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 .
Election/Restrictions
Applicant's election with traverse of invention I in the reply filed on 08/25/2026 is acknowledged. The traversal is on the ground(s) that searching the method of producing the cannula assembly of claims 13-16 involves searching the cannula assembly of claims 1-11 and that the search burden would not be undue in searching both inventions I and II. This is not found persuasive because searching for the method of producing would require searching for the step of plastically deforming at least a portion of the sealing sleeve to form a compressing section, which is not required when searching the cannula assembly. Furthermore, the method of producing lies in a different classification and would require different search strategies/queries, and thus the search burden for both the method of producing and the cannula assembly would be undue.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the 5-face cutting of the rigid cannula of claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 11 is 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.
Regarding claim 11, line 2 refers to a “5-face cutting”, however the specification fails to supply sufficient information to allow proper interpretation of the claim, and thus the metes and bounds of the claim are unclear. For examination purposes, the broadest reasonable interpretation has been applied and this limitation will be interpreted as any surface containing five or more faces and capable of cutting or penetrating the skin.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-10, and 12 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Olivas (US 20190060562 A1).
Regarding claim 1, Olivas discloses a cannula assembly for a portable or wearable drug delivery device, comprising:
a soft cannula (cannula 140 in Fig. 2; paragraph [0005] discloses that the cannula may be made of a flexible material as to adjust to the patient’s body movements and to provide comfort, and paragraph [0027] discloses that the flexibility of the cannula may allow it to be disposed within the patient’s tissue for a period of time without causing pain or discomfort);
a rigid cannula (needle 121 in Fig. 2; paragraph [0027] discloses that the needle may be made of a material that is more rigid than the cannula); and
a sealing sleeve (flexible boot 130 in Fig. 2),
wherein the soft cannula comprises a wall defining a lumen configured to surround at least a portion of the rigid cannula and to provide a sliding connection (see below; paragraph [0047] discusses a configuration in which the needle 121 is retracted from the patient but the cannula 140 remains in place, thereby defining a sliding connection),
wherein the sealing sleeve is configured to radially surround at least a portion of the soft cannula (see below),
wherein a flange of the soft cannula (first cannula coupling mechanism 142) comprises an extended wall thickness and is arranged at or near a proximal end of the soft cannula, and
wherein an inner surface of the sealing sleeve at least partially engages an outer surface of the soft cannula (see below; paragraph [0045] discloses that the first cannula coupling mechanism 142 of the cannula 140 engages with both the flexible boot 130 and the needle 121) and provides a sealing pressure radially between the rigid cannula and the soft cannula, thereby defining a sealing area on an outer surface of the rigid cannula (paragraph [0038] discloses that the fit between the boot 130 and the cannula coupling mechanism 142 provides a seal).
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Regarding claim 2, Olivas discloses the cannula assembly according to claim 1, wherein the flange comprises a proximal stop or a distal stop configured to engage a stop of the sealing sleeve (paragraph [0038] discloses that the cannula coupling mechanism 142 is retained by the ledge 134, while paragraph [0036] discloses that the ledge is disposed on the flexible boot 130).
Regarding claim 3, Olivas discloses the cannula assembly according to claim 1, wherein the flange is configured to at least partially cover the sealing area.
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Regarding claim 4, Olivas discloses the cannula assembly according to claim 1, wherein the flange comprises an elastic deformable material (paragraph [0027] discloses that the cannula 23 of Fig. 1 may be made of plastic or another polymer, and paragraph [0034] discloses that the needle insertion mechanism 120 of Figs. 2-4 corresponds to the insertion mechanism 12 of Fig. 1).
Regarding claim 5, Olivas discloses the cannula assembly according to claim 4, wherein the sealing sleeve comprises a compressing section configured to receive the cannula flange in an elastically deformed or compressed state (paragraph [0038] discloses that the cannula coupling mechanism 142 can couple the cannula 140 to the flexible boot 130 via interference fit).
Regarding claim 6, Olivas discloses the cannula assembly according to claim 4, wherein the sealing sleeve comprises an entrance section (see below) configured to receive the cannula flange in an elastically undeformed or uncompressed state (paragraph [0049] discloses that to attach the cannula 140 to the boot, the first cannula attachment mechanism 142 is forced into the first end 130a of the flexible boot 130 such that the ledge 134 of the flexible boot 130 engages the first cannula opening mechanism 142).
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Regarding claim 7, Olivas discloses the cannula assembly according to claim 1, wherein the sealing sleeve is constructed of a plastically deformable material (paragraph [0045] discloses that the flexible boot 130 bends and compresses to fit between the needle hub 122 and the floor member 160).
Regarding claim 9, Olivas discloses the cannula assembly according to claim 7, wherein the sealing sleeve comprises a compressing section configured to receive the cannula flange in an elastically deformed or compressed state (paragraph [0038] discloses that the cannula coupling mechanism 142 can couple the cannula 140 to the flexible boot 130 via interference fit), and wherein the compressing section of the sealing sleeve is in a deformed state (paragraph [0045] discloses that the flexible boot 130 bends and compresses to fit between the needle hub 122 and the floor member 160).
Regarding claim 10, the limitation “at least a portion of the sealing sleeve is crimped or swaged onto the soft cannula” is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product is a sealing sleeve configured to radially surround at least a portion of a soft cannula. Manufacturing steps such as crimping or swaging are not given patentable weight in the claim. “[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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
Regarding claim 12, Olivas a portable or wearable drug delivery device comprising the cannula assembly of claim 1, wherein the device is configured as a patch pump or a patch injector (drug delivery device 10 in Fig. 1).
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.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Olivas in view of Griffin (US 20080051738 A1)
Regarding claim 8, while Olivas discloses the cannula assembly according to claim 7, Olivas is silent to the specifics as to the plastically deformable material of the sealing sleeve being a metal.
However, Griffin discloses a soft cannula (cannula 954 in Fig. 29) and a sealing sleeve (cannula nest 956 in Fig. 29), where the sealing sleeve is secured to one end of the soft cannula (paragraph [0166]). Griffin further discloses that the sealing sleeve is made of a plastically deformable material being a metal (paragraph [0166]). It would have been obvious to one of ordinary skill in the art to make the plastically deformable material of the sealing sleeve of Olivas to be made of metal as taught by Griffin, as both Olivas and Griffin teach a plastically deformable sealing sleeve, and Griffin teaches that the sealing sleeve should be constructed of a suitably rigid material that also has sufficient flexibility (paragraph [0166]).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Olivas in view of Isaacson (US 20200324086 A1).
Regarding claim 11, while Olivas discloses the cannula assembly according to claim 1, however Olivas fails to disclose the rigid cannula comprises a 5-face cutting at a distal end to support damage-free insertion of the rigid cannula into the soft cannula.
However, Isaacson discloses a rigid cannula (needle 10) comprising a 5-face cutting (paragraph [0089]. Because of Isaacson’s teaching of including a cutting with multiple beveled surfaces, one of ordinary skill in the art would have found it obvious before the effective filing date of the claimed invention to modify the rigid cannula of Olivas to include the 5-face cutting as taught by Isaacson, as such a structure is well-known in the art for needles or cannulas that are used to pierce skin of a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AIDAN L NATHAN whose telephone number is (571)270-0798. The examiner can normally be reached Monday-Friday 8:00 AM - 5:00 PM.
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/AIDAN L NATHAN/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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