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 .
Response to Arguments
Applicant’s arguments, see pg. 7, filed 07/02/2026, with respect to the objection to claim 1 have been fully considered and are persuasive. The objection of claim 1 has been withdrawn.
Applicant’s arguments, see pg. 7, with respect to claim interpretation under 112(f) have been fully considered and are persuasive. The 112(f) interpretations detailed in the non-final rejection filed 03/05/2026 have been withdrawn. Amendments to the claims to include “motorized movement structure” (claims 1, 16, 18-19) warrants claim interpretation under 112(f); see below for more details.
Applicant’s arguments, see pg. 8-14, with respect to claim rejections under 35 USC 102(a)(1) and 103, have been fully considered. The amendments to the independent claim to include the added limitations overcomes the rejection detailed in the non-final filed 03/05/2026. Since independent claim 1 was amended to include new limitations, new grounds of rejection are warranted for independent claim 1 and dependent claims 3-10 and 16-20. See prior art rejections below.
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:
Motorized movement structure in claims 1, 16, 18-19: interpreted as a stepper motor (pg. 19, pp. 3)
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.
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.
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.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the preamble of the claim recites: “a computer program product comprising a program code”, which is directed to software per se; see MPEP 2106.03. The examiner suggests the following amendment: “a program code stored on a non-transitory computer storage medium, and configured to run on an electronic device…”.
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 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.
Claims 1-7, 10, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US Pre-Grant Publication 2015/0065916), hereinafter ‘Maguire’, in view of McGrath et al. (US Pre-Grant Publication 2021/0220059), hereinafter ‘McGrath’, further in view of Moskowitz et al. (US Pre-Grant Publication 2019/0125470), hereinafter ‘Moskowitz’.
Regarding claim 1, Maguire teaches a blood vessel detection device (Fig. 1B, [0034], detect vessels), further comprising:
a housing or frame (Fig. 1B, housing unit(s) 5);
a surface structure configured with a shape that matches a shape of an anatomical region selected from the group consisting of: frontal part of a thigh, frontal part of a pelvis, frontal part of a groin, a wrist, a frontal part of an arm and a frontal part of a neck ([0096], cuff-like structure enclosed around appendage and adapted to different patient sizes, Fig. 1A, imaging system 4, around wrist of user);
a detection structure (Figs. 2A-2B, 3A-3C, [0103], sensors/processors) (Figs. 9A-9B, [0077], ultrasound components) for detecting presence of a blood vessel, the detection structure defining a detection path (Fig. 3A, path defined by gear railing 11) along the skin surface, and comprising:
at least one sensor ([0103], position sensors 18, 21) (Figs. 9A-9B, [0077], ultrasound probe and computer) arranged to provide a signal indicative of the presence of a blood vessel along the detection path;
a carriage (unlabeled, see Fig. 3B) holding the at least one sensor and configured to be moved along the detection path ([0105], front to back movement within gear railing 11);
a computing unit configured to:
receive the signal (Fig. 1A, computer 1); and
define an insertion procedure defining an entry location on the skin surface where a percutaneous needle and/or cannula can be inserted into the blood vessel (Fig. 5, step 1, [0103], first processor 19 determines target puncture position);
wherein the detection path is a medial-to-lateral anatomical line along the skin of the frontal part of a thigh, frontal part of a pelvis, frontal part of a groin, a wrist, a frontal part of an arm and/or a frontal part of a neck ([0105], Fig. 3B, left-to-right movement within gear railing 10, Fig. 1A, wrist), and
wherein the device comprises a first motorized movement structure arranged to move the carriage along the detection path (Fig. 5, step 4, [0103], processor moves carrier, [0105], driven by servo motors), and
the computing unit is configured to provide a control signal to the first motorized movement structure to position the carriage along the detection path based on the signal so that the guidance member is positioned at the entry location (Fig. 5, step 4, [0103], processor moves carrier, coincides with target spatial position for needle).
Maguire teaches a display (see [0030]), but does not specifically teach an interface to communicate an entry location for manual insertion, or a guidance member.
McGrath teaches an apparatus for inserting a needle ([0012]), further comprising:
an interface (Fig. 3B, visualization device 200’, [0303]) configured to communicate the entry location to a user for manual insertion or to an insertion structure for automatic insertion of the percutaneous needle and/or cannula ([0341], autonomous or semi-autonomous insertion of needle into patient).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to incorporate the teachings of McGrath to include a communication interface for automatic or manual needle insertion. Doing so would ensure precise placement of a cannula, as recognized by McGrath ([0303]).
Neither Maguire nor McGrath explicitly teach a guidance member.
Moskowitz teaches a needle guide (see [0002], Fig. 1B), further comprising:
a guidance member held by the carriage and arranged to define a limiting passageway (track 144, Fig. 2A) for manual insertion of the percutaneous needle and/or cannula, through the guidance member by the user ([0115], track guides needle into target tissue location), the limiting passageway defining an insertion direction of the percutaneous needle and/or cannula ([0105], track guides the needle at a predetermined angle),
wherein the guidance member comprises a proximal opening and a distal opening, and a lumen connecting the proximal opening (proximal opening 134a, Fig. 19A) and the distal opening (distal opening 134b, Fig. 19A), said openings configured to enable passage of a blood vessel access needle ([0105], track between openings, guides the needle into the subject).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire and McGrath to incorporate the teachings of Moskowitz to include a guidance member. Doing so would guide the needle and prevent it from slipping during insertion, as recognized by Moskowitz [0107].
Regarding claim 3, Maguire, McGrath, and Moskowitz teach the device according to claim 1. Maguire teaches the device further comprising:
wherein the at least one sensor comprises at least one receiver configured to receive an output signal from the anatomical region ([0077], ultrasound transducer includes signal pulser/receiver).
Regarding claim 4, Maguire, McGrath, and Moskowitz teach the device according to claim 1. Maguire teaches the device further comprising:
wherein the at least one sensor comprises at least one emitter capable of emitting an input signal into said anatomical region ([0077], ultrasound transducer includes signal pulser/receiver).
Regarding claim 5, Maguire, McGrath, and Moskowitz teach the device according to claim 4. Maguire teaches the device further comprising:
wherein the sensor is configured to detect the output signal in the form of an echo of the input signal emitted by the emitter ([0129], processing of returning echoes).
Regarding claim 6, Maguire, McGrath, and Moskowitz teach the device according to claim 4. Maguire teaches the device further comprising:
wherein the computing unit is configured to determine an echo return time, from emission of the input signal to detection of the output signal, and to use a change in time to detect the location of the blood vessel ([0021], ultrasound Doppler imaging) ([0081], conversion of echo waveforms).
Regarding claim 7, Maguire, McGrath, and Moskowitz teach the device according to claim 3. Maguire teaches the device further comprising:
wherein the computing unit is configured to determine a change in frequency between the input signal emitted by the emitter and the output signal received by the receiver, and to detect the location of the blood vessel based on the change in frequency ([0021], ultrasound Doppler imaging) ([0081], conversion of echo waveforms).
Regarding claim 10, Maguire, McGrath, and Moskowitz teach the device according to claim 1. Maguire teaches the device further comprising:
wherein the detection structure is configured to provide a depth measure indicating a depth of said blood vessel below the outer skin surface ([0024], depth of vessel).
Regarding claim 16, Maguire, McGrath, and Moskowitz teach a computer-implemented method for operating the device according to claim 1 (see above rejection of claim 1). Maguire teaches the method further comprising:
the method being performed by the computing unit ([0059], computer directing information), the method comprising the steps of:
receiving the signal indicative of the presence of a blood vessel along the detection path while the carriage is moved along the detection path (Fig. 5, vessel puncture control algorithm, step 1, target position is calculated);
determining the entry location on the skin surface ([0103], first processor 19 determines relative needle target puncture position); and
providing the control signal to the first motorized movement structure to position the carriage so that the guidance member is positioned at the entry location (Fig. 5, step 4).
Regarding claim 17, Maguire, McGrath, and Moskowitz teach a computer program product comprising a program code which, when executed by one or more processors of the computing unit of the device according to any of claims 1, causes the computing unit to perform the method of claim 16. See above rejections of claims 1 and 16, and the vessel puncture control algorithm of Maguire (Fig. 5).
Regarding claim 18, Maguire, McGrath, and Moskowitz teach the device according to claim 1. Maguire teaches the device further comprising:
a second motorized movement structure configured for moving the percutaneous needle and/or cannula and/or the guidance member relative to the housing or frame ([0029], motors for moving needle, Fig. 5, step 5, [0103], movement of needle is controlled by a fourth processor 23).
Regarding claim 19, Maguire, McGrath, and Moskowitz teach the device according to claim 18. Maguire teaches the device further comprising:
wherein the second motorized movement structure is configured to receive a signal from the computing unit ([0103], movement of needle is controlled by a fourth processor 23).
Regarding claim 20, Maguire, McGrath, and Moskowitz teach the device according to claim 18. Moskowitz teaches the device further comprising:
wherein the guidance member is structurally configured to be physically attached to, or arranged into the carriage, wherein, when the carriage is moved, the guidance member is moved accordingly (Fig. 23B, needle guide 2 is attached to carriage 35).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US Pre-Grant Publication 2015/0065916) in view of McGrath et al. (US Pre-Grant Publication 2021/0220059), further in view of Moskowitz et al. (US Pre-Grant Publication 2019/0125470), further in view of Liu et al. (US Pre-Grant Publication 2013/0090600), hereinafter ‘Liu’.
Regarding claim 8, Maguire, McGrath, and Moskowitz teach the device according to claim 1, but do not teach the limitations of claim 8.
Liu teaches a vessel access device (Fig. 7) further comprising:
wherein the computing unit ([0039], control device (unlabeled), Fig. 7) is configured to a provide blood flow measure or recognition, indicating a blood flow in the blood vessel ([0026], ultrasound scanning in CFM mode to display blood flow information).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire, McGrath, and Moskowitz to incorporate the teachings of Liu to include a computing unit that can recognize or measure blood flow. Doing so would allow for the determination of the vessel type, as recognized by Liu [0027].
Regarding claim 9, Maguire, McGrath, and Moskowitz teach the device according to claim 7, but do not teach the limitations of claim 9. Liu teaches the device further comprising:
wherein the computing unit is configured to determine the blood flow direction based on a frequency shift of the output signal relative to the input signal ([0026], ultrasound scanning in CFM mode to determine if blood is flowing towards or away from probe).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire, McGrath, and Moskowitz to incorporate the teachings of Liu to include a computing unit that can determine the blood flow direction. Doing so would allow for the determination of the vessel type, as recognized by Liu [0027].
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 ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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