DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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 1 describes a device for removing heat from subcutaneous lipid-rich cells of a subject havening a skin, the device comprising: a heat exchanging member having a heat transfer surface configured to form a heat conducting interface with the subject's skin to remove heat from the lipid-rich cells such that “the lipid-rich cells are substantially affected while non-lipid-rich cells in the epidermis are not substantially affected” in lines 5-6.
Specification of the instant application recites in paragraphs [0017] and [0019] that the lipid-rich cells are affected while non-lipid-rich cells in the epidermis are not affected. However, the specification does not teach the impact or change on the lipid-rich and/or non-lipid-rich cells in the dermis. Thus, the extent of the effect/change on lipid-rich cells and non-lipid-rich cells cannot be determined from the specification or the claim. Therefore, the claim is indefinite, because it is unclear the structural limitation intended to be implied by reciting that the heat transfer interface is configured to remove heat from the lipid-rich cells are affected and the non-lipid rich cells are substantially not affected. Note that in this Office Action, heat exchange components are referred to as cooling devices.
Furthermore, the term “substantially” in claim 1 lines 5, 6 and 7 is a relative term which renders the claim indefinite. The term “substantially affected” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, this term renders the claim indefinite.
Appropriate correction is required.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Anderson et al., Pub. No. US 2005/0251120 (hereinafter “Anderson”) in view of Ozgur e al. Pub. No. US 2005/0096513 (hereinafter “Ozgus”).
Anderson discloses a device and methods for selective disruption of lipid-rich cells by controlled cooling of target tissue (see the abstract), the device comprising: a heat exchanging member having a heat transfer surface configured to form a heat conducting interface with the subject's skin to remove heat from the lipid-rich cells (a treatment system 100 including a control unit 105, a treatment/heat exchanging unit 107 including a cooling/heating element 110, and a treatment interface 115 between the cooling/heating element 110 and the epidermis 160 to remove heat from the target skin/subcutaneous lipid-rich cells for effecting treatment onto the epidermis 160, dermis 165 and/or fat cell 170, see Fig. 1A and paragraphs [0164, 0167, 0169]). Anderson further teaches “For example, the treatment interface 115 may include a cooling conductive plate, a cooling fluid-filled vessel, … and the like.” see paragraph [0169].
Furthermore, Anderson discloses a sensing/detector device 120 disposed in the interface 115 between the heat exchanging member 110 and the subject’s skin 162 (In paragraph [0165]), wherein the detector can be a temperature monitor, for example, a thermocouple, thermistor and the like In paragraph. In paragraph 0026, Anderson teaches the temperature probe can be a thermoprobe, such as a radiation thermometer, fiber optical temperature sensor and thermal imaging thermoprobe.” However, Anderson does not teach a substantially flexible sensing device disposed in the interface between the heat exchanging member and the subject's skin, wherein the sensing device is configured to sense a parameter at the interface as claimed.
Ozgus discloses a sensor system 30 including a flexible sensor module 10, wherein the flexible sensor module functions as a wireless data collection device that can be attached on the skin of a subject’s body and collect physiological data. The sensor module has a flexible thin sheet of silicon comprising a flexible power and flexible support substrate, wherein the silicon, power source and flexible substrate are integrated as layers of the sensor module (par. 0010).
Therefore, it would have been obvious to one of ordinary skill in the art the time applicant’s invention was filed to employ a flexible sensor as taught by Ozgus in the device of Anderson as an alternative sensing device since this is well within the scope of one having ordinary skill in the art. Furthermore, the flexible sensor substantially conforms to the interface member, the heat exchanging member and the subject’s skin, and thereby provides a more accurate measurements of the parameters at the interface.
Regarding the limitation in the claim that the lipid-rich cells are substantially affected while non-lipid-rich cells in the epidermis are not substantially affected is directed to expected results. Expected results or mare statements of intended use in a patent claim language are generally not given significant patentable weight.
The limitation of the claim that "lipid-rich cells are substantially affected, while non-lipid-rich cells in the epidermis are not substantially affected" refers to the expected results.
Expected results or mare statements of intended use in the language of a patent claim are generally not given significant patentable weight and do not have significant patent effect.
Furthermore, Anderson further teaches “adipose tissue comprising lipid-rich cells can be selectively disrupted without causing injury to the surrounding non lipid-rich tissue (e.g., dermal and epidermal tissue) by controlling the temperature and/or pressure applied to the respective tissues,” see Paragraph [0012]. Anderson further teaches “In one aspect, the invention relates to cooling methods for selective disruption of lipid rich cells in a non-infant human treatment subject, the methods comprising … ; utilizing the cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to disrupt and thereby reduce lipid rich cells therein; and while the temperature is decreased, utilizing at least one feedback device to provide feedback information sufficient to confirm that non lipid rich cells proximate to the cooling element are not disrupted, thereby selectively disrupting lipid rich cells in the subject.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mestrovic discloses a device including a flexible substrates 10 and 16 bonded together with the pairs of contact surfaces 13 and 14 in electrical connection (shown in the Figures 5 and 6), that can be worn by a person or fitted to an apparatus for sensing, monitoring or controlling one or more parameters such as temperature (see the abstract and paragraphs [0008] and [0009]). Mestrovic teaches It is preferred that the device be in the form of a textile and that the flexible substrate on which the first part of the circuit is carried be incorporated in the textile. In this situation and when the first part of the circuit includes a sensing element and/or control interface, an advantage provided by flexible substrate being incorporated into a textile or garment is that the sensing element can sense parameters very close to a person's skin such as surface temperature, skin conductivity and moisture and/or provide an intimate monitor interface and or control interface for controlling electronic devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AHMED M FARAH whose telephone number is (571)272-4765. The examiner can normally be reached Mon - Fri. 9:30AM -10:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AHMED M FARAH/Primary Examiner, Art Unit 3792