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 .
Continued examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/23/26 has been entered.
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 Objections
Claim(s) 2 is/are objected to because of the following informalities:
Claim 2 recites “to apply, to the soft tissue, of an electric field in a range.” This should be “to apply, to the soft tissue, an electric field in a range.”
Appropriate correction is required.
Claim Interpretation
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, 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenbach et al. [US 2009/0125091 A1, hereinafter “Schoenbach,” newly cited] in view of Hofmann [US Pat. 6120493].
Regarding claim 2, Schoenbach discloses a system [Par. 0001] for ablating soft tissue in a living subject [intended use, not given further patentable weight], the system comprising:
an electric pulse generator [“pulse generator,” Par. 0034, 0140] configured to produce a bi-polar pulse [Par. 0010];
a probe [antenna, Par. 0044; see e.g. Fig. 14] comprising an electrode [Par. 0044] connected to said electric pulse generator [Par. 0074];
a controller [“microcontroller,” Par. 0140] connected to the electric pulse generator and probe and configured to cause the probe and electric pulse generator to apply, to the soft tissue,
an electric field in a range of 1,500 V/cm to 10,000 V/cm [10,000 V/cm to 300,000 V/cm, Par. 0062. This overlaps with the claimed range as both recite 10,000 V/cm. In 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)].
that, with the bi-polar pulse produced by the electric pulse generator [Par. 0010], causes cell destruction [Par. 0133].
Regarding the pulse being sufficient to cause radio frequency electrical membrane breakdown (RF-EMB), in which RF-EMB is 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—Schoenbach discloses, like the instant application, a probe producing an electric field of 10 kV/cm with a bipolar pulse and short pulse duration (“The EMB protocol calls for a series of short and intense bi-polar electric pulses delivered from the pulse generator through one or more EMB treatment probes 20 inserted directly into, or placed around the target tissue 2,” Par. 0128, instant application) which does not operate by thermal techniques or electroporation. Thus, although Schoenbach does not recognize the mechanism of cell destruction being RF-EMB, the controller operates the apparatus in the same manner. The examiner holds that the above system would inherently perform the claimed function. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Schoenbach is silent regarding a needle configured to administer one or more immunologic response enhancing drugs intratumorally to the soft tissue. However, Hofmann teaches, in a cancer treatment system, 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 Schoenbach 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].
Re. claims 25-28: The modified Schoenbach teaches the one or more needles are configured to administer a composition [Hofmann teaches this as set forth above]. 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 Shoenbach 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) 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]; comprising an electrode connected to said electric pulse generator [Annotated Fig. 12],
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and a controller [microcontroller, Fig. 12] connected to the electric pulse generator and
electrode and configured to cause the electrode and electric pulse generator to apply, 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]
Regarding the limitation "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 result of the above-recited controller’s operation. The controller of Arena operates to apply a same strength electrical field and bi-polar pulse(s) of short duration to cancer cells, as in the instant application. Thus, although Arena does not recognize the mechanism of RF-EMB, the above device is capable of achieving the claimed result.
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 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 [Hofmann teaches this as set forth above]. 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 Schoenbach in view of Hofmann, or 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 Schoenbach/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 Schoenbach/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 Schoenbach/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 Schoenbach/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 Schoenbach/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 Schoenbach/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 Schoenbach in view of Hofmann, or 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 Schoenbach/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 Schoenbach/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 Schoenbach in view of Hofmann and Fruland, or Arena in view of Azure and Hofmann and Fruland, as applied to claim 5 above, and further in view of Davalos.
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Regarding claim 6, the modified Schoenbach/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 Schoenbach/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 Schoenbach/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 Schoenbach in view of Hofmann, or 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 Schoenbach/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 Schoenbach/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].
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenbach in view of Hofmann, or Arena in view of Azure and Hofmann, as applied to claim 2, and further in view of Azure [US 2011/0015630 A1].
Regarding claim 9, Schoenbach/Arena fails to teach the probe being flexible. Azure teaches a probe [272 and 274, Fig. 17] comprising an electrode [274] connected to an electric pulse generator [280]. 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 Schoenbach/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, Schoenbach/Arena fails to teach the probe being curved. Azure teaches a probe which 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 Schoenbach/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].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schoenbach in view of Hofmann, as applied to claim 2, and further in view of Arena et al. [US 2012/0109122 A1, hereinafter “Arena”].
Regarding claim 11, the modified Schoenbach discloses the system set forth above but it is unclear whether the charge reversal is instant or not. 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]. 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 Schoenbach such that charge reversal is instant as taught by Arena because Arena teaches that this amounts to a simple substitution of one type of charge reversal [immediate] for another [non-immediate] with predictable results [both Figs 15B and C are taught as being suitable, Par. 0115].
Response to Arguments
Applicant's arguments filed 4/23/26 have been fully considered but they are not persuasive.
Applicant argues that the various references fail to teach the claimed controller. However, the limitation “a controller…configured to cause the probe and…pulse generator to apply…an electric field in a range of 1,500 V/cm to 10,000 V/cm …with the bi-polar pulse produced by the electric pulse generator” is found to be taught at least by the above combination of references.
Similarly to previous findings, the examiner finds that Applicant uses functional language precisely at the point of novelty, as the intended result [RF-EMB] of the operation of the device rather than in any specific structure including a programmed step of operation of the controller. As indicated in past and current office actions, the structure of the device, including the claimed field strength and bipolar pulse, etc. is known in the art in one or another reference [see e.g. Schoenbach and Hofmann or Arena in view of Azure and Hofmann as set forth above].
Schoenbach in particular explicitly states that the method of cell disruption is rapid [Par. 0151] and operates by a mechanism which is “unclear” [Par. 0151] but excludes electroporation [Par. 0006] and thermal effects [Par. 0007]. Given that Schoenbach also teaches a probe producing an electric field of 10 kV/cm with a bipolar pulse and short pulse duration (“The EMB protocol calls for a series of short and intense bi-polar electric pulses delivered from the pulse generator through one or more EMB treatment probes 20 inserted directly into, or placed around the target tissue 2,” Par. 0128, instant application), the examiner finds that the apparatus of Schoenbach would inherently produce the claimed intended result. As noted above, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Applicant is requested to recite specific structure (which may include a programming or configuration of the controller itself) which causes the RF-EMB beyond what is taught by either Schoenbach or Arena. For example, need the device operate at a specific frequency or with a specific pulse duration which is different from Schoenbach, Arena, or one of the above-cited references? For example, Par. 00132 of the specification may provide “structure” (including programming/configuration of the controller to perform a step) which could be added to the independent claim to distinguish over Schoenbach or Arena.
Applicant is invited to contact the examiner to request an interview to discuss the above.
Conclusion
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-Th 9 am to 3 pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACKIE HO can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
Prosecution Insights