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
This office action is responsive to the amendment filed on June 4, 2024. As directed by the amendment: no claims have been amended, claims 1-15 have been cancelled, and claims 16-35 have been added. Thus, claims 16-35 are presently pending in this application.
Claim Objections
Claim 28 is objected to because of the following informalities: delete “(2)” from line 13. Appropriate correction is required.
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 16-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the set dose" in line 7. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “a set dose”. Claims 17-27 are rejected at least because they depend from claim 16. Claim 28 is similarly rejected and interpreted wherein “the set dose” is recited in line 8. Claims 29-35 are rejected at least because they depend from claim 28.
Claim 16 recites the limitation "the axis of the dose setting member" in line 9. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “an axis of the dose setting member”. Claims 17-27 are rejected at least because they depend from claim 16. Claim 28 is similarly rejected and interpreted. Claims 29-35 are rejected at least because they depend from claim 28.
Claim 16 recites the limitation "the axis of a region of the housing" in line 10. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “an axis of a region of the housing”. Claims 17-27 are rejected at least because they depend from claim 16. Claim 28 is similarly rejected and interpreted. Claims 29-35 are rejected at least because they depend from claim 28.
Claim 34 line 2 recites “…the electronic module…”. It is not clear how the flexible clip is received within itself. For purposes of examination, this is interpreted as “…the dose setting member…”.
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.
Claims 16-24, 28-30 and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre WO 2021/11687 A1 in view of Enge US 2020/01088600 A1.
Regarding claim 16, Plumptre discloses a drug delivery device 100 and shown in Figs. 1-3 and described on pages 24-25 for setting and dispensing doses of a liquid drug, the drug delivery device comprising: a housing (housing 102) at least partially encasing a dose setting and drive mechanism, wherein the dose setting and drive mechanism comprises a piston rod (piston rod 104) and a dose setting member (actuating element 108 used to dial the amount of a dose), wherein the dose setting and drive mechanism are configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device by moving the dose setting member relative to the housing and a dose delivery operation for delivering a set dose by axially displacing the piston rod along an axis (page 25 lines 1-3).
Plumptre does not teach wherein a maximum radial extension perpendicular to an axis of the dose setting member is smaller than a maximum radial extension perpendicular to an axis of a region of the housing located adjacent to the dose setting member.
However, Enge teaches a medicament delivery device wherein a maximum radial extension perpendicular to an axis of the dose setting member is smaller than a maximum radial extension perpendicular to an axis of a region of the housing located adjacent to the dose setting member (Figs. 15-16 and 18).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the housing of Plumptre to extend further proximally thereby partially surrounding the dose setting member as taught by Enge for the purpose of more securely protecting the dose setting member from shear stresses.
Regarding claim 17, Plumptre in view of Enge teaches the drug delivery device according to claim 16, wherein the housing has an essentially circular cross-section (Plumptre, Figs. 1-3).
Regarding claim 18, Plumptre in view of Enge teaches the drug delivery device according to claim 16, wherein an external diameter of the dose setting member is smaller than or equal to an internal diameter of a region of the housing located adjacent to the dose setting member (Plumptre in view of Enge, wherein the modified proximal housing partially surrounds the dose setting member).
Regarding claim 19, Plumptre in view of Enge teaches the drug delivery device according to claim 16, wherein the dose setting member comprises attachment features (Plumptre, K1b) for mounting a separate attachable module (Plumptre, electronic module).
Regarding claim 20, Plumptre in view of Enge teaches the drug delivery device according to claim 19, wherein the dose setting member comprises a substantially circular groove (Plumptre, inverse shaped keying feature K1b for the annular ring) extending in a proximal end face of the dose setting member.
Regarding claim 21, Plumptre in view of Enge teaches the drug delivery device according to claim 20, wherein the attachment features are provided in the groove (Plumptre, an annular groove having essentially the same or a slightly smaller inner diameter as annular ring K1a and the same outer or a slightly greater outer diameter an annular ring K1a).
Regarding claim 22, Plumptre in view of Enge teaches the drug delivery device according to claim 19, wherein the attachment features are radial apertures provided in the dose setting member (Plumptre, Fig. 3).
Regarding claim 23, Plumptre in view of Enge teaches the drug delivery device according to claim 16, wherein the dose setting member comprises two separate components permanently fixed to each other to function as a single component (Plumptre, grooves 330 and cylindrical portion 312).
Regarding claim 24, Plumptre in view of Enge teaches the drug delivery device according to claim 16, wherein the dose setting member comprises a tubular sleeve (Plumptre, tubular sleeve, see annotated Fig. 3 below), the tubular sleeve comprising: a profiling as a gripping surface (Plumptre, grooves 310).
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Regarding claim 28, Plumptre discloses a dose recording system 100 and shown in Figs. 1-3 and described on pages 24-25 comprising: a drug delivery device comprising: a housing (housing 102) at least partially encasing a dose setting and drive mechanism, wherein the dose setting and drive mechanism comprises a piston rod (piston rod 104) and a dose setting member (actuating element 108 used to dial the amount of a dose) , wherein the dose setting and drive mechanism is configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device by moving the dose setting member relative to the housing and a dose delivery operation for delivering a set dose by axially displacing the piston rod along an axis (page 25 lines 1-3); and an electronic module (electronic module 120/220 page 30 line 35) for attachment to the dose setting member of the drug delivery device, wherein the electronic module (2) comprises: at least one sensor (optical sensor 266, page 31 line 17), a processor (processor Pr illustrated in Fig. 5, and see page 35 lines 8-10) configured to control operation of the at least one sensor and to process or store signals from the at least one sensor (page 35 line 23 to page 36 line 8), and attachment features (hooks 320, wherein chassis 222a may be similar or identical to chassis 222 of Fig. 1, see page 33 lines 5-8 and see page 33 lines 32-34) for attaching the electronic module to the dose setting member.
Plumptre does not teach wherein a maximum radial extension perpendicular to an axis of the dose setting member is smaller than a maximum radial extension perpendicular to an axis of a region of the housing located adjacent to the dose setting member.
However, Enge teaches a medicament delivery device wherein a maximum radial extension perpendicular to an axis of the dose setting member is smaller than a maximum radial extension perpendicular to an axis of a region of the housing located adjacent to the dose setting member (Figs. 15-16 and 18).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the housing of Plumptre to extend further proximally thereby partially surrounding the dose setting member as taught by Enge for the purpose of more securely protecting the dose setting member from shear stresses.
Regarding claim 29, Plumptre in view of Enge teaches the dose recording system according to claim 28, wherein the processor of the electronic module is configured to process and store signals from the at least one sensor (Plumptre, Fig. 5 and page 35 lines 8-18).
Regarding claim 30, Plumptre in view of Enge teaches the dose recording system according to claim 28, wherein a maximum external diameter of the dose setting member is equal to or smaller than an inner diameter of the electronic module (Plumptre, Fig. 2 and page 31 lines 29-30).
Regarding claim 32, Plumptre in view of Enge teaches the dose recording system according to claim 28, wherein the electronic module comprises attachment features (Plumptre, clip connection 326a, page 34 lines 4-6) for mounting the electronic module to a proximal end of the drug delivery device.
Regarding claim 33, Plumptre in view of Enge teaches the dose recording system according to claim 32, wherein the attachment features comprise at least one flexible clip (Plumptre, clip 326a, and clip connection may be opened by a user, page 34 lines 4-6) for axially and rotationally fixing the electronic module to the dose setting member.
Regarding claim 34, Plumptre in view of Enge teaches the dose recording system according to claim 33, wherein the at least one flexible clip is received within the dose setting member (Plumptre, 326b, page 34 lines 4-6) and extends substantially distally from a chassis (chassis 222a, page 33 line 7) holding the at least one sensor and the processor (Plumptre, Fig. 3).
Regarding claim 35, Plumptre in view of Enge teaches the dose recording system according to claim 28, wherein the dose setting member comprises a mechanical coding (Plumptre, clip connection 326b, page 34 lines 4-6) and the electronic module comprises a mechanical counter-coding (Plumptre, clip connection 326a, page 34 lines 4-6) which engages with the mechanical coding when the electronic module is attached to the drug delivery device (Plumptre, page 34 lines 4-6).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Plumptre in view of Enge as applied to claim 24 above, and further in view of Plumptre ‘701 US 2015/0238701 A1.
Regarding claim 25, Plumptre in view of Enge teaches the drug delivery device according to claim 24.
Plumptre in view of Enge does not explicitly teach wherein the dose setting member comprises a button having a proximal end face and a stem extending distally from the proximal end face, wherein the stem comprises at least one axially extending spline.
However, Plumptre ‘701 teaches a drug delivery device wherein the dose setting member comprises a button (button 70) having a proximal end face and a stem (sleeve-like part 72) extending distally from the proximal end face, wherein the stem comprises at least one axially extending spline (rib 73, P0129 and shown in Figs. 15a-b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dose setting member of Pumptre as claimed for the purpose of linking a plunger driver to dispense the dose to the rotatable dose setting member.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre in view of Enge as applied to claim 16 above, and further in view of Li et al. (Li) US 11,184,696 A1.
Regarding claim 26, Plumptre in view of Enge teaches the drug delivery device according to claim 16, wherein the dose setting member is made from a plastic material (Plumptre, the chassis may be made from a plastic material).
Plumptre teaches use of areas having different absorption, but does not explicitly teach the dose setting member with an infrared (IR) absorbing masterbatch (this is being interpreted as a product by process claim limitation, wherein MPEP 2113 recites "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.". Here, IR absorption can be accomplished by coating plastic as well as by altering the masterbatch).
However, Li teaches a wireless headphone having a coating that can absorb IR light (700 nm to 900 nm).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the plastic material of Plumptre for the purpose of reducing noise as taught by Li.
Regarding claim 27, Plumptre in view of Enge teaches the drug delivery device according to claim 16, wherein the dose setting member is made from a plastic material (Plumptre, the chassis may be made from a plastic material).
Plumptre teaches use of areas having different absorption, but does not explicitly teach the dose setting member with a light absorbing surface finish.
However, Li teaches a wireless headphone having a coating that can absorb IR light (700 nm to 900 nm).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the plastic material of Plumptre for the purpose of reducing noise as taught by Li.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Plumptre in view of Enge as applied to claim 28 above, and further in view of Byerly et al. (Byerly) US 2020/0171246 A1.
Regarding claim 31, Plumptre in view of Enge teaches the dose recording system according to claim 28.
Plumptre in view of Enge does not teach wherein a maximum external diameter of the electronic module is equal to or slightly larger than an external diameter of the housing.
However, Byerly teaches a dose detection module for a medication delivery device wherein a maximum external diameter of the electronic module is equal to or slightly larger than an external diameter of the housing (Fig. 5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the external diameter of the electronic module relative to the external diameter of the housing for the purpose of providing a larger gripping surface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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