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 .
Response to Amendment
The preliminary amendment filed May 7, 2025 has been entered. Claims 1-5, 7-10, 13-19 have been amended. Claims 6 and 20-33 are canceled. Currently, claims 1-5, 7-19 are pending for examination.
The amendment to the specification filed May 7, 2025 has been entered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “apertures having rounded corners 112a-f” as described in the specification ([0025] of the published application). Figure 1 is annotated with reference number 112, but omits 112a-f. 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.
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 1-5, 7-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-20 of U.S. Patent No. 12,241,480. Although the claims at issue are not identical, they are not patentably distinct from each other because while the patented claims recite a plurality of blood exhaust apertures defined by an inner edge and an outer edge with rounded and chamfered features, these edges between each of the blood exhaust apertures are equivalent in structure to the struts claimed in the application that are between blood exhaust apertures, each strut having a cross section including a pair of non-adjoining, chamfered corners and a pair of non-adjoining, non-chamfered corners, regarded as obvious variations of the blood pump.
Application claim
Patented claim
Reason
1, 13
1, 12, 19
See reason above; claim 13 is also broader in scope as it omits a pump, impeller with blades
2, 14
2, 13
Equivalent limitation
3, 16
1, 12, 19
Equivalent limitation
4, 17
4, 20
Equivalent limitation
5, 18
5
Equivalent limitation
7, 15
6, 14
Equivalent limitation
8, 19
7
Equivalent limitation
9
8, 15
Equivalent limitation
10
9, 16
Equivalent limitation
11
10, 17
Equivalent limitation
12
11, 18
Equivalent limitation
Claims 1, 3-5, 7, 9-13, 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 8-11, 13, 15 of U.S. Patent No. 11,364,373. Although the claims at issue are not identical, they are not patentably distinct from each other because while the patented claims recite a plurality of blood exhaust apertures defined by an inner edge and an outer edge with rounded and chamfered portions, these edges between each of the blood exhaust apertures are equivalent in structure to the struts claimed in the application that are between blood exhaust apertures, each strut having a cross section including a pair of non-adjoining, chamfered corners and a pair of non-adjoining, non-chamfered corners, regarded as obvious variations of the blood pump.
Application claim
Patented claim
Reason
1, 13
1, 15
See reason above; claim 13 is also broader in scope as it omits a pump, impeller with blades
3, 16
3, 6
Equivalent limitation
4, 17
5
Equivalent limitation
5, 18
4
Equivalent limitation
7, 15
13
Equivalent limitation
9
8
Equivalent limitation
10
9
Equivalent limitation
11
10
Equivalent limitation
12
11
Equivalent limitation
Claims 1-2, 7, 9-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-16 of U.S. Patent No. 15/237,836. Although the claims at issue are not identical, they are not patentably distinct from each other because while the patented claims recite one or more blood exhaust apertures defined by an inner edge and an outer edge, wherein each inner edge is chamfered between an inner surface and outer surface and each inner and outer edges include rounded corners, these edges between each of the blood exhaust apertures are equivalent in structure to the struts claimed in the application that are between blood exhaust apertures, each strut having a cross section including a pair of non-adjoining, chamfered corners and a pair of non-adjoining, non-chamfered corners, regarded as obvious variations of the blood pump.
Application claim
Patented claim
Reason
1
10
See reason above
2
11
Equivalent limitation
7
12
Equivalent limitation
9
13
Equivalent limitation
10
14
Equivalent limitation
11
15
Equivalent limitation
12
16
Equivalent limitation
13
1
See reason above
14
2
Equivalent limitation
15
6
Equivalent limitation
16
5, 8
Equivalent limitation
17
3
Equivalent limitation
18
4
Equivalent limitation
19
7
Equivalent limitation
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.
Claims 3-5, 16-18 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.
Regarding claim 3, claim 1 has been amended to recite, “each strut having a cross section including a pair of non-adjoining, chamfered corners and a pair of non-adjoining, non-chamfered corners”. Claim 3 further limits, “wherein at least one non-chamfered corner of the pair of non-adjoining, non-chamfered corners is rounded”. A review of the specification (see amendment of specification dated 05/07/2025) indicates paragraph [0029]) as best supporting this limitation, but fails to disclose the limitation in its entirety. For example, while Figure 6 is described as having strut cross section 602 with chamfered corners 603b,d “in which corners 603 d and 603b are not adjoining corners”, paragraph [0029] does not describe at least one non-chamfered corner of the pair of non-adjoining, non-chamfered corners is rounded, as the specification explicitly states sharp corners. While the embodiment shown in Figure 5 is disclosed to have rounded corners 503a-d, these are not non-adjoining and the embodiment does not also have a pair of non-adjoining, chamfered corners.
Claims 4-5 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 3.
Claim 16 is directly dependent on claim 13 and similarly states limitations directed to, “wherein at least one non-chamfered corner of the pair of non-adjoining, non-chamfered corners is rounded” as described for claim 3. For the same reasons as claim 3, this claim is rejected to as failing to comply with the written description requirement.
Claims 17-18 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 16.
Statement Regarding Prior Art
Spanier et al. (US 2015/0141842), Siess et al. (US 2015/0051435), Siess et al. (US 2010/0268017), Siess (US 2010/0041939), Siess (US 2008/0103591), Sammler et al. (US 6,544,216) and Siess (US 2003/0187322) all describe openings or slots on a housing of a blood pump, regarded as blood exhaust apertures, but fail to detail the structural details of the edges or corners of the openings or slots, specifically each having a cross section including a pair of non-adjoining, chamfered corners and a pair of non-adjoining, non-chamfered corners. Applicant states in their specification that these structural details “causes significant reduction in hemolysis” and “allows the blood to follow a flow pattern in which the shear stresses may be decreased compared to flow past sharp or unblunted edges”, therefore causing fewer red blood cells to be ruptured as the blood flows through the cannula and out through the blood pump housing, resulting in lower hemolysis. Therefore these structural limitations are not regarded as an obvious matter of design choice. Charest et al. (US 2011/0158847) describes rounded or semi-circular cross sectional geometries minimize shear stress experienced by fluid traveling through chambers but this teaching is not directed to edges or corners of blood exhaust apertures of a blood pump assembly.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERICA S LEE/Primary Examiner, Art Unit 3796
Prosecution Insights