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 § 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.
Claims 1-2 and 5-9 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2003/0149451 A1 to Chomenky et al. (hereinafter “Chomenky”).
As per claim 1, Chomenky describes a method of electroporating adipocytes in the adipose layer of tissue (FIG. 1; para [0044]), the method comprising:
providing a first electrode (14) having a first contact surface, and wherein the first contact surface has a first perimeter (para [0044]);
providing a second electrode (16) having a second contact surface, and wherein the second contact surface has a second perimeter (para [0044]);
obtaining a fold (18) of tissue (para [0044]);
positioning the fold of tissue between the first electrode and the second electrode such that the first contact surface of the first electrode is facing toward the second contact surface of the second electrode (para [0044]), producing a treatment zone therebetween (FIG. 1; para [0044]), and wherein the tissue positioned within the treatment zone includes an adipose layer or fat deposit (22) of tissue (para [0044]); and
applying an electrical signal to the first electrode and second electrode (para[0044]: high voltage electroporation pulses).
As per claim 2, Chomenky teaches that the tissue positioned within the treatment zone does not include skeletal muscle (FIG. 1, para [0044], [0032]: showing substantially all fat within the fold).
As per claim 5, Chomenky teaches that applying an electrical signal to the first electrode and the second electrode further includes applying electrical pulses (para [0044]).
As per claim 6, Chomenky teaches that applying electrical pulses includes applying an electrical pulse of between 5 volts and 1000 volts (para [0046]).
As per claim 7, Chomenky teaches that applying electrical pulses includes applying an electrical pulse between approximately 100 microseconds and 100 milliseconds (para [0046]).
As per claim 8, Chomenky teaches that applying electrical pulses includes applying between approximately 1 pulse and approximately 10 pulses (para [0046]; para [0063]-[0064] showing a single pulse).
As per claim 9, Chomenky teaches that at least one of the first contact surface and the second contact includes a plurality of protrusions extending therefrom (FIC. 1, para [0044]).
Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2014/0277219 A1 (Nanda).
As per claim 1, Nanda describes a method of electroporating adipocytes in the adipose layer of tissue (Abstract; Fig. 6), the method comprising:
providing a first electrode (614a) having a first contact surface, and wherein the first contact surface has a first perimeter (para [0109]-[0110]);
providing a second electrode (614b) having a second contact surface, and wherein the second contact surface has a second perimeter (para [0109]-[0110]);
obtaining a fold of tissue (tissue within vacuum cup in Fig. 5; para [0109]-[0110], [0105]);
positioning the fold of tissue between the first electrode and the second electrode such that the first contact surface of the first electrode is facing toward the second contact surface of the second electrode (para [0109]-[0110], [0105]), producing a treatment zone therebetween, and wherein the tissue positioned within the treatment zone includes an adipose layer of tissue (para [0109], [0045]); and
applying an electrical signal to the first electrode and second electrode (para [0110], [0105]-[0107]).
As per claim 9, Nanda teaches that at least one of the first contact surface and the second contact surface includes a plurality of protrusions extending therefrom (FIG. 6, para [0110]: see electrodes 616).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chomenky.
As per claim 3, Chomenky describes the method of claim 1, but fails to describe wherein obtaining the fold of tissue further comprises obtaining a fold of tissue including a skin layer, an adipose layer, and a smooth muscle layer.
Chomenky discloses targeting fat cells specifically (para [0019]-[0022]), and discloses a method including skin and fat (FIG. 1; para [0044]), but is silent on smooth muscle. However, it would have been obvious to one skilled in the art to also utilize the device for any area of external fat treatment (such as those that might contains superficial arteries/veins) so as to treat fat all areas of the body.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Nanda.
As per claim 3, Nanda describes the method of claim 1, but fails to describe wherein obtaining the fold of tissue further comprises obtaining a fold of tissue including a skin layer, an adipose layer, and a smooth muscle layer.
Nanda describes drawing tissue into a vacuum cup (FIG. 1, 6; para [0109]-[0110],[0105]-[0106]), but is silent on smooth muscle. However, it would have been obvious to one skilled in the art to also utilize the device for any area of external fat treatment (such as those that might contains superficial arteries/veins) so as to treat fat all areas of the body.
As per claim 4, Nanda describes the method of claim 3, further comprising injecting a predetermined amount of an agent into the adipose layer of the fold of tissue before applying the electrical signal to the first electrode and the second electrode (para [0110]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nanda as applied to claim 9 above, and further in view of US 2011/0190659 A1 to Long et al. (hereinafter “Long”).
As per claim 10, Nanda describes the method of claim 9, but fails to describe specifically wherein each protrusion is substantially pyramidal in shape.
However, Nanda depicts such shape with the same cross section, but is silent on shape (FIG. 6: note protrusion could be conical or pyramidal).
Long also describes electroporation electrodes (para [0028]) that operate on tissue folds (Fig. 8; para [0074]) and discloses wherein electrode protrusions is substantially pyramidal in shape (FIG. 7; para [0069]: pyramidal).
It would have been obvious to one skilled in the art to shape the electrodes in any common manner, such as pyramidal. as alternate design choices to balance pain and effectiveness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1777
JK
11/13/25
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