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 .
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, 4-10, 12, and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9 of U.S. Patent No. 12,220,515 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patented case recite the claim limitations required in the current application. The table below shows the mapping of the overlapping claims between the current application and the patented case.
Instant Application Claims
Patented Case of US Patent No. 12,220,515 B2
1
1
4
2
5
3
6
4
7
5
8
6
9
9
10
1
12
3
16
1
17
3
18
5
19
6
20
9
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, 5, 10, 12-14, and 16 and its dependents 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 1 recites the limitation "the first end" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "a releasable, sealing connection" in line 21. It is unclear if “a releasable, sealing connection” in line 21 is the same “a releasable sealing connection” in line 19. For the purposes of examination, “a releasable, sealing connection” in line 21 is interpreted to be the same “a releasable sealing connection” in line 19.
Claim 1 recites the limitation "a first end" in line 24. It is unclear if “a first end” in line 24 is the same “the first end” in line 14.
Claim 5 recites the limitation "the angle" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the first end" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "a first end" in line 27. It is unclear if “a first end” in line 27 is the same “the first end” in line 14.
Claim 12 recites the limitation "an angle" in line 2. It is unclear if “an angle” in claim 12, line 2 is the same “an angle” in claim 10, line 19.
Claim 13 recites the limitation "the flow channel" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "a flow channel" in line 1. It is unclear if “a flow channel” in claim 14, line 1 is the same “the flow channel” in claim 13, line 1.
Claim 16 recites the limitation "the first end" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "a first end" in line 26. It is unclear if “a first end” in line 26 is the same “the first end” in line 14.
Allowable Subject Matter
Claims 10-20 are rejected under 35 U.S.C. 112(b) and non-statutory double patenting, but would be allowable if the non-statutory double patenting and 35 U.S.C. 112(b) rejections are overcome.
Claims 7-8 are rejected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if the independent claims overcome the non-statutory double patenting and 35 U.S.C. 112(b) rejections.
Reasons for Indicating Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the prior art of the record, alone or in combination, fails to disclose all of the structural and functional limitations as described in the claims.
The invention is drawn to a lung assistance device that has removable hollow gas permeable fiber bundle sections that are used to permit diffusion of gas between the blood and the hollow gas permeable fiber bundles. The device has an extending section to interface the fiber bundle sections and a base section that has a pressurizing pump to allow for gas and blood to pump through the device for blood oxygenation.
The closest prior art found are Madhani et al. (International Publication No. WO 2016/210089 A1), Federspiel et al. (International Publication No. WO 2014/085620 A1), and Wu et al. (Publication No. US 2016/0296685 A1), with none of the references disclosing the required claim limitations of independent claim 10 which recites “the interface section including an extending section which is positioned at a lateral end of the pressurizing section and extends at an angle from the lateral end of the pressurizing section and a second interface formed on the extending section, the second interface including the second connector that is configured to form a releasable, sealing connection with the first connector of the first interface of the fiber bundle section such that the fiber bundle housing of the fiber bundle section extends substantially parallel to the pressurizing section, wherein the base section housing and the fiber bundle housing are separate elements connected by the releasable, sealing connection between the first and second connectors”, and claim 16 which recites “the interface section including an extending section which is positioned at a lateral end of the pressurizing section and extends at an angle from the lateral end of the pressurizing section and a second interface formed on the extending section configured to form a releasable, sealing connection with the first interface of the fiber bundle section such that the fiber bundle housing of the fiber bundle section extends substantially parallel to the pressurizing section, wherein the base section housing and the fiber bundle housing are separate elements connected to one another only by the releasable, sealing connection between the first and second interfaces at the lateral end of the pressurizing section”.
Madhani discloses a system for lung assist (Abstract) with a fiber bundle section (upper half of system 10 is housing 20 comprising a fiber bundle 200 in a fiber bundle compartment 22; Paragraph 83; Figure 5A) and base section with the pressurizing pump (lower half of housing 20 is pressuring/pumping compartment 24 with impeller 100; Abstract; Paragraph 83; Figure 3A). However, Madhani does not teach an extending section which is positioned at a lateral end of the pressurizing section and extends at an angle from the lateral end of the pressurizing section and a second interface formed on the extending section and configured to form a releasable, sealing connection with the first interface of one of the plurality of fiber bundle sections such that the fiber bundle housing of the one of the plurality of fiber bundle sections extends substantially parallel to the pressurizing section and that base section and the fiber bundle section are separate elements.
Federspiel discloses a system for lung assist (system 10; Figure 3B; Paragraph 51) with fiber bundle sections (fiber bundle 200; Figure 3B; Paragraph 51) with different fiber bundle properties (Paragraph 62) and a base section with the pressurizing pump (first end section 30 with impeller 100; Figure 3B; Paragraph 51). However, Federspiel does not teach an extending section which is positioned at a lateral end of the pressurizing section and extends at an angle from the lateral end of the pressurizing section and a second interface formed on the extending section and configured to form a releasable, sealing connection with the first interface of one of the plurality of fiber bundle sections such that the fiber bundle housing of the one of the plurality of fiber bundle sections extends substantially parallel to the pressurizing section.
Wu discloses a system for lung assist (Figure 11; Paragraph 0046) with fiber bundle sections (fiber bundle 120; Figure 2; Paragraphs 0033-0035) and a pressurizing pump (pump 230; Paragraph 0046; Figure 11). However, Wu does not teach an extending section with a second interface that is releasably sealable with a first interface.
The closest is the disclosure of Madhani, however, the prior art, alone or in combination, does not provide a reasoning or teaching to have the extending section at the lateral end of the pressurizing section to have a releasable connection with the fiber bundle section such that the fiber bundle housing of the one of the plurality of fiber bundle sections extends substantially parallel to the pressurizing section, since that would disrupt the functionality of the fiber bundles within the integrally formed device.
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 (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.
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.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (Publication No. US 2016/0296685 A1).
Regarding claim 1, Wu teaches a system for lung assist (Paragraph 0046; Figure 11), comprising:
a fiber bundle section (blood oxygenator 100; Paragraph 0046; Figure 11) comprising a fiber bundle housing defining a fiber bundle compartment therein (housing of oxygenator 100 defines a fiber bundle compartment to hold a fiber bundle 150; Paragraph 0033-0034 and 0046; Figures 4 and 11), a fiber bundle positioned within the fiber bundle compartment (fiber bundle 150 within compartment of housing of oxygenator 100; Figure 4; Paragraph 0033-0034), the fiber bundle comprising a plurality of hollow gas permeable fibers (fiber bundle 150 made of plurality of hollow gas permeable fibers; Paragraph 0035), the plurality of hollow gas permeable fibers being adapted to permit diffusion of gas between blood and an interior of the plurality of hollow gas permeable fibers (Paragraph 0035 and 0037), the plurality of hollow gas permeable fibers being positioned such that blood flows around the plurality of hollow gas permeable fibers when flowing through the fiber bundle compartment (Paragraph 0037), the fiber bundle housing further comprising a gas inlet in fluid connection with the fiber bundle housing and in fluid connection with inlets of the plurality of hollow gas permeable fibers (gas inlet 130 in fluid connection with housing of 100 and inlets of fibers in bundle 150; Figure 2; Paragraph 0038), a gas outlet in fluid connection with the fiber bundle housing and in fluid connection with outlets of the plurality of hollow gas permeable fibers (vent 137 in fluid connection with housing of oxygenator 100 and with outlets of fibers in bundle 150; Figure 2; Paragraph 0031 and 0039), a blood outlet in fluid connection with a first end of the fiber bundle housing (blood outlet 125 at the first end of housing of oxygenator 100; Figure 2; Paragraph 0037) and a first interface disposed on a second end of the fiber bundle housing opposite the first end (first interface is connector 190 is at the second end of apparatus 100; Figure 2 and annotated Figure 11 below; Paragraph 0046), and
a base section comprising a housing comprising a pressurizing section including a pressurizing compartment (pump 230 has a housing and creates pressure within its volume in a compartment; Paragraph 0046; Figure 11) and an interface section (interface section is tubing that extends out to connector 190; annotated Figure 11 below; Paragraph 0046), the interface section including an extending section which extends from a lateral end of the pressurizing section (tubing is extending section that extends from a lateral end of pump 230; annotated Figure 11 below; Paragraph 0046), the interface section including a second interface formed on the extending section (second interface/connector 190 of pump 230 at end of extending section; annotated Figure 11 below; Paragraph 0046), the second interface including a releasable seal member configured to form a releasable sealing connection with the first interface of the fiber bundle section (quick connector 190 is releasable and sealable between the first and second interfaces of the apparatus 100 and the pump 230; annotated Figure 11 below; Paragraph 0046), wherein the base section housing and the fiber bundle housing are separate elements connected by a releasable, sealing connection between the first and second interfaces (base section 230 and fiber bundle housing 100 are separate elements that is connected by quick connector 190 between the first and second interfaces; annotated Figure 11 below; Paragraph 0046), a pressurizing mechanism within the pressurizing compartment (pump 230 contains a mechanism that forces blood through the pump and into the oxygenator; Paragraph 0046 and 0052; Figure 11), a blood inlet in fluid connection with the pressurizing compartment (blood inlet is where arrow going into the pump 230; annotated Figure 11 below; Paragraph 0046) and a conduit in fluid connection with the pressurizing compartment at a first end thereof via which pressurized fluid exits the pressurizing compartment (conduit is the flow channel of the extending section where pressurized fluid exits at a first end from the pump 230 and into the oxygenator 100; Figure 11; Paragraph 0052, wherein a second end of the conduit is placed in fluid connection with the second end of the fiber bundle when the fiber bundle housing of the fiber bundle section is connected to the housing of the base section via the first interface and the second interface (second end of conduit is connected to second end of fiber bundle 150 when the first interface and second interface are connected at connector 190; annotated Figure 11 below; Paragraph 0046).
PNG
media_image1.png
454
601
media_image1.png
Greyscale
Annotated Figure 11
Claim Rejections - 35 USC § 103
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.
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) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Publication No. US 2016/0296685 A1) in view of Muller et al. (Publication No. US 2020/0345337 A1).
Regarding claim 2, Wu discloses the system of claim 1. Wu does not teach wherein the releasable seal member is disposed in a recess on the second interface.
However, Muller teaches wherein the releasable seal member is disposed in a recess on the second interface (annular recess 232 of tube structure 230 receives an O-ring; Figure 5; Paragraph 0038).
Wu and Muller are both considered to be analogous to the claimed invention because they are in the same field of fluid-sealable medical connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Muller and incorporate the recess and O-ring of Muller within the second interface of Wu. This allows for the connection to be releasably fixed in position between the two components (Muller; Paragraph 0038).
Regarding claim 3, Wu in view of Muller teaches the system of claim 2. The combination of Wu in view of Muller further teaches wherein the releasable seal member is an O-ring (Muller; O-ring is the releasable seal member; Figure 5; Paragraph 0038; see rejection of claim 2 above).
Claim(s) 4-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Publication No. US 2016/0296685 A1) in view of Madhani et al. (Publication No. WO 2016/210089 A1).
Regarding claim 4, Wu discloses the system of claim 1. Wu does not teach wherein the pressurizing mechanism comprises an impeller rotatable within the pressurizing compartment.
However, Madhani teaches wherein the pressurizing mechanism comprises an impeller rotatable within the pressurizing compartment (pressuring mechanism is rotation of impeller 100 in pumping/pressuring compartment 24; Paragraphs 84, 86, and 88; Figure 1B).
Wu and Madhani are both considered to be analogous to the claimed invention because they are in the same field of blood oxygenators. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Madhani and incorporate the impeller of Madhani as the pressure mechanism within the pressurizing compartment of the blood pump of Wu. This allows for the blood traveling through the pump to be drawn towards the fiber bundles for oxygenation (Madhani; Paragraph 88).
Regarding claim 5, Wu in view of Madhani teaches the system of claim 4. Wu further teaches wherein the angle at which the extending section extends from the pressurizing section is 90 degrees, wherein the conduit comprises a flow channel which extends through the extending section (extending section is 90 degrees with respect to the longitudinal axis of the pressurizing section, conduit has a flow channel that extends through the extending section; see annotated Figure 11 above; Paragraph 0046).
Regarding claim 6, Wu in view of Madhani teaches the system of claim 5. Wu further teaches wherein the flow channel is in fluid connection with a manifold formed in the extending section (manifold is volume at the first end of the conduit’s flow channel that is formed in the extending section; see annotated Figure 11 above; Paragraph 0046).
Regarding claim 9, Wu discloses the system of claim 1. Wu does not teach wherein the plurality of hollow gas permeable fibers extends generally perpendicular to a direction of bulk flow of blood through the fiber bundle from the second end of the fiber bundle to the first end of the fiber bundle.
However, Madhani teaches wherein the plurality of hollow gas permeable fibers extends generally perpendicular to a direction of bulk flow of blood through the fiber bundle from the second end of the fiber bundle to the first end of the fiber bundle (Abstract; Paragraph 06 and 94-95).
Wu and Madhani are both considered to be analogous to the claimed invention because they are in the same field of blood oxygenators. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Madhani and have the plurality of hollow gas permeable fibers of Wu by perpendicular to the direction of blood flow through the fiber bundle, as taught by Madhani. This allows for the device to be more compact by decreasing the volume of the device while still providing functionality of the device (Madhani; Paragraph 95).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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, Rebecca Eisenberg can be reached at (571) 270-5879. 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.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
