DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 1 and 80 are objected to because of the following informalities:
In claim 1, the recitation of “be-ing” should read as “being”, for clarity.
In claim 80, the recitation of “mate-rial” should read as “material”, for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 72 – 90 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lang et al. (US Pub. 2007/0198022 A1) in view of Truckai et al. (US Pub. 2007/0191858 A1).
Claims 1, 81 and 84 - 90, Lang discloses an apparatus for treatment of arthrosis in a joint of a mammal or human patient [abstract, paras.6 and 8], the apparatus comprising:
a reservoir [a body portion of 1560 “needle or injection instrument”, para.329, Fig.124G] configured to hold a volume of a biocompatible material in liquid form having a temperature outside of a body containing a joint (J) to be treated [paras.37, 252, 301 and 459], and
an instrument [a tip portion of 1560 and/or 1515] having a general tube shape [wherein 1515 exhibits a tubular shape, configured to engage with cap 1514 or the tip of instrument 1560, best shown in Figs.14G – J], a distal end [defined by an end towards the anatomy by 1510] of the instrument being configured to be inserted into the joint [Fig.14G], a proximal end [toward cap 1514 or instrument 1560] of the instrument being connected to the reservoir and configured to receive the liquid material there from, the instrument being configured to feed the liquid material having a temperature from the proximal end to the distal end for deposition on at least one damaged surface of the joint [para.64], such that adjacent nerves are damaged by the heat of the material thus preventing pain from the damaged surface, the material being configured to assume a solid form under predefined conditions, and when in the solid form the material having a resistance to wear adapted to replace a worn out joint surface [paras.2 and 140-155. With regards to the statements of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over the apparatus of Lang (having i.e. reservoir, instrument and biocompatible in situ curable material), which is capable of being used as claimed if one so desires to do so. Furthermore, the manner in which a device is intended to be employed does not differentiate the claimed apparatus from prior art apparatus satisfying the claimed structural limitations].
Although, Lang discloses a biocompatible material having a temperature, being the general condition of the claim. Lang does not explicitly disclose the step of heating the biocompatible material to, or having the biocompatible material at a temperature ranging between 50, 70, 90, or 100 – 400°C.
One having ordinary skill in the art at the time the invention was made, would have been motivated to heat the biocompatible material “polycarbonate” of Lang to, or have the biocompatible material “polycarbonate” of Lang at a temperature in the range of 100 – 400°C in order to accelerate its polymerization, wherein polycarbonate glass transition temperature is known to be about 147 °C (297 °F), and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Lang does not explicitly disclose wherein reservoir is constructed from a material capable of holding a flowable material having a temperature in the range 100 – 400 ºC.
Truckai teaches an analogous apparatus [abstract, i.e. 100, Fig.2A] comprising a reservoir [body portion of 110A] which is thermally and electrically insulated by an internal sleeve [154] defining the volume through which the heated material flows, the apparatus is fabricated from a suitable polymer (i.e. Polyimide) [para.77], (wherein polyimide is a known polymer in the art as having thermal stability and high tensile strength which are maintained at high temperatures i.e. up to approx. 400 ºC).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify / construct the reservoir (body portion of 1560) of the apparatus of Lang to include / including the polyimide insulating internal sleeve (154) used in the apparatus (110) of Truckai. One would have been motivated to make such modification in order to provide the apparatus of Lang with a thermally insulated reservoir that maintains a high tensile strength under high temperatures and reduce the biocompatible material heat loss during delivery [Truckai, para.77].
The combination of Lang and Truckai discloses the limitations of claim 1, as above, and further, Lang discloses:
Claim 72, a flexible and collapsible mould member [at least a portion of 1510 including ridge 1546, Fig.14H, para.327, having soft and compressible material that helps achieving a tight seal between the apparatus and the anatomy] having a pre-produced shape adapted to a shape and size of at least one of the at least one damaged surface so as to contact and cover this surface [Figs.14G, para.45], the mould member being configured to be inserted into the joint and be form-fitted to said damaged surface [Fig.14G], be connected to the distal end of the instrument and when placed in the joint receive the material in liquid form being fed through the instrument, the mould member having an internal volume configured to be filled with liquid material received via the instrument, and the mould member being configured to enable the predefined conditions for accomplishing a transition from the liquid form to the solid form after that the mould member has been filled with the liquid material [Fig.14G, para.329].
Claims 73, wherein the mould member is configured to be inserted into the joint by passing via a bone of the body; (claim 74) wherein the mould member is configured to be inserted into the joint by passing via a bone of the body from inside the abdomen; (claim 75) wherein the mould member is configured to be inserted into the joint by passing via the femoral bone of the body; (claim 76) wherein the mould member is configured to be inserted into the joint by passing the capsula of said joint; (claim 77) wherein the mould member is configured to be at least partly withdrawn from the joint after that the material has assumed its solid form; (claim 78) wherein the reservoir is configured to hold the material at an elevated pressure level exceeding the normal atmospheric level, and the mould member is configured to expand in response to receiving the material [with regards to the statements of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over the apparatus of Lang (i.e. having injection instrument, reservoir and mould 1510, Fig.14G), which is capable of being used as claimed if one so desires to do so, i.e. capable of being manipulated relative to a subject, paras.324 – 326; para.37, being injected under pressure to achieve permeation of portions of the marrow space with bone cement, and the mould 1510 includes ridge by 1546 capable of expanding, para.327, being soft and compressible].
Claim 79, an injection member configured to inject the liquid material into the mould member at the elevated pressure [para.329, needle 1560 or injection instrument defines an injection member to inject the material 1570].
Claim 80, wherein the mould member comprises an isolation material [defined by a body portion of 1510 including ridge 1546, which forms a tight seal] configured to reduce the risk of body tissue being damaged by the liquid material having a temperature above 37 degrees Celsius.
Claim 82, wherein the reservoir comprises at least one shield member [1510 include ridge 1546] configured to isolate the reservoir from the body [para.327, Figs. 14G].
Claim 83, wherein the instrument comprises at least one shield member [1510 include ridge 1546] configured to isolate the body from liquid material passing through the instrument [para.327, Figs. 14G].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL S. HANNA whose telephone number is (571)270-3248. The examiner can normally be reached 8-5 M-F.
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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775