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
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.
Claim(s) 44,46-47,50,53,62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bene et al. (US 2008/0161741 A1).
With regard to claim 44, Bene discloses A drug delivery ocular implant (Fig. 8) comprising: an outer shell (160) having an interior chamber (see where 164/168 is pointing) providing a drug reservoir; a distal seal member (162 is a stack of seal members and thus one of the seals on the end can be considered a distal seal member) inside the outer shell; a proximal seal member (the other end of the stack of three seal members can be considered the proximal seal member); and a membrane (the stack of three seals comprises a middle membrane is that is considered the compressed membrane as its is located between the distal and proximal seal members) compressed between the distal seal member and the proximal seal member such that the membrane is in a compressed state, wherein the membrane in the compressed state is configured to be permeable to a drug to permit the drug to elute through the membrane ([0044]).
With regard to claim 46, Bene discloses wherein the proximal seal member has a generally annular shape with an opening extending therethrough ([0044], the proximal seal is one of the stack of seals 162 and contains holes of varying pore sizes to extend therethrough), and wherein the drug delivery ocular implant is configured such that the drug that elutes through the membrane passes through the opening in the proximal seal member ([0044]).
With regard to claim 47, Bene discloses wherein the distal seal member has a generally annular shape with an opening extending therethrough ([0044], the distal seal is one of the stack of seals 162 and contains holes of varying pore sizes to extend therethrough), and wherein the drug delivery ocular implant is configured such that the drug that elutes through the membrane passes through the opening in the distal seal member ([0044]).
With regard to claim 50, Bene discloses wherein the interior chamber has an inner diameter of less than 500 microns ([0031]).
With regard to claim 53, Bene discloses wherein an exterior of the outer shell includes an indentation configured to interface with a tool for implantation and/or explantation (see 165 where there the body comprises an indent between 165 and 167, the limitation “configured to” is functional and therefore the tool itself does not need to be taught by the prior art as long as the indentation is capable of interfacing with a tool).
With regard to claim 62, Bene discloses A method of making a drug delivery ocular implant, the method comprising: providing an outer shell (fig. 8, element 160) having an interior chamber that provides a drug reservoir (at 164/168); placing a drug into the drug reservoir of the interior chamber ([0010], [0059]); inserting a distal seal member into the outer shell (162 is a stack of seal members and one of the end of the stacks can be considered the distal seal); providing a membrane (the middle seal of the stack of 162 is the membrane); providing a proximal seal member (162 is a stack of seal members and the other end of the stack is considered the proximal seal); compressing the membrane between the distal seal member and the proximal seal member such that the membrane is in a compressed state (see Fig. 8, the middle membrane of the stack 162 is considered compressed between the distal and proximal seal), wherein the membrane in the compressed state is configured to be permeable to the drug to permit the drug to elute through the membrane ([0044]).
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.
Claim(s) 45, 54-61,63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bene et al. (US 2008/0161741 A1) in view of Guo et al. (US 2002/0102307 A1).
With regard to claim 45, Bene discloses a shelf (see at the top of 164 between 164 and 166 which is considered a shelf at the distal end).
However, Bene does not disclose the distal seal member seated against the shelf.
Guo teaches a similar ocular implant (Fig. 2) with a membrane (222) and a shelf (230/228) wherein the distal seal member is seated against the shelf (as shown in Fig. 2).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bene with the shelf having the distal seal member seated against the shelf as taught by Guo for the purpose of controlling the exposed surface area of the membrane to control fluid flow ([0060]).
With regard to claim 54 and 63, Bene discloses the claimed invention except for a retainer.
Guo teaches comprising a retainer (228/230) separate from the outer shell (210) and configured to engage with a portion of the outer shell to retain the membrane in the compressed state (shown in Fig. 2).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bene with the retainer as taught by Guo for the purpose of controlling the exposed surface area of the membrane to control fluid flow ([0060]).
With regard to claim 55, Bene discloses the claimed invention except for a retainer.
Guo teaches comprising a retainer (228/230) wherein is disposed at least partially inside the interior chamber of the outer shell (as shown in fig. 2, shown at slot 240).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bene with the retainer as taught by Guo for the purpose of controlling the exposed surface area of the membrane to control fluid flow ([0060]).
With regard to claim 56, Bene discloses the claimed invention except for the retainer.
Guo teaches wherein the retainer has a lateral length that is greater than an inner diameter of the interior chamber adjacent the retainer (the length between 230 and 228 is larger than the interior diameter of the chamber 214).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bene with the retainer as taught by Guo for the purpose of controlling the exposed surface area of the membrane to control fluid flow ([0060]).
With regard to claim 57, Bene disclose the claimed invention except for the slots.
Guo teaches wherein the outer shell comprises one or more slots ( at 240) and wherein the retainer is configured to extend into the one or more slots (Fig. 2).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bene with the retainer and the slots as taught by Guo for the purpose of controlling the exposed surface area of the membrane to control fluid flow ([0060]).
With regard to claim 58, Bene discloses the claimed invention except for the retainer.
Guo teaches wherein the retainer is positioned proximally of the proximal seal member (see Fig. 2, element 228 and 230 is located at an end of the outer shell), wherein force from the membrane in the compressed state presses the retainer in a proximal direction against one or more portions of the outer shell that are proximal of the one or more slots (a shown in Fig. 2).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bene with the retainer as taught by Guo for the purpose of controlling the exposed surface area of the membrane to control fluid flow ([0060]).
With regard to claim 59, Bene discloses the claimed invention except for the slots.
Guo teaches wherein the outer shell comprises a first slot (one of 240) and a second slot (the other of 240) positioned opposite of the first slot (Fig. 2).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bene with the retainer and the slots as taught by Guo for the purpose of controlling the exposed surface area of the membrane to control fluid flow ([0060]).
With regard to claim 60, Bene discloses the claimed invention except for the retainer.
Guo teaches wherein the retainer (228/230) includes one or more openings (230/228 is a ring and thus has a central opening) extending therethrough, and wherein the drug delivery ocular implant is configured such that the drug that elutes through the membrane passes through the one or more openings in the retainer (as shown in Fig. 2).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bene with the retainer as taught by Guo for the purpose of controlling the exposed surface area of the membrane to control fluid flow ([0060]).
With regard to claim 61, Bene discloses the claimed invention except for the retainer.
Guo teaches wherein the retainer (228/230) is bent to secure the retainer (Fig. 2, [0060]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bene with the retainer as taught by Guo for the purpose of controlling the exposed surface area of the membrane to control fluid flow ([0060]).
Claim(s) 48-49, 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bene et al. (US 2008/0161741 A1).
With regard to claim 48, Bene discloses the claimed invention except for the exact volume of the drug reservoir.
However, it would be prima facie obvious to optimize the size of the drug reservoir to be between 40nanoliters to about 200 nanoliters as doing so would be within the skill of one of ordinary skill in the art and would not alter the overall function of the device.
With regard to claim 49, Bene discloses the claimed invention except for the exact volume of the drug reservoir.
However, it would be prima facie obvious to optimize the size of the drug reservoir to be between 100 nanoliters to about 150 nanoliters as doing so would be within the skill of one of ordinary skill in the art and would not alter the overall function of the device.
With regard to claim 51, Bene discloses the claimed invention except for the exact thickness of the membrane.
However, it would be prima facie obvious to optimize the thickness of the membrane to be between 50 microns and about 125 microns as doing so would be within the skill of one of ordinary skill in the art and would not alter the overall function of the device.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 44-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,992,551 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 44 of the present invention recites similar limitations to that of claim 1 of U.S. Patent No. 11,992,551 B2 including a drug delivery device including an outer shell, a distal seal member, a proximal seal member and a membrane compressed between the distal and proximal seal members. Claim 1 of the present invention is a broader version of U.S. Patent No. 11,992,551 B2 and therefore is taught by U.S. Patent No. 11,992,551 B2.
Further the dependent claims of the present invention recite similar subject matter as the dependent claims of U.S. Patent No. 11,992,551 B2 as outlined below:
Present Invention
U.S. Patent No. 11,992,551 B2
45
14
46
1
47
1
48
10
49
10
51
7
52
8
53
13
54
3
55
3
56
5
57
4
59
6
60
1
61
2
62
16
63
16
Allowable Subject Matter
Claim 52 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and overcoming the Double Patenting Rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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