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 .
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.
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 actuation mechanism” in claim 2 interpreted to be the structures as disclosed in claims 3, 11, or 12 and equivalents thereof.
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.
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.
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.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9844363 and claims 1-8 of U.S. Patent No. 10856856. Although the claims at issue are not identical, they are not patentably distinct from each other because see the chart below. The difference between the rejected claims of the instant application and patented claims of the patent lies in the fact that the patented claims are more specific. Thus, the invention of patented claims is in effect a “species” of the “generic” invention of rejected claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since rejected claims are anticipated by patented claims, it is not patentably distinct from patented claims.
Instant Application 18/509,478
US Patent No. 9844363
US Patent No. 10856856
2. (New) A biopsy system comprising:
an instrument set housing;
an outer cannula having an outer cannula lumen, a proximal portion coupled to the instrument set housing, and a distal portion having a tissue receiving aperture in a side wall thereof in communication with the outer cannula lumen;
an inner cannula having an open distal end disposed within the outer cannula lumen;
an instrument drive housing configured to removably couple to the instrument set housing;
a motorized inner cannula driver disposed within the instrument drive housing, wherein the inner cannula driver is operatively coupled with the inner cannula and configured to axially oscillate the inner cannula relative to the outer cannula during operation of the biopsy system such that the open distal end of the inner cannula moves back and forth across the tissue receiving aperture; and
an aspiration vent comprising:
an aspiration valve defining an aspiration opening that fluidly couples the outer cannula lumen to atmosphere and a sealing member configured to seal the aspiration vent opening; and
an actuation mechanism selectively moveable at least partially into the aspiration vent opening to thereby contact the sealing member and prevent the sealing member from sealing the aspiration vent opening.
1. A biopsy system, comprising:
(a) an instrument set, the instrument set comprising
an instrument set housing,
an elongate outer cannula having an axial lumen, a proximal portion coupled to the instrument set housing, and a distal portion having a tissue receiving aperture in a side wall thereof in communication with the lumen,
an elongate inner cannula disposed within the outer cannula lumen, an aspiration vent disposed within the instrument set housing, wherein the aspiration vent fluidly couples the outer cannula lumen to atmosphere through an aspiration vent opening,
an aspirate valve assembly interposed in the aspiration vent, the aspirate valve assembly including a sealing member configured to seal the aspiration vent opening, and
an interference member that may be selectively moved at least partially into the aspiration vent opening to thereby contact the sealing member and prevent the sealing member from sealing the aspiration vent opening: and
(b) an instrument drive removably coupled to the instrument set, the instrument drive comprising
an instrument drive housing removably coupled to the instrument set housing,
a motorized inner cannula driver disposed within the instrument drive housing and configured to axially oscillate the inner cannula relative to the outer cannula during operation of the biopsy system, such that an open distal end of the inner cannula moves back and forth across the tissue receiving aperture to sever tissue extending therethrough, and
an actuating member disposed within the instrument drive housing, wherein the actuating member is configured to selectively move the interference member at least partially into the vent opening to thereby prevent the sealing member from sealing the aspiration vent opening.
1. A biopsy system, comprising:
(a) an instrument set, the instrument set comprising
an instrument set housing,
an outer cannula having an outer cannula lumen, a proximal portion coupled to the instrument set housing, and a distal portion having a tissue receiving aperture in a side wall thereof in communication with the outer cannula lumen,
an inner cannula disposed within the outer cannula lumen,
an aspiration vent that fluidly couples the outer cannula lumen to atmosphere through an aspiration vent opening,
a sealing member interposed in the aspiration vent and configured to seal the aspiration vent opening so that the outer cannula lumen is not vented to atmosphere through the aspiration vent, and
an interference member that is movable at least partially into the aspiration vent opening to thereby contact the sealing member and prevent the sealing member from sealing the aspiration vent opening; and
(b) an instrument drive removably coupled to the instrument set, the instrument drive comprising
an instrument drive housing removably coupled to the instrument set housing,
a motorized inner cannula driver disposed within the instrument drive housing, wherein the inner cannula driver is operatively coupled with the inner cannula and configured to axially oscillate the inner cannula relative to the outer cannula during operation of the biopsy system, such that an open distal end of the inner cannula moves back and forth across the tissue receiving aperture to sever tissue extending therethrough, and
an actuating member configured to selectively contact and move the interference member into contact with the sealing member.
Allowable Subject Matter
Claims 2-21 would be allowable if rewritten or amended or the filing of a terminal disclaimer to overcome the double patenting rejection(s), set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: See the parent patents’, U.S. Patent No. 9844363 and U.S. Patent No. 10856856, prosecution history which provide the reasons for allowance. No prior art of record teaches or fairly suggests a biopsy system comprising, inter alia, an instrument set comprised of an elongate outer and inner cannulas, a valve assembly, an instrument drive, a motorized inner cannula driver, an interference member that is movable into an aspiration vent to contact a sealing member and prevent the sealing member from sealing the aspiration vent; and an actuating member adapted to move the interference member at least partially into the vent to prevent the sealing member from sealing the aspiration vent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JASON 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.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
Prosecution Insights