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 .
This office action is in response to applicant’s communication of 7/10/2023. Currently claims 1 and 35-53 are pending and rejected below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, and 35-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (US 2010/0286668 A1), in view of Imran et al. (US 2020/0222318 A1).
Tanaka discloses a drug delivery device (see figures 5-8 for example) having a central axis, the drug delivery device comprising: a first body part (31); a second body part (1); an actuator mechanism (35) configured to rotate at least one of the first body part or the second body part with respect to one another about the central axis; and a first attachment part (32) comprising a connector component (32) and a first spike component (34), wherein the connector component (32) is connected to the first body (31) part and the first spike component is connected to the connector component.
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Tanaka discloses the claimed invention except for the first spike component is releasably connected to the connector component. Imran teaches that it is known to use the first spike component is releasably connected to the connector component as set forth in paragraphs [0016], [0193]-[0195] to provide a means to temporarily attach to an anatomical structure and provide a fail safe mechanism for detaching from the intestinal wall. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Tanaka with the first spike component is releasably connected to the connector component as taught by Imran, since such a modification would provide the system with the first spike component is releasably connected to the connector component] for providing a means to temporarily attach to an anatomical structure and provide a fail safe mechanism for detaching from the intestinal wall.
Note Imran such as connector component 175 and spike 140 for examples.
Concerning claim 35 and the first spike component is made of a dissolvable material (see paragraphs [0016], [0193]-[0195])
Concerning claim 36 and the first attachment part comprises a coupling component (as in Imran 175), wherein the coupling component couples the first spike component (140)to the connector component (175), and wherein when the coupling component decouples, the first spike component is released from the connector component (see Imran figure 20I for one example).
Concerning claim 37 and the coupling component comprises a sleeve configured to at least partially surround the first spike component (see Imran 175 and sleeve 174).
Concerning claim 38 and the sleeve is configured to at least partially surround the connector component (see Imran figures 19-20h).
Concerning claim 39 and the sleeve is formed from a material comprising one or more of polyethylene, polypropylene, acrylonitrile butadiene styrene, polyethylene oxide, polyethylene glycol, poly(methyl methacrylate), hydroxypropylmethylcellulose acetate succinate, or hypromellose phthalate (see para [0016], [0103], [0172]. [0198]).
Concerning claim 40 and the sleeve has a longitudinal length of 1.5 to 15 mm and a diameter of 0.15 to 2 mm. The prior art discloses the claimed invention except for a longitudinal length of 1.5 to 15 mm and a diameter of 0.15 to 2 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made have a longitudinal length of 1.5 to 15 mm and a diameter of 0.15 to 2 mm., since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). These are common and known dimensions a PHOSITA would know to craft tissue penetrating members from in order to safely treat a patient.
Concerning claim 41 and the first spike component has a chamber configured to contain an active drug substance (see figure 18d for example and chamber 101/142 that holds a drug).
Concerning claim 42 and the first attachment part (175) comprises a coupling component (175), wherein the coupling component (175) couples the first spike (140) component to the connector component (178), and wherein when the coupling component decouples, the first spike component is released from the connector component (as shown in figure 20I), and the coupling component (175) comprises a sleeve configured to at least partially surround the first spike component, wherein the chamber is exposed to an outer surface of the first spike component, and wherein the sleeve provides a fluid tight connection with the first spike component preventing release of the active drug substance (as in the 18f and 19 figures).
Concerning claim 43 and the first spike component comprises a channel, which fluidly connects the chamber and an outer surface of the first spike component (see figure 18d through 18g and note chamber 101/142).
Concerning claim 44 and the first attachment part comprises a coupling component (175), wherein the coupling component couples the first spike (140) component to the connector component (178), and wherein when the coupling component decouples, the first spike component is released from the connector component (as in figure 20I), and the coupling component comprises a sleeve (174) configured to at least partially surround the first spike component and, wherein the sleeve comprises a mating protrusion configured to block the channel (when spike 140 is attached).
Concerning claim 45 and the connector component of the first attachment part is rotatably connected to the first body part (see Tanaka first attachment part (32) comprising a connector component (32), and body component (31)
Concerning claim 46 and the first spike component comprises a distal spike component having a distal spike mating feature and a proximal spike component having a proximal spike mating feature (note ends of 140 of Imran).
Concerning claim 47 and the coupling component is dissolvable (note Imran paragraphs [0016], [0193]-[0195]).
Concerning claim 48 and the first spike component is configured to translate with respect to the coupling component (see Tanaka 5-8 and spike 34).
Concerning claim 49 and the connector component is configured to separate from the first body part (see Imran figure 20h and separation).
Concerning claim 50 and the connector component is configured to separate into a first connector section and a second connector section and, wherein the second connector section is configured to remain attached to the first body part (see figures 20g-20h of Imran and note element (178 multiples in relation to 175).
Concerning claim 51 and the connector component comprises a pre-weakened area comprising a biodegradable area and/or a water-soluble area (see paragraphs [0016], [0193]-[0195]).
Concerning claim 52 and the pre-weakened area is located between the first connector section and the second connector section or wherein the pre-weakened area is located at an attachment point between the connector component and the first body part (see discussion at para 198 and the discussion of forming biodegradable areas of material 105).
Concerning claim 53 and the drug delivery device comprising: a first body part (Tanaka 31); a second body part (1); an actuator mechanism (35) configured to rotate at least one of the first body part or the second body part with respect to one another about the central axis; and a first attachment part (32) connected to the first body part.
Tanaka discloses the claimed invention except for the first spike component is releasably connected to the connector component (or configured to separate from the first body part). Imran teaches that it is known to use the first spike component is releasably connected to the connector component (or configured to separate from the first body part) as set forth in paragraphs [0016], [0193]-[0195] to provide a means to temporarily attach to an anatomical structure and provide a fail safe mechanism for detaching from the intestinal wall. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Tanaka with the first spike component is releasably connected to the connector component as taught by Imran, since such a modification would provide the system with the first spike component is releasably connected to the connector component (or configured to separate from the first body part) for providing a means to temporarily attach to an anatomical structure and provide a fail safe mechanism for detaching from the intestinal wall.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783