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 .
Response to Arguments
Applicant's arguments filed 03/06/2026 have been fully considered but they are not persuasive.
The examiner has made new grounds of rejection for clarity, uniformity and simplicity.
Regarding Applicant’s remarks with respect to the support for the amendments to the claims, see page 7, line 4 through page 8, line 5, the specific amendments to claims 1 and 13 are fully supported by the written description.
Next, beginning on page 8 and ending on page 10, line 6 Applicant discusses in the Claim Interpretation- "Configured To" Language section. However these comments are moot since the examiner has removed these comments since 1) they were not needed to provide a rejection to each pending claim, and 2) to avoid duplicate rejections using Gildersleeve et al. as the primary reference.
Next, beginning on page 10, 2nd full paragraph and ending on page 11, last line Applicant traverses the anticipation rejections (the 102 rejections) based solely on the Gildersleeve et al. prior art. Again, these rejections have been removed since they were unnecessary and redundant, so these arguments/remarks are moot and slightly off point. It should be noted, rejections based on Gildersleeve et al. have been removed to in order to comply with the USPTO’s policy of trying to avoid duplicate rejections using different prior art references.
Next 103 rejections beginning on page 12, 1st line and ending on page 14, line 5 Applicant traverses the obviousness based on the combination of Neev in view of DeBenedictis et al. in view of Gildersleeve et al. and argues neither 1) Neev (page 12, 3rd full paragraph), 2) DeBenedictis et al. (page 12, last paragraph through page 13, line 2), nor 3) Gildersleeve et al. (page 13, 1st full paragraph) disclose or make obvious “(a) establishing a closed or essentially closed volume over the treatment area to contain the cooling stream; and (b) introducing the gaseous cooling medium into a distribution gap between the applicator body and an apertured layer, followed by uniform distribution through the apertures across the treatment area” see page 13, 2nd full paragraph. The examiner agrees with Applicant regarding both the Neev and DeBenedictis et al. prior art references. However, the disagrees with this argument with respect to the Gildersleeve et al. prior art reference. These particular limitations were added with the amendments to claims 1 and 13 so the examiner did not have an opportunity to establish that Gildersleeve et al. disclose these limitations. The examiner has updated the obviousness rejections to reflect that these limitations are disclosed by Gildersleeve et al. and therefore the presently claimed invention as defined by claims 1-3, 6-13, and 16-20 are made obvious by the combination of Neev in view of DeBenedictis et al. in view of Gildersleeve et al. prior art references. See the rejections below.
Next, beginning on page 14, last paragraph through page 15, line 2 Applicant asserts:
“Because claims 1 and 17 are patentable for the reasons discussed above, the rejection of claims 11-12 and 20 fails for at least the same reasons. Withdrawal of this rejection is respectfully requested.”
As noted in the rebuttal paragraph immediately above, claims 1 and 17 (as well as all other pending claims) are NOT – in fact patentable – and so this argument is unpersuasive.
As shown in the below rejections, Gildersleeve et al. clearly disclose the newly added limitations of the amended claims – see the rejections below.
Accordingly, due to the new grounds of rejection this action is made non-final.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 6-11, 13, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neev (U.S. Patent Application Publication 2013/0184693) in view of DeBenedictis et al. (Patent Application Publication 2015/0216720) in view of Gildersleeve et al. (U.S. Patent Application Publication 2013/0238042).
Regarding claims 1, 13, 16-17, and 19, Neev discloses a cryogenic applicator device, a cryogenic system/apparatus having an applicator and a method using a cryogenic applicator comprising:
providing an applicator device ( comprising at least the "treatment head," see [0113]-[0114] and figures la-2c) that delivers cold/cryogenic thermal energy to tissue in form of forced/compressed air having a temperature a)-100° C to -25° C, b)-25° C to 0° C over short bursts of time in order to provide a known and workable manner of providing thermal treatment to tissue (see [0178] and figures la-29).
Here the ranges disclosed by Neev a)-100° Cto-25° C, b)-25° C to 0° C "overlap" with the presently claimed range of -40° C to -21 ° C. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5 % thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 13 62, 13 65-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that' suitable protection' is provided if the protective layer is 'about' 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant's] claimed range."). See MPEP 2144.05(1).
Yet Neev fails to explicitly recite:
1) a temperature within the range of -40° C to -21 ° C, and
2) cold-induced thermal shock response is developed in skin and an underlying tissue within the body area covered by said applicator device.
Like Neev, DeBenedictis et al. disclose an applicator device ( albeit with an internally circulating coolant), a system having an applicator device, and a method of using the system having an applicator device to cool the skin or tissue surface of a patient and teach using "desired treatment temperatures" including -40° C, -30° C, and -25° C (see [0125]) in order to induce cold-induced thermal shock response in skin and an underlying tissue within the body area covered by said applicator device (see [0045], [0050]-[005 l ], [0060], [0064], [0081] and claim 31) and also in order to provide a known and workable manner of inducing a cold shock response to the skin and underlying tissue (see [0045], [0050]-[0051], [0060], [0064], [0081 , [0125] and claim 31).
Additionally, although Neev disclose compressed (or forced) cold air is applied to skin (tissue, see [00178]), Neev fails to explicitly recite:
3) the applicator device is configured to establish a closed or essentially closed volume over the body area to be treated,
4) the applicator device is configured to uniformly distribute a stream or gaseous medium, across the entire area covered by said applicator device and directed, at a predetermined speed within a range of 5 to 1 7 meters per second, via said applicator device to the body area to be treated, and
5) a blower configured to generate and to direct, at a speed within a range of 5 to 17 meters per second, a stream of gaseous medium to the applicator device.
Like Neev, Gildersleeve et al. disclose an applicator device, system having the applicator device, and method of using the system having the applicator device using cold thermal therapy and teach providing A) an applicator that is configured to establish an essentially closed volume over the body area to be treated (since the area to be effectively treated is essentially limited to the area covered by the applicator, see figures 6, 7A, 8A, 11A, 12A-12B, and 15-18A), and B) providing "the blower may be configured to deliver the gas at a velocity of at least 1 meter per second, between about 2 and about 5 meters per second, or between about 1 and about 10 meters per second. In alternative implementations, the blower can be configured to deliver the gas at velocities less than 1 meter per second or greater than 10 meters per second, as determined to be appropriate for effective temperature regulation of the therapy site" (see [0012]) in order to provide a known and workable manner of providing cold therapy to the skin and underlying tissue.
Here Gildersleeve et al. teach providing a blower configured to provide the applicator device with a forced air velocity/speed of 1 m/s to 10 m/s and the presently claimed range is 5 m/s to 17 m/s. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of" about 1-5 % "while the claim was limited to "more than 5%." The court held that "about 1- 5%" allowed for concentrations slightly above 5% thus the ranges overlapped.);In re Geisler, 116F.3d 1465, 1469-71,43 USPQ2d 1362, 1365- 66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that' suitable protection' is provided if the protective layer is 'about' 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant's] claimed range."). See MPEP 2144.05(1).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Neev, as taught by DeBenedictis et al., to use "desired treatment temperatures" including -40° C, -30° C, and -25° C in order to induce cold-induced thermal shock response in skin and an underlying tissue within the body area covered by said applicator device and also in order to provide a known and workable manner of inducing a cold shock response to the skin and underlying tissue, and as further taught by Gildersleeve et al., to provide A) the applicator device that is configured to establish a closed or essentially closed volume over the body area to be treated and B) a blower that is capable of providing the gaseous medium with a velocity of 5 m/s 10 10 m/s in order to provide a known and workable means of providing thermal treatment to tissue.
Regarding claim 2, Neev in view of DeBenedictis et al. in view of Gildersleeve et al. disclose (or make obvious) the claimed invention, see Gildersleeve et al. [0091] and figures 5-8B, 12A-12C, and 15-17 for example.
Regarding claim 3, Neev in view of DeBenedictis et al. in view of Gildersleeve et al. disclose (or make obvious) the claimed invention, see Gildersleeve et al. the innermost surface ("inner face 500," see [007 l]-[0075] and figures 5-8B, 12A-12C, and
15-17).
Regarding claim 6, Neev in view of DeBenedictis et al. in view of Gildersleeve et al. disclose (or make obvious) the claimed invention, see Gildersleeve et al. the foldable/folded knee wrap (see figures 12A-12C).
Regarding claim 7, Neev in view of DeBenedictis et al. in view of Gildersleeve et al. disclose (or make obvious) the claimed invention, see Gildersleeve et al. the foldable/folded knee wrap (see figures 12A-12C) other bodily areas (see [0091]).
Regarding claim 8, Neev in view of DeBenedictis et al. in view of Gildersleeve et al. disclose (or make obvious) the claimed invention, see Gildersleeve et al. the fastener(s) (see "fastener" in [0006] and [0099] and "straps" in [0006], [0064], [0072], and [0113]).
Regarding claim 9, Neev ([0066][ and figure 12) in view of DeBenedictis et al. ([0045]-[0046]) in view of Gildersleeve et al. disclose (or make obvious) the claimed invention.
Regarding claim 10, Neev in view of DeBenedictis et al. in view of Gildersleeve et al. disclose (or make obvious) the claimed invention, see Gildersleeve et al. figures 7A-8B.
Regarding claims 11, 18 and 20, Neev disclose the claimed invention see [0026]-[0030], [0046], [0131] and figure 3a for example.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Neev (U.S. Patent Application Publication 2013/0184693) in view of DeBenedictis et al. (Patent Application Publication 2015/0216720) in view of Gildersleeve et al. (U.S. Patent Application Publication 2013/0238042) as applied to claim 11 above, and further in view of Donahue et al. (U.S. Patent Application Publication 2008/0281307).
Regarding claim 12, Neev in view of DeBenedictis et al. in view of
Gildersleeve et al. show the invention above including a light source in conjunction
with cold/thermal treatment
but fail to explicitly recite the light sources are configured as variable wavelength light sources.
Like Neev, Donahue discloses a dual or multiple energy modality wrap treatment device used to provide cool the treatment to tissue and teach providing the system with a controller that "may include systems to vary the intensity of the light from individual emitter elements, to switch emitter individual elements on and off in various patterns, to integrate the multiple modalities, if present, and to vary the wavelength of the emitted light in connection with light emitters that may have such capacity," (see [0020]), o in order to enhance treatment by providing dual or multiple treatment modalities (e.g., cold treatment and light treatment, see [0008]-[0009], [0020] and/or claims 1, 4, and 9) for treating traumatized tissue.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Neev, as taught by Donahue, to provide the system with a controller that "may include systems to vary the intensity of the light from individual emitter elements, to switch emitter individual elements on and off in various patterns, to integrate the multiple modalities, if present, and to vary the wavelength of the emitted light in connection with light emitters that may have such capacity," in order to enhance treatment by providing dual or multiple treatment modalities for treating traumatized tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792
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