DETAILED ACTION
The following Office Action is in response to the Response to Restriction filed on April 1, 2026. Claims 24-43 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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on May 28, 2026 is acknowledged. 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 § 818.01(a)).
Although the applicant states that claims 23-43 read on the election of Group I, the Restriction Requirement filed on April 1, 2026 clearly sets out that Group I is drawn towards claims 24-34. Given the applicant has elected Group I, and has not distinctly and specifically pointed out any supposed errors in the grouping of the inventions, claims 35-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 28, 2026.
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.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 32 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claim defines the conduit as a second vessel, wherein a vessel is directed to a human organism, therein claiming a part of a human organism.
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.
Claim(s) 24-27 and 32-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bagaoisan et al. (US 2010/0168789, hereinafter Bagaoisan).
Concerning claim 24, an arteriotomy formation system (Figures 1-8; 101), comprising: a center puncturing device, comprising: an elongated cylindrical body (Figure 1B; 130) including an outer wall that slidably engages an inner conduit wall of a conduit mated to a first vessel (Figure 4A; 20), the elongated cylindrical body including a centering passageway extending along a longitudinal axis of the elongated cylindrical body; and a puncturing element that is movable along the centering passageway ([¶ 0038], needle = puncturing element), the puncturing element being movable between a retracted configuration and an extended configuration, a distal end of the puncturing element being positioned within the centering passageway when in the retracted configuration, the distal end of the puncturing element extending out of the elongated cylindrical body when in the extended configuration (needle may be inserted into elongated cylindrical body, with its tip proximal to the distal end of the elongated cylindrical body defining a retracted configuration, and then extended out to puncture a vessel, defining an extended configuration), the puncturing element extending along the longitudinal axis of the elongated cylindrical body thereby allowing formation of a puncture along a wall of the first vessel at a position central to a conduit passageway of the conduit (needle inserted through lumen 136 of elongated cylindrical body); and an arteriotomy formation device, comprising: a tissue fixation element (Figure 1B; 140) including an elongate body having a fixation passageway extending along a length of the tissue fixation element (inflation lumen of 140); a tissue capturing element (Figure 1B; 146) configured to form a first configuration having a first outer diameter (deflated configuration) and a second configuration having a second outer diameter that is larger than the first outer diameter (inflated configuration), the first configuration allowing the capturing element to pass through the puncture (Figure 5A) and the second configuration allowing the tissue capturing element to capture cut out tissue from the wall of the first vessel (Figure 5B); and a tissue cutting element being moveable relative to the tissue fixation element and the tissue capturing element to form an arteriotomy along the wall of the first vessel (Figure 1B; 125), the tissue cutting element including an outer cutting wall that slidably engages the inner conduit wall of the conduit and forms an arteriotomy along the first vessel such that the arteriotomy is centered relative to the conduit passageway (Figure 1B; 120).
Concerning claim 25, the Bagaoisan reference teaches the arteriotomy formation system of claim 24, wherein the tissue capturing element includes an inflatable balloon ([¶ 0049]).
Concerning claim 26, the Bagaoisan reference teaches the arteriotomy formation system of claim 25, wherein the inflatable balloon forms a disc shape in the second configuration (Figure 5B; 146).
Concerning claim 27, the Bagaoisan reference teaches the arteriotomy formation system of claim 25, wherein the first outer diameter is smaller than a diameter of the puncture (Figure 4B; after puncture is dilated).
Concerning claim 32, the Bagaoisan reference teaches the arteriotomy formation system of claim 24, wherein the conduit is a sheath.
Concerning claim 33, the Bagaoisan reference teaches the arteriotomy formation system of claim 24, wherein the puncturing element may include a removable guidewire therethrough ([¶ 0038]).
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.
Claim(s) 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bagaoisan et al. (US 2010/0168789, hereinafter Bagaoisan) in view of Houser et al. (US 2007/0225642, hereinafter Houser).
Concerning claims 28 and 29, the Bagaoisan reference teaches the arteriotomy formation system of claim 24, but does not teach the cutting element comprising a radio-frequency electrode.
However, the Houser reference teaches a tissue cutting element to cut a portion of a tissue wall, wherein the reference teaches that the cutting element may include an RF electrode, which may define it as a distal probe configured to perform electrocautery (Houser; [¶ 0256]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the tissue cutting element of the Bagaosian reference include a radio-frequency electrode, therein defining it as a distal probe configured to perform electrocautery as in the Houser reference to provide a more complete circumferential cut through a vessel wall that prevents leaking or oozing (Houser; [¶ 0256]).
Claim(s) 30 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bagaoisan et al. (US 2010/0168789, hereinafter Bagaoisan) in view of Arevalos et al. (US 2019/0374254).
Concerning claim 30, the Bagaoisan reference teaches the arteriotomy formation system of claim 24, but does not teach the tissue cutting element comprising at least one expandable blade.
However, the Arevalos reference teaches an arteriotomy formation system similar to that of the Bagaoisan reference, wherein the Arevalos reference teaches a cutting element (Figure 1; 108) including at least one expandable blade (Arevalos; Figure 23).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the tissue cutting element of the Bagaoisian reference include at least one expandable blade as in the Arevalos reference to allow the cutting element to allow for excised tissue to be capture and retrieved (Arevalos; [¶ 0340]).
Concerning claim 34, the Bagaoisan reference teaches the arteriotomy formation system of claim 33, but does not teach the capturing element being configured to slidably travel along the guidewire.
However, the revalos reference teaches an arteriotomy formation system similar to that of the Bagaoisan reference, wherein the Arevalos reference teaches a capturing element that is configured to slidably travel along a guidewire (Arevalos; [¶ 0309]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the capturing element of the Bagaoisan reference be configured to slidably travel along the guidewire as in the Arevalos to assist in the guidance and delivery of the capturing element through the puncture (Arevalos; [¶ 0307-0310).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bagaoisan et al. (US 2010/0168789, hereinafter Bagaoisan) in view of Olson et al. (US 2016/0287797, hereinafter Olson).
Concerning claim 31, the Bagaoisan reference teaches the arteriotomy formation system of claim 33, but does not teach the elongated cylindrical body including a beveled distal end.
However, the Olsen reference teaches a pushing member for pushing out a sealing member similar to the functionality of the elongated cylindrical body of the Bagaoisan reference, wherein the Olsen reference teaches that the pushing member has a beveled distal end that matches a bevel of the sealing member (Figure 2).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the distal end of the elongated cylindrical body and the proximal end of the sealing member of the Bagaoisan reference be beveled as in the Olsen reference to provide the elongated cylindrical body and the sealing member with a matching substantially single planar surface to assist in deployment and translation of the sealing member (Olsen; [¶ 0030]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Popov et al. (US 5,702,412) reference teaches an arteriotomy formation system including a cylindrical body within a conduit, a puncturing element, and a tissue cutting element; the Goldsteen et al. reference (US 2001/0041931) teaches an arteriotomy formation system including a cylindrical body within a conduit, a puncturing element, a tissue fixation element, and a tissue capturing element; and the Berg et al. reference (US 2002/0108621) teaches a cylindrical body within a conduit, a tissue puncturing element, a tissue fixation element, a tissue capturing element, and a tissue cutting element.
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 7/11/2026
Prosecution Insights