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 without traverse of Group I (claims 1-28) in the reply filed on 01/05/2026 is acknowledged.
Claims 29-37 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/05/2026.
Claim Rejections - 35 USC § 102
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.
Claims 1-9, 18-19, and 22-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roth US 20190117827 A1.
Roth teaches a medical device comprising titanium coating with one or more agents with one or more polymers, or at least partially encapsulate one or more agents into and/or with one or more polymers, or 3) insert one or more agents in pores, passageway, cavities, etc. in the medical device and at least partially coat or cover such pores, passageway, cavities, etc. with one or more polymers. As can be appreciated, other or additional arrangements can be used to control the release of one or more agents from the medical device. See paragraphs 0009-0012 and 0033-0040. The claimed coating polymers including chitosan and PLGA can be found in paragraphs 0042 and 0048-0049. Coating including bioactive agent can be found in paragraph 0043.
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 1-28 are rejected under 35 U.S.C. 103 as being unpatentable over Roth US 20190117827, in view of Imran US 20220257502 A1.
Roth is relied upon for the reason stated above. Roth does not teach a housing compartment for the medical device.
Imran teaches a delivery device for delivering a payload to a site, such as a site within a body (e.g., a human or other animal body). A payload can be or include a formulation, electronics, another delivery device, or a combination of two or more of the foregoing. See paragraph 0045 and Figures 1-37. The device comprising a shell (e.g., any of shell 105, 125, 145, 165, 205, 225, 245, or 265, or other shell embodiment) is constructed integrally, meaning that the entire shell is formed as a unit. In one or more other embodiments, a shell (e.g., any of shell 105, 125, 145, 165, 205, 225, 245, or 265, or other shell embodiment) is constructed using two or more components which are then assembled together to form the finished shell; in such embodiments, the components can be attached to each other in a semi-permanent or non-permanent structure with connection mechanisms (e.g., using snap features, hook-and-loop features, adhesives, adhesive tape) or attached to each other in a more permanent fashion (e.g., using heat staking, vibration welding, compression welding), or a combination thereof. An example of a shell incorporating multiple components is a tube cut to a desired length with a closed component attached at one end and a component with an orifice attached at the other end. Another example of a shell incorporating multiple components is a shell (e.g., any of shell 105, 125, 145, 165, 205, 225, 245, or 265, or other shell embodiment) molded in two halves lengthwise and attached together after molding. See paragraph 0067. The device can be coated with a delay agent such as poly(lactic acid) (PLA), poly(glycolic acid) (PGA), polyethylene glycol (PEG), poly(ethylene oxide) (PEO), poly (l-lactic acid) (PLLA), poly(D-lactic acid) (PDLA), other polymers, hydrogel, and combinations of two or more of the foregoing. See paragraph 0057. Shell of a delivery device is formed of PGA; in one or more embodiments, a shell of a delivery device is formed of PLA. PGA and PLA have different degradation rates. In one or more embodiments, a shell of a delivery device is formed of a PLA-PGA blend to select a different degradation time as compared to PGA or PLA alone. Other degradation times can be achieved by using different materials, in addition or alternatively. See paragraph 0082. Figs 16-17 disclosed a delivery device having a wall disposed internal to shell. A delivery device can itself be a payload for another delivery device. For example, delivery device 2400 can be contained inside a capsule, or inside a spring-loaded or other mechanical mechanism within a housing which mechanism ejects delivery device 2400 out of the housing (e.g., into human tissue). See paragraph 0139. FIGS. 26A, 26B illustrate examples of embodiments of delivery devices containing electronics. According to various embodiments, the components included or associated with electronics in an embodiment of the present disclosure can correspond to one or more of a receiver, a transmitter, a processor, a digital signal processor, power management circuitry, a battery, and/or a battery charger interface for charging remotely, or other circuitry. It is to be understood that processors and various circuitry may include instructions, such as hard-wired instructions, firmware, or software, for controlling the processor or circuitry in a desired fashion. Shell 3410 is constructed of Mg, PLA, or PLGA, or a combination of two or more of the foregoing. In one or more embodiments, a designed time for degradation of shell 3410 in a target environment is greater than a designed time for formulation 3440 to diffuse out of delivery device 3400 by way of orifice(s) 3430. In one or more other embodiments, a designed time for degradation of shell 3410 in the target environment is approximately equal to or greater than the designed time for formulation 3440 to diffuse out of delivery device 3400. In the second example of FIG. 34, plug 3420 is also degradable. For example, plug 3420 is constructed of Mg, PLA, or PLGA, or a combination of two or more of the foregoing. Paragraph 0178. A coating (e.g., coating 1420 in FIG. 14) can be disposed over all of, or a portion of, a delivery device such as a delivery device incorporating any of the features discussed herein, to further define an elution profile. A coating is a protective coating and can include multiple coating layers, such as a protective coating which protects portions of a delivery device from coming into contact with tissues or fluids (e.g., biological tissue or fluid.) One such protective coating is wax, such as beeswax or other wax. In a first example, a protective coating can be used to cover a shell except where a plug is to be positioned, such that only the plug is exposed to fluid. In a second example, a protective coating can be used to cover a shell and also cover a portion of a plug, such as to focus degradation of the plug for a more uniform degradation across the exposed surface of the plug, or such as to use the same shell/plug design to implement multiple elution profiles by adjusting an amount of plug surface exposed by the coating. See paragraphs 0190-0192. Examples of coatings include: a three-layer coating of PLA-Mg-PLA; a two-layer coating of PLA-PLA; a one-layer coating of Mg; a one-layer coating of PLA; a three-layer coating of Mg-PLA-opacifier, where the opacifier is in the outer layer and can also include coloring; a four-layer coating of PLA-Mg-radiopaque marker-opacifier, where the opacifier is in the outer layer and can also include coloring. Many other examples abound. In one or more embodiments, a coating includes a peptide layer. The peptide (e.g., P15) appears to the body as a naturally-occurring substance in the body (e.g., collagen), and thus the body's natural immunosuppression mechanisms can be avoided, to repress the body's rejection of the delivery device. Desired characteristics of a coating can be incorporated by design, such as design of thickness of coating(s), relative location of a plug and a coating with respect to each other, selection of one or more layers of a degradable coating each having selected properties, selection of a chemical composition of the degradable coating or layers thereof, position and extent of a protective coating, and many other attributes. See paragraphs 0198-0199.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in Roth to include a housing device in view of the teaching in Imran with the expectation to improve delivery of the medical device for a wide range of administration routes in view of the teaching in Imran. This is because Imran teaches using a smart pill for the delivery of any medical device is known in the art.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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