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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19) in the reply filed on November 17, 2025 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged.
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 7-8 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 Claims 7-8, it is not understood what is meant by “micro-ultrasound probe” or by “micro-ultrasound probe/MRI fusion probe”. The disclosure provides paragraph 00270 and Figures 39A-39E element 3900 as showing the “micro-ultrasound probe” and asserts that “micro-ultrasound/MRI fusion probe” is equivalent to “micro-ultrasound probe”. As such, claim 7 and claim 8 appear to be the same scope and therefore duplicate claims. It is unclear if claims 7 or 8 further limit the scope of the invention from claim 1 because it is not understood how a “micro-ultrasound probe” is any different than the “ultrasound probe” from claim 1. There is no disclosure related to what makes the probe “micro” and one of ordinary skill would not understand this meaning in the context of the disclosure. For example, Figure 39C micro-ultrasound probe 3900 shows the probe is handheld size, thereby contradicting the plain meaning of “micro-ultrasound probe” being an ultrasound probe of micro size. As such, the scope sought by claims 7 and 8 cannot be determined. During examination, the claim terms “micro-ultrasound probe” and “micro-ultrasound/MRI fusion probe” will be given the interpretation of a handheld angled ultrasound probe.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7-8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
For the reasons above in the rejection of claims 7-8 under USC 112(b), the claims do not limit the requirements of their parent claim 1 and therefore are not proper dependent claims.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-9, 12-13, 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20160022309 to Allaway.
Regarding Claim 1, Allaway teaches a transperineal biopsy system (Figure 30) for use with an angled ultrasound probe including an angled distal tip (any appropriately sized ultrasound probe can be used with the system of Figure 30, e.g. the side-viewing ultrasound probe shown in Figure 37H has an blunted angled tip, “The biopsy guide may be placed on or fitted to an assortment of ultrasound probes of different sizes and shapes due to an adjustable mounting system.” par. 0122), a shaft extending proximally of the angled distal tip and including an accessory coupling portion (the portion of the ultrasound shaft where the biopsy system is fastened onto is the accessory coupling portion), the angled ultrasound probe configured to provide imaging in an angled imaging plane that is at an offset angle from an ultrasound probe axis of the angled ultrasound probe (side viewing ultrasound probe, e.g. the ultrasound probe of Figure 37H, TRUS probe, par. 0189; axial, transverse, side-view are considered synonymous, par. 0007), the transperineal biopsy system comprising:
a transperineal adaptor (2704, Figure 30) comprising a shaft body (2706, Figure 30) and a mounting body extending from the shaft body (2714, Figure 30), the shaft body configured to releasably couple to the accessory coupling portion of the shaft of the angled ultrasound probe (par. 0203), the mounting body including a curvate surface (the surface that contacts the ultrasound probe is curved, as seen in Figure 30), a first connector portion (first flange that extends from 2714), and a second connector portion (second flange that extends from 2714 – see annotated figure 30 below); and
a biopsy guide (2702, Figure 30) configured to releasably couple to the transperineal adaptor (par. 0203, 0239) and comprising: a guide member (2708, Figure 30), a displacement member (2710, Figure 30) configured to slide relative to the guide member (par. 0204); and a fastener extending from the guide member (),
wherein the displacement member includes a first needle guide configured to receive and align a needle (hole 2768, Figure 30), and
wherein the fastener includes a first end having a first fastener portion and a second end having a second fastener portion, the first fastener portion configured to couple to the first connector portion of the mounting body of the transperineal adaptor and the second fastener portion configured to couple to the second connector portion of the mounting body of the transperineal adaptor (as shown in the annotated figures 30 and 31B, there are two grooves on the underside of the fastener which couple to the first and second connector portions).
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Regarding Claim 2, Allaway further teaches wherein the needle is an access needle that is sized to receive a biopsy needle there through (par. 0202, 0204, access needle 2712, Figure 30).
Regarding Claim 3, Allaway further teaches the access needle (par. 0202, 0204, access needle 2712, Figure 30).
Regarding Claim 4, Allaway further teaches wherein the access needle has a needle size of 15 gauge or 16 gauge (14-18 gauges, par. 0133).
Regarding Claim 5, Allaway further teaches wherein the biopsy needle has a needle size of 18 gauge (par. 0192).
Regarding Claim 6, Allaway further teaches the angled ultrasound probe (the probe shown in Figure 37H has an angled tip and traverse/side-viewing imaging plane).
Regarding Claims 7-8, Allaway further teaches wherein the angled ultrasound probe is a micro-ultrasound probe/MRI fusion probe (see rejection under 112(b) above for claim interpretation; e.g. the probe shown in Figure 37H).
Regarding Claim 9, Allaway further teaches wherein when the transperineal adaptor is coupled to the angled ultrasound probe and when the biopsy guide is coupled to the transperineal adaptor, the first needle guide of the displacement member is configured to align the needle along a first trajectory axis within the angled imaging plane and at a first trajectory angle relative to the ultrasound probe axis, the first trajectory angle being the same as the offset angle (the trajectory is aligned parallel to the ultrasound probe axis and parallel to the ultrasound transducer, thereby having the same offset angle, par. 0204).
Regarding Claim 12, Allaway further teaches wherein the displacement member further includes a second needle guide configured to receive and align the needle along a second trajectory axis (par. 0214, array of needle receive ports 2868, Figure 30, there are several needle receive ports/needle guides).
Regarding Claim 13, Allaway further teaches wherein the second trajectory axis is parallel to the first trajectory axis (as shown in Figure 30 and described in par. 0214).
Regarding Claim 15, Allaway further teaches wherein the displacement member includes a pair of outwardly extending portions configured to frictionally slide on the guide member (tabs 2780, Figures 30, 32A, 32B, 32C, par. 0217).
Regarding Claim 16, Allaway further teaches wherein the guide member includes a pair of opposing members defining a slot therebetween, the displacement member configured to slide within the slot (as shown in Figure 30, the displacement member 2710 inserts in between the pair of opposing members defining a slot therebetween of the guide member 2708, shown in more detail in Figures 31A, 31B, 31C, assembled in 35C, 37A).
Regarding Claim 17, Allaway further teaches wherein the biopsy guide is configured to releasably couple via the fastener to an ultrasound probe having a non-angled ultrasound imaging plane (“The biopsy guide may be placed on or fitted to an assortment of ultrasound probes of different sizes and shapes due to an adjustable mounting system.” par. 0122), wherein, when coupled to the ultrasound probe, the biopsy guide is configured to align the needle parallel to a longitudinal axis of the ultrasound probe (parallel alignment, par. 0214).
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.
Claims 10, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160022309 to Allaway in view of US 20160242810 to Neice.
Regarding Claims 10-11, Allaway does not teach wherein the offset angle is more than ten degrees or about 13 degrees. Instead, Allaway teaches wherein the offset angle is zero, i.e. parallel with the ultrasound probe axis and parallel to the ultrasound transducer (par. 0204).
Regarding Claim 14, Allaway does not teach wherein the second trajectory axis is non-parallel to the first trajectory axis. Instead, Allaway teaches they are parallel (par. 0214).
Neice teaches a biopsy needle guide coupled to an ultrasound probe (Figure 3). Neice shows in Figure 3 variable offset angles resulting in separate nonparallel trajectories D1 and D2. Neice further teaches wherein variable offset angles are used to increase the number of depths and angles to increase accuracy, precision and measurement resolution, especially to change the imaging plane alignment in anesthetic procedures, which may be difficult to perform in only parallel/in-plane ultrasound imaging (par. 0057).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide an offset angle of about 13 degrees, as shown by Neice in Figure 3, in the second trajectory of Allaway in order to offset from the imaging plane for increase accuracy in especially anesthetic procedures as taught by Neice (par. 0057). For example, in the proposed combination, the user would select from the desired guide trajectory (parallel or offset) from the same guide, to thereby increase versatility of the device.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160022309 to Allaway in view of US 20100049186 to Ingle.
Regarding Claims 18-19, Allaway further teaches a kit with the transperineal biopsy system of claim 1 and the needle being an access needle sixed to receive a biopsy needle there through (par. 0202, 0204, access needle 2712, Figure 30; see details with respect to claim 1 in the rejection of claim 1 above). However, Allaway does not expressly teach packaging to enclose the needle and the transperineal biopsy system or instructions for using the transperineal biopsy system.
Ingle teaches a kit with common packaging (packaging 114, par. 0175), wherein the packaging holds the components of the kit together (par. 0175). It is further well-known to one of ordinary skill in the medical arts to keep instruments sterile. Ingle further teaches instructions in the kit for using the contents therein (instructions 112, par. 0175-0176).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include packaging in the system of Allaway as taught by Ingle to keep the kit together and clean/sterile before use. One of ordinary skill in the art before the effective filing date of the claimed invention would have also found it obvious to include instructions in the kit in order to provide directions for using the kit contents, as taught by Ingle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20250152197, 12402908 to Zeng, US 20230123079, 12502200 to Wang, US 20220354455 to Leroy teach a removable needle guide with multiple guide ports. US 20220273373, 12053248 to Rossen, US 20190175214 to Wood teach variable angle needle ports (i.e. offset angles). WO 2020181388, US 12303162 to Wen teaches offset needle guides parallel to an offset imaging plane. US 20250064479, 12144519, 20230149041, 20230157719, 20250248735, 11583310, 12114890, 12114889, 12121259, 12133663, 12150672, 12226120, 12251129, 12303164, 12303163, 12502201, 11096762 to Allaway teach aspects of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 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, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799