DETAILED ACTION
The following Office Action is in response to the Amendment filed on November 6, 2025. Claims 1-14, 16-17, and 27-29 are currently pending.
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 Amendment
Concerning the “Claim Objections” section on page 5 of the Applicant’s Response filed on November 6, 2025, the amendments to claims 9, 13, and 14 to address the informalities have obviated the necessity of the objections to the claims. Therefore, the objections are withdrawn.
Response to Arguments
Concerning the “Claim Rejections – 35 U.S.C. § 102” section on pages 5-6 of the Applicant’s Response filed on November 6, 2025, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the prior art references do not teach the limitation of “a hydrostatic skeleton including a fluid channel through the hydrostatic skeleton”, arguing that the Ho, Madrid, Harrison, and Anderson references teach balloons where the blood flows around the balloons, and arguing that the Madrid reference similarly teaches that blood flows around the balloons and not through a channel defined by the balloons. However, the examiner asserts that the applicant has too narrowly interpreted the claims. The applicant assumes that blood must flow through a central channel defined by the hydrostatic skeleton, but this is not stated in the claims. The claims simply state that the hydrostatic skeleton defines a fluid channel through the hydrostatic skeleton. Each of the balloons of the prior art references includes a lumen through which it is inflated, which may be interpreted as a channel, wherein said channel may have fluid pass through said channel to inflate the balloon, therein defining a fluid channel through the hydrostatic skeleton defined by the balloon. Furthermore, the plurality of balloons of the Ho reference together may be interpreted as a hydrostatic skeleton wherein the gaps between the balloons may be interpreted as channels through which blood may flow. The same interpretation may be taken with the Madrid and Anderson references. Additionally, the helical balloon of the Harrison defines a fluid channel through which blood may flow (Harrison; Figure 10; 224) contrary to what the applicant argues. The examiner would also like to note that the applicant states that the examiner admitted that Madrid, Harrison, and Anderson do not teach the limitations of previous claim 15, but the examiner has made no such admissions. Therefore, the rejections of the claims under 35 U.S.C. §102(a)(1) stand.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 6, 7, 9, 11, 13-14, and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho (US 9,308,086).
Concerning claim 1, the Ho prior art reference teaches a device (Figures 2-6B; 10), comprising: a tubular member (Figure 2; 12); and one or more radially expandable features (Figure 2A; 20) configured to be selectively expanded from a collapsed configuration (Figure 2B; 20b) to an expanded configuration (Figure 2A; 20) to allow blood flow within a blood vessel of a patient to flow from a point upstream of the one or more radially expandable features, around and/or through the one or more radially expandable features, and to a point downstream of the one or more radially expandable features (Figure 3A & 4A), wherein the one or more radially expandable features includes a hydrostatic skeleton (Figure 4A; 20a | the expandable features together may define, and therein include a hydrostatic skeleton, given they form a frame structure [skeleton] that relates to fluids at rest or to the pressures they exert [hydrostatic]), each hydrostatic skeleton defining a fluid channel through the hydrostatic skeleton (Figure 5A; flow passages 34a define fluid channels).
Concerning claim 2, the Ho reference teaches the device according to claim 1, wherein the one or more radially expandable features comprises one or more balloons (Figure 2A; 20).
Concerning claim 3, the Ho reference teaches the device according to claim 1, wherein the one or more radially expandable features extend along a portion of a length of the tubular member (Figure 2A; 20).
Concerning claim 4, the Ho reference teaches the device according to claim 1, wherein each radially expandable feature has an identical axial length (Figure 2A; 20).
Concerning claim 6, the Ho reference teaches the device according to claim 1, wherein the one or more radially expandable features comprises a plurality of radially expandable features (Figure 2A; 20).
Concerning claim 7, the Ho reference teaches the device according to claim 6, wherein each of the plurality of radially expandable features is separated circumferentially from an adjacent radially expandable feature by an identical distance (Figure 2B; if expandable features 20a are interpreted as the plurality of radially expandable features, each is separated circumferentially from an adjacent expandable feature by an identical distance equal to the other subset of balloons 20b).
Concerning claim 9, the Ho reference teaches the device according to claim 1, wherein the central axis of each radially expandable feature is parallel to a central axis of the tubular member (Figure 4B; 20a, 26).
Concerning claim 11, the Ho reference teaches the device according to claim 1, wherein at least one radially expandable feature has a circular cross section (Figure 4B; 20a).
Concerning claim 13, the Ho reference teaches the device according to claim 1, wherein each of the at least one radially expandable features is fluidly connected to a fluid source (Figure 2; 22, 24).
Concerning claim 14, the Ho reference teaches the device according to claim 1, wherein each of the at least one radially expandable features is operably connected to a connector (Figure 2; 24).
Concerning claim 29, the Ho prior art reference teaches a method, comprising: positioning a tubular member within a blood vessel (Figure 3A; AA), the tubular member having an outer surface and at least open radially expandable member coupled to the outer surface (Figure 3A; 20a), at least one radially expandable feature including a hydrostatic skeleton (Figure 4A; 20a | the expandable features together may define, and therein include a hydrostatic skeleton, given they form a frame structure [skeleton] that relates to fluids at rest or to the pressures they exert [hydrostatic]), each hydrostatic skeleton defining a fluid channel through the hydrostatic skeleton (Figure 5A; flow passages 34a define fluid channels); expanding the at least one radially expandable feature from a collapsed configuration (Figure 3A) to an expanded configuration to allow blood flow from a point upstream of the at least one radially expandable feature, around and/or through the at least one radially expandable feature, and to a point downstream of the at least one radially expandable feature (Figure 4A; arrows).
Claim(s) 1, 5, 6, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madrid et al. reference (US 2016/0206425, hereinafter Madrid).
Concerning claim 1, the Madrid et al. prior art reference teaches a device (Figures 1-10; 10), comprising: a tubular member (Figure 2A; 26); and one or more radially expandable features (Figure 2B; 50, 52) configured to be selectively expanded from a collapsed configuration (Figure 7) to an expanded configuration (Figure 9) to allow blood within a blood vessel of a patient to flow from a point upstream of the one or more radially expandable features, around and/or through the one or more radially expandable features, and to a point downstream of the one or more radially expandable features (Figure 9; blood may flow through gaps 60), wherein the one or more radially expandable features includes a hydrostatic skeleton (Figure 4; 52 | the expandable features together may define, and therein include a hydrostatic skeleton, given they form a frame structure [skeleton] that relates to fluids at rest or to the pressures they exert [hydrostatic]), each hydrostatic skeleton defining a fluid channel through the hydrostatic skeleton (Figure 4; flow passages 60 define fluid channels).
Concerning claim 5, the Madrid reference teaches the device according to claim 1, wherein at least one of the one or more radially expandable features has a different axial length than another of the one or more radially expandable features (Figure 3; inner balloon 50 is longer than outer balloons 52).
Concerning claims 6 and 8, the Madrid reference teaches the device according to claim 1, wherein the one or more radially expandable features comprises a plurality of radially expandable features (Figure 6; 72, 74), wherein each of the plurality of radially expandable features is separated from an adjacent radially expandable feature, and wherein a circumferential separation distance of a first pair of the plurality of adjacent radially expandable features (Figure 6; 72) is different from a circumferential separation distance of a second adjacent pair of the plurality of adjacent expandable features (Figure 6; 74).
Claim(s) 1, 10, 16, 17, 27, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harrison et al. (US 5,554,119, hereinafter Harrison).
Concerning claim 1, the Harrison et al. prior art reference teaches a device (Figures 10-13; 200), comprising: a tubular member (Figure 10; 208); and one or more radially expandable features (Figure 11; 210, 212, 214, 216, 218, 220) configured to be selectively expanded from a collapsed configuration (Figure 12) to an expanded configuration (Figure 13) to allow blood within a blood vessel of a patient to flow from a point upstream of the one or more radially expandable features, around and/or through the one or more radially expandable features, and to a point downstream of the one or more radially expandable features (Figure 11; blood may flow through central channel of 202), wherein the one or more radially expandable features includes a hydrostatic skeleton (Figure 11; 220 | the expandable features together may define, and therein include a hydrostatic skeleton, given they form a frame structure [skeleton] that relates to fluids at rest or to the pressures they exert [hydrostatic]), each hydrostatic skeleton defining a fluid channel through the hydrostatic skeleton (Figure 11; 224).
Concerning claim 10, the Harrison reference teaches the device according to claim 1, wherein at least one radially expandable feature is disposed in a helical pattern on the outer surface of the tubular member (Figure 11; 202).
Concerning claim 16, the Harrison et al. prior art reference teaches a device (Figures 10-13; 200), comprising: a tubular member (Figure 10; 208); and a hydrostatic skeleton coupled to the tubular member (Figure 10; 202), the hydrostatic skeleton configured to be selectively expanded from a collapsed configuration (Figure 12) to an expanded configuration (Figure 13) to create at least a first channel for allowing blood to flow from a point upstream of the hydrostatic skeleton, through the first channel, to a point downstream of the hydrostatic skeleton (Figure 13).
Concerning claim 17, the Harrison reference teaches the device according to claim 16, wherein the hydrostatic skeleton is configured to be selectively inflated or deflated to create at least the first channel and a second channel (Figure 18; hydrostatic skeleton may be split into to portions, therein defining two channels).
Concerning claim 27, the Harrison reference teaches the device according to claim 17, wherein the diameter of the first channel increases when the hydrostatic skeleton is inflated (Figures 13 & 14).
Concerning claim 28, the Harrison reference teaches the device according to claim 17, wherein each portion of the hydrostatic skeleton may be defined as an annular ring of the hydrostatic skeleton (Figure 18; 322ab).
Claim(s) 1 and 12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Anderson et al. (US 2022/0249108, hereinafter Anderson).
Concerning claims 1 and 12, the Anderson et al. prior art reference teaches a device (Figures 1A-C; 102), comprising: a tubular member (Figure 1A; 112); and one or more radially expandable features (Figure 1C; 114) configured to be selectively expanded from a collapsed configuration (Figure 1A) to an expanded configuration (Figure 1B) to allow blood within a blood vessel of a patient to flow from a point upstream of the one or more radially expandable features, around and/or through the one or more radially expandable features, and to a point downstream of the one or more radially expandable features (Figure 1B; blood may flow through central channel of 106), wherein the one or more radially expandable features includes a hydrostatic skeleton (Figure 1C; 114 | the expandable features together may define, and therein include a hydrostatic skeleton, given they form a frame structure [skeleton] that relates to fluids at rest or to the pressures they exert [hydrostatic]), each hydrostatic skeleton defining a fluid channel through the hydrostatic skeleton (Figure 2C; gaps between balloons 214 define a fluid channel), wherein at least one radially expandable feature has a polygonal cross-section (Figure 1C; 114).
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 MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN T TON/Examiner, Art Unit 3771 12/11/2025