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 .
Specification
The disclosure is objected to because of the following informalities: the specification contains apparent typographical errors. Specifically, in paragraphs [0018]-[0019], each occurrence of "application of the portion of the blood vessel" should be amended/corrected to "applanation of the portion of the blood vessel."
Appropriate correction is required.
Claim Objections
Claim(s) 5-6 is/are objected to because of the following informalities: as with the specification as discussed above, each occurrence of "application of the portion of the blood vessel" should be amended/corrected to "applanation of the portion of the blood vessel."
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 ("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: "a surgical implantation tool that positions the first portion and the second portion of the sensor on opposite sides of the blood vessel in a selected x-y-z alignment" in claim(s) 2-6.
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. The corresponding disclosed structure is a J-shaped surgical tool as best illustrated in Applicant's Figure 7.
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) 10 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 10 and claims dependent thereon, the limitation "promoting tissue ingrowth of the portion of the peripheral artery sufficient to couple the portion of the peripheral artery to one of the support structure and the sensor" is indefinite. Claim 9 requires providing a support structure having a tissue ingrowth surface for the peripheral artery. It is unclear what additional steps, if any, are required to "promot[e] tissue ingrowth." Applicant discloses providing a tissue ingrowth surface (e.g., openings, apertures, textured or porous architecture, etc.) facilitates ingrowth of adjacent tissue (e.g., ¶ [0048]). Accordingly, it is unclear if the limitations of claim 10 are met by providing the support structure having a tissue ingrowth surface, or requires additional steps, such as, e.g., coating the sensor module retaining device or sensor module with an agent and/or drugs to further promote said ingrowth (e.g., ¶ [0058]).
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 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2007/0163353 A1 (Lec).
Regarding claim 1, Lec discloses a method of associating a sensor with a blood vessel, comprising:
providing a sensor defining a passage therethrough (implantable blood pressure sensor, or tonometer, including a support structure (including any insert(s) therein, e.g., ¶¶ [0165]-[0166]) and sensor head), the sensor comprising a first portion and a second portion (support structure and sensor head), each defining a portion of the passage through the sensor, for cooperatively encircling the blood vessel (see, e.g., Figs. 2-3, 6, 8, 12, etc.), and
at least partially encircling the outside wall of the blood vessel with at least a portion of the sensor (e.g., Figs. 2-3, 6, 8, 12, etc.; ¶ [0169] encircling the artery with the tonometer); and
compressing the passage through the sensor until a portion of the blood vessel is flattened such that the sensor is positioned within the area of vessel wall flattening. (¶¶ [0047]-[0048] the sensing head compresses the artery to provide an elongated, flat area, e.g., Fig. 2, 8, etc.), and
positioning a pressure/force transducer of the sensor within the area of vessel wall flattening by mechanically coupling a pressure/force transducer to the outside wall of the blood vessel in an area of vessel wall flattening (¶¶ [0047-0048] transducer(s), e.g., an array of force sensors, of the sensor/sensing head is placed on the elongated, flat area, e.g., when the sensor head and support structure are connected using a tongue-and-groove mechanism (e.g., ¶ [0183]m Figs. 2, 8; etc.); and/or ¶ [0162] coupling mechanism/rigid plastic pin for coupling the artery and transducer when the sensor head and support structure are connected; etc.).
Regarding claim 8, Lec discloses the passage therethrough of the sensor encircles the blood vessel with at least a portion of the sensor and reduces the diameter of the passage through of the sensor until a portion of the blood vessel is flattened (e.g., ¶ [0047] the support structure has dimensions and/or geometry which allows the sensing head to compress and flatten the artery decreasing the distance between the top and the bottom of the artery by 5 to 20% of arteries original size (outer diameter), e.g., Figs. 2, 8, etc.), wherein the pressure/force transducer measures pressure within the blood vessel and outputs a signal to an electronic module that analyzes and displays the blood vessel blood pressure waveform and calculates blood pressure based upon a sensed movement (¶¶ [0040]-[0041] an electronic device may be used receive sensor output, correlate said output with blood pressure, transmit information on blood pressure to a user, e.g., by displaying sensor response numerically or graphically on a panel display; Fig. 3; ¶ [0151]; etc.).
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) 2-5 is/are rejected under 35 U.S.C. 103 as obvious over Lec.
Regarding claims 2-3, Lec discloses the sensor comprises a first portion and a second portion, each defining a portion of the passage through the sensor, for cooperatively encircling the blood vessel, and positioning the sensor (e.g., at least the pressure/force transducer thereof) within the area of vessel wall flattening, as discussed above. Lec further discloses, for implantable embodiments, the method may comprise providing a surgical implantation tool (e.g., ¶ [0169] hook-like support structure) that positions the first portion and the second portion of the sensor on opposite sides of the blood vessel in at least a z-axis alignment and urging the first portion toward the second portion to join the first portion and the second portion, thereby encircling the blood vessel (i.e., compressing the artery against the sensor head using the support structure) (e.g., ¶ [0169] hook-like support structure includes a micrometer screw for elevating the support structure to push against the force transducer; ¶ [0047] the support structure has dimensions and/or geometry which allows the sensing head to compress the artery). Lastly, Lec discloses the applanation level and the support for the artery may be provided by the geometry of the support structure, which may be attached to the sensor head by a tongue-and-groove mechanism (e.g., ¶ [0183]). In view of the above, though Lec does not expressly disclose the surgical implantation tool positions the first portion and the second portion of the sensor on opposite sides of the blood vessel "in a selected x-y-z alignment," it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lec with the provided surgical implantation tool positioning the first portion and the second portion of the sensor on opposite sides of the blood vessel in a selected x-y-z alignment in order to facilitate aligning the complementary portions of the attachment mechanism on the first and second portions (e.g., tongue-and-groove mechanism) to provide and subsequently maintain (e.g., via said attachment mechanism) a stable position on the artery with respect to the transducer sensing area (Lec, ¶ [0169]).
Regarding claims 4-5, Lec as modified discloses/suggests flattening a portion of the blood vessel causes at least 10% or at least 15% applanation of the portion of the blood vessel (¶ [0047] 5-20% applanation; ¶ [0149] 8-22% applanation; etc.).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as obvious over Lec as applied to claim(s) 3 above; or alternatively, over Lec as applied to claim(s) 3 above, and further in view of US 6,015,386 A (Kensey).
Regarding claim 6, Lec as modified discloses/suggests the limitations of claim 3, as discussed above, but does not expressly disclose flattening a portion of the blood vessel causes at least 25% applanation of the portion of the blood vessel. 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 of Lec with flattening a portion of the blood vessel causing at least 25% applanation of the portion of the blood vessel because Applicant has not disclosed that disclosed causing the claimed level, or range of levels, of applanation provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, the specification as filed appears to treat 25% applanation as an upper limit of a suitable or preferred range (¶ [0026] "up to 25% applanation"; ¶ [0045] "to produce an amount of applanation (10% to 25% flattening) of the target blood vessel 16"; ¶ [0066] "joining the sensor portions causes applanation of the blood vessel in the range of 10% to 25%"; etc.). Accordingly, 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 the level of applanation disclosed by Lec/Lec as modified because either arrangement permits positioning the transducer on a flattened portion of the blood vessel for pressure measurement(s).
Alternatively/Additionally, Kensey discloses a comparable method, disclosing flattening a portion of a blood vessel to cause at least 25% applanation of the portion of the blood vessel (e.g., col. 6, line 65 - col. 7, line 4, flattening approximates a reduction in cross-sectional area of about 30-35 percent). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lec with flattening a portion of the blood vessel to cause at least 25% applanation of the portion of the blood vessel as taught and/or suggested by Kensey (e.g., 30-35%) in order to ensure any stress detected by the transducer is solely a function of blood pressure within the artery while having a negligible effect on blood flow (Kensey, col. 6, line 65 - col. 7, line 4) and/or as a simple substitution of one suitable amount of applanation of the blood vessel suitable for measuring pressure therein for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 7 and 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lec in view of US 2016/0287094 A1 (Joseph).
Regarding claim 7, Lec discloses the limitations of claim 1, as discussed above, but does not disclose the method further comprises promoting tissue ingrowth into at least a portion of the sensor to enhance mechanical coupling of the sensor to the blood vessel in the area of flattening. However, Lec does disclose the sensor should be/remain stable for accurate measurements (e.g., ¶ [0163]; ¶ [0183]; etc.).
Joseph discloses a comparable sensor comprising first and second portions (sensor housing 26 and sensor module retaining element 34) encircling the outside wall of a blood vessel (e.g., Figs. 1-4), wherein the sensor is configured to promote tissue ingrowth into at least a portion thereof to enhance mechanical coupling of the sensor to the blood vessel (e.g., ¶ [0030] the inner surface of each link 36 of sensor module retaining element 34 may define a porous/textured surface such that it may fuse with vessel wall tissue such that the wall and links 36 may move substantially simultaneously during pulsatile blood flow and/or links 36 may also have one or more through and through openings or channels that permit the ingrowth of vessel wall tissue and vaso-vasorum).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lec to comprise promoting tissue ingrowth into at least a portion of the sensor to enhance mechanical coupling of the sensor to the blood vessel in the area of flattening as taught/suggested by Joseph in order to maintain/further enhance stability of the sensor during long term use (Joseph, ¶ [0030]).
Regarding claims 9-10 and 14, Lec discloses/suggests a method of surgically implanting a sensor within a human body, comprising:
locating a peripheral artery at the approximate level of an aortic valve (¶ [0071] the potential tonometer implantation may be around a muscular artery close to the aortic valve preferably inside the rib cage, e.g., mammary or internal thoracic artery);
measuring an outer diameter of the peripheral artery (¶ [0166] a surgeon may measure the diameter of the target artery with a caliper);
choosing an optimum size of a sensor module (sensor/sensing head) and a support structure (support structure, including any insert(s) therein, e.g., ¶¶ [0165]-[0166])) and providing the support structure for the peripheral artery (e.g., ¶ [0166] choosing an appropriate insert to optimize mechanical fixation and minimize vessel lumen compression for the measured target artery; ¶ [0180] the choice of the target artery may determine the tonometer size and shape; ¶ [0183] applanation level and support for the artery may be provided by the geometry of the support structure);
positioning a portion of the peripheral artery within the support structure (e.g., ¶ [0169] artery may be encircled by the tonometer; Figs. 2, 8, 17, etc.);
positioning a sensor module over the portion of the peripheral artery with sufficient force to deform the peripheral artery and to join the sensor module to the support structure (e.g., ¶ [0169] using a micrometer screw to push the support structure and artery against the force transducer to compress/flatten the artery; ¶ [0047] the sensing head compresses the artery); and
joining the support structure to the sensor module to maintain the deformation of the peripheral artery (¶ [0183] the support structure may be attached to the tonometer housing by the tongue-and-groove mechanism, for example, to secure a very stable measurement platform after the support structure is fixed, e.g., Figs. 2, 8, 17, etc.), thereby mechanically securing an array of force transducers to the outer surface of the blood vessel wall (¶¶ [0047-0048] transducer(s), e.g., an array of force sensors, of the sensor/sensing head is positioned on the elongated, flat area, e.g., when the sensor head and support structure are connected using a tongue-and-groove mechanism (e.g., ¶ [0183]m Figs. 2, 8; etc.); and/or ¶ [0162] coupling mechanism/rigid plastic pin for coupling the artery and transducer when the sensor head and support structure are connected; etc.)
Lec does not disclose the measuring the outer diameter of the peripheral artery with ultrasound. Rather, as noted above, Lec discloses using calipers for said measurement.
Joseph discloses a comparable method comprising measuring an outer diameter of the peripheral artery with ultrasound (¶ [0023] ultrasound may be used to measure the artery wall outer diameter, wall thickness, and inner diameter to determine the appropriate length/size of the housing 12, the first portion 14, and the second portion 22); and choosing an optimum size of at least a sensor module for the measured artery (¶ [0023] the surgeon may select from pre-fabricated bases with a particular height of the first portion 14 and length of the second portion 22 to accommodate differently sized vessels).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lec with measuring the outer diameter of the peripheral artery with ultrasound as taught and/or suggested by Joseph as a simple substitution of one suitable means for measuring vessel diameter to determine the appropriate sensor size(s) for another to yield no more than predictable results. See MPEP 2143(I)(B).
Lec as modified does not disclose the support structure has a tissue ingrowth surface. However, Lec does disclose the sensor should be/remain stable for accurate measurements (e.g., ¶ [0163]; ¶ [0183]; etc.).
Joseph discloses a comparable sensor comprising a support structure (sensor module retaining element 34) encircling the outside wall of a blood vessel (e.g., Figs. 1-4), wherein the support structure has a tissue ingrowth surface to promote tissue ingrowth of the blood vessel sufficient to couple the portion of the blood vessel to the support structure (e.g., ¶ [0030] the inner surface of each link 36 of sensor module retaining element 34 may define a porous/textured surface such that it may fuse with vessel wall tissue such that the wall and links 36 may move substantially simultaneously during pulsatile blood flow and/or links 36 may also have one or more through and through openings or channels that permit the ingrowth of vessel wall tissue and vaso-vasorum).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lec with the support structure having a tissue ingrowth surface to promote tissue ingrowth of the portion of the peripheral artery sufficient to couple to the portion of the peripheral artery to the support structure as taught and/or suggested by Joseph in order to maintain/further enhance stability of the sensor during long term use (Joseph, ¶ [0030]).
Regarding claims 11-13, Lec as modified discloses/suggests the force to deform the portion of the peripheral artery is sufficient to cause at least 10%, at least 15%, or up to 25% applanation of the portion of the peripheral artery (¶ [0047] 5-20% applanation; ¶ [0149] 8-22% applanation; etc.).
Regarding claim 15, Lec as modified discloses/suggests when the sensor module is positioned over the portion of the peripheral artery with sufficient force to deform the peripheral artery and the sensor module is joined to the support structure, the sensor module and the support structure cooperatively encircle the blood vessel (e.g., Figs. 2, 8, 17, etc.).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lec in view of Joseph as applied to claim(s) 9 above, and further in view of US 5,693,088 A (Lazarus).
Regarding claim 10, Lec as modified discloses/suggests the limitations of claim 9, as discussed above, and further discloses promoting tissue ingrowth of the portion of the peripheral artery sufficient to couple the portion of the peripheral artery to the support structure by providing the support structure with a tissue ingrowth surface, as noted above.
Alternatively/Additionally, Lazarus discloses providing a support structure with a tissue ingrowth surface; and further promoting tissue ingrowth of an artery sufficient to couple said artery to said support structure (e.g., col. 9, lines 1-17, where an attachment means has a porosity and is treated with a substance to promote healing and ingrowth of tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lec with promoting tissue ingrowth of the portion of the peripheral artery sufficient to couple the portion of the peripheral artery to at least the support structure (e.g., further coating the support structure with a substance for promoting tissue ingrowth) as taught/suggested by Lazarus in order to facilitate initiation of incorporation of the sensor into the vessel environment (Lazarus, col. 9, lines 1-17).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791