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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1, line 4, states “and contacts said neck”. The claiming of a connection to the human body renders the claim as being directed to or encompassing a human organism.
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 1 recites a temperature control means. Based on the specification, this is the actual heating/cooling element that heats/cools the liquid. The specification discloses this may be a peltier cell with a liquid exchanger. For the purposes of examination, temperature control means will be interpreted as any of the disclosed species or equivalents thereof.
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 3 is 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 3 recites the limitation "said quick coupling means" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 2 recites a quick coupling means. The dependency of claim 3 was amended to depend from claim 1 and no longer from claim 2.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, and 15 is/are rejected under 35 U.S.C. 102a1 and a2 as being anticipated by Maher et al. (US 20140039365).
Maher discloses a cervical collar including thermotherapy means comprising a flexible body (e.g. front and back portions 102 and 106; paragraphs 34 and 45), of the disposable or reusable type (e.g. the body is disclosed to be a soft foam material which reasonably reads on either/both of a disposable or reusable type; additionally the limitation disposable or reusable appears to cover any and every type of material, even if there was some sort of distinction between a reusable or disposable type material), configured to be filled with a thermally conductive liquid (e.g. paragraph 43 discuses the embodiment of Figs. 5-8, Fig. 13 which has cooling fluid circulated through the collar), which in a wrapped configuration has an annular shape and contacts said neck (e.g. see Fig. 5, see previous citations which detail that the prior art is a cervical collar), a temperature control means for controlling the temperature of said liquid (e.g. paragraph 59 discloses the temperature of the cooling can be adjusted), of the reusable type (e.g. Examiner considers the cooling fluid can be reused. The claims fail to define what parameters/characteristics of the cooling fluid make it reusable or non-reusable), associated with said flexible body in a removable manner and connected to a control unit (e.g. the temperature control means is removably connected by way of inlet and outlet ports that extend from the collar as seen in fIg 5 (534 and 536); Examiner considers this to be associated with the flexible body since it extends from the flexible body; Maher discloses a control system 1402 which controls the cooling system see Fig. 14), configured to control the thermoregulation of said liquid (e.g. Fig. 14), and in that it comprises a duct (e.g. inlet/outlets 534 and 536), and a valve (e.g. paragraph 52 discloses a valve for the inlet/outlet ports), through which a desired quantity of liquid can be inserted into said flexible body in order to adjust its stiffness (e.g. paragraph 54 discloses the fluid is pumped into the chambers 530; it is of note that any pumping of fluid into the chambers would meet the limitation “in order to adjust its stiffness.” The claims fail to recite a specific stiffness or amount of fluid so the limitation only requires that the system be capable of pumping liquid).
With regard to claim 4, Maher discloses at least two bags each of which is filled with said liquid by means of said duct and is contact with said temperature control mean which thermos-regulate said liquid by conduction/contact (e.g. chambers 530).
With regard to claim 15, Maher discloses the valve will regulate flow of cooling fluid into and/or out of the bladder (e.g. paragraph 52). Examiner considers that because the valve is disclosed to regulate flow into and out of the bladder, that meets the claim limitations of a two way valve.
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) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maher as applied above to claim 1, in view of Stegmann (US 2022/0142814).
With regard to claim 5, Maher discloses the invention as claimed including a temperature control means but fails to teach the temperature control means comprises at least two refrigeration and/or heating units configured as a Peltier cell and an exchanger module configured as a liquid exchanger, each refrigeration unit being associated with a respective one of said bags.
Stegmann teaches that it is known to use thermoelectric modules such as a peltier element and fluid heat exchanger as set forth in Paragraph 55.
It would have been obvious to of modify the system of Maher with the temperature control means comprises at least two refrigeration and/or heating units configured as a Peltier cell and an exchanger module configured as a liquid exchanger, each refrigeration unit being associated with a respective one of said bags since Stegmann teaches that it is known to use Peltier cells and fluid heat exchangers for controlling a temperature in a thermal therapy system. One of ordinary skill in the art would recognize that any known temperature control mechanism would be interchangeable with another.
With regard to claim 6, Maher discloses the system is comprises a control unit to manage the temperature of the system (e.g. paragraph 64). However, Maher fails to teach the independent control of separate temperature control means (the at least two refrigeration and/or heating units). As discussed above Maher in view of Stegmann sufficiently teach the use of multiple refrigeration and/or heating units.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Maher in view of Stegmann with using the disclosed control means of Maher with providing independent control of the multiple refrigeration and/or heating units in order to better control the desired temperature range of the cervical collar.
With regard to claim 7, Maher discloses the use of temperature sensors which are used to provide feedback and control on the temperature regulation (e.g. paragraphs 60-64). However Maher fails to teach said refrigeration and/or heating units are provided with the temperature sensors and disposed on the a first heat exchange surface of the Peltier cell which, during use, is in contract with said flexible body and at least one is disposed on said liquid exchanger.
It would have obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Maher in view of Stegmann with said refrigeration and/or heating units are provided with the temperature sensors and disposed on the a first heat exchange surface of the Peltier cell which, during use, is in contract with said flexible body and at least one is disposed on said liquid exchanger since such a modification would provide the predictable results of providing for multiple temperature sensing locations to provide for achieving a desired temperature range feedback means for controlling the thermal therapy system.
With regard to claim 8, Maher discloses a strap/connection means 512 as seen in Fig. 7. Examiner considers the strap of Maher to connect said bags to each other since the bags are located on the collar device and the strap is used to connect the ends of the collar together.
Claim(s) 2-3 and 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maher in view of Stegmann as applied above, further in view of Fan et al (CN 110420380A).
For the clarity, Examiner will reference a google patents translated copy.
With regard to claim 8, as discussed above, Examiner’s position is that the straps of Maher to connect said bags to each other since the bags are located on the collar and the strap connects the ends of the collar together. In the alternative, if claim 8 were interpreted to require the straps to make a physical connection with the bags, the combination of Maher in view of Stegmann fails to meet this limitation.
However, Fan teaches that it is known to use a connecting mechanism for connecting/passing a strap portion through loops/grommets, 10, attached to a bag and loops/grommets attached to a magic tape portion that contacts the treatment site, 30, seen generally in the embodiment of Fig. 3 and disclosed on page 3/5 “Embodiment Four” of the google translation.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Maher in view of Stegmann with use of a pair of loops grommets and a strap that passes through the loops that would arrive at the claimed invention of a strap that connects said bags to each other and is sized so that the flexible body wraps around the neck since such a modification would be a simple substitution of one known technique for attaching a fluid reservoir to a treatment structure for another.
With regard to claim 9, Maher in view of Stegmann disclose the invention as claimed but fails to teach each refrigeration and/or heating unit comprises a shell which contains said Peltier cell and said liquid exchanger, said shell being provided with releasable coupling means for the temporary connection with said strap or directly with said bags.
Fan teaches that it is known to use a releasable coupling means for connection with said strap or directly to a bag structure as set forth in page 3/5 “Embodiment Three” with disclosed snap button (button surfaces 70 and 71). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Maher in view of Stegmann with each refrigeration and/or heating unit comprises a shell which contains said Peltier cell and said liquid exchanger, said shell being provided with releasable coupling means for the temporary connection with said strap or directly with said bags since it would be a simple substitution of one known connection means with another connection means.
With regard to claims 2-3, Maher discloses the invention as claimed but fails to teach a quick coupling means onto which a support structure couples in a removable manner for the temporary support of said temperature control means, the quick coupling means are provided on an external wall of said flexible body so that said temperature control means are associated with said external wall in a removable manner. Examiner considers the proffered combined teachings of Maher in view of Stegmann and Fan, to sufficiently teach the use of a quick connection means that couple the supports structure of Maher with a temperature control means on an external surface of the support structure (e.g. general body portion of the collar device from Maher).
With regard to claim 10, Maher discloses the bags have section widenings or convex zones which during use are disposed in correspondence with blood vessels of said neck in order to improve the heat exchange efficiency of said collar. See Fig. 5 which shows chambers 530 which have tapered, curved portions (which are widenings and convex areas) to conform to the collar that is anatomically shaped to match the user’s neck.
With regard to claim 11, Maher in view of Stegmann and Fan disclose the invention as claimed but fail to teach each of said bags comprises two convex zones, disposed at opposite ends of the bag, separated by a central portion, wherein the height of said convex zones is greater than the heigh of said central zone. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Maher in view of Stegmann and Fan with each of said bags comprises two convex zones, disposed at opposite ends of the bag, separated by a central portion, wherein the height of said convex zones is greater than the heigh of said central zone since it has been held that where the general conditions of a claim are met by the prior art, changes in shape would be within the level of ordinary skill in the art (In re Dailey, 357 F.2d 669, 149 USPQ 47). Additionally, one of ordinary skill in the art would be motivated to make such changes to the shape of the bags and/or general shape of the collar device to arrive at a collar device that best conforms to the anatomical shape of the patient.
With regard to claim 12, Maher discloses said duct enters the bag in correspondence with one of said two convex zones (e.g. Fig. 8 shows the ducts entering the tapered portions of the bags). Additionally the proffered combination of Maher in view of Stegmann and Fan as applied to claim 11 above, would have at least a pair of convex zones and Maher already teaches the use of ducts that enter the bag portion to supply the thermal fluid.
With regard to claim 13, Maher discloses the bags can have internal passageways, 532, as seen in Fig. 12. Examiner notes the claim as written fails to significantly limit how the internal welds/channels direct liquid to convex zones. Because the passageway/channels of Maher direct the fluid flow through the entire bag, the passageways/channels would also be directing fluid to the convex areas of the proffered combination set forth above with respect to claim 10.
With regard to claim 14, Maher in view of Stegmann and Fan disclose use of various coupling means such as snap buttons or loops/grommets (e.g. rejection of claims 8-9). But, Maher in view of Stegmann and Fan fail to teach that each of said bags is connected to a respective on of said refrigeration and/or heating units by means of magnetic or ferromagnetic elements. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Maher in view of Stegmann and Fan with using a connection means such as a magnetic or ferromagnetic element for connecting the refrigeration and/or heating unit to the bags because magnetic/ferromagnetic elements are well known in the art and the selection of any well known connection means would be within the level of ordinary skill in the art. This would be a simple substitution of one known element for another.
Conclusion
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/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794