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 .
Status of Claims
Claims 1-20 are pending. Claim 20 remains withdrawn as being directed to a non-elected invention.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is directed towards a transperineal biopsy system, including a biopsy guide with guide member and “a fastener extending from the guide member…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 releasably couple to the second fastener portion”.
In par. 0292, it states “On each outer lateral end of the curvate top surface 4634 is a fastener end 4638 sized and shaped to releasably couple to a corresponding fastener end of a fastener of the biopsy guide (not shown). The corresponding fastener ends of the biopsy guide may be the fastening mechanism 2706 shown in FIGS. 28-30, among others.” Examiner provides annotated Figure 47C as showing the fastener ends of the adaptor and annotated Figure 44B showing the assembled device (adaptor and biopsy guide together) including the first and second fastener portions of the biopsy guide. However, Examiner cannot find support for “the first fastener portion [of the biopsy guide] configured to releasably couple to the second fastener portion [of the biopsy guide]” as required by claim 1. Instead, the first and second fastener portions of the biopsy guide releasably connect to the adaptor. As such, the claim is not supported by the original disclosure and constitutes new matter.
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Claim Rejections - 35 USC § 112(b)
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+6 because it is not understood how a “micro-ultrasound probe” is any different than the “angled ultrasound probe” from claim 1+6. 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. Should Claim 7 be “handheld” ultrasound probe instead? Should Claim 8 be canceled as being a duplicate?
Claim Rejections - 35 USC § 112(d)
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+6 and therefore are not proper dependent claims. As discussed above, being “micro-ultrasound probe” and “micro-ultrasound probe/MRI fusion probe” do not appear to narrow the scope of “angled ultrasound probe”.
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.
Response to Arguments
Applicant’s arguments, see remarks, filed April 16, 2026, with respect to the rejection(s) of claim(s) 1-19 in view of the prior art have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of new matter introduced into the claims. The rejection under USC 112(b) and 112(d) are also maintained. Changing the dependency of claims 7-8 to depend on claim 6 did not resolve the issue for the reasons in the rejection above. Should Claim 7 be “handheld” ultrasound probe instead? Should Claim 8 be canceled as being a duplicate?
Regarding the prior art, Applicant argues Allaway (US 20160022309) does not teach the amended limitation “the first fastener portion configured to releasably couple to the second fastener portion”. Examiner notes the fastener is part of the biopsy guide and extends from the guide member, and clearly in Allaway the first fastener portion and the second fastener portion do not releasably couple from each other. Rather, in the interpretation used by the examiner in the previous office action for the fastener portions, they are an integrated piece (shown annotated below for reference). As such, Allaway does not teach the amended claim 1. Examiner notes that the adaptor of Allaway is different than the adaptor disclosed in the instant application (e.g. Figure 47C). However, the claims do not yet distinguish between the structure of the adaptors.
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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
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