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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 7-22 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.
Regarding claim 7, the phrase “wherein a ratio of content of said second polymer in a surface of said blood component adsorbent material is 3 to 30 mg/g” is unclear. For example, it is unclear what the ratio of second polymer is in ratio with, since “a surface of said blood component adsorbent material” is not a numerically defined component. Further, the claim requires the second polymer is fixed to the surface of the porous particles but the ratio is not listed in regard to the first polymer (i.e. the polymer the second polymer is fixed to) but rather to “a surface of said blood component adsorbent material.” Accordingly, the ratio could also be interpreted as possibly including the second polymer as well because the second polymer is included in the “blood adsorbent material” as a whole. In the interest of compact prosecution and in view of the instant specification, the ratio was interpreted broadly as the ratio of second polymer on the support particle surface. Further, formula 2 in the instant specification ([0061]) for calculating the ratio content of second polymer in surface of blood component adsorbent material served to aid the interpretation of the limitation.
Regarding claim 8, recites the limitation "said ratio of content of said second polymer in said blood component adsorbent material as a uniformized whole" however there is insufficient antecedent basis for this limitation in the claim. In the interest of compact prosecution and in view of the instant specification, the term was interpreted as intending to read “wherein the ratio of content (mg/g) of second polymer in blood component adsorbent material as uniformized whole”, consistent with [0060] in the instant specification.
Claims 8-22 all depend from claim 7 and thus, are also rendered indefinite.
Claim Rejections - 35 USC § 103
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 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 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.
Claims 7, 9-11, 15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Qu et al. (ACS Appl. Mater. Interfaces 2014, 6, 12752-12760).
Regarding claim 7, Examiner first notes that when reading the preamble in the context
of the entire claim, the recitation “a blood component adsorbent material” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations or serve to limit the structure of the claimed catalyst. Thus, the preamble of the claim is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Qu teaches a polystyrene microsphere coated with cross-linked poly(vinyl alcohol) (PVA) that is used as an adsorbent (Abstract; Title; 3.7-3.8). Qu teaches the PVA is attached to the surface of the polystyrene (Scheme 1; Pg. 12753, left col.; Pg. 12755, right col.). Polystyrene is consistent with “a first polymer having an aromatic hydrocarbon group in a repeating unit” as described in Claim 9 and [0027] of the instant specification. Poly(vinyl alcohol) is consistent with “a second polymer having a hydroxy group in a repeating unit” as described in claim 10 and [0033] of the instant specification.
Qu further teaches the amount of PVA in the coating layer ranges from 20.1 to 52.7 mg/g of polystyrene resin (Figure 2). As described above in the 112(b) section, the limitation “wherein a ratio of content of said second polymer in a surface of said blood component adsorbent material is 3 to 30 mg/g” is interpreted as the amount of second polymer on the support particle surface. Examiner notes formula 2 in the instant specification ([0061]) describes the limitation as:
“Ratio of content (mg/g) of second polymer in surface of blood component adsorbent material= ratio of content (mg/g) of second polymer in blood component adsorbent material as uniformized whole x { absorption intensity of peak derived from OH group on surface of blood component adsorbent material/ absorption intensity of peak derived from CH stretching on surface of blood component adsorbent material} / { absorption intensity of peak derived from OH group in blood component adsorbent material as uniformized whole / absorption intensity of peak 5 derived from CH stretching in blood component adsorbent material as uniformized
whole}”.
While Qu does not explicitly describe this formula, Qu teaches a direct value of PVA on the surface of the polystyrene resin in the same units as those required by the claim (mg/g). Qu further teaches the composition of the PVA coated polystyrene microspheres is determined with the aid of X-ray photoelectron spectroscopy (XPS) (VG Scientific ESCALab220i-XL) and Fourier transform infrared spectroscopy (FTIR) (Nicolet6700, USA), respectively. The adsorption values used in Formula 2 of the instant specification are obtained using infrared spectroscopy and accordingly, not only does the value taught by Qu appear to meet the limitation, but Qu also determines the amount of PVA on the surface of the polystyrene with the same measuring technique as that of the instant invention. Therefore, Qu is considered to meet the limitation.
In 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). In the instant case, the range taught by Qu (PVA at 20.1 to 52.7 mg/g in coating layer) overlaps with the claimed range (3 to 30 mg/g second polymer in a surface of said blood component adsorbent material). Therefore, the range in Qu renders obvious the claimed range.
Regarding claim 9, Qu teaches the material of claim 7 and Qu teaches the first polymer is polystyrene (Scheme 1; Pg. 12753, left col.; Pg. 12755, right col.).
Regarding claim 10, Qu teaches the material of claim 7 and Qu teaches the second polymer is polyvinyl alcohol (Abstract; Title; 3.7-3.8).
Regarding claim 11, Qu teaches the material of claim 7. Qu does not explicitly state the material is used for “the adsorptive removal of leucocytes.” However, the recitation in the claims that the blood component adsorbent material is “for use in the adsorptive removal of leucocytes” is merely an intended use.
Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
The present claim does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Qu discloses an adsorbent material as presently claimed, it is clear that the adsorbent material of Qu would be capable of performing the intended use, i.e. in the adsorptive removal of leucocytes, presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
Regarding claim 15, Qu teaches the material of claims 7 and 9 and Qu teaches the second polymer is polyvinyl alcohol (Abstract; Title; 3.7-3.8).
Regarding claim 17, Qu teaches the material of claim 7 and 9. Qu does not explicitly state the material is used for “the adsorptive removal of leucocytes.” However, the recitation in the claims that the blood component adsorbent material is “for use in the adsorptive removal of leucocytes” is merely an intended use.
Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
The present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Qu discloses an adsorbent material as presently claimed, it is clear that the adsorbent material of Qu would be capable of performing the intended use, i.e. in the adsorptive removal of leucocytes, presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
Regarding claim 18, Qu teaches the material of claim 7 and 10. Qu does not explicitly state the material is used for “the adsorptive removal of leucocytes.” However, the recitation in the claims that the blood component adsorbent material is “for use in the adsorptive removal of leucocytes” is merely an intended use.
Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
The present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Qu discloses an adsorbent material as presently claimed, it is clear that the adsorbent material of Qu would be capable of performing the intended use, i.e. in the adsorptive removal of leucocytes, presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
Claims 8, 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Qu et al. (ACS Appl. Mater. Interfaces 2014, 6, 12752-12760) in view of Li et al. (CN103980403A English).
Regarding claim 8, Qu teaches the material of claim 7 and Qu teaches the amount of PVA in the coating layer ranges from 20.1 to 52.7 mg/g of polystyrene resin (Figure 2).
Qu does not explicitly teach a “ratio of content of said second polymer in said blood component adsorbent material as a uniformized whole is 0.3 mg/g or less”.
However, the term “uniformized whole,” while definite, is described in the instant specification as being obtained by grinding down the adsorbent material (i.e. the material with the second polymer coated on the first polymer), and then analyzing the content of second polymer in the sum of the material. See [0042] in the instant specification.
Accordingly, because Qu teaches an overlapping amount of second polymer on the surface of the first polymer, as understood and applied in the rejection of claim 7, the material of Qu would be expected to possess an overlapping “ratio of content of said second polymer in said blood component adsorbent material as a uniformized whole is 0.3 mg/g or less.” This would be expected to be the case by a skilled artisan because if the material of Qu, which contains an overlapping coating amount of second polymer on the surface of the first polymer as that of the instant invention, is ground into a powder and then analyzed, the amount of second polymer as a whole of the material would be in the range required by the claim.
The claim further requires the “volume of the pores is 0.5 to 1.8 cm3 per 1 g of the material,” to which Qu does not explicitly teach a pore volume in cm3/g. Qu teaches the pore sizes (Pg. 12756, right col.).
Li teaches a styrene-based adsorbent comprising polyvinyl alcohol that displays a pore volume of 0.75-0.84 mL/g (i.e. cm3/g) (Abstract; Claims 1, 4). In 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). In the instant case, the range taught by Li (pore volume of 0.75-0.84 mL/g) overlaps with the claimed range (volume of pores is 0.5-1.8 cm3/1g material). Therefore, the range in Li renders obvious the claimed range.
Advantageously, the adsorbent taught by Li is simple to prepare and displays significant reduction in toxin and inflammatory factors in blood after being used as an adsorbent (Pg. 3, par. 11).
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to provide a pore volume of 0.75-0.84 mL/g in the material of Qu in order to provide an adsorbent that displays significant reduction in toxins and inflammatory factors when treating blood, while also being simple to prepare, as taught by Li.
Regarding claim 13, Qu teaches the material of claim 7 and Qu in view of Li teach the adsorbent of claim 8. Qu further teaches first polymer is polystyrene (Scheme 1; Pg. 12753, left col.; Pg. 12755, right col.).
Regarding claim 14, Qu teaches the material of claim 7 and Qu in view of Li teach the adsorbent of claim 8. Qu teaches the second polymer is polyvinyl alcohol (Abstract; Title; 3.7-3.8).
Regarding claim 16, Qu teaches the material of claim 7 and Qu in view of Li teach the adsorbent of claim 8. Qu and Li do not explicitly state the material is used for “the adsorptive removal of leucocytes.” However, the recitation in the claims that the blood component adsorbent material is “for use in the adsorptive removal of leucocytes” is merely an intended use.
Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
The present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Qu in view of Li discloses an adsorbent material as presently claimed, it is clear that the adsorbent material of Qu in view of Li would be capable of performing the intended use, i.e. in the adsorptive removal of leucocytes, presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
Claims 12 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Qu et al. (ACS Appl. Mater. Interfaces 2014, 6, 12752-12760) in view of Oishi et al. (US6977044B1).
Regarding claim 12, Qu teaches the material of claim 7 and Qu teaches the PVA-coated polystyrene beads can be packed in a column (Pg. 12754, 2.6). Qu does not explicitly teach a blood purification column.
Oishi teaches a filter for selectively removing leukocytes from blood that comprises a hydrophilic synthetic polymer that is packed into a column for use (col. 23, lines 34-47).
Advantageously, the polymer filter taught by Oishi exhibits not only high leukocyte removal efficiency, but also high platelet passage ratio applicable to treatment of blood (col. 4, lines 3-22).
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use the column of Qu as a blood purification column in order to provide not only high leukocyte removal efficiency, but also a high platelet passage ratio applicable to treatment of blood as taught by Oishi.
Regarding claim 20, Qu teaches the adsorbent of claim 7 and 9 and Qu further teaches the PVA-coated polystyrene beads can be packed in a column (Pg. 12754, 2.6). Qu does not explicitly teach a blood purification column.
Oishi teaches a filter for selectively removing leukocytes from blood that comprises a hydrophilic synthetic polymer that is packed into a column for use (col. 23, lines 34-47).
Advantageously, the polymer filter taught by Oishi exhibits not only high leukocyte removal efficiency, but also high platelet passage ratio applicable to treatment of blood (col. 4, lines 3-22).
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use the column of Qu as a blood purification column in order to provide not only high leukocyte removal efficiency, but also high platelet passage ratio applicable to treatment of blood as taught by Oishi.
Regarding claim 21, Qu teaches the adsorbent of claim 7 and 10 and Qu further teaches the PVA-coated polystyrene beads can be packed in a column (Pg. 12754, 2.6). Qu does not explicitly teach a blood purification column.
Oishi teaches a filter for selectively removing leukocytes from blood that comprises a hydrophilic synthetic polymer that is packed into a column for use (col. 23, lines 34-47).
Advantageously, the polymer filter taught by Oishi exhibits not only high leukocyte removal efficiency, but also high platelet passage ratio applicable to treatment of blood (col. 4, lines 3-22).
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use the column of Qu as a blood purification column in order to provide not only high leukocyte removal efficiency, but also high platelet passage ratio applicable to treatment of blood as taught by Oishi.
Regarding claim 22, Qu teaches the adsorbent of claim 7 and 11 and Qu further teaches the PVA-coated polystyrene beads can be packed in a column (Pg. 12754, 2.6). Qu does not explicitly teach a blood purification column.
Oishi teaches a filter for selectively removing leukocytes from blood that comprises a hydrophilic synthetic polymer that is packed into a column for use (col. 23, lines 34-47).
Advantageously, the polymer filter taught by Oishi exhibits not only high leukocyte removal efficiency, but also high platelet passage ratio applicable to treatment of blood (col. 4, lines 3-22).
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use the column of Qu as a blood purification column in order to provide not only high leukocyte removal efficiency, but also high platelet passage ratio applicable to treatment of blood as taught by Oishi.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Qu et al. (ACS Appl. Mater. Interfaces 2014, 6, 12752-12760) in view of Li et al. (CN103980403A English) and further in view of Oishi et al. (US6977044B1).
Regarding claim 19, Qu teaches the adsorbent of claim 7 and Qu in view of Li teach the adsorbent of claim 8. Qu further teaches the PVA-coated polystyrene beads can be packed in a column (Pg. 12754, 2.6).
Qu and Li do not explicitly teach a blood purification column.
Oishi teaches a filter for selectively removing leukocytes from blood that comprises a hydrophilic synthetic polymer that is packed into a column for use (col. 23, lines 34-47).
Advantageously, the polymer filter taught by Oishi exhibits not only high leukocyte removal efficiency, but also high platelet passage ratio applicable to treatment of blood (col. 4, lines 3-22).
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use the column of Qu in view of Li as a blood purification column in order to provide not only high leukocyte removal efficiency, but also high platelet passage ratio applicable to treatment of blood as taught by Oishi.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jordan Wayne Taylor whose telephone number is (571)272-9895. The examiner can normally be reached Monday - Friday, 7:30 AM - 5 PM EST; Second Fridays Off.
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/JORDAN W TAYLOR/Examiner, Art Unit 1738
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