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 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 1-3, 5, 6, 9, 12, 20, 22, 23, 25, 27-29, 33-35, 37, 38, 40, 48 and 49 (all pending claims) 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification fails to provide adequate description to support the modulation of gene expression by the application of microwave energy as recited in the claims. While the specification makes very broad statements about the parameters (e.g. power, duration, frequency, etc.), there is no disclosure of which values are deemed necessary to effectively modulate the expression of genes, and in particular the values which are necessary to provide the specific expression (e.g. upregulate or downregulate) of the specific genes in specific tissues as claimed. Rather, the disclosure merely provides a very broad range of parameters which may be used in many different microwave devices. Further, the disclosure provides a variety of different potential outcomes (e.g. no heating, minimal heating, considerable heating) and fails to delineate the necessary parameters that would be ideal for each outcome with the particular type of modulation of gene expression. It appears as though a very wide range of parameters is disclosed in such a manner that any device capable of delivering these parameters for tissue treatment would inherently result in the claimed modulation of the expression of the genes as there is no criticality given to any of the specific parameters for the treatment of specific tissues or the expression of specific genes. Additionally, each of the independent claims recites a single step (i.e. applying microwave energy) making the scope of the claims unclear since the step would cover any feasible type of microwave energy, including types not specifically identified in applicant’s specification.
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 5, 6, 9, 12, 22, 23, 25, 38, 40, 48 and 49 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 5 is unclear with the frequency being used, particularly in the recitation of numerous different ranges and numerous singular values. Similarly, claim 6 recites numerous different ranges for the time and energy with various ranges of overlapping scope such that the values being claimed are indefinite. Claims 9 and 12 recite various options in the alternative making the scope of the claim unclear. Claim 22 recites a plurality of singular values not all necessarily in the alternative making the scope of the claim unclear. Claim 23 is indefinite with the language “may not reach”. Claim 25 is unclear with the various different time ranges and recitation of specific values.
Claim 38 is unclear with the listing of genes that may or may not cause a disease, particularly since they are not presented in a proper Markush grouping.
Claim 40 is unclear with what is being treated given the various different alternative genes and expressions (i.e. upregulating or down-regulating) that may be occurring. Claims 48 and 49 are similarly unclear with the method step given the various alternatives.
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 1- 3, 5, 6, 9, 12, 20, 27, 33 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beale et al (2019/0274758).
Regarding claim 1, Beale et al disclose providing microwave energy to tissue, which is the only active method step recited in the claim. Beale et al provide microwave energy at levels consistent with applicant’s disclosed levels and would inherently have the same effect on gene expression, particularly given that applicant’s claims and specification fail to provide sufficient disclosure to delineate any specific requirements for the expression of genes that would distinguish over the Beale et al microwave energy source. Moreover, Beale et al expressly teach that the application of microwave energy may cause gene expression (paragraphs [0021] and [0123], for example).
Regarding claim 2, Beale et al disclose a microwave system comprising a generator (1), a controller (2), a conduit cable (4) and a microwave antenna (5/6) as seen in Figure 1. Regarding claim 3, Beale et al disclose using the device to treat epithelial tissue (para. [0041, for example). Regarding claims 5 and 6, Beale et al disclose similar ranges for frequency, energy and time (para. [0051] and [0070], for example. Regarding claims 9 and 12, Beale et al disclose various different doses and times (para.[0052], for example). Regarding claim 20, see paragraph [0030], for example. Regarding claim 27, see paragraph [0052]. Regarding claim 33, any subject may be susceptible to an inflammatory disease or condition. Regarding claim 37, the examiner maintains the steps performed by Beale et al (‘758) are identical to those recited in the claims and would necessarily result in the same effect on tissue.
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.
Claims 22, 23, 25, 28, 29, 34, 35, 38, 40, 48 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Beale et al (‘758).
As addressed above, Beale et al disclose a device for providing microwave energy to tissue, that energy being known to modulate the expression of one or more genes. These claims all recite different parameters (e.g. energy, time, etc.) for the microwave power or the expression of specific genes. The examiner maintains that given the fact that Beale et al disclose similar parameters (e.g. energy, time, temperature, etc) for the treatment of tissue, the resulting gene expression would obviously, if not inherently, occur. Moreover, the slight modification of the parameters would be an obvious consideration for one of ordinary skill in the art, particularly given that applicant’s specification has no associated criticality for any of the parameter values and further since applicant’s own specification indicates that one of ordinary skill in the art would be capable of adjusting any of the parameters in order to achieve a desired result. See paragraph [0148] of the printed publication associated with the instant application (i.e. PgPUB 2024/0173561). The examiner maintains that the variations cited in the above rejected claims would all be obvious to one of ordinary skill in the art given the same structural components and ranges of operation and given the fact that Beale et al acknowledge the notion that gene expression may be achieved by delivering microwave energy to tissue. Again, applicant’s specification merely points out a broad range of treatment values to express a wide variety of genes and specifically states that one of ordinary skill in the art could “tweak” the microwave dose to achieve the desired effects. There is no criticality for the disclosed ranges of operation, and no indication that one range may be more preferable for expressing one or more genes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Beale et al (2022/0219007; 2019/0255348; and 2016/0324577) disclose various other microwave devices for treating tissue. Lin et al (2018/0168727) discloses another microwave device for modulating gene expression, and Deem et al (2010/0114086) disclose another microwave device for treating tissue.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/Primary Examiner, Art Unit 3794