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 Arguments
Applicant's arguments filed 2/25/2026 have been fully considered but they are not persuasive.
Applicant argues that the value for standard deviation is strongly influenced by measurement location, and that in order to properly conclude that the standard deviation in the present disclosure is comparable to the standard deviation in Matsuura, the methods for measuring the standard deviations must be substantially the same.
This argument has not been found persuasive. The specific method by which standard deviation is measured is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, standard deviation is a well-known statistical concept, and the specific method by which it is measured is not relevant to the underlying structure of the device. In this case, Matsuura’s Coefficient of Variation value is defined as the division of the standard deviation by the average value of the thickness (paragraph [0107]). Since the average value of thickness and Coefficient of Variation variables are known, it is clear that Matsuura’s standard deviation falls within the claimed range. See the rejection below. The fact that one arrives at this standard deviation by different means does not mean the standard deviation is not the same.
Additionally, while Applicant argues that the value for standard deviation is strongly influenced by measurement location, Matsuura teaches that the Coeficient of Variation formula uses an average of thickness values at several locations [0107].
Finally, as noted in the rejection, Example 12 of Matsuura also teaches a standard deviation of 0.32mm (paragraphs [0181-0184]), which is also within the claimed range. It does not appear that applicant has presented any arguments with respect to Example 12 of Matsuura.
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.
Claims 1, 2, and 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ozeki et al. (US 2007/0199897) in view of Matsuura (US 2017/0112982).
With respect to Claims 1, 2, and 4, Ozeki teaches a blood processing filter (specifically a leukocyte removal filter; Figures 1-4; see Abstract and paragraphs [0001-0044]) comprising:
a container 3 having an inlet 4 and an outlet 5 for blood (Figure 2; paragraph [0034]; and
a filter medium 6 disposed between the inlet and the outlet of the container 3 (Figure 2, paragraph [0034]);
wherein the filter medium 6 comprises a filter element (the filter medium comprises a plurality of laminated sheets that are each formed by fibers; each these sheets have been interpreted as “filter elements”; see paragraphs [0061-0062] and [0077]);
an average thickness of the filter medium is 7-12mm (the filter has a thickness of 8.2-8.6mm, which falls completely within the claimed ranges of claims 1 and 4 with sufficient specificity; see paragraphs [0016], [0018], [0024], [0058], [0061-0062], and [0077]).
In addition, Ozaki teaches performing measurement at least five different locations of the filter material and obtaining the average thickness of the filter material from the average value thereof (paragraph [0061]), which implies some degree of variation in the thickness. Ozaki, however, is silent as to the exact standard deviation in thickness of the filter medium.
Matsuura teaches a similar blood processing filter for removing leukocytes, the filter having an inlet and an outlet for blood, and a filter medium disposed between the inlet and the outlet of the container (Figures 1-2). The filter medium comprises a filter element having an average thickness of 9.1 (which is within the ranges required in Claims 1 and 4) and a Coefficient of Variation of 5.9% (see Example 9; paragraphs [0170-0171]. Given that the Coefficient of Variation value is defined as the division of the standard deviation by the average value (paragraph [0107]), the standard deviation is equal to 0.53, which is within the ranges required in Claims 1 and 2. The examiner notes that Example 12 of Matsuura also teaches a standard deviation of 0.32mm (paragraphs [0181-0184]), which is also within the claimed range. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Ozaki’s blood processing filter to have an average thickness of 8-11mm and standard deviation of the thickness between 0.3-0.8mm (or between 0.4-0.7mm, as per Claim 2), as suggested by Matsuura, in order to provide a well-known configuration for removing leukocytes from blood passing through the filter.
With respect to Claims 5 and 6, Ozeki teaches that the substrate for forming the filter material is a fibrous material with a bulk density of 0.1-0.5 g/cm3, which includes the claimed range of 0.18-0.3 g/cm3 with sufficient specificity.
In the alternative, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05, II. A.). In this case, the claimed range falls within Ozeki’s disclosed bulk density range of 0.1-0.5 g/cm3. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Ozeki’s filter element to have a bulk density of 0.18-0.3 g/cm3, because since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
With respect to Claim 7, Ozaki teaches that the 8.2-8.6mm blood filter [0016] may be formed by laminating a total of 34 layers of filter material of differing types (i.e. 34 filter elements; see paragraph [0077]). Ozaki, however, is silent as to the average thickness of each of these elements. However, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (MPEP 2144.05, II. A.). In this case, Ozeki’s filter has a thickness that falls within the claimed range, and Ozeki clearly recognizes the relationship between the thickness of the filter elements and the resulting pressure drop [0077]. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to further modify at least one of Ozeki’s filter elements to have a thickness of 0.38-0.5mm, or any other thickness that was determined to be optimal for a given application, because discovering the optimum or workable ranges involves only routine skill in the art
With respect to Claim 8, Ozeki teaches that the optimal effective filtration area of the filter medium is 50-70 cm2 which overlaps with the claimed range of 40-50 cm2.
In the alternative, the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP 2144.05.I.). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Ozeki’s filter to have an effective filtration area of 40-50 cm2, or any other size that was determined to be desirable for a given application, because Ozeki reasonably suggests a range that overlaps with the claimed range.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ozeki and Matsuura as applied to claim 1 above, and further in view of Tokunaga et al. (JP 2007252463; translation provided by applicant in the IDS filed 11/28/2022).
With respect to Claim 3, Ozeki and Matsuura reasonably suggest the filter of Claim 1, and Ozeki further teaches that the container consists of an inlet-side container (surrounding inlet 4) material having the inlet 4 and an outlet-side container material (surrounding outlet 5) having the outlet 5 (Figure 2), and wherein the filter comprises a plurality of layers that are fused together (paragraph [0077]). Ozeki, however, does not specifically teach that the inlet-side container material and the outlet-side container material are welded at the periphery thereof while pinching the filter medium, and a thickness of the welded part is 1.2 mm to 1.8 mm.
Tokunaga teaches a similar blood processing filter in the same field of endeavor, the blood processing filter being manufactured by using flexible polyvinyl chloride sheets to sandwich the top and bottom of a porous body laminate, and performing high-frequency fusion such that the cross-sectional thickness of the fusion sites is 1.4 mm (paragraphs [0057-0058]), which falls within the claimed range of 1.2-1.8mm. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Ozeki’s blood processing filter to have the filter medium comprise a plurality of sheets that are pinched and welded together at the periphery with a weld thickness of 1.2-1.8mm, as suggested by Tokunaga, in order to maintain a stable sheet lamination structure within the filter housing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nagamine (US 2021/0268415) teaches a leukocyte filter having a non-woven filter element with the claimed average thickness [0052].
Ducoroy (US 2014/0291227) teaches a leucocyte filter comprising a housing and a filter element with welded edges.
Andou (US 2012/0165176) teaches a blood processing filter with welded edges.
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 Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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