DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 19 November 2024 has been considered by the Examiner.
Claim Objections
3. Claim 5 is objected to because of the following informalities.
Claim 5 contains a minor grammatical error.
Claim 5, lines 1-2: The Examiner suggests changing “extends along a longitudinal axis of the structure the at least one radial elements” to “extends along a longitudinal axis of the structure, wherein the at least one radial elements”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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.
5. Claim 5 is 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 5 recites the limitation "extends along a longitudinal axis of the structure" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The Examiner respectfully submits that claim 5 depends upon claim 1 which does not recite “the structure”.
Claim Rejections - 35 USC § 102
6. 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.
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.
7. Claims 1-6, 8-17, and 19-22 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Evans (US 2013/0303831 A1).
Regarding claim 1, Evans teaches an apparatus ([abstract]), comprising:
an impeller (the impeller 500[0095, FIG. 5A]), comprising:
an impeller frame that comprises proximal and distal end portions (the impeller 500 comprises impeller blades 502 that are disposed on the frame 508 [0095-0096, 0106]. Specifically, the frame 508 includes a proximal section 514 and a distal section 516 [0095-0096, FIG. 5A]) and a plurality of blades (the impeller 500 comprises impeller blades 502 [0095-0096, FIG. 5A, FIGS. 5C, FIG. 5E]), each of the impeller blades comprising:
a curved elongate element (figures 5A, 5D, and 5E illustrates the impeller blades 502 comprising flexible curved members 506 [0095, FIG. 5A, FIG. 5D, FIG. 5E]); and
at least one radial element extending radially from the curved elongate element toward a longitudinal axis of the impeller frame (figures 5A, 5C and 5E illustrates the radial webs 504 extending radially inward from the flexible curved members 506 towards a longitudinal axis of the frame 508 [0095, 0099, 0106, FIG. 5A, FIG. 5C, FIG. 5E]).
Regarding claim 2, Evans teaches wherein the at least one radial element within each of the impeller blades comprises a single radial element within each of the impeller blades (figures 5A, 5C, and 5E illustrates the radial webs 504 within each of the impeller blades 502 [0095, 0099, FIG. 5A, FIG. 5C, FIG. 5E]).
Regarding claim 3, Evans teaches wherein the curved elongate elements comprise helical elongate elements (figures 5C-5E illustrates the flexible curved members 506 of the impeller blades 502 forming a helical pattern [FIGS. 5C-5E]).
Regarding claim 4, Evans teaches wherein the impeller further comprises a plurality of sutures around the curved elongate elements (the radial web 504 comprises a suture or web material (e.g., woven mesh or fabric weave) that which surrounds and attaches to flexible curved members 506 [0108, FIG. 5A, FIG. 5C, FIG. 5E]).
Regarding claim 5, Evans teaches an axial element that extends along a longitudinal axis of the structure the at least one radial elements within each of the impeller blades extends radially from the curved elongate element toward the axial element (the impeller 500 comprises impeller blades 502 that are disposed on the frame 508 which slides axially along the pumps rotational axis 518 (e.g., axial element) [0095-0096, 0104, 0106]. Furthermore, the radial webs 504 extend radially inward from the flexible curved members 506 towards the pumps rotational axis 518 [0095, 0106, FIG. 5A, FIG. 5C, FIG. 5E]).
Regarding claim 6, Evans teaches wherein the impeller further comprises a material that is coupled to the curved elongate elements (the impeller blades 502 comprises the radial webs 504 which are composed of a web material (e.g., woven mesh) [0095, 0108, FIGS. 5A, FIG. 5C, FIG. 5E]. Specifically, the web material (e.g., woven mesh) of the radial webs 504 is attached to the flexible curved members 504 ([0095, 0108, FIG. 5A, FIG. 5C, FIG. 5E]), such that each of the curved elongate elements with the material coupled thereto defines a respective blade of the impeller (the impeller blades 502 comprises the radial webs 504 which are composed of a web material (e.g., woven mesh) [0095, 0108, FIGS. 5A, FIG. 5C, FIG. 5E]. Specifically, the web material (e.g., woven mesh) of the radial webs 504 is attached to the flexible curved members 506 ([0095, 0108, FIG. 5A, FIG. 5C, FIG. 5E]. The Examiner respectfully submits that the structure of the impeller blades 502 is defined by the radial web 504 being attached to flexible curved members 506 [0095, 0108, FIG. 5A, FIG. 5C, FIG. 5E]).
Regarding claim 8, Evans teaches wherein the at least one radial element comprises at least one string (the radial webs 504 may be a woven mesh that is composed fabric weave or string [0106, 0108]).
Regarding claim 9, Evans teaches wherein the at least one string is made of silicone (the radial webs 504 may be fabric weave or string that is made of silicone ([0108-0109]).
Regarding claim 10, Evans teaches wherein the at least one radial element comprises at least one wire (the radial webs 504 may be a woven mesh consisting of nitinol wires [0108, 0123]).
Regarding claim 11, Evans teaches wherein the at least one wire is made of nitinol (the radial webs 504 may be a woven mesh consisting of nitinol wires [0108, 0123]).
Regarding claim 12, Evans teaches a method ([0082-0083]), comprising:
manufacturing an impeller by cutting a tube such that the cut tube defines a structure having first and second end portions at proximal and distal ends of the structure, the end portions being connected to one another by a plurality of elongate elements (the impeller 500 comprises impeller blades 502 having curved elongate support members 506 that are formed by laser cut tubing [0095, 0109]. Specifically, figures 5C-5E illustrates the curved elongate support members 506 includes a first end portion 512 and a second end portion 510 which are interconnected by the curved elongate support members 506 [0095, FIGS. 5C-5E]. Furthermore, the first end portion 512 is disposed at the distal section 514 and the second end portion 510 is disposed at the proximal section 516 [0095, 0097, FIG. 5A]);
causing the elongate elements to radially expand and form curved elongate elements, by axially compressing the structure (the first end portion 512 of the distal section 514 and the second end portion 510 of the proximal section 516 are adjusted relatively towards each other (e.g., compressed configuration), which causes the curved elongate support members 506 to radially expand outward [0095, 0097, 0105-0106]); and
coupling at least one radial element to each of the curved elongate elements, such that the radial element extends radially from the curved elongate element toward a longitudinal axis of the structure (figures 5A, 5C and 5E illustrates the radial webs 504 extending radially inward from the curved elongate support members 506 towards a longitudinal axis that extends through first end portion 512 and the second end portion 510 of the structure [0095, 0099, 0106, FIG. 5A, FIG. 5C, FIG. 5E]. The Examiner respectfully submits that the radial webs 504 are attached to the curved elongate support members 506 [0095, 108]).
Regarding claim 13, Evans teaches wherein coupling at least one radial element to each of the curved elongate elements comprises coupling a single radial element to each of the curved elongate elements (the impeller blades 502 may each include respective radial webs 504 which are coupled to the curved elongated support members 506 [0095, 0106, 0108, FIG. 5A, FIG. 5C, FIG. 5E]).
Regarding claim 14, Evans teaches wherein causing the elongate elements to radially expand and form curved elongate elements comprises causing the elongate elements to radially expand and form helical elongate elements (figures 5C-5E illustrates the curved elongated support members 506 of the impeller blades 502 forming a helical pattern [FIGS. 5C-5E]).
Regarding claim 15, Evans teaches wherein manufacturing the impeller further comprises tying a plurality of sutures around the curved elongate elements (the radial web 504 comprises a suture or web material (e.g., woven mesh or fabric weave) that which surrounds and attaches to the curved elongated support members 506 [0108, FIG. 5A, FIG. 5C, FIG. 5E]).
Regarding claim 16, Evans teaches an axial element to the structure such that the axial element extends along a longitudinal axis of the structure wherein coupling the at least one radial element to each of the curved elongate elements comprises coupling the at least one radial element to each of the curved elongate elements such that the at least one radial element extends from each of the curved elongate elements toward the axial element (the impeller 500 comprises impeller blades 502 that are disposed on the frame 508 which slides axially along the pumps rotational axis 518 (e.g., axial element) [0095-0096, 0104, 0106, FIG. 5A, FIG. 5C, FIG. 5E]. Furthermore, the radial webs 504 extend radially inward from the curved elongated support members 506 towards the pumps rotational axis 518 [0095, 0106, FIG. 5A, FIG. 5C, FIG. 5E]).
Regarding claim 17, Evans teaches wherein manufacturing the impeller further comprises coupling a material to the curved elongate elements (the impeller blades 502 comprises the radial webs 504 which are composed of a web material (e.g., woven mesh) [0095, 0108, FIGS. 5A, FIG. 5C, FIG. 5E]. Specifically, the web material (e.g., woven mesh) of the radial webs 504 is attached to the flexible curved members 504 ([0095, 0108, FIG. 5A, FIG. 5C, FIG. 5E]), such that each of the curved elongate elements with the material coupled thereto defines a respective blade of the impeller (the impeller blades 502 comprises the radial webs 504 which are composed of a web material (e.g., woven mesh) [0095, 0108, FIGS. 5A, FIG. 5C, FIG. 5E]. Specifically, the web material (e.g., woven mesh) of the radial webs 504 is attached to the flexible curved members 506 ([0095, 0108, FIG. 5A, FIG. 5C, FIG. 5E]. The Examiner respectfully submits that the structure of the impeller blades 502 is defined by the radial web 504 being attached to flexible curved members 506 [0095, 0108, FIG. 5A, FIG. 5C, FIG. 5E]).
Regarding claim 19, Evans teaches wherein the at least one radial element comprises at least one string (the radial webs 504 may be a woven mesh that is composed fabric weave or string [0106, 0108]).
Regarding claim 20, Evans teaches wherein the at least one string includes at least one string made from silicone (the radial webs 504 may be fabric weave or string that is made of silicone ([0108-0109]).
Regarding claim 21, Evans teaches wherein the at least one radial element comprises at least one wire (the radial webs 504 may be a woven mesh consisting of nitinol wires [0108, 0123]).
Regarding claim 22, Evans teaches wherein the at least one wire is made of nitinol (the radial webs 504 may be a woven mesh consisting of nitinol wires [0108, 0123]).
Claim Rejections - 35 USC § 103
8. 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 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.
9. Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Siess et al. (WO 2016/174257 A1, with citations to the corresponding US Publication No. 2018/0149165 A1)
Regarding claim 7, Evans teaches the apparatus according to claim 6. Evans does not explicitly teach wherein the material is configured to be coupled to the curved elongate elements by the impeller frame being dipped in the material while the material is in a liquid state.
The prior art by Siess is analogous to Evans, as they both teach a blood pump comprising an impeller ([abstract, 0091, 0093-0094]).
Siess teaches wherein the material is configured to be coupled to the curved elongate elements by the impeller frame being dipped in the material while the material is in a liquid state (the coating 86 is formed on the impeller element 82 by dipping or inserting the impeller element 82 in a liquid coating [0121]. The Examiner respectfully submits that Siess’s liquid coating process can be used to couple the coating to Evan’s flexible curved members 506 of the impeller blades 502 [Evans: 0095, 0108-0109, FIG. 5A, FIG. 5C, FIG. 5E]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Evan’s coating to be applied to the curved elongate elements by dipping the impeller in the material while the material is in a liquid state, as taught by Siess. The advantage of such modification will provide reinforcement fibers on the impeller (see paragraph [0116, 0121-0122] by Siess).
Regarding claim 18, Evans teaches the method according to claim 17. Evans does not explicitly teach wherein coupling the material to the curved elongate elements comprises dipping the structure into the material, while the material is in a liquid state.
The prior art by Siess is analogous to Evans, as they both teach a blood pump comprising an impeller ([abstract, 0091, 0093-0094]).
Siess teaches wherein coupling the material to the curved elongate elements comprises dipping the structure into the material, while the material is in a liquid state (the coating 86 is formed on the impeller element 82 by dipping or inserting the impeller element 82 in a liquid coating [0121]. The Examiner respectfully submits that Siess’s liquid coating process can be used to couple the coating to Evan’s curved elongate support member 506 of the impeller blades 502 [Evans: 0095, 0108-0109, FIG. 5A, FIG. 5C, FIG. 5E]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Evan’s coating to be applied to the curved elongate elements by dipping the structure in the material while the material is in a liquid state, as taught by Siess. The advantage of such modification will provide reinforcement fibers on the impeller (see paragraph [0116, 0121-0122] by Siess).
Double Patenting
10. 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.
11. Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-7, 9, 11-13, 15, 17-19, 21, 23-25, and 27 of U.S. Patent No. 11,291,824 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite an apparatus and a method comprising an impeller, an impeller frame, impeller blades, a curved elongate element (e.g., helical elongate elements), and a radial element (e.g., string or wire).
Although not exhaustive, a brief matching of the pending claims to those of US Publication No. 11,291,824 B2 is provided below.
Application No. 18/952,273
U.S. Publication No. 11,291,824 B2
1
1, 11, 17, 23
2
11
3
1, 11, 17, 23
4
9, 15, 21, 27
5
2
6
1, 11, 17, 23
7
7, 13, 19, 25
8
1, 11
9
6, 12
10
17, 23
11
18, 24
12
1, 17
13
1, 17
14
1, 17
15
9, 15, 21, 27
16
2
17
1, 17
18
7, 19
19
1
20
6
21
17
22
18
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. 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 https://ppair-my.uspto.gov/pair/PrivatePair. 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.
/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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