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 Objections
Claim 5 objected to because of the following informalities:
Claim 5, line 2 recites “andIor” in line 4-5. It should read --and/or--.
Appropriate correction is required.
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.
Claim 1-16 and 49 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 1 recites the limitation "the body" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 2-4 and 6-9 depend on claim 1 and therefore rejected.
Claim 5 recites the limitation "the periphery" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the thermal therapy treatment" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the body" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the rheumatic type" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 11-15 depend on claim 10 and therefore are rejected.
Claim 16 recites the limitation "wherein at least one of the at least two heat transfer units (4), in particular the second one of the at least two heat transfer units (4), is a heat transfer unit" in 1-3. The scope of this claim is unclear. Both the first and second heat transfer units are configured to transfer heat. The limitation stating that in particular the second one is heat transfer unit is unclear. For examination purpose, the examiner is interpreting both the first and second heat transfer unit to be heat transfer unit.
Claim 49 recites the limitation "the body" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-8 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by LOWE (US 2017/0216129).
Regarding claim 1, Lowe discloses a heat transfer unit (fig.1 and 3) which is provided to be brought into contact with a selected region of the body of a human or of an animal and which is arranged to transfer heat to the selected region of the body, the heat transfer unit (fig.1 and 9) being for use with a temperature control fluid arranged to flow through the heat transfer unit (fig.1 and 9), wherein the heat transfer unit (fig.1 and 9) comprises: a first flexible material layer (the lower part of sleeve 41) having a first skin contact surface which is arranged to face at least partially towards the selected region of the body (fig.3), and having a first temperature control fluid contact surface which faces away from the first skin contact surface (middle layer 35), a second flexible material layer (the upper part of sleeve 41) having a second temperature control fluid contact surface, which, between itself and the first temperature control fluid contact surface of the first flexible material layer (fig.3), at least partially delimits one or more temperature control fluid chambers through which a heat transferring temperature control fluid can flow, wherein the first flexible material layer (fig.3) and the second flexible material layer (fig.3) together are folded over or are arranged to be folded over, in particular by hand, generally along a folding line or folding region (the wrap 30 or 30e are folded or bent to conform to the patient's anatomy and/or to secure the wrap and/or are subject to flexure [0231]) so as to define a first heat transfer unit portion (see annotated figure below) comprising or defining a first temperature control fluid chamber portion (see annotated figure below) and a second heat transfer unit portion (see annotated figure below) comprising or defining a second temperature control fluid chamber portion (see annotated figure below), wherein the heat transferring temperature control fluid is arranged to flow from the first temperature control fluid chamber portion (fluid flow from inlet to the wrap and from the wrap to the outlet. This flow includes from the right side of the wrap, which is first chamber, to the left side of the wrap, which is second chamber) to the second temperature control fluid chamber portion (5b) passing the folding line or folding region (see annotated figure below), wherein, in the folding region (see annotated figure below) or at or near the folding line (see annotated figure below), the heat transfer unit (wrap 30 or 30e) comprises a stiffening material (one or more reinforcement members 101) to counteract a reduction in the flow of the heat transferring temperature control fluid from the first temperature control fluid chamber portion (the reinforcement members selectively reinforce the flow path and resist bending in a transverse direction to the flow path. Similarly, the reinforcement members may be configured to resist bending (increase tensile strength) in one or two bending directions but not in the other directions) to the second temperature control fluid chamber portion (see annotated figure below) via the folding line or folding region (see annotated figure below) when the first flexible material layer (fig.3 and 9) and the second flexible material layer (fig.3 and 9) together are folded over generally along the folding line or folding region [0207].
Examiner note: the reinforced therapeutic wrap is configured to be wrapped around a body portion. The fold line or region can be defined anywhere in the wrap. The one or more reinforcement members 101 are configured to resist kink which acts counteract a reduction in the flow of the heat transferring temperature control fluid from the first temperature control fluid chamber portion.
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Regarding claim 2, Lowe discloses the heat transfer unit according to claim 1, wherein the stiffening material (one or more reinforcement member 101) is inserted between the first flexible material layer (fig.3 and 9) and the second flexible material layer [0194].
Regarding claim 3, Lowe discloses the heat transfer unit according to claim 1, wherein the stiffening material (one or more reinforcement member 101) has a higher bending stiffness than a material of, or making up, the first flexible material layer (fig.3 and 9) and the second flexible material layer [0198].
Regarding claim 4, Lowe discloses the heat transfer unit according to claim 1, wherein the stiffening material (one or more reinforcement member 101) exhibits sufficient flexibility to enable the first flexible material layer (fig.3 and 9) and the second flexible material layer (fig.3 and 9) together to be folded over, in particular by hand, generally along the folding line or folding region [0202].
Regarding claim 5, Lowe discloses the heat transfer unit according to claim 1, wherein the first flexible material layer (fig.1 and 9) and the second flexible material layer (fig.1 and 9) are connected, in particular via welding lines or fusion lines, in particular along the periphery of the first flexible material layer (fig.1 and 9) and the second flexible material layer (fig.1 and 9), and I or along lines within the periphery of the first flexible material layer (fig.1 and 9) and the second flexible material layer (fig.1 and 9), thereby in particular defining a labyrinth-type pattern along which, or through which, the heat transferring temperature control fluid can flow (fig.1 and 9).
Regarding claim 6, Lowe discloses the heat transfer unit according to claim 1, wherein the stiffening material (fig.9) comprises one or more stiffening ribs (fig.9), in particular extending from a location in the first heat transfer unit portion (fig.9), in particular from a location within the first temperature control fluid chamber portion (fig.9), to a location in the second heat transfer unit portion (see annotated figure above), in particular to a location within the second temperature control fluid chamber portion (5b), passing the folding line or folding region (see annotated figure above).
Regarding claim 7, Lowe discloses the heat transfer unit according to claim 1, wherein a plurality of webs (fig.1 and 9) connecting the first flexible material layer and the second flexible material layer (fig.1 and 9), the webs (fig.1 and 9) forming individual islands or columns leaving spaces (25) through which the heat transferring temperature control fluid can flow (fig.3).
Regarding claim 8, Lowe discloses the heat transfer unit according to claim 7, wherein the one or more stiffening ribs (fig.9) are inserted into respective ones of said spaces (fig.3).
Claims 10-12, 14, 16 and 49 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Schneider (US 4,951,665).
Regarding claim 10, Schneider discloses a device for use in the thermal therapy treatment of at least two selected regions of the body of a human or of an animal, and in particular for use in the treatment of tissue damage after surgical interventions, of injuries, of inflammations and of chronic diseases of the rheumatic type, and in particular for assisting chemotherapeutic treatments, comprising: a temperature control device (fig.1) which is provided in order to control a temperature of a temperature control fluid (col.1, line 11-20); at least two heat transfer units (the pads 10 and 11) which are respectively arranged to transfer heat to the at least two selected regions of the body, wherein the temperature control device (col.1, line 63-col.2, line 2) is connected, in a fluid conducting manner, to the at least two heat transfer units (the pads 10 and 11), and is further arranged to temper the at least two heat transfer units (the pads 10 and 11) with the temperature control fluid flowing through the at least two heat transfer units (the pads 10 and 11), wherein the at least two heat transfer units (the pads 10 and 11) are connected in series so that the temperature control fluid is arranged to flow in the following order (col.1, line 63-col.2, line 2): a) from the temperature control device (source not shown in the figure, see col.2, line 1-2) to a first one of the at least two heat transfer units (pad 10); b) through the first one of the at least two heat transfer units (pad 10); c) from the first one of the at least two heat transfer units (pad 10) to a second one of the at least two heat transfer units (pad 11);d) through the second one of the at least two heat transfer units (4); e) from the second one of the at least two heat transfer units (pad 11) back to the temperature control device (source, see col.1, line 63-col.2, line 2).
Regarding claim 11, Schneider discloses the device according to claim 10, wherein exactly two of the at least two heat transfer units (fig.1) are connected in series so that, after flowing through the second one of the exactly two heat transfer units, the temperature control fluid is arranged to flow back to the temperature control device (source) without flowing through another one of the at least two heat transfer units (col.1, line 63-col.2, line 2).
Regarding claim 12, Schneider discloses the device according to claim 10, wherein the first one of the at least two heat transfer units (pad 10) is arranged to provide temperature control for a foot and the second one of the at least two heat transfer units (pad 11) is arranged to provide temperature control for a hand. The pad 10 and 11 are configured to be used in two different body regions including one on a foot and the other one on hand (fig.1).
Regarding claim 14, Schneider discloses the device according to claim 10, the first one of the at least two heat transfer units (fig.1) is arranged to provide temperature control for a foot, the second one of the at least two heat transfer units (fig.1) is arranged to provide temperature control for a foot, in particular a further foot, and any further ones of the at least two heat transfer units (fig.1), if provided, are arranged to provide temperature control for a hand or hands. The pad 10 and 11 are configured to be used in two different body regions including one on a foot and the other one on hand (fig.1).
Regarding claim 16, Schneider discloses the device according to claim 10, wherein at least one of the at least two heat transfer units (fig.1), in particular the second one of the at least two heat transfer units (fig.1), is a heat transfer unit (col.1, line 63-col.2, line 2).
Regarding claim 49, Schneider discloses a method of performing thermal therapy treatment of at least two selected regions of the body of a human or of an animal, the method comprising: providing a device according to claim 10; causing the temperature control fluid to flow in the following order: a) from the temperature control device (source, see col.1, line 63-col.2, line 2) to a first one of the at least two heat transfer units; b) through the first one of the at least two heat transfer units (see col.1, line 63-col.2, line 2); c) from the first one of the at least two heat transfer units to a second one of the at least two heat transfer units (pad 11, see col.1, line 63-col.2, line 2); d) through the second one of the at least two heat transfer units; and e) from the second one of the at least two heat transfer units back to the temperature control device (see col.1, line 63-col.2, line 2).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lowe et al. (US 2017/0216129).
Regarding claim 9, Lowe teaches reinforcement member 101 can be provided in a variety of shapes and sizes [0232]. However, Lowe does not specifically teach wherein the one or more stiffening ribs have a cross section which varies along a longitudinal direction of the stiffening ribs, in particular wherein the one or more stiffening ribs comprise one or more barbs or other projections. It would have been an obvious matter of design choice to have the desired shape including one or more barbs or other projections for the purpose of having the desired properties of the thermal device, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider (US 4,951,665) in view of Scott et al. (US 2019/0240067).
Regarding claim 13, Schneider does not disclose wherein more than two of the at least two heat transfer units are connected in series so that, after flowing through the second one of the at least two heat transfer units, the temperature control fluid is arranged to flow through at least a further one of the at least two heat transfer units before flowing back to the temperature control device.
Scott teaches multi-sectional warming blanket to be configured for a variety of patient warming and/or cooling applications [0005]. The sectional warming blanket may be configured to be couple to a plurality of additional sectional warming blankets. The coupling of a plurality of sectional warming blankets may be accomplished by coupling the sectional warming blankets is a series configuration, or in multiple-branching configurations, such as a parallel or a “Y” shaped configuration, as star shaped configuration, or a circular configuration, and any combination thereof [0005]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed as taught by Schneider with more than two heat transferring unit that are arranged to have the desired order of thermal fluid flow as taught by Scott for the purpose of treating the desired area in the desired order.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Richardson (US 2011/0152982).
Regarding claim 15, Schneider does not disclose wherein the temperature control device has a separate output port and return port for each series connection of heat transfer units.
Richardson teaches system 100 for maintaining and altering temperatures of objects (fig.2). The system 100 a fluid at a desired temperature through a series of pads 102 to maintain or alter the temperature of an object that is in direct contact with pads 102 [0021]. The system 100 includes flow divider manifold 114 that has a separate output port and return port for each series connection of heat transfer units (fig.2, see also [0024]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed as taught by Schneider with the temperature control device has a separate output port and return port for each series connection of heat transfer units as taught by Richardson for the purpose of conveniency.
Conclusion
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/TIGIST S DEMIE/ Primary Examiner, Art Unit 3794