DETAILED ACTION
The following is a non-final Office action (“Action”) in response to the reissue application filed Oct. 6, 2023 from U.S. Patent No. 11,278,349 (“the ‘349 patent”), which issued from U.S. patent application no. 14/930,048 (“the ’048 application”). Claims 1-9 were originally patented in the ‘349 patent and amended in an amendment filed Oct. 6, 2023 in this reissue.
Notice of Pre-AIA or AIA Status
The ‘349 patent has an effective filing date of July 29, 2011, which is prior to March 16, 2013, thus, examination of this reissue application will be conducted using the pre-AIA first to invent provisions. All references to sections 102 and 103 of U.S.C. title 35 in this Order are pre-AIA unless otherwise stated.
While the examination of the current reissue application falls under the pre-AIA first to invent provisions due to the effective filing date of the ‘349 patent, the filing date of this reissue application is on or after September 16, 2012, which subjects this application to the reissue rule changes enacted under the Leahy-Smith American Invents Act (“AIA ”). See Federal Register, Vol. 77, No. 157, pg. 48820, August 16, 2012. As a result, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.75, and 3.73 are to the current provisions enacted under the AIA . See id.
Information Disclosure Statement
The information disclosure statements (“IDSs”) submitted on 10/6/2023, 10/11/2023, 2/6/2024, 4/16/2024, 8/7/2024, 10/16/2024, 12/13/2024, 3/21/2025, and 5/22/2025 are in compliance with the provisions of 37 C.F.R. §§ 1.97 and 1.98 and have been considered, except that the NPL cite #1 (European Patent Office Search Report for Appl. No. 19218891.01 dated June 19, 2023 (13 pages)) on the IDS filed 10/11/2023 is lined through because there has been no copy provided in this reissue application or any parent application.
Prosecution History Summary of the ‘349 Patent
U.S. non-provisional patent application no. 14/930,048 (“the ‘048 application”) was filed on Nov. 2, 2015.
After several rounds of Office actions and Responses, a final Office action was mailed on Nov. 27, 2019 in which claims 1, 3-6, 8, 9, 13, and 14 (not the same numbering as in the ‘349 patent) were rejected as unpatentable under section 103(a) over Francischelli1 in view of Swanson2.
On Feb. 27, 2020, Applicant filed a Notice of Appeal, and on April 24, 2020 an Appeal Brief was filed appealing all of the rejections in the final Office action.
On Oct. 27, 2021, the Patent Trial and Appeal Board (“Board”) reversed all the rejections in a Decision (“Board Dec.”) finding that: (1) “[t]he Examiner has not shown by a preponderance of the evidence that the pulse generator of Francischelli would have the programming or structure needed to meet the claim limitation,” that is “a treatment energy source configured to,” which was interpreted by the Board such that “the treatment energy source is programmed to deliver the biphasic electroporation pulses having the recited pulse width”; (see Board Dec. 4-5); and (2) the 37 C.F.R. § 1.132 declaration filed by inventor Mark T. Stewart (“’048 Stewart Decl.”) was persuasive to show unexpected results and show the claims are not obvious over Francischelli and Swanson (Board Dec. 6-9).
On Nov. 15, 2021, a Notice of Allowance was mailed allowing claims 1, 3-6, 8, 9, 13, and 14, renumbered to claims 1-9, respectively, of the ‘349 patent, based on the Board’s reversal.
Claim Interpretation
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in this Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. These claim limitations are:
In claim 1, “a treatment energy source being configured to: deliver … electroporation pulses.”
The term “treatment energy source” is not a known structure in the art and there is no other structure further limiting the “treatment energy source,” and is thus, a generic placeholder. Also, “configured to” is a transitional phrase and “deliver … electroporation pulses” is the associated function.
In claim 6, “a treatment energy source configured to deliver electroporation energy.”
The term “treatment energy source” is not a known structure in the art and there is no other structure further limiting the “treatment energy source,” and is thus, a generic placeholder. Also, “configured to” is a transitional phrase and “deliver electroporation energy” is the associated function.
Because these claim limitations are being interpreted under pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The specification of the ‘349 patent describes at column 7, lines 57-61, “The treatment energy source 54 may include an electrical current or pulse generator having a plurality of output channels, with each channel coupled to an individual electrode or electrically conductive portion 24 of the medical device 12,”; at column 8, lines 25-26, the “treatment energy source 54 may be configured and programmed,”; and at column 9, lines 34-39, “the treatment energy source 54 may include one or more controllers, processors, and/or software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein.” In other words, the “treatment energy source configured to” deliver electroporation pulses/energy is interpreted as having, in any combination, “an electrical current or pulse generator” and “one or more controllers, processors, and/or software modules containing instructions or algorithms to provide for the automated operation and performance of” the “treatment energy source.”
If applicant does not intend to have these limitations interpreted under pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under pre-AIA 35 U.S.C. 112, sixth paragraph.
Examiner Note on Francischelli
It is acknowledged the Board in their reversal Decision in the underlying prosecution requires “a treatment energy source being configured to” carry out various functions as recited in independent claims 1 and 6 to mean a “treatment energy source” that is programmed (with software) to carry out the subsequent functions recited in the claims, and the Board was not convinced the Examiner showed the pulse generator in Francischelli discloses this limitation. See Board Dec. 4-5. Initially, while not specifically mentioned in the Board Dec., it appears the Board was interpreting “a treatment energy source configured to” carry out the recited functions under 35 U.S.C. § 112, sixth paragraph (i.e., “means plus function”), since they were reading the corresponding structural limitations from the specification of the ‘048 application into the interpretation of the claim limitation, which is generally not done in a standard broadest reasonable interpretation analysis. Compare MPEP § 2181 with MPEP § 2111.01, subsection II. Regardless, this limitation is considered to invoke section 112, sixth paragraph, as explained above.
Additionally, while the Board found that the Examiner did not show sufficient evidence that Francischelli teaches the pulse generator to be programmed with software to deliver the described pulses, and carry out other functions, Francischelli is understood to disclose “the pulse generator 22 can include … a controller/software (e.g., LabVIEW software) that permits user selection of various pulse parameters such as pulse width, interval, number of pulses, and burst frequency,” and “a controller 34 (e.g., a computer loaded with Lab VIEW software) permits selection of burst pulses in various frequencies on the function generator 30. With this construction, the pulse generator 22' is capable of delivering a wide range of burst pulses (e.g., minimum pulse width of 1μs and inter-pulse interval of 10μs both in monophasic and biphasic modes).” Francischelli, ¶29. Despite this, and consistent with the Board Dec., Francischelli is not used as a primary reference in the rejections below, and is instead, relied upon for various specific teachings that may be missing from the newly applied primary references.
The Stewart 37 C.F.R. § 1.132 Declarations
As explained above, during the examination of the ‘048 application, the ‘048 Stewart Decl. was filed and was found convincing by the Board to show the claims as being non-obvious over the cited and applied art. However, in this reissue application, Applicant has explained in a new and “updated” section 1.132 declaration by inventor Mark T. Stewart (“New Stewart Decl.”) that the ‘048 Stewart Decl. was filed by mistake. In particular, in paragraph 13 of the New Stewart Decl., it is explained that the “’048 Application Declaration mistakenly stated that the research activities performed in 2015 to 2016 led to the inventions described in the ‘048 Application when in actuality such research activities in 2016 and 2016 led to the inventions described in the [15/228,406 U.S. non-provisional patent] Application” filed Aug. 4, 2016 (now issued U.S. patent no. 10,531,914). As such, the range of pulse widths at issue in the ‘048 Stewart Decl. have been amended in this reissue application from “between 3 μs and 5 μs” to “5 μs”. Therefore, based on the New Stewart Decl., the range “between 3 μs and 5 μs” is no longer considered critical, as the Board determined, nor is the specific value of “5 μs” considered to show unexpected results, as the Board also determined, because the “research activities” that led to this conclusion by the Board in the ‘048 Application were not and are no longer relevant to the invention of the ‘349 patent.
Drawings
The drawings are objected to for the following reasons:
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “58” has been used to designate multiple components, such as “other secondary electrically conductive tool,” “instrument,” and “treatment energy source.” See ‘349 Pat. 8:44-52, 10:15-22.
Applicant is requested to review the drawings and specification for compliance with 37 CFR 1.84(p).
Corrected drawing sheets in compliance with 37 CFR 1.173(b)(3) are required in reply to the Office action to avoid abandonment of the application. Amendments in reissue applications are different from standard utility application practice and are governed by 37 CFR 1.173. In particular, 37 CFR 1.173(b)(3) reads, with emphasis:
Drawings. One or more patent drawings shall be amended in the following manner: Any changes to a patent drawing must be submitted as a replacement sheet of drawings which shall be an attachment to the amendment document. Any replacement sheet of drawings must be in compliance with § 1.84 and shall include all of the figures appearing on the original version of the sheet, even if only one figure is amended. Amended figures must be identified as "Amended," and any added figure must be identified as "New." In the event that a figure is canceled, the figure must be surrounded by brackets and identified as "Canceled." All changes to the drawing(s) shall be explained, in detail, beginning on a separate sheet accompanying the papers including the amendment to the drawings.
(i) A marked-up copy of any amended drawing figure, including annotations indicating the changes made, may be included. The marked-up copy must be clearly labeled as "Annotated Marked-up Drawings" and must be presented in the amendment or remarks section that explains the change to the drawings.
(ii) A marked-up copy of any amended drawing figure, including annotations indicating the changes made, must be provided when required by the examiner.
The objection to the drawings will not be held in abeyance. See also MPEP 1453.
Objection – Reissue Declaration
The reissue declaration filed with this application is defective for the following reasons. See 37 CFR 1.175 and MPEP § 1414.
The reissue declaration is of very poor quality and illegible in parts. For example, the listed patent number, grant date, and title at the top of the form are illegible.
All three boxes indicating the reasons for filing the reissue are checked. While there is an amendment to the specification and a narrowing claim amendment related to the updated 37 C.F.R. § 1.132 declaration, it is not entirely clear what “other errors” are being corrected.
For the reasons above, the reissue declaration is objected to. A new declaration correcting the above issues must be filed. Applicant is also reminded to check the appropriate “specification” box at the top of the form.
Claim Rejections - 35 USC § 251
The following is a quotation of 35 U.S.C. 251 that form the basis for the rejections under this section made in this Office action:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
(b) MULTIPLE REISSUED PATENTS.— The Director may issue several reissued patents for distinct and separate parts of the thing patented, upon demand of the applicant, and upon payment of the required fee for a reissue for each of such reissued patents.
(c) APPLICABILITY OF THIS TITLE.— The provisions of this title relating to applications for patent shall be applicable to applications for reissue of a patent, except that application for reissue may be made and sworn to by the assignee of the entire interest if the application does not seek to enlarge the scope of the claims of the original patent or the application for the original patent was filed by the assignee of the entire interest.
(d) REISSUE PATENT ENLARGING SCOPE OF CLAIMS.—No reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent.
Claims 1-9 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 for the reasons set forth above. See 37 C.F.R. § 1.175.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The factual inquiries3 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
The following applies to all rejections below, absent any discussion elaborating on any of the elements. Regarding element 1, the scope and contents of the prior art are evident based on the citations and explanations provided in the rejections below. See MPEP § 2141(II)(A). Regarding element 2, the differences between the prior art and claims are noted in the rejections below. See MPEP § 2141(II)(B). Regarding element 3, the level of ordinary skill is expressly or implicitly found in the prior art of record as applied in the rejections below, where the teachings of the art show a presumed knowledge of the relevant art at the relevant time. See MPEP §§ 2141(II)(C), 2141.03(III). Regarding element 4, to the extent that there is evidence available as to secondary considerations, they will be addressed below, otherwise, it is assumed there are no secondary considerations to take into account.
Claims 1-5 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Long4 in view of Francischelli, both of which are in the same field of electromagnetic pulse treatments, as the claimed invention.
Independent Claim 1
Claim 1 recites and Long discloses:
An electrosurgical system (Long, ¶¶3, 44, Fig. 1 shows “an electrical ablation system”), comprising:
a treatment energy source (Long, ¶44, Fig. 1, energy source 14 can include “an electrical waveform generator”) being configured to:
deliver at least one train of … biphasic electroporation pulses, … each of the … biphasic electroporation pulses of each of the at least one train of … biphasic electroporation pulses having a pulse width of 5 μs, and delivery of the electroporation energy at an output voltage that is between 800 and 2000 volts (Long, ¶77, Fig. 9, the first and second biphasic trains have pulses with widths between 1 μs and 100ms, which includes the 5 μs claimed width, and be based on an output voltage in the range of 100 V to 10,000 V, which includes the 800 to 2,000 V claimed range).
Long does not necessarily disclose all of the details of the claimed “train” as are recited in the claim. Even so, Francischelli remedies this and teaches a “train of 10 to 60 pulses,” (Francischelli, ¶31, “[e]ach train can consist of 10 to 60 biphasic (i.e., half positive phase and half negative phase) pulses”) and “each of the at least one train of … biphasic electroporation pulses lasting at most approximately 50 milliseconds,” (Francischelli, ¶31, “each train or train segment 52 comprised of 40 pulses over 8 milliseconds”). While Long discloses the following limitations, Francischelli is also considered to teach “a treatment energy source,” (Francischelli, ¶¶29-31, Figs 1, 2, pulse generator 22 and 22’ (not labeled), where each pulse generator is controlled by programmed processors (i.e., software executed on a computer)), and “a pulse width of 5 μs,” (Francischelli, ¶31, “5-200 microseconds in width”).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the electromagnetic pulse treatment of Long with the more specific number of pulses in a train and duration of a train, as in Francischelli, to apply an effective electroporation ablation of cardiac tissue based on “one or more characteristics of the cardiac tissue target site (e.g., tissue type (such as fatty tissue, thickness, cell orientation, naturally-occurring electrical activity, etc.)),” and as such, by “reliably deliver[ing electroporation ablation pulses of] high voltage.” See Francischelli, ¶¶28, 29, 35.
It is noted that neither Long nor Francischelli necessarily disclose the described ranges in a single embodiment. However, both references teach systems that may operate in the described ranges, as explained above. As a result, since the claimed ranges lie within the disclosed ranges of Long and Francischelli, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Dependent Claim 2
Claim 2, which depends from claim 1, recites and Long in view of Francischelli make obvious the “electrosurgical system of claim 1,” as explained above. Long further discloses “the output voltage is between 800 and 1000 volts,” as recited in claim 2. Long, ¶77, the first and second biphasic trains have pulses based on an output voltage in the range of 100 V to 10,000 V, which includes the 800 to 1,000 V claimed range. Long does not necessarily disclose the remaining limitations. Even so, Francischelli remedies this and teaches that the pulses may be generated “at a current in a range of between 8 and 25 Amps,” as recited in claim 2. Francischelli, ¶31, “an output voltage from the pulse generator 22 … at currents in the range of 8-25 Amps.
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the electromagnetic pulse treatment of Long with the operating current, as in Francischelli, to apply an effective electroporation ablation of cardiac tissue based on “one or more characteristics of the cardiac tissue target site (e.g., tissue type (such as fatty tissue, thickness, cell orientation, naturally-occurring electrical activity, etc.)),” and as such, by “reliably deliver[ing electroporation ablation pulses of] high voltage.” See Francischelli, ¶¶28, 29, 35.
It is noted that neither Long nor Francischelli necessarily disclose the described ranges in a single embodiment. However, both references teach systems that may operate in the described ranges, as explained above. As a result, since the claimed ranges lie within the disclosed ranges of Long and Francischelli, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Dependent Claim 3
Claim 3, which depends from claim 1, recites and Long in view of Francischelli make obvious the “electrosurgical system of claim 1,” as explained above. Francischelli further teaches “each of the at least one train of 10 to 60 biphasic electroporation pulses includes 40 biphasic electroporation pulses and lasts 8 milliseconds,” as recited in claim 3. Francischelli, ¶31, “[e]ach train can consist of 10 to 60 biphasic (i.e., half positive phase and half negative phase) pulses,” which includes 40 pulses, and “each train or train segment 52 comprised of 40 pulses over 8 milliseconds.” It would have been obvious to one of ordinary skill in the art at the time of invention to modify the electromagnetic pulse treatment of Long with the 40 pulses over 8 milliseconds, as in Francischelli, to apply an effective electroporation ablation of cardiac tissue based on “one or more characteristics of the cardiac tissue target site (e.g., tissue type (such as fatty tissue, thickness, cell orientation, naturally-occurring electrical activity, etc.)),” and as such, by “reliably deliver[ing electroporation ablation pulses of] high voltage.” See Francischelli, ¶¶28, 29, 35.
It is noted that neither Long nor Francischelli necessarily disclose the described ranges in a single embodiment. However, both references teach systems that may operate in the described ranges, as explained above. As a result, since the claimed ranges lie within the disclosed ranges of Long and Francischelli, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Dependent Claim 4
Claim 4, which depends from claim 3, recites and Long in view of Francischelli make obvious the “electrosurgical system of claim 3,” as explained above. Francischelli further teaches “each of the 40 biphasic electroporation pulses has an inter-pulse interval of 20 μs,” as further recited in claim 4. Francischelli, ¶¶29, 31, there is a minimum value of 10 μs for an inter-pulse interval and upwards of 400 μs, where 20 μs lies in between these values.
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the electromagnetic pulse treatment of Long with the claimed inter-pulse interval, as in Francischelli, to apply an effective electroporation ablation of cardiac tissue based on “one or more characteristics of the cardiac tissue target site (e.g., tissue type (such as fatty tissue, thickness, cell orientation, naturally-occurring electrical activity, etc.)),” and as such, by “reliably deliver[ing electroporation ablation pulses of] high voltage.” See Francischelli, ¶¶28, 29, 35.
It is noted that neither Long nor Francischelli necessarily disclose the described ranges in a single embodiment. However, both references teach systems that may operate in the described ranges, as explained above. As a result, since the claimed ranges lie within the disclosed ranges of Long and Francischelli, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Dependent Claim 5
Claim 5, which depends from claim 1, recites and Long in view of Francischelli make obvious the “electrosurgical system of claim 1,” as explained above. Long further discloses “the output voltage is between 800 and 1000 volts.” Long, ¶77, the first and second biphasic trains have pulses based on an output voltage in the range of 100 V to 10,000 V, which includes the 800 to 1,000 V claimed range. It is noted that neither Long nor Francischelli necessarily disclose the described ranges in a single embodiment. However, both references teach systems that may operate in the described ranges, as explained above. As a result, since the claimed ranges lie within the disclosed ranges of Long and Francischelli, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Claims 1, 2, and 5-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Neal5, which is in the same field of electromagnetic pulse treatments, as the claimed invention.
Independent Claim 1
Claim 1 recites and Neal teaches:
An electrosurgical system (Neal, ¶140, Fig. 5 shows “electrical circuit for an electroporation system”), comprising:
a treatment energy source (Neal, ¶140, Fig. 5, pulse generation circuit 72 generates pulses at the control of controller 71, which may be controlled by computer 40 as shown in Figs. 7, 8, and as described in ¶¶158, 160 is programmed to carry out the described functions) being configured to:
deliver at least one train of 10 to 60 biphasic electroporation pulses, each of the at least one train of 10 to 60 biphasic electroporation pulses lasting at most approximately 50 milliseconds, each of the 10 to 60 biphasic electroporation pulses of each of the at least one train of 10 to 60 biphasic electroporation pulses having a pulse width of 5 μs (Neal, ¶¶110-111, various ranges of the number of biphasic pulses and pulse widths are disclosed, including ranges covering 10-60 pulses with each pulse having a width of 5 μs, where 10 to 60 pulses at 5 μs is not more than a 50 millisecond interval), and delivery of the electroporation energy at an output voltage that is between 800 and 2000 volts (Neal, ¶¶110, 112, the amperage includes 25 Amps and the voltage range includes 800 to 2000 volts).
It is noted that Neal does not necessarily disclose the described ranges in a single embodiment. However, Neal does disclose that the overall system may operate in the described ranges, as explained above. As such, Neal is able to achieve the advantages of “targeting only the diseased portions of the vascular structure.” See Neal, ¶15. As a result, since the claimed ranges lie within the disclosed ranges of Neal, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Dependent Claim 2
Claim 2, which depends from claim 1, recites and Neal further discloses the “electrosurgical system of claim 1, wherein the output voltage is between 800 and 1000 volts at a current in a range of between 8 and 25 Amps,” as recited in claim 2. Neal, ¶110. It is noted that Neal does not necessarily disclose the described ranges in a single embodiment. However, Neal does disclose that the overall system may operate in the described ranges, as explained above. As such, Neal is able to achieve the advantages of “targeting only the diseased portions of the vascular structure.” See Neal, ¶15. As a result, since the claimed ranges lie within the disclosed ranges of Neal, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Dependent Claim 5
Claim 5, which depends from claim 1, recites and Neal further discloses “electrosurgical system of claim 1, wherein the output voltage is between 800 and 1000 volts.” Neal, ¶¶110, 112, the amperage includes 25 Amps and the voltage range includes 800 to 2000 volts. It is noted that Neal does not necessarily disclose the described ranges in a single embodiment. However, Neal does disclose that the overall system may operate in the described ranges, as explained above. As such, Neal is able to achieve the advantages of “targeting only the diseased portions of the vascular structure.” See Neal, ¶15. As a result, since the claimed ranges lie within the disclosed ranges of Neal, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Independent Claim 6
Claim 6 recites and Neal teaches:
An electrosurgical system (Neal, ¶140, Fig. 5 shows “electrical circuit for an electroporation system”), comprising:
a treatment energy source configured to deliver electroporation energy (Neal, ¶140, Fig. 5, pulse generation circuit 72 generates pulses (“electroporation energy”) at the control of controller 71, which may be controlled by computer 40 as shown in Figs. 7, 8, and as described in ¶¶158, 160 is programmed to carry out the described functions), the electroporation energy:
including at least one train of 10-60 biphasic electroporation pulses, each of the at least one train of 10-60 biphasic electroporation pulses lasting at most approximately 50 milliseconds, each of the 10 to 60 biphasic electroporation pulses of each of the at least one train of 10 to 60 biphasic electroporation pulses having a pulse width of 5 μs (Neal, ¶¶110-111, various ranges of the number of biphasic pulses and pulse widths are disclosed, including ranges covering 10-60 pulses with each pulse having a width of 5 μs, where 10 pulses at 5 μs is a 50 millisecond interval); and
including a cycle length of approximately 800 μs (Neal, ¶110, “a pulse length in the range of about 1 μs to 1 ms; a number of pulses ranging from 1 to 10,000,” where if there is a 5 μs pulse width and 160 pulses, that is an 800 μs cycle),
the treatment energy source being further configured to deliver the electroporation energy at an output voltage that is between 800 and 2000 volts at a current in a range of between approximately 8 and approximately 25 Amps (Neal, ¶¶110, 112, the amperage includes 25 Amps and the voltage range includes 800 to 2000 volts)
It is noted that Neal does not necessarily disclose the described ranges in a single embodiment. However, Neal does disclose that the overall system may operate in the described ranges, as explained above. As such, Neal is able to achieve the advantages of “targeting only the diseased portions of the vascular structure.” See Neal, ¶15. As a result, since the claimed ranges lie within the disclosed ranges of Neal, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Dependent Claim 7
Claim 7, which depends from claim 6, recites and Neal further discloses the “electrosurgical system of claim 6, further comprising a medical device including a plurality of electrodes in electrical communication with the treatment energy source.” Neal, ¶110, “from 1-20 electrodes and/or electrically conductive wires.”
Dependent Claim 8
Claim 8, which depends from claim 7, recites and Neal further discloses the “electrosurgical system of claim 7, wherein each of the plurality of electrodes includes an electrically conductive surface and an electrically insulated surface.” Neal, ¶91, “electrodes according to embodiments of the invention are shown in FIGS. 1A-E. More particularly, as shown in FIGS. 1A-B, some of the components of the electrode device include a guidewire, tip, outer body, connector, balloon, and partially insulated conducting wires.” Figs. 1A-E, at least the “exposed electrode wire” is conductive and is covered by insulation.
Claims 3, 4, and 9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Neal in view of Francischelli, both of which are in the same field of electromagnetic pulse treatments, as the claimed invention.
Dependent Claim 3
Claim 3, which depends from claim 1, recites and Neal makes obvious the “electrosurgical system of claim 1,” as explained above. Francischelli further teaches “each of the at least one train of 10 to 60 biphasic electroporation pulses includes 40 biphasic electroporation pulses and lasts 8 milliseconds,” as recited in claim 3. Francischelli, ¶31, “[e]ach train can consist of 10 to 60 biphasic (i.e., half positive phase and half negative phase) pulses,” which includes 40 pulses, and “each train or train segment 52 comprised of 40 pulses over 8 milliseconds.” It would have been obvious to one of ordinary skill in the art at the time of invention to modify the electromagnetic pulse treatment of Neal with the 40 pulses over 8 milliseconds, as in Francischelli, to apply an effective electroporation ablation of cardiac tissue based on “one or more characteristics of the cardiac tissue target site (e.g., tissue type (such as fatty tissue, thickness, cell orientation, naturally-occurring electrical activity, etc.)),” and as such, by “reliably deliver[ing electroporation ablation pulses of] high voltage.” See Francischelli, ¶¶28, 29, 35.
It is noted that Neal does not necessarily disclose the described ranges in a single embodiment. However, Neal does disclose that the overall system may operate in the described ranges, as explained above. As such, Neal is able to achieve the advantages of “targeting only the diseased portions of the vascular structure.” See Neal, ¶15. As a result, since the claimed ranges lie within the disclosed ranges of Neal, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Dependent Claims 4 and 9
Claim 4, which depends from claim 3, and claim 9, which depends from claim 6, recites and Neal makes obvious the “electrosurgical system of claim 3” and the “electrosurgical system of claim 6,” as explained above. Francischelli further teaches “each of the 40 biphasic electroporation pulses has an inter-pulse interval of 20 μs,” as further recited in claim 4, and “each of the 10 to 60 biphasic electroporation pulses has an inter-pulse interval of 20 μs,” as recited in claim 6. Francischelli, ¶¶29, 31, there is a minimum value of 10 μs for an inter-pulse interval and upwards of 400 μs, where 20 μs lies in between these values. It would have been obvious to one of ordinary skill in the art at the time of invention to modify the electromagnetic pulse treatment of Neal with the claimed inter-pulse interval, as in Francischelli, to apply an effective electroporation ablation of cardiac tissue based on “one or more characteristics of the cardiac tissue target site (e.g., tissue type (such as fatty tissue, thickness, cell orientation, naturally-occurring electrical activity, etc.)),” and as such, by “reliably deliver[ing electroporation ablation pulses of] high voltage.” See Francischelli, ¶¶28, 29, 35.
It is noted that Neal does not necessarily disclose the described ranges in a single embodiment. However, Neal does disclose that the overall system may operate in the described ranges, as explained above. As such, Neal is able to achieve the advantages of “targeting only the diseased portions of the vascular structure.” See Neal, ¶15. As a result, since the claimed ranges lie within the disclosed ranges of Neal, they would have been obvious to one of ordinary skill in the art at the time of invention. See MPEP § 2144.05, subsection I, for discussion on claimed ranges that lie inside a range disclosed in the prior art; see also In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003), “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.”
Applicant Obligations
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 11,278,349 is or was involved. These proceedings would include interferences, reissues, reexaminations, post-grant proceedings before the Patent Trial and Appeal Board, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Amendments in Reissue Applications
Amendments made during examination of a reissue application are different than amendments made during examination of a standard utility application. See 37 CFR § 1.173; see also MPEP § 1453.
A few notable, but by no means the only, differences are:
Throughout examination of a reissue application, amendments are always with respect to the original patent regardless of any amendments that have already been filed. See 37 CFR § 1.173(g).
Deleted limitations must be shown in single brackets while newly added limitations and the entirety of newly added claims are underlined, including number and status identifier. See 37 CFR § 1.173(d).
Changes to the specification must mention where in the issued patent (i.e., column and lines numbers) the changes are to be made and the entirety of an amended paragraph must be presented, unless canceling the paragraph. See 37 CFR § 1.173(b)(1)(i); see also MPEP § 1453, subsection V.A., Example (1).
Status identifiers, after the first amendment, must indicate how many times an original patent claim has been amended during examination of the reissue application (e.g., “Twice Amended”, etc.). See 37 CFR § 1.173(b)(2).
When claims are amended, “there must also be supplied, on pages separate from the pages containing the changes, the status (i.e., pending or canceled), as of the date of the amendment, of all patent claims and of all added claims, and an explanation of the support in the disclosure of the patent for the changes made to the claims.” 37 CFR § 1.173(c).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Application Publication No. 2003/0208236, 2013/0030503, 2012/0095459, 2018/0161086, and U.S. Patent No. 7,908,003 are all directed to electroporation treatment of various tissues and organs in the body.
The citation of these references, which are not applied in the rejections above, should not be taken as an indication that the invention described in the instant application is distinguishable from them. These references, along with any newly found references in the future, may still be applied in subsequent Office actions to reject the claims in their current form or as amended. Applicant is strongly encouraged to review these references, and all art of record, prior to making claim amendments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA KADING whose telephone number is (571)270-3413. The examiner can normally be reached Monday-Friday, 8:00 AM to 5:00 PM Eastern Time.
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/JOSHUA KADING/ Reexamination Specialist, Art Unit 3993
Conferees:
/WILLIAM V GILBERT/ Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/ SPRS, Art Unit 3993
1 U.S. Patent Application Publication No. 2010/0023004 A1, to Francischelli et al. (“Francischelli”).
2 U.S. Patent Application Publication No. 2012/0310237 A1, to David K. Swanson (“Swanson”).
3 See MPEP § 2141; see also Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966).
4 U.S. Patent Application Publication No. 2012/0220998 A1, to Long et al. (“Long”).
5 U.S. Patent Application Publication No. 2013/0184702 A1, to Neal, II et al. (“Neal”).
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