DETAILED ACTION
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 . Claims 18-37 are currently pending with claims 28-37 being withdrawn below (Election).
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 18-27, drawn to an intravascular device, classified in CPC A61B5/02007 and USPC 600/381.
II. Claims 28-37, drawn to a method, classified in classified in CPC A61B5/02007 and USPC 600/381.
The inventions are independent or distinct, each from the other because:
Inventions of Group I and Group II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the apparatus can utilize a materially different process including impedance mapping and ablation once a lesion has been located.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or --the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Sam Rapaport on 05/21/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 18-27. Affirmation of this election must be made by applicant in replying to this Office action. Claims 28-37 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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.
Claim 24 is 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.
Claim 24 recites the limitation "the helical coil" in line three. There is insufficient antecedent basis for this limitation in the claim.
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.
The factual inquiries 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.
Claim 18-24 are rejected under 35 U.S.C. 103 as being unpatentable over Littmann et al. US Patent 5,509,411 (hereinafter Littman) in view of Littmann et al. US Patent US 5,706,809 (hereinafter Littmann ‘809).
Regarding claim 18, Littman discloses an intravascular device (column 1 lines 52–62, abstract, Figures 1-10) comprising: an elongate tubular body having a distal end region configured to be positioned within a vessel of a heart of a patient (element 13, see also Figures 1–5, depicting the elongated shaft 11 with distal section 12 disposed within coronary arteries 47 and 48 of a patient's heart as shown in Figure 9), and one or more proximal electrode pairs disposed on an exterior surface of the elongate tubular body proximate the distal end region, wherein the one or more proximal electrode pairs are configured to be positioned upstream (as well as downstream) of a narrowing within the vessel (electrodes 16 on tubular member 11, see also column 2 lines 14-20, where the electrodes are capable of being placed up or downstream, or both with respect to a narrowing portion of a vessel), and a computing system operatively coupled to the elongate tubular body and comprising at least one data processor and a memory storing instructions (display unit is mentioned as being connected to the pins as per column 2 lines 22-26 and column 3 lines 10-20, and in order to show the obtained signals a processor, a memory, and display are required) which, when executed by the at least one processor, cause the at least one processor to perform operations comprising: acquiring a first electrical signal from the one or more proximal electrode pairs and a second electrical signal from the one or more distal electrode pairs (column 3 10-20) and generating, within a user interface display of the computing system, a first electrogram from the first electrical signal and a second electrogram from the second electrical signal (Figure 17 which shows the output signal; see column 2 lines 23-28), however Littmann does not provide any extensive detail about the second electrogram nor a specific comparison.
Littmann ‘809 teaches a similar catheter device that includes electrode on an elongated tubular member that are electrically connected to a computing system (electrodes 46 body 41, Figures 14-15 showing the displayed data on a display as per column 9 lines 10-25), wherein the user interface display enables a comparison of the first electrogram to the second electrogram to determine a clinical relevance of the narrowing (column 3 lines 4-19 which details that the electrode pairs sense electrical signals at two different locations to locate an arrhythmic site which can include a narrowing; though it should be noted that the narrowing is a portion of the human body and not a part of the device/system and that the information provided can allow the health care provider to make a determination as claimed). It would have been obvious to the skilled artisan before the effective filing date to utilize the process as taught by Littmann ‘809 with the device of Littman in order to aid in locate lesions/stenosis or any other tissue causing arrhythmias for correction.
Further, nether reference explicitly details that the computer/display actually includes a processor/memory as prat of the computer system, however these again are either inherent in order to function as disclosed or at worst are so common and well-known that Official Notice is taken regarding their use in EGM catheters (the processor and memory with instruction for said processor).
Regarding claims 19-22, Littman discloses a ratio of the measurement distance to the interelectrode distance for both the proximal and distal electrode pairs is between 5:1 and 40:1 along with the ranges from the other claims (see column 5 lines 8–20; selecting 0.75 mm from the disclosed interelectrode range and 10 mm from the disclosed measurement distance range yields a ratio of 13.3:1, which falls squarely within the claimed ranges). Routine selection of values within the ranges expressly disclosed in Littmann produces ratios within the claimed range, and optimization of these spacing parameters would have been motivated by the well-understood principle that a larger inter-pair separation relative to intra-pair spacing improves spatial discrimination of intracoronary electrogram signals at distinct axial locations (see column 5 lines 59-65 and Figures 2–5).
Regarding claim 23, Littmann discloses a helical coil coupled to the elongate tubular body distally of the one or more distal electrode pairs (column 2 lines 35-45, see also element 80 as per Figure 12), wherein the helical coil is configured to facilitate torquing and steering of the elongate tubular body within the vessel (column 2 lines 35-45, see also element 80 as per Figure 12).
Regarding claim 24, Littmann discloses a bead tip coupled to the elongate tubular body distally of the one or more distal electrode pairs (Figure 12 element 79), wherein the helical coil is configured to facilitate torquing and steering of the elongate tubular body within the vessel (coil 80, Figure 12).
Claim 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Littmann in view of Littmann ‘809 and in further view of Nabel et al. “Detection of Pacing-Induced Myocardial Ischemia by Endocardial Electrograms Recorded During Cardiac Catheterization” JACC Vol. 11 Issue 5. 1988 (hereinafter Nabel).
Regarding claims 25, 27, Littmann discloses that an electrical pulse is provided (column 3 lines 19-23, which details finding arrhythmic sites sensing at multiple locations which would include a third and fourth electrical signal from the distal electrodes). Littmann is silent however on the pacing pulses between the two sets of signals over a predetermined period of time.
Nabel teaches an electrogram sensing system that includes providing an electrical pulse to the one or more proximal electrode pairs for a predetermined period of time, wherein the electrical pulse is operative to pace the heart, acquiring electrical signals via electrodes over the period of time (Figure 2 which shows the electrode electrical signals before and after pacing to induce ischemia, and mentions in page 989 paragraph 2 details sensing a third electrical signal during pacing), generating, within the user interface display, a third electrogram from the third electrical signal and a fourth electrogram from the fourth electrical signal, wherein the operator can compare the third electrogram to the fourth electrogram to determine the clinical relevance of the narrowing (Figures 2-4, which shows the different electrical signals, where 15 of 21 patients in the study had varying levels of stenosis in their arteries). It would have been obvious to the skilled artisan before the effective filing date to utilize the pacing then sensing methodology as taught by Nabel with the device of Littmann in order to improve sensitivity in detecting ischemia associated with coronary narrowing.
The criteria listed in claims 25, 27 of the first and second electrical signals being substantially identical or in the case of 27, having an amplitude and frequency being lower are both dependent on the location in the body as well as the device’s location with respect to the occlusion/stenosis/narrowing. Given that Littman ‘809 explicitly details sensing electrical signals at the proximal and distal electrodes then moving the device to do so again, which will occur dependent on the location of the device in the artery/vessel. The processing of the above combination does not explicitly detail automating these steps, however given that the same device is being used in the same location and used in the same way (locating the cause of the narrowing and its extent) it would have been obvious to automate this process (see MPEP 2144.04-III) in lieu of doing this manually.
Regarding claim 26, Littmann is silent on the time period. Nabel teaches an electrogram analyzing device that includes utilizing the electrical pulse having a magnitude that is sufficient to pace the heart (Figure 2 and description). And though Navel discloses bpm range (108 bpm on page 989 paragraphs 1-2 and is increased to 140bpm), the time is not disclosed as this is something that varies from patient to patient (Navel is basically performing a pacing stress test while also determining the extent of coronary diseased tissue). It would have been obvious to the skilled artisan before the effective filing date to allow for enough time (one minute) to obtain the level of stress and patient response as desired by Nabel with the device of Littmann as a matter of routine optimization.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights