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The rejections pursuant to 112(b) are withdrawn in light of amendments.
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
With regards to applicants’ argument under “Rejections under 35 U.S.C. § 103” on pages 5-9 of Remarks for claim 1, have been fully considered but they are not persuasive. In response to applicants’ argument that Streit and Yavorsky fail to teach or suggest at least “a movable piston rod mounted in the housing… wherein a shape of a circumference of a cross-section of the piston rod is approximately a non-trivial curve of constant width”, Streit in view of Yavorsky does disclose wherein a shape of a circumference of a cross-section of the piston rod is approximately a non-trivial curve of constant width (See Annotated Fig.6 Below).
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As shown in the annotated figure 6 above, it is clearly shown that the piston rod has been mapped to the entire structure, including the non-trivial curve of constant width triangle. Even though part of the piston rod has a circular shape configured to mate with the recess of the plunger of the reservoir, it is not the circular shape that is being relied on to meet the limitation of wherein a shape of a circumference of a cross-section of the piston rod is approximately a non-trivial curve of constant width as shown in the annotated figure 6 above.
Applicants’ argument that the corners of the triangular shape of the connection structure 110 of Streit only appear rounded due to the width of the line and the fact that the two lines indicate the inner and the outer limit of a triangular recess overlap is not persuasive. Streit does not disclose that the illustrated lines represent inner and outer limits of a recess and does not describe the shape as being triangular with overlapping boundaries. Rather, Fig.2a, Fig.3a, and Fig.6 depict a rounded triangular configuration.
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 1-4, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Streit et al. (WO 2020148581 A1, herein, Streit) in view of Yavorsky et al. (US Pub No. 20130046252 A1, herein, Yavorsky).
Regarding claim 1, Streit discloses a delivery device for delivering a fluid drug, comprising:
a housing (Fig.2c) comprising a reservoir module (200 – Fig.2a) and a drive module (100 – Fig.2a) configured to be detachably connected (Fig.2b, Para [0033]);
a reservoir (280 – Fig.9) configured with a variable internal volume for storing the fluid drug (Para [0034]), wherein the reservoir is at least partially arranged in the reservoir module of the housing (Fig.9);
a drive device at least partially arranged in the drive module of the housing (Para [0011]), the drive device comprising:
a movable piston rod (180- Fig.3a) mounted in the housing and configured to be movable by the drive to change the variable internal volume of reservoir (“volume within the reservoir may be varied” – Para [0007]),
wherein the piston rod is configured to be guided via an aperture (212 – Fig. 1) through at least one of an inner wall of the housing, an outer wall of the reservoir module, or an outer wall of the drive module (Fig.1, “opening through which the piston rod can be moved” – Para [0009]),
wherein the piston rod is displaceably and non-rotationally mounted in the aperture (“A slidable stopper or piston” – Para [0007]), and
wherein a shape of a circumference of a cross-section of the piston rod is approximately a non-trivial curve of constant width (See Annotated Fig.6 Below).
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However, Streit does not expressly disclose the drive module comprising a drive that comprises a motor or a spring and wherein a bearing surface between the piston rod and the aperture comprises an elastically deformable seal configured to prevent liquid from passing through the aperture while permitting displacement of the piston rod.
Yavorsky teaches a drive that comprises a motor and a threaded drive shaft (Para [0084]) and wherein a bearing surface (110 – Fig.5) between a delivery needle (134 – Fig.12) and a aperture (114 – Fig.5) comprises an elastically deformable seal (“deformable material” – Para [0089], “ pliable and deformable feature” – Para [0091]) configured to prevent liquid from passing through the aperture while permitting displacement of the delivery needle (“to inhibit fluid ingress into the needle cavity” – Para [0094]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the delivery device’s drive disclosed by Streit to comprise a motor and a seal as taught by Yavorsky to help establish a good radial seal between the seal and the aperture to prevent liquids from passing through the aperture (Yavorsky, Para [0092]).
Regarding claim 2, Streit further discloses the delivery device as stated above wherein the curve of constant width is a curve of constant width with three or more corners (See Annotated Fig.6 Above).
Regarding claim 3, Streit, as modified, discloses the delivery device as stated above wherein the curve of constant width is a curve of constant width with three corners but Streit does not expressly disclose wherein the curve of constant width comprises five corners or seven corners.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the corners of the curve of constant width since it has been held that mere changes in shape are obvious, MPEP 2144.04 IV B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant). In the instant case, the modified device of Streit would not operate differently with the claimed corners of the curve of constant width considering Streit discloses the curve of constant width comprises three corners. Further, applicant places no criticality on the corners claimed, indicating simply “For instance, the curve of constant width may include three or more corners such as five corners or seven corners” in paragraph [0026].
Regarding claim 4, Streit further discloses the delivery device as stated above wherein the curve of constant width is a curve of constant width with rounded corners (See Annotated Fig.6 Above).
Regarding claim 12, Streit further discloses wherein the delivery device is an infusion pump (“the infusion path and the infusion cannula” – Para [0034]).
Regarding claim 13, Streit further discloses wherein the infusion pump is a patch pump (“configured as a patch pump” – Para [0007]).
Regarding claim 14, Streit further discloses wherein the delivery device is an injection device (“the infusion cannula may be inserted into the tissue of a user” – Para [0018], Para [0020]).
Regarding claim 15, Streit further discloses wherein the injection device is a pen-shaped injection device (292, 291, 290 – Fig.5c).
Claims 5-6 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Streit in view of Yavorsky as applied to claim 1 above and further in view of Hilber et al. (US Pub No. 20090123309 A1, herein, Hilber)
Regarding claim 5, Streit, as modified, discloses the delivery device as stated above wherein a housing of the reservoir module (200 – Fig.2a) and a housing of the drive module (100 – Fig.2a) are configured to be detachably connectable to each other (Fig.2b, Para [0033]).
However, Streit does not expressly disclose wherein at least an area of the outer wall comprising the aperture, which is a portion of the housing of the drive module, is a two-component injection-molded part, wherein a first material, from which the outer wall is molded differs from a second material, from which a seal component is molded, wherein the seal component defines the seal.
Hilber teaches a delivery device wherein at least an area of the outer wall, which is a portion of the housing of the drive module, is a two-component injection-molded part (Para [0054]), wherein a first material (“in plastics material” – Para [0054]), from which the outer wall is molded differs from a second material, from which a seal component is molded, wherein the seal component defines the seal (“silicon-based or thermoplastic elastomers or rubber” – Para [0054]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the housing of the reservoir module disclosed by Streit to comprise a two-component injection-molded part as taught by Hilber because Hiber teaches that it is well known that the outer wall of the housing can be a different material than the seal and that it provides a particularly cost-effective method for manufacturing components, while providing less components and improving precision of the assembled components (Hilber, Para [0054]).
Regarding claim 6, Streit, as modified, discloses the delivery device as stated above but Streit does not expressly disclose wherein the second material is a thermoplastic elastomer.
Hilber teaches wherein the second material is a thermoplastic elastomer (“The seals may for example be injected from silicon-based or thermoplastic elastomers” – Para [0054]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the second material disclosed by Streit to be of thermoplastic elastomer as taught by Hilber because Hilber teaches that the second material provides no liquid communication between two parts in the housing provided with that material (Hilber, Para [0073]).
Regarding claim 8, Streit, as modified, discloses the delivery device as stated above but Streit does not expressly disclose wherein the second material is a silicone.
Hilber teaches wherein the second material is a silicone (“such as a silicone” – Para [0070]), while Yavorsky also teaches wherein the second material is a silicone (“the sealing element… are formed from a pliable silicone material” – Para [0089]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the second material as disclosed by Streit to be silicone as taught by Hilber and Yavorsky since the material is selected to be resistant to the fluid being delivered, biocompatible, and capable of being sterilized after manufacturing (Yavorsky, Para [0089]).
Regarding claim 9, Streit, as modified, discloses all the limitations of the delivery device as stated in claim 5, wherein a region of the outer wall comprising the aperture comprises at least one additional aperture (222 – Fig.3b) comprising at least one additional seal (223 – Fig.3b).
However, Streit does not expressly disclose wherein the at least one additional seal is constructed of the second material of the two-component injection-molded part.
Yavorsky teaches wherein at least one additional seal is constructed of the second material of the two-component injection molded part (“the sealing element and the second sealing element are formed from a pliable silicone material” – Para [0089]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the additional seal disclosed by Streit to be constructed of the second material as taught by Yavorsky to be resistant to the fluid being delivered, biocompatible, and capable of being sterilized after manufacturing (Yavorsky, Para [0089]).
Regarding claim 10, Streit as modified, discloses all the limitations of the delivery device as stated in claim 9, but Streit does not expressly disclose wherein the seal component further defines the at least one additional seal, wherein the seal and the at least one additional seal are coupled by at least one arm of the seal component.
Yavorsky teaches wherein the seal component further defines the at least one additional seal, wherein the seal and the at least one additional seal are coupled by at least one arm of the seal component (130 - Fig.6).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the seal component as disclosed by Streit to have a seal component with an arm to couple the seal and the additional seal as taught by Yavorsky in order to provide another configuration of the seal components.
Regarding claim 11, Streit as modified, discloses all the limitations of the delivery device as stated in claim 9, further disclosing wherein the at least one additional aperture is configured as an aperture for at least one of an operating element or for one or more electrical contacts (121 – Fig. 3a).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Streit in view of Yavorsky and Hilber as applied to claim 6 above and further in view of Ashby et al. (US Pub No. 20150217059 A1, herein, Ashby).
Regarding claim 7, Streit, as modified, discloses the delivery device as stated above. Even though Hilber teaches a thermoplastic elastomer, Hilber does not disclose wherein the thermoplastic elastomer comprises at least one of a thermoplastic polyurethane or a thermoplastic polyamide.
Ashby teaches wherein a thermoplastic elastomer comprises at least one of a thermoplastic polyurethane or a thermoplastic polyamide (“thermoplastic or thermosetting elastomers such as polyurethanes” – Para [0082]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the thermoplastic elastomer as disclosed by Streit (as modified) to comprise a thermoplastic polyurethane as taught by Ashby for low or high temperature performance, flexibility, or otherwise for compatibility with the fluid being handled and exhibiting rubber-like properties of compliancy, resiliency or compression deflection, low compression set, flexibility, and an ability to recover after deformation (Ashby, Para [0082]).
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.
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783