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 1-6 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 lines 4-5 recite, “a tip which is attached to a first side surface of the handpiece and which is in close contact with skin of a user…” By stating the tip is in contact with a user applicant is claiming a human organism. Applicant is suggested to use functional language such as “configured to contact…” or the like to overcome this rejection.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: a first power source unit, a first control unit, a storage unit, an energy generation unit, a cooling unit, a second power source unit, a second control unit, an energy transfer unit, a gas transferring unit, an electrode unit, and a data collection unit in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 limitation “a first power source unit”, “a first control unit”, “a storage unit”, “an energy generation unit”, “a cooling unit”, “a second power source unit”, “a second control unit”, “an energy transfer unit”, “a gas transferring unit”, “an electrode unit”, and “a data collection unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function of the claim. The specification only relies on using the same generic placeholder modified by function terminology. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nobbio (WO 2009/106969) in view of Stern et al. (US 2004/0034346).
Nobbio discloses a system and method for treating a patient’s skin comprising; a body configured to control an overall operation (e.g. reference numeral 1, housing 2 which encloses the whole electronic circuitry; page 5, line 16-18),
a handpiece connected to the body and configured to be operated by receiving power from the body (e.g. Fig. 1 shows various contemplated handpieces for use; page 7, lines 3-16), and a tip which is attached to a first side surface of the handpiece and which is in close contact with skin of a user (e.g. Fig. 3 shows the tip portion of handpiece(s) 12 which comprises first and second electrodes for transmitting the RF signal through the skin of the patient; page 8, lines 1-9),
wherein the body comprises a first power unit coupled to an inside of the body and configured to generate supply power required for operation (e.g. electronic control unit 8 controls housing and the first electronic treatment unit 3, page 6, lines 9-12; Examiner notes there must be some power delivery system in the body 1 in order to deliver the RF signal as disclosed by Nobbio),
a first control unit coupled to an inside of the body and configured to receive the power of the first power source unit and to perform and operation control (e.g. electronic control unit 8 controls housing and the first electronic treatment unit 3, page 6, lines 9-12; Examiner notes there must be some power delivery system in the body 1 in order to deliver the RF signal as disclosed by Nobbio),
a storage unit which is attached to the first control unit inside the body and which contains data required for the operation control in the first control unit (e.g. Examiner takes the position that Nobbio inherently discloses a storage unit. Nobbio explicitly teaches the selection of a plurality of different skin treatments (e.g. page 5, line 8-15) which would require some form of a storage unit to store the instruction for the different treatments, additionally, Nobbio discloses the treatment parameters of the RF/IR subsystem to have preset ranges of values (e.g. page 9, line 1-15). In short if values are pre-set they must be somehow stored in some form)
an energy generation unit attached to the inside of the body and configured to generate radio frequency energy by receiving the power of the first power source unit (e.g. Examiner considers the first treatment unit 3 to read on this limitation. Nobbio discloses the first treatment to be the RF treatment and the functional relationship between the electronic control unit 8 and the individual treatment units 3, 5, and 6)
a cooling unit to which a gas can is capable of being attached so that the cooling unit is capable of receiving the power of the first power source unit and emitting cooling gas to the skin (e.g. Fig. 3 heat exchanger 40; page 11, line 23 – page 12, line 4)
the handpiece comprises
a second power source unit coupled to an upper portion of an inner side surface of the handpiece and configured to receive the power from the first power source unit of the body in a wired manned and to enable an operation of the handpiece (e.g. Examiner considers the conductor within the handpiece to be second power source)
an energy transferring unit configured to receive energy generated from the energy generation unit of the body and to transfer the energy to the tip (e.g. Examiner has considered this limitation to only require some distal portion of the conductive pathway. Since Nobbio clearly discloses discharge electrodes and a handpiece, there must also be a conductive pathway that extends longitudinally through the handpiece and therefore there would also be a distal portion of that pathway where that connects to the electrodes)
a gas transferring unit for transferring the cooling gas from the gas can of the cooling unit of the body (e.g. Fig. 3, cooling circuit 24 shows the cooling pathway from the body 1 to the handpiece)
the tip comprises
a housing which comprises a component of the tip (e.g. see Fig. 1 which shows handpieces 12 and 14 for RF delivery, Examiner notes both of these handpieces comprise a distal most portion which can reasonably be considered the tip)
an electrode unit coupled to the inside of the housing and configured to transfer an electrical signal through an electrical connection with the energy transferring unit, the electrode unit being configured such that the radio frequency energy generated from the energy generation unit of the body is transferred to a first energy applying portion of the handpiece (e.g. see Fig. 3 which shows electrodes 13a and 13b extend into the handpiece housing (phantom/dashed lines))
and a chamber which is formed inside the housing and to which the gas cooling the skin of the user is injected finally through the gas transferring unit of the handpiece when the cooling gas is output from the cooling unit of the body (e.g. Fig. 3 shows chamber 42 receiving the cooling fluid).
Nobbio discloses the invention as claimed but fails to teach a data collection unit configured to be operated by receiving power from the electrode unit and configured to measure detailed information of a patient and a second control unit fixed to an inner side surface of the handpiece, the second control unit having a portion that protrudes in a shape of a plurality of buttons on an outer side surface of the handpiece, and the second control unit being configured to be operated by receiving power of the second power source unit and being configured to interwork with the first control unit so that direct control of the user is capable of being performed.
In a similar field, Stern teaches that it is known to use a second control unit having a portion that protrudes in a shape of a plurality of buttons on an outer side surface of the handpiece, and the second control unit being configured to be operated by receiving power of the second power source unit and being configured to interwork with the first control unit so that direct control of the user is capable of being performed in the form of buttons and/or switches as set forth in paragraph 87 for providing the predictable results of providing the user with control of the delivery of treatment to the patient on the handpiece itself and reducing delays from making adjustments at the remote housing. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Nobbio with use a second control unit having a portion that protrudes in a shape of a plurality of buttons on an outer side surface of the handpiece, and the second control unit being configured to be operated by receiving power of the second power source unit and being configured to interwork with the first control unit so that direct control of the user is capable of being performed in the form of a plurality of buttons/switches since such a modification would provide the predictable results of providing the user with control of the delivery of treatment to the patient on the handpiece itself and reducing delays from making adjustments at the remote housing.
Stern also teaches that it is known to use a data collection unit configured to be operated by receiving power from the electrode unit and configured to measure detailed information of a patient as set forth in paragraph 87 (thermal sensors), for providing the predictable results of monitoring the skin/electrode temperature during operation so that better temperature control can be exercised to prevent harm to the patient. 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 Nobbio with use a data collection unit configured to be operated by receiving power from the electrode unit and configured to measure detailed information of a patient since such a modification would provide the predictable results of monitoring the skin/electrode temperature during operation so that better temperature control can be exercised to prevent harm to the patient.
With regard to claim 2, Nobbio discloses controlling the RF output based on an output amount, references time intervals for treatment but fails to specifically disclose the energy emission time, cooling gas emission time and cooling gas output amount being stored to memory in the storage unit.
Stern teaches that it is known to have stored control of on/off times, duty cycles, of the heating/cooling system as set forth in paragraph 100. Stern also teaches a memory devices for storing the therapy control information including the amount of current delivered, controlling the duty cycle of the fluid delivery, duration time, temperature control relative to a target temperature etc. as set forth in paragraph 89. 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 Nobbio with storing disclose the energy emission time, cooling gas emission time and cooling gas output amount being stored to memory in the storage unit since such a modification would provide the predictable results of having preset programs to deliver therapy rather than individually inputting known parameters each time therapy session.
With regard to claim 3, Examiner takes the position that a third power source can just be some other distal portion of the conductive pathway. Accordingly, the disclosed invention of Nobbio must have a conductive pathway traveling through the handpiece and terminating at the electrode, and therefore there exists an infinite number of “power sources” along this pathway. Examiner notes Applicant has failed to specify what this power source may be. The use of such broad disclosure within the specification fails to impart any additional limitations on the claim term beyond its plain meaning. Nobbio additionally discloses a first and second electrode plate (Fig. 3, 13a and 13b). Nobbio in view of Stern fail to teach the use of a third electrode connected to the first and second electrode. It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a third electrode connected to first and second electrodes since there exists many known multi electrode configurations in the field of RF therapy for cosmetic skin treatments and the selection of any combination of electrodes would be within the level of ordinary skill in the art.
With regard to claim 4, Nobbio discloses the invention as claimed but fails to teach the gas emission time being at least longer than the rf energy emission time. Stern teaches that it is known to select various cooling profiles including at least one embodiment that outlines applying precooling to the treatment site before RF energy is delivered, continuing delivery of the cooling while RF is delivered, and even continuing cooling after RF energy is delivered. The pre and post cooling define an emission time at least greater than the RF delivery emission time since cooling is delivered during that time as well as set forth in paragraph 98 for providing the predictable results of ensuring the patient skin surface is properly cooled in order to prevent patient harm. 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 Nobbio with the cooling gas emission time being at least longer than the radio frequency energy emission time since such a modification would provide the predictable results of ensuring the patient skin surface is properly cooled in order to prevent patient harm.
With regard to claim 5-6, Nobbio in view of Stern disclose the invention as claimed but fail to teach specific cooling gas emission time being between 0.1-6 seconds and rf energy emission time being between 0.2-7 seconds. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the gas emission time and rf energy emission time from Nobbio in view of Stern from between 0.1-6 seconds and 0.2 – 7 seconds respectively, as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A STOKLOSA whose telephone number is (571)272-1213. The examiner can normally be reached M-F 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Teixeira-Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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