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 .
Election/Restrictions
Newly submitted device claims 12-20 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the newly submitted device claims 12-20 can be used to treat non cervical tissue.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 12-20 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 12-20 are withdrawn and original claims 1-11 will be examined and searched.
Response to Arguments
Applicant's arguments filed 07/18/2026 have been fully considered but they are not persuasive.
On page 7, 1st full paragraph Applicant asserts “O'Brien fails to teach or suggest creating multiple discrete ablation zones associated with individual pin electrodes and separated from each other by non-damaged tissue, as required by independent claim 1.” The examiner agrees with Applicant. Likewise beginning on page 7, last line through page 8, line 2 Applicant asserts “Sachs does not teach or suggest creating multiple discrete ablation zones created by individual pin electrodes, as required by independent claim 1.” Again, the examiner agrees with Applicant.
Next, beginning on page 8, 2nd and 3rd full paragraphs Applicant traverses the Official Notice rejection of "creating multiple ablation zones in a vicinity of each of said pin electrodes, each of said ablation zones being discrete zones separated from each other by non-damaged tissue", as recited in independent claim 1, is the easiest or first order way of accomplishing the method of O'Brien in view of Sachs to simply limit the regions of actual ablated tissue around each pin/needle electrode 700a-700f of O'Brien to regions centered about each pin/needle electrode 700a-700f of O'Brien that do not connect and are separated by non-ablated and non-damaged tissue.
As shown in the newly cited prior art Long I, the Official Notice rejection is proper and well supported since Long I teach ablating cervical tissue with non-overlapping ablation zones centered on/around the pin/needle electrodes.
Accordingly, Applicant’s arguments are not persuasive and this action is made FINAL.
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 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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over O'Brien et al. (U.S. Patent Application Publication 2022/0133401) in view of Sachs et al. (U.S. Patent Application Publication 2014/0039356) in further view of Long et al. (U.S. Patent 8,361,066) (wherein Long et al. is necessitated due to Applicant’s traversal of the Official Notice rationale).
Regarding claim 1, O'Brien et al. disclose a method of treating the cervix comprising:
inserting a hand piece (the distal end of the handpiece, i.e., "energy delivery body 108," see [0144] and figure 3A, and alternate/equivalent counterparts in other embodiments, e.g., figure l 9C) into a vaginal canal (see abstract, [0013 ]-[0014], and [0016]-[0017] and figures 4A-4B, 6D, 7B, 8B, 9B, and l0B for example), said hand piece comprising a plurality of pin electrodes ("probe elements 700a, 700b, 700c may function in a monopolar manner or in a bipolar manner between pairs of probe elements," see [0255] and figure l 9C);
applying said pin electrodes to the cervix surface (see "the energy delivery body 108 is positioned against squamous cells of the ectocervix," see [0 159] for example);
applying at least one pulse of radio-frequency (RF) energy to the plurality of pin electrodes (see [0255]-[0256], [0298], and [0306] for example).
O'Brien et al. fail to disclose is a single embodiment creating multiple ablation zones in a vicinity of each of said pin electrodes, each of said ablation zones being discrete zones separated from each other by non-damaged tissue.
However, O'Brien et al. disclose 1) in one embodiment creating multiple ablation zones in a vicinity of each of said pin electrodes (see [0253 ]-[025 5] and figure l 9C, each element 700a-700f creates its own local ablation zone (albeit even if the local ablation zone connect and combine to form one large ablation zone)), and 2) that it is undesirable to overlap treated tissue ( see [03 07]).
Like O'Brien et al., Sachs et al. disclose a multiple pin/needle electrode device used to ablate cervical tissue and teach providing the treatment area pattern with ablated tissue separated by non-ablated tissue in order to "ensure that an entirely ablate region does not present a risk of rupture immediately post treatment, or that scar tissue does not cause the bladder wall to become unduly rigid after once the ablated region fully heals," see [0099].
Therefore the examiner takes Official Notice of the recited "creating multiple ablation zones in a vicinity of each of said pin electrodes, each of said ablation zones being discrete zones separated from each other by non-damaged tissue" since the easiest or first order way of accomplishing the method of O'Brien et al. in view of Sachs et al. is to simply limit the regions of actual ablated tissue around each pin/needle electrode 700a-700f of O'Brien et al. to regions centered about each pin/needle electrode 700a-700f that do not connect and are separated by non-ablated and non-damaged tissue.
As noted above Applicant traversed the Official Notice rejection of providing unconnected, non-overlapping ablation zones centered around each pin/needle.
Like both O'Brien et al. and Sachs et al., Long et al. disclose a method and device for treating cervical tissue with ablation and teach treating the tissue with non-overlapping ablation zones (electrically and thermally necrosed tissue 63a and 63b, see col. 15:20-44 and figure 4) in order to provide a known and workable manner of providing non-overlapping ablation areas centered around pin/needle electrodes in order to ablate cervical tissue.
If applicant does not traverse the examiner's assertion of official notice or applicant's traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner's assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate," see MPEP 2144.03C.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of O'Brien et al., as taught by Sachs et al., to teach provide the treatment area pattern with ablated tissue separated by non-ablated tissue in order to "ensure that an entirely ablate region does not present a risk of rupture immediately post treatment, or that scar tissue does not cause the bladder wall to become unduly rigid after once the ablated region fully heals," and as is taken Official Notice of – and shown and taught by Long et al., to limit the regions of actual ablated tissue around each pin/needle electrode 700a-700f of O'Brien et al. to regions centered about each pin/needle electrode 700a-700fthat do not connect and are separated by non-ablated and nondamaged tissue.
Regarding claim 2, O'Brien et al. disclose the cervix surface is on an ectocervix and/or
an endocervix (see [0017], [0159], and [0162] for example).
Regarding claim 3, O'Brien et al. disclose the treatment 1 s used to treat cervical
interepithelial neoplasia and/or HPV (see abstract, and [0140] for example).
Regarding claim 4, O'Brien et al. disclose comprising rotating (see [0266]) said hand
piece around a rotation axis to treat the cervix surface uniformly (see the use of a uniform
distribution of elements 700a-700f, see [0255]-[0258]).
Regarding claim 5, O'Brien et al. disclose ablation zones have a depth between 0.1 mm
to 1 mm (see [0027]).
Regarding claim 6, O'Brien et al. disclose the RF energy is applied between said pin
electrodes (elements 700a-700f, see [0255]-[0258] and figure l 9C).
Regarding claim 7, O'Brien et al. disclose the RF energy is applied between at least one of said pin electrodes and a return electrode (see [0255] and [0259]).
Regarding claim 8, O'Brien et al. disclose the RF frequency is in a range of 100 kHz to
6 MHz (see [0169]).
Regarding claim 9, O'Brien et al. disclose the RF energy has a pulse width between 1
msec and 1 sec (see [0172]-[0l 73]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over O'Brien et al. (U.S. Patent Application Publication 2022/0133401) in view of Sachs et al. (U.S. Patent Application Publication 2014/0039356) in further view of Long et al. (U.S. Patent 8,361,066) (Long I) (wherein Long et al. is necessitated due to Applicant’s traversal of the Official Notice rationale) as applied to claim 1 above, and further in view of Long et al. (U.S. Patent Application Publication 2014/0052126) (Long II).
Regarding claim 10, O'Brien et al. in view of Sachs et al. in view of Long I (Official Notice) show the invention above,
but fail to explicitly recite diameter of each of said pin electrodes is in the range of 0.1 mm to 1 mm.
Like O'Brien et al., Sachs et al. and Long I, Long II disclose radio frequency device and method of treating the cervix and cancerous tissue with a device having multiple pin/needle electrodes and teach providing the pin/needle electrodes with diameters of 0.5 mm, 0.75 mm, or 1 mm in order to provide a known and workable diameter for treating cancerous cervical tissue (see [0055]).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of O'Brien et al. in view of Sachs et al. in view of Long I (Official Notice), as taught by Long II, to provide the pin/needle electrodes with diameters of 0.5 mm, 0.75 mm, or 1 mm in order to provide a known and workable diameter for treating cancerous cervical tissue.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over O'Brien et al. (U.S. Patent Application Publication 2022/0133401) in view of Sachs et al. (U.S. Patent Application Publication 2014/0039356) in further view of Long et al. (U.S. Patent 8,361,066) (Long I) (wherein Long et al. is necessitated due to Applicant’s traversal of the Official Notice rationale) as applied to claim 1 above, and further in view of Solomon et al. (U.S. Patent Application Publication 2017/0209695).
Regarding claim 11, O'Brien et al. in view of Sachs et al. in view of Long I (Official Notice) show the invention above,
but fail to explicitly recite per pin electrode is in a range from 10 mJ up to 1 J.
O'Brien et al., Sachs et al. and Long I, Solomon et al. disclose radio frequency device and method of treating the cervix and cancerous tissue with a device having multiple pin/needle electrodes and teach the "energy transmitted by each microneedle can be between 0.01-100 Joule/channel," (see [0106]), wherein each channel refers to channels formed in a body tissue - that is the pins/needles 700a-700f of O'Brien et al.) in order to provide a known and workable manner of treating cervical cancer.
So, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide each pin/needle with an energy range from 10 mJ up to 1 J, since 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 USPQ 233.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of O'Brien et al. in view of Sachs et al. in view of Long I (Official Notice), as taught by Solomon et al., to provide the "energy transmitted by each micro-needle can be between 0.01-100 Joule" per pin/needle, and as further taught by In re Aller, to provide each pin/needle with an energy range from 10 mJ up to 1 J, since 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.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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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.
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/AARON F ROANE/Primary Examiner, Art Unit 3792
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