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 .
Status of Claims
Claim 1 is pending and examined on the merits.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In particular, the abstract is objected to for referring to the purported merits of the invention and using legal phraseology.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hansson et al. (WO 2014/147028 A1), hereinafter Hansson.
Regarding claim 1, Hansson discloses a system for performing therapeutic apheresis on a patient (Figs. 1 and 8; Page 1, lines 7 - 9 recite use with a patient subjected to extracorporeal blood processing; also see Page 12, lines 15 - 32; the secondary lymphoid system being inherent to a patient) that has a hearth that generates a pulse (page 4, line 27- page 5, line 11 describes heartbeats), an arterial system (page 26, lines 1-16 describe arterial access and sensors) having a pulse velocity defined as the velocity of blood when the pulse is at peak amplitude, and a secondary lymphoid system (have a pulse velocity and secondary lymphoid system are inherent to a living patient) comprising:
a pump (Page 12, lines 30 - 32 indicate a rotary peristaltic pump; also see Page 14, lines 24 - 28);
an automated blood cell separator (Page 1, lines 19-23 and Page 36, lines 13-20 indicate apheresis which requires a blood cell separator; Page 20, lines 1-8 indicate the device functions may be implemented using a processor and computer software i.e. automation);
a pulse detector (Figs. 1 and 7, pressure sensors 6a - 6c, 7; Page 13, line 32 - Page 14, line 15; Page 18, lines 15 - 17 indicate if cardiac arrest is detected, the pump will stop i.e. the pulsing of the blood from the pump is reliant on and created by heart pulse waves); and
a controller (Page 20, lines 1-8 indicate the device functions may be implemented using a processor and computer software),
wherein the system is configured to receive arterial blood and returns a portion of the blood (Page 1, lines 19-23 and Page 36, lines 13-20 indicate apheresis which by definition requires receiving blood and returning a portion of blood; page 26, lines 1-16 describe arterial access and sensors), perform apheresis on the blood to remove one or more components from the blood (Page 1, lines 7 - 9 recite use with a patient subjected to extracorporeal blood processing; Page 1, lines 19-23 and Page 36, lines 13-20 indicate apheresis).
Further, limitations of the system is configured to “receive arterial blood having a first pulse vel0ocity from the patient, perform apheresis on the blood to remove one or more components from the blood, and return a portion of the blood to the arterial system of the patient in pulsatile flow at a second pulse velocity that is different from the first pulse velocity” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Hansson has all the structure as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to receive atrial blood and return a portion of the blood; Hansson does not disclose matching the return pulse velocity, thus the inherent pulsatile flow of the peristaltic pump would not be identical to the patient’s heart).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,121,642 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the present application are anticipated by the patented claim. In addition, the claims of the present application are more generic than the patented claims and are therefore anticipated. The patented claims present the species, while the claims of the current application present a genus. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,484,637 B2
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the present application are anticipated by the patented claim. The claims of the present application are more generic than the patented claims and are therefore anticipated. The patented claims present the species, while the claims of the current application present a genus. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E 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.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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