DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 14 is objected to because of the following informalities: line 4 should be amended to - wherein [[a]] the flexible connecting portion is disposed on each side of each of the one or more bulbous-. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 6 and 9-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1:
The claim recites the limitation "the flow path holes" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Further, the limitation “wherein a combination of the flow path holes is configured as the flow path opening in the unstressed state” in line 10 is unclear. Line 9 indicates there is one flow path hole and line 10 indicates there is a plurality of flow path holes. This makes it unclear if there are multiple holes or only one. Also, it’s not clear if the applicant is attempting to combine embodiments or claim the embodiment with one flow path hole or the embodiment multiple flow path holes. For the sake of examination, the office has assumed this claim is attempting to claim the embodiment with one flow path hole.
Claim 6 is rejected due to its dependence on claim 1.
Regarding claim 9:
The claim recites the limitation "the membrane" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claims 10-11 are rejected due to their dependence on claim 9.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5041081 A to Odrich.
Odrich discloses:
Regarding claim 9:
An intraocular drainage device, comprising:
a drainage tube (12/22) comprising an interior surface (see the interior of 12) defining a fluid flow path (column 3, lines 40-60); and
a self-clearing device (valve 32/50/48) disposed within the drainage tube (12/22) and across the fluid flow path, the self-clearing device (valve 32/50/48) comprising a flow path opening (see the opening 32 shows between 50/32/48 when the valve is opened) configured to provide a selected fluid flow pressure when the self-clearing device (valve 32/50/48) is in an unstressed state (under the broadest reasonable interpretation, when the valve 32/50/48 is opened it is in an unstressed state since the pressure within the eye and section 14/18 is relieved and allowed to flow past the valve, in other words the valve is stressed when it is closed and the pressure is applied to the valve portion 32 just prior to opening),
wherein the membrane (32/50) comprises:
a coupling portion (50) coupled to the interior surface (as shown in figure 3) of the drainage tube (12/22); and
a flap (32) connected to the coupling portion (50) (connected to 50 as shown in figure 3), wherein an outer perimeter of the flap (32) and the interior surface of the drainage tube (12/22) define the flow path opening as a crescent shaped area when the self-clearing device in in the unstressed state (when the valve 32 is opening or opened a crescent shaped hole is defined between 32 and the interior of 12 since the valve end is rounded and the interior of 12 is rounded which occurs when the valve is closing in the unstressed state).
Regarding claim 10:
The intraocular drainage device of claim 9, wherein the membrane (32/50) is configured such that at least a portion of the flap (32) moves in a downstream direction of the fluid flow path in response to an increased fluid pressure on the membrane (32/50) (as shown in figurer 3 where the valve 32 extends downstream towards 22), thereby increasing the size of the crescent shaped area and thus increasing the flow path opening (as shown in figure 3 the crescent shape hole defined between 32 and 12 increases the further back the valve 32 extends).
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5041081 A to Odrich as applied to claim 9 above, and further in view of US 5127901 A to Odrich (Odrich ‘901).
Regarding claim 11:
Odrich fails to disclose:
The intraocular drainage device of claim 9, wherein the membrane further comprises at least one structural member disposed across portions of the coupling portion and the flap, the at least one structural member configured to provide an increased resistance of the flap to movement.
Odrich ‘901 teaches:
A membrane that includes a flap (24) and a coupling portion (30b) for controlling the flow of fluid through a tube (12). Further, the system includes a structural member (40/34) that improves the rigidity of the flap and coupling portion (column 4, lines 15-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Odrich to further include a structural member attached to the flap and coupling portion as taught by Odrich ‘901 to increase the rigidity of the flap (Odrich ‘901, column 4, lines 15-25).
Allowable Subject Matter
Claims 1 and 6 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Furthermore, the prior art of record does not teach “a flow path hole disposed in an interior portion of each of the one or more of the flaps, wherein a combination of the flow path holes is configured as the flow path opening in the unstressed state” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 1.
The following is a statement of reasons for the indication of allowable subject matter: claims 12-15 is/are allowed primarily because the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Furthermore, the prior art of record does not teach “a flexible connecting portion having a narrower circumference than the two opposing funnel shaped end portions and disposed between the two opposing funnel shaped end portions and having a flow path hole disposed through the center of the flexible connecting portion” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 12.
Therefore, the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 4/14/26 have been fully considered but they are not persuasive.
Regarding the 35 USC 102 rejection of claim 9 by Odrich:
The applicants has argued that the amendments to the claims have overcome the previous claim rejections and for this reason the rejections should be withdrawn (see page 7 of the remarks). However, as indicated above, the Odrich reference still reads on the claims and for this reason the above rejections is maintained.
Regarding the 35 USC 102 rejections of the claims by Price:
The applicant’s amendments to the claims have overcome the previous claim rejections and for this reasons they are withdrawn.
Regarding the 35 USC 102 rejections of the claims by Errico:
The applicant’s amendments to the claims have overcome the previous claim rejections and for this reasons they are withdrawn.
Regarding the 35 USC 102 rejections of the claims 1, 2, 12 and 15 by Odrich:
The applicant’s amendments to the claims have overcome the previous claim rejections and for this reasons they are withdrawn.
Regarding the 35 USC 102 rejections of the claims by Sekiya:
The applicant’s amendments to the claims have overcome the previous claim rejections and for this reasons they are withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WESLEY G HARRIS/Examiner, Art Unit 3783
Prosecution Insights