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 § 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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lafferty (US 20080171996 A1).
Regarding Claim 1, Lafferty discloses a drug delivery device (Fluid dispensing device; Fig 34) for delivering drug from a plurality of drug cartridges (vessel 1550, Fig 32) to a patient, each of the drug cartridges (1550) including an elongated body (sidewall 1558, Fig 33) having a first end (end where septum 1556 is located, Fig 33) sealed with a septum (septum 1556, Fig 33) and a second open end (Open end of 1550, Fig 32), and, a stopper (piston 1552, Fig 32) located in the body (1558), wherein, in an initial state (before delivery), each of the drug cartridges (1550) includes at least one drug (drug, [0008]) contained in the body (1558) between the stopper (1552) and the septum (1556) thereof ([0128]), the drug delivery device (Fig 34) comprising: a cylindrical cassette (cartridge assembly 1500, Fig 34) configured to accommodate the plurality of drug cartridges (1550) (Fig 34); a plurality of cannulas (lances 1520, Fig 31) positioned to simultaneously pierce the septa (1556) of the plurality of drug cartridges (1550) ([0128]); a plurality of fluidic channels (channels of lances 1520, Fig 31) individually connected to the plurality of cannulas (1520), the plurality of fluidic channels (channels of lances 1520) converging to a common outlet (common output; claim 1); a reversibly advanceable plunger (head 1120 + shaft 1112, Fig 26); and, an indexer (head assembly 1100, Fig 26) for incrementally rotating the cassette (1500) to align the plurality of drug cartridges (1550) individually with the plunger (1120+1112) ([0122]), the plunger (1120+1112) being advanceable to urge the stopper (1552) of the aligned drug cartridge (1550) towards the septum (1556) of the aligned drug cartridge (1550) to cause the at least one drug (drug; [0008]) contained in the body (1558) of the aligned drug cartridge (1550) to be expelled through the cannula (1520) piercing the septum (1556) of the aligned drug cartridge (1550) ([0128]).
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 3-7, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lafferty (US 20080171996 A1) in view of Heald et al. (GB 2524525 A).
Regarding Claim 3, Lafferty/Heald discloses a drug delivery device as in claim 11. Lafferty is silent wherein the indexer further includes a tubular carrier, the first shaft and the second shaft extending into the tubular carrier.
Heald teaches a device (training cassette unit 101, Fig 8) comprising an indexer (index guide 126+ index crown + shuttle crown 180) further includes a tubular carrier (index guide 126, Fig12), a first (index crown 185, Fig 7) and second shafts (shuttle crown 180, Fig 7) extending into the tubular carrier (index guide 126, Fig 7) (See Fig 7).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the indexer of device of Lafferty/Heald with similar indexing mechanism and components as taught by Heald for the purpose of reposition the cassette upon injection (Page 27, lines 1-10).
Regarding Claim 4, Lafferty/Heald discloses a drug delivery device as in claim 3. Lafferty is silent wherein the tubular carrier includes a plurality of notches defined on an inner surface thereof, wherein the first shaft includes a plurality of slant-cut teeth formed to interface with the plurality of notches, and, wherein the first shaft is biased to have the slant-cut teeth normally interface with the plurality of notches.
Heald teaches a device (training cassette unit 101, Fig 8) comprising the tubular carrier (126) includes a plurality of notches (detents 183, Fig 13a) defined on an inner surface thereof (detents 183 are partially defined by inner surface of the guide 126, Fig 13a), wherein the first shaft (185) includes a plurality of slant-cut teeth (index teeth 187, Fig 13a) formed to interface with the plurality of notches (183), and, wherein the first shaft (185) is biased to have the slant-cut teeth (187) normally interface with the plurality of notches (183)(Page 30, lines 25-30: “ The axial force provided by the reset spring 175 urges the index crown 185 to move across the inclined faces 182 of the index guide 126 and the shuttle crown teeth 166 of shuttle crown 180, which causes it to rotate and move axially rearward until the index teeth 187 of the index crown 185 engage with the detents 183 on the index guide 126 as shown at Figure 13a”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the indexing mechanism of device of Lafferty/Heald with a similar spring, notches and slant-cut teeth interface as taught by Heald for the purpose of coupling the components to allow reposition of the cassette upon injection (Page 30, lines 25-30).
Regarding Claim 5, Lafferty/Heald discloses the drug delivery device as in claim 4. Lafferty is silent wherein the second shaft includes a plurality of teeth, wherein, with the axial shifting of the second shaft relative to the first shaft, the plurality of teeth engage the plurality of slant-cut teeth to cause the plurality of slant-cut teeth to separate from the plurality of notches.
Heald teaches a device (training cassette unit 101, Fig 8) comprising the second shaft (180) includes a plurality of teeth (crown teeth 166, Fig 13b), wherein, with the axial shifting of the second shaft (180) relative to the first shaft (185), the plurality of teeth (166) engages the plurality of slant-cut teeth (187) to cause the plurality of slant-cut teeth (187) to separate from the plurality of notches (Fig 13b)(Page 29, lines 27-30).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the indexing mechanism of device of Lafferty/Heald with similar plurality of teeth of second shaft as taught by Heald for the purpose of aiding in decoupling to reposition of the shuttle (Page 29, lines 27-30).
Regarding Claim 6, Lafferty/Heald discloses the drug delivery device as in claim 5. Lafferty is silent wherein, with return of the second shaft to being spaced from the first shaft, the plurality of slant-cut teeth are incrementally rotated and urged into engagement with the plurality of notches
Heald teaches a device (training cassette unit 101, Fig 8) comprising wherein with return of the second shaft (180) to being spaced from the first shaft (185), the plurality of slant-cut teeth (187) are incrementally rotated and urged into engagement with the plurality of notches (183) (Page 30, lines 24-30: “reset spring 175 urges the index crown 185 to move across the inclined faces 182 of the index guide 126 and the shuttle crown teeth 166 of shuttle crown 180, which causes it to rotate and move axially rearward until the index teeth 187 of the index crown 185 engage with the detents 183 on the index guide 126 as shown at Figure 13a”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Lafferty/Heald with similar indexing mechanism as taught by Heald for the purpose of rotate the cassette and reposition the shuttle upon injection (Page 30, lines 24-30).
Regarding Claim 7, Lafferty/Heald discloses the drug delivery device as in claim 4. Lafferty is silent wherein the tubular carrier includes a plurality of ramped surfaces defined on the inner surface thereof, the ramped surfaces being located among the plurality notches.
Heald teaches a device (training cassette unit 101, Fig 8) comprising the tubular carrier (126) includes a plurality of ramped surfaces (inclined faces 182, Fig 13a) defined on the inner surface thereof (inclined faces are partially defined by inner surface of index guide 126), the ramped surfaces(182) being located among the plurality notches (183) (Fig 13a).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the indexing mechanism device of Lafferty/Heald with similar ramped surfaces as taught by Heald for the purpose of rotate the cassette and reposition the shuttle upon injection (Page 30 lines 25-30).
Regarding Claim 11, Lafferty discloses the drug delivery device as in claim 1 wherein the indexer (head assembly 1100, Fig 26) including: a first shaft (shaft 1124, Fig 26) coupled to the cassette (cartridge assembly 1200, Fig 25) so as to be rotatable therewith [0117]; shaft 1124 is inserted in guide 1202 which couples the shaft 1124 and the cartridge assembly 1200 rotationally). Lafferty is silent regarding a second shaft coaxially aligned with, and normally biased to be spaced from, the first shaft, wherein, the second shaft is axially shiftable to engage the first shaft, and, wherein, the first and second shafts include cooperating elements which cause incremental rotation of the first shaft, relative to the second shaft, upon the second shaft engaging the first shaft.
Heald teaches a device (training cassette unit 101, Fig 8) comprising the indexer (index guide 126+ index crown + shuttle crown 180) including: a first shaft (index crown 185, Fig 12) and a second shaft (shuttle crown 180, Fig 12) coaxially aligned with, and normally biased (175) to be spaced from, the first shaft (185) (Fig 13a; show the resting position where the first shaft 185 and second shaft 180 are biased to be spaced from each other as result of spring 175 and index guide 126), wherein, the second shaft (180) is axially shiftable to engage the first shaft (185), and, wherein, the first (185) and second (180) shafts include cooperating elements (crown teeth 166, Fig 13b, index teeth 187, Fig 13a) which cause incremental rotation of the first shaft (185), relative to the second shaft (180), upon the second shaft (180) engaging the first shaft (185) (Fig 13a-e; Page 29, lines 11-14).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the indexing mechanism of device of Lafferty with similar indexing mechanism and components as taught by Heald for the purpose of reposition the cassette upon injection (Page 27, lines 1-10; Page 29, lines 11-14).
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive. Applicant submits that Lafferty fails to disclose or suggest all of the limitations of claim, specifically claim 1 limitation: (…) an indexer for incrementally rotating the cassette (…). Examiner respectfully disagrees. The claim limitation does not specify how the rotation occurs.
Please note claim functional limitation “(…) indexer for incrementally rotating the cassette” indicates that the indexer must be structurally capable and suitable for rotation of the cassette, but do not limit how the motion reaches the cassette or that the indexer directly drives the cassette rotation.
Lafferty discloses an indexer (head assembly 1100, Fig 26) for incrementally rotating the cassette (1500) to align the plurality of drug cartridges (1550) individually with the plunger (1120+1112) ([0122]). Head assembly 1100 is attached to the case assembly 500 containing cassette 1500 via threading 1118 and a key 1123, rotationally fixing the case assembly 500 and cassette 1500 to the grip 1113 and seat 1116 once threaded. Base plate 1114 is fixed to handle 1102 ([0063], similar mechanism as Fig 2). Rotation between base plate 1114 and cassette 1500 is configured to select dose to be injected ([0122]). When user holds the handle 1102 and rotates the head assembly 1100 as seen in [0122], the cassette 1500 is rotating relative to base plate 1114 of head assembly 1100 and handle 1102.
Therefore the indexer (1100) is structurally capable of incrementally rotating the cassette (1500) due to permissible relative rotation between base plate 1114 of indexer (1100) and the cassette (1500) to align the plurality of drug cartridges (1550) individually with the plunger (1120+1112) ([0122]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783