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 .
Election/Restrictions
Applicant's election with traverse of invention I (claims 1-4, 6, 9-11, 13-14, 16-17, 26) in the reply filed on 06/26/26 is acknowledged. The traversal is on the ground(s) that the inventions are “basically the same”. Applicant argues that any art searched for one group is applicable to the other group and so would not be a serious search burden. This is not found persuasive because it is impossible to know whether one piece of art applicable to one invention would be applicable to all three presented inventions. If the art would necessarily be the same, the scope of each of the claims would be the same (which it is not). Additionally, the standard is whether or not the search for each presented invention would be different, not the potential prior art used itself. Since the Examiner has provided (see page 5, mailed 04/29/26) evidence of the distinct searches each invention requires, the requirement is still deemed proper and is therefore made FINAL.
Claims 18, 20-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/26/26.
Claim Objections
Claims 1-4, 10-11 are objected to because of the following informalities:
Claim 1 is objected to for referring to “growth accommodating” when it is believed a hyphen is missing for grammatical correctness.
Claim 2 is objected to for having improper antecedent basis for “the diameter of the valve system” and “the diameter of the first position”.
Claim 3 is objected to for having improper antecedent basis for “a further date”.
Claim 4 is objected to because it is believed “partially expanded” and “fully expanded” both require hyphens for grammatical correctness.
Claim 10 is objected to for having improper antecedent basis for “at least one support beam”, “a support beam”, “a combination of support beams”, and “a leaflet”.
Claim 11 is objected to for referring to “the vertical axis” with improper antecedent basis.
Appropriate correction is required.
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 balloon, second inflatable balloon, partially expanded configuration, fully expanded configuration, first inflatable balloon, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because items 113 is in the figures but not in the specification, and items 201, 202 are in the specification but not in the figures.
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 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 9-11 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.
Claim 9 is indefinite for claiming the cage is “web-like” when it is unclear what “web-like” actually means. For example, it might be referring to web-like in color, size, shape, material, or any other characteristic of a web. Since web characteristics are not universally known or standard, and since the specification does not elaborate on what web-like means and what might be considered web-like or not web-like, the Examiner is unable to determine the boundaries of the claim.
Claim 11 is indefinite for claiming the angle of the path changes with respect to the vertical axis of the valve system “to accommodate an increased diameter of the second position of the expandable valve system”, but it appears that the diameter increase to get to the second position of the valve system, as opposed to the second diameter expanding, as the claim currently states. It is accordingly unclear on what this means.
Remaining claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 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.
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 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6, 9-11, 13-14, 16, 26 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Justino et al. (US 20170189175 A1) hereinafter known as Justino or in the alternative, under 35 U.S.C. 103 as being obvious over Justino as is applied above.
Regarding claims 1-3 and 26 Justino discloses a growth-accommodating prosthetic valve system (Abstract; [0076] the valve can be serially expanded to accompany the child’s growth) comprising:
an expandable stent ([0005] expandable cylindrical stent; item 102) and a plurality of leaflets each attached to the stent (Abstract; items 106a-c) along a path ([0092]; item 108) to form a heart valve,
wherein a length of the path is configured to stay the same as the stent expands from a first position to a second position, the diameter of the stent in the second position is greater than the diameter of the first position (clm 2) (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Justino was considered capable of performing the cited intended use. See, for example Figures 1a-b, 2, 3a-f, 5c,d, 7 (left figure), etc. show the stent in an expanded configuration to accompany the child’s growth, with [0103] explaining that after initial dilation (expansion) of the valve (understood to be the “first position”, the valve can be “re-dilated to a larger diameter late after implantation (such as to accommodate growth of a pediatric patient”, while still maintaining competence of the valve 100”) as a result of the coaptation zone Figures 11a-d items 904/906. This is considered to be the “second position”. Accordingly, after expansion to the first position, there can be a re-expansion (to the second position) which maintains coaptation of the leaflets based on the presence of the extended coaptation region. The length of the path 108 which attaches the leaflets 106 to the stent 102 inherently (or in the alternative, obviously) does not change in any way upon re-dilation. The Examiner finds nothing in Justino showing or discussing changing the length of the attachment path 108 in any re-dilation or secondary expansion, meaning it does not happen, or alternatively obviously does not happen.),
wherein the system is twice-expandable ([0076], [0103]), wherein the valve is deployed into the first position in a heart using a first inflatable balloon (clm 3, 26) and then expanded at a further date using a second inflatable balloon (clm 3, 26) into the second position to accommodate growth of the heart (Justin is understood capable of meeting this “intended use” limitation in that [0076], [0131], and [0135] indicates the valve is implantable and expandable via balloon catheter (e.g. a first balloon), and [0103] and [0076] indicates the valve system can be re-dilated, indicating the system is able to receive a second inflatable balloon, if desired, to dilate the diameter to the second position.).
Regarding claim 4 Justino discloses/teaches the valve system of claim 1 substantially as is claimed,
wherein Justino further discloses the first position comprises a partially-expanded configuration and the second position comprises a fully-expanded configuration (This only further defines the first and second positions the valve system is intended to be in. Paragraphs [0076] and [0103] describe implantation and subsequent serial expansion/re-dilation to a larger diameter, which indicates the first position can be considered to be a partially-expanded configuration and the second position can be considered a fully-expanded configuration.).
Regarding claim 6 Justino discloses/teaches the valve system of claim 1 substantially as is claimed,
wherein Justino further discloses in the first position, the stent has a diameter of about (+-10% [0075]) 12 mm, and in the second position the stent has a diameter of 20 mm (This only further defines the first and second positions the valve system is intended to be in. Since [0085] states that the stent has a diameter of between 5-30 mm for implantation in the subject, this indicates the stent is capable of occupying diameters in the range of 5-30 mm. This includes both a diameter of 12mm and a diameter of 20mm as is required by the claim.).
Regarding claim 9 Justino discloses/teaches the valve system of claim 1 substantially as is claimed,
wherein Justino further discloses the stent comprises a plurality of support beams (112, 110) interconnected by joints (see Figures 1-2, for example) that together form a web-like cylindrical cage (Figures 1-2 as the Examiner best understands, the stent is considered to be web-like. See also Figures 1-2 and [0016] regarding the shape being cylindrical).
Regarding claim 10 Justino discloses/teaches the valve system of claim 9 substantially as is claimed,
wherein Justino further discloses each leaflet is attached to at least one support beam of the plurality of support beams ([0080]),
wherein the path is defined as a length along a support beam or a combination of support beams to which a leaflet is attached (Figure 5b shows beams 112 agreeing with the leaflet attachment line 108).
Regarding claim 11 Justino discloses/teaches the valve system of claim 1 substantially as is claimed,
wherein Justino further discloses an angle of the path that attaches the leaflets to the stent is configured to change with respect to a vertical axis of the stent to accommodate an increased diameter of the second position of the stent (see Figure 7 which shows an expanded configuration (left) and a compressed configuration (right). While not illustrated in this figure, the leaflet attachment pathway Figure 5b item 108 can be observed to adjust its angle during the expansion from the right to the left figure).
Regarding claim 13 Justino discloses/teaches the valve system of claim 1 substantially as is claimed,
wherein Justino further discloses the leaflets are constructed from a material comprising biological tissue or a stretchable polymeric material ([0020]).
Regarding claim 14 Justino discloses/teaches the valve system of claim 1 substantially as is claimed,
wherein Justino further discloses a skirt around the system’s outer surface ([0083] the stent is covered with a polymer) to mitigate paravalvular leak (whether or not the skirt mitigates paravalvular leak appears to depend upon the valve annulus into which the system is implanted into. The Examiner understand the dip-formed skirt which envelops the stent to be capable of mitigating paravalvular leak if it is implanted within a valve of appropriate size. See also [0115].),
wherein the skirt is constructed from a material comprising a stretchable polymer or a biological tissue ([0119] the stent can be dip coated in polymer; [0033] the second polymer can be silicone).
Regarding claim 16 Justino discloses/teaches the valve system of claim 1 substantially as is claimed,
wherein Justino further discloses the leaflets are configured to maintain full coaptation as the diameter of the stent expands ([0103]).
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Justino as is applied above in view of Hofferberth et al. (WO 2019099864 A1) hereinafter known as Hofferberth.
Regarding claim 17 Justino discloses/teaches the valve system of claim 1 substantially as is claimed,
but is silent with regards to how the leaflets (106) attach to the stent (102) along the path (108).
However, regarding claim 17 Hofferberth teaches a valve system in which leaflets are sutured to a stent ([0131]). Justino and Hofferberth 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 filed to modify the valve system of Justino so that the leaflets attach to the stent with sutures as is taught by Hofferberth since this is a well-known attachment technique in the art which can be reasonably expected to succeed in Justino’s described attachment.
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 07/06/26
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