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 .
CLAIM INTERPRETATION
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 Objections
Claim 2 is/are objected to because of the following informalities: Please change “upper” to “upper surface” or “surface” to “surfaces”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 9-12, 15-17, 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marinoff (US 4,520,815).
Regarding claim 1, Marinoff discloses a device capable of guiding creation of an incision in a sclera of an eye using a cutting blade, the device includes an elongate handle (35) extending along a longitudinal axis for at least a portion of its length and having proximal and distal end regions. A footplate (21; Fig. 2) is coupled to the distal end region of the elongate handle. The footplate includes a plurality of struts defining a central opening (28) extending between an upper and lower surface (23, 22) of the footplate. A first strut (see annotated figure below) of the plurality of struts has a proximal-facing blade guide surface that is straight and extends between two lateral struts of the plurality of struts. A second strut (see annotated figure below) of the plurality of struts has a proximal-facing limbal guide surface that is curved. The blade guide surface is separated a distance from the limbal guide surface to identify a target location for creating an incision relative to a limbus of the eye. The blade guide surface has a length between the two lateral struts that limits a length of the incision that can be created between the two lateral struts using a cutting blade (50) inserted through the central opening.
PNG
media_image1.png
404
564
media_image1.png
Greyscale
Regarding claim 2, Marinoff discloses that the blade guide surface between the upper and lower surfaces of the footplate extends perpendicular preventing tunneling of the cutting blade relative to the sclera (Fig. 2).
Regarding claim 9, Marinoff discloses that an angle between each of the two lateral struts and the glade guide surface is about 90 degrees (Fig. 3).
Regarding claim 10, Marinoff discloses that the two lateral struts are parallel relative to one another (Fig. 3).
Regarding claim 11, Marinoff discloses that the footplate is coupled to the distal end region of the elongate handle at a proximal end region of the footplate near a location of the limbal guide surface (Fig. 3).
Regarding claim 12, Marinoff discloses that a thickness of the footplate between the upper and lower surfaces is less at a distal end region of the footplate near a location of the blade guide surface than a thickness of the footplate between the upper surface and lower surface near the proximal end region of the footplate (Fig. 3).
Regarding claims 15 and 16, Marinoff discloses that the footplate is coupled to the distal end region at an angle relative to the longitudinal axis of the elongate handle that is between 130 and 140 degrees (please see the marked up figure below).
PNG
media_image2.png
404
564
media_image2.png
Greyscale
Regarding claim 17, Marinoff discloses that the elongate handle includes a shaft (36; Fig. 3) between the footplate and the distal end region of the elongate handle.
Regarding claim 19, Marinoff discloses that the first strut has a distal-facing surface that is curved.
PNG
media_image1.png
404
564
media_image1.png
Greyscale
Regarding claim 20, Marinoff discloses that the plurality of struts of the footplate creates a shape of a rectangular prism ring (Fig. 3).
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) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marinoff.
Regarding claim 7, Marinoff discloses that the length of the opening should be between 3 and 7mm or at least 6mm. As seen in Marinoff, the distance between the blade guide surface and the limbal guide surface may be within the claimed range of about 3.9mm to about 4.1mm as such the distance between the blade guide surface and the limbal guide surface is disclosed to be a result effective variable in that changing the length of the footplate changes the length of the opening. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Marinoff to have a distance in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, 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 device of Marinoff by making the distance within the claimed range about 3.9mm to about 4.1mm, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8, Marinoff discloses that the distance (width) between the two lateral struts may be sufficient to accommodate most known knife blades without limiting their freedom of movement. As seen in Marinoff, the distance between the two lateral struts may be within the claimed range of about 3.45mm to about 3.55mm as such the distance between the two lateral struts is disclosed to be a result effective variable in that changing the width between the lateral struts changes the width of the footplate. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Marinoff to have a length in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, 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 device of Marinoff by making the distance within the claimed range about 3.45mm to about 3.55mm, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 21 and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marinoff in view of Kaplan et al. (US 2020/0113735A1, “Kaplan”).
Regarding claims 21, 31-32, Marinoff does not disclose that the lower surface of the footplate includes a plurality of cleats.
In the same field of endeavor, eye surgery, Kaplan teaches a footplate including a lower surface having a plurality of cleats (500; Fig. 5). The cleats are capable of creating depressions in the sclera upon application of a force by the footplate against the eye and are capable of resisting movement of the footplate during application of a force by a cutting blade along the blade guide surface [0082]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the lower surface of the footplate of Marinoff with a plurality of cleats, as taught by Kaplan, to resist movement of the footplate during application of a force by a cutting blade [0082].
Regarding claim 30, the combination of Marinoff and Kaplan does not disclose that the plurality of cleats has a minimum radius of about 0.0015” to prevent penetration and damage to the sclera upon application of a force by the footplate against the eye. The minimum radius of the plurality of cleats is disclosed to be a result effective variable in that changing the minimum radius of the cleats changes the width of the footplate. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the combination of Marinoff and Kaplan to have a radius in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, 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 device of the combination of Marinoff and Kaplan by making minimum radius of the plurality of cleats to be about 0.0015”, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Allowable Subject Matter
Claim(s) 3-6, 13-14, 18 and 22-29 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: WO-2016/196841A1 and Dishler et al. (US 2012/0046680A1) disclose a footplate with a plurality of struts.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOCELIN C TANNER/Primary Examiner, Art Unit 3771