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 § 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.
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.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Heitzmann et al. (US 2018/0333296).
With reference to claim 1, Heitzmann et al. (hereinafter “Heitzmann”) discloses an implant device for an eye disease to be inserted into an eyeball (abstract), the implant device for an eye disease comprising:
a tube having one end to be inserted into an anterior chamber of the eyeball, the tube comprising a hollow portion through which aqueous humor is drained [0033]; and
a matrix coupled to an outer surface of the tube and formed of a material capable of impregnating and releasing a drug as set forth in [0034].
The difference between Heitzmann and claim 1 is the explicit recitation that at least a part of the matrix has a cross-section larger than a diameter of the tube.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the device of Heitzmann with at least a part of the matrix having a cross-section larger than a diameter of the tube because changes in size and/or shape of an element previously set forth in the prior art is considered to be within the level of ordinary skill in the art especially in view of Heitzmann establishing the nexus between the thickness of the tube and/or the drug to control the rate of diffusion and/or transport of the drug in [0034].
It is further noted that Heitzmann recognizes that the shape of the drug release may be varied as desired to accomplish sufficient delivery as set forth in [0134].
With reference to claim 2, Heitzmann discloses an implant device for an eye disease wherein the tube comprises:
a body extending in one direction and a wing integrally formed with the body or detachably coupled to the body and extending in a lateral direction of the body (see [0225] and figure 19C),wherein the matrix is at least partially coupled to the wing as set forth in [0196].
As to claims 3 and 4, Heitzmann teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Heitzmann and claims discloses an implant device for an eye disease wherein the matrix comprises a pair of sheet members at least partially adhered to each other (cl. 4), wherein the tube is disposed between the pair of sheet members.
Heitzmann provides a retainer, which is disclosed as providing the matrix in [0225] as tabs as folded tabs (564) as set forth in [0279-0280] and as shown in figure 37-38.
It would have been obvious to one of ordinary skill in the art at the time of the invention to configure the matrix and tube to determine the desired configuration because Heitzmann discloses that any retention means may be used with any illustrated (and/or described) implant (even if not explicitly illustrated or described as such) wherein implants may be wedged or trapped (permanently or transiently) based on their shape and/or size in a particular desirable ocular space as set forth in [0222].
As to claims 5 and 6, see the rejection of claims 3-4.
With reference to claims 7-10, see [0370] and [0440-0445].
With respect to claim 11, see [0443].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hee et al. (US 2008/0058704) discloses a ocular implant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781
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