DETAILED ACTION
This action is responsive to the “RESPONSE A To Office Action dated July 11, 2025” dated 6 October 2025. The Examiner acknowledges the amendments to Fig. 6 of the drawings, and addition of new Fig. 6B; the amendments to the Specification; and the amendments to claims 1-2, 4, 6, 11-13, and 15. Claims 1-15 are pending.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “embodiment 130” [Applicant’s Specification ¶0021], “retention bead or ring bead 303” [Applicant’s Specification ¶0027], “probe tip 501” [Applicant’s Specification ¶0029].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 2-9 and 11-15 is/are objected to because of the following informalities:
Claims 2-9 should each read “[[A]] The disposable article according to…” [line 1 in each claim].
Claim 4 should read “for use with the contact ophthalmological instrument, wherein the contact ophthalmological instrument [[that]] is a contact tonometer” [lines 4-5].
Claim 4 should read “for use with the contact ophthalmological instrument, wherein the contact ophthalmological instrument [[that]] is a contact ultrasound pachymeter” [lines 18-19].
Claims 11-15 should each read “[[A]] The method according to…” [line 1 in each claim].
Claim 13 should be amended to read “wherein said covering includes substantially conforming said inner surface of the tip portion of the thin film body of the disposable article to the inwardly curved front surface of the tip of the probe[lines 6-13], as the Examiner notes that the limitation of lines 11-13 appears to be almost an exact duplicate of the limitation of lines 6-8 [the limitation of lines 6-8 recites “the thin film body of the disposable article” (line 7), while the limitation of lines 11-13 recites “the thin film body” (line 12), which is not considered to be substantively different].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 13 is/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.
Claim 13 recites in the preamble “satisfying one of the following conditions:…” [lines 1-2], and further recites “(a) wherein the inner surface of the first central area is convex as viewed from the open end of the disposable article” [lines 3-4] and additional “wherein” limitations that are not preceded with “(b)”, “(c)”, or “(d)” [lines 5, 6-8, 11-13], such that claim is considered indefinite, as it is not clear whether each limitation of lines 5, 6-8, and 11-13 should be preceded with “(b)”, “(c)”, or “(d)” based on the preamble defining a list and the limitation of lines 3-4 being preceded with “(a)” or whether each limitation of lines 5, 6-8, and 11-13 falls within option (a), such that claim 13 is not meant to define a list. For examination purposes, the Examiner has interpreted either interpretation to be applicable in light of any prior art applied under § 102 or § 103.
Examiner’s Note Regarding Subjective and Relative Terminology on p. 5-6 of the Non-Final Office Action dated 11 July 2025 is maintained.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 7, 9-12, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palese (US-5318029-A).
Regarding claim 1, Palese teaches
A disposable article of manufacture [the Examiner notes that any item may be considered “disposable”, such that the term “disposable” is not considered to apply any particular structural limitations] dimensioned to cover a tip of a probe of a contact ophthalmological instrument [placing the shield 10 on a tonometer tip 30 (Palese Col 3:20)], the article comprising:
a flexible thin film tubular body [The tonometer shield 10 comprises a tubular portion 12 with a closed end 14 and an insertion end 16 (Palese Col 2:59-60); The shield 10 can be prepared from various different flexible or elastic polymers such as silicone rubber, natural or synthetic rubber, thermoplastic elastomers such as polyurethanes or butadiene-styrene copolymers, or thermoplastic polymers such as polyethylene or polypropylene. The main criteria for selecting the material is that it is flexible, has at least a small amount of elasticity (Palese Col 3:36-43)] having an open end and a closed end, a tip portion defining the closed end of the body, and a flexible thin film wall portion connecting the closed end with the open end [Palese Col 2:59-60],
wherein the tip portion includes a first central area that has an inner surface [wherein shield 10 is tubular and thus defines an interior space and inner surface of shield 10 (see Palese Fig. 2)] and an outer surface, the outer surface being concave [indented center 20 (Palese Fig. 2)],
wherein said article is configured to create a barrier, when installed onto the tip of the probe, to transfer of microorganism between an eye of a patient and the tip of the probe of the contact instrument during a contact ophthalmological examination [The shield prevents transference of infectious agents from patient to patient (Palese Col 2:27-28)] while not impeding a measurement of a target parameter of the eye through said cover [FIG. 4 is a side view of the tonometer shield of FIG. 1 applied to an applanation tonometer (Palese Col 2:50-51, Fig. 4); The tonometer sensing tip is then brought forward and into contact with the cornea. The applanation pressure on the cornea is then slowly increased until the desired pattern, i.e., an overlapping of inner edges of two semicircular arcs, the visibility of which has been enhanced by addition of the fluorescein, has been obtained. The amount of applanation pressure applied by the tonometer is then recorded and converted to a measure of the internal pressure of the eye (Palese Col 4:39-48, Figs. 4-5)].
Regarding claim 2, Palese teaches
A disposable article according to claim 1, wherein:
the inner surface is convex [wherein the portion of the inner surface defined within the shield 10 opposite the indented center 20 (see Palese Fig. 2) is convex];
and wherein the concave outer surface is dimensioned to substantially conform to a corneal surface of an eye [Palese Col 3:36-43, 4:39-48, Figs. 4-5, wherein being flexible and applicable to a patient’s eye is considered to read on the instant limitation].
Regarding claim 3, Palese teaches
A disposable article according to claim 1, wherein said open end is circumscribed with a retention ring portion of the article [The shield 10 shown in the Figures includes a retaining ring 34 extending from the internal wall 36 at the point of attachment 24 between the tubular portion 12 and the skirt 22. During insertion the retaining ring 34 is stretched around the tonometer tip and holds the shield in place (Palese Col 3:5-11, Fig. 2)].
Regarding claim 5, Palese teaches
A disposable article according to claim 1, wherein the wall portion is dimensioned to secure said cover to said contact ophthalmological instrument [Palese Col 3:5-11, Fig. 2].
Regarding claim 7, Palese teaches
A disposable article according to claim 1, wherein, when the outer surface of the first central area the tip portion is necessarily concave [see indented center 20 (Palese Fig. 2)], the tip portion further includes a second peripheral area having an outer surface that is convex, the second peripheral area circumscribing the first central area [wherein the raised circumferential edge 18 is depicted as being convex and circumscribing the indented center 20 (Palese Fig. 2)].
Regarding claim 9, Palese teaches
A disposable article according to claim 1, wherein the thin film is formed from a material selected from the group consisting of polyurethane, polyethylene, polypropylene, polyisoprene, polychloroprene, nitrile, and silicone [Palese Col 3:36-43].
Regarding claim 10, Palese teaches
A method comprising:
removably covering a tip of a probe of a contact ophthalmological instrument with the disposable article of manufacture according to claim 1 to spatially-coordinate the first central area with a front surface of the tip of a probe [Palese Col 2:50-51, Figs. 4-5]; and
bringing the tip of the probe in indirect contact with the cornea of an eye through a layer of the thin film body of the article at the first central area such that an outer surface of the first central area is in physical contact with the cornea while the tip of the probe is in physical contact with an inner surface of the first central area [Palese Col 4:39-48, Figs. 4-5].
Regarding claim 11, Palese teaches
A method according to claim 10, wherein said bringing includes bringing substantially congruent with one another the inner surface of the first central area and the front surface of the tip of the probe in contact with one another [Palese Col 2:50-51, Figs. 4-5].
Regarding claim 12, Palese teaches
A method according to claim 10, wherein said covering includes creating a barrier against microorganisms from the eye to said tip of the probe during said indirect contact while allowing a measurement of a target parameter of the eye through said cover substantially without impeding said measurement [Palese Col 2:27-28].
Regarding claim 15, Palese teaches
A method according to claim 10, further comprising:
(a) performing a measurement of an intraocular pressure of an eye while pressing the tip of the probe and the covering into the cornea [Palese Col 4:39-48, Figs. 4-5]; or
(b) performing a measurement of a thickness of the cornea by transmitting ultrasound waves through said covering while the covering remains in contact with the cornea.
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.
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) 4 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palese, as applied to claims 1 and 10 above, in view of Kanngiesser (US-20050245802-A1) [the Examiner notes that the presently cited Kanngiesser reference is not the same as the previously cited Kanngiesser reference (US-6893398-B2), which is hereinafter referred to as Kanngiesser ‘398].
Regarding claim 4, Palese teaches
A disposable article according to claim 1, wherein one of the following conditions is satisfied:
(a) when the inner surface of the first central area is convex [wherein the portion of the inner surface defined within the shield 10 opposite the indented center 20 (see Palese Fig. 2) is convex],
the target parameter includes an intraocular pressure (IOP) [Palese Col 4:39-48]; and
(b) said article is configured for use with the contact ophthalmological instrument that is a contact ultrasound pachymeter employing a pachymeter probe having a tip with an inwardly curved cornea-contacting surface,
wherein the inner surface of the first central area is dimensioned to cover and substantially conform to said cornea-contacting surface of the tip of the pachymeter probe.
However, while Palese discloses that the dimensions and shape of the disposable article is/are dependent on the particular tonometer being used [The exact dimensions and shape of the shield 10 depends on the particular tonometer it is designed to fit (Palese Col 3:49-50)], Palese fails to explicitly disclose wherein said article is dimensioned for use with the contact ophthalmological instrument that is a contact tonometer employing a tonometer probe having a tip with an inwardly curved front surface, the convex inner surface of the first central area is substantially congruent with the inwardly curved front surface, the first central area is dimensioned to substantially cover the inwardly curved surface.
Kanngiesser discloses protective covers for contact tonometers configured to measure a pressure of an eye [a protective cover for ophthalmological tonometers which have a contact area for placing on an eye and a method for producing the protective cover, it being intended that the protective cover can be produced as inexpensively as possible and that the eye-pressure measurement is impaired as little as possible by the protective cover, or not at all (Kanngiesser ¶0005)], wherein Kanngiesser discloses contact tonometers that employ a tonometer probe having a tip with an inwardly curved front surface, wherein a corresponding protective cover has first central area that has a convex inner surface that is substantially congruent with the inwardly curved front surface, wherein the first central area is dimensioned to substantially cover the inwardly curved surface [As represented in FIG. 6, the proposed protective cover 1 is suitable not only for measuring heads 21 with planar contact areas 22, but also for concave (or convex) contact areas 22'. In the case of concave or convex contact areas, however, the radius of curvature of the pressure-exerting region of a stamp used for forcing out the air should be smaller than the radius of curvature of the contact area 22'. FIG. 6 shows in particular an example in which the protective cover 1 has been applied to a tip 21' of a contour tonometer according to EP 1250884, which has a concave contact area 22', into which a pressure sensor 24 with the same contour as the concave contact area 22' is set (Kanngiesser ¶0029, Fig. 6)].
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 the disposable article of Palese to employ said article is dimensioned for use with the contact ophthalmological instrument that is a contact tonometer employing a tonometer probe having a tip with an inwardly curved front surface, the convex inner surface of the first central area is substantially congruent with the inwardly curved front surface, the first central area is dimensioned to substantially cover the inwardly curved surface, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [application of the disposable article to a known type of tonometer] [MPEP § 2143(I)(D)].
Regarding claim 13, Palese teaches
A method according to claim 10, satisfying one of the following conditions:
(a) wherein the inner surface of the first central area is convex as viewed from the open end of the disposable article [wherein the portion of the inner surface defined within the shield 10 opposite the indented center 20 (see Palese Fig. 2) is convex].
However, Palese fails to explicitly disclose wherein the tip of the probe has an inwardly curved front surface, such that said covering includes substantially conforming said inner surface of the tip portion of the thin film body of the disposable article to the inwardly curved front surface of the tip of the probe.
Kanngiesser discloses protective covers for contact tonometers configured to measure a pressure of an eye [Kanngiesser ¶0005], wherein Kanngiesser discloses contact tonometers that employ a tonometer probe having a tip with an inwardly curved front surface, wherein a corresponding protective cover has first central area that has a convex inner surface that is substantially congruent with the inwardly curved front surface, wherein the first central area is dimensioned to substantially cover the inwardly curved surface [Kanngiesser ¶0029, Fig. 6].
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 the disposable article of Palese to employ the tip of the probe has an inwardly curved front surface, such that said covering includes substantially conforming said inner surface of the tip portion of the thin film body of the disposable article to the inwardly curved front surface of the tip of the probe, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [application of the disposable article to a known type of tonometer] [MPEP § 2143(I)(D)].
Claim(s) 6, 8, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palese, as applied to claims 1, 3, and 10 above, in view of Prisco (US-7287856-B2, previously presented).
Regarding claim 6, Palese teaches
A disposable article according to claim 3.
However, Palese fails to explicitly disclose wherein said retention ring portion is configured to compressingly fit into a corresponding groove of said contact instrument.
Prisco discloses a removable hypoallergenic cover for a tip of a probe of a tonometer, wherein the cover comprises a retention ring configured to compressingly fit into a corresponding groove of said contact instrument [the hypoallergenic disposable tip cover comprises a ring bead which fits into a groove on the probe of the contact tonometer to hold the tip cover in place (Prisco Col 2:65-67); the form for creating the probe tip cover contains an area which is modified or indented to form a thicker portion, often called a "bead" or "ring bead" of the wall section of the probe tip cover. Such a bead is used in combination with a contact tonometer including a groove in the probe. Such groove is located out of the measurement area and provides a means for holding the probe tip cover in place during examination (Prisco Col 5:9-16)].
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 the retention ring portion of Palese to be configured to compressingly fit into a corresponding groove of said contact instrument, to allow for the article to be securely attached to the instrument [Prisco Col 5:9-16].
Regarding claim 8, Palese teaches
A disposable article according to claim 1.
However, while Palese discloses that the article is configured to fulfill sufficient mechanical requirements to prevent tearing or rupturing [The main criteria for selecting the material is that it is flexible, has at least a small amount of elasticity, and that the material is not easily torn or ruptured under stress (Palese Col 3:41-44)], Palese fails to explicitly disclose wherein the article is configured to have: an ultimate elongation from about 500% to about 1000%, and/or a tensile strength from about 1000 to 5500 psi, and/or a modulus of elasticity, at 100% strain, from about 50 to about 2000 psi.
Prisco discloses a hypoallergenic cover for a tip of a probe of a tonometer, wherein the cover is configured to have: an ultimate elongation from about 500% to about 1000%, and/or a tensile strength from about 1000 to 5500 psi, and/or a modulus of elasticity, at 100% strain, from about 50 to about 2000 psi [Useful thin films formed from such elastomers are those having an ultimate elongation of from about 500 to 1000%, a tensile strength of from about 1000 to about 5500 psi and a modulus of elasticity at 100% strain of from about 50 to about 2000 psi. In one embodiment, the thin film has a modulus of elasticity is from about 50 to about 500 psi (Prisco Col 3:64-4:3)].
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 the article of Palese to employ an ultimate elongation from about 500% to about 1000%, and/or a tensile strength from about 1000 to 5500 psi, and/or a modulus of elasticity, at 100% strain, from about 50 to about 2000 psi, to impart sufficient mechanical strength to the article to allow for application and removal of the article without tearing [Prisco Col 2:12-14].
Regarding claim 14, Palese teaches
A method according to claim 10.
However, Palese fails to explicitly disclose wherein said removably covering includes securing the disposable article on the ophthalmological instrument by placing a retention ring portion of the article into a groove on said instrument.
Prisco discloses a removable hypoallergenic cover for a tip of a probe of a tonometer, wherein removably covering the cover onto the tonometer includes securing the cover on the tonometer by placing a retention ring portion of the cover into a groove on said tonometer [Prisco Col 2:65-67, 5:9-16].
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 the step of Palese of removably covering to include securing the disposable article on the ophthalmological instrument by placing a retention ring portion of the article into a groove on said instrument, to allow for the article to be securely attached to the instrument [Prisco Col 5:9-16].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 9, filed 6 October 2025, with respect to the previously presented Drawing Objections have been fully considered and are not entirely persuasive. The drawing objection directed towards claimed subject matter not being depicted in the drawings has been withdrawn.
The Examiner notes that the drawing objections directed towards reference characters recited in the specification but not depicted in the Applicant’s Drawings were not specifically addressed in the present drawing and specification amendments or Applicant’s Remarks and are thus maintained.
Applicant’s arguments, see Applicant’s Remarks p. 9, with respect to the previously presented Claim Objections have been fully considered and are not entirely persuasive. Not all of the previously presented claim objections have been withdrawn.
The Examiner notes that the claim objections directed towards the language in are considered to have support in the MPEP, which provides suggestions on how to structure dependent claims [A singular dependent claim 2 could read as follows: 2. The product of claim 1 in which . . . . (MPEP § 608.01(IV)]. The corresponding claim objections are maintained.
Applicant’s arguments, see Applicant’s Remarks p. 10, with respect to the previously applied claim rejections under § 112(b) have been fully considered and are persuasive. The rejections of claims 4 and 13 under § 112(b) have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 11-13, with respect to the rejection(s) of claim(s) 1 under § 102(a)(1) and those dependent therefrom have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Palese (US-5318029-A) with respect to claims 1-3, 5, 7, 9-12, and 15; Palese in view of Kanngiesser (US-20050245802-A1) [the Examiner notes that the presently cited Kanngiesser reference is not the same as the previously cited Kanngiesser reference (US-6893398-B2), which is hereinafter referred to as Kanngiesser ‘398] with respect to claims 4 and 13; and Palese in view of Prisco (US-7287856-B2, previously presented) with respect to claims 6, 8, and 14.
The Applicant asserts that Kanngiesser ‘398 fails to provide a teaching for the claimed “flexible tubular body”, as the Applicant argues that the only portion of the structure of Kanngiesser ‘398 that can be interpreted as a “tubular body” is frame 52 [see Kanngiesser ‘398 Fig. 5], but the Applicant notes that there is nothing in Kanngiesser ‘398 that would expressly indicate that the circular cylindrical frame 52 is “flexible” and that the language used by Kanngiesser ‘398 of “frame” implies an amount of rigidity. The Applicant further notes that body 53 of Kanngiesser ‘398 may be flexible, but is not considered to be “tubular”. The Applicant also asserts with respect to claims 2, 7, and 13, that the prior art does not teach, disclose, or suggest a tip portion (of the flexible tubular body) with that inner surface that is convex [Applicant cites Fig. 5 of Kanngiesser ‘398 as depicting a substantially planar surface]. The Applicant further asserts with respect to claim 4, that Kanngiesser ‘398 fails to teach, disclose, or suggest elements (a) and (b). However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1-2, 4, 7, and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claims 1-2, 7, and 13 are rejected under § 102 as being anticipated by Palese, and claim 4 is rejected under § 103 as being rendered obvious in view of Palese in view of Kanngiesser [not the same as the Kanngiesser ‘398 reference]. Regarding the Applicant’s arguments for claim 1, the Examiner notes that Palese teaches a flexible tubular body [The tonometer shield 10 comprises a tubular portion 12 with a closed end 14 and an insertion end 16 (Palese Col 2:59-60); The shield 10 can be prepared from various different flexible or elastic polymers such as silicone rubber, natural or synthetic rubber, thermoplastic elastomers such as polyurethanes or butadiene-styrene copolymers, or thermoplastic polymers such as polyethylene or polypropylene. The main criteria for selecting the material is that it is flexible, has at least a small amount of elasticity (Palese Col 3:36-43)].
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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791