DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7, in the reply filed on May 15th, 2026 is acknowledged.
Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 15th, 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “34” in fig. 2 has been used to designate both a distal end and an arrow representing a proximal direction in para. [0052]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “45” in fig. 4. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
Claims 1-4 and 6-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts. Thus, the claim is directed to a method, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
using the obtained one or more measurements to determine an effective vessel diameter at the deployment site.
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites a measurement apparatus including an expandable element, advancing the measurement apparatus to the deployment site with the expandable element in its collapsed configuration, causing the expandable element to expand from its collapsed configuration to its expanded configuration, obtaining one or more measurements pertaining to the expandable element in its expanded configuration, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)) necessary to perform the abstract idea. The advancing, causing, and obtaining steps do not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the advancing, causing, and obtaining steps, nor does the method use a particular machine to perform the Abstract Idea.
Regarding the measurement apparatus recited in the claims, the measurement apparatus is a generic device comprising generic components configured to perform the insignificant pre-solution activity necessary to perform the abstract idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a measurement apparatus, the measurement apparatus including an expandable element that is moveable between a collapsed configuration for advancement and an expanded configuration for measurement.
advancing the measurement apparatus to the deployment site with the expandable element in its collapsed configuration
causing the expandable element to expand from its collapsed configuration to its expanded configuration
obtaining one or more measurements pertaining to the expandable element in its expanded configuration
The measurement apparatus is a well-understood, routine and conventional apparatus and the advancing, causing, and obtaining steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, measurement apparatus and the advancing, causing, and obtaining steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the measurement apparatus recited in the claim is a generic device comprising generic components configured to perform the insignificant pre-solution activity necessary to perform the abstract idea - as evidenced by the non-patent literature of record: H P Pieper and L T Paul. Catheter-tip gauge for measuring blood flow velocity and vessel diameter in dogs. 1968. Journal of Applied Physiology 1968 24:2, 259-261 10.1152/jappl.1968.24.2.259; Tautorat, C., Schümann, K., Specht, O., Kamke, F., Behrens, P., Schmitz, K.-P., Grabow, N., & Schmidt, W. (2018). Balloon-based measuring system for compliance investigations. Current Directions in Biomedical Engineering, 4(1), 539–542. https://doi.org/10.1515/cdbme-2018-0129; Allie, MD. (2009, January). Optimal Vessel Sizing in Peripheral Vascular Interventions [Review of Optimal Vessel Sizing in Peripheral Vascular Interventions]. Endovascular Today. https://evtoday.com/articles/2009-jan/EVT0109_02-php; and Miller (US 20090203962 A1) discloses in para. [0005] a conventional device utilizes an inflatable balloon which is typically introduced intravascularly in a deflated state and then inflated against the tissue region to be examined.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-4 are directed to the measurement apparatus comprising generic components configured to perform the insignificant pre-solution activity necessary to perform the abstract idea – as evidenced by the non-patent literature of record and claims 6-7 are directed to more abstract ideas (determining), which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 (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 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.
Claims 1-2 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jain (US 5919147 A).
Regarding claim 1, Jain discloses a method of determining an effective vessel diameter at a deployment site within a vessel using a measurement apparatus (“method for measuring the intravascular diameter of an anatomical duct ... catheter”, Abstract, col. 1 lines 54-65 & col. 2 line 61 – col. 3 line 10, claim 9), the measurement apparatus (vascular measuring device 10, figs. 5-6) including an expandable element (sensor 26 comprising radially outwardly-biased filaments 44, figs. 1-3 & sensor 54 comprising a pair of outwardly-biased arcuate arm springs 56 and 58, figs. 5-6) that is moveable between a collapsed configuration for advancement and an expanded configuration for measurement (as seen in figs. 5-6, col. 3 line 24 – col. 4 line 51), the method comprising: advancing the measurement apparatus to the deployment site with the expandable element in its collapsed configuration (“sheath 22 carrying the catheter 24 in a retracted position ... inserted ... blood vessel 14 ... desired position”, col. 3 lines 24-34 & col. 4 lines 12-51); causing the expandable element to expand from its collapsed configuration to its expanded configuration (“desired position ... longitudinal rod 50 ... urged forwardly ... arm springs 56 and 58 extend laterally outwardly where central outer portions 60 and 62 of the arm springs 56 and 58 contact the blood vessel wall 16”, col. 3 lines 37-53 & col. 4 lines 12-51); obtaining one or more measurements pertaining to the expandable element in its expanded configuration (“observing the graduated markings 42”; “read the graduated marketings on the catheter 24”, col. 3 lines 58-61 & col. 4 lines 12-51, fig. 4); and using the obtained one or more measurements to determine an effective vessel diameter at the deployment site (“properly proportioned indicia on the graduated scale, the inner diameter of the blood vessel can be read directly off the markings”, col. 4 lines 1-5, claim 9).
Regarding claim 2, Jain discloses the method of claim 1, wherein the expandable element is adapted to limit its expanded configuration when the expandable element apposes an interior wall of the vessel (“spring tension”; “filaments ... abut the interior surface ... no longer be able to push ... resistance ... against distal ends 48 of the filaments 44”; “outer portions 60 and 62 ... contact the blood vessel wall ... resistance”, col. 3 lines 50-57 & col. 4 lines 1-6 & 35-51).
Regarding claim 7, Jain discloses the method of claim 1, wherein obtaining one or more measurements comprises determining one or more changes for the expandable element in moving from its collapsed configuration to its expanded configuration (“determine the axial movement of the catheter 24 relative to the sheath 22 which corresponds to the outward lateral movement of the central portions 60 and 62 of the arm springs 56 and 58”, col. 4 lines 58-61 & col. 4 lines 45-51, claim 9).
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3-5 is rejected under 35 U.S.C. 103 as being unpatentable over Jain in view of Wu (US 20180256109 A1).
Regarding claim 3, Jain discloses the method of claim 1, wherein the measurement apparatus comprises an outer sheath (sheath 22, figs. figs. 5-6) adapted to extend over the expandable element (as seen in figs. 5-6, col. 3 line 24 - col. 4 line 51). Jain further discloses that electronic sensors could also be included in the sensor 26 to provide an audible or visible signal to confirm the contact of the sensor 26 with the blood vessel 14 (col. 2 lines 49-52).
Jain does not expressly disclose causing the expandable element to expand from its collapsed configuration to its expanded configuration comprises withdrawing the outer sheath proximally to uncover the expandable element.
However, Wu directed to an electrode assembly of an electrophysiologic catheter having controlled flexibility discloses an outer sheath (“guiding sheath 42”, para. [0047], fig. 9) and an expandable element (basket-shaped electrode assembly 16 & spines, para. [0047], fig. 9) and causing the expandable element to expand from its collapsed configuration to its expanded configuration comprises withdrawing the outer sheath proximally to uncover the expandable element (“guiding sheath 42 covers the spines ... guiding sheath is withdrawn to expose the basket-shaped electrode assembly 16 ... assume the expanded arrangement upon withdrawal of guiding sheath 42”, para. [0047], fig. 9 (see also para. [0035, 0038])).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jain such that causing the expandable element to expand from its collapsed configuration to its expanded configuration comprises withdrawing the outer sheath proximally to uncover the expandable element, in view of the teachings of Wu, as such a modification would have been merely a substitution of the sensor, longitudinal rod, and sheath of Jain for the basket/splines, catheter body, and sheath of Wu and would aid in more reliably collapsing the basket for passing through vasculature and radially expanding the basket for contacting the tissue (Wu, para. [0047]).
Regarding claim 4, Jain, as modified by Wu hereinabove, discloses the method of claim 3, wherein the expandable element is adapted to regain its expanded configuration when no longer covered by the outer sheath (“sheath 22 retains the arcuate arm springs ... prevents ... bowing ... extend the arm springs 56 and 58 ... beyond ... sheath 22 ... bow laterally outwardly”, col. 4 lines 13-34 & Wu, para. [0047]).
Regarding claim 5, Jain discloses the method of claim 1. Jain does not expressly disclose wherein the measurement apparatus comprises: an outer member secured to a proximal region of the expandable element; and an inner member extending through an interior of the outer member, the inner member secured to a distal region of the expandable element; wherein causing the expandable element to expand from its collapsed configuration to its expanded configuration comprises withdrawing the inner member proximally in order to shorten a length of the expandable element, thereby causing the expandable element to move towards its expanded configuration.
However, Wu directed to an electrode assembly of an electrophysiologic catheter having controlled flexibility discloses an expandable element (basket-shaped electrode assembly 16 & spines 18, fig. 1, para. [0034]) and a measurement apparatus (electrophysiologic catheter 10) comprising: an outer member (elongated catheter body 12, fig. 1, para. [0034]) secured to a proximal region of the expandable (“proximal ends of spines 18 ... secured at the catheter body 12”, para. [0034, 0036]); and an inner member (pulling member 22, fig. 1, para. [0036]) extending through an interior of the outer member (“extends ... through central lumen”, para. [0036], fig. 1), the inner member secured to a distal region of the expandable element (“distal ends of spines 18 ... attached to a pulling member 22”, para. [0036]); wherein causing the expandable element to expand from its collapsed configuration to its expanded configuration (“deflected from the collapsed arrangement to the expanded deployed arrangement”, para. [00035-036]) comprises withdrawing the inner member proximally in order to shorten a length of the expandable element, thereby causing the expandable element to move towards its expanded configuration (“distance between the distal and proximal ends of spines 14 may be shortened with relative movement of pulling member 22 in the proximal direction, causing spines 18 to bow outwards and assume an expanded arrangement”, para. [0036, 0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jain such that the measurement apparatus comprises an outer member secured to a proximal region of the expandable element; and an inner member extending through an interior of the outer member, the inner member secured to a distal region of the expandable element; wherein causing the expandable element to expand from its collapsed configuration to its expanded configuration comprises withdrawing the inner member proximally in order to shorten a length of the expandable element, thereby causing the expandable element to move towards its expanded configuration, in view of the teachings of Wu, as such a modification would have been merely a substitution of the sensor and longitudinal rod of Jain for the basket/splines and pulling member of Wu and would aid in more reliably collapsing the basket for passing through vasculature and radially expanding the basket for contacting the tissue (Wu, para. [0047]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jain in view of Kellerman (US 20110251482 A1).
Regarding claim 6, Jain discloses the method of claim 1. Jain further discloses confirming the measurement using fluoroscopic imaging (col. 2 lines 53-60 & col. 3 lines 24-61, claims 9-10). Jain does not disclose wherein obtaining one or more measurements comprises using fluoroscopy to determine a diameter of the expandable element in its expanded configuration.
However, Kellerman directed to systems and methods are described for visualizing the anatomy of a patient using an expanding portion systems and methods are described for visualizing the anatomy of a patient (Abstract) discloses obtaining one or more measurements comprises using fluoroscopy to determine a diameter of the expandable element in its expanded configuration (“100d ... radially expanded state ... visualizable ... fluoroscopy ... markers ... measure and/or located diameters of artery 10”, para. [0044-0045, 0047, 0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jain such that obtaining one or more measurements comprises using fluoroscopy to determine a diameter of the expandable element in its expanded configuration, in view of the teachings of Kellerman, as this would aid in visualizing markers on a radially expanded distal portion for confirming measurements of the diameter of the artery/vessel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gifford (US 20180177486 A1) directed to implantable devices for continuously monitoring vascular lumen dimensions (figs. 14-16);
Balmforth (US 20230047610 A1) directed to methods for determining required radial forces to select an appropriate stent for a target vessel and software to receive data relating to the target vessel such as diameter of the target vessel along its length (para. [0115-0118]);
Conklin (US 20130345801 A1) directed to methods and apparatus for determining a size of a valve annulus;
Schwarcz (US 20210282921 A1) directed to measurement devices for monitoring the diameter and radial force of implantable, mechanically expandable prosthetic devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/A.E.H./Examiner, Art Unit 3791
Prosecution Insights