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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “26” has been used to designate both stiffening band (¶ 62) and anchoring skirt (¶ 64+).
Reference character “80” has been used to designate both inner stent frame (¶ 65) and reservoir (¶ 82).
Reference character “86” has been used to designate both upper end of the stent frame (¶ 65) and rotary motor (¶ 82).
Reference character “401” has been used to designate both holder (¶ 71) and fibrous material (¶ 129).
Reference character “409” has been used to designate both line of sight (¶ 70) and suturing needle (¶ 71).
Reference character “800” has been used to designate both rotary jet spinning system (FIG. 8A) and docking device (¶¶ 183+).
Reference character “820” has been used to designate both docking device and docking station (¶ 184).
Reference character “850” has been used to designate both legs (¶ 178) and frame (¶ 184).
Reference character “862” has been used to designate both end and end struts (¶¶ 179+).
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. 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.
Specification
The disclosure is objected to because of the following informalities:
In ¶ 17 “FIG. 3 and 4 shown another” should be show.
In ¶ 22 “is close-up view” is missing a.
In ¶ 36 “FIGS. 23 shows” should be FIG.
In ¶ 48 “FIGS. 35 shows” should be FIG.
In ¶ 42 “a frames for” should be frame.
In ¶ 56 “methods for methods and devices” repeats methods.
In ¶ 71 “second hand 507” should be 407.
In ¶ 77 “In particular embedment” is a typo and should be embodiment.
In ¶ 80 “a tube that that is coupled” is a typo.
In ¶ 83 “employed for to provide” is a typo.
In ¶ 83 “collector assembly 79” is recited as “collection assembly 79” elsewhere (¶¶ 84, 88, 93).
In ¶ 87 ”In some implementations, by slowly moving the collection device (e.g., holder 70) along the axis 13 through a path of the polymeric fibers 85 while rotating the collection device/assembly 70, completely aligned coverage of the holder and/or medical device component held thereby.” Is an incomplete sentence.
In ¶ 89 “a platform (not shown)” and “a platform 10”
In ¶ 89 “collection assembly (70, 71, 73, 76 11)” is missing a comma and 71 and 76 are not elsewhere defined.
In ¶ 180 “annular wall 18” but no 18 is shown in the drawings.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities, the claim recites “a medical device component” in the preamble but then refers only to “a prosthetic heart valve docking frame” in the claim body.
Claim 5 is objected to because of the following informalities, the claim recites “a distal eyelet open cells” which is grammatically improper and unclear.
Claim 10 is objected to because of the following informalities, the claim recites “in response to a centripetal force” but the instant spec recites “centrifugal ejection” (¶ 81).
Claim 13 is objected to because of the following informalities, the claim recites "a valve seat" in lines 4-5 and in line 14. It is unclear if these are the same.
Claim 16 is objected to because of the following informalities, the claim recites “an end of the retaining portion” in line 3 and “a proximal edge of the frame” in line 4. It is unclear if these are different.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 17 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 17 recites “the reservoir is rotated at a tip speed of at least 20 m/s” which is not defined in the instant specification. Only a rotational rate is defined and the tip speed cannot be calculated without the reservoirs diameter.
Claim 19 recites “bioresorbable polymer selected from the group consisting of polycaprolactone, polylactide, polyglycolide, and copolymers thereof” but no support for polylactide and copolymers thereof is found in the instant specification, nor are these polymers defined as bioresorbable.
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 14, 15, and 20 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 14 and 20 recite “rotary jet spinning or electrospinning” but the instant specification only defines electrospinning as a syringe/needle process driven by electric field and not a rotary process (¶¶ 74, 79-80, 81). It is unclear how the electrospinning can further limit the rotary process.
Claim 15 recites “re-bending the end struts” however no straightening step is recited after the struts are allowed to bend and it is unclear if the re-bending step is the same as claim 13’s bending step or additional.
Claim 20 recites “when the end struts are bent radially inwardly, they form a toroidal annular skirt that radially bridges a gap” with “they” referring to the end struts and not the fibers deposited thereon. It is unclear how the end struts form the toroidal annular skirt that radially bridges a gap when the gap is bridged by the spun fibers. How does the “continuous porous fibrous layer that coats radially outer surfaces of the end struts” relate to the skirt?
Allowable Subject Matter
Claims 1-13, 16, 18 are allowed.
Claims 14, 15 and 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art taken either singularly or in combination fails to anticipate or fairly suggest the limitations of the independent claims, in such a manner that a rejection under 35 U.S.C. §102 or §103 would be proper. As discussed in the parent the closest prior art to Park and Nguyen generally discloses similar method for spin coating medical devices. Additionally, Tayeb et al. (US 11,291,540 B2) and Majercak et al. (US 7,070,616 B2) discloses similar frames. However, the closest prior art fails to discloses spin coating straightened legs of a prosthetic heart valve docking frame (claim 1) or end struts of a radially-expandable frame sized for implantation in a blood vessel (claim 13) or a radially-expandable lattice frame (claim 13) and allowing them to bend or curve inward to create a valve seat (claim 13 or 20).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Benjamin A Schiffman whose telephone number is (571)270-7626. The examiner can normally be reached M-F 9a-530p EST.
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/BENJAMIN A SCHIFFMAN/ Primary Examiner, Art Unit 1742
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