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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/10/2023 and 01/25/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election with traverse of species (I) and species (ii) drawn to claims 1-11, and claims 12-20 are withdrawn as directed to non-elected species in the reply filed on 07/21/2025 is acknowledged.
Response to Arguments
Applicant's arguments filed 07/21/2025 regarding there is no serious burden in examining all the claims that are directed to different species/embodiments have been fully considered but they are not persuasive, because the non-elected claims are directed to different embodiments of the probes having distinct crown/caps having different structural elements that operates differently. Thus, there is a serious burden in examining all different types of probes with distinct crown/caps.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “to reduce errors of ophthalmological measurements of the cornea” in line 7 should be amended to read –configured to reduce errors of ophthalmological measurements of the cornea--. Appropriate correction is required.
Claims 2-11 are objected to because of the following informalities: the phrase “An instrument” in line 1 should be amended to read –The instrument--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: the phrase “the ridge of a material” in line 4 should be amended to read –the ridge of the material--. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: the phrase “the ridge of a material” in line 4 should be amended to read –the ridge of the material--. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “the body” in line 10 should be amended to read –the article body--. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “a front surface” in line 10 should be amended to read –the front surface--. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “an outer surface” in line 12 should be amended to read –the outer surface--. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “an aperture-- in line 17 should be amended to read –the aperture--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the phrase “to transfer” in line 9 should be amended to read –configured to transfer--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the phrase “a probe” in line 9 should be amended to read –the probe--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the phrase “dimensioned to” in line 5 should be amended to read –configured to be dimensioned to--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the phrase “an eye” in line 6 should be amended to read –the eye--. 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.
Claim 1 recites the limitation "the cornea" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claims 2, 6 and 8 recite the limitation “and/or” this limitation is not defined by the claims, which renders the claims indefinite. One with ordinary skill in the art would not be able to know what constitutes the metes and bounds of the claims. The claims are indefinite because the metes and bounds of the invention cannot be properly ascertained.
Claims 2, 6, 7 and 11 recite the limitation “substantially” this limitation a relative term that is not defined by the claims, which renders the claims indefinite. The specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As broadly as claimed the scope of the claims is indeterminate with respect to the claimed “substantially”.
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, 2, 8 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCafferty et al (US 2018/0296090).
As to claim 1, McCafferty discloses a contact ophthalmological instrument (tonometer shown in fig.3 and 13A), comprising: a transducer (transducer in tonometer 300, abstract, par.82-87, fig.3 and 13A), and
a transducer probe (tonometer body 300, as best shown in fig.3A and 13A, par.38 and par.82) having a front cornea-contacting surface (corneal contact surface 304, par.82, fig.3),
wherein the front cornea-contacting surface includes a central region (corneal contact surface 304 includes a central concave surface portion 304A, which in one specific implementation is adapted to with the curvature of the cornea of a typical eye, par.82, fig.3) representing a transducer surface and a peripheral ridge of material (a peripheral surface portion 304B that has a curvature of an opposite sign, par.83, fig.3A) that circumscribes the central region and that is raised over the central region (304B is raised over central region 304A, par.82-84, cornea contact surface includes a central concave portion and a peripheral convex portion that circumscribes the central concave portion, par.93, as best seen in fig.3A) to reduce errors of ophthalmological measurement of the cornea during the use of the instrument (equipping the tonometer tip's surface with a specifically-defined curvature as discussed reduces and, in some cases, eliminates measurement errors caused by corneal curvature and intracorneal stress, abstract and par.8).
As to claim 2, McCafferty discloses the instrument, wherein the central region is substantially planar (the most bottom/lower portion of central region 304A is planar, as best seen in fig.3A) and/or the central region is substantially opaque to light (end of par.93 and par.142).
As to claim 8, McCafferty discloses the instrument, wherein the ridge of material is inseparable from and/or monolithic with the central region (regions 304A and 304B are integrated, single structure, par.82-85, fig,3A).
As to claim 9, McCafferty discloses the instrument, wherein the peripheral ridge of material includes an inwardly-shaped surface portion having a curvature with a first sign and an annularly-shaped surface portion circumscribing the inwardly-shaped surface portion and merging with said inwardly-shaped surface portion in a tangentially-parallel fashion, wherein a second sign of a curvature of the annularly-shaped surface portion is opposite to the first sign (a periphery of the corneal contact surface 304, the central concave surface portion 304a passes over into and merges with, in a tangentially-parallel fashion, par.83 and par.85, as best seen in fig.3A-B).
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) 10 and 11 is/are rejected under 35 U.S.C. 103 as being obvious over McCafferty et al (US 2018/0296090) in view of Prisco et al (US 7,287,856).
As to claims 10 and 11, McCafferty discloses the invention substantially as claimed above, but failed to explicitly teach the probe further comprising a disposable cover.
However, Prisco teaches an analogous tonometer device (300, fig.3) having hypoallergenic disposable cover (100, fig.1) covering the tip (301, fig.3) of tonometer device (col.5, lines 40-65), wherein the disposable cover includes:
a flexible thin film tubular body (tubular body 100 made of rubber, col.3 and col.5, fig.1) having an open (upper open end of 100, fig.1) and a closed end (lower closed end of 100, fig.1), a tip portion (tip 101, fig.1) defining the closed end of the tubular body, and a wall portion (wall 102, fig.1) connecting the closed end with the open end, wherein the tip portion of the tubular body includes a first central area (mid-point of tip 101, fig.1) that has an inner surface (inside surface, as best seen in fig.1) and an outer surface (outside surface, as best seen in fig.1), wherein said disposable cover is configured to create a barrier, when installed onto the probe tip, to transfer of microorganism between an eye of a patient and the tip of a probe of the contact instrument during a contact ophthalmological examination while not impeding a measurement of a target parameter of the eye through said disposable cover (the cover has a retention bead 103 which holds the probe tip cover 100 onto the probe tip 301. The contact tonometer is held by medical personnel using the grip area 303 and performs the test by contacting the contact area 302 of the probe tip 301 covered by the tip cover 100 to the eye of the patient. The disposable tip cover 100 protects the eye of the patient during the testing procedure, col.5),
wherein (i) the inner surface is either convex or substantially planar as viewed internally to tubular body from the open end (as best seen in fig.1, the inside surface of tip 101 is substantially planar as viewed from inside wall 102) or (ii) the inner surface is convex; and wherein the outer surface is dimensioned to substantially conform to a corneal surface of an eye (the outside surface of tip 101 is inherently dimensioned to substantially conform to a corneal surface of an eye, as best seen in fig.1 and 3).
Since tonometer’s cover is well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to include a tip cover to the tonometer taught by McCafferty’s invention, as cover 100 taught by Prisco’s invention, to protect the eye while testing and acts as a barrier against microorganisms from the eye of a patient to said probe tip, as taught by Prisco’s invention (abstract, col.1, lines 58-65).
Still, as to claims 10 and 11, McCafferty/Prisco combination teaches the invention substantially as claimed above, but does not explicitly teach the outer surface being concave. Nevertheless, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was made to design the outer surface being concave because the Applicant has not disclosed that this shape of the outer surface provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the cover of Prisco’s invention and the Applicant’s invention, to perform equally well with either the shape of the tip of the cover taught by Prisco’s invention or the claimed concave tip because both covers would perform the same function of covering the probe tip and protect the eye while testing and acts as a barrier against microorganisms from the eye of a patient to said probe tip, as taught by Prisco’s invention (abstract, col.1, lines 58-65).
Therefore, it would have been prima facie obvious to modify the cover taught by Prisco’s invention to obtain the invention as specified in Claim 10 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Prisco. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791