DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
The amendment submitted August 18th, 2026 has been entered. Claims 1-21 are currently pending. Claim 16 has been withdrawn from consideration as being drawn toward the unelected species II as detailed in the Remarks submitted on August 18th, 2026 that applicant has elected species 1 with claims 1-14 being generic and claim 15 reading upon the elected species. Claims 17-21 have been withdrawn from consideration in accordance with the election of Group I as detailed in the response to the restriction requirement mailed on July 29th, 2026 received August 18th, 2026. Claims 1 and 13-15 have been amended. Thus claims 1-15 are currently under consideration.
Examiner notes that the claim amendments submitted on August 18th, 2026 have claim 16 listed as (Previously Presented) rather than (Withdrawn), however, it is clear from the Remarks submitted on August 18th, 2026 electing species I, and the lack of arguments presented, that applicant has elected to examine species I thus withdrawing claim 16 from consideration.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7, and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by John (U.S. Publication 2004/0122352).
Regarding claim 1, John discloses an ocular (Abstract eye) treatment ring (Fig. 1) comprising: a substantially a substantially circular ring (Fig. 1 shows substantially circular shape surrounding cornea of eye) comprising a medical grade material (¶0006 silicone plastic); and a plurality of fenestrations (24a and 24b) around a circumference of the circular ring (Fig. 1 shows spacing around circumference surrounding cornea).
While John does not expressly disclose the treatment being for “chemical injury”, this limitation of is considered functional language (relating to the use of the device to treat chemical injury, with patients receiving irrigation through the device to the eye to wash chemical exposure). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of John discloses all the structure as claimed, and is further capable of conducting fluid through the tubing (Abstract liquid drawn into the tubular member). As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as a chemical injury treatment device).
Regarding claim 2, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses the circular ring comprises plastic (¶0006 silicone plastic).
Regarding claim 3, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses the fenestrations are equally spaced about the circumference of the ring (¶0007 equally spaced apart).
Regarding claim 4, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses the fenestrations are of the same size (¶0007 each have a diameter of from about 0.15 mm to about 0.18 mm each has a diameter of d3).
Regarding claim 5, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses
Regarding claim 7, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses
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Illustrative diagram of Fig. 1 of John (U.S. Publication 2001/0122352).
Regarding claim 12, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses two sets of holes (24a and 24b) positioned at a different location around a circumference of the circular ring and around a circumference of tubing forming the circular ring (holes occur on opposite sides of eye and thus positioned at a different location around a circumference of the circular ring and are positioned around a circumference of the tubing forming the circular ring, Fig. 1).
Regarding claim 13, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses the substantially circular ring having a cap 16 at a distal end (end distal to element 12b)
Regarding claim 14, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses the substantially circular ring at a proximal end (end proximal line 12b) is integral with a section of tubing 12b having no fenestrations and having a connector E configured to attach to a pump P.
Regarding claim 15, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses no corneal shield or dome (no corneal shield present in Fig. 1).
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) 5 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over John (U.S. Publication 2004/0122352) in view of Pearson et al. (U.S. Publication 2003/0212394).
Regarding claims 5 and 11, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses two sets of holes (24a and 24b) that extend from a proximal connection point (point at which connects to tubing 12b) to a distal end (end at 18a/b respectively) on each side of the circular ring. John does not expressly disclose the fenestrations being of a different size (Claim 5) or the plurality of fenestrations comprising a first set of holes having a first size and a second set of holes having a second size larger than said first size (Claim 11).
However, Pearson, in the same field of endeavor of tubing for delivering fluid, teaches providing fenestrations 23 having an increasing diameter 23d and thus different sizes with a first hole size being smaller than a second hole size (increased diameter thus larger) (¶0086 the apertures are configured to have increasing diameters going in a distal direction with respect to electrode as to provide a substantially constant flow rate over the apertured portion by decreasing the fluid resistance moving in the distal direction according to Poiseuille’s law) for the purpose of providing a substantially constant flow rate through the apertures (¶0086 substantially constant flow rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each set of holes of John to have been smaller at the proximal connection point end (end proximal to single tubing 12b) and larger as it progressed toward its distal end, as taught by Pearson, resulting in a first set of holes (holes closer to the proximal connection) having a first size and a second set of holes (holes closer to the distal end) having a second size larger than said first size (progressive enlargement as progresses toward distal end) for the purpose of providing a substantially constant flow rate through each of the apertures as a function of Poiseuille’s law (¶0086 of Pearson substantially constant flow rate) .
Claim(s) 6, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over John (U.S. Publication 2004/0122352).
Regarding claim 6, John discloses the ocular chemical injury treatment ring according to claim 1. John does not expressly disclose the plurality of fenestrations including about 20 to about 50 fenestrations with John only disclosing 16 in Fig. 1.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included about 20 to about 50 fenestrations rather than the 16 disclosed by John as this constitutes a simple duplication of parts and it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), See MPEP 2144.04. Since applicant has not placed any criticality on this number of fenestrations with applicants’ disclosure simply stating “the number of fenestrations may be, but is not limited to, about 20 to about 80, for example about 20 to about 50” on Page 7 of applicant’s specification. As such this limitation is considered to have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 9, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses each of the fenestrations comprising an opening of about 0.15 mm to about 0.18 mm.
While John does not expressly disclose the claimed range of 0.1 mm to about 0.5 mm, 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 opening of John to be about 0.01 mm to about 0.5 mm as applicant appears to have placed no criticality on the claimed range (Page 7 of applicant’s spec “each of the fenestrations may have an opening of about 0.1 mm to about 2 mm, for example, about 0.1 mm to about 0.5 mm) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, John would not operate differently with the claimed range and has disclosed the openings being about 0.15 mm to about 0.18 mm which lies inside of the current claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that each of the fenestrations may have an opening of about 0.1 mm to about 2 mm, for example, about 0.1 mm to about 0.5 mm.
Regarding claim 10, John discloses the ocular chemical injury treatment ring according to claim 1. John further discloses the circular ring having a diameter of about 25 to about 28 mm ¶0023. John does not expressly disclose the diameter range being about 10 mm to about 40 mm as claimed.
However, 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 diameter of John to be about 10 mm to about 40 mm as applicant appears to have placed no criticality on the claimed range (Page 7 of applicant’s spec “in an embodiment, the substantially circular ring 105 may have a diameter of about 10 mm to about 40 mm, for example about 15 mm to about 30 mm) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, John would not operate differently with the claimed range and has disclosed the diameter being about 25 to about 28 mm which lies inside of the current claimed range. Further, applicant places no criticality on the range claimed, indicating simply that the substantially circular ring 105 may have a diameter of about 10 mm to about 40 mm, for example about 15 mm to about 30 mm.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over John (U.S. Publication 2004/0122352) in view of Vila Vidal (WIPO Publication 2018/178484).
Regarding claim 8, John discloses the ocular chemical injury treatment ring according to claim 1. John does not expressly disclose the fenestrations comprising an angled V-shaped opening.
However, Vila Vidal, in the same field of endeavor of ocular treatment rings, teaches providing fenestrations comprising an angled V-shaped opening (51 has passage that tapers toward the inner passage such that the inner passage end is smaller than the outer passage end as seen in Fig. 6) for the purpose of improving the distribution of the wash solution/fluid flow therethrough (see attached annotated translation box 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each fenestration of John to have comprised an angled V-shaped opening, as taught by Vila Vidal, for the purpose of improving the distribution of the wash solution/fluid flow therethrough (see attached annotated translation box 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wong, Jr. et al. (U.S. Patent No. 7,229,468) discloses an ocular irrigation treatment ring.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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