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 .
Election/Restriction
Applicant's election with traverse of Group I (claims 1-31) and Species A (claim 2) in the reply filed on 05/18/2026, is acknowledged.
With regards to the election of Group I, because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Claim(s) 32 is hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.
With regards to the election of Species A, Applicant’s arguments have been fully considered. In response to applicant’s argument that the species do not require a different field of search (due to the same CPC classification codes and the assertion that the species are not mutually exclusive), this argument is not persuasive because the Restriction Requirement mailed 03/17/2026 provides explicit reasoning as to why the species are patentably distinct (e.g. they require different structural limitations and functional limitations directed to how images were assembled that would require different prior art searches beyond just CPC). Furthermore, Applicant has not submitted any evidence showing the inventions to be obvious variants or clearly admitting on the record that this is the case. Claims 6-10, 13, 14, 15-26, 28-31 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim. The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-5, 11, 12, 27 are under examination.
Claims 6-10, 13-26, 28-32 are withdrawn.
Priority
The instant application claims the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) to US Provisional Application 63/179,924 filed 04/26/2021.
Information Disclosure Statement
The information disclosure statement (IDS) document(s) submitted 11/16/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 11, 12, 27 are rejected under 35 U.S.C. 101 because these claims are drawn to non-statutory subject matter. Claim 1 is directed to a system comprising database for storing patient image records (PPIR) and nothing more, i.e. the claimed system only comprises data. However, claims reciting only data do not fall within at least one of the four categories of patent eligible subject matter. Moreover, a database, even when carried on a physical medium, is nonfunctional descriptive material and is not statutory subject matter.
In addition, it is not clear what functional relationship is intended between the database and the various suggested and/or intended use recitations in the claims (e.g. enabling access and assessment by “experts”, and images that “can be” updated to include scores) since it is well understood that a database merely stores data and does not perform any processing functions, per se. For these reasons, the claimed system is not limited to comprise any hardware elements or combination of software and hardware such that it is interpreted to be a physical article of manufacture. Therefore, the instant claims are not statutory. For an updated discussion of statutory considerations with regard to non-functional descriptive material and computer-related inventions see MPEP 2111.05 and MPEP 2106.
Claim Rejections - 35 USC § 101
This is a lack of utility rejection.
Claims 1-5, 11, 12, 27 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a substantial asserted utility or a well-established utility.
For an invention to be “useful” it must satisfy the utility requirement of section 101. The USPTO’s official interpretation of the utility requirement provides that the utility of an invention has to be (i) specific, (ii) substantial and (iii) credible. See MPEP § 2107 and Fisher, 421 F.3d at 1372, 76 USPQ2d at 1230.
In this case, as discussed above, the claimed system merely comprises a “database” having a plurality of patient image records (i.e. the claimed system only comprises data). The system also recites suggestive and/or intended use recitations (e.g. enabling access and assessment by “experts”, and images that “can be” updated to include scores) that have no limiting effect on the invention as claimed. Accordingly, the claimed invention would require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use and, therefore, does not define a "substantial utility" (i.e. a database comprising information that is not associated with any means for actually accessing the data is not useful for a physician). The specification appears to discuss providing information that is useful to a physician [0060] and DAT models for using expert opinion data and making predictions based on success scores [0087-0093]. However, such limitations are not being claimed. Therefore, the claimed invention is broader than the disclosure such that it does not require a practical application.
In addition, the claimed invention is deemed to be "inoperative" (i.e., it does not operate to produce the results claimed by the patent applicant) for the following reasons. In particular, the claimed invention does not require any particular computer, computer code, or programming logic for performing the suggested functions associated with database. Therefore, the claimed system is deemed to be inoperable since there is no defined computer or device for processing the claimed data. For the above reasons, the claimed invention is not supported by a specific and/or substantial utility.
Claims 1-5, 11, 12, 27 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, since the claimed invention is not supported by either a specific, substantial, and credible asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention. [See MPEP 2106.02].
Claim rejections - 35 USC § 112, 2nd Paragraph
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 1-5, 11, 12, 27 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 1 are also rejected due to said dependency.
Claim 1 recites “A system for analyzing tortuosity of a patient vasculature to provide input to a physical preparing an endovascular surgical procedure…comprising: a database having a plurality of past patient image records (PPIR) wherein each PPIR includes a visual representation of a patient’s vasculature, the database enabling access and assessment by one or more experts and wherein each PPIR can be updated to include one or more success scores where a success score is a rating of difficulty for completing an endovascular procedure (EP) access from an access point to a target vessel. The above limitations are problematic for the following reasons. Firstly, the system as claimed only comprises a “database” in addition to suggested functional limitations and/or intended use recitations (e.g. enabling access and assessment by “experts”, and images that “can be” updated to include scores). As such, it is unclear in what way the claim achieves the purpose of the preamble and what functional limitations of the claimed system is intended. Applicant is reminded that a single claim which claims both an apparatus/system and the method steps of using the apparatus is indefinite. Clarification is requested via amendment.
Secondly, it is unclear what structural limitation of the claimed system is intended by the phrase “the database enabling access and assessment by one or more experts and wherein each PPIR can be updated to include one or more success scores where a success score is a rating of difficulty for completing an endovascular procedure (EP) access from an access point to a target vessel”. Applicant is reminded that intended use recitations are not given patentable weight and claim scope is not limited by claim language that “suggests” but does not limit a claim to a particular structure. See MPEP 2111.04. Clarification is requested via amendment.
Lastly, with regards to “an access point to a target vessel”, there is no previous mention of any such access points nor are they being stored as data within the database as claimed. Accordingly, there is lack of antecedent basis for this limitation. In addition, it is also unclear in what way the claimed “target vessel” further limits the claimed system (since the only data being stored includes PPIR data representing patient vasculature and not a “target vessel”, per se). Clarification is requested via amendment.
Claim 1 recites “further comprising: a current patient input system…; a comparison system….to determine a closest match…; and a success score display system…”. In this case, it is unclear as to the metes and bounds of the claimed “patient input system” and “comparison system” such that the artisan would recognize what structural limitations are intended. A review of the specification fails to provide any limiting definitions or structures that would achieve the intended function. Clarification is requested via amendment.
Claim 11 recites “where the success score further includes a risky manoeuvre (RM) output score and where the RM output score includes any one of or a combination of a measure of risk of local injury to a blood vessel and risk of dislodging a plaque or thrombus.” As discussed above, the system does not include any structural limitations that would serve to perform analysis---only a database. Moreover, a review of the specification does not describe, to any appreciable extent, any algorithms, equations, or prose equivalent that correspond to the claimed function. As a result, it is unclear in what way the above “where” clause further limits the claimed system and who or what is performing the suggested analysis. In addition, by claiming a method for performing such a specialized function in a database without disclosing the internal structure of any system/processor in the form of an algorithm, the claim is indefinite. Clarification is requested via amendment.
Claim Rejections - 35 USC § 102 or 103
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
Claims 1-5, 11, 12, 27 are rejected under 35 U.S.C. 102(b) as being anticipated by or, in the alternative, under 35 U.S.C. 103(a) as being obvious over Goyal et al. (US 2018/0085167; Pub. Date: 03/29/2018).
Regarding claim(s) 1, Goyal teaches systems and methods enabling a personalized solution for allowing more efficient access to the carotid artery (or vertebral arteries) in patients needing endovascular procedures using a catheter system. In particular, Goyal teaches a database comprising patient vascular image data [ref. claim 20; para. 0120], which reads on a database storing PPIR as claimed. With regards to the additional limitations directed to enabling database access or updating PPIR to include success scores, applicant is reminded that suggested limitations and/or intended use limitations are not given patentable weight. That being said, Goyal additionally teaches identifying entry points (e.g. femoral, radial, brachial or carotid artery) depending on the particular vessel or task or procedure being used [0168] and ranking preferred vessels [0213], i.e. scoring. Goyal also teaches methods for accessing blood vessels and analyzing access route parameters against the physical properties of the at least one catheter system to determine a ranking of catheter systems suitable for navigating from an entry point to a destination [0008; ref. claim 20].
Regarding claim(s) 2, Goyal teaches uploading image records to their system [ref. claim 20; para. 0120, 0215], identifying a best match patient model record based on a comparison of measured anatomical features from step b and a plurality of patient model records [0120], and a display for displaying a comparison of the user's performance to the pre-determined procedure parameters [ref. claim 26]. Regarding claim(s) 3, 4, Goyal teaches identifying entry points (e.g. femoral, radial, brachial or carotid artery) depending on the particular vessel or task or procedure being used [0168]. Regarding claim(s) 5, 11, 12, Goyal teaches ranking preferred vessels and arteries [0007, 0213] and times associated with various treatment procedures [0063 and Table 2]. Regarding claim(s) 27, Goyal teaches functionality for storing image data, patient data, and expert opinion/input data [0089, 0199, 0219], which reasonably suggests questionnaire data. Applicant is reminded that intended use recitations are not given patentable weight.
For these reasons, the claimed invention as a whole does not recite any new element, new function, or unpredictable result, and would have been prima facie obvious at the time it was made.
Cited Prior Art
The following prior art made of record and not presently relied upon is considered pertinent to applicant' s disclosure.
Alilou et al. (Scientific Reports, 2018, volume 8, Article number: 15290, pp.1-16) teaches methods of quantitative analysis of vessel tortuosity using patient CT image data.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619
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