DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of species 1e (the delivery occurs at least in part using a self-assembly member with the use of a push-rod), species 2e (the locking mechanism comprises an integral snap-fit mechanism), in the reply filed on 03/2426, and 06/24/26 (06/09/26) is acknowledged. The traversal is on the ground(s) that the species the Examiner set forth are not patentably distinct inventions and quotes MPEP 802.02 regarding independent or distinct inventions. This is not found persuasive because MPEP 802 and arguments with regards to independent/distinct inventions are related to restriction requirements as opposed to species election, which is discussed in MPEP 806. Species election has different requirements than those Applicant has argued.
The requirement is still deemed proper and is therefore made FINAL.
While Applicant indicates in all the different responses that different claims are pending or withdrawn, the Examiner understands claims 4, 10, 15, 21 to be withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/24/26 and 06/09/26.
Claim Objections
Claims 2, 13, 19-20 are objected to because of the following informalities:
Claims 2 and 13 are objected to for referring to the valve having a “single piece” construction but it is believed a hyphen is needed for correct grammar.
Claim 19 is objected to for apparently missing a word between “member” and “formed” multiple times.
Claim 20 is objected to for claiming “said second locking members is formed” for being grammatically incorrect.
Further, the claim is unclear for claiming the leaflets substructure is partially overlapped, but it is unclear what the substructure is overlapped with or by.
Regarding claims 23-24, the Examiner notes that these claims may be objected to upon allowance of the remaining claims, for being substantial duplicates of claims 5 and 16, respectively.
Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: first and second locking members.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first and second locking members, the push-rod, the self-assembly member, the flattened unassembled one-layer structure which is folded into a delivery configuration, the temporary valve being co-expensive with the delivery system, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Further, items 101 and 5626 are present in the specification but not the figures.
Further, items 1370 and 1285 are present in the figures but not the specification.
Further, items 1151, 1152, 1153, and 1154 from figures 14a-b are pointing towards structurally different things.
Further, item “1153” is referred to as both “bulbous edge” and a “bulbous cross-section”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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: “locking mechanism” in claims 1, 6, 12, 17, and “self-assembly members” in claims 11 and 22.
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.
The “locking mechanism” is accordingly understood to be a set of lockable tabs, a set of geometrical engagement structures such as a ring in a groove, female to male components, pins, rivets, zip-lock-type attachment ([015]).
The “self-assembly member” is understood to be a wire, a band, a strip, a plurality of wires, bands, or strips ([072] refers to US patent application 12/686338, who describes the self-assembly member in [036]).
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.
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 1-3, 5-9, 11-14, 16-20, 22-24 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 pre-AIA the applicant regards as the invention.
Claims 1, 6, 12, and 17 are indefinite for claiming the leaflets substructure has a "flattened unassembled one-layer structure which is folded into a delivery configuration". The specification [042] describes the embodiment in which the leaflets substructure is one layer as being one that is rolled into a delivery configuration (e.g. see Figure 5b). The specification describes the embodiment in which the leaflets substructure is folded into a delivery configuration as being a two-layer structure (which makes sense, since something which is folded inherently has two layers). The Examiner is accordingly unclear on which embodiment is being claimed by Applicant.
Claims 3 and 14 are indefinite for claiming the temporary valve is co-extensive with the delivery device. As the Examiner best understands, the delivery device extends from the inside of the patient, near the heart, to the outside of the patient, to the endovascular cardiologist performing the surgery in question. The temporary valve, as is seen for example in Applicant’s figure 16, is simply a valve which is provided to temporarily provide leaflet function during the procedure. It is shown as item 1395 which forms a few leaflets which appear to be rather thin, as opposed to the longitudinally long dimensions the leaflets of the valve would be required to have if they were to be co-extensive with the delivery system which extends a meter or more. The Examiner is unable to examine these two claims substantively until this is clarified, as it appears to go against the figures and the Examiner’s understanding of a temporary valve. However, if clarification occurs, prior art may be applied in the future.
Remaining claims are rejected for depending on an indefinite claim.
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 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, 5-7, 9, 11-12, 16-18, 20, 22-24 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Yang (US 20020138138 A1).
Regarding claim 17 Yang discloses a modular (Abstract: two-piece stent) prosthetic percutaneous valve device ([0052] heart valve deliverable by catheter) comprising:
a plurality of device modules including:
a support structure (Abstract: primary stent) and
a valve module (Abstract: secondary stent), which comprises:
a locking mechanism (a set of lockable tabs, a set of geometrical engagement structures such as a ring in a groove, female to male components, pins, rivets, zip-lock-type attachment) (264/308) formed integral thereto (Figure 9, 13a-c) which locks together said support structure and said valve module ([0071]), wherein the valve module comprises:
a leaflets substructure (102/200/250/290/300) having a flattened unassembled one-layer structure (Figure 7) which is loaded into a delivery configuration (Figure 13a, Figure 22; [0069] rolled into a relatively tight configuration),
the leaflets substructure having a first end (202a) and a second end (202b) which are brought into a ring shape as a working configuration (Figures 3a-c, 8, 9, 12, etc.),
wherein the device modules are assembled into a working configuration valve device (Figure 3a) after deployment from a percutaneous delivery device ([0100]) and locked in the working configuration via the locking mechanism ([0071], [0074]).
Regarding claim 18 Yang discloses the valve of claim 17 substantially as is claimed,
wherein Yang further discloses the leaflets substructure has a first locking member and a second locking member (216, 220) which interlock said first end and said second end of the leaflets substructure in the working configuration ([0069]).
Regarding claim 20 Yang discloses the valve of claim 18 substantially as is claimed,
wherein Yang further discloses the first and second locking members are complementary interlocking to each other (Figure 7; [0069]),
and wherein the first locking member is formed on an inner surface of the first end of the leaflets substructure and the second locking member is formed on an outer surface of the second end of the leaflets substructure (Figure 7 shows how the locking members are formed through the surface, indicating their presence on both inner and outer surfaces),
wherein the leaflets substructure is partially overlapped in the working configuration (Figure 7, [0069] the notches and tabs would overlap the leaflets substructure when in the ring formation based on their placement).
Regarding claim 22 Yang discloses the valve of claim 17 substantially as is claimed,
wherein Yang further discloses a self-assembly member (wire, a band, a strip, a plurality of wires, bands, or strips) (Figure 22 item 704).
Regarding claim 6 Yang discloses the valve of claim 17 substantially as is claimed,
wherein Yang further discloses the leaflets substructure’s flattened unassembled one-layer structure is folded into the delivery configuration (as is best understood (See 112 rejections above), see [0019] the secondary stent is rolled into the delivery configuration).
Regarding claim 7 see the rejection to claim 18 above.
Regarding claim 9 see the rejection to claim 20 above.
Regarding claim 11 see the rejection to claim 22 above.
Regarding claim 12 Yang discloses a system for assembling the modular prosthetic percutaneous valve device of claim 17 substantially as is claimed,
wherein Yang further discloses the system comprising a percutaneous delivery device and the valve device being contained within the delivery device ([0102], Figure 22; the delivery device inherently has the valve contained therein at least at some point during delivery).
Regarding claims 16 and 24 Yang discloses the system of claim 12 substantially as is claimed,
wherein Yang further discloses a push-rod ([0081] pusher).
Regarding claim 1, Yang discloses a system for assembling the modular prosthetic percutaneous valve device in a body in need thereof of claim 6 substantially as is claimed,
wherein Yang further discloses the system comprising a percutaneous delivery device and the valve device being contained within the delivery device ([0102], Figure 22; the delivery device inherently has the valve contained therein at least at some point during delivery).
Regarding claims 5 and 23 see the rejection to claims16/24 above.
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 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 negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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).
Claim(s) 8, 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yang as is applied above in view of Osborne et al. (US 20050182483 A1) hereinafter known as Osborne.
Regarding claim 19 Yang discloses the valve of claim 18 substantially as is claimed,
wherein Yang further discloses the first and second locking members are formed near the ends of the leaflets substructure (Figure 7),
but is silent with regards to the first and second locking members being formed on the first and second ends of the substructure.
However, regarding claim 19 Osborne teaches locking members of valve devices that are formed on the ends of an interlocking member (Figure 18 item 61). Yang and Osborne are involved in the same field of endeavor, namely valves. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the valve of Yang so that the locking members are formed on the end of the leaflets substructure as opposed to being adjacent the end, as is taught by Osborne since it is obvious to try to choose from a finite number of identifiable, predictable solutions with a reasonable expectation of success. In this case, using any known connectors and placing them at any location along the leaflets substructure would have been obvious to try.
Regarding claim 8 see the rejection to claim 19 above.
Claims 2, 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yang as is applied above in view of Robin et al. (US 20080200980 A1) hereinafter known as Robin.
Regarding claim 13 Yang discloses the system of claim 12 substantially as is claimed,
but is silent with regards to there being a temporary valve.
However, regarding claim 13 Robin teaches that a valve system can include a temporary valve ([0323]) with a single-piece or multi-piece construction (this is considered to be inherent). Yang and Robin are involved in the same field of endeavor, namely valves. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of Yang so that there is a temporary valve as is taught by Robin in order to allow the system to utilize a temporary valve after modifying/removing the native leaflets, during delivery, positioning, expansion, etc. of the new valve, thus providing and preserving necessary temporary valve function.
Regarding claim 2 see the rejection to claim 13 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
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