DETAILED ACTION
Claims 1-4, 6, 8-11, 13-14, 16-17, and 20-26 are hereby under examination.
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 06/14/2024 is being considered by the examiner.
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.
Claims 4 and 6 are 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.
Regarding claim 4, lines 1-2 recite “the shaft defines a longitudinal axis extending between a first end and a second end”. However, claim 1, line 2 recites “a shaft with a first end and a second end”. In light of the specification, it is current unclear if the first end and the second end recite in claim 4 is the same as, related to, or different from the first end and the second end recited in claim 1. For the purposes of examination, the two recitations are being interpreted as being the same. It is recommended to the Applicant to clearly recite if the elements are the same or different.
The dependent claims of the above rejected claim are rejected due to their dependency.
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.
Claims 1-4, 9-11, 13, 21, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burney et al. (US 20010001811 A1), hereinafter referred to as Burney.
The claims are generally directed towards a biopsy needle accessory comprising: a shaft with a first end, a second end, and a passageway extending between the first end and the second end; wherein the shaft includes a circumferential wall, an aperture formed in the circumferential wall, and a ramp positioned within the passageway at the aperture.
Regarding claim 1, Burney discloses a biopsy needle accessory (Abstract, Fig. 1, para. [0015-0016]) comprising:
a shaft with a first end, a second end, and a passageway extending between the first end and the second end (Fig. 2, element 20, 21, 22, Fig. 3, element 25, para. [0048], “cannula having a first end and a second end … cannula defines a lumen which extends between the first end and the second end …”);
wherein the shaft includes a circumferential wall (Fig. 2, Fig. 3, para. [0048], “cannula defines a lumen …”), an aperture formed in the circumferential wall (Fig. 3, element 24, para. [0049], “cannula also defines a lateral opening which is communication with the lumen … preferable adjacent the first end of the cannula …”), and a ramp positioned within the passageway at the aperture (Fig. 3, element 35, para. [0051], “ramp disposed within the cannula … ramp is inclined toward the lateral opening …”).
Regarding claim 2, Burney discloses the accessory of claim 1, wherein the passageway is configured to receive a biopsy needle such that the biopsy needle extends through the aperture (Fig. 4, element 11, para. [0062], “biopsy needle is sized and configured to be movable, rotatable and coaxially received within the lumen … configured to exit from the lumen through the lateral opening …”).
Regarding claim 3, Burney discloses the accessory of claim 1, wherein the aperture is formed in the circumferential wall at the second end (Fig. 3, element 24, para. [0049], “cannula also defines a lateral opening which is communication with the lumen … preferable adjacent the first end of the cannula …”).
Regarding claim 4, Burney discloses the accessory of claim 1, wherein the shaft defines a longitudinal axis extending between a first end and a second end (Fig. 2, Fig. 3, para. [0048], “cannula defines a lumen …”, [0049], “cannula also defines a lateral opening which is communication with the lumen … preferable adjacent the first end of the cannula …”); and wherein the ramp is oriented at an angle with respect to the longitudinal axis (Fig. 3, element 35, para. [0051], “ramp disposed within the cannula … ramp is inclined toward the lateral opening …”).
Regarding claim 9, Burney discloses the accessory of claim 1, wherein the shaft includes an axial end surface at the second end (Fig. 4, element 21, element 30, para. [0048], “cannula defines a lumen which extends between the first end …” - the first end as disclosed by Burney includes an axial end surface; para. [0052], “solid tip … secured to the fist end …”).
Regarding claim 10, Burney discloses the accessory of claim 1, further including a handle coupled to the first end of the shaft (Fig. 1, Fig. 2, element 40, para. [0056], “hub attached to the second end of the cannula”), wherein the handle includes a handle passageway coupled to the passageway of the shaft (Fig. 2, element 45, para. [0056], “hub defines a channel for delivering a biopsy needle to the cannula …”).
Regarding claim 11, Burney discloses the accessory of claim 10, wherein the handle passageway includes a funnel portion (Fig. 2, para. [0056], “channel of the hub is preferably funnel shaped … channel tapers from the second end of the channel to the first end of the channel …”); and wherein the handle includes a boss coupled to the first end of the shaft (Fig. 2, element 46, para. [0056], “first end of the channel surrounds the second end of the cannula …”).
Regarding claim 13, Burney discloses the accessory of claim 10, wherein the handle includes an indicia aligned with the ramp (Fig. 1, element 27, para. [0059], “cannula … includes a plurality of depth markings …” - depth markings are aligned on the same longitudinal axis as the ramp).
Regarding claim 21, Burney discloses a kit (Abstract, Fig. 1, para. [0015-0016]) comprising:
a biopsy needle (Fig. 1, element 11, para. [0048], “biopsy needle”); and
an accessory (Fig. 1) including a handle (Fig. 1, element 40, para. [0056], “hub …”) and a shaft (Fig. 2, element 20, Fig. 3, element 25, para. [0048], “cannula having a first end and a second end … cannula defines a lumen which extends between the first end and the second end …”), the shaft includes an aperture formed in a circumferential wall and a ramp positioned at the aperture (Fig. 2, Fig. 3, element 24, element 35, para. [0048], “cannula defines a lumen …”, para. [0049], “cannula also defines a lateral opening which is communication with the lumen … preferable adjacent the first end of the cannula …”, para. [0051], “ramp disposed within the cannula … ramp is inclined toward the lateral opening …”); and
wherein the biopsy needle is receivable within the shaft and configured to extend through the aperture (Fig. 4, element 11, para. [0062], “biopsy needle is sized and configured to be movable, rotatable and coaxially received within the lumen … configured to exit from the lumen through the lateral opening …”).
Regarding claim 26, Burney discloses the kit of claim 21, further including a stylet, wherein the stylet is receivable within the shaft (para. [0057], “hub also preferably includes a fitting end … configured for engagement with a stylet …”, para. [0061], “introduced stylet us received within the lumen …”).
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:
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.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Burney et al. (US 20010001811 A1), hereinafter referred to as Burney.
Regarding claim 6, Burney discloses the accessory of claim 4.
However, Burney does not explicitly disclose wherein the angle is within a range of 5 degrees and 30 degrees.
Burney clearly teaches that variability of the dimensions and dimensional relationships of the components (para. [0051], “slope of the ramp may be altered to obtain a desired angle of deflection of the needle as it exists the lateral opening”), which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Burney as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Claims 8, 14, 16-17, 20, and 22-25 rejected under 35 U.S.C. 103 as being unpatentable over Burney et al. (US 20010001811 A1), hereinafter referred to as Burney as applied to claims 1, 10, and 21 above, and further in view of Cicenas et al. (US 20040153003 A1), hereinafter referred to as Cicenas.
Regarding claim 8, Burney discloses the accessory of claim 1.
However, Burney does not explicitly disclose wherein the shaft is configured to be inserted into a guide needle.
Cicenas teaches an analogous biopsy needle accessory, including a shaft (Abstract, Fig. 1, Fig. 3, para. [0027]). Cicenas further teaches the shaft is configured to be inserted into a guide needle (Fig. 1A, Fig. 1B, element 100, para. [0024]). 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 shaft disclosed by Burney to additionally be configured to be inserted into a guide needle, as taught by Cicenas. This is because Cicenas teaches a guide needle allows for the shaft to be used in conjunction with other elements, such as a vacuum, to assist in drawing in the tissue samples (para. [0024]).
Regarding claim 14, Burney discloses the accessory of claim 10.
However, Burney does not explicitly disclose the accessory further includes a seal positioned within the handle; wherein the handle includes a first portion and a second portion, and wherein the seal is positioned between the first portion and the second portion.
Cicenas teaches an analogous biopsy needle accessory (Abstract, Fig. 1, Fig. 3). Cicenas further teaches a seal is positioned within a handle (Fig. 3, element 208), and the handle includes a first portion and a second portion, and wherein the seal is positioned between the first portion and the second portion (Fig. 1, element 200, Fig. 1, element 516, Fig. 3, element 208). 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 handle disclosed by Burney to explicitly include a first portion and a second portion, wherein a seal is positioned between the first portion and the second portion, as taught by Cicenas. This is because Cicenas teaches a seal provided between two portions allows for an air seal to be formed between two elements (para. [0036]). Additionally, it would have been obvious to make the handle portion of Burney be separable with more than one portion (see MPEP 2144.04, V, C).
Regarding claim 16, Burney discloses the accessory of claim 1.
However, Burney does not explicitly disclose the accessory further includes a first cap having a first cap proximal end and a first cap distal end, wherein the first cap proximal end is coupled to the handle.
Cicenas teaches an analogous biopsy needle accessory (Abstract, Fig. 1, Fig. 3). Cicenas further teaches the accessory includes a first cap having a first cap proximal end and a first cap distal end (Fig. 3, element 206, element 206a, element 206b), wherein the first cap proximal end is coupled to the handle (Fig. 3, element 206a, para. [0029]). 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 accessory disclosed by Burney to additionally include a first cap having a first cap proximal end and a first cap distal end, wherein the first cap proximal end is coupled to the handle, as taught by Cicenas. This is because Cicenas teaches the cap allows for the biopsy needle to be joined to the piston (para. [0028]).
Regarding claim 17, modified Burney discloses the accessory of claim 16
However, modified Burney does not explicitly disclose wherein the first cap includes a first seal positioned within a bore; and wherein the accessory further includes a second cap having a second cap proximal end and a second cap distal end, wherein the second cap distal end is coupled to the handle, and wherein the second cap includes a second seal; wherein the second cap includes a stem at least partially received within the handle passageway.
Cicenas further teaches the first cap includes a first seal positioned within a bore (Fig. 3, element 206c, para. [0029]); and wherein the accessory further includes a second cap having a second cap proximal end and a second cap distal end, wherein the second cap distal end is coupled to the handle, and wherein the second cap includes a second seal (Fig. 3, element 204, element 208, para. [0036]); wherein the second cap includes a stem at least partially received within the handle passageway (Fig. 1, element 100, element 200, element 300, element 516, para. [0023]). 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 accessory taught by modified Burney to additionally have the first cap include a first seal positioned within a bore; and wherein the accessory further includes a second cap having a second cap proximal end and a second cap distal end, wherein the second cap distal end is coupled to the handle, and wherein the second cap includes a second seal; wherein the second cap includes a stem at least partially received within the handle passageway, as taught by Cicenas. This is because Cicenas teaches a seal provided with a cap allows for an air seal to be formed between two elements (para. [0036]). Additionally, it would have been obvious to make the handle portion of Burney be separable with more than one cap (see MPEP 2144.04, V, C).
Regarding claim 20, Burney discloses the accessory of claim 1.
However, Burney does not explicitly disclose the accessory further includes a first air-tight cap coupled to a first handle end.
Cicenas teaches an analogous biopsy needle accessory (Abstract, Fig. 1, Fig. 3). Cicenas further teaches the accessory further includes a first air-tight cap coupled to a first handle end (Fig. 1, element 200, Fig. 1, element 516, Fig. 3, element 208). 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 handle disclosed by Burney to explicitly include a first air-tight cap coupled to a first handle end, as taught by Cicenas. This is because Cicenas teaches an air seal prevents air from entering the handle (para. [0036]).
Regarding claim 22, Burney discloses the kit of claim 21.
However, Burney does not explicitly disclose the kit further includes a guide needle with a guide needle handle; wherein the shaft is receivable within the guide needle.
Cicenas teaches an analogous kit comprising a biopsy needle and an accessory including a handle and a shaft (Abstract, Fig. 1, Fig. 3). Cicenas further teaches the kit includes a guide needle with a guide needle handle; wherein the shaft is receivable within the guide needle (Fig. 1A, Fig. 1B, element 100, para. [0024]). 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 kit disclosed by Burney to additionally include a guide needle with a guide needle handle; wherein the shaft is receivable within the guide needle, as taught by Cicenas. This is because Cicenas teaches a guide needle allows for the shaft to be used in conjunction with other elements, such as a vacuum, to assist in drawing in the tissue samples (para. [0024]).
Regarding claim 23, modified Burney discloses the kit of claim 22.
However, modified Burney does not explicitly disclose the kit further includes a first cap with a first seal and a second cap with a second seal; wherein the first cap is positioned between the guide needle handle and the handle; and wherein the handle is positioned between the first cap and the second cap.
Cicenas further teaches the kit further includes a first cap with a first seal (Fig. 1, Fig. 3, element 206c, para. [0029]) and a second cap with a second seal (Fig. 1, Fig. 3, element 204, element 208, para. [0036]); wherein the first cap is positioned between the guide needle handle and the handle (Fig. 3, element 206), and wherein the handle is positioned between the first cap and the second cap (Fig. 1, Fig. 3, para. [0027-0029]). 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 kit taught by modified Burney to additionally include a first cap with a first seal and a second cap with a second seal; wherein the first cap is positioned between the guide needle handle and the handle; and wherein the handle is positioned between the first cap and the second cap, as taught by Cicenas. This is because Cicenas teaches a seal provided with multiple caps allows for an air seal to be formed between two elements (para. [0036]).
Regarding claim 24, modified Burney discloses the kit of claim 22.
However, modified Burney does not explicitly disclose further including a guide needle cap and a seal positioned in the guide needle cap.
Cicenas further teaches the kit includes multiple caps and multiple seals (Fig. 1, Fig. 3, Fig. 5, para. [0027], para. [0034]). 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 kit taught by modified Burney to additionally include a guide needle cap and a seal positioned in the guide needle cap, as taught by Cicenas. This is because Cicenas teaches multiple separate pieces can be joined together, in conjunction with a seal, to provide an air-tight connection and protection (para. [0034], para. [0036]).
Regarding claim 25, Burney discloses the kit of claim 21.
However, Burney does not explicitly disclose the kit further includes a seal positioned in the handle.
Cicenas teaches an analogous kit comprising a biopsy needle and an accessory including a handle and a shaft (Abstract, Fig. 1, Fig. 3). Cicenas further teaches a seal is positioned in the handle (Fig. 3, element 208). 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 handle disclosed by Burney to additionally include a seal, as taught by Cicenas. This is because Cicenas teaches a seal allows for an air seal to be formed between two elements (para. [0036]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 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, Jason M Sims can be reached at (571)272-7540. 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.
/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791