The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Rejections - 35 USC § 112
First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4 is rejected because, for example, paragraphs 60-61 of application’s PGPUB 2024/0269480 teach an upper limit for the single pulse mode. However, claim 4 provides no upper limit to the “0.1 ms or more in the single pulse mode” and the “5 ms or more in the sub-pulse mode”. However, a continuous single pulse of 10 minutes would likely cause undesired results, which is the supposed intention of the sub-pulse mode (i.e., to allow heat to diffuse from the treatment site). It is believed that the example of a single pulse having a pulse width of 10 minutes is not supported by the specification, and claim 4 would therefore require an upper limit.
Claim 10 is rejected because the specification fails to teach a pulse width in a first sub-pulse mode having a range of 1-3 ms, and a pulse width in a second sub-pulse mode having a range of 100-700 µs. Rather, paragraph 55 of the application’s PGPUB 2024/0269480 teaches these ranges as relating to the pulse duration. Claim 10 will be examined as if it states “pulse duration” instead of “pulse width”.
Second Paragraph
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 2-4 and 10 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 2 is rejected because the term “relatively large” with regard to blood vessel size in line 2 is a relative term which renders the claim indefinite. The term “relatively large” with regard to blood vessel size 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. It is not clear what diameter of a blood vessel, or which particular blood vessels within the body, would constitute the “relatively large blood vessels” that are claimed as needing to be treated with the single pulse mode.
Claim 3 is rejected because the term “relatively short pulse width” in line 5 is a relative term which renders the claim indefinite. The reasoning for this rejection of claim 3 is the same as described above for claim 2.
Claim 4 is rejected because it is unclear if there is an upper limit to the “0.1 ms or more in the single pulse mode” and the “5 ms or more in the sub-pulse mode”. In other words, the claim reads on either mode being used for a pulse width of 6 ms, or additionally either mode being used for a pulse width of 10 minutes. However, a continuous single pulse of 10 minutes would likely cause undesired results, which is the supposed intention of the sub-pulse mode (i.e., to allow heat to diffuse from the treatment site). Additionally and for example, paragraphs 60-61 of application’s PGPUB 2024/0269480 teach an upper limit for the single pulse mode. Improved clarity on this claimed subject matter is requested.
Claim 10 is rejected because this claim recites the term “pulse width” in regards to the sub-pulses. However, it appears that this claim is actually referring to the “duration” of the sub-pulses, as described in paragraph 55 of the application’s PGPUB 2024/0269480 as opposed to the pulse width. See figures 4(b) and 4(c) below illustrating the difference. The claim is being interpreted as if this refers to “duration”.
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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.
Claims 1-4 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davenport et al. (US Patent Pub. No. 2009/0093799).
Davenport discloses a light treatment apparatus for treating vascular lesions (see Title, “System and method for dermatological lesion treatment…the area of skin being treated has a vascular lesion”), the apparatus comprising:
A light generating unit (see paragraph 50, “It should also be noted that much of the discussion herein refers to a flashlamp as being the source which generates the light (or more broadly speaking electromagnetic radiation EMR) which is used to treat the skin”); and
A setting unit configured to set a pulse pattern of treatment light generated in the light generating unit (see paragraph 84, “The system is operable in two or more modes, allowing the user to select a mode most suitable for the procedure. For example, the different display buttons shown as A, B and C are implemented for controlling the operation”; see buttons “A”, “B” and “C” in Figure 10),
Wherein a single pulse mode for irradiating treatment light comprising a single pulse (see pulse 2002 in Figure 20A), and a sub-pulse mode for irradiating treatment light comprising a plurality of sub-pulses (see pulses 2004 in Figure 20A) are set through the setting unit. With regard to Figure 20A, paragraph 73 states the following:
FIGS. 20A-B illustrate some aspects of the operation of the controllable power supply of an embodiment herein, and further illustrates some aspects of the ability to have control over the fluence, current density and pulse width, and the inter-relationship between this parameters, where the vertical axis is current density "J" and the area under the curves relate to fluence FIG. 20A shows first pulse 2002 of current having a duration of t1 which could be used to drive a flashlamp, and would produce corresponding EMR output. Pulses of current 2004 applied over a time duration t2 would apply the same current density the flashlamp of and hence produce the same spectral output from the flashlamp, and the overall fluence of the output EMR would be the same as for pulse 2002. However, the four incremental pulses 2004 with the time interval between the pulses, creates a different effective pulse width in terms of the effect of the output EMR applied to the area of skin being treated…
Regarding claim 2, it is noted that claim 2 is a recitation of intended use. In other words, it is intended by the application that the single pulse mode be used to treat relatively large blood vessels compared to the sub-pulse mode. However, if a user had a reason to utilize the sub-pulse mode to treat a “relatively large blood vessels”, then the device of Davenport, as well as the claimed invention, would operate in that mode and provide the treatment. Since there are no structural distinctions in claim 2 over the limitations of claim 1, and the fact that Davenport may be operated to use pulse 2002 in Figure 20A for a “relatively large blood vessel”, Davenport reads on these limitations.
Regarding claim 3, it can be seen in Figure 20A that pulse width t1 of pulse 2002 is smaller than pulse width t2 of pulse 2004. This teaches that the setting unit is configured to adjust a pulse width of the treatment light. And with regard to the recitations of the “an adjustable range for the pulse width … in the single pulse mode is configured to allow adjustment up to a relatively short pulse width compared to… the sub-pulse mode”, it is noted that Figure 20A illustrates the pulse width t1 for the single pulse 2002 to be shorter than for the pulse width t2 of pulse train 2004.
Regarding claim 4, it is re-iterated that the pulse width t1 in single pulse option 2002 of Figure 20A is illustrated as being shorter than the pulse width t2 in the multiple pulse option 2004 of Figure 20A. However, Davenport does not teach specific time frames for these pulse widths (i.e., 0.1 ms or more in the single pulse mode, and 5 ms or more in the sub-pulse mode). However, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USQ 233 (see MPEP 2144.05(II)(A)).
Regarding claim 9, it can be seen in the reproduction below of Figure 20A that within the unit time equal to t1, there is only half as much energy delivered with pulse 2004 as compared to pulse 2002. As such, this meets the limitations of the claim.
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Regarding claim 10, Davenport does not explicitly teach specific time frames for these pulse durations (i.e., 1-3 ms or in the single pulse mode, and 100-700 µs in the sub-pulse mode). However, Davenport teaches different sub-pulse modes (see Figures 20A-C below) in which the pulse duration may be larger (see Figure 20A) and others where the pulse duration may be smaller (see Figures 20B and 20C). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USQ 233 (see MPEP 2144.05(II)(A)). Therefore, it would be obvious to one of ordinary skill in the art to find a first larger optimum range of pulse duration in a first sub-pulse mode (e.g., between 1-3 ms) and a second optimum range of pulse duration in a second sub-pulse mode (e.g., between 100-700 µs), such different optimum ranges being dictated by other factors such as, for example, the desired outcome of the procedure, the wavelength used, the power used, etc.
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Allowable Subject Matter
Claims 5-8 and 11-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 5-6 and 11-12 are indicated as allowable because the prior art fails to teach a setting unit comprising a sub-pulse mode in which a first option changes the number of pulses delivered while adjusting the pulse width and a second option where a change in pulse width results from an adjustment of an off-time between sub-pulses while the number of sub-pulses remains unchanged, as recited in claims 5 and 11.
Claims 7-8 and 13-14 are indicated as allowable because the prior art fails to teach a setting unit comprising a sub-pulse mode in which a first option changes the number of pulses delivered while adjusting the pulse width and a second option where a change in pulse width results from an adjustment of an off-time between groups of sub-pulses while the number of sub-pulses remains unchanged, as recited in claims 7 and 13.
Conclusion
The following prior art is herein made of record is considered pertinent to applicant's disclosure, but not relied upon in the rejections above:
CA 2198826 A1 to Denis Dudley teaches the general ideas behind varying pulse widths and pulse durations with off-times therebetween, being based on thermal relaxation time of the targeted vessels (see Abstract). Dudley discusses the issues of varying blood vessel size playing a factor in the various different pulse sequences investigated, which are generally found in Tables throughout the disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792