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 .
Status of Claims
This office action is responsive to the amendment filed 20 April 2026.
Claims 1-11 are canceled.
Claims 17-20 are added.
Claims 12-20 are presently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 12-16 in the reply filed on 20 April 2026 is acknowledged.
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.
Claims 12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Koska (US Patent Publication No. 20190060168 A1) in view of Sund et al. (US Patent Publication No. 20150190311 A1), hereinafter Sund, in further view of Meyer (US Patent No. 6053892 A).
Regarding claim 12, Koska discloses a cannula for a pre-filled medical delivery assembly (Koska: Fig. 2A, delivery system 200), comprising: an elongate hollow tube body portion (Fig. 2G, elongate body 282) defining an interior fluid conduit (elongate body 282 defines an internal fluid conduit; para. 0046) and a first end (Fig. 2E, second end 282-3) and a second end (Fig. 2E, first end 282-2) thereof; the first end (282-3) comprising a first bevel (Fig. 2F, second end 282-3 is shown to be beveled) defining a first point (Fig. 2G, piercing tip 284) for engagement with a patient.
Koska does not expressly disclose the second end comprising a triple-bevel defining a second point for piercing of a vial.
Sund teaches an end (Sund: Fig. 11, spike tip 122) comprising a triple-bevel (spike tip 122 has facets 124, which are three bevels; para. 0045) defining a point (Fig. 3, point 122) for piercing of a vial.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cannula of Koska such that the second end comprising a triple-bevel defining a second point for piercing of a vial as taught by Sund in order to allow for cutting edges to better pierce the container (Sund: para. 0008 and 0011).
Koska in view of Sund does not expressly disclose rotational piercing of a vial.
Meyer teaches rotational piercing of a container (Meyer: rotational piercing; col 4, ln 64 – col 5, ln 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cannula of Koska in view of Sund such that the vial is rotationally pierced as taught by Meyer in order to allow for simple, sterile construction of the cannula (col 1, ln 45-51) and prevent medication from contacting the cannula until it is put into a ready-to-use position (col 3, ln 46-59).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Koska in view of Sund and Meyer, in further view of Genosar (US Patent Publication No. 20150136622 A1).
Regarding claim 13, Koska in view of Sund and Meyer discloses the cannula above.
Koska in view of Sun and Meyer does not expressly disclose that the cannula is made of steel.
Genosar teaches a cannula made of steel (stainless steel cannula; para. 0005).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cannula of Koska in view of Sun and Meyer such that the cannula is made of steel as taught by Genosar in order to provide hypodermic administration (para. 0005).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Koska in view of Sund and Meyer, in further view of Keiser-Nielsen (Foreign Patent Publication No. WO 2019219480 A1), hereinafter Keiser.
Regarding claim 14, Koska in view of Sund and Meyer discloses the cannula above.
Koska in view of Sund and Meyer does not expressly disclose that the first bevel also comprises a triple-bevel.
Keiser teaches a bevel also comprises a triple-bevel (bevel is triple-facet; pg. 13, ln 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cannula of Koska in view of Sund and Meyer such that the first bevel also comprises a triple-bevel as taught by Keiser in order to provide a skin piercing needle that is hook resistant (Keiser: pg. 13, ln 31-32).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Koska in view of Sund and Meyer, in further view of Mayle et al. (US Patent Publication No. 20230211091 A1), hereinafter Mayle.
Regarding claim 15, Koska in view of Sund and Meyer discloses the cannula above.
Koska in view of Sund and Meyer does not expressly disclose the cannula comprises a 23-guage needle.
Mayle teaches a 23-guage needle (Mayle: Fig. 2A, delivery element 38 may be a 23 gauge needle; para. 0177).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cannula of Koska in view of Sund and Meyer such that the cannula comprises a 23-guage needle as taught by Mayle in order to allow for injection into a joint (para. 0177). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the cannula of any particular gauge, as it is known to be a result effective variable depending on which location which yield the best injection (Mayle: lower gauges are used for injections into a joint, whereas higher gauges are useful for facial injections; para. 0177). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Koska in view of Sund and Meyer, in further view of Pesis et al. (US Patent Publication No. 20230380858 A1), hereinafter Mayle.
Regarding claim 16, Koska in view of Sund and Meyer disclose the cannula above.
Koska in view of Meyer does not expressly disclose that the triple bevel of the second point defines both an outside edge and an inside edge.
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Sund teaches a triple bevel (Sund: spike tip 122 has facets 124, which are three bevels; para. 0045) of a point (Fig. 3, point 122) that defines both an outside edge (Fig. 10, facet 124) and an inside edge (Fig. 10 above, inside edge A).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cannula of Koska in view of Meyer such that the triple bevel of the second point defines both an outside edge and an inside edge as taught by Sund in order to allow for cutting edges to better pierce the container (Sund: para. 0008 and 0011).
Koska in view of Sund and Meyer does not expressly disclose and the inside edge is dulled.
Pesis discloses an inside edge (Pesis: Fig. 6B, edge 19) that is dulled (Fig. 6B, edge 19 is rounded; para. 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cannula of Koska in view of Sund and Meyer such that the inside edge is dulled as taught by Pesis in order to avoid coring (Pesis: para. 0037).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Koska in view of Sund, Meyer, and Pesis, in further view of Gallegos et al. (US Patent Publication No. 20230111219 A1), hereinafter Gallegos.
Regarding claim 17, Koska in view of Sund, Meyer, and Pesis discloses the cannula above.
Koska in view of Sund, Meyer, and Pesis does not expressly disclose that the interior edge is dulled to a Brubacher Edge Sharpness Scale (BESS) rating of higher than 500.
Gallegos disclose an edge (Gallegos: Fig. 2, cutting edge portion 330) that is dulled to a BESS rating of higher than 500 (cutting edge portion 330 may have a sharpness greater than 500 grams; para. 0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the interior edge of Koska in view of Sund, Meyer, and Pesis such that the interior edge is dulled to a Brubacher Edge Sharpness Scale (BESS) rating of higher than 500 as taught by Gallegos in order to produce a desirably dulled edge (Gallegos: para. 0029).
Regarding claim 18, Koska in view of Sund, Meyer, and Pesis discloses the cannula above.
Koska in view of Sund, Meyer, and Pesis does not expressly disclose the interior edge has an edge apex thickness of greater than one micrometer (1 micron).
Gallegos disclose an edge (Gallegos: Fig. 2, cutting edge portion 330) that is dulled to a BESS rating of higher than 500 (cutting edge portion 330 may have a sharpness greater than 500 grams; para. 0029). It is known in the art that a BESS of over 500 grams is equivalent to an edge apex thickness of over 1 micron.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the interior edge of Koska in view of Sund, Meyer, and Pesis such that the interior edge has an edge apex thickness of greater than one micrometer (1 micron) as taught by Gallegos in order to produce a desirably dulled edge (Gallegos: para. 0029).
Regarding claim 19, Koska in view of Sund, Meyer, and Pesis discloses the cannula above.
Koska in view of Sund, Meyer, and Pesis does not expressly disclose the interior edge has a Cutlery and Allied Trades Research Association (CATRA) Razor Edge Sharpness Test (REST) push-cutting force of greater than five Newtons (5N).
Gallegos disclose an edge (Gallegos: Fig. 2, cutting edge portion 330) that is dulled to a BESS rating of higher than 500 (cutting edge portion 330 may have a sharpness greater than 500 grams; para. 0029). It is known in the art that a BESS of over 500 grams is equivalent to an CATRA REST push-cutting force of over 5 newtons.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the interior edge of Koska in view of Sund, Meyer, and Pesis such that the interior edge has a Cutlery and Allied Trades Research Association (CATRA) Razor Edge Sharpness Test (REST) push-cutting force of greater than five Newtons (5N) as taught by Gallegos in order to produce a desirably dulled edge (Gallegos: para. 0029).
Regarding claim 20, Koska in view of Sund, Meyer, and Pesis discloses the cannula above.
Koska in view of Sund, Meyer, and Pesis does not expressly disclose that the interior edge is dulled to a Brubacher Edge Sharpness Scale (BESS) rating of higher than 500.
Gallegos disclose an edge (Gallegos: Fig. 2, cutting edge portion 330) that is dulled to a BESS rating of higher than 600 (cutting edge portion 330 may have a sharpness greater than 500 grams; para. 0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the interior edge of Koska in view of Sund, Meyer, and Pesis such that the interior edge is dulled to a Brubacher Edge Sharpness Scale (BESS) rating of higher than 600 as taught by Gallegos in order to produce a desirably dulled edge (Gallegos: para. 0029).
Conclusion
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
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