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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 04, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on April 04, 2025 are accepted.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – 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 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 35 U.S.C. 112(f) or 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 35 U.S.C. 112(f) or 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.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited 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 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or 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 use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses 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. Such claim limitation(s) is/are:
Claims 1 and 2: the claim limitations of “a/the first/second field generator for generating a/the first/second spatially variant electric field” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “generator” coupled with functional language “for generating” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “generator”.
Claim 1: the claim limitation of “a processing system configured to determine alignment” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “system” coupled with functional language “to determine” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “system”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claims 1 and 2: “a/the first/second field generator” refers to the specification, PG Pub US 2025/0228591 A1, [0121]: in the embodiment of FIG.5, a first spatially variant field generator 508 and a second spatially variant field generator 510 are mounted on the source catheter 502; [0122]: spatially variant field generators are, for example, one or more pairs of electrodes configured to create dipoles, quadrupoles, octopoles etc. between the electrodes”.
Claim 1: “a processing system” refers to the specification [0129]: the processor 518 calculates the alignment angle between the received spatially variant signal and the type of spatially variant signal”.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or 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 limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dickinson et al., WO 2016/145202, hereinafter Dickinson.
Claim 1. Dickinson teaches FIG.3a-3c an apparatus for determining alignment between a source device and a target device (Abstract: the apparatus and methods…relates to the creation of an AVF using catheters and an alignment methodology that is based upon detection of asymmetric electric fields), the apparatus comprising:
the source device comprising a first spatially variant field generator for generating a first spatially variant electric field and a second spatially variant field generator for generating a second spatially variant electric field, the second spatially variant electric field being angularly offset with respect to the first spatially variant electric field (p.6, ll. 5-7: a) a first source device that is located in a first body cavity, the first device comprising at least one signal electrode for generating an asymmetric electric field; p.17, ll.1-3: In Figure 3a a penetrating member 20 is shown that has a positive ring electrode 39 and a negative ring electrode 41 on its distal tip. The electrodes 39, 41 together generate a directional electric field; and ll.12-18: FIG.3b shows an alternative embodiment of the penetrating member 20 having two pairs of source electrodes 39, 41 on its distal end. Each pair of source electrodes 39, 41 are arranged in a diametrically opposed fashion on a circumference of the penetrating member 20l the first pair of electrodes 39, 41 angularly displaced by approximately 90 degrees from the other pair of electrodes. This is best shown in Figure 3c which is a cross-sectional view of the penetration member 20 at the position of the electrode pairs);
the target device comprising at least one sensor configured to detect a first signal from the first spatially variant electric field and a second signal from the second spatially variant electric field (p.3, ll. 36-37: the second device…is referred herein as the “target device”; p.6, ll.9-11: b)…the second device comprising a detector for detecting the asymmetric electric field generated by the first source device; and p.17, ll.3-4: the sensing electrodes 108, 110 on the sensing catheter 100 measures the dipole electric field created by the two source electrodes 39, 41) - the sensing catheter that comprises the sensing electrodes are the “target device” as claimed; and
a processing system configured to determine alignment between the first source device and the target device based on the first and second signals from the first and second spatially variant electric fields detected by the target device (p.6, ll.16-19: d) an electronic alignment monitor unit that is in communication with the first and second devices that is capable of generating the asymmetric electric field in the source device, and detected signal in the target device, and provide a visual or audible display to indicate alignment to the user; and p.17, ll.20-28: Each pair of electrodes creates a dipole electric field with a zero value along a plane that lies equidistant between them when the electrodes are activated. In this arrangement the signal measured by the electrodes 108, 110 on the sensing catheter will vary with movement of the penetrating member 20 in the x-y plan…A measured value of 0V when both pairs of electrode are active indicates that the penetrating member 20 is aligned with the positive sensing catheter electrode 108. A value greater than 0V indicates a degree of misalignment. The amplitude of signal is indicative of alignment with values closer to null (0V) indicating greater alignment).
Claim 2. Dickinson teaches in FIGS.3a-3c and claim 55 a method for determining an angle of alignment between a source device and a target device (Abstract: the apparatus and methods…relates to the creation of an AVF using catheters and an alignment methodology that is based upon detection of asymmetric electric fields),
the source device comprising a first spatially variant field generator for generating a first spatially variant electric field, and a second spatially variant field generator for generating a second spatially variant electric field, wherein the second spatially variant electric field is angularly offset with respect to the first spatially variant electric field (p.6, ll. 5-7: a) a first source device that is located in a first body cavity, the first device comprising at least one signal electrode for generating an asymmetric electric field; p.17, ll.1-3: In Figure 3a a penetrating member 20 is shown that has a positive ring electrode 39 and a negative ring electrode 41 on its distal tip. The electrodes 39, 41 together generate a directional electric field; and p.17, ll.12-18: FIG.3b shows an alternative embodiment of the penetrating member 20 having two pairs of source electrodes 39, 41 on its distal end. Each pair of source electrodes 39, 41 are arranged in a diametrically opposed fashion on a circumference of the penetrating member 20l the first pair of electrodes 39, 41 angularly displaced by approximately 90 degrees from the other pair of electrodes. This is best shown in Figure 3c which is a cross-sectional view of the penetration member 20 at the position of the electrode pairs),
the target device comprising at least one sensor configured to detect a first signal from the first spatially variant electric field and a second signal from the second spatially variant electric field (p.3, ll. 36-37: the second device…is referred herein as the “target device”; p.6, ll.9-11: b)…the second device comprising a detector for detecting the asymmetric electric field generated by the first source device; and p.17, ll.3-4: the sensing electrodes 108, 110 on the sensing catheter 100 measures the dipole electric field created by the two source electrodes 39, 41) - the sensing catheter that comprises the sensing electrodes are the “target device” as claimed, the method comprising:
a) generating a first spatially variant electric field from the first spatially variant field generator on the source device; c) generating a second spatially variant electric field from the second spatially variant field generator on the source device (p.17, ll.12-18: FIG.3b shows an alternative embodiment of the penetrating member 20 having two pairs of source electrodes 39, 41 on its distal end; and Claim 55: the first device comprising at least one signal electrode for generating an asymmetric electric field);
b) detecting the signal of the first spatially variant electric field using the sensor on the target device to provide a first spatially variant signal; d) detecting the signal of the second spatially variant electric field using the sensor on the target device to provide a second spatially variant signal (Claim 55: b) a second device…comprising a detector for detecting the asymmetric electric field generated by the first source device); subsequently followed by:
e) determining the alignment angle between the source device and the target device as a function of the detected signals for the first spatially variant electric field and the second spatially variant electric field (Claim 55: d) an electronic alignment monitor unit that is in communication with the first and second devices that is capable of generating the asymmetric electric field in the source device, and receive the detected signal in the target device, and provide a visual or audible display to indicate alignment to the user; and p.17, ll.20-28: Each pair of electrodes creates a dipole electric field with a zero value along a plane that lies equidistant between them when the electrodes are activated. In this arrangement the signal measured by the electrodes 108, 110 on the sensing catheter will vary with movement of the penetrating member 20 in the x-y plan…A measured value of 0V when both pairs of electrode are active indicates that the penetrating member 20 is aligned with the positive sensing catheter electrode 108. A value greater than 0V indicates a degree of misalignment. The amplitude of signal is indicative of alignment with values closer to null (0V) indicating greater alignment) – 0V indicates that the two devices are aligned, i.e., in parallel or 180 degrees to each other. The voltage value closer to 0V means it is more aligned – hence the voltage value determined by the electronic alignment monitor unit presents the angle between the two devices.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of U.S. Patent No. 12,279,790. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications appear to disclose substantially identical subject matter with the instant claims being simply broader than the patent claims.
Both the instant application and the ‘790 patent disclose an apparatus for determining alignment between a source device and a target device, and a method for determining an angle of alignment between a source device and a target device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798