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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/6/2026 has been entered.
Response to Amendment
The Amendment filed on 4/6/2026 has been entered. Claims 1, 3, 5, 7-9, 11, 14-16, 22, 24, and 27 remain pending in the application. Claims 28-29 are new. Claims 9, 11, 14-16, 22, 24, and 27 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 4/3/2025.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Final Office Action mailed 2/9/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 objected to because of the following informalities:
Line 6-7 recites “or drug volume.” Examiner suggests replacing “or drug volume” with “or a drug volume” in line 6-7 of claim 1 to put the claim in clearer form and clearly introduce the drug volume.
Line 15 recites “or drug volume”. If the drug volume is intended to be the same as the drug volume of line 6-7, Examiner suggests replacing “or drug volume” in line 15 of claim 1 with “or the drug volume” to put the claim in clearer form.
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, 7-8, and 28-29 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 6-7 recites “identifying, based on an injection time for a desired drug viscosity and/or drug volume”. It is unclear if “identifying, based on an injection time for a desired drug viscosity and/or drug volume” requires identifying, based on an injection time for a desired drug viscosity and/or identifying, based on an injection time for a drug volume or if “identifying, based on an injection time for a desired drug viscosity and/or drug volume” requires identifying, based on an injection time for a desired drug viscosity and/or identifying, based on a drug volume. For examination purposes Examiner construes “identifying, based on an injection time for a desired drug viscosity and/or drug volume” to require identifying, based on an injection time for a desired drug viscosity and/or identifying, based on a drug volume. Examiner suggests clarifying what is meant by line 6-7 in claim 1.
Examiner notes claims 3, 5, 7-8, and 28-29 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, 3, 5 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Stefansen (U.S. PG publication 20170312435) further in view of Shang (U.S. PG publication 20180099094).
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);
wherein the set of base components are configured to accept the varying characteristics of different sub-assemblies/components (paragraph [0008] and [0174]);
a rear sub-assembly including a spring (spring; paragraph [0129]);
identifying, based on the desired drug viscosity and/or drug volume (desired drug viscosity and/or drug volume; 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]), wherein the set of base components are geometrically identical between all possible combinations of the group of front sub-assemblies (paragraph [0161] and [0174]).
Although Stefansen discusses that different springs (i.e. drive mechanisms) may be used (see paragraph [0129] wherein a press-stressed spring, non-pre-stressed spring, or a torsion spring may be utilized), Stefansen is silent as to identifying, based on an injection time for a desired drug viscosity and/or 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 spring selected from a plurality of springs, each spring of the plurality of springs having varying characteristics; wherein the set of base components are configured to accept the varying characteristics of each spring of the plurality of 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, wherein the set of base components are geometrically identical between all possible combinations of the group of rear sub-assemblies and the group of front sub-assemblies.
Shang teaches identifying, based on an injection time for a desired drug viscosity and/or drug volume (an injection time for a desired drug viscosity; paragraph [0106]-[0110], [0114], [0116], [0135] and [0139]), a rear sub-assembly (one of the springs shown in figure 25) for the drug delivery device (item 200) from a group of rear sub-assemblies (see figure 25), each of the rear-sub assemblies in the group of rear sub-assemblies including a different drive mechanism in the form of a spring selected from a plurality of springs (see figure 25), each spring of the plurality of springs having varying characteristics (see figure 25 and paragraph [0118]); wherein the set of base components (see components that are generic within the drug delivery device) are configured to accept the varying characteristics of each spring of the plurality of springs (paragraph [0137] and [0139]); selecting the identified rear sub-assembly (paragraph [0137]); and assembling the drug delivery device using the set of base components and the selected rear sub-assembly (paragraph [0137] and [0139]).
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 an injection time for a desired drug viscosity and/or 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 spring selected from a plurality of springs, each spring of the plurality of springs having varying characteristics; wherein the set of base components are configured to accept the varying characteristics of each spring of the plurality of springs; selecting the identified rear sub-assembly, as taught by Shang, 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, wherein the set of base components are geometrically identical between all possible combinations of the group of rear sub-assemblies and the group of front sub-assemblies, for the purpose of providing a reduction in delivery time (paragraph [0106] of Shang). Examiner notes the selection between springs of Shang would depend on the desired injection time for a desired drug viscosity, as supported by paragraph [0106]-[0110], [0114], [0116], [0135] and [0139] of Shang. Furthermore, as noted above, Stefansen supports different springs can be used (see paragraph [0129] of Stefansen), and supports that modifications can be made (see paragraph [0175] of Stefansen).
In regard to claim 3,
Stefansen in view of Shang 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).
In regard to claim 5,
Stefansen in view of Shang teaches the method of claim 3, wherein each syringe assembly includes a syringe (see analysis of claim 3 above).
Stefansen in view of Shang 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 Shang since it has been held that substituting parts of an invention involves only routine skill in the art.
In regard to claim 28,
Stefansen in view of Shang teaches the method of claim 1, wherein the plurality of springs include a plurality of compression springs (see figure 25 of Shang and paragraph [0048] of Shang and analysis of claim 1 above), each compression spring of the plurality of compression springs having varying characteristics (see figure 25 of Shang and paragraph [0118] of Shang), and wherein a torque spring and a compression spring could all be used to achieve the same result (paragraph [0129] of Stefansen) and thus a torque spring and a compression spring were art-recognized equivalents before the effective filing date of the claimed invention.
Stefansen in view of Shang fails to disclose wherein the plurality of springs include a plurality of torque springs, each torque spring of the plurality of torque springs having varying characteristics.
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 plurality of torque springs having varying characteristics in place of a plurality of compression springs having varying characteristics since it has been held that substituting parts of an invention involves only routine skill in the art.
Additionally, It would have been an obvious matter of design choice to modify Stefansen in view of Shang to include a plurality of torque springs rather than a plurality of compression springs since applicant has not disclosed that having wherein the plurality of springs include a plurality of torque springs, each torque spring of the plurality of torque springs having varying characteristics solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the plurality of springs include a plurality of torque springs, each torque spring of the plurality of torque springs having varying characteristics, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 29,
Stefansen in view of Shang teaches the method of claim 1, wherein the set of base components (figure 10, item 100b and 100d of Stefansen, and figure 13, item 310 of assembly 100a of Stefansen; paragraph [0161]-[0162]) includes at least one of: a housing, a shield member, a spring housing, a syringe holder, a plunger rod, a plunger rod guide, a cap, a nut, a shield spring, an end-of- dose device, a trigger ring, a shield lock, a top housing, a damper member, or a spring guide (see analysis above and figure 10, item 100b and 100d of Stefansen, and figure 13, item 310 of assembly 100a of Stefansen).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Stefansen (U.S. PG publication 20170312435) in view of Shang (U.S. PG publication 20180099094) and further in view of Dette (U.S. PG publication 20090264828).
In regard to claim 7,
Stefansen in view of Shang teaches the method of claim 1.
Stefansen in view of Shang 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 Shang 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 Shang 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 with respect to Stefansen in view of Brereton have been considered but are moot because the new ground of rejection does not rely on Stefansen in view of Brereton for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 4/6/2026 in regard to Shang have been fully considered but they are not persuasive. Applicant argues that Shang fails to disclose or suggest at least the above-quoted features of amended claim 1. Applicant has provided no specific arguments as to why they believe Shang fails to disclose the features of amended claim 1. As detailed above, Shang does teach identifying, based on an injection time for a desired drug viscosity and/or drug volume (an injection time for a desired drug viscosity; paragraph [0106]-[0110], [0114], [0116], [0135] and [0139]), a rear sub-assembly (one of the springs shown in figure 25) for the drug delivery device (item 200) from a group of rear sub-assemblies (see figure 25), each of the rear-sub assemblies in the group of rear sub-assemblies including a different drive mechanism in the form of a spring selected from a plurality of springs (see figure 25), each spring of the plurality of springs having varying characteristics (see figure 25 and paragraph [0118]); wherein the set of base components (see components that are generic within the drug delivery device) are configured to accept the varying characteristics of each spring of the plurality of springs (paragraph [0137] and [0139]); selecting the identified rear sub-assembly (paragraph [0137]); and assembling the drug delivery device using the set of base components and the selected rear sub-assembly (paragraph [0137] and [0139]). Therefore, Applicants arguments in regard to Shang are not found to be persuasive.
Applicants argues in regard to claims 7 and 8 that Dette fails to disclose or suggest at least the above-quoted features of amended claim 1. This argument is not found to be persuasive as Dette has not been used to reject amended claim 1.
Applicant argues that claim 28-29 are allowable by virtue of their dependence from allowable claim 1. As claim 1 has not been found allowable, claims 28-29 are not allowable due to their dependence on claim 1. As detailed above, claims 28-29 are taught by Stefansen in view of Shang. No other specific arguments in regard to claims 28-29 have been provided.
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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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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