DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
CLAIM INTERPRETATION
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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 35 U.S.C. 112 (pre-AIA ), 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) 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "the plurality of transverse grooves" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-3, 5, 6, 10, 12 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shiono et al. (JP 2009165822A).
Regarding claim 1, Shiono discloses a puncture needle (4; Fig. 6) includes a rod-shaped main body portion. A first ultrasound reflection structure (R1; dimples;12) formed in the main body portion and a second ultrasound reflection structure (R2; 12) formed in the main body portion and arranged on a proximal end side in an axial direction of the main body portion with respect to the first ultrasound reflection structure. The second ultrasound reflection structure is located separated from the first ultrasound reflection structure in the axial direction.
Regarding claim 2, Shiono discloses that the main body portion includes a rod-shaped body portion and a needle tip portion (Fig. 6) arranged at a distal end of the body portion. The first ultrasound reflection structure (R1) is located at the needle tip portion and the second ultrasound reflection structure (R2; Fig. 6) is located at the body portion.
Regarding claim 3, Shiono discloses that the first ultrasound reflection structure is located at a distal end portion of the needle tip portion (Fig. 6).
Regarding claim 5, Shiono discloses that the needle tip portion has a pyramid shape (Fig. 6).
Regarding claim 6, Shiono discloses that the body portion is formed in a cylindrical shape and the needle tip portion has an opening that communicates an internal space and an external space of the body portion (Fig. 6).
Regarding claim 10, Shiono discloses that the first ultrasound reflection structure comprises a plurality of circular recesses in the form of dimples (12;Fig. 6).
Regarding claim 12, Shiono discloses that the second ultrasound reflection structure comprises a plurality of annular grooves in the form of dimples (12) that are adjacent to each other in the axial direction of the main body portion (Fig. 6).
Regarding claim 20, Shiono discloses that a rod-shaped main body portion, a first ultrasound reflection structure (R1; Fig. 6) formed in the main body portion, and a second ultrasound reflection structure (R2) formed in the main body portion and arranged on a proximal end side in an axial direction of the main body portion with respect to the first ultrasound reflection structure. The second ultrasound reflection structure is located separated from the first ultrasound reflection structure in the axial direction (Fig. 6) and the first ultrasound reflection structure comprises a plurality of grooves or recesses (12), and the second ultrasound reflection structure comprises a plurality of grooves or recesses (12; Fig. 6).
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) 4 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shiono in view of Quearry (US 2014/0265024A1).
Regarding claim 4, Shiono does not disclose that the second ultrasound reflection structure comprises a spiral groove formed on an outer peripheral surface of the body portion.
In the same field of endeavor, echogenic needles, Quearry teaches a variety of geometric configurations of features (30; ultrasound reflection structure), e.g. dimples, divots, grooves, lines or ridges (30;[0049]) to increase or modify the echogenic response across a range of frequencies and spatial orientations between and ultrasound transducer and device (20; [0047]). The ultrasound reflection structure is in a helical or spiral pattern [0043]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the dimples/grooves of Shiono as a helical pattern, as taught by Quearry, for greater visibility around the circumference, allowing the physician to maintain the location of the device across a wider range of needle insertion angles, transducer angles and depths of insertion [0043].
Regarding claim 11, the combination of Shiono and Quearry discloses a plurality of triangular recesses (Fig. 6). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the dimples/grooves of Shiono as a plurality of triangular recesses, as taught by Quearry, for greater visibility around the circumference, allowing the physician to maintain the location of the device across a wider range of needle insertion angles, transducer angles and depths of insertion [0043].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shiono in view of Fulton, III (US 6,053,870, “Fulton”).
Regarding claim 7, Shiono does not disclose that the first ultrasound reflection structure comprises a plurality of transverse grooves
In the same field of endeavor, echogenic needles, Fulton teaches a plurality of transverse grooves (12; Fig. 1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dimples/grooves of Shiono with transverse grooves, as taught by Fulton, as this modification involves the simple substitution of one echogenic feature with another for the predictable result of providing a relatively significant area to reflect incidence of ultrasonic energy, thus creating an ultrasonic echo that can be received over a substantial area and having an amplitude significant enough to provide the desired image on an appropriate monito or imaging device (C3;L23-30).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shiono in view of Fulton, III (US 2013/0267942A1, “Fulton”).
Regarding claim 8, Shiono does not disclose that the plurality of transverse grooves comprise a first transverse groove and a second transverse groove on a proximal end side of the first transverse groove and a length of the second traverse groove is greater than a length of the first transverse groove.
In the same field of endeavor, echogenic needles, Fulton teaches a plurality of transverse grooves (32; Fig. 3). 14C includes both ridges and indentations/grooves [0036] wherein a proximal ridge and proximal indentation has a length greater than a distal ridge and a distal indentation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dimples of Shiono with transverse grooves, as taught by Fulton, as this modification involves the simple substitution of one means of reflectivity for another for the predictable result of enhancing reflectivity of the needle by the presence and retention of small amounts of air within the transverse grooves.
Claim(s) 9, 16-18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shiono in view of Nguyen et al. (US 2017/0043100A1, “Nguyen”).
Regarding claims 9 and 16-18, Shiono does not disclose that the first ultrasound reflection structure comprises a plurality of intersecting grooves.
In the same field of endeavor, echogenic needles, Nguyen teaches a plurality of intersecting grooves (121; Fig. 1C), wherein the grooves have alternating proximal and distal facing peaks that are connected by lines that intersect at each peak [0036]. Each peak and connected line forms a V-shaped groove. The peaks may be arc-shaped which is interpreted as rounded [0036] and Fig. 1B discloses first and second sets that are arranged in a circumferential direction of the main body portion. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dimples of Shiono with the intersecting grooves, as taught by Nguyen, as this modification involves the simple substitution of one means of echogenicity for another for the predictable result of improving visibility under ultrasound to prevent improper insertion that can inhibit the success of a procedure [0027].
Regarding claim 19, Nguyen teaches a zigzag pattern that may be formed of grooves, recesses, channels, pits, pores or the like [abs]. Shiono discloses that the first ultrasound reflection structure comprises a plurality of circular recesses. Therefore, it would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to have arranged the recesses of Shiono a zig-zag lattice shape, as taught by Nguyen, for the predictable result of providing enhanced echogenicity regardless of the section of the needle underlying the ultrasound beam in use [abs].
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shiono in view of McWeeney et al. (US 2012/0116248A1, “McWeeney”).
Regarding claims 13-15, Shiono does not disclose that the second ultrasound reflection structure comprises a plurality of annular grooves that are adjacent to each other in the axial direction of the main body portion and each annular groove has an interrupted portion.
In the same field of endeavor, echogenic needles, McWeeney teaches a plurality of annular grooves (622; Fig. 10K) that are adjacent to each other in the axial direction of the main body portion and has an interrupted portion and include first and second sets of grooves. The annular grooves are oblique or slanted, not straight or parallel (Fig. 10K). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dimples/grooves of Shiono with the interrupted annular grooves, as taught by McWeeney, as this modification involves the simple substitution of one echogenic pattern for another for the predictable result of improving the visibility of the needle under endoscopic ultrasound [0087].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Crisman et al. (US 2017/0112528A1) and Giovannini et al. (US 2010/0160731A1) discloses echogenic needles with surface features.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771