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 .
Response to Amendment
The claim amendments dated 8/12/25 overcome the previous claim objections and 112(b) rejections.
Double Patenting
Claims 2-6, 8, 11 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7, 9, and 1, respectively, of U.S. Patent No. 11141216 [hereinafter “Patent”].
Although the claims at issue are not identical, they are not patentably distinct from each other because the differences in the claims are either (1) features which are in the patent but not claimed in the instant application (that is, the patent is narrower in scope than the claimed invention), or (2) minor grammatical differences which do not affect the scope of the claims.
Claim Interpretation
Claim 2 recites, as amended, “with the bi- polar pulse produced by the electric pulse generator sufficient to cause …RF-EMB…characterized by immediate destruction of cell membranes of cells of the soft tissue and immediate spillage of non-denatured intracellular components and antigens into an extracellular space”: this is functional language describing the use or result of the system. In an apparatus/system claim, functional language limits the apparatus insofar as it limits its structure; in this case, the examiner believes that the claim limitations make clear that this functional language imparts only the structural requirement that the system is capable of producing an RF frequency pulse. The limitation “the…pulse…is sufficient.” does not appear to limit the structure of the probe, needles, etc., but refer to field strength and pulse characteristics, so a device capable of achieving the claimed field strength and bi-polar pulse, now an RF pulse, as amended, assuming it is also capable of being applied to cells in the human body, would have sufficient structure to perform the claimed function.
New claims 25-28 are directed to the composition which a needle delivers. However, the composition itself is not a positively recited part of these claims: rather, the needle is “configured to administer” such a composition. The composition of the substance is not limiting of the structure of the needle, so long as the needle is capable of delivering some substance.
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.
Claim(s) 2, 9-11, 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arena et al. [US 2012/0109122 A1, hereinafter “Arena”] in view of Azure [US 2011/0015630 A1] and Hofmann [US Pat. 6120493].
Regarding claim 2, Arena discloses a system [“for ablating soft tissue in a living subject” comprises the intended use of the system and is not given further patentable weight], the system comprising:
an electric pulse generator [Annotated Fig. 12] configured to produce a bi-polar pulse [“bipolar pulses,” Par 0106];
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in which the electrode and electric pulse generator are configured to cause application, to the soft tissue, of an electric field in a range of 1,500 V/cm to 10,000 V/cm [Par. 0020],
wherein the system is configured to produce a radio frequency pulse [in the range of 250 kHz to 1 MHz, Par. 0035]
(“with the bi- polar pulse produced by the electric pulse generator sufficient to cause …RF-EMB…characterized by immediate destruction of cell membranes of cells of the soft tissue and immediate spillage of non-denatured intracellular components and antigens into an extracellular space”: this is the intended use of the above device. Due to its electrical field and bi-polar pulse, as well as its application to cells, the above device is capable of performing the claimed function; see claim interpretation above);
and a controller [microcontroller, Fig. 12] connected to the electric pulse generator and electrode.
Arena fails to disclose the needle configured to administer drugs, and while Arena discloses the possibility of a probe [Par. 0024], Arena does not explicitly disclose the structure of the probe/electrode.
Regarding the probe: Azure teaches, in the field of electric field delivery to cancer cells, a probe [272 and 274, Fig. 17] comprising an electrode [274] connected to an electric pulse generator [280]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Arena by using, for the electrode, a probe comprising an electrode as taught by Azure because this configuration allows the electrode to be introduced, via the probe, through the skin so that the electrodes are positioned at or within a target site [Azure Par. 0073].
Regarding the needles: Hofmann teaches, in an electroporation apparatus, one or more needles [“needle,” Col. 7 line 16] configured to administer one or more (“immunologic response enhancing”: since the drug itself is not positively recited, the type of drug used does not limit the structure of the needle) drugs intratumorally to the soft tissue [“a drug is administered directly into the tumor,” Col. 7 lines 11-15]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Arena by adding a needle configured to administer a drug intratumorally to the soft tissue as taught by Hofmann in order to improve the tumor treatment: the application of the electric field allows the drug to be more effective [Hofmann Col. 6 line 65-Col. 7 line 4].
[Note that Azure also teaches one or more needles configured to administer one or more drugs (“drug delivery needles,” Par 0068)]
Regarding claim 9, Azure teaches the probe as set forth above. Azure further teaches the probe is flexible [electrode 274 is flexible, Par. 0015]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Arena such that the probe is flexible in order to allow the probe to be used in locations with less hardened/dense tissue [Par. 0015] [As claimed above, the electrode is considered part of the probe].
Regarding claim 10, Azure teaches the probe as set forth above. Azure further teaches the probe is curved [electrode 274 is curved, Par. 0015/Fig. 17]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Arena such that the probe is curved in order to allow the electrodes to be deployed into a desired shape/for a particular application [As claimed above, the electrode is considered part of the probe].
Regarding claim 11, Arena discloses the electric pulse generator is configured to produce a bi-polar pulse characterized by an instant charge reversal between a positive and a negative polarity [Par. 0026; Fig. 15B, Par. 0115].
Re. claims 25-28: The modified Arena teaches the one or more needles are configured to administer a composition. As set forth with respect to claim 2 above: Hofmann teaches, in an electroporation apparatus, one or more needles [“needle,” Col. 7 line 16] configured to administer one or more (“immunologic response enhancing”: since the drug itself is not positively recited, the type of drug used does not limit the structure of the needle) drugs intratumorally to the soft tissue [“a drug is administered directly into the tumor,” Col. 7 lines 11-15]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Arena by adding a needle configured to administer a drug intratumorally to the soft tissue as taught by Hofmann in order to improve the tumor treatment: the application of the electric field allows the drug to be more effective [Hofmann Col. 6 line 65-Col. 7 line 4].
Regarding the specific composition or combination of substances administered, because the substance(s) are not a positively recited part of the claim, the needle(s) need only be capable of administering the claimed substances, which they are, structurally, as set forth above. See Claim Interpretation.
Claim(s) 3-4, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arena in view of Azure and Hofmann, as applied to claim 2 above, and further in view of Davalos [US Pat. 8814860].
Regarding claim 3, the modified Arena discloses the apparatus set forth above, but fails to detail the structure of the probe. However, Davalos teaches, in an electroporation device,
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a probe [Figs. 8A-B] comprises: a core electrode [Annotated Fig. 8A] comprising an electrically conductive material [Col 21 lines 8-9];
an outer electrode at least partially covering the core [Fig. 8A]; and
an insulating sheath [Fig 8A] comprising an electrically insulating material and disposed between the core electrode and the outer electrode [Col. 21 line 10. Note that a non-conducting material is an insulating material]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of the modified Arena to form the probe to include the electrode structure taught by Davalos in order to vary the length of insulating regions to fine tune electrical field generation based on the tumor size and shape [Davalos, Col 21, lines 13-26].
Regarding claim 4, Davalos further teaches the outer electrode is mounted on the insulating sheath [Figs. 8A-B], and in which the outer electrode and the insulating sheath are movable as a unit laterally relative to the core to enable adjustment of the lateral distance between a distal end of the core electrode and the outer electrode [“one or more of the alternating conducting 820 or non-conducting 830 elements is movable,” Col. 21 lines 20-25]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Arena such that the outer electrode and insulating sheath are movable as a unit relative to the core electrode in order to “configure the device to deliver a three-dimensional electrical killing field to suit the needs of the particular situation,” [Davalos Col. 21 lines 22-25].
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Regarding claim 8, the modified Arena discloses the apparatus set forth above, but fails to teach the claimed electrode structure. However, Davalos teaches : a first electrode disposed at a first location on an outer surface of the probe; and a second electrode disposed at a second location on the outer surface of the probe, in which the first location and the second location are separated along a length of the probe [see Annotated Fig. 8B].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Arena to include the first and second electrodes are disposed as set forth above in order to “configure the device to deliver a three-dimensional electrical killing field to suit the needs of the particular situation,” [Davalos Col. 21 lines 22-25]. Regarding the positive and negative polarities: Davalos further teaches that “alternating polarity of adjacent electrodes minimizes charge build up and provides a more uniform treatment zone,” [Col. 10 lines 37-39]. Since the above electrodes are adjacent, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Arena such that the polarity of the needle electrode is different than a polarity of the outer electrode in order to minimize charge buildup and provide a more uniform treatment zone. Note that in this case selecting the first electrode to be the positive and the second electrode to be the negative are arbitrary and that the first and second designations may be reversed if the opposite polarity is applied.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arena in view of Azure and Hofmann, as applied to claim 2 above, and further in view of Fruland et al. [US 2010/0049031 A1, hereinafter “Fruland”].
Regarding claim 5, the modified Arena discloses the apparatus set forth above, but fails to describe the claimed probe structure. However, Fruland teaches, in an electrical treatment device, a probe [720, Figs. 10A-B] having electrodes 722, the probe comprising a lumen [721] configured to receive a surgical tool [721, Fig. 10B. Note that the surgical tool itself is not a positively recited element of the claim]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Arena such that the probe has a lumen configured to receive a surgical tool as taught by Fruland in order to allow additional tools to be used with the system [such as a camera, in Fruland, or any other desired tool] while only penetrating the tissue once.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arena in view of Azure, Hofmann, and Fruland, as applied to claim 5 above, and further in view of Davalos.
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Regarding claim 6, the modified Arena discloses the apparatus set forth above, but fails to describe the claimed electrode/needle structure. However, Davalos teaches, in an electroporation device, the electrode comprises an outer electrode disposed on an outer surface of the probe [see Annotated Fig. 8B below],
and in which the system comprises: a needle [831] sized to fit within the lumen of said the probe, and a needle electrode disposed on a distal end of the needle [Annotated Fig. 8B]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Arena to include the electrode structure taught by Davalos “configure the device to deliver a three-dimensional electrical killing field to suit the needs of the particular situation,” [Davalos Col. 21 lines 22-25].
Regarding the polarity of the needle electrode being different than a polarity of the outer electrode: Davalos further teaches that “alternating polarity of adjacent electrodes minimizes charge build up and provides a more uniform treatment zone,” [Col. 10 lines 37-39. Note that in this case the middle electrode is disclosed as a ground electrode]. Since the above electrodes are adjacent, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Arena such that the polarity of the needle electrode is different than a polarity of the outer electrode in order to minimize charge buildup and provide a more uniform treatment zone.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arena in view of Azure and Hofmann, as applied to claim 2 above, and further in view of Demarais et al. [US 7620451 B2, hereinafter “Demarais”]
Regarding claim 7, the modified Arena discloses the apparatus set forth above, but fails to disclose the expandable balloon and stent. However, Demarais teaches, in a probe device for providing a pulsed electric field, the probe comprises an expandable balloon [410, Fig. 19A] and a stent [402]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Arena such that the probe comprises a balloon and stent as taught by Demarais because the balloon allows a stent to be deployed, and the stent allows the electrodes to be properly placed in the case where the device penetrates a vessel wall [Demarais Col. 19 lines 35-60].
Response to Arguments
Applicant's arguments filed 8/12/25 have been fully considered but they are not persuasive. Applicant argues that Arena’s invention (and those of the secondary references) refer to systems for electroporation, not RF-electrical membrane breakdown, and that Arena’s invention causes slow cell death, not immediate destruction of cell membranes. The examiner appreciates that the method of use of the claimed invention and that of Arena’s system differ. However, Applicant has not claimed any structural differences between the systems. How does a system which applies a field causing electrical membrane breakdown characterized by immediate cell destruction differ structurally from a system which produces slow cell death? In the specification, it appears that the EMB system applies higher energy levels than the IRE system (Par. 0078) and specific pulse intervals (Par. 0132). Is the system of Arena incapable of producing these energy levels or intervals? A different method of use does not impart patentability to a system claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771