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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1-3, 5, and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2014/0046268 to Quinn et al. (“Quinn”) in view of U.S. Patent Publication No. 2017/0007763 to MCLOUCHLIN et al. (“Mcloughlin”) and alternatively further in view of U.S. Patent Publication No. 2019/0022357 to Burkholz et al. (“Burkholz).
Regarding claim 1, Quinn teaches a brake tower (5/66/11, Fig. 2B) for a medical injection device comprising a proximal end (Fig. 2B, left end of 5), a distal end having a distal face (11), and a sidewall (5) therebetween defining a longitudinal axis, but does not teach the protrusions and securing the protrusions using an adhesive.
Mcloughlin teaches a plurality of elastomeric protrusions (447, Fig. 20a) arranged on a distal face (distal face of 446), wherein each protrusion of the plurality of protrusions comprises a cylinder secured to the distal face (Fig. 20a). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified with distal face of Quinn with protrusions as taught by Mcloughlin to yield the predictable result of providing biasing/damping for a cartridge of an injection device.
Mcloughlin does not explicitly mention that the protrusions are secured by an adhesive, however claim 1 is interpreted as including a product-by-process limitation. The cited prior art teaches all of the positively recited structure of the claimed apparatus or product. The determination of patentability is based upon the apparatus structure itself. The patentability of a product or apparatus does not depend on its method of production or formation. 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. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113). In the instant case, Mcloughlin contains are the structural limitations of the invention except for the specific method of production for the protrusion, which is securement using an adhesive, however the patentability of claim 1 is based on the recited structure, namely the protrusion and the shape of the protrusion, not in its method of production or formation.
Alternatively, Burkholz teaches using an adhesive as a means for attaching a protrusion in a medical device as an alternative to other manufacturing methods such as, for example, molding ([0051]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an adhesive to secure the protrusions of Mcloughlin as taught by Burkholz to yield the predictable result of securing protrusions to a medical device. Mcloughlin inherently secures the protrusions, Burkholz merely shows an old and well-known alternative securement means.
Regarding claim 2, Quinn, Mcloughlin, and alternatively Burkholz teach the brake tower according to claim 1 as shown above, Mcloughlin further teaching the plurality of elastomeric protrusions comprise an elastomeric polymer ([0379] & [0388]).
Regarding claim 3, Quinn, Mcloughlin, and alternatively Burkholz teach the brake tower according to claim 1 as shown above, Mcloughlin further teaching the plurality of elastomeric protrusions comprise a rubber ([0172]).
Regarding claim 5, Quinn, Mcloughlin, and alternatively Burkholz teach the brake tower according to claim 3 as shown above, Mcloughlin further teaching the rubber is a synthetic rubber ([0172]).
Regarding claim 8, Quinn, Mcloughlin, and alternatively Burkholz teach the brake tower according to claim 1 as shown above, Quinn further teaching the proximal end, the distal end, and the sidewall define a cylinder (5, Fig. 2B).
Regarding claim 9, Quinn, Mcloughlin, and alternatively Burkholz teach the brake tower according to claim 1 as shown above, Quinn further teaching the distal end (66, Fig. 2B) has a larger circumference than the proximal end and/or the sidewall (5).
Regarding claim 10, Quinn, Mcloughlin, and alternatively Burkholz teach the brake tower according to claim 1 as shown above, Quinn further teaching the sidewall defines an interior that is at least partially hollow (Fig. 3).
Regarding claim 11, Quinn, Mcloughlin, and alternatively Burkholz teach the brake tower according to claim 1 as shown above, Mcloughlin further teaching the plurality of elastomeric protrusions comprises two to ten elastomeric protrusions arranged on the distal face (Fig. 20a).
Regarding claim 12, Quinn, Mcloughlin, and alternatively Burkholz teach the brake tower according to claim 1 as shown above, Mcloughlin further teaching the one or more elastomeric protrusions comprise a circular shape (Fig. 20a).
Regarding claim 14, Quinn teaches a medical injection device comprising a housing (1, Fig. 2B) having a distal end (17) and a proximal end (53), a brake tower comprising a proximal end (left end of 5), a distal end having a distal face (11), and a sidewall (5) therebetween defining a longitudinal axis, a cartridge (15) received within the housing distally of the brake tower and holding a composition therein, a cartridge housing (14) received within the housing distally of the brake tower (Fig. 2B) and configured to hold the cartridge therein, an injection needle (56) at a distal end of the housing and in fluid communication with the cartridge, and an actuation member (3) at a proximal end of the housing, the actuation member configured to actuate the medical injection device to deliver the composition through the injection needle, but does not teach the protrusions and securing the protrusions using an adhesive.
Mcloughlin teaches a plurality of elastomeric protrusions (447, Fig. 20a) arranged on a distal face (distal face of 446), wherein each protrusion of the plurality of protrusions comprises a cylinder secured to the distal face (Fig. 20a). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified with distal face of Quinn with protrusions as taught by Mcloughlin to yield the predictable result of providing biasing/damping for a cartridge of an injection device.
Mcloughlin does not explicitly mention that the protrusions are secured by an adhesive, however claim 1 is interpreted as including a product-by-process limitation. The cited prior art teaches all of the positively recited structure of the claimed apparatus or product. The determination of patentability is based upon the apparatus structure itself. The patentability of a product or apparatus does not depend on its method of production or formation. 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. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113). In the instant case, Mcloughlin contains are the structural limitations of the invention except for the specific method of production for the protrusion, which is securement using an adhesive, however the patentability of claim 1 is based on the recited structure, namely the protrusion and the shape of the protrusion, not in its method of production or formation.
Alternatively, Burkholz teaches using an adhesive as a means for attaching a protrusion in a medical device as an alternative to other manufacturing methods such as, for example, molding ([0051]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an adhesive to secure the protrusions of Mcloughlin as taught by Burkholz to yield the predictable result of securing protrusions to a medical device. Mcloughlin inherently secures the protrusions, Burkholz merely shows an old and well-known alternative securement means.
Claim 4, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Quinn, Mcloughlin, and alternatively Burkholz as applied to claims 1, 3, and 6 above, and further in view of U.S. Patent Publication No. 2013/0085473 to Weilbacher et al. (“Weilbacher”).
Regarding claim 4, Quinn, Mcloughlin, and alternatively Burkholz teach the brake tower according to claim 3 as shown above, but do not teach natural rubber. Weilbacher teaches the use of a natural rubber as an alternative to synthetic rubber as a biasing material ([0035]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the rubber material of Mcloughlin with natural rubber as taught by Weilbacher to yield the predictable result of providing a durable elastomeric material as a biasing material in a medical device.
Regarding claim 6, Quinn, Mcloughlin, and alternatively Burkholz teach the brake tower according to claim 1 as shown above, but do not teach silicone. Weilbacher teaches silicone as a biasing material ([0035]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the biasing material of Mcloughlin with silicone as taught by Weilbacher to yield the predictable result of providing a durable elastomeric material as a biasing material in a medical device.
Regarding claim 7, it is noted that claim 7 includes a product-by-process limitation. Quinn, Mcloughlin, and alternatively Burkholz teach all of the positively recited structure of the claimed apparatus as shown above regarding claim 6. The determination of patentability is based upon the apparatus structure itself. The patentability of a product or apparatus does not depend on its method of production or formation. 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. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113). In the instant case, silicone has already been shown in the prior art, the method of production or formation of the silicone through vulcanization at room temperature does not affect the patentability of the material itself in an apparatus claim.
Response to Arguments
The drawings were received on 03/12/2026. These drawings are acceptable.
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to the art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Quinn, Mcloughlin, and alternatively Burkholz as shown above.
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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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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