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 .
Information Disclosure Statement
The information disclosure statement filed 12 February 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the IDS does not include any cited references. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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: oxygenator inlet “42” (Para. 0065). 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.
Claim Objections
Claims 14-22 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only (claim 14 recites claims 9 and 1), and cannot depend from any other multiple dependent claim (see claim 21). See MPEP § 608.01(n). Accordingly, the claims 14-22 have not been further treated on the merits.
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 2-6 and 8 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.
In regards to claim 2, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “the frame section (5), the other frame section (6)…are designed as one piece”, and the claim also recites “and in particular the rest of the frame (4)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In regards to claim 8, “the handle” in line 4 lacks proper antecedent basis. Appropriate correction is required.
Claims 3-6 are rejected based on their respective dependencies.
Claim Rejections - 35 USC § 102
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.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mortensen (US Pat. No. 4,610,656).
In regards to claim 1, Mortensen teaches holding means (10) for holding an oxygenator (44) and a blood pump (26 or 58), characterised by a frame (24) that can be connected with a carrying case housing (12) in a torque-proof way (e.g.; the platform 24 is securely mounted; Col 3, Lines 64-67) for fitting the oxygenator and the blood pump relative to each other, wherein the frame has a frame section for connection with the oxygenator in a torque-proof way (e.g.; oxygenator is secured in the section having tubing 46) and another frame section for connection with the blood pump in a torque-proof way (e.g.; the pump 26 or 58 is secured in the section having fitting 33 or tubing 42/49)(i.e.; each component is secured in the case 12 via the platform 24).
In regards to claim 2, Mortensen teaches the frame section, the other frame section, and in particular the rest of the frame (24), are designed as one piece (i.e.; 24 is a platform).
In regards to claim 3, Mortensen teaches a handle (20), which is connected with the frame in a torque-proof way (e.g.; via cover 14 with latch 16 and hook 18).
In regards to claim 4, Mortensen teaches the handle (20) and the frame (24) are always connected with each other (e.g.; via cover 14 with latch 16 and hook 18).
In regards to claim 5, Mortensen teaches the handle (20) is arranged at one end of the frame (i.e.; a top end).
In regards to claim 6, Mortensen teaches the handle (20) is arranged at the end of the frame that is furthest from the oxygenator and the blood pump (i.e.; at the top end).
In regards to claim 7, Mortensen teaches fluid lines (e.g.; 46, Fig. 2) are fitted on the frame with fittings (33)
In regards to claim 8, Mortensen teaches the other frame section is positioned in such a way that blood flowing out of the blood pump (26) flows in a direction facing the handle (20) (i.e.; the blood flows up through 44 and exits out at 54).
In regards to claim 9, Mortensen teaches a carrying case (12, 14) with a holding means (10) according to claim 1, characterized in that the holding means is partly arranged in a carrying case housing (12).
In regards to claim 10, Mortensen teaches the blood pump (26 or 58) can be driven by means of a gas flowing in one or in several fluid lines (via tank 52; Col 4, Lines 20-34, 55-61).
In regards to claim 11, Mortensen teaches the handle (20) is arranged outside of the carrying case housing (12, 14).
In regards to claim 12, Mortensen teaches a footprint designed and arranged in such a way that an oxygenator inlet (46) is arranged in a vertical direction above a blood pump outlet (64) when the carrying case is placed on a positioning surface with the footprint.
In regards to claim 13, Mortensen teaches the carrying case has a set of interchangeable oxygenators (Col 7, Lines 63-68).
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, 3 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,226,559 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of claims 1, 3, and 8-13 are encompassed by claims 1-20 of the patent by broadening the subject matter of the claims.
Claims 2 and 4-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,226,559 B2 in view of Mortensen (US Pat. No. 4,610,656). Mortensen teaches a holding means (i.e.; a system) having the limitations of claims 2 and 4-7 as discussed in the prior art rejection above. It would be obvious to one of ordinary skill in the art before the effective filing date and with reasonable expectation of success to modify the claims of the patent such that the system includes the limitations of claims 2 and 4-7 as taught by Mortensen. The motivation would be for the purpose of having a complete operative device that has the components securely attached within a single blood oxygenator system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see the PTO-892 for additional prior art related to the Applicant’s disclosed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STANTON L KRYCINSKI whose telephone number is (571)270-5381. The examiner can normally be reached Monday-Friday, 10:00AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Liu can be reached at (571)272-8227. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Stanton L Krycinski/Primary Examiner, Art Unit 3631