DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/29/2024 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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:
“an operation portion…that is for operating the sheath and the needle tube” in claim 9.
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 “an operation portion…that is for operating the sheath and the needle tube” is described in the specification in paragraph [0015]-[0017] and will be interpreted as having a body and an operation member provided on the body for operating the sheath and needle tube, or equivalents thereof.
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 § 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 7 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.
The term “sharp needle tip” in claim 7 is a relative term which renders the claim indefinite. The term “sharp” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In essence, there is no boundary for when a needle tip is considered to be sharp or not, and thus the metes and bounds of the claim are indefinite.
For the purpose of advancing prosecution, the examiner will interpret the claim limitation as recite “a cutting needle tip” as that describes the function of the needle tip as intended in view of the specification without reciting the indefinite terminology.
Claim Rejections - 35 USC § 103
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 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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura (US 2022/0273274 A1).
Regarding claims 1-9; Nishimura discloses a needle tube (figures 5-20) comprising
a tubular body (element 54), wherein:
the body (element 54) has a slit (element 58) that extends in a longitudinal direction of the body from a distal end opening of the body toward a proximal end side, and that penetrates a side wall of the body in a radial direction (wherein slit element 58 extends from distal tip to cutting blade 60 into the sidewall of the tube body element 54; figures 5-20);
a length from a distal end of the body to a proximal end of the slit is 3 to 25 mm (wherein the disclosed range of 0.5 mm – 25.0 mm anticipated 3.0 – 25.0 mm with sufficient specificity; paragraphs [0018], [0108], claim 9; figure 3); and
an opening angle formed by two line segments connecting a center of the body and side ends on both sides of the slit in a width direction in a cross section perpendicular to a longitudinal axis of the body is less than 180° (wherein examiner notes that it discloses that the width B is less than the inner diameter element ID, and therefore such an angle formed from the ends of both sides of the slit must be less than 180° as it would be 180° is B was equal to ID; paragraph [0109]; figure 7).
However, Nishimura differs from the instant invention in that it does not explicitly disclose that the opening angle formed by two line segments connecting a center of the body and side ends on both sides of the slit in a width direction in a cross section perpendicular to a longitudinal axis of the body is between 30° to 90°.
The examiner first notes that the width (element B) of the slit (element 58) is directly related to the opening angle formed by two line segments connecting a center of the body and side ends on both sides of the slit in a width direction in a cross section perpendicular to a longitudinal axis of the body (see annotated figure 7 which exhibits that as B changes, then an angle formed between elements 64 and 66 and center point element 54C would inherently change). Further, although Nishimura is silent to the value for the width (element B, figure 7) of the slit (element 58); Nishimura does disclose that the width (element B) of the slit (element 58) can vary from a with larger than B (depicted by element B1 in figure 11) to a width smaller than B (depicted by element B2 in figure 12) to provide different functions for the slit (paragraphs [0109], [0117]-[0120]; figures 7, 11 and 12). As such, Nishimura establishes the width B as a result effective variable.
PNG
media_image1.png
792
507
media_image1.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the width B of Nishimura such that the opening angle formed by two line segments connecting a center of the body (element 54c) and side ends on both sides of the slit (elements 64 and 66) in a width direction in a cross section perpendicular to a longitudinal axis of the body to be between 30° to 90° as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Further regarding claim 2; Nishimura discloses the slit (element 58) has a narrow portion in a proximal end portion thereof (portion of slit defined by the curved cutting blade element 60 in figure 11), and the narrow portion has a width smaller than that of another portion of the slit (wherein Nishimura discloses the cutter element 60 is formed in a shape tapered toward the distal end of the slit, element 58; paragraph [0081]; and therefore the width of the slit at the distal end of by the cutter element 60 in figure 11 would be less than the width at the non-tapered portion where the cutter is not formed; see annotated figure 11 below).
PNG
media_image2.png
408
538
media_image2.png
Greyscale
Further regarding claim 3; Nishimura discloses the body may have a slit blade (element 60) that is formed of an outer circumferential surface of the body (outer surface of element 54) and a side surface of the slit (element 60D), which forms an acute angle with the outer circumferential surface (angle formed at 60a between the surface of 54 and surface of 60D; see figure 16); and a blade edge (element 60A) of the slit blade is located at a radially outer end of the side surface (paragraphs [0128]-[0129]; figure 16).
Further regarding claim 4; Nishimura discloses a product of the length and the opening angle is within a prescribed range (wherein the examiner notes that in the absence of a value for the range, modified Nishimura meets the BRI of the claim as there is inherently a range for the product of the length and the opening angle described in the rejection of claim 1).
Further regarding claim 5; Nishimura discloses body has a slit blade (part of blade defined by sidewalls of slit in figure 11) that is formed of an outer circumferential surface or an inner circumferential surface of the body and a side surface of the slit (wherein the side surface of the slit and the outer body of the tube form the cutting edge of sidewalls of slit element 58 in annotated figure 11), which forms an acute angle with the outer circumferential surface or the inner circumferential surface (wherein examiner notes that edge of blade is acute in annotated figure 11); and a position of the blade edge of the slit blade changes from a radially outer end of the side surface to a radially inner end thereof at an intermediate position in the longitudinal direction (wherein the blade edge moved to the radially inner surface at points 64 and 66 in figure 11; see annotated figure 11).
PNG
media_image3.png
420
652
media_image3.png
Greyscale
Further regarding claim 6; Nishimura discloses the body has a distal end blade (blade defined by sidewalls of tube element 55 and distal tip element 62) that is formed of an outer circumferential surface or an inner circumferential surface of the body (blade formed on inner circumferential surface as depicted in annotated figure 11 below) and a distal end surface of the body (element 62), which forms an acute angle with the outer circumferential surface or the inner circumferential surface (paragraph [0082]); and a position of a blade edge of the distal end blade changes from a radially outer end of the distal end surface to a radially inner end thereof at an intermediate position in the longitudinal direction (wherein the blade edge changes from the inner circumferential surface at tip element 62 to the outer circumferential surface at the sidewalls of the slit element 58 at an intermediate position; see annotated figure 11 below).
PNG
media_image4.png
435
717
media_image4.png
Greyscale
Further regarding claim 7-8; Nishimura discloses the body has a sharp needle tip (element 62) at the distal end thereof (see figures 3-20); and the slit (element 58) is provided at a position that does not overlap the needle tip, when the body is viewed in a direction along the longitudinal axis (wherein the examiner notes that needle tip element 62 extends distal of the defined slit and is thus does not overlap with the slit element 58; paragraph [0084]; figures 3-6, 9, 11-13 and 16-20).
Further regarding claim 8; Nishimura discloses the slit (element 58) is provided at a position where a straight line passing through the needle tip (element 62) and the longitudinal axis (element 54C) passes through the slit, when the body is viewed in the direction along the longitudinal axis (see at least figures 3-20, specifically 3, 4, 7, 9, 16).
Regarding claim 9; Nishimura discloses a biopsy device (figure 2) comprising:
a sheath (element 34);
the needle tube according to claim 1 (see rejection of claim 1 above), which is provided in the sheath (element 34) so as to be able to protrude from a distal end of the sheath (see figure 2); and
an operation portion (element 32) that is provided on a proximal end side of the sheath, and that is for operating the sheath and the needle tube (paragraphs [0057]-[0075]; figure 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2007/0123935 A1 to Myers; discloses a needle tube having a slit similar to the claimed invention (see at least figure 2 and 4).
US 2008/0281226 A1 to Peters; discloses a core biopsy device with specimen length adjustment which includes a needle tube with a slit similar to the claimed invention (see figure 5).
US 5,251,641 to Xavier; discloses a biopsy needle having a slit similar to the claimed invention (see figures 2, 3, 8, 11, and 12).
US 10,076,352 B2 to Oostman, Jr. et al; discloses an implantation needle which has a similar structure to the claimed needle tube (see figure 4a-4b, 5, 7a, 7b).
US 8,641,640 B2 to Lubock et al; discloses a tissue cutting member for a biopsy device.
US 4,708,147 to Haaga; discloses a universal biopsy needle.
US 7,201,722 B2 to Krueger; discloses a bone biopsy instrument having improved sample retention (see figure 3).
US 6,517,523 B1 to Kaneko et al; discloses a needle for a syringe.
US 9,017,299 B2 to Iwase et al; discloses a medical hollow needle.
US 11,793,942 B2 to Chopra; discloses a needle with mutli-bevel tip.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 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, Jacqueline Cheng can be reached at 571-272-5596. 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.
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
Prosecution Insights