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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 06/23/2026 is acknowledged.
Response to Amendment
This office action is responsive to the amendment filed on 06/23/2026. As directed by the amendment: no claims have been amended, claims 28-35 have been cancelled, and claims 36-43 have been added. Thus, claims 16-27 and 36-43 are presently pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a first drug release element” and “a second drug release element” in claims 16 and 36.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding “a first drug release element” and “a second drug release element” in claims 16 and 36, 112(f) is invoked because: (i) it uses a generic placeholder (element), (ii) it is coupled with functional language (drug release), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Para. 0008-0010 disclose the drug release elements as either a membrane or a structure comprising two seal membranes with openings and a membrane compressed therebetween. Examiner is interpreting the limitations as a membrane itself or a membrane construction configured to release a drug or equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 16-18, 21, 23-24, 26-27, 36-38, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Haffner et al. (U.S Patent Pub. No. 20120078362 A1, “Haffner”).
Regarding claim 16, Haffner discloses the limitations of (Claim 16) a drug delivery ocular implant (see Fig. 19S) comprising an outer shell defining at least one interior lumen (58 in Fig. 19S) and one or more orifices (56a in Fig. 19S) for the exit of drugs within the interior lumen (58, see para. 0106, 0127, and 0173).
However, the implant of Fig. 19S of Haffner fails to disclose (Claim 16) a proximal portion; a distal portion; a barrier dividing the proximal portion and the distal portion, the proximal portion defined by the barrier and a first drug release element, the distal portion defined by the barrier and a second drug release element; a first drug positioned within the proximal portion and configured to elute into an anterior chamber of an eye; and a second drug positioned within the distal portion and configured to elute into Schlemm's canal.
The embodiment of Fig. 5 of Haffner discloses an implant (see Fig. 5 and para. 0113) comprising:
a proximal portion (58a in Fig. 5);
a distal portion (58 in Fig. 5);
a barrier (64 in Fig. 5) dividing the proximal portion (58a) and the distal portion (58, see para. 0106 and 0113), the proximal portion (58a) defined by the barrier (64) and a first drug release element (56 in Fig. 5, examiner notes the first drug release element is interpreted under 112(f) as a membrane itself or a membrane construction configured to release a drug or equivalents thereof, see para. 0033, 0110 and 0113 – proximal portion 58a is defined by partition 64 and the regions 56 of drug release, the regions 56 of drug release may be areas of reduced thickness or different material having an increased permeability to the drug 62 therewithin and thus are equivalents to a membrane construction as they are thin sheets of material providing a selective barrier), the distal portion (58) defined by the barrier (64) and a second drug release element (56 in Fig. 5, examiner notes the second drug release element is interpreted under 112(f) as a membrane itself or a membrane construction configured to release a drug or equivalents thereof, and para. 0033, 0110 and 0113 – the distal portion 58 is defined by the partition and the regions 56 of drug release, the regions 56 of drug release may be areas of reduced thickness or different material having an increased permeability to the drug 62 therewithin and thus are equivalents to membrane construction as they are thin sheets of material providing a selective barrier),
a first drug (62a in Fig. 5) positioned within the proximal portion (58a) and configured to elute into an anterior chamber of an eye (see para. 0113 – the varying regions of drug release such as that in proximal portion 58a may be placed within the eye to specifically target certain intraocular tissues); and
a second drug (62 in Fig. 5) positioned within the distal portion (58) and configured to elute into Schlemm’s canal (see para. 0113 – the varying regions of drug release in the distal portion 58 may be placed within the eye to specifically target certain intraocular tissues that are different than those targeted by the proximal portion 58a).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant in the embodiment of Fig. 19S of Haffner to be the dual-compartment implant in the embodiment of Fig. 5 of Haffner such that the embodiment of Fig. 19S comprises the dual compartments, the barrier therebetween, and the regions of drug release in each compartment. The embodiment of Fig. 5 of Haffner teaches the dual-compartment implant with specific targeting of tissues for the regions of drug release reduces the amount of drug needed to achieve a therapeutic effect, reduces non-specific side effects of an eluted drug, and increases overall potential duration of drug delivery from the implant (see para. 0113).
Regarding claim 17, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above. In modified Haffner, the embodiment of Fig. 5 of Haffner discloses (Claim 17) wherein the barrier (64 in Fig. 5) is impermeable to the first drug (62a) and the second drug (62, see para. 0106 and 0113).
Regarding claim 18, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above. In modified Haffner, the embodiment of Fig. 19S of Haffner discloses (Claim 18) further comprising an inflow pathway (38k in Fig. 19S) at a distal end of the drug delivery ocular implant (see para. 0174 – the implant comprises inflow portion 38k disposed at one end of the implant interpreted as the distal end), the inflow pathway (38k) configured to allow ocular fluid to enter the drug delivery ocular implant (see para. 0174).
In modified Haffner, the embodiment of Fig. 5 discloses the second drug release element (56 in Fig. 5) that allows ocular fluids to flow through said second drug release element (56) into the distal portion (58) thereby allowing the second drug (62) to elute through the second drug release element (56, see para. 0087 and 0113).
Therefore, in combination, the implant of Fig. 19S of Haffner modified to have the dual-compartment implant structure of the embodiment of Fig. 5 of Haffner would thus place the second drug release element (56 in Fig. 5) of the distal portion (58) into fluid communication with the inflow pathway (38k) of the shunt device as claimed.
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Regarding claim 21, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above. In modified Haffner, the embodiment of Fig. 19S of Haffner discloses (Claim 21) further comprising a flange extending laterally outward a predetermined distance from a first inlet (38k in Fig. 19S, see annotated Haffner drawing 1 below and see para. 0174 – the implant comprises a flange extending laterally outward from its distal end and said flange is a predetermined distance from the first inlet 38k to ensure the implant is deployed in the correct anatomical location), the first inlet (38k) positioned adjacent the flange and between the flange and a proximal end of an interior chamber (58 in Fig. 19S) of the drug delivery ocular implant (see Fig. 19S and annotated Haffner drawing 1 below).
Regarding claim 23, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above. In modified Haffner, the embodiment of Fig. 19S of Haffner discloses (Claim 23) further comprising a retention protrusion (359 in Fig. 19S, see para. 0146).
However, the embodiment of Fig. 19S of Haffner fails to disclose that retention protrusion (359) extending from a distal end of the drug delivery ocular implant. Rather, Fig. 19S illustrates the retention protrusion (359) on a proximal end.
The embodiment of Fig. 15 of Haffner discloses a retention protrusion (359), wherein the implant “having the distal portion being the implant end and the proximal portion being the retention protrusion 359 end, in some embodiments, depending on the site and orientation of implantation, the distal portion and proximal portion may be reversed relative to the orientation in FIG. 15.”
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the retention protrusion on the proximal end of the embodiment of modified Haffner to instead be on the distal end as taught by the embodiment of Fig. 15 of Haffner according to known methods to yield predictable results. The embodiment of Fig. 15 discloses that it would have been obvious to have reversed the location of the retention protrusion as needed for the site and orientation of implantation (see para. 0146), and thus one of ordinary skill in the art would have recognized that placed the retention protrusion on the distal end of the implant in Fig. 19S distal of the outflow pathway (56k) would yield results that were predictable as the implant would still be retained in its location and orientation just anchored at the opposite end.
Regarding claim 24, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above. In modified Haffner, the embodiment of Fig. 19S discloses (Claim 24) wherein the retention protrusion (359) comprises a cone shaped portion (see reference number “351” in Fig. 19S).
Regarding claim 26, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above. In modified Haffner, the embodiment of Fig. 5 discloses the first drug release element (56 in Fig. 5, see para. 0033, 0110 and 0113 –the regions 56 of drug release may be areas of reduced thickness or different material having an increased permeability to the drug 62 therewithin and thus are equivalents to a membrane construction as they are thin sheets of material providing a selective barrier).
However, modified Haffner fails to disclose (Claim 26) wherein the first drug release element is a membrane.
The embodiment of Fig. 10F of Haffner discloses an implant (50 in Fig. 10C) comprising the drug release regions (56a) in the form of orifices covered with elution membranes (100) that provide a barrier to the release of drug (62) from the interior lumen (58) and is permeable to both the drug (62) and bodily fluids (see para. 0134).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug release regions of modified Haffner to be in the form of orifices covered with elution membranes as taught by the embodiment of Fig. 10F of Haffner. This embodiment teaches that the elution membranes provide said barrier to the release of the drug and allows for controlling the inception of bodily fluids and egress of therapeutic agent from the implant (see para. 0134).
Regarding claim 27, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above. In modified Haffner, the embodiment of Fig. 5 discloses the second drug release element (56 in Fig. 5, see para. 0033, 0110 and 0113 –the regions 56 of drug release may be areas of reduced thickness or different material having an increased permeability to the drug 60 therewithin and thus are equivalents to a membrane construction as they are thin sheets of material providing a selective barrier).
However, modified Haffner fails to disclose (Claim 27) wherein the second drug release element is a membrane.
The embodiment of Fig. 10F of Haffner discloses an implant (50 in Fig. 10C) comprising the drug release regions (56a) in the form of orifices covered with elution membranes (100) that provide a barrier to the release of drug (62) from the interior lumen (58) and is permeable to both the drug (62) and bodily fluids (see para. 0134).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug release regions of modified Haffner to be in the form of orifices covered with elution membranes as taught by the embodiment of Fig. 10F of Haffner. This embodiment teaches that the elution membranes provide said barrier to the release of the drug and allows for controlling the inception of bodily fluids and egress of therapeutic agent from the implant (see para. 0134).
Regarding claim 36, Haffner discloses the limitations of (Claim 36) a drug delivery ocular implant (see Fig. 19S) comprising an outer shell defining at least one interior lumen (58 in Fig. 19S) and one or more orifices (56a in Fig. 19S) for the exit of drugs within the interior lumen (58, see para. 0106, 0127, and 0173).
However, the implant of Fig. 19S of Haffner fails to disclose (Claim 36) a first portion; a second portion; a barrier dividing the first portion and the second portion, the first portion defined by the barrier and a first drug release element, the second portion defined by the barrier and a second drug release element; a first drug positioned within the first portion and configured to elute through the first drug release element; and a second drug positioned within the second portion and configured to elute through the second drug release element.
The embodiment of Fig. 5 of Haffner discloses an implant (see Fig. 5 and para. 0113) comprising:
a first portion (58a in Fig. 5);
a second portion (58 in Fig. 5);
a barrier (64 in Fig. 5) dividing the first portion (58a) and the second portion (58, see para. 0106 and 0113), the first portion (58a) defined by the barrier (64) and a first drug release element (56 in Fig. 5, examiner notes the first drug release element is interpreted under 112(f) as a membrane itself or a membrane construction configured to release a drug or equivalents thereof, see para. 0033, 0110 and 0113 – first portion 58a is defined by partition 64 and the regions 56 of drug release, the regions 56 of drug release may be areas of reduced thickness or different material having an increased permeability to the drug 62 therewithin and thus are equivalents to a membrane construction as they are thin sheets of material providing a selective barrier), the second portion (58) defined by the barrier (64) and a second drug release element (56 in Fig. 5, examiner notes the second drug release element is interpreted under 112(f) as a membrane itself or a membrane construction configured to release a drug or equivalents thereof, and para. 0033, 0110 and 0113 – the second portion 58 is defined by the partition and the regions 56 of drug release, the regions 56 of drug release may be areas of reduced thickness or different material having an increased permeability to the drug 62 therewithin and thus are equivalents to a membrane construction as they are thin sheets of material providing a selective barrier),
a first drug (62a in Fig. 5) positioned within the first portion (58a) and configured to elute through the first drug release element (see para. 0033, 0113, and 0154); and
a second drug (62 in Fig. 5) positioned within the distal portion (58) and configured to elute through the second drug release element (see para. 0033, 0113, and 0154).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant in the embodiment of Fig. 19S of Haffner to be the dual-compartment implant in the embodiment of Fig. 5 of Haffner such that the embodiment of Fig. 19S comprises the dual compartments, the barrier therebetween, and the regions of drug release in each compartment. The embodiment of Fig. 5 of Haffner teaches the dual-compartment implant with specific targeting of tissues for the regions of drug release reduces the amount of drug needed to achieve a therapeutic effect, reduces non-specific side effects of an eluted drug, and increases overall potential duration of drug delivery from the implant (see para. 0113).
Regarding claim 37, modified Haffner discloses the drug delivery ocular implant of claim 36, as discussed above. In modified Haffner, the embodiment of Fig. 5 of Haffner discloses (Claim 37) wherein the barrier (64 in Fig. 5) is impermeable to the first drug (62a) and the second drug (62, see para. 0106 and 0113).
Regarding claim 38, modified Haffner discloses the drug delivery ocular implant of claim 36, as discussed above. In modified Haffner, the embodiment of Fig. 19S of Haffner discloses (Claim 38) further comprising an inflow pathway (38k in Fig. 19S) at a distal end of the drug delivery ocular implant (see para. 0174 – the implant comprises inflow portion 38k disposed at one end of the implant interpreted as the distal end), the inflow pathway (38k) configured to allow ocular fluid to enter the drug delivery ocular implant (see para. 0174).
In modified Haffner, the embodiment of Fig. 5 discloses the second drug release element (56 in Fig. 5) that allows ocular fluids to flow through said second drug release element (56) into the second portion (58) thereby allowing the second drug (62) to elute through the second drug release element (56, see para. 0087 and 0113).
Therefore, in combination, the implant of Fig. 19S of Haffner modified to have the dual-compartment implant structure of the embodiment of Fig. 5 of Haffner would thus place the second drug release element (56 in Fig. 5) of the second portion (58) into fluid communication with the inflow pathway (38k) of the shunt device as claimed.
Regarding claim 42, modified Haffner discloses the drug delivery ocular implant of claim 36, as discussed above. In modified Haffner, the embodiment of Fig. 5 discloses the first drug release element (56 in Fig. 5) and the second drug release element (56 in Fig. 5, see para. 0033, 0110 and 0113 –the regions 56 of drug release may be areas of reduced thickness or different material having an increased permeability to the drugs 60 and 62 therewithin and thus are equivalents to a membrane construction as they are thin sheets of material providing a selective barrier).
However, modified Haffner fails to disclose (Claim 42) wherein at least one of the first drug release element and the second drug release element is a membrane.
The embodiment of Fig. 10F of Haffner discloses an implant (50 in Fig. 10C) comprising the drug release regions (56a) in the form of orifices covered with elution membranes (100) that provide a barrier to the release of drug (62) from the interior lumen (58) and is permeable to both the drug (62) and bodily fluids (see para. 0134).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug release regions of modified Haffner to be in the form of orifices covered with elution membranes as taught by the embodiment of Fig. 10F of Haffner. This embodiment teaches that the elution membranes provide said barrier to the release of the drug and allows for controlling the inception of bodily fluids and egress of therapeutic agent from the implant (see para. 0134).
Regarding claim 43, modified Haffner discloses the drug delivery ocular implant of claim 36, as discussed above. In modified Haffner, the embodiment of Fig. 19S of Haffner discloses (Claim 43) further comprising a retention protrusion (359 in Fig. 19S, see para. 0146).
However, the embodiment of Fig. 19S of Haffner fails to disclose that retention protrusion (359) extending from a distal end of the drug delivery ocular implant. Rather, Fig. 19S illustrates the retention protrusion (359) on a proximal end.
The embodiment of Fig. 15 of Haffner discloses a retention protrusion (359), wherein the implant “having the distal portion being the implant end and the proximal portion being the retention protrusion 359 end, in some embodiments, depending on the site and orientation of implantation, the distal portion and proximal portion may be reversed relative to the orientation in FIG. 15.”
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the retention protrusion on the proximal end of the embodiment of modified Haffner to instead be on the distal end as taught by the embodiment of Fig. 15 of Haffner according to known methods to yield predictable results. The embodiment of Fig. 15 discloses that it would have been obvious to have reversed the location of the retention protrusion as needed for the site and orientation of implantation (see para. 0146), and thus one of ordinary skill in the art would have recognized that placed the retention protrusion on the distal end of the implant in Fig. 19S distal of the outflow pathway (56k) would yield results that were predictable as the implant would still be retained in its location and orientation just anchored at the opposite end.
Claim(s) 19-20 and 39-30 rejected under 35 U.S.C. 103 as being unpatentable over Haffner in view of Brandau et al. (U.S Patent No. 6740077 B1, “Brandau”).
Regarding claim 19, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above.
However, modified Haffner fails to disclose (Claim 19) wherein the first drug release element is positioned within an interior chamber of the drug delivery ocular implant.
Brandau disclose an generic, drug delivering implant (1 in Fig. 1) comprising a first portion (12 in Fig. 1) containing a first drug (3, see Col.4, lines 4-5), a second portion (11 in Fig. 1) containing a second drug (13, see Col.4, lines 5-6), a barrier (10 in Fig. 1) between the two portions (see Col.4, line 59 – Col.5, line 3), a first drug release element (5, 8 in Fig. 1) in the form of a permeable element (5) and two grating-like support elements (8), and a second drug release element (5 in Fig. 1) in the form of a permeable element (5) and two grating-like support elements (8, examiner notes the drug release elements are interpreted as a membrane itself or a membrane construction configured to release a drug or equivalents thereof, see Col.3, lines 23-46 – the permeable elements 5 held between the grate-like support elements 8 together form an equivalent to a membrane construction as they are a thin, sheet like material that form a selective barrier for drug release), wherein the drug release elements (5,8) are positioned on either end openings (4) of the implant (1) within the interior chambers of said implant (1, see Fig. 1 and Col.4, lines 36-45).
Since Fig. 5 of modified Haffner discloses drug release regions in fluid communication with each the first portion and the second portion and on opposite ends of the implant allowing drug release, and Brandau discloses drug release regions positioned within each the first portion and the second portion and on opposite ends of the implant allowing drug release, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug release regions in the form of orifices or thinner regions of material integral with the outer shell of the implant of modified Haffner to be substituted with the permeable element sandwiched between two grating-like support elements positioned within the interior chamber of each portion of the implant near an open end of the implant as taught by Brandau. Brandau teaches that the two permeable elements (5) are inserted into the openings within the interior chamber of the implant to reliably prevent undesired and/or uncontrolled leakage of the therapeutic agent from the interior chamber (see Col.3, lines 21-31). One of ordinary skill in the art could have substituted the multiple drug release regions in modified Haffner for a singular orifice at each opposing end sealed by the permeable elements as taught by Brandau, and the results of said combination would have been predictable. Further, manufacturing and assembly of the implant would be simplified.
Regarding claim 20, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above.
However, modified Haffner fails to disclose (Claim 20) wherein the second drug release element is positioned within an interior chamber of the drug delivery ocular implant.
Brandau disclose an generic, drug delivering implant (1 in Fig. 1) comprising a first portion (12 in Fig. 1) containing a first drug (3, see Col.4, lines 4-5), a second portion (11 in Fig. 1) containing a second drug (13, see Col.4, lines 5-6), a barrier (10 in Fig. 1) between the two portions (see Col.4, line 59 – Col.5, line 3), a first drug release element (5, 8 in Fig. 1) in the form of a permeable element (5) and two grating-like support elements (8), and a second drug release element (5 in Fig. 1) in the form of a permeable element (5) and two grating-like support elements (8, examiner notes the drug release elements are interpreted as a membrane itself or a membrane construction configured to release a drug or equivalents thereof, see Col.3, lines 23-46 – the permeable elements 5 held between the grate-like support elements 8 together form an equivalent to a membrane construction as they are a thin, sheet like material that form a selective barrier for drug release), wherein the drug release elements (5,8) are positioned on either end openings (4) of the implant (1) within the interior chambers of said implant (1, see Fig. 1 and Col.4, lines 36-45).
Since Fig. 5 of modified Haffner discloses drug release regions in fluid communication with each the first portion and the second portion and on opposite ends of the implant allowing drug release, and Brandau discloses drug release regions positioned within each the first portion and the second portion and on opposite ends of the implant allowing drug release, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug release regions in the form of orifices or thinner regions of material integral with the outer shell of the implant of modified Haffner to be substituted with the permeable element sandwiched between two grating-like support elements positioned within the interior chamber of each portion of the implant near an open end of the implant as taught by Brandau. Brandau teaches that the two permeable elements (5) are inserted into the openings within the interior chamber of the implant to reliably prevent undesired and/or uncontrolled leakage of the therapeutic agent from the interior chamber (see Col.3, lines 21-31). One of ordinary skill in the art could have substituted the multiple drug release regions in modified Haffner for a singular orifice at each opposing end sealed by the permeable elements as taught by Brandau, and the results of said combination would have been predictable. Further, manufacturing and assembly of the implant would be simplified.
Regarding claim 39, modified Haffner discloses the drug delivery ocular implant of claim 36, as discussed above.
However, modified Haffner fails to disclose (Claim 39) wherein the first drug release element is positioned within an interior chamber of the drug delivery ocular implant.
Brandau disclose an generic, drug delivering implant (1 in Fig. 1) comprising a first portion (12 in Fig. 1) containing a first drug (3, see Col.4, lines 4-5), a second portion (11 in Fig. 1) containing a second drug (13, see Col.4, lines 5-6), a barrier (10 in Fig. 1) between the two portions (see Col.4, line 59 – Col.5, line 3), a first drug release element (5, 8 in Fig. 1) in the form of a permeable element (5) and two grating-like support elements (8), and a second drug release element (5 in Fig. 1) in the form of a permeable element (5) and two grating-like support elements (8, examiner notes the drug release elements are interpreted as a membrane itself or a membrane construction configured to release a drug or equivalents thereof, see Col.3, lines 23-46 – the permeable elements 5 held between the grate-like support elements 8 together form an equivalent to a membrane construction as they are a thin, sheet like material that form a selective barrier for drug release), wherein the drug release elements (5,8) are positioned on either end openings (4) of the implant (1) within the interior chambers of said implant (1, see Fig. 1 and Col.4, lines 36-45).
Since Fig. 5 of modified Haffner discloses drug release regions in fluid communication with each the first portion and the second portion and on opposite ends of the implant allowing drug release, and Brandau discloses drug release regions positioned within each the first portion and the second portion and on opposite ends of the implant allowing drug release, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug release regions in the form of orifices or thinner regions of material integral with the outer shell of the implant of modified Haffner to be substituted with the permeable element sandwiched between two grating-like support elements positioned within the interior chamber of each portion of the implant near an open end of the implant as taught by Brandau. Brandau teaches that the two permeable elements (5) are inserted into the openings within the interior chamber of the implant to reliably prevent undesired and/or uncontrolled leakage of the therapeutic agent from the interior chamber (see Col.3, lines 21-31). One of ordinary skill in the art could have substituted the multiple drug release regions in modified Haffner for a singular orifice at each opposing end sealed by the permeable elements as taught by Brandau, and the results of said combination would have been predictable. Further, manufacturing and assembly of the implant would be simplified.
Regarding claim 40, modified Haffner discloses the drug delivery ocular implant of claim 36, as discussed above.
However, modified Haffner fails to disclose (Claim 40) wherein the second drug release element is positioned within an interior chamber of the drug delivery ocular implant.
Brandau disclose an generic, drug delivering implant (1 in Fig. 1) comprising a first portion (12 in Fig. 1) containing a first drug (3, see Col.4, lines 4-5), a second portion (11 in Fig. 1) containing a second drug (13, see Col.4, lines 5-6), a barrier (10 in Fig. 1) between the two portions (see Col.4, line 59 – Col.5, line 3), a first drug release element (5, 8 in Fig. 1) in the form of a permeable element (5) and two grating-like support elements (8), and a second drug release element (5 in Fig. 1) in the form of a permeable element (5) and two grating-like support elements (8, examiner notes the drug release elements are interpreted as a membrane itself or a membrane construction configured to release a drug or equivalents thereof, see Col.3, lines 23-46 – the permeable elements 5 held between the grate-like support elements 8 together form an equivalent to a membrane construction as they are a thin, sheet like material that form a selective barrier for drug release), wherein the drug release elements (5,8) are positioned on either end openings (4) of the implant (1) within the interior chambers of said implant (1, see Fig. 1 and Col.4, lines 36-45).
Since Fig. 5 of modified Haffner discloses drug release regions in fluid communication with each the first portion and the second portion and on opposite ends of the implant allowing drug release, and Brandau discloses drug release regions positioned within each the first portion and the second portion and on opposite ends of the implant allowing drug release, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug release regions in the form of orifices or thinner regions of material integral with the outer shell of the implant of modified Haffner to be substituted with the permeable element sandwiched between two grating-like support elements positioned within the interior chamber of each portion of the implant near an open end of the implant as taught by Brandau. Brandau teaches that the two permeable elements (5) are inserted into the openings within the interior chamber of the implant to reliably prevent undesired and/or uncontrolled leakage of the therapeutic agent from the interior chamber (see Col.3, lines 21-31). One of ordinary skill in the art could have substituted the multiple drug release regions in modified Haffner for a singular orifice at each opposing end sealed by the permeable elements as taught by Brandau, and the results of said combination would have been predictable. Further, manufacturing and assembly of the implant would be simplified.
Claim(s) 22 rejected under 35 U.S.C. 103 as being unpatentable over Haffner in view of Rodstrom (U.S Patent Pub. No. 20100022945 A1).
Regarding claim 22, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above.
While the embodiment of Fig. 5 of Haffner in modified Haffner discloses the distal portion (58 in Fig. 5) and the proximal portion (58a in Fig. 5), modified Haffner fails to disclose (Claim 22) wherein the distal portion is smaller than the proximal portion.
Rodstrom discloses an implantable drug delivery system (1110 in Fig. 10) for use treating conditions affecting an inner portion of an eye (see para. 0042), wherein the implant (1110) comprises a proximal portion (1147 in Fig. 10) having a first drug release element (1150 in Fig. 10) formed as a perforated screen for controlled release of a first drug (M2 in Fig. 10) disposed therein (see para. 0006 and 0070), a distal portion (1143 in Fig. 10) having a second drug release element (1154 in Fig. 10) in the same form as the first drug release element (1150) for controlled release of a second drug (M1 in Fig. 10, see para. 0070), and an impermeable barrier (1141 in Fig. 10) disposed therebetween (see para. 0070). Rodstrom teaches (Claim 22) wherein the distal portion (1143) is smaller than the proximal portion (1147, see Fig. 10).
Since both modified Haffner and Rodstrom disclose dual-compartment ocular implants for controlled release of two different drugs, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sizes of the distal and proximal portions of modified Haffner such that the distal portion is smaller than the proximal portion as taught by Rodstrom according to known methods to yield predictable results. Rodstrom teaches that each basin (1143, 1147) is sized according to the size and shape of the medicament placed therein such that they are substantially the same to minimize the amount of free air (see para. 0050), and that the amount of medicament is based upon what is needed for the prolonged internal treatment of said condition or disease (see para. 0005). Thus, one of ordinary skill in the art could have made the distal portion smaller than the proximal portion of modified Haffner as taught by Rodstrom based upon what is needed for the prolonged internal treatment, and said combination would yield results that were predictable.
Claim(s) 25 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Haffner in view of Weaver et al. (U.S Patent Pub. No. 20050171490 A1, “Weaver”).
Regarding claim 25, modified Haffner discloses the drug delivery ocular implant of claim 16, as discussed above.
While modified Haffner discloses that the regions of drug release (56 in Fig. 5) may be regions of reduced thickness, orifices, orifices covered by membranes, etc.. (see para. 0114), modified Haffner fails to disclose (Claim 25) wherein the first drug release element comprises:
a distal seal member that includes at least one opening;
a proximal seal member that includes at least one opening; and
a membrane compressed between the distal seal member and the proximal seal member,
wherein the first drug release element is configured such that the first drug passes through the at least one opening in the distal seal member, through the membrane, through the at least one opening in the proximal seal member, and out a proximal end of the drug delivery ocular implant.
Weaver discloses a pressure activated valve (20 in Fig. 1) used to seal a lumen of a medical catheter and comprising a flow control membrane (100 in Fig. 2) extending across the lumen to control flow therethrough (see Abstract and para. 0012); however, the stacked membrane construction of the flow control membrane would have been reasonably pertinent and one in the art would have consulted such art and applied its teaching when faced with solving the problem of a stacked membrane construction for controlled drug release. Weaver teaches (Claim 25) wherein the first drug release element (100 in Fig. 2) comprises:
a distal seal member (104) that includes at least one opening (see Fig. 2 and para. 0026 – “alternatively, the thin membrane 102 may be sandwiches between a pair of base membranes 104 for extra support”, examiner is interpreting a first base membrane 104 having the central bore as the distal seal member with an opening therethrough);
a proximal seal member (104) that includes at least one opening (see para. 0026 – examiner is interpreting a second base membrane 104 having the central bore as the proximal seal member with an opening therethrough); and
a membrane (102 in Fig. 2) compressed between the distal seal member (104) and the proximal seal member (104, see para. 0026),
wherein the first drug release element (100) is configured such that the fluid passes through the at least one opening in the distal seal member (104), through the membrane (102), through the at least one opening in the proximal seal member (104, see para. 0026 and 0029).
Since modified Haffner discloses drug release regions (56) that may be regions of reduced thickness, orifices, orifices covered by membranes, etc.. (see para. 0114), and Weaver discloses a stacked membrane construction for a flow control membrane (102) to control fluid flow through a lumen (see Abstract), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug release regions of modified Haffner to have the orifices covered by the stacked membrane construction of Weaver. Weaver discloses that the base membranes (104) provide the extra necessary at the periphery of the flow control membrane (102) to withstand the compressive forces exerted thereon and sandwiching said membrane (102) between two of the base membranes (104) provides extra support (see para. 0026). In combination, modified Haffner would have the stacked membrane construction of Weaver at the drug release regions (56) such that the first drug (62a) is configured to pass through the stacked membrane construction as claimed and out a proximal end (52) of the drug delivery ocular implant of modified Haffner (see Fig. 5).
Regarding claim 41, modified Haffner discloses the drug delivery ocular implant of claim 36, as discussed above.
While modified Haffner discloses that the regions of drug release (56 in Fig. 5) may be regions of reduced thickness, orifices, orifices covered by membranes, etc.. (see para. 0114), modified Haffner fails to disclose (Claim 41) wherein the first drug release element comprises:
a distal seal member that includes at least one opening;
a proximal seal member that includes at least one opening; and
a membrane compressed between the distal seal member and the proximal seal member,
wherein the first drug release element is configured such that the first drug passes through the at least one opening in the distal seal member, through the membrane, through the at least one opening in the proximal seal member, and out a proximal end of the drug delivery ocular implant.
Weaver discloses a pressure activated valve (20 in Fig. 1) used to seal a lumen of a medical catheter and comprising a flow control membrane (100 in Fig. 2) extending across the lumen to control flow therethrough (see Abstract and para. 0012); however, the stacked membrane construction of the flow control membrane would have been reasonably pertinent and one in the art would have consulted such art and applied its teaching when faced with solving the problem of a stacked membrane construction for controlled drug release. Weaver teaches (Claim 41) wherein the first drug release element (100 in Fig. 2) comprises:
a distal seal member (104) that includes at least one opening (see Fig. 2 and para. 0026 – “alternatively, the thin membrane 102 may be sandwiches between a pair of base membranes 104 for extra support”, examiner is interpreting a first base membrane 104 having the central bore as the distal seal member with an opening therethrough);
a proximal seal member (104) that includes at least one opening (see para. 0026 – examiner is interpreting a second base membrane 104 having the central bore as the proximal seal member with an opening therethrough); and
a membrane (102 in Fig. 2) compressed between the distal seal member (104) and the proximal seal member (104, see para. 0026),
wherein the first drug release element (100) is configured such that the fluid passes through the at least one opening in the distal seal member (104), through the membrane (102), through the at least one opening in the proximal seal member (104, see para. 0026 and 0029).
Since modified Haffner discloses drug release regions (56) that may be regions of reduced thickness, orifices, orifices covered by membranes, etc.. (see para. 0114), and Weaver discloses a stacked membrane construction for a flow control membrane (102) to control fluid flow through a lumen (see Abstract), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug release regions of modified Haffner to have the orifices covered by the stacked membrane construction of Weaver. Weaver discloses that the base membranes (104) provide the extra necessary at the periphery of the flow control membrane (102) to withstand the compressive forces exerted thereon and sandwiching said membrane (102) between two of the base membranes (104) provides extra support (see para. 0026). In combination, modified Haffner would have the stacked membrane construction of Weaver at the drug release regions (56) such that the first drug (62a) is configured to pass through the stacked membrane construction as claimed and out a proximal end (52) of the drug delivery ocular implant of modified Haffner (see Fig. 5).
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 16-21, 25-27, and 36-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 12 of U.S. Patent No.11925578 B2 in view of Haffner et al. (U.S Patent Pub. No. 20120078362 A1, “Haffner”). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 16, claim 1 of the reference patent is not patentably distinct from claim 16 of the instant application. Both claims disclose all of the same structure of a drug delivery ocular implant having two chambers each containing a drug together defined by a first drug release element, a barrier, and a second drug release element. While the claims are not identical given that the instant application claim 16 recites “proximal” and “distal” directions and functional language for the elution location of the first and second drug, these limitations are obvious limitations that do not make the structure of the implant of the reference application patentably distinct from the reference patent.
Haffner discloses a dual chambered, drug delivery ocular implant (see Fig. 5) comprising a first drug (62a in Fig. 5) positioned within a proximal portion (58a in Fig. 5) and configured to elute into a particular intraocular region (see para. 0113), and a second drug (62) positioned within a distal portion (58 in Fig. 5 and configured to elute into a different intraocular region than the first drug (see para. 0113), wherein said ocular implant may comprise an additional shunt feature (see Fig. 19S) that allows for anchoring the implant within the Schlemm’s canal such that a portion of the implant resides in the anterior chamber of the eye and the another portion resides in the Schlemm’s canal (see para. 0173-0174). Thus, Haffner discloses an ocular implant with a proximal portion and distal portion containing a first drug and second drug, respectively, that would be capable of being configured to elute into the anterior chamber of the eye and the Schlemm’s canal, respectively.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reference patent to have the first drug in a proximal portion and the second drug in a distal portion of the implant and configured to elute said drugs into specific regions of the eye as taught by Haffner. Haffner teaches an implant that can comprise two drugs either of the same or different composition for use in specifically targeting certain intraocular tissues which reduces the amount of drug needed to achieve a therapeutic effect, reduces non-specific side effects of an eluted drug, and increases overall potential duration of drug delivery from the implant (see para. 0113).
Regarding claims 17-21, 25-27, and 36-42, these claims are not patentably distinct from claims 1-2 and 12 of the reference patent for similar reasons as stated above as they claims all of the same structures of the drug delivery ocular implant.
See the Table below for the mapping of the instant application claims to the reference patent claims.
Claim #’s of Instant Application 18/407,936
Claim #’s of Reference Patent 11,925,578 B2
16
1
17
12
18
1
19
1
20
1
21
1
25
2
26
1
27
1
36
1
37
12
38
1
39
1
40
1
41
2
42
1
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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