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 § 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.
Claims 1-4, 7-12, 17-19, 21-22, 24, 26-27, 32, and 38 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 "selected from the group" in line 13. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “selected from a group” and suggests amending.
Claims 2-4 are rejected based on their dependency on claim 1.
Claim 7 recites the limitation “the light source is a laser light source” in line 2. There is insufficient antecedent basis for this limitation in the claim. With this claim being dependent on claim 1 and claim 1 reciting “the light source being selected from the group consisting of laser light sources and wavelength- filtered light sources” if a wavelength-filtered light source was selected, then claim 7 would lack antecedent basis for the laser light source. Examiner suggests positively reciting the selection of the light source in claim 7.
Claim 8 recites the limitation “the light source is an intense-pulsed-light source” in line 2. This limitation is unclear and indefinite. It is unclear if the claim is intending to have an intense-pulsed-light source in addition to the light sources disclosed in claim 1 (“the laser light source” or “the wavelength-filtered light source”) or if the intention is to have the light source be an intense-pulsed-light source. Claim 1 states “the light source being selected from the group consisting of laser light sources and wavelength- filtered light sources”. The term “consisting of” is a transitional phrase that excludes any element, step, or ingredient not specified in the claim (See MPEP 2111.03 II). Therefore claim 1 limits the light source to be “the laser light source” or “the wavelength-filtered light source” and therefore, the recitation of “an intense-pulsed-light source” in claim 8 broadens the scope of the claim. Examiner suggests amending to clarify.
Claim 9 recites the limitation “the light source is a wavelength-filtered light source” in line 2. There is insufficient antecedent basis for this limitation in the claim. With this claim being dependent on claim 1 and claim 1 reciting “the light source being selected from the group consisting of laser light sources and wavelength- filtered light sources” if a laser light source was selected, then claim 9 would lack antecedent basis for the wavelength-filtered light source. Examiner suggests positively reciting the selection of the light source in claim 9.
Claims 10-12, 17-19, 21-22, 24, and 26-27 are rejected based on their dependency on claim 1.
Claim 32 recites the limitation "selected from the group" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “selected from a group” and suggests amending.
Claim 38 recites the limitation "selected from the group" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as “selected from a group” and suggests amending.
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.
Claim(s) 1-4, 7-12, 17-19, 21-22, 24, 26-27, 32, and 38 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 2008/0215039 Slatkine et al., hereinafter “Slatkine”.
Regarding claim 1, Slatkine discloses a device for treating a condition of skin of a subject (Para 1 and 162), the device (Device of Figure 48) comprising:
a chamber (Figure 48, element 1106) having an end wall (Figure 48, element 1100), a side wall extending away from the end wall (See annotated Figure 48, these are also shown in Figure 47 as element 1091), and an opening opposite the end wall (See annotated Figure 48, the opening is opposite end wall 1100), wherein the end wall, the side wall and the opening define an interior space of the chamber (This is shown in annotated Figure 48, the sidewall, opening, and the end wall 1100 form a chamber 1106), wherein the end wall comprises a transparent window (figure 48, element 1100 is a transmitting element, Para 148 discloses “transmitting element being transparent or translucent”), wherein the side wall terminates in a contact surface for sealing against skin of a subject (This is shown in Figure 48, side wall terminates at skin 1142; Para 100 discloses “an opening at the bottom of said interior which is sealable by the skin target”), wherein the contact surface defines the opening (Annotated Figure 48; the opening contacts skin 1142), wherein the side wall has a longitudinal length (Annotated Figure 48 shown by height ‘H’) such that the end wall is spaced greater than ten millimeters from the skin of the subject when the contact surface seals against skin of the subject (Para 165 discloses a range that encompasses 10-50mm);
a vacuum source (figure 48, element 1109) in fluid communication with the interior space of the chamber (Figure 48; vacuum source 1109 is in fluid communication via conduit 1107; see also Para 452), the vacuum source being structured to create negative pressure in the chamber (Para 90; also note that “to create negative pressure in the chamber” is an intended use limitation); and
a light source (Figure 48, element 1116) for irradiating a region of the skin of the subject with light (Para 451), the light source being selected from a group consisting of laser light sources and wavelength- filtered light sources (Para 161 discloses a laser source and wavelength filtered light sources, supported further by Para 99 that shows the wavelength selectable, therefore filtered), the light source being positioned to direct the light through the transparent window at the region of the skin of the subject when the light source is activated (Para 451 and indicated in Figure 48 by arrows 1105; also note “to direct the light …” is an intended use limitation).
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Annotated Figure 48 (Slatkine)
Regarding claim 2, Slatkine discloses a pressure regulator (Figure 48, element 1124) operable to control a suction level of the vacuum source such that when the contact surface seals against the skin of the subject, the negative pressure created in the chamber by the vacuum source does not draw the skin of the subject into contact with the end wall of the chamber (Para 458 and as can be seen in Figure 48 skin 1142 does not contact 1100; also note “to control a suction level” is an intended use limitation).
Regarding claim 3, Slatkine discloses the light source emits wavelengths that are preferentially absorbed by hemoglobin and/or oxyhemoglobin (Para 473 “Dye lasers or any yellow light, which is strongly absorbed by hemoglobin”).
Regarding claim 4, Slatkine discloses the light source emits wavelengths in a range of wavelengths from 500 nanometers to 2000 nanometers (Para 99; 500-1800 nm is disclosed).
Regarding claim 7, Slatkine discloses the light source is a laser light source (Para 161 discloses a laser source).
Regarding claim 8, Slatkine discloses the light source is an intense-pulsed-light source (Para 161; “a non-coherent intense pulse light source”).
Regarding claim 9, Slatkine discloses the light source is a wavelength-filtered light source (Para 161 discloses wavelength filtered light sources, supported further by Para 99 that shows the wavelength selectable, therefore filtered).
Regarding claim 10, Slatkine discloses a spot size of the light has a diameter in a range of 1 to 20 millimeters (Para 166; 5 mm).
Regarding claim 11, Slatkine discloses the negative pressure is between about -10 and -760 mm Hg (Para 67 and 69; both 150 mmHg and 400 mmHg fall within this range, see also Para 90 that describes it as “negative” pressure).
Regarding claim 12, Slatkine discloses the end wall and the side wall of the chamber are transparent (Para 145; the chamber all together is transparent).
Regarding claim 17, Slatkine discloses a coolant source in fluid communication with the interior space of the chamber (Para 198-201, specifically 201).
Regarding claim 18, Slatkine discloses a controller (Figure 48, element 1119) in electrical communication with the vacuum source and the light source (Figure 48, element 1119 in communication with 1116 and 1109, see also Para 79), the controller being configured to execute a program stored in the controller to (Para 120 and 233; although the word “program” isn’t explicitly disclosed, the controller is able to receive data and modulate the therapies based on received data, so a program is inherently disclosed): (i) activate the vacuum source to create the negative pressure in the chamber (Figure 48, elements 1126, 1124 and Para 463; also note the limitation “to create negative pressure” is an intended use limitation), and (ii) irradiate the region of the skin with light (Figure 48, elements 1120 and 1122, see also Para 454-458) for a period of time (Figure 48, element 1122) such that the light is provided at a radiant exposure of at least 5 J/cm2 (Para 214; 5-150 J/cm2 is disclosed).
Regarding claim 19, Slatkine discloses a pressure sensor (Para 79) for determining a pressure level within the interior space of the chamber (Para 108), the pressure sensor being in electrical communication the controller (Para 79), wherein the controller executes the program stored in the controller to (Para 120 and 233; although the word “program” isn’t explicitly disclosed, the controller is able to receive data and modulate the therapies based on received data, so a program is inherently disclosed): (iii) receive electrical signals from the pressure sensor and continue activation of the vacuum source for a time duration based on electrical signals received from the pressure sensor (Para 79 and 374).
Regarding claim 21, Slatkine discloses a controller in electrical communication with the pressure regulator and the light source (Figure 48, element 1119 in communication with 1116, see also Para 79), the controller being configured to execute a program stored in the controller to: (i) activate the pressure regulator to create the negative pressure in the chamber (Figure 48, elements 1126, 1124 and Para 463; also note the limitation “to create negative pressure” is an intended use limitation), and (ii) irradiate the region of the skin with light (Figure 48, elements 1120 and 1122, see also Para 454-458) for a period of time (Figure 48, element 1122) such that the light is provided at a radiant exposure of at least 5 J/cm2 (Para 214; 5-150 J/cm2 is disclosed).
Regarding claim 22, Slatkine discloses a pressure sensor (Para 79) for determining a pressure level within the interior space of the chamber (Para 108), the pressure sensor being in electrical communication the controller (Para 79), wherein the controller executes the program stored in the controller to (Para 120 and 233; although the word “program” isn’t explicitly disclosed, the controller is able to receive data and modulate the therapies based on received data, so a program is inherently disclosed): (iii) receive electrical signals from the pressure sensor and continue activation of the pressure regulator for a time duration based on electrical signals received from the pressure sensor (Para 79 and 374).
Regarding claim 24, Slatkine discloses the controller executes the program stored in the controller to (Para 120 and 233; although the word “program” isn’t explicitly disclosed, the controller is able to receive data and modulate the therapies based on received data, so a program is inherently disclosed): (ii) irradiate the region of the skin with light (Figure 48, elements 1120 and 1122, see also Para 454-458) for a period of time (Figure 48, element 1122) such that the light is provided at a radiant exposure of at least 50 J/cm2 (Para 214; 50-150 J/cm2 is disclosed).
Regarding claim 26, Slatkine discloses the controller executes the program stored in the controller to (Para 120 and 233; although the word “program” isn’t explicitly disclosed, the controller is able to receive data and modulate the therapies based on received data, so a program is inherently disclosed): (ii) irradiate the region of the skin with pulsed light at a pulse duration of 1 to 10 milliseconds (Para 158; the range is disclosed).
Regarding claim 27, Slatkine discloses the time duration is greater than 1 second (Para 78; the duration of pressure activation is no more than 6 seconds so a range of 1-6 seconds is disclosed).
Regarding claim 32, Slatkine discloses a method for treatment of a skin neoplasm of skin of a subject (Para 1, 131, and 162), the method comprising:
(a) providing a chamber (Figure 48, element 1106) having an end wall (Figure 48, element 1100), a side wall extending away from the end wall (See annotated Figure 48, these are also shown in Figure 47 as element 1091), and an opening opposite the end wall (See annotated Figure 48, the opening is opposite end wall 1100), wherein the end wall, the side wall and the opening define an interior space of the chamber (This is shown in annotated Figure 48, the sidewall, opening, and the end wall 1100 form a chamber 1106), wherein the side wall terminates in a contact surface for sealing against skin of a subject (This is shown in Figure 48, side wall terminates at skin 1142; Para 100 discloses “an opening at the bottom of said interior which is sealable by the skin target”), wherein the contact surface defines the opening (Annotated Figure 48; the opening contacts skin 1142);
(b) positioning the contact surface of the chamber on the skin of the subject such that the contact surface surrounds the skin neoplasm and the contact surface seals against the skin of the subject (Para 131; Para 100 discloses “an opening at the bottom of said interior which is sealable by the skin target”);
(c) creating negative pressure in the interior space of the chamber (Para 90); and
(d) irradiating the skin neoplasm with light from a light source (Para 451; Figure 48, element 1116) selected from a group consisting of laser light sources and wavelength-filtered light sources (Para 161 discloses a laser source and wavelength filtered light sources, supported further by Para 99 that shows the wavelength selectable, therefore filtered).
Regarding claim 38, Slatkine discloses a method for treatment of a skin malformation of skin of a subject (Para 1, 131, and 162), the method comprising:
(a) providing a chamber (Figure 48, element 1106) having an end wall (Figure 48, element 1100), a side wall extending away from the end wall (See annotated Figure 48, these are also shown in Figure 47 as element 1091), and an opening opposite the end wall (See annotated Figure 48, the opening is opposite end wall 1100), wherein the end wall, the side wall and the opening define an interior space of the chamber (This is shown in annotated Figure 48, the sidewall, opening, and the end wall 1100 form a chamber 1106), wherein the side wall terminates in a contact surface for sealing against skin of a subject (This is shown in Figure 48, side wall terminates at skin 1142; Para 100 discloses “an opening at the bottom of said interior which is sealable by the skin target”), wherein the contact surface defines the opening (Annotated Figure 48; the opening contacts skin 1142);
(b) positioning the contact surface of the chamber on the skin of the subject such that the contact surface surrounds the skin malformation and the contact surface seals against the skin of the subject (Para 131; Para 100 discloses “an opening at the bottom of said interior which is sealable by the skin target”);
(c) creating negative pressure in the interior space of the chamber (Para 90); and
(d) irradiating the skin malformation with light from a light source (Para 451; Figure 48, element 1116) selected from a group consisting of laser light sources and wavelength-filtered light sources (Para 161 discloses a laser source and wavelength filtered light sources, supported further by Para 99 that shows the wavelength selectable, therefore filtered).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/Benjamin J Klein/ Supervisory Patent Examiner, Art Unit 3792
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