DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 12 December 2025 has been entered. Claim(s) 12-20 has/have been canceled. New claim(s) 21-28 has/have been added. Claim(s) 1-11 and 21-28 is/are pending.
Election/Restrictions
Applicant's election without traverse of Invention I (claims 1-11 and 21-29) in the above-noted reply is acknowledged.
Information Disclosure Statement(s) ("IDS")
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular reference in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this Office action.
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 ("BRI") 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 BRI 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(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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), 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), 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) 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: "stabilizer structure" and "stabilizer member" in claim(s) 1 and 28 (and claims dependent thereon).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), 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), Applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
Claim Rejections - 35 USC § 112
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 22, 27 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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.
Regarding claim 22 and claims dependent thereon, the limitation the sensor-holding extension comprises a curved cradle form shaped as a cylindrical arc segment, the curved cradle form including opposing sidewall segments configured to partially rise along an outer surface of the sensor device so as to nest the sensor device therein" are indefinite, particularly the "so as to nest the sensor device therein" portion thereof. Specifically, as there is no explicit indication as to the shape of the sensor device recited in the claim, it is unclear what limit(s), if any, the "nesting" or ability to nest the sensor device within the curved cradle form, is intended to place on the shape of the sensor device. Does "nesting" require complementary shapes (i.e., sensor-holding extension forming the curved cradle/cylindrical arc segment is shaped to receive and retain a cylindrical sensor device, as described/illustrated throughout the application as filed), or if "nesting" only requires the sensor device to be of an adequate size to be placed in the cradle, regardless of its shape?
Regarding claim 27 and claims dependent thereon, the limitation "a distal cross-bar of the sensor-holding extension is configured to be deflected to extend transversely across a lower peripheral portion of the cylindrical arc segment is a positioned to intersect a distal profile of the sensor device…" is syntactically unclear, particularly the "arc segment is a positioned to intersect" portion thereof, and is therefore indefinite. Further, the scope of "to be deflected" is indefinite, as it is unclear from what said cross-bar is deflected. To the best of the examiner's understanding, Applicant appears to be reciting the features of disclosed distal stopper bar 644 (e.g., ¶ [0139]; Fig. 15D; etc.) and will be further discussed with this understanding below.
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 and 6-11 is/are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by US 2008/0071178 A1 ("Greenland").
Regarding claim 1, Greenland discloses a sensor-retention structure (e.g., Figs. 6A-D) comprising:
a sensor-support arm configured to hold a sensor device (hub portion 368 including shank members 380, 382 and annular ring 379; ¶ [0046] an implantable medical device, e.g., implantable physiologic sensor, is adapted to be coupled to/held by the hub portion 368); and
a stabilizer structure associated with the sensor-support arm (e.g., Fig. 6C structure of the intermediate portion 372 and distal portion 376, e.g., structure comprising diverging arms 388, 390) and configured to project away from the sensor-support arm and provide stabilizing support for the sensor-support arm (e.g., ¶ [0048] nested jaw structures extending from the distal ends of the diverging arms engage the inner surface of a target vessel to fixate the sensor assembly therein).
Regarding claim 2, Greenland discloses the stabilizer structure comprises an elongate leg portion (intermediate portion 372 of the above-noted structure, less hinge elements 384, 386); an end portion (distal portion 376 of the above-noted structure); and a base portion that is integrated with the sensor-support arm (hinge elements 384, 386 extending distally from the shank members 380, 382).
Regarding claims 3-4, Greenland discloses the stabilizer structure is configured to bend at the base portion to cause the end portion of the stabilizer structure to project away from a distal end and a proximal end of the sensor-support arm (e.g., ¶ [0049] the hinge configuration allows the intermediate and distal portions 372, 376 to be collapsed and expanded radially inwardly, as indicated by the arrow R in Fig. 6B, wherein said expansion causes the end portion stabilizer to project, e.g., radially, away from the either end of the sensor-support arm/hub portion 368).
Regarding claim 6, Greenland discloses the end portion of the stabilizer structure comprises two feet configured to be bent in opposite directions (e.g., Fig. 6B, peripheral surface 404 and peripheral surface 406 bent in opposite directions).
Regarding claim 7, Greenland discloses the end portion comprises a foot portion (peripheral surface 404) having a width at one or more portions thereof that is greater than a width of the elongate leg portion (e.g., Fig. 6C, where the anchor is wider at the peripheral surface 404 than at the intermediate portion 372).
Regarding claim 8, Greenland discloses the end portion comprises a foot portion ((peripheral surface 404) that is configured to deflect at an angle relative to the elongate leg portion to provide a tissue-contact surface (e.g., Fig. 6B, bend/angle proximal to peripheral surfaces 404, 406).
Regarding claims 9-10, Greenland discloses the stabilizer structure comprises a first leg and a second leg relatively oriented in parallel (e.g., Fig. 6C, where peripheral surfaces 404 of each nested jaw are parallel).
Regarding claims 9 and 11, Greenland discloses the stabilizer structure comprises a first leg and a second leg angled relative to one another (Fig. 6B, upper arm and lower arm that are angled).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenland in view of US 2020/0023186 A1 ("Reddy").
Regarding claim 5, Greenland discloses the limitations of claim 2, as discussed above, but does not disclose the end portion of the stabilizer structure has an atraumatic coating disposed over at least a portion thereof.
Reddy discloses a retention structure (e.g., retention device 700) having an atraumatic coating disposed over at least a portion thereof (e.g., ¶ [0100] above-noted device may comprise a nitinol or other metal base piece that is coated with a polymer such as a silicone or other polymer that may reduce trauma).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor-retention structure of Reddy with the end portion of the stabilizer structure (e.g., the tissue contacting portion) having an atraumatic coating disposed over at least a portion thereof as taught/suggested by Reddy in order to reduce trauma associated with deploying the device (Reddy, ¶ [0100]).
Claim(s) 21 and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/123338 A1 ("Rowe") in view of US 2015/0230742 A1 ("Silver").
Regarding claim 21, Rowe discloses and/or suggests a sensor-retention structure (e.g., Fig. 6) comprising:
a shunt body shaped for implantation in a tissue wall separating first and second anatomical spaces (shunt structure 620), the shunt body defining a flow channel that passes through the tissue wall when implanted (generally circular or oval opening defining a flow channel, e.g., channel 166 of Fig. 4);
a plurality of tissue-engaging anchor arms extending from the shunt body and configured to deploy radially outward to engage tissue on opposite sides of the tissue wall to thereby secure the shunt body in the tissue wall (arms 621, 623 on each side of the flow channel, e.g., Figs. 5, 7, etc.); and
a sensor-holding extension extending from one of the plurality of tissue-engaging anchor arms and shaped to receive and retain a sensor device (sensor support 627 including retention features 629).
Rowe does not disclose the structure comprises a sensor-stabilizing kickstand coupled to the sensor-holding extension, the kickstand including a base portion integrated with the sensor-holding extension and configured to bend, an elongate leg extending from the base portion, and a tissue-contact end portion configured to contact the tissue wall. However, Rowe does disclose the sensor-holding extension may be configured to be spaced from the tissue wall at an angled orientation relative to the tissue wall (¶ [0084]; Fig. 6, θ; etc.).
Silver discloses a structure (e.g., Fig. 21B) comprising a sensor-stabilizing kickstand (anchoring platform or positioning anchors 14) coupled to a sensor-holding extension (catheter containing sensor 20), the kickstand including a base portion integrated with the sensor-holding extension and configured to bend, an elongate leg extending from the base portion, and a tissue-contact end portion configured to contact the tissue wall (see, e.g., Fig. 21B, kickstand-type positioning anchors 14, which may be made from a shape-memory material and delivered to a monitoring site through a larger guide catheter, as discussed in ¶ [0406], indicating/suggesting the anchors can bend/collapse at the base toward the sensor catheter during said delivery).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor-retention structure of Rowe with a sensor-stabilizing kickstand coupled to the sensor-holding extension, the kickstand including a base portion integrated with the sensor-holding extension and configured to bend, an elongate leg extending from the base portion, and a tissue-contact end portion configured to contact the tissue wall to space the sensor-holding extension from the tissue wall at the an angled orientation relative to the tissue wall as taught/suggested by Silver in order to orient a sensing surface of the sensor device as desired (e.g., into a chamber cavity, Rowe, ¶ [0084]), prevent sensor movement, etc. (Silver, ¶ [0390]).
Regarding claim 28, Rowe discloses and/or suggests a sensor-retention structure (e.g., Fig. 6) comprising:
a tubular frame defining a flow passage (central flow channel (e.g., Fig. 4, channel 166) formed by a pair of side walls (e.g., Fig. 4, 170a, 170b) and end walls (e.g., Fig. 4, 172a, 172b);
a plurality of deployable anchor arms configured to deflect radially from an axial end of the tubular frame to secure the tubular frame relative to a tissue wall (Fig. 6, arms 621, 623 adapted to engage a tissue wall on each side of the flow channel, e.g., Figs. 5, 7, etc.); and
a sensor holder associated with one of the plurality of anchor arms (sensor support 627 including retention features 629) and configured to support an elongate cylindrical sensor device (sensor 610) in an orientation that is angled relative to an axis of the tubular frame and a plane of the tissue wall (e.g., ¶ [0084]; Fig. 9, etc.).
Rowe does not disclose the structure comprises a stabilizer member coupled to the sensor holder, the stabilizer member comprising a bendable base portion, an elongate leg extending from the base portion, and a tissue-contacting end portion, the stabilizer member being configured to bend away from the sensor holder such that the tissue-contacting end portion engages the tissue wall and cooperates with the sensor holder to establish a controlled angular orientation of the sensor holder relative to the tissue wall.
Silver discloses a structure (e.g., Fig. 21B) comprising a stabilizer member (anchoring platform or positioning anchors 14) coupled to a sensor holder (catheter containing sensor 20), the stabilizer member comprising a bendable base portion, an elongate leg extending from the base portion, and a tissue-contacting end portion, the stabilizer member being configured to bend away from the sensor holder such that the tissue-contacting end portion engages the tissue wall (see, e.g., Fig. 21B, kickstand-type positioning anchors 14, which may be made from a shape-memory material and delivered to a monitoring site through a larger guide catheter, as discussed in ¶ [0406], indicating/suggesting the anchors can bend/collapse at the base toward the sensor catheter during said delivery) and cooperates with the sensor holder to establish a controlled angular orientation of the sensor holder relative to the tissue wall (e.g., ¶ [0390])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor-retention structure of Rowe with a stabilizer member coupled to the sensor holder, the stabilizer member comprising a bendable base portion, an elongate leg extending from the base portion, and a tissue-contacting end portion, the stabilizer member being configured to bend away from the sensor holder such that the tissue-contacting end portion engages the tissue wall and cooperates with the sensor holder to establish a controlled angular orientation of the sensor holder relative to the tissue wall as taught/suggested by Silver in order to orient a sensing surface of the sensor device as desired (e.g., into a heart chamber, Rowe, ¶ [0084]), prevent sensor movement, etc. (Silver, ¶ [0390]).
Regarding claim 29, Rowe as modified discloses/suggests the limitations of claim 28, as discussed above, but does not disclose the stabilizer member is configured to bend to an angle substantially perpendicular to a length of the sensor holder. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the sensor-retention structure of Rowe with the stabilizer member being configured to bend to an angle substantially perpendicular to a length of the sensor holder because Applicant has not disclosed that the recited stabilizer member bend angle provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant appears to disclose any value between 15-165° as suitable (e.g., ¶ [0121]). As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with any suitable stabilizer member bend angle that positions the sensor into the desired location (e.g., heart chamber, Rowe, ¶ [0084]).
Allowable Subject Matter
Claim(s) 22 and claims dependent thereon would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Rowe as modified by Silver above discloses/suggests the limitations of claim 21. Rowe further discloses the sensor-holding extension further comprises a back-support band (a sensor support 627) and a retention finger(s) (one or more retention features 629 that may comprise clamps, straps, ties, sutures, collars, clips, tabs). Rowe/Silver as modified does not disclose and/or suggest the sensor-holding extension comprises a curved cradle form shaped as a cylindrical arc segment, the curved cradle form including opposing sidewall segments configured to partially rise along an outer surface of the cylindrical sensor device so as to nest the sensor device therein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791