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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 2-6, 8-15, and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable by Beasley (US 20050273076) in view of Chattaraj (US 20150112302).
Regarding claim 2, Beasley discloses a system for delivering fluid to a user transcutaneously (fig. 20), the system comprising:
a flexible subcutaneous infusion cannula configured to be inserted into a user's skin to deliver fluid from an ambulatory infusion pump to the user (cannula 20 in fig. 2), wherein the flexible subcutaneous infusion cannula is configured to be driven into the user's skin at an angle of less than 45° (cannula 20 in fig. 2 is capable of being driven at an angle less than 45° as there is nothing about the structure of the cannula which would prevent this function and since the angle is not defined relative to anything else).
While Beasley discloses that the system is intended to connect to an infusion pump (paragraph 5), Beasley does not explicitly teach or disclose an ambulatory infusion pump configured to contain a fluid. Additionally, Beasley does not explicitly teach or disclose the cannula is flexible.
Chattaraj is directed towards an infusion system (fig. 1) comprising a flexible subcutaneous infusion cannula (“cannula” in fig. 1; paragraph 114) which is coupled to an ambulatory fusion pump configured to contain a fluid (fig. 1; paragraph 44 discloses an “infusion pump includes a self-contained reservoir”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the system of Beasley to include the infusion pump of Chattaraj, in order to make the system of Beasley operable for its intended purpose and to have modified the cannula of Beasley to be flexible in order to improve patient comfort (paragraph 114).
Regarding claim 12, Beasley discloses a system for delivering fluid to a user transcutaneously, the system comprising:
a subcutaneous infusion cannula configured to be inserted into a user's skin to deliver fluid from the ambulatory infusion pump to the user (cannula 20 in fig. 2, wherein the flexible subcutaneous infusion cannula comprises an outer tube having a central lumen with an inner reinforcement coil extending along a portion of the central lumen (coil 16 in fig. 2).
While Beasley discloses that the system is intended to connect to an infusion pump (paragraph 5), Beasley does not explicitly teach or disclose an ambulatory infusion pump configured to contain a fluid. Additionally, Beasley does not explicitly teach or disclose the cannula is flexible.
Chattaraj is directed towards an infusion system (fig. 1) comprising a flexible subcutaneous infusion cannula (“cannula” in fig. 1; paragraph 114) which is coupled to an ambulatory fusion pump configured to contain a fluid (fig. 1; paragraph 44 discloses an “infusion pump includes a self-contained reservoir”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the system of Beasley to include the infusion pump of Chattaraj, in order to make the system of Beasley operable for its intended purpose and to have modified the cannula of Beasley to be flexible in order to improve patient comfort (paragraph 114).
Regarding claim 3, in the modified system of Beasley, Beasley discloses the flexible subcutaneous infusion cannula comprises an outer tube having a central lumen (fig. 2) with an inner reinforcement coil extending along a portion of the central lumen (coil component 16 in fig. 2).
Regarding claims 4 and 13, in the modified system of Beasley, Beasley discloses the inner reinforcement coil comprises an outer diameter matching an inner diameter of the flexible subcutaneous infusion cannula (fig. 2).
Regarding claims 5 and 14, in the modified system of Beasley, Beasley discloses gaps between adjacent turns of the reinforcement coil (fig. 2).
Regarding claims 6 and 15, in the modified system of Beasley, Beasley discloses all of the claimed limitations set forth in claims 2-5 and 12-14, respectively, but does not explicitly teach or disclose the flexible subcutaneous infusion cannula comprises a plurality of holes through the outer tube, the gaps permitting fluid flow from the central lumen of the cannula laterally outward through the plurality of holes.
In a separate embodiment (fig. 9), Beasley teaches a cannula comprising a plurality of holes through the outer tube (apertures 66 in fig. 9), the gaps permitting fluid flow from the central lumen of the cannula laterally outward through the plurality of holes (paragraph 56). Since Beasley discloses that, in this embodiment, other coil configurations are conceivable (paragraph 57), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the first embodiment of Beasley (fig. 2) to include the plurality of holes through the outer tube, as taught by the second embodiment of Beasley, since Beasley teaches these holes provide enhanced absorption of the medication at the delivery site and a potential increase of indwelling time (paragraph 56).
Regarding claims 8 and 17, in the modified system of Beasley, Beasley discloses the inner reinforcement coil comprises a round wire (fig. 2 shows a round cross-section of coil 16).
Regarding claims 9 and 18, modified Beasley teaches all of the claimed limitations set forth in claims 2/3 and 12, respectively, as discussed above, but does not explicitly teach or disclose the inner reinforcement coil comprises a flat wire.
In a different embodiment (fig. 11), Beasley teaches a cannula (cannula 60 in fig. 11) having an inner reinforcement coil (coil 68 in fig. 11) comprised of a flat wire (paragraph 57 discloses a rectangular cross-section). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the first embodiment of Beasley (fig. 2) to comprise a flat wire, as taught by the second embodiment of Beasley since Beasley teaches that the coil component can be many different shapes (paragraph 51) so that it appears the modification is within the scope implied by Beasley and since it seems the cannula of the first embodiment would operate equally well with a flat wire.
Regarding claims 10 and 20, in the modified system of Beasley, Beasley discloses an infusion set including the flexible subcutaneous infusion cannula (fig. 20) and infusion tubing connecting the ambulatory infusion pump to the infusion set (conduit 100 in fig. 20).
Regarding claims 11 and 21, in the modified system of Beasley, Beasley discloses an adhesive configured to adhere to the user (paragraph 59 discloses “tape or other adhesives”).
Regarding claim 19, in the modified system of Beasley, Beasley discloses the flexible subcutaneous infusion cannula is configured to be driven into the user's skin at an angle of less than 45° (cannula 20 in fig. 2 is capable of being driven at an angle less than 45° as there is nothing about the structure of the cannula which would prevent this function and since the angle is not defined relative to anything else).
Claim(s) 7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beasley in view of Chattaraj, as applied to claims 2-5 and 12-14 above, respectively, and further in view of Lenker (US 20140343538).
Regarding claims 7 and 16, modified Beasley does not teach or disclose the gaps comprise a width between about 25% and about 100% of a width of a diameter of the reinforcement coil.
Lenker is directed towards a medical device comprising a coil (coil 1102 in fig. 11) which comprises gaps (spaces 1110 in fig. 11) which comprise a width about 100% of a width of a diameter of the coil (paragraph 88 discloses the coil spaces are about equal in width to the coil element diameter). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the system of modified Beasley so that the gaps comprise a width between about 25% and about 100% of a width of a diameter of the reinforcement coil, as taught by Lenker, since it appears that the cannula of modified Beasley would operate equally well with the claimed spacing as the spacing.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10413658 in view of Chattaraj and Beasley (see table below).
Regarding claims 2 and 12, claim 1 of the issued patent claims all of the claimed limitations set forth in instant claims 2 and 12 except an ambulatory infusion pump configured to contain a fluid and the infusion cannula comprises an outer tube having a central lumen with an inner reinforcement coil extending along a portion of the central lumen.
Chattaraj teaches this limitation, as discussed above. It would have been obvious to have modified the issued claim to further claim an ambulatory infusion pump configured to contain a fluid since the claim is drawn towards a system “for delivering fluid to a user”. This modification would render the issued claim operable for its intended purpose.
Beasley discloses a flexible subcutaneous infusion cannula comprises an outer tube having a central lumen with an inner reinforcement coil extending along a portion of the central lumen (coil 16 in fig. 2). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the cannula of the issued claim to include an outer tube having a central lumen with an inner reinforcement coil extending along a portion of the central lumen, as taught by Beasley, for the purpose of rending the cannula resistant to kinking (paragraph 5).
Instant Claim
Reference Claim
Teaching
2
1
see discussion above
3
Beasley teaches this limitation above. It would have been obvious to have modified the issued claim to include the claim limitations to render the cannula resistant to kinking (paragraph 5).
4
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as Beasley teaches that this position helps ensure the cannula will not kink.
5
Beasley teaches this feature above. It would have been obvious to have modified the cannula of the issued claim since the gaps would render the cannula more flexible.
6
Beasley teaches this feature above. It would have been obvious to have modified the cannula of the issued claim since Beasley teaches this allows for greater indwelling time (paragraph 56).
7
Lenker teaches this limitation above. It would have been obvious to have modified the patent claim for the same reason given above.
8
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as it appears the cannula of the issued claim would operate equally well with the claimed shape.
9
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as it appears the cannula of the issued claim would operate equally well with the claimed shape.
10
13
11
9
12
1
see discussion above
13
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as Beasley teaches that this position helps ensure the cannula will not kink.
14
Beasley teaches this feature above. It would have been obvious to have modified the cannula of the issued claim since the gaps would render the cannula more flexible.
15
Beasley teaches this feature above. It would have been obvious to have modified the cannula of the issued claim since Beasley teaches this allows for greater indwelling time (paragraph 56).
16
Lenker teaches this limitation above. It would have been obvious to have modified the patent claim for the same reason given above.
17
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as it appears the cannula of the issued claim would operate equally well with the claimed shape.
18
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as it appears the cannula of the issued claim would operate equally well with the claimed shape.
19
1
20
9
21
13
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11273255 in view of Chattaraj and Beasley (see table below).
Regarding claim 2, claim 1 of the issued patent claims all of the claimed limitations set forth in instant claim 2 except an ambulatory infusion pump configured to contain a fluid.
Chattaraj teaches this limitation, as discussed above. It would have been obvious to have modified the issued claim to further claim an ambulatory infusion pump configured to contain a fluid since the claim is drawn towards a system “for delivering fluid to a user”. This modification would render the issued claim operable for its intended purpose.
Regarding claim 12, claim 1 of the issued patent claims all of the claimed limitations set forth in instant claim 12 except an ambulatory infusion pump configured to contain a fluid and the infusion cannula comprises an outer tube having a central lumen with an inner reinforcement coil extending along a portion of the central lumen.
Chattaraj teaches this limitation, as discussed above. It would have been obvious to have modified the issued claim to further claim an ambulatory infusion pump configured to contain a fluid since the claim is drawn towards a system “for delivering fluid to a user”. This modification would render the issued claim operable for its intended purpose.
Beasley discloses a flexible subcutaneous infusion cannula comprises an outer tube having a central lumen with an inner reinforcement coil extending along a portion of the central lumen (coil 16 in fig. 2). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the cannula of the issued claim to include an outer tube having a central lumen with an inner reinforcement coil extending along a portion of the central lumen, as taught by Beasley, for the purpose of rending the cannula resistant to kinking (paragraph 5).
Instant Claim
Reference Claim
Teaching
2
1
see discussion above
3
Beasley teaches this limitation above. It would have been obvious to have modified the issued claim to include the claim limitations to render the cannula resistant to kinking (paragraph 5).
4
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as Beasley teaches that this position helps ensure the cannula will not kink.
5
Beasley teaches this feature above. It would have been obvious to have modified the cannula of the issued claim since the gaps would render the cannula more flexible.
6
Beasley teaches this feature above. It would have been obvious to have modified the cannula of the issued claim since Beasley teaches this allows for greater indwelling time (paragraph 56).
7
Lenker teaches this limitation above. It would have been obvious to have modified the patent claim for the same reason given above.
8
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as it appears the cannula of the issued claim would operate equally well with the claimed shape.
9
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as it appears the cannula of the issued claim would operate equally well with the claimed shape.
10
9
11
4
12
1
see discussion above
13
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as Beasley teaches that this position helps ensure the cannula will not kink.
14
Beasley teaches this feature above. It would have been obvious to have modified the cannula of the issued claim since the gaps would render the cannula more flexible.
15
Beasley teaches this feature above. It would have been obvious to have modified the cannula of the issued claim since Beasley teaches this allows for greater indwelling time (paragraph 56).
16
Lenker teaches this limitation above. It would have been obvious to have modified the patent claim for the same reason given above.
17
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as it appears the cannula of the issued claim would operate equally well with the claimed shape.
18
Beasley teaches this feature above. It would have been obvious to have modified the patent claim as it appears the cannula of the issued claim would operate equally well with the claimed shape.
19
1
20
9
21
4
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 of U.S. Patent No. 12048828 in view of Chattaraj (see table below).
Regarding claims 2 and 12, claim 1 of the issued patent claims all of the claimed limitations set forth in instant claims 2 and 12 except an ambulatory infusion pump configured to contain a fluid.
Chattaraj teaches this limitation, as discussed above. It would have been obvious to have modified the issued claim to further claim an ambulatory infusion pump configured to contain a fluid since the claim is drawn towards a system “for delivering fluid to a user”. This modification would render the issued claim operable for its intended purpose.
Instant Claim
Reference Claim
Teaching
2
1
see discussion above
3
1
4
4
5
5
6
6
7
5
8
7
9
8
10
12
11
2
12
1
see discussion above
13
4
14
5
15
6
16
5
17
7
18
8
19
1
20
12
21
2
Conclusion
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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