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 claim(s) 1-19 in the reply filed on 7/8/25 is acknowledged.
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.
Examiner notes: currently, NO limitation invokes interpretation under § 112(f).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/ patents/apply/applying-online/eTerminal-disclaimer
Claim(s) 1-2, 11, and 15 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2 and 7 of U.S. Patent No. 12150627. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim(s) substantially anticipate(s) the identified claim(s) of this application.
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1-4, 6-10, 14, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muse (US 20190328370 A1).
For claim(s) 1 and 15, Muse teaches A bone biopsy device, [100/400] comprising:
a handle housing; [472]
a powertrain assembly; [470]
a tissue sampling assembly [404] configured to be rotated about a longitudinal axis by the powertrain assembly;
a coax assembly [402] selectively couplable to the handle housing;
and a spacer [412, 422, 442] longitudinally disposed between the handle housing and the coax assembly and selectively coupleable to the handle housing and the coax assembly.
For claim 2, Muse teaches The bone biopsy device of claim 1,
wherein the tissue sampling assembly comprises:
an intermediate cannula [424] configured to cut a hole in a tissue;
an inner cannula [444] coaxially disposed within the intermediate cannula and configured to receive a tissue sample;
a trocar [414] coaxially disposed within the inner cannula;
and a trocar displacement member [proximal end of 412 per ¶224] coupled to the trocar and configured to longitudinally displace the trocar relative to the inner cannula.
For claim 3, Muse teaches The bone biopsy device of claim 2,
wherein the inner cannula comprises at least one slot extending through a wall of a distal portion, and wherein the at least one slot is configured to allow radial expansion of the distal portion. [¶129]
For claim 4, Muse teaches The bone biopsy device of claim 2,
wherein the tissue sampling assembly further comprises an inner cannula displacement member [442] operably coupled to the trocar displacement member, [via 449 in ¶243] and
wherein the inner cannula displacement member is configured to longitudinally displace the inner cannula relative to the intermediate cannula. [¶¶175-179]
For claim 6, Muse teaches The bone biopsy device of claim 2,
wherein the trocar displacement member comprises:
a guide track comprising a plurality of segments; [ribs/crenellations of 412 shown in Fig. 10A]
and a proximal recess and a distal recess for engagement with an inner cannula displacement member. [either one or more of 482]
For claim 7, Muse teaches The bone biopsy device of claim 6,
further comprising a track arm [484] coupleable to the guide track and configured to control longitudinal movement of the trocar. [¶¶186-187]
For claim 8, Muse teaches The bone biopsy device of claim 7,
wherein the plurality of segments of the guide track comprise:
a first segment;
a second segment;
a third segment;
and a fourth segment; [any four protrusions of crenellations in Fig. 10A]
wherein when the track arm is disposed in the first segment, the trocar is in a first extended position; wherein when the track arm is disposed in the second segment, the trocar is in a first retracted position; wherein when the track arm is disposed in the third segment, the trocar is in a second retracted position; and wherein when the track arm is disposed in the fourth segment, the trocar is in a second extended position. [the use of ‘when’ as a transitional term makes this limitation a conditional limitation; as such, Muse teaches the limitation because the hub 412 of Saporito is capable of operated / arranged to perform the conditional limitation under BRI; see MPEP § 2111.04]
For claim 9, Muse teaches The bone biopsy device of claim 2, further comprising an inner cannula displacement member,
wherein the trocar displacement member comprises a proximal recess and a distal recess configured to engage with the inner cannula displacement member, [either one or more of 482]
wherein the inner cannula displacement member distally displaces the inner cannula to an extended position when the inner cannula displacement member is engaged with the distal recess, and wherein the inner cannula displacement member proximally displaces the inner cannula to a retracted position when the inner cannula displacement member is engaged with the proximal recess. [the use of ‘when’ as a transitional term makes this limitation a conditional limitation; as such, Muse teaches the limitation because the hub 412 of Muse is capable of operated / arranged to perform the conditional limitation under BRI; see MPEP § 2111.04]
For claim 10, Muse teaches The bone biopsy device of claim 8, further comprising a slider comprising a proximally facing ramp,
wherein the track arm comprises a distally facing ramp, [shape of 484 which has a triangular detent tooth and thus a type of ramp under BRI] and
wherein the track arm is displaced from the first track segment to the second track segment when the slider is displaced proximally causing the proximally facing ramp to slidingly engage with the distally facing ramp. [the use of ‘when’ as a transitional term makes this limitation a conditional limitation; as such, Muse teaches the limitation because the hub 412 of Muse is capable of operated / arranged to perform the conditional limitation under BRI; see MPEP § 2111.04]
For claim 14, Muse teaches The bone biopsy device of claim 1,
wherein the coax assembly comprises:
a connector; [412]
and a coax cannula [424] coupled to the connector and comprising a trephine tip.
For claim(s) 18, Muse teaches The bone biopsy system of claim 15, further comprising a trocar assembly [402] comprising:
a handle [412] configured to be gripped by a user;
and a trocar [414] coupled to the handle.
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muse in view of Faciszewski (US 20030083592 A1).
For claim(s) 5, Muse teaches
The trocar comprising a multi-faceted penetrating tip. [Fig. 15A]
Muse fails to teach the trocar comprising a groove to receive a guidewire.
Faciszewski teaches a biopsy trocar grooved to receive a guidewire. [¶42]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the trocar of Muse to incorporate the guidewire groove of Faciszewski in order to aid in proper placement of the device. As motivated by Faciszewski ¶42.
Claim(s) 11-13 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muse in view of Vetter (US 20140180302 A1).
For claim 11, Muse teaches The bone biopsy device of claim 1,
wherein the powertrain assembly comprises a reusable component comprising:
a motor; [472]
a power source. [¶210]
For claim(s) 11-13 and 16-17, Muse fails to teach the powertrain assembly comprising a controller and a clutch.
Vetter teaches a biopsy device comprising a motor [31-32] and controller [11] housed together; [Fig. 14] the powertrain comprising a clutch [35] and driver assembly [Fig. 15] with a ramped sleeve [42] to rotate and displace the components of the device. [¶¶81-84]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the motor of Muse to incorporate the motor of Vetter in order to aid in effective sampling with minimal tissue disruption. As motivated by Vetter ¶99
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muse in view of Jamshidi (US 5807275 A).
For claim(s) 19, Muse fails to teach an aspiration device utilizing male and female luer fittings.
Jamshidi teaches a biopsy aspiration device utilizing male and female luer fittings. [col. 5 ll. 40-50]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the device of Muse to incorporate the aspiration arrangement of Jamshidi in order to permit sample acquisition with minimal to no losses. As motivated by Jamshidi col. 1 ll. 35-50.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791