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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 (and thereby dependent claim 17) recites the limitation "the passive seal" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 17 recites the limitation "the passive seal" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-2 and 11-13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Dehdashtian (US 2007/0112422).
Dehdashtian discloses (see Figs. 1-6B and 10-15) a valve delivery system comprising the following claim limitations:
(claim 1) A system for delivery of a prosthetic heart valve to a beating heart (see claim 1; [0010]; [0014]; [0090]), comprising: a delivery catheter (54, Fig. 5) having a proximal control handle (158, Fig. 5) in which a proximal end (i.e., proximal end of tube 156 in Fig. 10) of a balloon deflection tube (156, Figs. 5-6B and 10-11) is held and which extends distally therefrom (as shown in Figs. 5-6B and 10-11), an expandable heart valve (50, Fig. 12) crimped on a distal balloon (52) of the balloon deflection tube (156) just distal to a deflectable portion (164) of the balloon deflection tube (156) (as expressly shown in Figs. 10-12; [0078]; [0080]-[0081]), wherein the control handle (158) further has an actuator (i.e., ribbed handle body 240, Figs. 5, 6A-6B and 10) on an exterior thereof for moving a tubular pusher body (160, Fig. 5) axially (as expressly shown in Figs. 5, 6A-6B and 10; [0077]-[0078]; [0091]; actuated sliding expressly disclosed), the pusher body (160) arranged to slide concentrically over the balloon deflection tube (156) and having a proximal end terminating within the control handle (158) (as expressly shown in Figs. 10-12; [0077]-[0078]), the pusher body (160) extending distally from the control handle (158) to a distal pusher sleeve (162, Fig. 11) which engages and is configured to (i.e., capable of) push a proximal end of the balloon (52) (as shown in Fig. 14; [0078]; [0083]; [0089]), wherein the actuator (240) is affixed to and enables proximal retraction of the pusher body (160) to disengage the pusher sleeve (162) from the proximal end of the balloon (52) (as expressly shown in Figs. 5-6B and 10-12; [0078]; [0091]; proximal retraction expressly disclosed), the control handle (158) further enclosing a passive seal (252, Fig. 10) that moves with the pusher body (160) and seals against blood leakage between the balloon deflection tube (156) and the pusher body (160) without preventing relative sliding movement therebetween ([0077]; ring-shaped seal 252 expressly provides a fluid seal between the defection tube 156 and the pusher tube 160 while allowing for axial sliding therebetween when the compression connection 244 is not fixed);
(claim 2) wherein the pusher sleeve (162) is an outwardly flared distal end of the pusher body (160) (as expressly shown in Figs. 5-6B and 10-11; [0078]; [0089]);
(claim 11) further including: an introducer (100, Fig. 4A) that receives the delivery catheter (54) (as shown in Figs. 3B-3D) therethrough and has an elongated tubular sheath (70, Fig. 4A) extending distally from a proximal housing (102, Fig. 4A) containing at least one introducer valve (106/110/112, Fig. 4B) for fluidly sealing around devices passed therethrough ([0062]; valves providing seal expressly disclosed), the introducer (100) having a length sufficient to extend from outside a patient through an intercostal incision (20, Fig. 1) and into the left ventricle of the patient (as shown in Figs. 1-3E; see claim 9; [0014]; [0022]; [0041]), and wherein the delivery catheter (54) has a fluoroscopically-visible marker located proximal to the heart valve (50) crimped on the balloon (52) ([0056]; markers disposed adjacent the proximal end of the balloon 52 on both the valve 50 and balloon catheter 54 expressly disclosed), and the introducer sheath (70) has a fluoroscopically-visible marker on a distal tip thereof distinguishable from the marker of the delivery catheter (54) ([0054]-[0055]; markers on the distal end of introducer sheath 70 expressly disclosed);
(claim 12) A system for delivery of a prosthetic heart valve to a beating heart (see claim 1; [0010]; [0014]; [0090]), comprising: a delivery catheter (54, Fig. 5) having a proximal control handle (158, Fig. 5) in which a proximal end (i.e., proximal end of tube 156 in Fig. 10) of a balloon tube (156, Figs. 5-6B and 10-11) is held and which extends distally therefrom (as shown in Figs. 5-6B and 10-11), an expandable heart (50, Fig. 12) valve crimped on a distal balloon (52) of the balloon tube (156), wherein the control handle (158) further has an actuator (i.e., ribbed handle body 240, Figs. 5, 6A-6B and 10) on an exterior thereof for moving a tubular pusher body (160, Fig. 5) axially (as expressly shown in Figs. 5, 6A-6B and 10; [0077]-[0078]; [0091]; actuated sliding expressly disclosed), the pusher body (160) arranged to slide concentrically over the balloon tube (156) and having a proximal end terminating within the control handle (158) (as expressly shown in Figs. 10-12; [0077]-[0078]), the pusher body (160) extending distally from the control handle (158) to a distal pusher sleeve (162, Fig. 11) which engages and is configured to (i.e., capable of) push a proximal end of the balloon (52) (as shown in Fig. 14; [0078]; [0083]; [0089]), wherein the actuator (240) is affixed to and enables proximal retraction of the pusher body (160) to disengage the pusher sleeve (162) from the proximal end of the balloon (52) (as expressly shown in Figs. 5-6B and 10-12; [0078]; [0091]; proximal retraction expressly disclosed), the control handle (158) further enclosing at least one O-ring (252, Fig. 10) that moves with the pusher body (160) and seals around the balloon tube (156) and prevents blood leakage between the balloon tube (156) and the pusher body (160) without preventing relative sliding movement therebetween ([0077]; ring-shaped seal 252 expressly provides a fluid seal between the defection tube 156 and the pusher tube 160 while allowing for axial sliding therebetween when the compression connection 244 is not fixed); and
(claim 13) wherein the pusher sleeve (162) is an outwardly flared distal end of the pusher body (160) (as expressly shown in Figs. 5-6B and 10-11; [0078]; [0089]).
Claim Rejections - 35 USC § 103
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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 5-6 and 16-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Dehdashtian as applied to claims 1 and 12 above, and further in view of Yamamoto et al. (US 5,059,186).
Dehdashtian discloses the invention substantially as claimed except for the passive seal comprising an annular polymer washer disposed therebetween a pair of adjacent O-rings/seals.
Yamamoto teaches the use of a washer (140) disposed between two o-rings/seals (138,145) for helping to prevent distortion of the seals/valves during assembly or adjustment (Fig. 16; col. 11, lines 27-52). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Dehdashtian to include a washer disposed between adjacent o-rings/seals in order to beneficially assist in preventing distortion of adjacent seals or valves during assembly or adjustment, as taught by Yamamoto.
Yamamoto discloses its seals to comprise resilient polymer material (see claims 2-3; 11 and 13-14; col. 5, lines 31-41; col. 6, line 60-col. 7, line 2), but fails to expressly discloses the annular washer being composed of a polymer. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the washer from a polymer, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
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 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 12 of U.S. Patent No. 8,439,970. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 8,439,970
1
2,12
12
2,12
Allowable Subject Matter
Claims 3-4, 7-10, 14-15 and 18-20 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. 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.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
Prosecution Insights