DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The disclosure is objected to because of the following informalities: the listing in the heading on page 17 of “DETAILED DESCRIPTION OF THE FIGURES” should be amended to read as “BRIEF DESCRIPTION OF THE FIGURES” in view of the direction of the headings to be used in the Specification as in MPEP 608.01(a).
Appropriate correction is required.
Claim Objections
Claims 1-18 are objected to because of the following informalities:
Regarding claim 11, the claim recites “the catheter comprises catheter tip possessing electrodes” therein. The Examiner is of the position that the noted claim language is improperly drafted as presented. The Examiner respectfully suggests that Applicant utilize language such as “the catheter comprised a catheter tip possessing electrodes” to correct the grammatical issue. Appropriate correction is required.
Regarding claims 1-18, the Examiner respectfully requests Applicant review each of the listed claims to ensure that the claims maintain consistent naming conventions for the various limitations throughout. Additionally, the Examiner respectfully requests Applicant ensure that claim limitations are properly introduced with an appropriate article (a/an) when applicable and that subsequent recitations are introduced with an appropriate article (the/said) so as to thereby maintain proper reference between the limitations in the claims and to maintain proper antecedent basis throughout the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites the limitation of “introducing catheters” in line 4 of the claim and then further recites the limitations of 1) “the catheter” in line 8 and 2) “the catheter tip of the catheters” in line 11. It is the Examiner’s position that the various recitations noted above render the scope of the claim as indefinite because it is unclear how many catheters are required to perform the steps of the claimed method, and what structural relationship is required between the catheter/catheters. In particular, it is unclear to the Examiner which of the catheters in line 4 of the claim the recitation of “the catheter” in line 8 is referring to, if any. Further, it is unclear how “the catheter” in line 8 relates to the “the catheters” in line 11.
The Examiner respectfully suggests Applicant utilize consistent claim language through the claim when referring to the number of catheters, and further utilize language that properly specifies the relationship between a single catheter of the group of catheters. Claims 2-9 and 11-18 are rejected due to their dependency on claim 1. Appropriate correction is required.
Regarding claim 1, the claim recites the limitation of “the catheter tip of the catheters” in line 11. There is insufficient antecedent basis for this limitation in the claim. At no time has any other portion of claim 1 established that one or more of the catheters set forth in claim 1 has “a tip” so as to properly establish basis for the limitation set forth in line 11. The Examiner further notes that the lack of antecedent basis renders the scope of the claim as indefinite because it is unclear how multiple catheters can include a single catheter tip as presently set forth in line 11. Claims 2-9 and 11-18 are rejected due to their dependency on claim 1. Appropriate correction is required.
Regarding claim 1, the claim recites “indicia of disease” in line 6 and then repeats this limitation in line 14. The Examiner is of the position that these recitations render the scope of the claim as indefinite because it is unclear if the “indicia of disease” in line 14 are the same as those set forth in line 6, partially overlap with those in claim 6, or are entirely different than those in line 6. The Examiner respectfully requests that Applicant clarify the at-issue claim language to better define the relationship between the two recitations in lines 6 and 14.
Additionally, the Examiner notes that the further recitation of “disease indicia” in line 17 further renders the scope of the claim as indefinite because it is unclear what, if any, relationship these indicia have to the recited “indicia of disease” in each of lines 6 and 14. The Examiner respectfully suggests consistent claim naming and conventions be utilized throughout the claims address this issue.
Claims 2-9 and 11-18 are rejected due to their dependency on claim 1. Appropriate correction is required.
Regarding claim 2, the claim recites the requirement of “ablative catheters currently in use to treat cardiac arrhythmias” therein. The Examiner is of the position that the defining of the catheters as those “currently in use to treat cardiac arrhythmias” renders the scope of the claim as indefinite because “currently in use” is a relative term which renders the claim indefinite. The terminology of “currently in use” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Said differently, the Examiner is not aware of any standard to determine whether a catheter or plurality of catheters qualify as currently in use to treat cardiac arrhythmias. Appropriate correction is required.
Regarding claims 5 and 6, each claim recites “the stimulatory or ablative section of the catheter tip” therein. This limitation fails to have proper antecedent basis in the claims. Appropriate correction is required.
Regarding claim 9, the claim recites the limitation of “the catheter” therein. This recitation renders the scope of the claim as indefinite for substantially the same reasoning as set forth with respect to claim 1 above. Appropriate correction is required.
Regarding claim 10, the claim sets forth in line 9 that the mapping is performed “according to the method of claim 1” and then recites within the remaining body of the claim for a/the “catheter”. The Examiner is of the position that the scope of claim 10 is indefinite given that it is unclear if the catheter in claim 10 is the same catheter as required by the steps of the method of claim 1 or, alternatively, is a different catheter from that set forth in claim 1. Appropriate correction is required.
Regarding claim 11, the claim recites “the catheter comprises catheter tip possessing electrodes that lie proximal to the arterial lumen” therein. This recitation includes method-like language in an apparatus claim in positively reciting the use of the catheter relative to the human anatomy. Such a recitation renders the scope of the claim as indefinite given that it is unclear in infringement of the claim would occur when a catheter capable of being used a claimed in provided, or only once the electrodes of the catheter tip of the catheter are specifically positioned as claimed. The Examiner respectfully suggests that language such as “wherein the electrodes are configured to lie proximal to the arterial lumen” to correct the issue. Claims 12-18 are rejected due to their dependency on claim 11. Appropriate correction is required.
Again, regarding claim 11, the claim recites “the arterial lumen” therein. This recitation renders the scope of the claim as indefinite because it is unclear if such refers to the lumen of the renal artery as set forth in referred to limitations in claim 1, or if such is directed towards a different arterial lumen. Claims 12-18 are rejected due to their dependency on claim 11. Appropriate correction is required.
Regarding claim 17, the claim recites “wherein spaced along the length of the helical coil or the umbrella component are electrodes”. Parent claim 11 recites electrodes on the catheter tip. Thus, the Examiner is of the position that the further recitation in claim 17 of the “electrodes” render the scope of the claim as indefinite because it is unclear what structural and/or functional relationship the electrodes of claim 17 have in relation to the electrodes of claim 11. Claim 18 is rejected due to its dependency on claim 17. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 nonobviousness.
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).
Claims 1-14, 17 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Crow et al. (US Pat. Pub. 2012/0265198 A1).
Regarding claim 1, Crow provides for a method of mapping renal nerves for ablative procedures to treat disease caused by systemic renal nerve hyperactivity, comprising the steps of:
a) introducing catheters that perform stimulatory and ablative processes into renal artery (introducing of the catheter 200 as in figure 5 into the body),
c) introducing electrical current through the catheter in a site- specific manner to portions of the renal artery lumen in order to stimulate underlying renal nerves (delivery of energy from 217; see at least [0062]-[0066] for the energy to elicit a physical response),
d) optionally moving the catheter tip of the catheters according to a specified protocol in order to make contact with desired portions of the renal artery lumen,
e) measuring indicia of disease after each site-specific electrical stimulation and recording changes over baseline (see at least [0020], [0022], [0027], [0064] and [0065] discussing the determination of changes),
and f) correlating changes in disease indicia with the portions of the renal artery lumen which were stimulated to produce said changes, thereby mapping specific locations of renal nerves underlying the renal artery lumen (see again [0020], [0022], [0027], [0064] and [0065] discussing the determination of changes to provide for the location of nerves along the renal artery).
While Crow fails to specifically provide for the step of b) measuring indicia of disease before site-specific electrical stimulation to obtain baseline measurements, the Examiner is of the position that such would have been an obvious, if not inherent, consideration to the methodology described in Crow in view of the disclosure in each of paragraphs [0020], [0022], [0027], [0064] and [0065] describing the determination of changes in the indicia of disease. In particular, the Examiner is of the position that a baseline value for each of the identified parameters would be an obvious consideration to measure in order to effectively determine the disclosed “change” in the parameter as a result of stimulation. This would ensure that the method provides site-specific indications of changes for each patient based and pre- and post-stimulation values.
Regarding claim 2, the Examiner is of the position that the catheters of Crow are indeed catheters that perform stimulatory and ablative processes are ablative catheters currently in use to treat cardiac arrhythmias.
Regarding claim 3, Crow provides that the indicia of disease measured comprise indicia of hypertension, indicia of diabetes, or indicia of congestive heart failure (the various factors described in [0020], [0022], [0027], [0064] and [0065] are indicators of at least one of the claimed diseases).
Regarding claim 4, Crow provides that the claimed indicia of hypertension are selected from the group consisting of systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, muscular sympathetic activity, and urine output (see the various parameters disclosed in paragraphs [0020], [0022], [0027], [0064] and [0065]).
Regarding claim 8, while Crow indicates that the applied stimulation is electrical stimulation (see [0027]) but fails to disclose the specific parameters set forth in claim 8. The Examiner is of the position, however, that the selection of such parameters as set forth in claim 8 would have been an obvious consideration to one of ordinary skill in the art when applying electrical stimulation within the renal artery to elicit nerve-based responses in the body. The Examiner further finds that the selection of such parameters would have been an obvious consideration given that it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. The Examiner further notes that no criticality or unexpected results were identified in the disclosure to show that the selection of such parameters would have been non-obvious.
Regarding claim 9, Crow provides for a method of ablating renal nerves to treat disease caused by systemic renal nerve hyperactivity, comprising the steps of: a) applying the mapping method of claim 1 to map renal nerves (see the rejection of claim 1 above), and
(b) applying radiofrequency energy through the catheter to site- specific portions of the renal artery lumen to ablate the mapped renal nerves (see [0068] providing for radiofrequency via the ablation arrangement of 215).
Regarding claim 10, Crow provides for a method for mapping and ablating renal nerves to treat disease caused by systemic renal nerve hyperactivity, comprising the steps of:
(a) introducing a catheter into the renal architecture at a desired location where it remains stationary (placing the catheter 200 at the location within the renal artery as shown in figure 5),
(b) keeping the catheter stationary while electrical current is introduced through individual electrodes of the catheter and while indicia of disease are measured to perform renal nerve mapping according to the method of claim 1 (via 200 being stationary while performing the mapping per the rejection of claim 1 above), and
(c) keeping the catheter stationary while radiofrequency energy is introduced through individual electrodes of the catheter to ablate the mapped renal nerves (maintaining the location of 200 such that 215 as in [0068] applies RF energy).
Regarding claim 11, Crow provides for a catheter for performing the mapping functions of claim 1 wherein the catheter comprises catheter tip possessing electrodes that lie proximal to the arterial lumen, and wherein the electrodes can deliver both a direct and alternating current as well as radiofrequency energy (catheter 200 with the electrode array 301 capable of applying the various energy as claimed).
Regarding claim 12, Crow provides throughout that the electrodes are functionally capable of performing both stimulatory and ablative functions.
Regarding claim 13, Crow provides that the electrodes may be activated independently of one another or in any combination (see [0079]).
Regarding claim 14, the Examiner is of the position that the claimed catheter length, catheter tip length and catheter tip diameter would have been an obvious consideration to one of ordinary skill in the art at the time of filing. Crow provides for its catheter to be specifically configured to treat within the same location as the claimed catheter and, thus, the Examiner finds that the selection of values within the claimed parameters ranges would have been obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 17 and 18, Crow provides that the catheter tip comprises a balloon (support structure 210 includes a balloon as in [0063]) around which is wrapped a close-ended umbrella component (via the ablation arrangement being a closed umbrellas as in figures 6-9), wherein spaced along the length of the helical coil or the umbrella component are electrodes (via 306 disposed therealong).
Claims 15 and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Crow et al. (US Pat. Pub. 2012/0265198 A1) as applied to claim 1 above, and further in view of Oral et al. (US Pat. Pub. 2005/0033137 A1).
Regarding claims 15 and 16, while Crow provides for various shapes of its catheter tip (see figures 6-10), Crow fails to specifically provide that the shape of the catheter tip is either a single helix or a double helix, wherein the coil of the helix is either round or flat in shape and the electrodes are spaced along the length of the coil, wherein said electrodes may be round in shape if the coil is round or flat in shape if the coil is flat in shape. Crow further fails to provide that the electrodes are evenly spaced along the length of the helix or helices 90° or 120° from each other.
Oral provides for a similarly shaped catheter tip as that of Crow (See figures 5-11) and then further provides for a single helix in the form of a round/flat coil with a plurality of electrodes spaced therealong (See figures 1-4), wherein the electrode are one of round or flat and spaced even along the length of the helix at one of 90° or 120° (conductive coils 20 as patterned in the figures). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the alternative expandable form as in Oral in place of the expandable treatment element of Crow to provide for an alternative manner of applying energy to the tissue of the renal artery. Oral readily provides that interchanging between a helical arrangement (figures 1-4) and a splined/umbrella arrangement (figures 5-11) is known in the art with either functioning equally as well as one another to provide the interaction of a plurality of conductive electrodes with tissue for the application of energy thereto.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,324,408 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant independent claim 1, it is clear that all the elements of instant claim 1 are to be found in patented independent claim 1. The difference between instant claim 1 and patented claim 1 lies in the fact that the patented claim includes many more elements and is thus much more specific. Thus the invention of patented claim 1 is, in effect, a “species” of the “generic” invention of instant claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since instant claim 1 is anticipated by patented claim 1, it is not patentably distinct from the patented claim.
Regarding instant claim 2, see patented claim 2;
Regarding instant claim 3, see patented claim 3;
Regarding instant claim 4, see patented claim 4;
Regarding instant claim 5, see patented claim 1;
Regarding instant claim 6, see patented claim 1;
Regarding instant claim 7, see patented claim 5;
Regarding instant claim 8, see patented claim 6;
Regarding instant claim 9, see patented claim 7;
Regarding instant claim 10, see patented claim 8;
Regarding instant claim 11, see patented claim 9;
Regarding instant claim 12, see patented claim 10;
Regarding instant claim 13, see patented claim 11;
Regarding instant claim 14, see patented claim 12;
Regarding instant claim 15, see patented claim 13;
Regarding instant claim 16, see patented claim 14;
Regarding instant claim 17, see patented claim 15;
Regarding instant claim 18, see patented claim 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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