DETAILED ACTION
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.
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 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) 1-11 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Manor WO 2021/136969.
Claim 1: Manor discloses a device as best seen in figures 1-3, comprising: a body 100 having a first end, a second end opposite the first end, a top side 102 extending from the first end to the second end, and a bottom side 104 opposite the top side, wherein the body comprises: a first portion having a hollow and substantially conical shape at 110 about a longitudinal axis, the first portion extending from the first end of the body to a transition intermediate the first and second ends of the body, and a second portion having a hollow and substantially cylindrical shape at 120 about the longitudinal axis, the second portion extending from the transition to the second end of the body, wherein the first portion and the second portion define a passage (at the hollow interior of 110, 120, figures 1-3) having a first inner diameter at the first end and a second inner diameter at the second end, wherein the first inner diameter is larger than the second inner diameter (see fig. 1, claim 1, paragraph 33), wherein the first end is configured to engage an intra-ocular lens injector ( IOL injector now shown, fig. 3, paragraph 43); wherein the second end includes a pointed tip configured to penetrate tissue of an eye (152, fig. 1, claim 1), and wherein an insertion opening at 140, fig 1 is formed in the bottom side of the body and extends from the second end of the body toward the first end of the body, wherein the insertion opening is configured to allow to pass therethrough an implantable device received at the first end of the body from the intra-ocular lens injector that is engaged with the first end of the body for implantation of the implantable device in the eye see figures 1-3, paragraphs 59-60, wherein the insertion opening, when viewed from a lateral side of the body, is defined by: first and second beveled portions extending from the top side of the body toward the longitudinal axis and from the pointed tip toward the first end of the body (150, figures 1-3, paragraph 40), wherein each of the first and second beveled portions is concave with respect to the longitudinal axis when viewed from the lateral side of the body, and wherein the first and second beveled portions are positioned within the second portion of the body (it is noted that 150 positioned within 120, paragraph 40); first and second parallel portions extending from corresponding ones of the first and second beveled portions in a direction toward the first end of the body (see figures 1-3, paragraph 39), wherein each of the first and second parallel portions is substantially parallel to the longitudinal axis when viewed from the lateral side of the body, and wherein the first and second beveled portions extend across the transition between the first and second portions of the body; first and second concave portions extending from corresponding ones of the first and second parallel portions in a direction toward the first end of the body and toward and past the longitudinal axis of the body (at 146, see claim 1, paragraphs 37-38), wherein the first and second concave portions are concave with respect to the longitudinal axis when viewed from the lateral side of the body, and wherein the first and second concave portions are positioned within the first portion of the body (at 146 disposed within 110, figures 1-3, paragraph 17, claim 1). Note that Figures 1-3, the bottom 104 of the device 100 includes an insertion portion 140, which includes certain surfaces that will be described hereinafter. In some embodiments, the insertion portion 140 defines an insertion opening. In some embodiments, such as that shown in Figures 1-3, the insertion portion 140 is symmetric (i.e., the two sides of the insertion portion 140 are mirror images of one another to opposite sides of the longitudinal axis A). However, in other embodiments, the insertion portion 140 is not symmetric (i.e., is different to the “left” side of the device than to the “right” side of the device). In some embodiments, the insertion portion 140 includes a planar face 142 formed in the fitting section 110. In some embodiments, the planar face 142 is angled with respect to the longitudinal axis A. In some embodiments, the planar face 142 is angled with respect to the longitudinal axis A by an angle that is from 5 degrees to 45 degrees. In some embodiments, the planar face 142 provides for a smooth progression of the device 100 along tissues of the eye.[0037] Continuing to refer to Figures 1-3, in some embodiments, the insertion portion 140 includes first and second convex portions 144 extending from the planar face 142 toward the longitudinal axis A and away from the first end 112 of the fitting section 110. In some embodiments, the convex portions 144 are convex with respect to the longitudinal axis A , as viewed from the side as shown in Figure 2, with a first one of the convex portions 144 being located to the left side 106 and a second one of the convex portions 144 being located to the right side 108 of the device 100. In some embodiments, the size of the first and second convex portions 144 (e.g., the radius of curvature of the first and second convex portions) is determined as the sizing necessary to provide a smooth transition between the planar face 142 and the first and second concave portions 146. In some embodiments, the radius of curvature of the first and second convex portions 144 is from 0 (e.g., the first and second convex portions 144 are missing and the planar face 142 transitions directly into the first and second concave portions 146) to 3.5 millimeters (see paragraphs 36-37). Alternatively ,it would have been obvious that the above description of Manor’s device would have a planar face 142 extending from the first and second concave portions in a direction toward the first end of the body and away from the longitudinal axis of the body, wherein the planar face is angled at a bevel angle that is an acute angle with respect to the longitudinal axis of the body when viewed from the lateral side of the body, and wherein the planar face is positioned within the first portion of the body. Thus, claim 1 is unpatentable over Manor.
Claims 2-4: Manor discloses wherein respective transitions between the first and second concave portions and the planar face are curved (it is noted that the curved transitions between 146 and 142, fig. 2); wherein the bevel angle is in a range of from 10 degrees to 14 degrees (see claim 3, fig. 2). , wherein the pointed tip is angled with respect to the planar face at a lancet angle that is in a range of from 8 degrees to 12 degrees (see claim 4, fig. 2).
Claims 5-7: Manor discloses wherein the first and second concave portions have a radius of curvature that is in a range of from 1 millimeter to 3 millimeters (see figures 1-3, claim 5, paragraph 38); wherein the pointed tip defines a tip angle that is in a range of from 60 degrees to 68 degrees (see claim 6, paragraph 41). , wherein the device is configured for use with an implantable device having an implantable device length, and wherein the insertion opening has a length along the longitudinal axis that is greater than the implantable device length by from 0.5 mm to 2 mm (see claim 7, paragraph 22).
Claims 8-11: Manor discloses wherein the second portion of the body and the first and second parallel portions define an arc angle that is in a range of from 90 degrees to 150 degrees (arc angle gamma, fig. 8, paragraph 53);wherein the second portion of the body has an inner diameter that is in a range of from 1.5 mm to 3 mm (fig. 4, claim 9, paragraph 52). , wherein the first end of the body has an inner diameter that is in a range of from 2 mm to 5 mm (inner diameter of 112, figures 1-3, claim 10, paragraph 25). , wherein a length of the device along the longitudinal axis is in a range of from 7 mm to 20 mm (see claim 11, paragraph 26, figures 1-3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VI X NGUYEN whose telephone number is (571)272-4699. The examiner can normally be reached Monday-Friday (6:30-4:30).
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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