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 Objections
Claims 1-2 are objected to because of the following informalities:
Claim 1 recites “a punch [Figs. 1-4] for cutting a corneal graft, comprising….” This should be “a punch [Figs. 1-4] for cutting a corneal graft, the punch comprising: ….”
Claim 2 recites “the partitioning blade.” However, Claim 1 recites “a blade for partitioning.” The same language should be used throughout.
Appropriate correction is required.
Claim Interpretation
Claim limitations relating to intended use of the claimed device (i.e., “for corneal tissue,” see claim 1) are not given further patentable weight.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “means for angularly indexing the blade holder” in claim 9.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
Claims 7-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 is indefinite for the following reason: Claim 1 recites “the base comprising a guide.” Claim 7 recites “the guide comprises two…surfaces…with one belonging to the base and the other belonging to the blade holder.” The limitation of claim 7 appears to contradict that of Claim 1, which requires the guide to be part of the base. Further clarification is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 purports to depend on claim 1 but in fact does not require all the limitations of claim 1. The limitation “for the punch [of] claim 1” does not lend patentable weight. Claim 10 positively recites only a blade holder and blade. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 2, 7, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oganesyan et al. [RU 177469 U1, hereinafter “Oganesyan”] in view of Li [CN 114848291 A1].
Re. claim 1, Oganesyan discloses a punch [Figs. 1-4] for cutting a corneal graft, comprising
a base (“second unit” 4) having a support surface (“the site for the cornea on the second unit,” Page 3) for corneal tissue and a blade holder (“first block” 1) provided with at least one blade (3), the base (4) comprising a guide (one hole of holes 5) for guiding the blade holder (1) in translation along a central axis (up-down in Fig. 4) normal to the support surface between a first position in which the blade is spaced apart from the support surface (prior to compression, see Page 3, fifth paragraph) and a second position in which the blade is adjacent to the support surface (“By compression (by physical pressure with the thumb on the first block of the die cutter,” where the second position is that after application of pressure) wherein the blade (3) is a blade for partitioning corneal tis-sue (intended use, but this is the use of the blade 3) extending substantially in a radial direction with respect to the central axis (see Figs. 1, 4).
Oganesyan fails to teach the blade having an s-shaped section in a plane perpendicular to the central axis. However, Li teaches, in a punch for cutting a corneal graft, a blade [32] and having an S-shaped section (33) in a plane perpendicular to the central axis (Fig. 1). The purpose of the S-shaped section in Li is to provide an indication of providing an asymmetric mark to indicate the direction of the transplant layers even when they are curled [see Li Page 2, first two paragraphs]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Oganesyan such that the blade of Oganesyan incorporates an S-shaped section, as taught by Li, in order to provide an asymmetric mark indicating the preferred direction of implantation.
Re. claim 2, Oganesyan discloses the partitioning blade extends on either side of the central axis in order to divide the corneal tissue into two portions (“The technical result is…obtaining from one sclero-corneal block of a donor two or four graft-shaped or segmented grafts….achieved due to the presence of a half-moon blade,” Page 2).
Re. claim 7, as best understood, Oganesyan discloses the guide (2 and 5; see 112(b) above) comprises two complementary guide surfaces, parallel to the central axis (Fig. 4), cooperating with each other (Fig. 4) and with one (5) belonging to the base (4) and the other (2) belonging to the blade holder (4).
Re. claim 10, Oganesyan discloses a blade holder (“first block” 1) provided with at least one partitioning blade (3), for use in the punch of claim 1 (see 112(d) above).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oganesyan in view of Li, as applied to claim 1, and further in view of Arnott [US Pat. 5269795]
Re. claim 3, the modified Oganesyan discloses the punch of claim 1 but fails to teach three partitioning blades. However, Arnott teaches, in a device for cutting a cornea, wherein the blade holder is provided with at least three partitioning blades [Fig. 2C, blades 204, 205, and 206] defining an angular sector in pairs [each two blades intersect, defining an angular sector]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Oganesyan to form three blades as taught by Arnott because this allows for different sizes and shapes of corneal tissue to be prepared, which would be desirable to suit different operations/patients, improving the flexibility of the device.
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oganesyan in view of Li, as applied to claim 1, and further in view of La Russa et al. [US Pat. 4236519, hereinafter “La Russa”].
Re. claim 4, the above modified Oganesyan fails to teach a peripheral blade centered on the central axis. However, La Russa teaches, in a corneal punch, a blade holder (22) has a peripheral blade (18, which is cylindrica, and coaxial with the axis see Col. 2 lines 35-40) centered on the central axis (14). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus the modified Oganesyan to add a peripheral blade, as taught by La Russa, in order to form the cornea “of a size suitable for surgical transplant into the eye of a patient,” La Russa Col. 2 lines 40-44].
Re. claim 5, the modified Oganesyan teaches the punch as claimed in claim 4, wherein the peripheral blade (taught by La Russa, above) and the partitioning blade have heights such that the peripheral blade penetrates into the corneal tissue to a depth equal to a total thickness of said corneal tissue (it cuts “through the cornea,” La Russa Col. 2 lines 40-42), the partitioning blade penetrating into the corneal tissue to a depth at least equal to a thickness of the Descemet membrane [See Page 3, “transplant (to each) Descemet membrane obtained from one donor cornea…In these clinical situations, the most appropriate method of surgical treatment is…transplantation of the Descemet membrane,”; thus, the donor cornea was cut at least to the thickness of the Descemet membrane).
Re. claim 6, Oganesyan discloses at least one of the blades is removable [blade 3 is removable; see Claim 1].
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oganesyan in view of Li, as applied to claim 7, and further in view of Collins [US Pat. 5649944]
Re. claim 8, Oganesyan discloses the blade holder fitting into the base [via elements 2, Fig. 3] but fails to disclose the base fitting into the blade holder. However, Collins teaches a blade holder [612 and 601, Fig. 6A, taken together] and base [602 and 606, together] wherein the base fits into the blade holder [via element 606, Fig. 6A]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Oganesyan such that the base fits into the blade holder as taught by Collins because this further improves the stability and alignment of the device.
Re. claim 9, Oganesyan discloses the punch as claimed in claim 8, comprising means for angularly indexing the blade holder (the indexing means comprising the remaining three holes and guides 2/5 other than that recited in claim 1) with respect to the base, the indexing means comprising a positioning index (respective elements 2) integral with the blade holder for positioning in a notch (respective holes 5) provided in the base.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-Th 9 am to 3 pm ET.
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/ERIN MCGRATH/ Primary Examiner, Art Unit 3771
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