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 Species 1A, Figures 2A-2B, and Species 2A, Figure 5, in the reply filed on February 11, 2026 is acknowledged.
Claim Rejections - 35 USC § 102
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 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) 1-5, 16-21, 23-24, 26-28, and 30-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams et al. (US 2002/0156413), submitted with the IDS of September 21, 2022.
Regarding claim 1, Williams discloses a biological fluid drainage device for draining a fluid from a fluid-filled body cavity (see Figs. 1-2), the device comprising: a body configured to receive biological fluid drainage (see par. 33) including a microporous diffusion material having a plurality of microporous membranes 11, 12 including a first microporous membrane 11 and a second microporous membrane 12, wherein the plurality of microporous membranes are formed such that there is a tissue ingrowth proliferation side (see par. 30, pores 1-500 microns, with applicant admitting in par. 83 of the applicant’s current specification that smaller than one or two microns resists or prevents ingrowth, and as this range is greater than it would allow for ingrowth, similar to applicant’s with overlapping pore sizes) and a tissue diffusion proliferation side (see par. 30, pores less than or equal to 0.8 microns, with applicant admitting in par. 83 of the current specification that under 1 micron would prevent ingrowth) is adjacent the tissue ingrowth proliferation side (see Fig. 2, par. 30), wherein the second microporous membrane 12 is configured to resist tissue ingrowth (see par. 30), and wherein the first microporous membrane is configured to permit a fluid conduit 7 having a first end (see Fig. 2, end inside body) and a second end (see Fig. 2, end outside body), the first end being fluidly coupled to the body (see Fig. 1) and the second end extending outside the body and being insertable into the fluid-filled body cavity such that the biological fluid drainage from the fluid-filled body cavity is transferrable to the body (see Fig. 1).
Regarding claim 2, Williams further discloses the first microporous membrane 11 is situated with the second microporous membrane 12 to form a first tissue ingrowth proliferation side (first tissue ingrowth proliferation side on the tissue ingrowth proliferation side) at the first microporous membrane and a first tissue diffusion proliferation side (first tissue diffusion proliferation side as one of the sides, like top and bottom sides, of the tissue diffusion proliferation side) at the second microporous membrane (see par. 30 and rejection of claim 1 above).
Regarding claim 3, Williams further discloses the first and second microporous membranes are facing outwardly from each other (see par. 30, top side of first microporous membrane and bottom side of second microporous membrane face outwardly from each other).
Regarding claim 4, Williams further discloses the first and second microporous membranes each have a permeability that is different from each other (see par. 30, different porosity would lead to different permeability).
Regarding claim 5, Williams further discloses at least one of the first and second microporous membranes comprise expanded polytetrafluoroethylene (see par. 30).
Regarding claim 16, Williams further discloses the fluid-filled body cavity is an anterior chamber of an eye and wherein the biological fluid drainage is aqueous humor (see par. 32, 55).
Regarding claim 17, Williams further discloses the microporous diffusion material is uncompressed (see Fig. 2, par. 30).
Regarding claim 18, Williams further discloses the fluid conduit and body are formed from the same materials (see par. 30 and 32, first and second regions as well as catheter/conduit can be made from silicone).
Regarding claim 19, Williams discloses a device for draining a biological fluid from an eye to a tissue surrounding the eye (see Figs. 1-2), the device being implantable at least in part within the tissue of the eye (see Fig. 1), the device comprising: a body that is formed from a plurality of microporous membranes 11, 12; and a conduit 7 having a conduit proximal end in fluid communication with the body and a conduit distal end that opposes the proximal end (see Fig. 2), the conduit distal end being insertable into the eye so as to facilitate a drainage of the biological fluid into the conduit via the distal end of the conduit (see Fig. 1), wherein the body permits a portion of tissue ingrowth such that the device is anchorable at an implantation site (see par. 30, pores 1-500 microns, with applicant admitting in par. 83 of the applicant’s current specification that smaller than one or two microns resists or prevents ingrowth, and as this range is greater than it would allow for ingrowth, similar to applicant’s with overlapping pore sizes).
Regarding claim 20, Williams further discloses each of the microporous membranes in the plurality of microporous membranes has a different porosity (see par. 30-31).
Regarding claim 21, Williams further discloses the plurality of microporous membranes forms a diffusion membrane 12, the diffusion membrane extending from a first interface surface to a second interface surface (see Figs. 1, 2, interfaces on top and bottom), the diffusion membrane having regions of high porosity that extend through the body to thereby form stabilizing structures (see par. 30, pores 1-500 microns, with applicant admitting in par. 83 of the applicant’s current specification that smaller than one or two microns resists or prevents ingrowth, and as this range is greater than it would allow for ingrowth, similar to applicant’s with overlapping pore sizes, areas having such a porosity allowing for stabilizing structures via tissue ingrowth).
Regarding claim 23, Williams further discloses at least one of the microporous membranes in the plurality of microporous membranes is permitted to resist tissue ingrowth (see par. 30, pores less than or equal to 0.8 microns, with applicant admitting in par. 83 of the current specification that under 1 micron would prevent ingrowth) and at least one of the microporous membranes in the plurality of microporous membranes is permitted to promote tissue ingrowth (see par. 30, pores 1-500 microns, with applicant admitting in par. 83 of the applicant’s current specification that smaller than one or two microns resists or prevents ingrowth, and as this range is greater than it would allow for ingrowth, similar to applicant’s with overlapping pore sizes).
Regarding claim 24, Williams further discloses each of the microporous membranes in the plurality of microporous membranes has a different permeability (see par. 30).
Regarding claim 26, Williams further discloses at least one of the microporous membranes in the plurality of microporous membranes comprise expanded polytetrafluoroethylene (see par. 30).
Regarding claim 27, Williams discloses a biological fluid drainage device (see Figs. 1-2) comprising: a body comprising: an interior region 12 (alternatives, 12 and region between 12 and 13) including a plurality of pores that is configured to resist tissue ingrowth (see par. 30, pores less than or equal to 0.8 microns, with applicant admitting in par. 83 of the current specification that under 1 micron would prevent ingrowth), and an exterior region 11 including a plurality of pores that is configured to promote tissue ingrowth (see par. 30, pores 1-500 microns, with applicant admitting in par. 83 of the applicant’s current specification that smaller than one or two microns resists or prevents ingrowth, and as this range is greater than it would allow for ingrowth, similar to applicant’s with overlapping pore sizes), wherein a porosity of the exterior region is different than a porosity of the interior region (see par. 30); and a fluid conduit 7 having a first end (see Fig. 2, first end in reservoir created by 11/12 and 13) and a second end (see Fig. 2, end opposite first end outside of reservoir), the first end being coupled to the body (see Fig. 2) and the second end extending outside the body and being insertable into a fluid-filled body cavity such that a fluid from the fluid-filled body cavity is transportable to the body (see Figs. 1-2, par. 29).
Regarding claim 28, Williams discloses the porosity of the exterior region exceeds the porosity of the interior region (see par. 30-31, pores or channels may be referred to as “internodal distances,” which is considered a measure of porosity).
Regarding claim 30, Williams discloses a size of the plurality of pores of the exterior region exceeds a size of the plurality of pores of the interior region (see par. 30, 1-500 micron greater than less than or equal to 0.8 micron).
Regarding claim 31, Williams discloses a tissue diffusion rate of the exterior region exceeds the tissue diffusion rate of the interior region (see rejection of claim 27, interior region resists ingrowth and would have a lower diffusion than exterior region that is configured to promote tissue ingrowth).
Regarding claim 32, Williams discloses at least one of the interior and exterior regions comprise expanded polytetrafluoroethylene (see par. 30).
Regarding claim 33, Williams discloses the interior region includes at least one porous membrane that is permeable to the biological fluid drainage of the fluid-filled body cavity (see par. 14, 29).
Regarding claim 34, Williams discloses the first end of the fluid conduit extends into the interior region (see Fig. 2, interior region considered 12 and region between 12 and 13).
Regarding claim 35, Williams discloses the biological fluid drainage device is configured to allow the fluid to percolate from the interior region to the exterior region (see par. 29-30).
Claim(s) 19, 22, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nigam (US 2005/0182350), submitted with the IDS of September 21, 2022.
Regarding claim 19, Nigam discloses a device for draining a biological fluid from an eye to a tissue surrounding the eye (see Figs. 1-2, 5), the device being implantable at least in part within the tissue of the eye (see Fig. 5), the device comprising: a body that is formed from a plurality of microporous membranes 22a, 22b (see par. 39-40, permeable or semipermeable membrane material); and a conduit 12 having a conduit proximal end in fluid communication with the body and a conduit distal end that opposes the proximal end (see Figs. 1-2 and 5), the conduit distal end being insertable into the eye so as to facilitate a drainage of the biological fluid into the conduit via the distal end of the conduit (see Fig. 5), wherein the body permits a portion of tissue ingrowth such that the device is anchorable at an implantation site (see par. 41, 54).
Regarding claim 22, Nigam discloses each of the microporous membranes in the plurality of microporous membranes has a porosity (see par. 39-40, would be permeable or semipermeable so would inherently be porous to allow for permeability) and the porosity of some of the microporous membranes is equal to each other (see par. 57, since membranes are sealed by edges, only some of the membranes have the porosity).
Regarding claim 25, Nigam discloses each of the microporous membranes in the plurality of microporous membranes has a permeability (see par. 39-40, would be permeable or semipermeable) and the permeability of some of the microporous membranes is equal to each other (see par. 57, since membranes are sealed by edges, only some of the membranes have the porosity).
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.
Claim(s) 1, 6-12, and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nigam (US 2005/0182350) in view of Williams.
Regarding claim 1, Nigam discloses a biological fluid drainage device for draining a fluid from a fluid-filled body cavity (see Figs. 1-2), the device comprising: a body configured to receive biological fluid drainage (see Fig. 5, par. 54, drainage of aqueous humor) including a microporous diffusion material (see par. 39-40, upper membrane 22a and lower membrane 22b, membranes made of permeable or semipermeable membrane material that allows particles of predetermined size and creating diffusion chamber 20) having a plurality of microporous membranes 22a, 22b and wherein the plurality of microporous membranes are configured to permit a fluid conduit 12 having a first end (see Fig. 2, inside inner cavity 26) and a second end (see Fig. 2, end outside body), the first end being fluidly coupled to the body (see Figs. 1-2) and the second end extending outside the body and being insertable into the fluid-filled body cavity AC such that the biological fluid drainage from the fluid-filled body cavity is transferrable to the body (see Fig. 5, par. 54).
Nigam does not disclose the plurality of microporous membranes including a first microporous membrane and a second microporous membrane, wherein the plurality of microporous membranes are formed such that there is a tissue ingrowth proliferation side and a tissue diffusion proliferation side is adjacent the tissue ingrowth proliferation side, wherein the second microporous membrane is configured to resist tissue ingrowth, wherein the first microporous membrane is configured to permit the fluid conduit.
Nigam specifically discloses the desire for the membrane material to allow particles of predetermined size while also preventing tissues from invading inner cavity 26 created by the upper and lower membrane and the outer surface of tube 12 that is within the inner cavity 26 (see par. 39). Williams discloses a biological fluid drainage device for draining a fluid from a fluid-filled body cavity (see Figs. 1-2, par. 29, drainage of aqueous humor), the device comprising: a body configured to receive biological fluid drainage (see par. 33) and a membrane material including a first microporous membrane 11 and a second microporous membrane 12, wherein there is a tissue ingrowth proliferation side on membrane 11 (see par. 30, pores 1-500 microns, with applicant admitting in par. 83 of the applicant’s current specification that smaller than one or two microns resists or prevents ingrowth, and as this range is greater than it would allow for ingrowth, similar to applicant’s with overlapping pore sizes) and a tissue diffusion proliferation side on membrane 12 (see par. 30, pores less than or equal to 0.8 microns, with applicant admitting in par. 83 of the current specification that under 1 micron would prevent ingrowth) is adjacent the tissue ingrowth proliferation side (see Fig. 2, par. 30), wherein the second microporous membrane 12 is configured to resist tissue ingrowth (see par. 30). It would have been obvious to such a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the upper membrane and lower membranes of Nigam each with a first microporous membrane and a second microporous membrane such as that disclosed by Williams, with the second microporous membranes facing toward inner cavity 26 and the first microporous membranes facing outward from inner cavity 26, this predictably resulting in having the benefit of allowing cells to pass through via the first microporous membranes, disclosed as desirable by Nigam, while also preventing tissue ingrowth into inner cavity 26 and the tube via the second microporous membranes, also disclosed as desirable by Nigam. As the upper and lower membranes each are configured to permit the fluid conduit (see Nigam, Fig. 2) and each include the first and second microporous membranes, the first microporous membrane is therefore configured to permit the fluid conduit.
Regarding claim 6, Nigam and Williams disclose the limitations of claim 1 and as the plurality of microporous membranes include two of the first microporous membranes and two of the second microporous membranes, the second of the first microporous membranes is interpreted as a third microporous membrane situated adjacent the body, wherein the third microporous membrane extends between the body and the second end of the fluid conduit (see Fig. 2, Nigam, lower membrane 22b would include the third microporous membrane on the outside facing away from inner cavity 26 with the second of the second microporous membranes, which could be considered a fourth microporous membrane, facing inward toward inner cavity 26 and adjacent the third microporous membrane, and therefore the third microporous membrane would be adjacent the body and extending between the body and second end of the fluid conduit in such a position when placed like in Fig. 5 of Nigam).
Regarding claim 7, Nigam and Williams disclose the limitations of claim 6 and further disclose the third microporous membrane is configured to permit tissue ingrowth (see rejection of claims 1 and 6 above, as third microporous membrane would be like the first microporous membrane, would have pores 1-500 microns, and as this range would allow for ingrowth.
Regarding claim 8, Nigam and Williams disclose the limitations of claim 6 and further disclose the third microporous membrane is coupled to the fluid conduit (see Nigam, Figs. 1-2 and rejection of claims 1 and 6 above, as third microporous membrane is part of structure that would replace lower membrane 22b, it would be coupled to the fluid conduit).
Regarding claim 9, Nigam and Williams disclose the limitations of claim 6 and Nigam further discloses the membranes sealed together to form a sealed perimeter flange 24 (see par. 40), and therefore the third microporous membrane is integral with one of the first and second microporous membranes as they would be sealed together to form the sealed perimeter flange.
Regarding claim 10, Nigam and Williams disclose the limitations of claim 9 and as the third microporous membrane is the second of the two first microporous membranes (see rejection of claims 1 and 6 above), the third microporous membrane and the first microporous membrane would be the same.
Regarding claim 11, Nigam and Williams disclose the limitations of claim 6 and further disclose the plurality of microporous membranes further includes a fourth microporous membrane situated adjacent the body, wherein the fourth microporous membrane extends between the body and the second end of the fluid conduit (see rejection of claim 6 above along with Fig. 5 of Nigam).
Regarding claim 12, Nigam and Williams disclose the limitations of claim 11, and as the fourth microporous membrane is the second of the two second microporous membranes (see rejection of claims 1 and 6 above), the fourth microporous membrane and the second microporous membrane would be the same.
Regarding claim 14, Nigam and Williams disclose the limitations of claim 1 and like with the current application, as the porosities overlap for the first and second microporous membranes (see rejection of claim 1 above and applicant’s specification, par. 83-84), those disclosed by the prior art would result in a configuration that remains permeable to the biological fluid drainage after an ingrowth of tissue occurs in what are described as the two first microporous membranes above. However, calling such membranes the two first microporous membranes is not required, as the important part is that there are two membranes that are configured for ingrowth and two membranes configured to resist ingrowth, and those two membranes configured for ingrowth could be interpreted as the first and second microporous membranes while the two configured to resist ingrowth could be considered third and fourth microporous membranes.
Regarding claim 15, Nigam and Williams disclose the limitations of claim 1 and as explained above, disclose two microporous membranes configured to resist tissue ingrowth via the size of a plurality of small holes and two microporous membranes configured to permit tissue ingrowth via the size of a plurality of small holes, and as explained above in the rejection of claim 1, an upper membrane (see Nigam, Figs. 1-2, 22a) would include one of the microporous membranes configured to resist tissue ingrowth and one of the microporous membranes configured to permit tissue ingrowth while the lower membrane (see Nigam, Figs. 1-2, 22b) would include the other of the microporous membranes configured to resist tissue ingrowth and the other of the microporous membranes configured to permit tissue ingrowth. However, calling such membranes the two first microporous membranes and two second microporous membranes as done with the rejection of claim 1 is not required as the important part is that there are two membranes that are configured for ingrowth and two membranes configured to resist ingrowth resulting in two membranes, each containing a layer of membrane that is configured for ingrowth and a layer of membrane configured to resist ingrowth, and therefore those resulting two membranes could be interpreted as the first and second microporous membranes.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nigam and Williams as applied to claim 12 above, and further in view of Ahmed (US 5,681,275), submitted with the IDS of September 21, 2022.
Regarding claim 13, Nigam and Williams disclose limitations of claim 12 but do not disclose the fourth microporous membrane includes a perforation sized to accommodate the fluid conduit such that the fluid conduit can be extended through the perforation and into the fluid-filled body cavity when implanted.
Ahmed discloses a fluid conduit 18 extending through a perforation 15b into a body cavity 21 (see Figs. 2-2A), the perforation sized to accommodate the fluid conduit such that the fluid conduit can be extended through the perforation and into the body cavity when implanted (see Figs. 2-2A, 14). The substitution of one known element (fluid conduit between membranes to enter chamber) for another (fluid conduit through membrane to enter chamber) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the perforation shown in Ahmed would have yielded predictable results, mainly, the entrance of the fluid conduit into the fluid-filled body cavity such that fluid could travel via the conduit. Consequently, since the upper or lower membrane could comprise the conduit and since the upper or lower membrane would include the fourth microporous membrane (it depends on labeling, as the fourth and the second, as explained above, are the same microporous membrane), the membrane having the perforation could be considered the one that includes the fourth microporous membrane.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Smith (US 4,946,436).
Regarding claim 29, Williams discloses the limitations of claim 28 but does not disclose a quantity of the plurality of pores of the exterior region exceeds a quantity of the plurality of pores of the interior region.
Smith discloses pores of such size and quantity as to permit drainage of fluid from one area to another (see col. 3, lines 44-47), therefore showing that pore quantity is a result effective variable such that changing the quantity of pores also changes the drainage permitted. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the quantity of pores to have such pores in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device to have a quantity of the plurality of pores of the exterior region exceed a quantity of the plurality of pores of the interior region as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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