DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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: a holding mechanism…configured for engaging with the catheter assembly…can releasably couple a proximal end of the outer shaft to the motorized handle so as to hold the outer shaft in an axially fixed position and a rotationally fixed position in claim 1; and a holding mechanism…configured to engage a proximal end portion of a second shaft of the prosthetic heart valve delivery apparatus such that the second shaft is axially and rotationally fixed relative to the housing. The corresponding structure in the specification is as follows: in [0123], the holding mechanism comprises a latch mechanism having an engaging portion
216 configured to extend into a groove 212 of main shaft 104, which has a flat surface portion that is
positioned against a corresponding flat surface portion of the engaging portion 216 to form an
engagement. The engagement holds the main shaft 104 stationary relative to the torque shaft 110 as
the torque shaft is rotated. The engaging portion is biased into this position via a spring 220, but a
button 218 in the handle can be depressed to disengage the engaging portion from the main shaft.
Thus, the structure corresponding to the claimed functions of 1) (claim 1) configured for engaging with
the catheter assembly…can releasably couple a proximal end of the outer shaft to the motorized handle
so as to hold the outer shaft in an axially fixed position and a rotationally fixed position and 2) (claim 17)
configured to engage a proximal end portion of a second shaft of the prosthetic heart valve delivery
apparatus such that the second shaft is axially and rotationally fixed relative to the housing is structures
including latch mechanism 214 having engaging portion 216 having a flat surface portion, groove 212 in
main shaft 104 having corresponding flat surface portion to that of engaging portion 216, spring 220,
and button 218.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,737,868. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are virtually identical but broaden out the inner torque shaft and outer shaft of ‘868 to the more generic first shaft and second shaft of the current claims, and thus the current claims are “anticipated” by the claims of ‘868 as set forth below with respect to the column/line numbers of the issued ‘868 patent.
Regarding current claim 1, ‘868 patent claim 1 recites: 1. A motorized handle for a prosthetic heart valve delivery apparatus (C33L51-52), the motorized handle configured to be releasably coupled to a proximal end of a catheter assembly of the prosthetic heart valve delivery apparatus (C33L52-56), the catheter assembly having a first shaft and a second shaft (C33L56-57), wherein the first shaft extends through the second shaft (C33L57), the motorized handle comprising (C33L57-58) a housing (C33L59); and a motorized mechanism mounted within the housing for rotating the first shaft of the catheter assembly (C33L61-62), wherein the housing is configured to receive the proximal end of the catheter assembly such that a proximal end of the first shaft can be positioned within the housing and releasably connected to the motorized mechanism (C33L66-C34L3), and such that a proximal end of the second shaft can be releasably coupled to the motorized handle so that the second shaft is in an axially fixed position and a rotationally fixed position (C33L64-65; C34L3-7), and wherein when the motorized handle is coupled to the catheter assembly, and wherein the motorized mechanism, when actuated, is configured to rotate the first shaft relative to the second shaft (C34L8-11).
Regarding current claim 17, ‘868 patent claim 17 recites: 17. A handle for a prosthetic heart valve delivery apparatus (C35L25), the handle comprising: a housing comprising a distal opening (C35L27-28); a motorized mechanism disposed within the housing and configured to be releasably coupled to a proximal end portion of a first shaft of the prosthetic heart valve delivery apparatus (C35L29-32), wherein when actuated, the motorized mechanism is configured to rotate the first shaft relative to the housing (C35L32-34); and a second shaft, wherein a proximal end portion of the second shaft of the prosthetic heart valve delivery apparatus is coupled to the housing such that the second shaft is axially and rotationally fixed relative to the housing (C35L35-39), wherein the first shaft extends through the second shaft (C35L39-40).
Regarding current claim 19, ‘868 patent claim 19 recites: 19. A prosthetic heart valve delivery apparatus (C36L5) comprising: a catheter assembly that includes a first shaft, a second shaft, and a delivery sheath (C36L7-8), wherein the first shaft extends through the second shaft (C36L8-9), wherein the delivery sheath is disposed at a distal portion of the second shaft (C36L9-10), and wherein a proximal end portion of the second shaft includes a groove (C36L10-11); and a handle that includes a housing a motorized mechanism (C36L14), and a latch having an engaging surface (C36L15), wherein a proximal end portion of the first shaft and the proximal end portion of the second shaft are disposed within the housing (C36L16-20), wherein the motorized mechanism is disposed within the housing and is releasably coupled to the proximal end portion of the first shaft (C36L20-23), wherein the latch is at least partially disposed within the housing and movable between an engaged state and a disengaged state (C36L23-25), wherein in the engaged state the latch extends at least partially into the groove of the second shaft such that the second shaft is axially and rotationally fixed relative to the housing (C36L25-30), and wherein in the disengaged state the latch is outside of the groove of the second shaft (C36L30-31).
Further, there is correspondence between dependent claims of the current application and dependent claims of the ‘868 patent as follows:
Current claim #
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
18
20
'868 claim #
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
18
20
Allowable Subject Matter
Claims 1-20 would be allowable when the non-statutory double patenting rejection set forth above is overcome.
The following is a statement of reasons for the indication of allowable subject matter: the following reasons are reproduced from parent application 16/783005 in the notice of allowance dated 12/28/2022. The current claims contain virtually the same allowable subject matter and thus would be allowable for the same reasons as set forth in the parent application.
US 2010/0049313 A1 to Alon et al. is considered the closest prior art of record. However, Alon fails to teach or suggest 1) (claim 1) a holding mechanism…configured for engaging with the catheter assembly…can releasably couple a proximal end of the outer shaft to the motorized handle so as to hold the outer shaft in an axially fixed position and a rotationally fixed position; 2) and (claim 17) a holding mechanism…configured to engage a proximal end portion of a second shaft of the prosthetic heart valve delivery apparatus such that the second shaft is axially and rotationally fixed relative to the housing, wherein these limitations are interpreted under 112f as set forth above. The corresponding structure - latch mechanism 214 having engaging portion 216 having a flat surface portion, groove 212 in main shaft 104 having corresponding flat surface portion to that of engaging portion 216, spring 220, and button 218 is not taught or suggested in the prior art, nor is any equivalent thereof, which would function to hold the outer shaft in an axially and rotationally fixed position. Further, with respect to claim 19, Alon fails to teach or suggest a groove in the shaft, a latch with an engaging surface, wherein the latch is moveable between an engaged state where the latch extends into the groove to axially and rotationally fix the shaft to the housing, and a disengaged state where the latch is outside of the groove. It is further noted that a review of the corresponding EPO application showed that identical claims were also indicated as being allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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