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 .
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:
Actuating mechanism, in claim 1, which has structural support in paragraph [0022] of Applicant’s specification.
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 1, 16, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 19, and 16 of U.S. Patent No. 12,239,290. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 16, and 19 under examination are anticipated, respectfully, by claims 1, 19, and 16 of the reference patent. Every limitation in the application under examination claims is recited in the conflicting reference patent claims, and the similarities between the claims are highlighted below in bold.
Current Application 19/046021
Reference US Patent No. 12,239,290
A medical device assembly comprising:
a collet having a sleeve and a tab that is radially inset relative to an outer surface of the sleeve; and
an actuator having a washer-shaped portion, a protrusion extending radially inward from an inner surface of the washer-shaped portion, and an actuating mechanism extending from an outer surface of the washer-shaped portion, wherein the actuating mechanism is configured to be contacted by a user;
wherein rotation of the actuator causes the protrusion of the actuator to interact with the tab to move the tab radially inward in order to transition the collet from a first configuration to a second configuration, wherein, in the first configuration of the collet, an axle extending through the sleeve is rotatable to deflect a portion of a medical device, and, wherein, in the second configuration of the collet, the axle is inhibited from rotating due to a frictional force applied to the axle by the tab in a radially inward direction.
An assembly comprising:
an axle having an axis of rotation, wherein rotation of the axle about the axis of rotation causes deflection of a portion of a medical device;
a collet having an opening, wherein the axle extends through the opening; and
an actuator configured to interact with the collet, wherein the actuator includes a lever extending radially outward from an outer surface of the actuator and a protrusion extending radially inward from an inner surface of the actuator, toward the axis of rotation;
wherein a first configuration of the collet permits rotation of the axle relative to the collet and a second configuration of the collet inhibits rotation of the axle relative to the collet,
wherein, in the second configuration, the actuator is rotated relative to the collet such that the protrusion of the actuator contacts the collet and applies a radially inward force on the collet, toward the axis of rotation, to move a portion of the collet radially inward toward the axis of rotation, and wherein rotation of the actuator relative to the collet transitions the collet from the first configuration to the second configuration.
16. A medical device assembly comprising:
a collet having: a sleeve;
a tab that is radially inset relative to an outer surface of the sleeve; and
an axle extending through the sleeve;
wherein, in a first configuration of the sleeve, a gap is defined between the tab and the axle,
wherein, in a second configuration, the tab of the collet is moved radially inward to interact with the axle,
wherein, in the first configuration of the collet, the axle is rotatable relative to the collet to deflect a portion of a medical device, and
wherein, in the second configuration of the collet, the axle is inhibited from rotating relative to the collet.
19. A locking assembly comprising:
an axle, wherein rotation of the axle causes deflection of a sheath of a medical device;
a collet having a sleeve portion, wherein the axle extends through a central opening of the sleeve portion, and wherein the sleeve portion has a flexible tab; and an actuator having a washer-shaped portion radially outward, away from a central longitudinal axis of the axle, of the sleeve portion of the collet, wherein the actuator includes a protrusion extending radially inward, toward the central longitudinal axis of the axle, from an inner surface of the washer-shaped portions and a lever that extends radially outward, away from the central longitudinal axis of the axle, from an outer surface of the washer-shaped portion;
wherein the protrusion is adjacent to at least a portion of the flexible tab, and
wherein the actuator rotates relative to the collet so that the protrusion applies a radially-inward radially inward force, toward the central longitudinal axis of the axle, on the flexible tab such that the tab moves radially inward, toward the central longitudinal axis of the axle, to interact with and prevent rotation of the axle.
19. A medical device assembly, comprising:
a collet having a tab; and
an actuator having a radially inwardly extending protrusion, wherein at least a portion of the collet extends through the actuator;
wherein rotation of the actuator relative to the collet causes the protrusion of the actuator to interact with the tab to move the tab radially inward toward an axle extending through the collet, in order to transition the collet from a first configuration, in which a gap is defined between the axle and the tab so that the axle is rotatable to deflect a portion of a medical device, to a second configuration, in which the tab contacts the axle.
16. A locking assembly comprising:
a collet having a tab; and
an actuator having a protrusion extending radially inward, toward an axis of rotation of the actuator, from an inner surface of the actuator and a lever extending radially outward, away from the axis of rotation of the actuator, from an outer surface of the actuator;
wherein the actuator is rotated such that the protrusion of the actuator interacts with the tab to move the tab radially inward toward the axis of rotation of the actuator in order to transition the collet from a first configuration to a second configuration, wherein, in the first configuration of the collet, an axle is rotatable to deflect a portion of a medical device, and, wherein, in the second configuration of the collet, the axle is not rotatable due to a frictional force applied to the axle by the tab in a radially inward direction toward the axis of rotation of the actuator.
As show in the mapping above, claims 1, 16, and 19 of the reference patent includes all the limitations of claims 1, 16, and 19 of current application. Claims 2-15, 7-18, and 20 are also rejected because of their dependence on their rejected respective base claim.
Allowable Subject Matter
Claims 1-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to overcome the double patenting rejection identified above.
The following is an examiner’s statement of reasons for allowance:
Golden et al. (US2009/0287188) teaches the above devices, except for wherein the actuating mechanism is configured to be contacted by a user; wherein rotation of the actuator causes the protrusion of the actuator to interact with the tab to move the tab radially inward in order to transition the collet from a first configuration to a second configuration, wherein, in the first configuration of the collet, an axle extending through the sleeve is rotatable to deflect a portion of a medical device, and, wherein, in the second configuration of the collet, the axle is inhibited from rotating due to a frictional force applied to the axle by the tab in a radially inward direction.
BenMaamer et al. (US2013/0103001) teaches the above devices, except for a collet having: a sleeve;a tab that is radially inset relative to an outer surface of the sleeve; and an axle extending through the sleeve; wherein, in a first configuration of the sleeve, a gap is defined between the tab and the axle, wherein, in a second configuration, the tab of the collet is moved radially inward to interact with the axle, wherein, in the first configuration of the collet, the axle is rotatable relative to the collet to deflect a portion of a medical device, and wherein, in the second configuration of the collet, the axle is inhibited from rotating relative to the collet. BenMaamer et al. lacks a lever and a protrusion extending radially inward from an inner surface of the actuator.
Fujii et al. (US2001/0037051) teaches the above devices, except for wherein at least a portion of the collet extends through the actuator; wherein rotation of the actuator relative to the collet causes the protrusion of the actuator to interact with the tab to move the tab radially inward toward an axle extending through the collet, in order to transition the collet from a first configuration, in which a gap is defined between the axle and the tab so that the axle is rotatable to deflect a portion of a medical device, to a second configuration, in which the tab contacts the axle.
Nagashige Takahasji (US5014685) teaches the above devices, except for an actuator having a washer-shaped portion, a protrusion extending radially inward from an inner surface of the washer-shaped portion, and an actuating mechanism extending from an outer surface of the washer-shaped portion, wherein the actuating mechanism is configured to be contacted by a user; wherein rotation of the actuator causes the protrusion of the actuator to interact with the tab to move the tab radially inward in order to transition the collet from a first configuration to a second configuration, wherein, in the first configuration of the collet, an axle extending through the sleeve is rotatable to deflect a portion of a medical device, and, wherein, in the second configuration of the collet, the axle is inhibited from rotating due to a frictional force applied to the axle by the tab in a radially inward direction.
There is no reason or suggestion provided in the prior art to modify the above prior art to have the additional features as claimed above, alone or in combination, and the only reason to modify the references would be based on Applicant’s disclosure, which is impermissible hindsight reasoning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795
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