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 Objections
Claims 1 and 13 are objected to because of the following informalities:
Claims 1 and 13 recite water that freezes lower than 18oC, which appears to by a typo and should be 0.18oC.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1 and 13 have been amended to recite, “…the low-melting-point moisture content including water that freezes at higher than 0oC and lower than 0.18oC. The specification as originally filed defines low-melting-point water as water that freezes at lower than 0.18oC. Thus, the definition of low-melting-point water given in the specification encompasses water that freezes at a temperature lower than the range of 0oC-0.18oC. There is nothing in the specification that indicates that water that freezes between 0oC and 0.18oC must be or is present or even if water that freezes within that small range provides any particular benefit. For at least these reasons the recitation of water that freezes at higher than 0oC and lower than 0.18oC constitutes new matter.
The additional claims are rejected as depending from claims 1 or 13.
Claim Rejections - 35 USC § 102 and 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 (i.e., changing from AIA to pre-AIA ) 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 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) 1-5 and 7-12 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Naoki et al. JP 2017-086563.
Claims 1, 3-5 and 7-8, Naoki teaches a blood purification device comprising: a porous molded body composed of a porous molded body forming polymer (polysulfone) (paragraph 29), hydrophilic biocompatible polymer (PVP) (paragraph 42), and an inorganic ion adsorbent containing at least one metal oxide represented by the claimed formula (paragraph 31), the metal oxide being hydrated titanium oxide, hydrated zirconium oxide, hydrated tin oxide, hydrated cerium oxide, hydrated lanthanum oxide, hydrated yttrium oxide, complex metal oxides comprising titanium, zirconium, tin, cerium, lanthanum and yttrium and at least one metal of aluminum, silicon and iron and activated alumina (paragraph 32). Naoki does not specifically teach the recited low melting point moisture content or the number of microparticles in 1mL after 3 or 6 months. The porous molded body of Naoki is made by the same methods taught in the present specification and therefore, the amount of low melting point moisture is assumed to be the same as that claimed as it would inherently flow as a property of the porous molded body made of the same materials and by the same method. If not inherent, it would have at least been obvious in view of applicant’s admission that, “It is known that a greater amount of intermediate water [corresponding to the recited low melting point moisture] present on the surface of the polymer composing the porous molded body results in more excellent blood compatibility (see NPL 1, for example)” (paragraph 43 of the printed publication). Thus, one of ordinary skill in the art would recognize that the amount of low melting point moisture is a result effective variable that would be optimized to achieve the desired biocompatibility. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, In re Aller, 105 USPQ 233 (1955).
Regarding the recitation of the number of microparticles, it appears applicant is reciting the device conforms to the eluting material test criteria listed in the approval standards for artificial kidney devices as established by the ministry of health, labour and welfare (paragraph 121 of the printed publication). The prior art device would also be subject to and would have to meet the same standards as it is also a blood filter. Additionally, the device of the prior art is made by the same method and is therefore assumed to have the same property regarding the amount of microparticles.
Naoki further teaches the porous molded body is washed (par 71, 75). One of ordinary skill in the art would readily recognize that washing will inherently be done with a fluid and a fluid will either be inherently be super or subcritical. Therefore, the washing step of Naoki will inherently be done with a fluid that is either super or subcritical. The removal of microparticles is also taught as the washing is paired with classification to achieve a particular particle diameter.
Claim 2, Naoki does not expressly teach the recited contact change rate. The present specification states, “In order to adjust the contact change rate to the range of 0% to 0.2%, in the case of a porous molded body obtained by coating a porous molded body with a hydrophilic polymer, the porous molded body prior to coating with the hydrophilic polymer is preferably composed of a hydrophobic polymer.” (paragraph 54 of the printed publication). This is the same way the prior art porous molded body is made and therefore the recited contact change rate is deemed to be inherent in the prior art device.
Claim 9, Naoki teaches the device adsorbs phosphorus (paragraph 50) but does not specifically teach the adsorption capacity. The prior art device is made by the same method and of the same materials as the present invention and is therefore assumed to have the same or similar property of phosphorus adsorption.
Claims 10-12, Naoki further teaches the recited adsorption rates for cytokines (paragraph 72) and for alarmin (paragraph73).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as obvious over Naoki et al. JP 2017-086563 in view of Naoki et al. JP 2016-077570.
Naoki ‘563 teaches the device of claim 1 but does not teach the porous molded body is coated with a biocompatible polymer.
Naoki ‘570 teaches a blood purification device comprising a porous molded body of polysulfone and PVP that is coated with a biocompatible polymer (PMEA) (paragraph 10). It would have been obvious to one of ordinary skill in the art to use the coating of Naoki ‘570 because the coating has very good hemocompatibility and maintains its hemocompatibility even when sterilized under an atmosphere (paragraph 10).
Claim(s) 13-18 and 20 is/are rejected under 35 U.S.C. 103 as obvious over Naoki et al. JP 2017-086563 in view of Omori et al. US 2007/0128424.
Claims 13-17, Naoki teaches a blood purification device comprising: a porous molded body composed of a porous molded body forming polymer (polysulfone) (paragraph 29), hydrophilic biocompatible polymer (PVP) (paragraph 42), and an inorganic ion adsorbent containing at least one metal oxide represented by the claimed formula (paragraph 31), the metal oxide being hydrated titanium oxide, hydrated zirconium oxide, hydrated tin oxide, hydrated cerium oxide, hydrated lanthanum oxide, hydrated yttrium oxide, complex metal oxides comprising titanium, zirconium, tin, cerium, lanthanum and yttrium and at least one metal of aluminum, silicon and iron and activated alumina (paragraph 32). Naoki does not specifically teach the recited low melting point moisture content or the number of microparticles in 1mL after 3 or 6 months. The porous molded body of Naoki is made by the same methods taught in the present specification and therefore, the amount of low melting point moisture is assumed to be the same as that claimed as it would inherently flow as a property of the porous molded body made of the same materials and by the same method. If not inherent, it would have at least been obvious in view of applicant’s admission that, “It is known that a greater amount of intermediate water [corresponding to the recited low melting point moisture] present on the surface of the polymer composing the porous molded body results in more excellent blood compatibility (see NPL 1, for example)” (paragraph 43 of the printed publication). Thus, one of ordinary skill in the art would recognize that the amount of low melting point moisture is a result effective variable that would be optimized to achieve the desired biocompatibility. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, In re Aller, 105 USPQ 233 (1955).
Regarding the recitation of the number of microparticles, it appears applicant is reciting the device conforms to the eluting material test criteria listed in the approval standards for artificial kidney devices as established by the ministry of health, labour and welfare (paragraph 121 of the printed publication). The prior art device would also be subject to and would have to meet the same standards as it is also a blood filter. Additionally, the device of the prior art is made by the same method and is therefore assumed to have the same property regarding the amount of microparticles.
Naoki further teaches the porous molded body is washed (par 71, 75). One of ordinary skill in the art would readily recognize that washing will inherently be done with a fluid and a fluid will either be inherently be super or subcritical. Therefore, the washing step of Naoki will inherently be done with a fluid that is either super or subcritical. The removal of microparticles is also taught as the washing is paired with classification to achieve a particular particle diameter.
Naoki teaches the porous molded body is composed of an inorganic ion adsorbent but does not specifically teach the inorganic ion adsorbent is formed of a dried powder. Naoki is silent as to how the inorganic ion adsorbent is made, thus, one of ordinary skill in the art would look to the prior art, such as Omori who teaches a porous molded boy composed of a porous molded body forming polymer (par. 16, 82), a hydrophilic polymer (par. 16, 87) and an inorganic ion adsorbent (par. 16) formed of a dried powder (par. 107). It would have been obvious to one of ordinary skill in the art to use a dried powder as this is a typical step in a method of producing an inorganic ion adsorbent as demonstrated by Omori. The claim would have been obvious because a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art, KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claim 18, Naoki does not expressly teach the recited contact change rate. The present specification states, “In order to adjust the contact change rate to the range of 0% to 0.2%, in the case of a porous molded body obtained by coating a porous molded body with a hydrophilic polymer, the porous molded body prior to coating with the hydrophilic polymer is preferably composed of a hydrophobic polymer.” (paragraph 54 of the printed publication). This is the same way the prior art porous molded body is made and therefore the recited contact change rate is deemed to be inherent in the prior art device.
Claim 20, Naoki teaches the device adsorbs phosphorus (paragraph 50) but does not specifically teach the adsorption capacity. The prior art device is made by the same method and of the same materials as the present invention and is therefore assumed to have the same or similar property of phosphorus adsorption.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as obvious over Naoki et al. JP 2017-086563 in view of Omori et al. US 2007/0128424 as applied to claim 13 above, and further in view of Naoki et al. JP 2016-077570.
Naoki ‘563 in view of Omori teaches the device of claim 13 but does not teach the porous molded body is coated with a biocompatible polymer.
Naoki ‘570 teaches a blood purification device comprising a porous molded body of polysulfone and PVP that is coated with a biocompatible polymer (PMEA) (paragraph 10). It would have been obvious to one of ordinary skill in the art to use the coating of Naoki ‘570 because the coating has very good hemocompatibility and maintains its hemocompatibility even when sterilized under an atmosphere (paragraph 10).
Response to Arguments
Applicant's arguments filed 6/10/25 have been fully considered but they are not persuasive.
Applicant states that washing with a super or subcritical fluid to remove microparticles imparts distinctive structure characteristics to the device. The prior art teaches washing the porous body and thus meets the limitations set forth in the claim as detailed in the rejection above. Applicant points to comparative example 3 as showing that without washing with a supercritical fluid a large number of microparticles resulted. Comparative example 3 and table 1 would indicate the importance of washing to achieve a desired number of microparticles. The type of fluid used does not appear to be critical or important as the comparison is between a washed and unwashed porous body. However, as detailed above, Naoki teaches washing of the porous body to achieve a particular particle size and therefore is deemed to meet the limitations of the claim for the reasons set forth above.
Regarding claims 2 and 18, applicant argues that the recited contact change rate is not inherent. Applicant points to example 1 and comparative example 3. The only difference between these examples being example 1 is washed with a supercritical fluid and comparative example 3 is not washed. The prior art to Naoki teaches washing the porous body and therefore meets the product by process limitations set forth in claims 1 and 13 as detailed above. The contact change rate is a measurement of the strength and fragility of the porous body (par 53 of the printed publication) and would be a property of the porous body that would depend on how the porous body is made. The porous body of Naoki is made in the same way as the claimed invention and is therefore assumed to have the same properties.
Conclusion
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/BENJAMIN M KURTZ/Primary Examiner, Art Unit 1778