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 .
Response to Amendment
The Amendment filed on 1/15/2025 has been entered. Claims 1, 3, 5, 7-9, 11, 14-16, 22, 24 and 27 remain pending in the application. Claims 9, 11, 14-16, 22, 24, and 27 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 4/3/2025.
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 1, 3, 5, and 7-8 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.
In regard to claim 1,
Line 5 recites “configurations of the drug delivery device”. It is unclear what is meant by this. It is unclear if configurations of the drug delivery device refer to different configurations such as a dose setting mode, a delivery mode, or a withdrawal mode, or if configurations of the drug delivery device refer to configurations of the drug delivery device which contain different rear sub-assemblies and front sub-assemblies. Examiner suggests specifying what is meant by “configurations of the drug delivery device”. For examination purposes Examiner construes “the set of base components are geometrically identical between configurations of the drug delivery device” to require the set of base components to be geometrically identical regardless of which rear sub-assembly and front sub-assembly is chosen.
Examiner notes claims 3, 5, and 7-8 are similarly rejected by virtue of their dependency on claim 1.
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.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Stefansen (U.S. PG publication 20170312435) further in view of Brereton (U.S. PG publication 20130324935).
In regard to claim 1,
Stefansen discloses a method of assembling a platform drug delivery device (paragraph [0156] and [0007]; see figure 10; Examiner notes the platform drug delivery device is construed as the resulting device formed once components are chosen and assembled), the method comprising:
providing a set of base components (figure 10, item 100b and 100d, and figure 13, item 310 of assembly 100a; paragraph [0161]-[0162]) for the drug delivery device (see figure 10), the set of base components including a plunger rod (figure 13, item 310), wherein the set of base components are geometrically identical between configurations of the drug delivery device (paragraph [0161] and [0174]);
wherein the set of base components are configured to accept the varying characteristics of different sub-assemblies/components (paragraph [0008] and [0174]);
a torque spring (torsion spring; paragraph [0129]);
identifying, based on at least one of the drug viscosity or the drug volume (viscosity of drug and volume of drug; paragraph [0159] and [0164]), a front sub-assembly (figure 10, item 600 and 100C; Examiner notes the cartridge 600 and needle unit 100C form a front sub-assembly which is a syringe) for the drug delivery device from a group of front sub-assemblies (see figure 10 where three front sub-assemblies are shown, the first being item 600 and 100C, the second being item 600’ and 100C’, and the third being item 600’’ and 100c’’; as noted in paragraph [0160] and [0174] the needle unit attached to each cartridge can alternatively be a generic needle. Additionally, many other variants of the cartridge and needle unit exist as supported in paragraph [0161]);
selecting the identified front sub-assembly (paragraph [0007], [0159], and [0164]); and
assembling the drug delivery device using the set of base components and the selected front sub-assembly (paragraph [0157], [0174], and [0007]).
Stefansen is silent as to identifying, based on at least one of a drug viscosity or a drug volume, a rear sub-assembly for the drug delivery device from a group of rear sub-assemblies, each of the rear-sub assemblies in the group of rear sub-assemblies including a different drive mechanism in the form of a torque spring selected from a plurality of torque springs, each torque spring of the plurality of torque springs having varying characteristics; wherein the set of base components are configured to accept the varying characteristics of each torque spring of the plurality of torque springs; selecting the identified rear sub-assembly. As a result, Stefansen is also silent as to assembling the drug delivery device using the set of base components, the selected rear sub-assembly, and the selected front sub-assembly.
Brereton teaches identifying, based on at least one of a drug viscosity or a drug volume (drug viscosity; paragraph [0033]), a rear sub-assembly (drive spring which is a torsion spring; paragraph [0124]) for the drug delivery device from a group of rear sub-assemblies ([0033]), each of the rear-sub assemblies in the group of rear sub-assemblies including a different drive mechanism in the form of a torque spring selected from a plurality of torque springs ([0033], and [0124]: wherein the drive spring is a torsion spring), each torque spring of the plurality of torque springs having varying characteristics ([0033], and [0124]; Examiner notes depending on the viscosity of the drug, a different drive spring (torsion spring) is used/selected), wherein the set of base components (generic components of the drug delivery device which serve as a platform including plunger 9; see figure 1A; paragraph [0033]; Examiner notes as the plunger is not modified when the drive spring is swapped depending on drug viscosity, it is construed as one of the base components) configured to accept the varying characteristics of each torque spring of the plurality of torque springs (paragraph [0033]); selecting the identified rear sub-assembly (paragraph [0033]).
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 modify Stefansen to include identifying, based on at least one of a drug viscosity or a drug volume, a rear sub-assembly for the drug delivery device from a group of rear sub-assemblies, each of the rear-sub assemblies in the group of rear sub-assemblies including a different drive mechanism in the form of a torque spring selected from a plurality of torque springs, each torque spring of the plurality of torque springs having varying characteristics, wherein the set of base components are configured to accept the varying characteristics of each torque spring of the plurality of torque springs; selecting the identified rear sub-assembly, as taught by Brereton, therefore resulting in assembling the drug delivery device using the set of base components, the selected rear sub-assembly, and the selected front sub-assembly, for the purpose of providing a spring which properly corresponds with the viscosity of the therapy (paragraph [0033] and [0035] of Brereton). Examiner notes the selection between torque springs would depend on the viscosity of the drug, which paragraph [0159] of Stefansen supports can be varied. Furthermore, Stefansen supports a torque spring can be used (see paragraph [0129] of Stefansen), and supports that modifications can be made (see paragraph [0175] of Stefansen) and that the set of base components are configured to accept varying characteristics of components (paragraph [0174] and [0008] of Stefansen).
In regard to claim 3,
Stefansen in view of Brereton teaches the method of claim 1, wherein each front sub-assembly in the group of front sub-assemblies includes a different syringe assembly (see analysis of claim 1 above wherein each cartridge and needle unit of each front-assembly collectively is a different syringe assembly; paragraph [0022] of Stefansen).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Stefansen (U.S. PG publication 20170312435) in view of Brereton (U.S. PG publication 20130324935) further in view of Shang (U.S. PG publication 20180099094).
In regard to claim 5,
Stefansen in view of Brereton teaches the method of claim 3, wherein each syringe assembly includes a syringe (see analysis of claim 3 above).
Stefansen in view of Brereton is silent as to the material of the syringe and therefore is silent as to a syringe that is constructed from one of glass or a polymeric material.
Shang teaches a syringe that is constructed from one of glass or a polymeric material (paragraph [0096]) and that any suitable material for a syringe including glass or polymeric materials could be used to achieve the same result (paragraph [0096]) and thus any suitable material for a syringe including glass and polymeric materials were art-recognized equivalents before the effective filing date of the claimed invention.
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 substitute a glass material or polymeric material in place of the material of the syringe of each syringe assembly of Stefansen in view of Brereton since it has been held that substituting parts of an invention involves only routine skill in the art.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Stefansen (U.S. PG publication 20170312435) in view of Brereton (U.S. PG publication 20130324935) and further in view of Dette (U.S. PG publication 20090264828).
In regard to claim 7,
Stefansen in view of Brereton teaches the method of claim 1.
Stefansen in view of Brereton is silent as to further comprising applying a skin to the drug delivery device.
Dette teaches further comprising applying a skin (figure 15, item 112; paragraph [0063]: wherein the skin/label includes a color indication of the type of insulin provided in the drug delivery device (e.g., long acting or short acting insulin) and could indicate that the drug delivery device is intended for right-handed or left-handed diabetics i.e. diabetics who tend to favor their left or right hand to inject a dose) to the drug delivery device (figure 15, item 1).
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 modify Stefansen in view of Brereton to include further comprising applying a skin to the drug delivery device, as taught by Dette, for the purpose of providing useful information to the user and providing visual confirmation of important information related to the drug delivery device (paragraph [0063] of Dette). Examiner notes paragraph [0087] of Stefansen further supports that insulin can be the drug within the drug delivery device.
In regard to claim 8,
Stefansen in view of Brereton in view of Dette teaches the method of claim 7, wherein the skin is selected based on at least one attribute from an intended user group (see analysis of claim 7 above and paragraph [0063] of Dette).
Response to Arguments
Applicant's arguments filed 1/15/2026 have been fully considered but they are not persuasive. Applicant argues that Stefansen fails to disclose “providing a set of base components for the drug delivery device, the set of base components including a plunger rod, wherein the set of base components are geometrically identical between configurations of the drug delivery device" and "identifying, based on at least one of a drug viscosity or a drug volume, a rear sub- assembly for the drug delivery device from a group of rear sub-assemblies, each of the rear-sub assemblies in the group of rear sub-assemblies including a different drive mechanism in the form of a torque spring selected from a plurality of torque springs, each torque spring of the plurality of torque springs having varying characteristics, wherein the set of base components are configured to accept the varying characteristics of each torque spring of the plurality of torque springs”. Examiner respectfully disagrees. As detailed above, Stefansen does disclose a set of base components (figure 10, item 100b and 100d, and figure 13, item 310 of assembly 100a; paragraph [0161]-[0162]) for the drug delivery device (see figure 10), the set of base components including a plunger rod (figure 13, item 310), wherein the set of base components are geometrically identical between configurations of the drug delivery device (paragraph [0161] and [0174]). It is noted that Stefansen was not cited as teaching "identifying, based on at least one of a drug viscosity or a drug volume, a rear sub- assembly for the drug delivery device from a group of rear sub-assemblies, each of the rear-sub assemblies in the group of rear sub-assemblies including a different drive mechanism in the form of a torque spring selected from a plurality of torque springs, each torque spring of the plurality of torque springs having varying characteristics, wherein the set of base components are configured to accept the varying characteristics of each torque spring of the plurality of torque springs”. Applicant further argues that nothing in the front body assembly or front cap includes a plunger rod. As detailed above, the set of base components have been construed as item 100b and 100d, and figure 13, item 310 of assembly 100a, not just item 100b and 100d. Applicant argues that the plunger device of Stefansen includes a drive ram assembly 310/320 and a ram spacer member 400. As noted above, the plunger rod has been construed as item 310 only. Item 310 structurally and functionally meets all limitations of a plunger rod as currently claimed. The ram spacer member 400 is not construed as a part of the plunger rod, therefore Applicant’s arguments are not found to be persuasive.
Applicant argues that Brereton fails to disclose "providing a set of base components for the drug delivery device, the set of base components including a plunger rod, wherein the set of base components are geometrically identical between configurations of the drug delivery device" and "identifying, based on at least one of a drug viscosity or a drug volume, a rear sub-assembly for the drug delivery device from a group of rear sub-assemblies, each of the rear-sub assemblies in the group of rear sub-assemblies including a different drive mechanism in the form of a torque spring selected from a plurality of torque springs, each torque spring of the plurality of torque springs having varying characteristics, wherein the set of base components are configured to accept the varying characteristics of each torque spring of the plurality of torque springs”. Examiner respectfully disagrees. As detailed above, Brereton does teach the limitations of claim 1 not taught by Stefansen. As noted above, Stefansen discloses the limitation “the set of base components including a plunger rod, wherein the set of base components are geometrically identical between configurations of the drug delivery device”. Applicant argues that Brereton explicitly discloses changing the length of the plunger to account for different liquid volumes. The length of the plunger rod of Brereton is not disclosed as being modified to account for different viscosities. Additionally, as cited above, Brereton taught identifying, based on at least one of a drug viscosity, not drug volume, a rear sub-assembly. Paragraph [0033] of Brereton explicitly states “The auto-injector is well suited to serve as a platform as the drive spring can be swapped to deliver different viscosity drugs without affecting the insertion or retraction functions”. Since the auto-injector of Brereton, which includes a plunger rod, can serve as a platform when swapping the drive spring to deliver different viscosity drugs, the set of base components are configured to accept the varying characteristics of each torque spring of the plurality of torque springs. Further, as detailed above, the plunger rod of Stefansen is a component that can be generic and serve as a platform (paragraph [0174] of Stefansen).
Applicant argues the dependent claims are allowable for similar reasons as claim 1. See response to arguments in regard to claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783