5 and paragraph [0040]).
In regard to claim 59,
Garson discloses the drug delivery device of claim 58, wherein a biasing force of the second biasing member urges the cam follower against the cam to urge the indicator to rotate relative to the housing (paragraph [0047] and [0053]-[0054]).
In regard to claim 60,
Garson discloses the drug delivery device of claim 59, wherein the indicator, when moving from the initial position to the second position, rotates relative to the housing and translates linearly in the proximal direction (paragraph [0053]-[0055]).
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 117 is rejected under 35 U.S.C. 103 as being unpatentable over Dasbach (U.S. PG publication 20210162133) as applied to claim 1 above, and further in view of Yie (U.S. PG publication 20170275370).
In regard to claim 117,
Dasbach discloses the drug delivery device of claim 1, wherein the drug storage container is filled or pre-filled with a drug (paragraph [0076], [0083], [0151]-[0155]; Examiner notes the drug can be used for treatment of diabetes mellitus or complications associated with diabetes mellitus).
Dasbach is silent as to and wherein the drug comprises one of: a drug containing a human IgG1 kappa antibody, a drug containing a small interfering RNA (siRNA) that lowers lipoprotein(a), a drug containing erenumab, etanercept, Tezepelumab, efavaleukin alfa, evolocumab, and a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist.
Yie, which is concerned with treatments for diabetes mellitus (paragraph [0001] and [0008]), teaches wherein the drug comprises one of a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist (paragraph [0009], [0505] and [0409]: wherein the drug is contained in a pre-filled syringe).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the drug within the drug storage container of Dasbach with a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist, as taught by Yie, for the purpose of employing a more beneficial treatment for diabetes mellitus (paragraph [0008]-[0010] of Yie).
Claims 118-119 are rejected under 35 U.S.C. 103 as being unpatentable over Garson (U.S. PG publication 20200101230) as applied to claim 31 and 54 above, further in view of Yie (U.S. PG publication 20170275370) as evidenced by Mosebach (U.S. PG publication 20170021103)
In regard to claim 118,
Garson discloses the drug delivery device of claim 31, wherein the drug storage container is filled or pre-filled with the drug (paragraph [0002]-[0004] and [0029]).
Garson is silent as to wherein the drug comprises one of: a drug containing a human IgG1 kappa antibody, a drug containing a small interfering RNA (siRNA) that lowers lipoprotein(a), a drug containing erenumab, etanercept, Tezepelumab, efavaleukin alfa, evolocumab, and a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist.
Yie, which is concerned with treatments for diabetes mellitus (paragraph [0001] and [0008]), teaches wherein the drug comprises one of a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist (paragraph [0009], [0505] and [0409]: wherein the drug is contained in a pre-filled syringe).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the drug within the drug storage container of Garson with a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist, as taught by Yie, for the purpose of employing a beneficial treatment for diabetes mellitus (paragraph [0008]-[0010] of Yie). Examiner notes as the drug delivered in Garson is not specified (paragraph [0001] of Garson), one of ordinary skill in the art would recognize that many different drugs could be delivered depending on the desired treatment result and as further evidenced by Mosebach which supports that a drug delivery device similar to Garson could be used to deliver a drug to treat diabetes mellitus (paragraph [0157]-[0161] of Mosebach).
In regard to claim 119,
Garson discloses the drug drug delivery device of claim 54, wherein the drug storage container is filled or pre-filled with the drug (paragraph [0002]-[0004] and [0029]).
Garson is silent as to wherein the drug comprises one of: a drug containing a human IgG1 kappa antibody, a drug containing a small interfering RNA (siRNA) that lowers lipoprotein(a), a drug containing erenumab, etanercept, Tezepelumab, efavaleukin alfa, evolocumab, and a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist.
Yie, which is concerned with treatments for diabetes mellitus (paragraph [0001] and [0008]), teaches wherein the drug comprises one of a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist (paragraph [0009], [0505] and [0409]: wherein the drug is contained in a pre-filled syringe).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the drug within the drug storage container of Garson with a drug containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and a GLP-1R agonist, as taught by Yie, for the purpose of employing a beneficial treatment for diabetes mellitus (paragraph [0008]-[0010] of Yie). Examiner notes as the drug delivered in Garson is not specified (paragraph [0001] of Garson), one of ordinary skill in the art would recognize that many different drugs could be delivered depending on the desired treatment result and as further evidenced by Mosebach which supports that a drug delivery device similar to Garson could be used to deliver a drug to treat diabetes mellitus (paragraph [0157]-[0161] of Mosebach).
Response to Arguments
Applicant's arguments filed 7/15/2026 have been fully considered but they are not persuasive. Applicant argues that a single case slot 2.3 is present in Dasbach. Applicant argues that Dasbach does not depict a separate opening, distal to the angled surface 2.11, that receives the plunger boss and guides it linearly. It is noted that claim 1 only requires a single opening. Additionally, as shown below in figure 15C of Dasbach, two openings are present, one opening in a linear direction and one opening in a radial direction. As shown in figure 5 of the instant disclosure, openings 82 and 86 are attached to one another similar to the openings in Dasbach. Claim 1 also does not require the openings to be separated/not connected.
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Applicant argues in regard to claim 31 and the claims that depend on claim 31 that Garson fails to disclose the releaser member is configured to rotate from an initial rotational position to a second rotational position under a biasing force exerted by the plunger biasing member. Applicant specifically argues in regard to the plunger biasing member, that a pip is a rigid protrusion, not a biasing member, and it exerts no biasing force. Examiner respectfully disagrees. Claim 31 does not specify the structure of the biasing member. Furthermore, the plunger biasing member does bias the plunger to rotate as detailed in paragraph [0047] and [0049] of Garson. Applicant argues that the alleged releaser member (clutch 116) is rotated not by any biasing member but by the user manually pressing the device. As stated by Applicant, “a surface (pip) of the lockout shroud bears against an angled surface on the clutch to translate the rearward motion of the shroud into rotation of the clutch”. The clutch is therefore biased to rotate due to a surface (pip) of the lockout shroud bearing against an angled surface on the clutch to translate the rearward motion of the shroud into rotation of the clutch. Examiner notes other components such as the lockout shroud move to enable the clutch to rotate. Claim 31 however does not preclude other components from moving/exerting a force prior to the biasing member exerting a biasing force on the releaser member. Applicant argues that Garson’s actual plunger driving member is the drive spring 112. Applicant states that the drive spring does not rotate the clutch 116 from an initial to a second rotational position. Applicant states that “The rejection thus rests on an internally inconsistent mapping in which the member that drives the plunger distally (drive spring 112) is different from the member designated the “plunger biasing member””. It is noted that claim 31 does not require the plunger biasing member to be a spring. Additionally, item 112 was not cited as the plunger driving member in the rejection of claim 31. The pip of the locking shroud 122 structurally and functionally meets all limitations of the claimed plunger biasing member in claim 31. The releaser member does not rotate until the pip of the locking shroud directly biases the releaser member (see paragraph [0047]). Applicant’s arguments are therefore not found to be persuasive.
Applicant argues in regard to claim 54 and the claims that depend on claim 54 that Garson does not disclose a separate second biasing member that biases the indicator proximally. Applicant argues that item 112 functions as the second biasing member, not item 120, 122, and 116. Applicant argues that item 120, 122, and 116 do not bias the indicator in the proximal direction. Examiner respectfully disagrees. Item 122 is pushed back against item 120 which causes item 116 to rotate along item 311 and bias the indicator in a proximal direction (see paragraph [0047] and [0053]-[0054]). As shown in figure 5, and described in paragraph [0054]: Part of the stop surface 311 may be slightly angled to encourage rotation of the lug 307 across the stop surface. It is noted that the indicator cannot move in the proximal direction without Item 122 being pushed back against item 120 and item 116 rotating which rotates the indicator along stop surface 311 to bias the indicator proximally. Examiner suggests further defining the structure of the second biasing member or further specifying how the second biasing member functions to bias the indicator in a proximal direction. For example, claim 56 does not require the second biasing member to move in the proximal direction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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