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 .
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.
Claims 1,-3 and 9 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.
The limitation, “have a minimum size of between about 20 microns and about 40 microns” is indefinite, because the word “minimum” means the least possible value, and should have one value, not a range of values. There is also no upper limit, which means no filter required. Claims 2 and 3 also lack an upper limit.
The ‘100 ml/min. at a flux of 0.2 ml/min/cm2’ is indefinite because it only shows a capability of the filter, not a required flow rate for the system. This flux rate depends on the applied pressure, which is not defined. Therefore,, indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2 and 3 recite average pore sizes of at least 25 and at least 30 microns, respectively, which are inside of the range in claim 1 for a minimum size, which change the scope of claim 1.. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102 and 103
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.
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.
Claim(s) 1-3 and 9 are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Barnes et al., (US 4,954,251).
Barnes teaches a filter for filtering aggregates from blood and infusing it to a patient. Filter pore sizes 20 – 150 microns, which anticipates claims 1-7. Fig. 2 shows prior art which has pore sizes from 20-40 microns. Barnes’ invention has pore size 40 and 150 microns. Column 1 lines 27-31 and 60-65, and col. 2 lines 20-55. Therefore, it meets a minimum pore size in the range claimed. The blood flow rate of 100 ml/min. at the requisite flow rate is only a capability requirement, which the Barnes filter should be, by applying the appropriate pressure.
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Th figures show inlet and outlet and the requisite chambers. Infusion to patient: col. 6 lines 45-50, claim 12.
Claim 8: material is plastic and polyester: col. 6, last line, col. 7, lines 25-45.
Claim 9: blood cell aggregates is same as cell clusters. Nonetheless, this is only a material worked upon; claims are for an apparatus.
Claim 10: Flow rate: this is a design consideration. See figure 8 for actual blood flow with time. Filter area is 25 and 36.5 cm2: Id.
Claims 11 and 12: extracorporeal circuit would have been obvious form the blood infusion. Intracorporeal circuit is only inserting the filter in to the patient’s vena cava like a thrombosis filter. Therefore, Barnes filter, being made to the appropriate size, could be similarly inserted, which would have been obvious to one of ordinary skill. It would have been obvious to one of ordinary skill in the art to have extracorporeal circuit as well-known in the art, or intracorporeal circuit as taught by the known greenfield filter to take advantage of a wider use of the filter.
Claim(s) 1-3 and 9 are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wegener et al (US 2017/0218330).
Wegener teaches a filter having the requisite structure for filtering biological cells having pore size 20-50 microns. See figures. It also teaches in fig. 1 an extracorporeal circuit. Material of construction is various plastics. See [0036]-[0038].
The pore size range in Wegner meets a minimum and the average pore size claimed. The blood flow rate of 100 ml/min. at the requisite flow rate is only a capability requirement, which the Wegener filter should be, by applying the appropriate pressure.
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Response to Arguments
Applicant's arguments filed 7/10/26 have been fully considered but they are not persuasive. They are addressed in the rejection.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISHNAN S MENON whose telephone number is (571)272-1143. The examiner can normally be reached Flexible, but generally Monday-Friday: 8:00AM-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Prem C Singh can be reached at 571-272-6381. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISHNAN S MENON/Primary Examiner, Art Unit 1777
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