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 .
Status of Amended Claims
This action is responsive to applicant’s amendments and arguments remarks filed on 1/15/2026.
Claims 1, 2, 5 and 8-19 are pending.
Claims 1, 2, 5, 12 and 13 are amended.
Claims 3, 4, 6, 7 and 20 are cancelled.
Response to Arguments
Applicant’s amendments and argument’s/remarks with regards to claim 20 are moot in view of the cancellation of claim 20. Accordingly, the 35 USC 112, 101 and 102 rejections of claim 20 are withdrawn.
Applicant's amendments and arguments filed 1/15/2026 have been fully considered but they are not persuasive. Specifically, the applicant has amended claims 1 and 12 to incorporate to incorporate the limitations of claims 3, 4, 6 and 7 to recite the specific positioning of the magnets and electrodes at radial locations along the position of the stent; and further arguing that the combination of the Gianchandani and Wehrs references used to reject claims 3, 4, 6 and 7 under 35 USC 103 is improper because (1) Wehrs is non-analogous art and (2) the office has not established a sufficient motivation to combine Wehrs with Gianchandani to modify Gianchandani. The examiner addresses the amended claims in the updated 35 USC 103 rejection below which still relies on the basis of rejection as the 35 USC 103 rejections of claims 3, 4, 6 and 7 in the previous office action. The following response addresses the applicant’s arguments.
The examiner finds the argument that Wehrs is non-analogous art to be non-persuasive as the examiner contends that (1) Wehrs is analogous art and (2) the applicant’s arguments that the technical challenges associated with the implantable or extravascular biological flow sensor are conclusory statements without evidentiary support. Regarding argument (1), MPEP 2141.01(a) discusses analogous and nonanalogous art, outlining that “a reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention).” In the instant case, Wehrs meets the burden of analogous art in that the reference is reasonably pertinent to the problem faces by the inventor, which in this case is measuring fluid flow in a massage through the use of a generated magnetic field and electrodes positioned to measure changes in the magnetic field. Both Wehrs and Gianchandani are concerned with flow monitoring in a passage, and both use magnetic fields and electrodes. Accordingly, both references meet the burden of being analogous art in that the references are from the same field of endeavor as the claimed invention (monitoring fluid flow in a passage) and they are both reasonably pertinent to the problem faced by the inventor (as the problem faced by the inventor is measuring fluid flow within a passage). Further, regarding argument (1) and argument (2), while there may be additional technical challenges faced by Gianchandani and the inventor as they are related to flowmetry within the body, that would not preclude one of ordinary skill in the art at the time of filing to looking to similar electromagnetic flowmetry techniques used in other situations such as industrial pipes (as Wehrs is related to), as both would face overlapping challenges/problems and have similar solutions to electromagnetic field monitoring. Essentially, as one of ordinary skill in the art at the time of filing would have motivation to look at problems and solutions in any art or field that would utilize a similar technique of electromagnetic flowmetry to measure the velocity/flow of material through a cylindrical passage. Finally, regarding argument (2), the applicant’s assertion the office has not established that Wehrs would be reasonably pertinent to the particular problem of biological flow sensing in a stent based system is non-persuasive as the examiner clearly establishes in the 103 rejection on pages 10 and 11 that Wehrs teaches a magnetic flowmeter that utilizes a generated magnetic field perpendicular to electrodes placed on the perimeter in a similar manner that Gianchandani teaches using electrodes to measure changes in a magnetic field going perpendicular to electrodes; thus establishing the relationship between the two pieces of art as analogous to the field of magnetic flowmetry.
Regarding the applicant’s arguments that the office has not established a sufficient motivation to combine Wehrs with Gianchandani or to somehow modify Gianchandani, the examiner finds the arguments non-persuasive. Specifically, the examiner sets forth in the 35 USC 103 rejection that both Wehrs and Gianchandani are in related fields of endeavor of magnetic flowmetry, and further clearly establishes the motivation using the KSR rationale (C) Use of known technique to improve similar devices (methods, or products) in the same way. In this case, the examiner relies on Wehrs teaching of placing electrodes at 90 degree intervales with the magnetic field generators as a known technique of generating a magnetic field that is perpendicular to the electrodes to maximize the monitoring of changes in the magnetic field due to the flow of material through the magnetic field which allows for the calculation of flow velocity. As Gianchandani also is concerned with utilizing electrodes to measure changes in a generated magnetic field across a passage, this relates as a similar device (magnetic flowmeter) and the improvement would provide the same improvement as Wehrs. The applicant has not provided sufficient evidence to show that there is no motivation to modify Gianchandani as taught by Wehrs as set forth in the 103 rejections. The applicant merely makes conclusory remarks (i.e. scale difference between industrial flowmeter of Wehrs and stent structure of Gianchandani weights against a showing of obviousness; the office has not established that position arrangement disclosed in Wehrs industrial scale device would be operable when scaled to the dimensions of a stent system; or that such adaption would accommodate the constraints of a support structure that is deliverable, expandable or collapsible and suitable for intravascular or extravascular deployment) without evidence to support their statements. The examiner has set forth the modification and an explicit motivation for the modification; and as such, the burden has shifted to the applicant to provide evidence that such a modification would not works as intended, rather than provide conclusory statements. Further, the examiner notes that “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396. In this case, a person of ordinary skill in the art at the time of the filing would thus also use the inferences and creative steps that a person of ordinary skill in the art would and thus would take into account the differences and challenges of applying an industrial technique to a biological one.
Finally, with regards to the applicant’s arguments to the examiner’s taking of official notice in the rejection of claim 5, the examiner has provided several evidentiary references in the rejection below to support the examiner’s position that it was well known and common that electromagnets used for generated and electromagnetic field comprise one or more coils which are excited to generate the magnetic field. The examiner maintains the position that it is well known and obvious that it would have been obvious to one of ordinary skill in the art at the time of filing to use known electromagnets as Gianchandani’s electromagnetic field generator.
Accordingly, the applicant’s amendments and arguments/remarks have been full considered, but are found to be non-persuasive in view of the updated rejections below and in the detailed response above.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 5 and 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gianchandani et al (US 2005/0273014 A1) in view of Wehrs et al (US 2006/0174715 A1) as evidenced by Appel et al (US 3,999,443), Rufer et al (US 2008/0262796 A1), and/or Fryer (US 3,751,980).
Regarding claims 1-2, 5 and 8-11; Gianchandani discloses a stent system (figures 3c, 4, 5, 7-11) comprising:
a support structure (stent element 98 and support structure element 130) defining a passage through which a biological fluid is to flow (paragraphs [0010]-[0089], specifically [0041]-[0045]; figures 1-11);
a magnetic apparatus (magnetic field generator element 234) mechanically coupled to the support structure (paragraph [0084] wherein it is disclosed that the magnetic element may be integrated with the electromagnetic cuff sensor), the magnetic apparatus configured to generate a magnetic field (element 68) through the passage, the field including a component perpendicular to a direction of flow of the biological fluid (paragraphs [0010]-[0089], specifically [0044] and [0084]); and
electrodes (element 82, 132, 134, 236) mechanically coupled to the support structure (elements 98 and 130, 131, 194, 230 ; paragraph [0059], [0066]), the electrodes connected to output a potential difference generated by the flow of the biological fluid through the magnetic field indicative of a velocity of flow of the biological fluid through the passage (paragraphs [0010]-[0089], specifically [0041]-[0045]).
While paragraph [0084] of Gianchandani specifically states:
While the permanent magnet 234 was used to generate and provide the magnetic field in this example, any number of other magnetic field generators may be used. Permanent magnets provide one low-power solution, but those skilled in the art will appreciate the variety of magnetic field generators that may be integrated with the electromagnetic cuff sensor.
There are no figures which show the magnetic apparatus is mechanically coupled to the support structure for some embodiments. Gianchandani discloses “those skilled in the art will appreciate that variety of magnetic field generated that may be integrated with the electromagnetic cuff sensor.” Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to integrate the magnetic apparatus into the support structure as taught by Gianchandani, including by mechanically coupling the magnet or electromagnet to the support structure in each of the disclosed embodiments as simple substitution of one known element for another to yield a predictable result (in this case, substituting an externally or locally generated magnetic field of the embodiments depicted in Gianchandani’s figures with a magnetic apparatus mechanically integrated into the stent and support structure to generate the required magnetic field to allow the electrodes of the electromagnetic flow sensor to measure potential difference generated by the flow of the biological fluid through the magnetic field indicative of the velocity of the flow of the biological fluid through the passage).
Further regarding claims 1, 2, 5 and 8-11; modified Gianchandani is described above and discloses generating a magnetic field perpendicular to the electrodes using magnets or electromagnets positioned on a support structure; but is silent to the explicit positioning of the first and second permanent magnets or electromagnets at first and second radial positions on the perimeter of the passage opposition of each other; and the electrodes positioned at third and fourth radial positions on the perimeter of the passage opposite each other and between the first and second magnets/electromagnets.
Wehrs teaches a magnetic flowmeter that uses the same principle of measuring the potential across a passage (element 30) via a generated magnetic field (element 90) perpendicular to electrodes (element 70) placed along the perimeter of a passage; wherein the magnetic field generating elements (elements 50) are positioned at first and second radial positions on the perimeter of the passage opposite of each other and the first and second electrodes (elements 70) are positioned at third and fourth radial positions of the passage opposite of each other (paragraph [0008] and [0030]-[0032]; figure 2).
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Gianchandani to position the magnets at first and second positions opposite of each other and perpendicular to the electrodes positioned at third and fourth positions opposite each other and between the magnets on the support structure as taught by Wehrs in order to generate the electric field perpendicular to the electrodes and measure the flow as use of a known technique in a known device to yield a predictable result (Gianchandani’s stent wherein the magnets are located on the support structure perpendicular to the electrodes such that the each magnet is radially spaced 90 degrees from the adjacent electrodes in a manner as depicted in Wehrs).
Further regarding claim 2; Gianchandani discloses the magnetic apparatus is a permanent magnet structure (paragraph [0084]).
Further regarding claim 5; Gianchandani discloses the magnetic apparatus comprises an electromagnet structure (paragraph [0084]). The examiner previously took official notice that although Gianchandani is silent to the electromagnet structure comprising one or more coils excited to generate the magnetic field, that it is well known in the art at the time of filing that electromagnets use at least one coil which are excited in order to generate a magnetic field and thus would have been obvious to one ordinary skill in the art at the time of filing to use known electromagnetic structures for generating magnetic fields. As the applicant has challenged the examiner’s taking of official notice, the examiner is providing the following references which show that electromagnets for generating magnetic field comprise on or more respective coils which are excited to generate the magnetic field:
Fryer teaches known electromagnets comprises respective excited coils (elements 12a and 12b) for generating the magnetic field (column 2, lines 33-59; figure 1).
Appel teaches known electromagnets (elements 2) for generating an electromagnetic field across a passage comprises at least one coils (elements 2) respectively on opposite sides of the passage which are excited to generate the magnetic field (column 4, lines 6-14 and 48-68; figure 1)
Rufer teaches known electromagnets (elements 6 and 7) for generating electromagnetic fields across a passage comprises at least one coil (elements 6 and 7) respectively on opposite sides of the passage to generate the magnetic field (paragraph [0042]; figure 1)
Accordingly, the examiner maintains the position and has provided additional evidentiary references that electromagnets comprise one or more coils excited to generate the magnetic field, and thus would have been obvious to one of ordinary skill in the art as the structure of Gianchandani’s disclosed electromagnets.
Further regarding claim 8-9; Gianchandani discloses wherein the support structure is configured for delivery to an extravascular location (wherein examiner notes that the stent system is deployed in a pump test system depicted in figures 10 and 11 and described in paragraphs [0081]-[0084], which is extravascular in that it is outside of a vessel).
Further regarding claim 9; Gianchandani discloses the support structure is at least one of expandable or collapsible (support and stent are deployable in body via expanding; paragraphs [0010]-[0089], specifically [0065]-[0068],[0073]; figures 1-11)
Further regarding claim 10-11; Gianchandani discloses the support structure is configured for delivery to an intravascular location (the stent and support are positioned within a vessel to detect blood flow; paragraphs [0010]-[0089], specifically [0050], [0077]; figures 1-11)
Further regarding claim 11; Gianchandani discloses the support structure is expandable after delivery to an intravascular location (the stent and support are delivered and expanded after delivery to a blood vessel location; paragraphs [0010]-[0089], specifically [0076]-[0077]; figures 1-11)
Regarding claims 12-19; Gianchandani discloses a method for measuring a flow of a biological fluid, the method comprising:
within a passage defined by a stent support structure (stent element 98, cuff element 86, and beam elements 102/104), establishing a magnetic field (element 68) oriented in a first direction perpendicular to a flow direction of a biological fluid (paragraphs [0010]-[0089], specifically [0058]-[0060]; figures 1-11, specifically 3c);
using electrodes (electrode elements 82) mechanically coupled to the stent support structure (paragraphs [0010]-[0089], specifically [0058]-[0060]; figures 1-11; specifically 3c),
measuring a potential across a region where the biological fluid flows, elicited by the magnetic field (measures potential via electrodes; paragraphs [0010]-[0089], specifically [0058]-[0060]; figures 1-11; specifically 3c); and
determining a velocity of the flow of the biological fluid using the potential (determines velocity as proportionate to potential difference; paragraphs [0010]-[0089], specifically [0058]-[0060]; figures 1-11, specifically 3c).
However, Gianchandani is silent to the explicit positioning of the first and second permanent magnets or electromagnets at first and second radial positions on the perimeter of the passage opposite of each other; and the electrodes positioned at third and fourth radial positions on the perimeter of the passage opposite each other and between the first and second magnets/electromagnets.
Wehrs teaches a magnetic flowmeter that uses the same principle of measuring the potential across a passage (element 30) via a generated magnetic field (element 90) perpendicular to electrodes (element 70) placed along the perimeter of a passage; wherein the magnetic field generating elements (elements 50) are positioned at first and second radial positions on the perimeter of the passage opposite of each other and the first and second electrodes (elements 70) are positioned at third and fourth radial positions of the passage opposite of each other (paragraph [0008] and [0030]-[0032]; figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Gianchandani to position the magnets at first and second positions opposite of each other and perpendicular to the electrodes positioned at third and fourth positions opposite each other and between the magnets on the support structure as taught by Wehrs in order to generate the electric field perpendicular to the electrodes and measure the flow as use of a known technique in a known device to yield a predictable result (Gianchandani’s stent wherein the magnets are located on the support structure perpendicular to the electrodes such that the each magnet is radially spaced 90 degrees from the adjacent electrodes in a manner as depicted in Wehrs).
Further regarding claims 13-19; The Gianchandani/Wehrs combination described in the rejection of claim 12 above discloses the electrodes are located at respective radial positions along the stent support structure that are offset by ninety degrees from corresponding radial positions of magnets used to establish the magnetic field (wherein Gianchandani discloses that the field orientation is perpendicular to the flow direction and the voltage sense axis and is thus 90 degrees; paragraphs [0010]-[0089], specifically [0058]-[0060] and [0084]; figures 1-11, specifically 3c; and Wehrs discloses the 90 degree radial spacing of magnets and electrodes; figure 2).
Further regarding claim 14; Gianchandani discloses the magnets comprise permanent magnets (paragraphs [0010]-[0089], specifically [0084]; figures 1-11, specifically 3c and 10-11).
Further regarding claim 15-17; Gianchandani discloses the magnets comprise electromagnets (paragraphs [0010]-[0089], specifically [0084]; figures 1-11, specifically 3c and 10-11).
Further regarding claim 16-17; Gianchandani discloses establishing the magnetic field comprises exciting the electromagnet structures using an alternating current waveform (discloses that an AC magnetic field may be used instead of a DC; paragraphs [0010]-[0089], specifically [0083]; figures 1-11, specifically 3c and 10-11).
Further regarding claim 17; Gianchandani discloses establishing the magnetic field comprises selecting at least one of an amplitude or a frequency of an excitation waveform to elicit a measurable potential for the electrodes (wherein the examiner notes that in order for an AC magnetic field to be generated at least one of an amplitude or frequency of the excitation waveform must be selected to elicit a measurable potential for the electrodes as all embodiment are excited to measure a potential difference, i.e. if not amplitude or frequency are selected then no AC magnetic field is generated; paragraphs [0010]-[0089], specifically [0083]; figures 1-11, specifically 3c and 10-11).
Further regarding claim 18; Gianchandani discloses deploying the stent support structure at an extravascular location (wherein it is disclosed as deployed in a test circuit which is extravascular or on the outside of a vasculature in the embodiments of figures 3a-3b; paragraphs [0010]-[0089], specifically [0055]-[0060] and [0084]-[0085]; figures 1-11, specifically 3a-c and 10-11).
Further regarding claim 19; Gianchandani discloses deploying the stent support structure at an intravascular location (paragraphs [0010]-[0089], specifically [0055]-[0060]; figures 1-11, specifically 3c)
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791