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) 14,18,19,22,25,26,29-30 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 Engstrand et al U.S 2017/0239054.
Claim 14: Engstrand et al disclose an implant 2010 for fixing a cranial bone flap in a cranial opening of a bony skull as best seen in fig. 26, the implant comprising a flexible mesh structure (mesh support frame 2020) with webs and openings (the openings as in the area 2040 a-c, i.e., eyelets/opening, figures 25, 26, paragraph 129) formed between the webs. Note that, for example, the support frame can be made more flexible at the outer ring of mosaic plates in order to facilitate, for example, modifications of the implant during the implantation procedure so that the implant will more precisely match the outer perimeter of the bone defect (see paragraph 144); Localized modifications to implant properties such as flexibility can be accomplished in a variety of ways. For example, struts (2014) connecting adjacent support rings (2040) can be made thicker or thinner to alter implant properties, or multiple struts may even be provided in certain regions of the support frame. Similarly, and as depicted in the alternative embodiment of an implant (2310) in FIG. 29, certain struts may be omitted entirely to provide increased flexibility (see paragraph 145); Digitally generating the mesh support frame design to fit the bone defect, including, for example, locating retention eyelets for optimal placement of fasteners (e.g., bone screws) into adequate bone or other tissue surrounding the defect, as well as locating the support rings so that the mosaic plates molded over those rings will optimally fill the bone defect with proper spacing and sizes of plates. [0154] 4. Digitally generating the mosaic plate arrangement so that the plates will be properly located with respect to the support rings. [0155] 5. Digitally generating the mold design based on the mesh support frame design and mosaic plate arrangement (see paragraph 150). Alternatively, it would have been obvious that the above description of Engstrand et al device would show the flexible mesh structure being made of a plastic material and configured to be fastened to the cranial bone flap and to the bony skull. Thus, claim 14 is unpatentable over Engstrand et al.
Claims 18-19: Engstrand et al disclose wherein the webs are arranged crossing over without knots (the area 2040a-c that have crossing over without knots in fig. 26); wherein the flexible mesh structure comprises a knitted fabric or a woven fabric (see paragraph 127).
Claims 22, 25, 26: Engstrand et al disclose wherein the plastic material contains glass fibers and/or ceramic particles (see paragraphs 72-73). further comprising an adhesive applied as an adhesive layer to the flexible mesh structure; further comprising an adhesive filling into the openings (see paragraphs 177,180).
Claims 29-30: Engstrand et al disclose and an adhesive arranged for bonding the flexible mesh structure to the cranial bone flap and to the bony skull (see paragraphs 177,180); and a plurality of fastening elements, for-example, pins 2614, fig. 32 that configured for force-fitting and/or form-fitting fastening of the flexible mesh structure to the cranial bone flap and to the bony skull.
Claims 15, 17,20-21,23,24: Engstrand et al disclose the invention substantially as claimed, but is silent regarding wherein the flexible mesh structure is translucent; wherein the flexible mesh structure has isotropic elasticity; wherein the plastic material contains polypropylene and/or polyglycolic acid; wherein the plastic material contains a
non-metallic additive; further comprising at least one medical active substance applied as an active substance coating to the flexible mesh structure; further comprising at least one medical active substance introduced as an active substance filling into the openings. 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 flexible mesh structure is translucent; wherein the flexible mesh structure has isotropic elasticity; wherein the plastic material contains polypropylene and/or polyglycolic acid; wherein the plastic material contains a non-metallic additive; further comprising at least one medical active substance applied as an active substance coating to the flexible mesh structure; further comprising at least one medical active substance introduced as an active substance filling into the openings, 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.
Claim 27 is rejected under 35 U.S.C 103 as being unpatenable over Engstrand et al in view of Attenborough WO 2017/077315.
Claim 27: Engstrand et al disclose the invention substantially as claimed but is silent regarding a medical tissue adhesive that cures under UV radiation. However, Attenborough teaches he use of adhesives in surgery is the curing time to establish effective placement. For large scale operations exposing bones and deep internal body cavities, the use of adhesives to place an implant is often discounted, as the curing time required would mean the internal parts of the body are exposed for too long. This thereby makes the risk for secondary infection too high. For some areas of surgery, adhesive curing is possible, such as in the mouth as it does not matter how long the internal tissues are exposed. In fact in these areas UV curing may be used, as this speeds up the adhesive process. However UV can only be used because the teeth, gums and applied false teeth are relatively UV transparent. Therefore adhesive laid behind them (i.e. under the tooth) will still cure using UV applied from the exterior of the tooth. In cases where implants are used that are opaque (i.e. metal implants), then light curing is not suitable. Also, whilst light curing is particularly suitable for oral use because the light can be shone from behind the implant, in general surgery it is often that the top surface of the tissues that is exposed, and getting behind the material, whether it be bone, skin or other tissue (which are all light transparent to a degree) is not possible (see paragraph 6); further teaches a medical tissue adhesive that cures under UV radiation (see paragraph 14). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Engstrand et al with a medical tissue adhesive that cures under UV radiation as taught by Attenborough in order to provide for a very targeted form of energy which reduces curing time and is less damaging to the surrounding internal tissues.
Allowable Subject Matter
Claim 28 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
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