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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/20/25 has been entered.
Response to Amendment
Claims 1, 30-32, and 36-48 are pending in the application. Claims 2-29 and 33-35 have been canceled. Claims 1 and 41 have been amended.
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.
Claims 1, 30, 32, 37, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Forcelledo et al. (US 5,339,839) (“Forcelledo”).
Regarding claim 1, Forcelledo discloses (Figure 4) a tool assembly capable of marking a cornea for ophthalmic procedures, comprising: an applicator, having a container (80) capable of containing an ink, and a handle (84) coupled to the container and configured to actuate the container (Column 4, lines 8-16); and a marking tip (10’), having a base (see Figure 4 annotated below) and a plurality of marking elements (teeth) extending along a longitudinal direction from the base, wherein each marking element has an elongated cross-sectional shape in a cross-section perpendicular to the longitudinal direction (see Figure 4 annotated below), wherein the base defines a hollow interior space, wherein each of the marking elements defines a hollow interior channel (22’) in fluid communication with the hollow interior space of the base, a distal end of the hollow interior channel being open; wherein the base of the marking tip is configured to mate with a distal portion of the container of the applicator (via spike 76), and wherein the hollow interior space of the marking tip is in fluid communication with the container (via orifice 78) of the applicator when the marking tip is mated with the distal portion of the container.
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Regarding claim 30, Forcelledo discloses (Figure 4) that the applicator further includes a sleeve (70), and wherein the container (80) is a separate piece disposed inside the sleeve.
Regarding claim 32, Forcelledo discloses (Figure 4) that the applicator further includes a sleeve (70), and wherein the handle (84) is partially disposed within and protrudes from the sleeve (at 94; Column 4, lines 8-16).
Regarding claim 37, the marking elements disclosed by Forcelledo are prongs extending from the base, and distal end surfaces of the prongs are shaped and capable to lie on a curved surface (Column 3, lines 23-26) having a radius of curvature from 11.0 to 12.0 mm. NOTE: the head is a curved structure with curved surfaces, and the prongs disclosed by Forcelledo are shaped and capable of lying on a portion of a curved surface of a head within the claimed range. The prongs can also be placed on other curved surfaces of a human body, such as an eye, ear, nose, etc.
Regarding claim 39, Forcelledo discloses (Figure 4) that the marking tip has two, three, or four marking elements.
Claims 1, 31, and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eckerson (US 7,077,146 B1).
Regarding claim 1, Eckerson discloses (Figures 1-4) a tool assembly capable of marking a cornea for ophthalmic procedures, comprising: an applicator (11), having a container (13) capable of containing an ink (within 15; Column 2, line 62 – Column 3, line 2) and a handle (14) coupled to the container and configured to actuate the container (Column 2, line 62 – Column 3, line 2); and a marking tip (12), having a base (21) and a plurality of marking elements (22) extending along a longitudinal direction from the base, wherein each marking element has an elongated cross-sectional shape in a cross-section perpendicular to the longitudinal direction (see Figure 1 annotated below), wherein the base defines a hollow interior space (20), wherein each of the marking elements defines a hollow interior channel (Figure 4) in fluid communication with the hollow interior space of the base (Column 3, lines 51-56), a distal end of the hollow interior channel being open (at 23); wherein the base of the marking tip (12) is configured to mate with a distal portion (18) of the container of the applicator (Column 3, lines 23-26), and wherein the hollow interior space (20) of the marking tip is in fluid communication with the container (13) of the applicator when the marking tip is mated with the distal portion of the container (Column 3, lines 30-36).
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Regarding claim 31, Eckerson discloses (Figure 1) that the applicator further includes a sleeve (13), and wherein the container is a chamber (15) formed by interior walls of the sleeve and a distal end face (17) of the handle (Column 4, lines 38-40).
Regarding claim 40, Eckerson discloses (Figure 1) the marking tip (12) is configured to be attachable to and detachable from the applicator (Eckerson, Column 3, lines 20-26).
Claims 1, 30, 32, 37, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garrett (US 5,913,314).
Regarding claim 1, Garrett discloses (Figures 1-5) a tool assembly capable of marking a cornea for ophthalmic procedures, comprising: an applicator (70), having a container (32) capable of containing an ink (Column 4, lines 66-67) and a handle (82) coupled to the container and configured to actuate the container (Column 5, lines 43-57); and a marking tip (42), having a base (22) and a plurality of marking elements (44) extending along a longitudinal direction from the base, wherein the base defines a hollow interior space, wherein each marking element has an elongated cross-sectional shape in a cross-section perpendicular to the longitudinal direction (see Figure 2 annotated below), wherein each of the marking elements defines a hollow interior channel in fluid communication with the hollow interior space of the base (Column 5, lines 12-16), a distal end of the hollow interior channel being open; wherein the base of the marking tip is configured to mate with a distal portion (34) of the container of the applicator, and wherein the hollow interior space of the marking tip is in fluid communication with the container of the applicator when the marking tip is mated with the distal portion of the container (Column 5, lines 43-57).
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Regarding claim 30, Garrett discloses (Figure 5) that the applicator further includes a sleeve (72, 76), and wherein the container (32) is a separate piece disposed inside the sleeve.
Regarding claim 32, Garrett discloses (Figure 5) that the applicator further includes a sleeve (72, 76), and wherein the handle (82) is partially disposed within (threaded piston rod 88 is disposed within the sleeve) and protrudes from the sleeve (Column 5, lines 43-57).
Regarding claim 37, the marking elements (44) disclosed by Garrett (Figure 4A) are prongs extending from the base (22), and distal end surfaces of the prongs are shaped and capable to lie on a curved surface (Garrett, Column 3, lines 23-26) having a radius of curvature from 11.0 to 12.0 mm. NOTE: the head is a curved structure with curved surfaces, and the prongs disclosed by Garrett are shaped and capable of lying on a portion of a curved surface of a head within the claimed range. The prongs can also be placed on other curved surfaces of a human body, such as an eye, ear, nose, etc.
Regarding claim 39, Garrett discloses (Figure 4A) that the marking tip has two, three, or four marking elements (44).
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 36 is rejected under 35 U.S.C. 103 as being unpatentable over Garrett (US 5,913,314) in view of Liebel et al. (US 2013/0340781 A1) (“Liebel”).
Regarding claim 36, Garrett discloses (Figure 4A) that the marking elements (44) are prongs extending from the base (22), wherein surfaces of the prongs taper and are angled inwardly toward a center axis of the applicator. However, Garrett fails to disclose the prongs are angled inwardly toward a center axis by less than 10 degrees.
In the same field of endeavor, Liebel teaches (Figure 1) prongs (20) extending from a base (30). Liebel teaches that surfaces of the prongs taper and are angled inwardly toward a center axis of the applicator. Liebel teaches the prongs are angled inwardly toward a center axis by less than 10 degrees (paragraph 0018).
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 prongs disclosed by Garrett o be angled inwardly toward a center axis by less than 10 degrees, as taught by Liebel, since it has been held that “in 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). Further, the Applicant appears to have placed no criticality on the claimed range, indicating “the exterior shapes of the prongs 22 of the tip 20 may have various different configurations. For example, as shown in Figs. 2A and 2B, the angle of the prongs 22 relative to a transverse plane (a plane perpendicular to the longitudinal direction of the tip and the applicator) may have a value from about 80 degrees (i.e. the prongs lean slightly inwardly) to 90 degrees (i.e. the prongs extends straight out).” See page 6, lines 23-27 of the Specification.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Garrett (US 5,913,314).
Regarding claim 38, Garrett discloses the invention substantially as claimed. Garrett discloses that that the marking tip, including the base and the prong marking elements, has a height. However, the combined teaching fails to teach a height of 16 mm to 17.5 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 height of the marking tip taught by Garrett to be 16 mm to 17.5 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Garrett would not operate differently with the claimed height. Further, it appears that the Applicant places no criticality on the range claimed, indicating simply that the “height of the tip 20 including the base 21 and the prong 22 may be from 16.0 mm to 17.5 mm, as shown in Figs. 2B and 2D.” See page 6, line 31 – page 7, line 1 of the Specification.
Allowable Subject Matter
Claims 41-48 are allowed.
The following is an examiner’s statement of reasons for allowance: Claim 41 has been amended to recite that distal end surfaces of all of the prongs are shaped to lie on a common curved surface having a radius of curvature from 11.0 to 12.0 mm. This limitation, in combination with the other limitations in claim 41 is not disclosed or suggested by the prior art of record. The previously cited references all fail to disclose or suggest distal end surfaces of all of the prongs being shaped to lie on a common curved surface having a radius of curvature from 11.0 to 12.0 mm.
Claims 42-48 are dependent on claim 41, thus are also allowable over the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 10/20/25 regarding the rejection of claims 1, 30-32, and 36-40 have been fully considered but they are not persuasive. The Applicant has argued that the amendment to claim 1 distinguishes over the previously cited Forcelledo, Eckerson, and Garrett references because all of the references disclose circular/round/uniform cross-sectional shapes in a cross-section perpendicular to the longitudinal direction. The Examiner respectfully disagrees with the Applicant’s arguments.
The Applicant references Figures 1B and 1C, which show perpendicular views where the marking elements 22 are wider in the view of Figure 1B than in the view of Figure 1C, indicating that the marking elements 22 have an elongated shaped in the cross-section perpendicular to the longitudinal direction. The Examiner acknowledges the distinction between the Applicant’s invention and the cited prior art. However, the claim as currently written does not capture this distinction. The claim only recites that each marking element has “an elongated cross-sectional shape” in a cross-section perpendicular to the longitudinal direction. But the claim does not specify what the cross-sectional is “elongated” relative to. The claim is written much broader than the arguments presented.
In each of the Forcelledo, Eckerson, and Garrett references, a perpendicular cross-section at the base of each marking tip is elongated (larger/wider) in comparison to a perpendicular cross-section at the distalmost tip of each marking tip due to the tapered shape of the marking tips. Therefore, the claims as currently written do not distinguish over the prior art of record.
The Examiner suggests clarifying the claims with similar language that was provided on page 9 of the response and as shown in Figures 1B and 1C.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771