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 § 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) 1-10, 12-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al U.S 2001/0010023 in view of Wiley et al WO 2021/067145.
Claims 1, 15-17: Schwartz et al disclose an implant as best seen in figures 25,26, comprising: an implant body (at the bottom part, fig. 26), the implant body having an engagement surface (at the top surface that 21k extends in figures 26-27) surrounded by an edge region that is substantially perpendicular to a perimeter of the engagement surface (21k, figures 26-27); one or more sheets of bacterial cellulose (BC) applied over the engagement surface and along the edge region (insert 16k, fig. 25); and a clamp (the top part, fig. 26) securing the one or more sheets of BC between the edge region and the clamp (figures 25, 28, paragraph 130). It is noted that Schwartz discloses cartilage matrix and holding implant see paragraph 99 and the sheet can be any composition, but is silent regarding the one or more sheets of BC over the engagement surface are infiltrated with a hydrogel material to form a BC-network hydrogel. Wiley et al, in the same filed of endeavor, teaches the cartilage implant see paragraph 3 that has BS sheets infiltrated with a hydrogel material to form a BC-network hydrogel see paragraph 10 “the artificial cartilage composition can include a hydrogel with a reinforcement network of polymers, the reinforcement network includes cellulose such as bacterial cellulose” see paragraph 15. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Schartz et al with the one or more sheets of BC over the engagement surface are infiltrated with a hydrogel material to form a BC-network hydrogel as taught by Wiley et al in order to meet the particular needs of the patient.
Claims 2, 4,9, 18-19: Schwartz in view of Wiley disclose the invention substantially as claimed but is silent regarding the implant body is titanium, or an adhesive on one or more of the engagement surface and the edge region or curing the adhesive under pressure, or the clamp with a memory alloy shape. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the device that included the implant body is titanium, or an adhesive on one or more of the engagement surface and the edge region or curing the adhesive under pressure, or the clamp with a memory shape, since it has been held to be within the general skill of a worker in the art to select a known material on the basic of its suitability for the intended use or as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 5, 23: Schwartz in view of Wiley disclose the invention substantially as claimed but is silent regarding the sheets of BC that has 3 or more sheets. However, Wiley et al do disclose the sheets see paragraph 67 and it is well known to have the device with the sheets of BC that has 3 or more sheets and further it would have been obvious to one skilled in the art to utilize as many sheets as necessary in order to provide the desired thickness of the implant.
Claims 10, 20: Schwartz in view of Wiley disclose the invention substantially as claimed but is silent regarding the clamp is configured to apply between 100 and 500 N of retaining force. However, Schwartz discloses a clamping device see figures 25-26 and the insert with composition see paragraph 84. Thus, it would have been obvious to one skilled in the art to implement any desired clamping force through routine experiments in order to provide sufficient clamping force of the composition to be chosen for the insert.
Claims 3, 7, 22: Schwartz in view of Wiley discloses the engagement is curved (see figures 26-27), and wherein wherein the hydrogel material comprises polyvinyl alcohol (PVA) and poly(2-acrylamido-2-methyl-1-propanesulfonic. acid (PAMPS) (see Wiley paragraphs 15, 67).
Claims 6, 21: Schwartz in view of Wiley discloses the hydrogel material comprises polyvinyl alcohol (PVA) (See Wiley paragraphs 14, 67).
Claim 12: Schwartz discloses wherein the one or more sheets of BC is cut to wrap over the edge region so that the one or more sheets of BC lays flush with a surface of the edge region (see fig. 25).
Claim 13: Schwartz in view of Wiley discloses the invention substantially as claimed but is silent regarding the engagement surface that has a non-circular perimeter. It would have been to one ordinary skill in the art at the time the invention was made to construct the device with a non-circular perimeter, since the applicant has not disclosed that doing so solves any stated problem or is anything more than selecting one of numerous shapes or configurations a person ordinary skill in the art would find available to substitute with the device that is with a non-circular perimeter which is known in the medical arts.
Allowable Subject Matter
Claim 11 is 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
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/VI X NGUYEN/Primary Examiner, Art Unit 3771