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 .
Specification
The disclosure is objected to because, in para. [0001] of the filed specification, U.S. Pat. No. 12,194,256 is not cited as being issued from U.S. Pat. App. No. 17/883,469.
Appropriate correction is required.
Claim Interpretation - 35 USC § 112
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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.
Claims 1-7 and 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nance et al. (7,780,692 or Nance ‘692) in view of Nance et al. (8,337,518 or Nance ‘518). Nance ‘692 discloses the invention substantially as claimed. Nance ‘692 discloses, in figures 15A-15E and col. 19, line 53 to col. 20, line 47 and col. 21, lines 18-30; a method of inserting an implant into a blood vessel of a patient, the method comprising: inserting a sheath (700) at least partially into the blood vessel of the patient, the sheath comprising: an expandable outer member (100) including a lumen extending therethrough; an expandable inner member (310) extending longitudinally within the lumen of the outer member, the inner member defining a central lumen of the sheath and including a folded portion (as shown in fig 15A and 15E); and at least two reinforcing members (704) extending longitudinally along a length of the sheath and embedded within (i.e., integrally formed with, according to col. 20, lines 8-12) a wall of the inner member; wherein expansion of the inner member causes a circumferential distance between the at least two reinforcing members to increase from a first circumferential distance to a second circumferential distance (as shown in fig. 15B); wherein expanding the inner member causes the folded portion to at least partially unfold, wherein the folded portion includes one or more folds comprising portions of the inner member arranged in an overlapping configuration (as shown in fig. 15A and 15C), wherein expanding the inner member causes the one or more folds to move to a less overlapping configuration increasing a diameter of the central lumen of the sheath; wherein the one or more folds wrap along an inner surface of the inner member; wherein when the sheath is in an unexpanded configuration, overlapping portions of the one or more folds extend longitudinally along a length of the inner member, and the overlapping portions extend generally parallel to and partially around a central longitudinal axis of the sheath; wherein the folded portion further comprises a second folded portion circumferentially spaced around the inner member from the folded portion and a third folded portion circumferentially spaced around the inner member from the folded portion and the second folded portion; wherein expanding the inner member causes the folded portion, second folded portion, and third folded portion to at least partially unfold; wherein the at least two reinforcing members (704) include a first, second and third reinforcing member each extending longitudinally along a length of the sheath; wherein the at least two reinforcing members are oriented generally parallel to each other and extending in a direction generally parallel to a central longitudinal axis of the sheath; wherein the at least two reinforcing members and the inner member form a unitary member (i.e., an integrally formed member); wherein the at least two reinforcing members are manufactured by (i.e., integrally formed with) at least one of coextrusion with the inner member, melting with the inner member, or reflowing with the inner member; wherein the at least two reinforcing members have a substantially constant width (e.g., at the base of each rail 704) along the length of the at least two reinforcing members; wherein the at least two reinforcing members have a width that varies along the length of the at least two reinforcing members (from the top of rail 704, in cross-section, to the base); and wherein the at least two reinforcing members include a thickness that varies along the length of the reinforcing member (from the top of rail 704, in cross-section, to the base).
Nance ‘692 also discloses a method of expanding a sheath (700), the method comprising: providing a sheath including an expandable outer member (100) including a lumen extending therethrough and an expandable inner member (310) extending longitudinally within the lumen of the outer member, the inner member defining a central lumen of the sheath and including a folded portion; and at least partially expanding the inner member and outer member, thereby increasing a circumferential distance between at least two reinforcing members (704) extending longitudinally along a length of the sheath and embedded within (i.e., integrally formed with) a wall of the inner member; wherein expanding the inner member causes the folded portion to at least partially unfold (as shown in fig. 15B); wherein the folded portion includes one or more folds comprising portions of the inner member arranged in an overlapping configuration (as shown in 15A and 15C), wherein expanding the inner member causes the one or more folds to move to a less overlapping configuration increasing a diameter of the central lumen of the sheath; wherein the at least two reinforcing members and the inner member form a unitary member; and wherein the at least two reinforcing members are manufactured by (i.e., integrally formed with) at least one of coextrusion with the inner member, melting with the inner member, or reflowing with the inner member.
However, Nance ‘692 does not explicitly disclose advancing an implant through the central lumen of the inner member into the blood vessel and expanding the inner member and outer member using an outwardly directed radial force of the implant, nor does Nance ‘692 explicitly disclose introducing an implant into the central lumen of the inner member and exerting an outward radial force on the inner member with the implant. Nevertheless, Nance ‘692 discloses, in col. 21, lines 18-30; that the sheath may be used to advance an implant (e.g., a valve replacement) through the central lumen or that the method may include introducing the implant into the central lumen of the inner member. Nance ‘518 teaches, in figures 6-8 and 11 and col. 18, lines 27-51 and col. 19, lines 34-51; advancing an implant (e.g., 1102) through the central lumen of an inner member of an expandable sheath (300) into the blood vessel and expanding the sheath using an outwardly directed radial force of the implant (in combination with catheter 1100), and Nance ‘518 teaches introducing the implant into the central lumen of the sheath and exerting an outward radial force on the sheath with the implant (in combination with catheter 1100). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Nance ‘518, to modify the method of Nance ‘692, so that it includes advancing an implant through the central lumen of the inner member into the blood vessel and expanding the inner member and outer member using an outwardly directed radial force of the implant, or so that the method includes introducing the implant into the central lumen of the inner member and exerting an outward radial force on the inner member with the implant. Such a modification would allow placement of an implant with minimal damage to tissues surrounding the sheath and/or an implant placed in a patient’s body.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: None of the prior art of record, alone or in combination, discloses a method of inserting an implant into a blood vessel of a patient, the method comprising, inter alia: inserting a sheath at least partially into the blood vessel of the patient, the sheath comprising: an expandable outer member including a lumen extending therethrough; an expandable inner member extending longitudinally within the lumen of the outer member, the inner member defining a central lumen of the sheath and including a folded portion; and at least two reinforcing members extending longitudinally along a length of the sheath; advancing the implant through the central lumen of the inner member into the blood vessel; expanding the inner member and outer member using an outwardly directed radial force of the implant, wherein expansion of the inner member causes a circumferential distance between the at least two reinforcing members to increase from a first circumferential distance to a second circumferential distance; wherein the folded portion further comprises a second folded portion circumferentially spaced around the inner member from the folded portion and a third folded portion circumferentially spaced around the inner member from the folded portion and the second folded portion; and wherein the folded portion, second folded portion and third folded portion are equally spaced circumferentially around the inner member.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
Any inquiry concerning this communication should be directed to Julian W. Woo at telephone number (571)272-4707. Normal office hours are: M-Th, 8-5:30 ET, 1st Fri. of biweek OFF; 2nd Fri., 8-4:30 ET.
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, Jackie Ho can be reached on (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571 -273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR.
Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIAN W WOO/Primary Examiner, Art Unit 3771