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
The preliminary amendment filed 17 April 2024 has been entered.
Claim Objections
Claim 7 is objected to because of the following informalities: "TIPS" in line 2 should be --transjugular intrahepatic portosystemic shunt (TIPS)--. Appropriate correction is required.
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: remote read-out device in claim 1.
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.
The limitation is thus interpreted according to the descriptions of page 5 and 6 of the instant specification of a device located outside of the patient’s body which wirelessly receives pressure from the pressure sensors and allows the pressure difference to be read without performing a surgery.
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 § 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) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kim (US 20160022447 A1).
Regarding claim 1, Kim teaches an implant for determining a pressure difference inside a bodily lumen (Paragraph 0027—pressure-sensor-embedded-stent for performing in situ measurements of blood pressure inside a vessel and thus could provide advance notices of restenosis), comprising:
an implantable body (Fig. 5; paragraph 0012, 0027, 0029-- the stent wire), the implantable body comprising a first conductive element and a second conductive element, the first and second conductive elements being electrically insulated relative to each other (Fig. 5; paragraph 0040-- In some embodiments, the stent may be made from multiple wires… the wires, which are electrically insulated from one another),
first and second pressure sensors, the first and second pressure sensors being arranged for measuring a pressure occurring inside the body, the first and second pressure sensors being arranged at different locations (Fig. 5—multiple pressure sensor electrodes arranged at different locations along the helically wound coil; Paragraph 0029, 0040-- capacitive pressure sensors are built onto a cavity created on the stent wire… each wire includes two sensors…),
wherein the first pressure sensor is arranged for sending the pressure to a remote read-out device by means of being coupled to the first conductive element, with the first conductive element serving as an antenna (Paragraph 0012-- The 1 -component structure is realized by building a pressure sensor into the stent wire and utilizing the stent wire also as the signal radiation LC coupler and antenna; paragraph 0027-0029-- a pressure sensor- integrated stent where the pressure sensor acts as a capacitor and the stent coil behaves as an inductor for the resonance and simultaneously as an antenna to transmit the signal during resonance), and
wherein the second pressure sensor is arranged for sending the pressure to a remote read-out device by means of being coupled to the second conductive element, with the second conductive element serving as an antenna (Paragraph 0012, 0027-0029),
wherein the implantable body comprises a stent (Paragraph 0027-0029—a pressure-sensor-embedded-stent), wherein the stent is a wire stent comprising a section made of a helically wound wire, wherein the first conductive element and/or the second conductive element are part of the helically wound wire (Fig. 5; paragraph 0027-0029, 0040--the stent may be made from multiple wires),
wherein the first conductive element and the second conductive element are connected to each other by means of an insulating connector sheath (Paragraph 0040--the wires, which are electrically insulated from one another).
Regarding claim 2, Kim teaches the implant according to claim 1. Kim additionally teaches wherein the first conductive element and/or the second conductive element are made of a single piece of wire (Figs. 1 and 5; paragraph 0012, 0027-0029, 0040-- 1 -component structure…a wire tube… In some embodiments, the stent may be made from multiple wires NOTE: with multiple wires, each wire is a conductive element and thus a single piece of wire.).
Regarding claim 3, Kim teaches the implant according to claim 1. Kim additionally teaches wherein the stent further comprises a section made of a woven wire (Figs. 1 and 5; Paragraph 0040-- the stent may be made from multiple wires).
Regarding claim 4, Kim teaches the implant according to claim 1. Kim additionally teaches the stent being self-expanding (Figs. 1 and 5; Paragraph 0027-0029-- a minimally-profiled "on-wire" pressure sensor that is embedded in the stent to prevent any difficulties during insertion surgery… stents with discrete components impose challenges when they are inserted through arbitrarily-shaped vessels which might require bending of the stent….A one-component stent has been reported which utilizes the subtle stiffness/mass changes of the stent as the indication of restenosis…Note: the improvements over existing stents demonstrate that this stent configuration must be capable of self-expanding after navigation through tortuous vessels and in order to change in stiffness in a measurable manner).
Regarding claim 5, Kim teaches the implant according to claim 1. Kim additionally teaches wherein the first and the second pressure sensors are arranged at opposite longitudinal ends of the stent (Figs. 1 and 5, see positions of multiple pressure sensor electrodes).
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) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Gleich (US 20200397320 A1).
Regarding claim 6, Kim teaches the implant of claim 1. However, Kim does not explicitly teach wherein the stent is at least partially covered with a covering material to form a stent graft.
Gleich, in the same field of endeavor of an implantable pressure sensor for being introduced into the circulatory system, teaches that such a device has uses in “coronary stents, stents in aneurisms (pressure monitoring can help detect endo-leaks), transjugular intrahepatic portosystemic shunts (TIPS), or stents used in peripheral vascular disease” (Paragraph 0112).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the implant of Kim to be used with a stent which is at least partially covered with a covering material to form a stent graft as described by Gleich in order to predictably allow the implant to be used not only in the monitoring of restenosis (see Kim, paragraph 0027) but also in other instances of possible disease or device failure (see Paragraph 0111 of Gleich-- characterize pressure profiles in and around such devices to detect clogging or monitor disease progression) so that the implant may have a greater number of applications while having the same configuration and structure.
Regarding claim 7, Kim teaches the implant of claim 1. However, Kim does not explicitly teach wherein the stent graft is a TIPS stent graft.
Gleich, in the same field of endeavor of an implantable pressure sensor for being introduced into the circulatory system, teaches that such a device has uses in “coronary stents, stents in aneurisms (pressure monitoring can help detect endo-leaks), transjugular intrahepatic portosystemic shunts (TIPS), or stents used in peripheral vascular disease” (Paragraph 0112).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the implant of Kim to be used wherein the stent graft is a TIPS stent graft as described by Gleich in order to predictably allow the implant to be used not only in the monitoring of restenosis (see Kim, paragraph 0027) but also in other instances of possible disease or device failure (see Paragraph 0111 of Gleich-- characterize pressure profiles in and around such devices to detect clogging or monitor disease progression) so that the implant may have a greater number of applications while having the same configuration and structure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20190269339 A1 to Najafi discloses an implant for determining two pressures within a bodily lumen which comprises an implantable housing body having a first conductive element and a second conductive element as well as first and second pressure sensors.
US 20220323012 A1 to Pool teaches an implanted cardiac shunt or stent device including a pressure sensor or plurality of pressure sensors and a conductive element formed as a coiled wire which serves as an antenna.
US 20160310077 A1 to Hunter teaches an implantable body comprising a first and second pressure sensor (Sensor module 10 including pressure sensors 14; paragraph 0095) and a conductive element (antenna 22) for determining a pressure across a lumen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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, Alexander Valvis can be reached at (571) 272-4233. 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.
/ANNA ROBERTS/Examiner, Art Unit 3791