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 .
Notice of Amendment
In response to the amendment filed on 6/14/2023, amended claims 1-6, 10-14, 16-17, 19, 22-23, 27-28, and 30-31 and cancelled claims 7-9, 15, 18, 20-21, 24-26, 29, and 32-91 are acknowledged. Claims 1-6, 10-14, 16-17, 19, 22-23, 27-28, and 30-31 are currently pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites the limitation “the front surface of th4e transducer is substantially flat” in lines 1-2, which it appears should instead recite “the front surface of the transducer is substantially flat”.
Appropriate correction is required.
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) 1-6, 11-14, 16-17, 19, and 30-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kanngiesser (US Patent No. 6,893,398 B2).
Regarding claim 1, Kanngiesser discloses a transducer probe comprising:
a probe body having:
a body axis (see Figures 4-5),
a first portion (3) of the probe body, the first portion defined by a front surface (5) of a transducer of said contact ophthalmological instrument,
a second portion of the probe body circumscribing and forming a ridge (43, 53) above the first portion of the probe body (see Figures 4-5 and col. 8, lines 57-61),
wherein the transducer probe is configured for use with the contact ophthalmological instrument employing said transducer (7) (see col. 6, lines 14-27), and
wherein a front surface of the probe body is transverse to the body axis and is inwardly shaped (see Figures 4-5 and col. 4, lines 27-29).
Regarding claim 2, Kanngiesser discloses the front surface of the transducer is substantially circumscribed with material different from a material of the front surface of the transducer and/or the front surface of the probe body is substantially opaque to light (see col. 7, lines 49-50).
Regarding claim 3, Kanngiesser discloses the front transducer surface defines at least an axial portion of the front surface of the probe body (see Figures 4-5); and/or the front surface of the transducer is substantially opaque to light (see col. 7, lines 49-50).
Regarding claim 4, Kanngiesser discloses the front surface of the transducer is substantially circumscribed with a layer of material different from a material of the front surface of the transducer; and/or the front surface of the transducer is separated from the second portion of the probe body, in a radial direction, with said layer of material (see Figures 4-5 and col. 8, lines 55-65 and col. 9, lines 2-5). Regarding claim 5, Kanngiesser discloses a cornea-contacting surface of the second portion of the probe body a first non-zero surface curvature with a first sign in a plane parallel to the body axis (see Figures 4-5 and col. 4, lines 27-29, col. 8, lines 54-57, and col. 9, lines 23-33), and/or
the cornea-contacting surface of the second portion of the probe body is dimensioned to be substantially tangentially-parallel with the front surface of the transducer along a perimeter of said front surface of the transducer (see Figures 4-5).
Regarding claim 6, Kanngiesser discloses the front surface of the transducer is substantially flat (see Figure 5 and col. 9, lines 20-21).
Regarding claim 11, Kanngiesser discloses (11A) the transducer includes a piezo or pressure sensor element (see col. 6, lines 14-18); and/or
(11B) the front surface of the transducer has non-zero surface curvature with a first sign (see Figures 4-5); and/or
(11 C) a surface of the second portion of the probe body and the front surface of the transducer are dimensioned to be tangentially parallel substantially at every point of a perimeter of the front surface of the transducer (see Figures 4-5).
Regarding claim 12, Kanngiesser discloses a sign of non-zero curvature of a cornea-contacting surface of the second portion of the probe body is equal to a sign of non-zero curvature of the front surface of the transducer (see Figures 4-5 and col. 4, lines 27-29, col. 8, lines 54-57, and col. 9, lines 23-33).
Regarding claim 13, Kanngiesser discloses the first sign is equal to a sign of a curvature of a surface of the cornea (see Figures 4-5 and col. 4, lines 27-29, col. 8, lines 54-57, and col. 9, lines 23-33).
Regarding claim 14, Kanngiesser discloses the front surface of the probe body surface is axially-symmetric about said body axis and/or the front surface of the transducer defines a portion of a spherical surface (see Figures 4-5 and col. 4, lines 27-29).
Regarding claim 16, Kanngiesser discloses a front surface of said ridge has a surface curvature with a sign that is opposite to a sign of a surface curvature of a cornea-contacting surface of the second portion of the probe body, the front surface of said ridge being substantially co-axial with the front transducer surface (see Figure 5 and col. 9, lines 23-33).
Regarding claim 17, Kanngiesser discloses the front surface of the transducer surface is substantially opaque to light and the transducer probe is configured as a tonometer probe for use with a hand-held portable contact tonometer (see col. 7, lines 49-52).
Regarding claim 19, Kanngiesser discloses a method for measuring an intraocular pressure (IOP) of an eye, the method comprising:
equipping a hand-held contact ophthalmological instrument with a transducer probe according to claim 1 (see rejection above),
mechanically connecting the front surface at least the front surface of the transducer surface with the cornea of the eye (see Figure 9 and col. 4, lines 17-29; and
operating the transducer to take a measurement of the IOP without transmitting light through a front surface of the transducer surface and/or through the first portion of a probe body and/or through the second portion of the probe body towards the cornea (see col. 4, lines 43-44 and col. 7, lines 49-50).
Regarding claim 30, Kanngiesser discloses (30A) said mechanically connecting includes establishing a direct physical contact between the front surface of the transducer and the cornea (see Figure 9); or
(30B) said mechanically connecting includes mechanically connecting the at least the front surface of the transducer with the cornea through a thin-film of elastic material (41, 53) disposed therebetween (see Figures 4-5 and col. 8, lines 54-57 and col. 9, lines 23-33).
Regarding claim 31, Kanngiesser discloses said equipping includes equipping a hand-held contact tonometer with the transducer probe having a front surface substantially opaque to light (see col. 7, lines 49-52).
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) 10 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanngiesser, further in view of Su (US Publication No. 2016/0213250 A1).
Regarding claim 10, it is noted Kanngiesser does not specifically teach said probe body is substantially monolithic. However, Su teaches said probe body is substantially monolithic (see [0081] – “In one embodiment, the disposable cap 200 can be constructed with the optical window cover 222 and the locking element 227 as a single integral piece”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kanngiesser to include said probe body is substantially monolithic, as disclosed in Su, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding claim 22, it is noted Kanngiesser does not specifically teach forming a barrier to transfer of microorganisms between the eye and the probe body prior to said mechanically connecting, and wherein said mechanically connecting includes mechanically connecting the at least the front surface of the transducer with the cornea through said barrier. However, Su teaches forming a barrier to transfer of microorganisms between the eye and the probe body prior to said mechanically connecting, and wherein said mechanically connecting includes mechanically connecting the at least the front surface of the transducer with the cornea through said barrier (see [0084] – “The material can also provide a physical barrier preventing all of virus and bacteria from penetrating the optical window cover 322 when the cover 322 is made with minimum thickness and exposed for at least 2 hours” and [0099] – “The optical window cover 322 can be made of materials which satisfy the sterilization requirements. The optical window cover 322 should be capable of providing an effective physical barrier from bacteria and viruses”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kanngiesser to include forming a barrier to transfer of microorganisms between the eye and the probe body prior to said mechanically connecting, and wherein said mechanically connecting includes mechanically connecting the at least the front surface of the transducer with the cornea through said barrier, as disclosed in Su, so as to provide an effective physical barrier from bacteria and viruses (see Su: [0099]).
Regarding claim 23, Su teaches said barrier is dimensioned to have a surface that substantially conforms to a corneal surface of the eye (see Figure 1(C) and [0073] – “Accordingly, the optical window 102 may have a concave surface 103 with a radius of curvature closely matching a curvature of the cornea of the eye”).
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanngiesser, further in view of Falck et al. (US Patent No. 6,179,779 B1)
Regarding claim 27, it is noted Kanngiesser does not specifically teach said operating includes repositioning the front surface of the transducer with respect to the cornea. However, Falck et al. teaches said operating includes repositioning the front surface of the transducer with respect to the cornea (see col. 5, lines 42-59 and col. 10, lines 23-25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kanngiesser to include said operating includes repositioning the front surface of the transducer with respect to the cornea, as disclosed in Falck et al., so as to ensure that inaccurate readings from eccentric corneal contact are avoided (see Falck et al.: col. 5, lines 56-59).
Regarding claim 28, it is noted Kanngiesser does not specifically teach said operating includes repositioning both the first portion of the probe body and the second portion of the probe body with respect to the cornea. However, Falck et al. teaches said operating includes repositioning both the first portion of the probe body and the second portion of the probe body with respect to the cornea (see col. 5, lines 42-59 and col. 10, lines 23-25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kanngiesser to include said operating includes repositioning both the first portion of the probe body and the second portion of the probe body with respect to the cornea, as disclosed in Falck et al., so as to ensure that inaccurate readings from eccentric corneal contact are avoided (see Falck et al.: col. 5, lines 56-59).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/Primary Examiner, Art Unit 3791