S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`REMARKS
`
`Applicant appreciates the courtesy shown by the Examiner in discussing this case
`
`with Applicant’s representative, Rong Yang, Reg. No. 71,641 on June 13, 2016. The
`
`revisions in the claims were discussed in the interview. The discussions of the interview are
`
`reflected in the above amendments and the following remarks.
`
`Reconsideration is requested in view of the above amendments and the following
`
`remarks. Claim 15 has been revised. New dependent claims 20-22 have been added.
`
`Support for the new claims can be found at, e.g., paragraph [0174] of the specification.
`
`Claims 15-22 are pending in the application. Claim 16 has been withdrawn.
`
`Claim 15 is rejected under 35 USC 103(a) as being unpatentable over Okamoto et al.
`
`(JP2007/315879A) in view of Roblin et al. (US. Patent Application Publication No.
`
`2008/0135419Al) and Korey et al. (J Parenter Sci Technol. 1989; 43(2): 80-3). Applicant
`
`respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol. With this feature,
`
`the analysis reagent can help control a removal rate of non-HDL to be in a range of
`
`100i20% (see paragraphs [Ol65]—[Ol73] of the specification).
`
`The rejection recognizes that Okamoto et al. fail to disclose the claimed reagent as
`
`required by claim 15. Roblin et al. do not remedy the deficiencies of Okamoto et al. Roblin
`
`et al. merely discuss a reagent mixture containing excipients that stabilize the reagent
`
`mixture, wherein amino acids are used as stabilizers. In fact, Roblin et al. are silent as to an
`
`analysis reagent including one substance or one compound of the substance as an additive,
`
`wherein the substance is at least one selected from the group consisting of succinic acid,
`
`gluconic acid, valine, histidine, and maltitol, as required by claim 15.
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`Korey merely discusses effects of excipients on the crystallization of pharmaceutical
`
`compounds during lyophilization, where the excipients can be glycine, alanine, etc., and does
`
`not remedy the deficiencies of Okamoto et al. and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over Okamoto et al., Roblin et al.
`
`and Korey. Applicant does not concede the relevance of the rejection to the remaining
`
`features of the claim.
`
`Claims 15 and 17-19 are rejected under 35 USC 103(a) as being unpatentable over
`
`Okamoto et al. (JP2007/315879A) in view of Roblin et al. (US. Patent Application
`
`Publication No. 2008/0135419Al), Korey et al. (J Parenter Sci Technol. 1989; 43(2): 80-3),
`
`Saeki et al. (JP 2007/078676A) and Bibbo et al. (US. Patent No. 6,981,794). Applicant
`
`respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol. With this feature,
`
`the analysis reagent can help control a removal rate of non-HDL to be in a range of
`
`100i20% (see paragraphs [Ol65]—[Ol73] of the specification).
`
`Likewise, the rejection recognizes that Okamoto et al. fail to disclose the claimed
`
`reagent as required by claim 15. Roblin et al. do not remedy the deficiencies of Okamoto et
`
`al. Roblin et al. merely discuss a reagent mixture containing excipients that stabilize the
`
`reagent mixture, wherein the excipients in Roblin et al. include mannitol or glycine. In fact,
`
`Roblin et al. are silent as to an analysis reagent including one substance or one compound of
`
`the substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol, as required by claim
`
`15. Korey merely discusses effects of excipients on the crystallization of pharmaceutical
`
`compounds during lyophilization, where the excipients can be glycine, alanine, etc., and does
`
`not remedy the deficiencies of Okamoto et al. and Roblin et al.
`
`Moreover, Saeki et al. and Bibbo et al. are not relied upon as suggesting the claimed
`
`reagent. These two references do not remedy the deficiencies of Okamoto et al., Roblin et al.
`
`and Korey.
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`For at least these reasons, claim 15 is patentable over Okamoto et al., Roblin et al.,
`
`Saeki et al. and Bibbo et al. Claims 17-19 depend ultimately from claim 15 and are
`
`patentable along with claim 15 and need not be separately distinguished at this time.
`
`Applicant does not concede the relevance of the rejection to the remaining features of the
`
`rejected claims.
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`Double Patenting
`
`Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claims 1 and 5 of US. Patent No. 9,134,286 in view of Roblin et
`
`al. (US. Patent Application Publication No. 2008/0135419) and Korey et al. (J Parenter Sci
`
`Technol. 1989; 43(2): 80-3). Applicant respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol. With this feature,
`
`the analysis reagent can help control a removal rate of non-HDL to be in a range of
`
`100i20% (see paragraphs [0165]-[0173] of the specification).
`
`The rejection recognizes that claims 1 and 5 of US. Patent No. 9,134,286 fail to
`
`require the claimed reagent. Roblin et a1. do not remedy the deficiencies of claims 1 and 5 of
`
`US. Patent No. 9,134,286. Roblin et a1. merely discuss a reagent mixture containing
`
`excipients that stabilize the reagent mixture, wherein the excipients in Roblin et a1. include
`
`mannitol or glycine. In fact, Roblin et al. are silent as to an analysis reagent including one
`
`sub stance or one compound of the substance as an additive, wherein the substance is at least
`
`one selected from the group consisting of succinic acid, gluconic acid, valine, histidine, and
`
`maltitol, as required by claim 15. Korey merely discusses effects of excipients on the
`
`crystallization of pharmaceutical compounds during lyophilization, where the excipients can
`
`be glycine, alanine, etc., and does not remedy the deficiencies of claim 1 and 5 of US. Patent
`
`No. 9,134,286 and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over claims 1 and 5 of US. Patent
`
`No. 9,134,286 in view of Roblin et a1. Applicant does not concede the relevance of the
`
`rejection to the remaining features of the claim.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claim 1 of US. Patent No. 9,046,503 in view of Roblin et al.
`
`(US. Patent Application Publication No. 2008/0135419) and Korey et al. (J Parenter Sci
`
`Technol. 1989; 43(2): 80-3). Applicant respectfully traverses this rejection.
`
`8
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claim 1 of US. Patent No. 9,046,503 fails to
`
`require the claimed reagent. Roblin et al. do not remedy the deficiencies of claim 1 of US.
`
`Patent No. 9,046,503. Roblin et al. merely discuss a reagent mixture containing excipients
`
`that stabilize the reagent mixture, wherein the excipients in Roblin et al. include mannitol or
`
`glycine. In fact, Roblin et al. are silent as to an analysis reagent including one sub stance or
`
`one compound of the substance as an additive, wherein the substance is at least one selected
`
`from the group consisting of succinic acid, gluconic acid, valine, histidine, and maltitol, as
`
`required by claim 15. Korey merely discusses effects of excipients on the crystallization of
`
`pharmaceutical compounds during lyophilization, where the excipients can be glycine,
`
`alanine, etc., and does not remedy the deficiencies of claim 1 of US. Patent No. 9,046,503
`
`and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over claim 1 of US. Patent No.
`
`9,046,503 in view of Roblin et al. Applicant does not concede the relevance of the rejection
`
`to the remaining features of the claim.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claim 1 of US. Patent No. 8,865,472 in view of Roblin et al.
`
`(US. Patent Application Publication No. 2008/0135419) and Korey et al. (J Parenter Sci
`
`Technol. 1989; 43(2): 80-3). Applicant respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claim 1 of US. Patent No. 8,865,472 fails to
`
`require the claimed reagent. Roblin et al. do not remedy the deficiencies of claim 1 of US.
`
`Patent No. 8,865,472. Roblin et al. merely discuss a reagent mixture containing excipients
`
`that stabilize the reagent mixture, wherein the excipients in Roblin et al. include mannitol or
`
`9
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`glycine. In fact, Roblin et al. are silent as to an analysis reagent including one sub stance or
`
`one compound of the substance as an additive, wherein the substance is at least one selected
`
`from the group consisting of succinic acid, gluconic acid, valine, histidine, and maltitol, as
`
`required by claim 15. Korey merely discusses effects of excipients on the crystallization of
`
`pharmaceutical compounds during lyophilization, where the excipients can be glycine,
`
`alanine, etc., and does not remedy the deficiencies of claim 1 of US. Patent No. 8,865,472
`
`and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over claim 1 of US. Patent No.
`
`8,865,472 in view of Roblin et al. Applicant does not concede the relevance of the rejection
`
`to the remaining features of the claim.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claim 1 of US. Patent No. 8,709,346 in view of Roblin et al.
`
`(US. Patent Application Publication No. 2008/0135419) and Korey et al. (J Parenter Sci
`
`Technol. 1989; 43(2): 80-3). Applicant respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claim 1 of US. Patent No. 8,709,346 fails to
`
`require the claimed reagent. Roblin et al. do not remedy the deficiencies of claim 1 of US.
`
`Patent No. 8,709,346. Roblin et al. merely discuss a reagent mixture containing excipients
`
`that stabilize the reagent mixture, wherein the excipients in Roblin et al. include mannitol or
`
`glycine. In fact, Roblin et al. are silent as to an analysis reagent including one sub stance or
`
`one compound of the substance as an additive, wherein the substance is at least one selected
`
`from the group consisting of succinic acid, gluconic acid, valine, histidine, and maltitol, as
`
`required by claim 15. Korey merely discusses effects of excipients on the crystallization of
`
`pharmaceutical compounds during lyophilization, where the excipients can be glycine,
`
`alanine, etc., and does not remedy the deficiencies of claim 1 of US. Patent No. 8,709,346
`
`and Roblin et al.
`
`10
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`For at least these reasons, claim 15 is patentable over claim 1 of US. Patent No.
`
`8,709,346 in view of Roblin et al. Applicant does not concede the relevance of the rejection
`
`to the remaining features of the claim.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claim 1 of US. Patent No. 8,667,833 in view of Roblin et al.
`
`(US. Patent Application Publication No. 2008/0135419) and Korey et al. (J Parenter Sci
`
`Technol. 1989; 43(2): 80-3). Applicant respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claim 1 of US. Patent No. 8,667,833 fails to
`
`require the claimed reagent. Roblin et al. do not remedy the deficiencies of claim 1 of US.
`
`Patent No. 8,667,833. Roblin et al. merely discuss a reagent mixture containing excipients
`
`that stabilize the reagent mixture, wherein the excipients in Roblin et al. include mannitol or
`
`glycine. In fact, Roblin et al. are silent as to an analysis reagent including one sub stance or
`
`one compound of the substance as an additive, wherein the substance is at least one selected
`
`from the group consisting of succinic acid, gluconic acid, valine, histidine, and maltitol, as
`
`required by claim 15. Korey merely discusses effects of excipients on the crystallization of
`
`pharmaceutical compounds during lyophilization, where the excipients can be glycine,
`
`alanine, etc., and does not remedy the deficiencies of claim 1 of US. Patent No. 8,667,833
`
`and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over claim 1 of US. Patent No.
`
`8,667,833 in view of Roblin et al. Applicant does not concede the relevance of the rejection
`
`to the remaining features of the claim.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claims 1, 5 and 9 of US. Patent No. 8,596,150 in view of Roblin
`
`et al. (US. Patent Application Publication No. 2008/0135419) and Korey et al. (J Parenter
`
`Sci Technol. 1989; 43(2): 80-3). Applicant respectfully traverses this rejection.
`
`11
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claims 1, 5 and 9 of US. Patent No. 8,596,150
`
`fail to require the claimed reagent. Roblin et al. do not remedy the deficiencies of claims 1, 5
`
`and 9 of US. Patent No. 8,596,150. Roblin et al. merely discuss a reagent mixture
`
`containing excipients that stabilize the reagent mixture, wherein the excipients in Roblin et
`
`al. include mannitol or glycine. In fact, Roblin et al. are silent as to an analysis reagent
`
`including one substance or one compound of the substance as an additive, wherein the
`
`substance is at least one selected from the group consisting of succinic acid, gluconic acid,
`
`valine, histidine, and maltitol, as required by claim 15. Korey merely discusses effects of
`
`excipients on the crystallization of pharmaceutical compounds during lyophilization, where
`
`the excipients can be glycine, alanine, etc., and does not remedy the deficiencies of claims 1,
`
`5 and 9 ofU.S. Patent No. 8,596,150 and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over claims 1, 5 and 9 of US. Patent
`
`No. 8,596,150 in view of Roblin et al. Applicant does not concede the relevance of the
`
`rejection to the remaining features of the claim.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claims 1, 2, 4 and 5 of US. Patent No. 8,415,140 in view of
`
`Roblin et al. (US. Patent Application Publication No. 2008/0135419) and Korey et al. (J
`
`Parenter Sci Technol. 1989; 43(2): 80-3). Applicant respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claims 1, 2, 4 and 5 of US. Patent No.
`
`8,415,140 fail to require the claimed reagent. Roblin et al. do not remedy the deficiencies of
`
`claims 1, 2, 4 and 5 of US. Patent No. 8,415,140. Roblin et al. merely discuss a reagent
`
`mixture containing excipients that stabilize the reagent mixture, wherein the excipients in
`
`12
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`Roblin et al. include mannitol or glycine. In fact, Roblin et al. are silent as to an analysis
`
`reagent including one substance or one compound of the substance as an additive, wherein
`
`the substance is at least one selected from the group consisting of succinic acid, gluconic
`
`acid, valine, histidine, and maltitol, as required by claim 15. Korey merely discusses effects
`
`of excipients on the crystallization of pharmaceutical compounds during lyophilization,
`
`where the excipients can be glycine, alanine, etc., and does not remedy the deficiencies of
`
`claims 1, 2, 4 and 5 of US. Patent No. 8,415,140 and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over claims 1, 2, 4 and 5 of US.
`
`Patent No. 8,415,140 in view of Roblin et al. Applicant does not concede the relevance of
`
`the rejection to the remaining features of the claim.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claim 1 of US. Patent No. 7,938,030 in view of Roblin et al.
`
`(US. Patent Application Publication No. 2008/0135419) and Korey et al. (J Parenter Sci
`
`Technol. 1989; 43(2): 80-3). Applicant respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claim 1 of US. Patent No. 7,93 8,030 fails to
`
`require the claimed reagent. Roblin et al. do not remedy the deficiencies of claim 1 of US.
`
`Patent No. 7,93 8,030. Roblin et al. merely discuss a reagent mixture containing excipients
`
`that stabilize the reagent mixture, wherein the excipients in Roblin et al. include mannitol or
`
`glycine. In fact, Roblin et al. are silent as to an analysis reagent including one sub stance or
`
`one compound of the substance as an additive, wherein the substance is at least one selected
`
`from the group consisting of succinic acid, gluconic acid, valine, histidine, and maltitol, as
`
`required by claim 15. Korey merely discusses effects of excipients on the crystallization of
`
`pharmaceutical compounds during lyophilization, where the excipients can be glycine,
`
`alanine, etc., and does not remedy the deficiencies of claim 1 of US. Patent No. 7,93 8,030
`
`and Roblin et al.
`
`13
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`For at least these reasons, claim 15 is patentable over claim 1 of US. Patent No.
`
`7,938,030 in view of Roblin et al. Applicant does not concede the relevance of the rejection
`
`to the remaining features of the claim.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claims 1 and 16 of US. Patent No. 7,897,398 in view of Roblin et
`
`al. (US. Patent Application Publication No. 2008/0135419) and Korey et al. (J Parenter Sci
`
`Technol. 1989; 43(2): 80-3). Applicant respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claims 1 and 16 of US. Patent No. 7,897,398
`
`fail to require the claimed reagent. Roblin et al. do not remedy the deficiencies of claims 1
`
`and 16 of US. Patent No. 7,897,398. Roblin et al. merely discuss a reagent mixture
`
`containing excipients that stabilize the reagent mixture, wherein the excipients in Roblin et
`
`al. include mannitol or glycine. In fact, Roblin et al. are silent as to an analysis reagent
`
`including one substance or one compound of the substance as an additive, wherein the
`
`substance is at least one selected from the group consisting of succinic acid, gluconic acid,
`
`valine, histidine, and maltitol, as required by claim 15. Korey merely discusses effects of
`
`excipients on the crystallization of pharmaceutical compounds during lyophilization, where
`
`the excipients can be glycine, alanine, etc., and does not remedy the deficiencies of claims 1
`
`and 16 of US. Patent No. 7,897,398 and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over claims 1 and 16 of US. Patent
`
`No. 7,897,3 98 in view of Roblin et al. Applicant does not concede the relevance of the
`
`rejection to the remaining features of the claim.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claims 1, 2 and 6 of US. Patent No. 7,854,893 in view of Roblin
`
`et al. (US. Patent Application Publication No. 2008/0135419) and Korey et al. (J Parenter
`
`Sci Technol. 1989; 43(2): 80-3). Applicant respectfully traverses this rejection.
`
`14
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claims 1, 2 and 16 of US. Patent No.
`
`7,854,893 fail to require the claimed reagent. Roblin et al. do not remedy the deficiencies of
`
`claims 1, 2 and 16 of US. Patent No. 7,854,893. Roblin et al. merely discuss a reagent
`
`mixture containing excipients that stabilize the reagent mixture, wherein the excipients in
`
`Roblin et al. include mannitol or glycine. In fact, Roblin et al. are silent as to an analysis
`
`reagent including one substance or one compound of the substance as an additive, wherein
`
`the substance is at least one selected from the group consisting of succinic acid, gluconic
`
`acid, valine, histidine, and maltitol, as required by claim 15. Korey merely discusses effects
`
`of excipients on the crystallization of pharmaceutical compounds during lyophilization,
`
`where the excipients can be glycine, alanine, etc., and does not remedy the deficiencies of
`
`claims 1, 2 and 16 of US. Patent No. 7,854,893 and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over claims 1, 2 and 16 of US.
`
`Patent No. 7,854,893 in view of Roblin et al. Applicant does not concede the relevance of
`
`the rejection to the remaining features of the claim.
`
`Claim 15 is provisionally rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claim 14 of co-pending US. Patent Application
`
`No. 14/692,315 in view of Roblin et al. (US. Patent Application Publication No.
`
`2008/0135419) and Korey et al. (J Parenter Sci Technol. 1989; 43(2): 80-3). Applicant
`
`respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claim 14 of co-pending US. Patent
`
`Application No. 14/692,315 fails to require the claimed reagent. Roblin et al. do not remedy
`
`the deficiencies of claim 14 of co-pending US. Patent Application No. 14/692,315. Roblin
`
`15
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`et al. merely discuss a reagent mixture containing excipients that stabilize the reagent
`
`mixture, wherein the excipients in Roblin et al. include mannitol or glycine. In fact, Roblin
`
`et al. are silent as to an analysis reagent including one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol, as required by claim
`
`15. Korey merely discusses effects of excipients on the crystallization of pharmaceutical
`
`compounds during lyophilization, where the excipients can be glycine, alanine, etc., and does
`
`not remedy the deficiencies of claim 14 of co-pending US. Patent Application No.
`
`l4/692,315 and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over claim 14 of co-pending US.
`
`Patent Application No. l4/692,315 in view of Roblin et al. Applicant does not concede the
`
`relevance of the rejection to the remaining features of the claim.
`
`Claim 15 is provisionally rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claim 19 of co-pending US. Patent Application
`
`No. 14/877,663 in view of Roblin et al. (US. Patent Application Publication No.
`
`2008/0135419) and Korey et al. (J Parenter Sci Technol. 1989; 43(2): 80-3). Applicant
`
`respectfully traverses this rejection.
`
`Claim 15 requires an analysis reagent including a combination of a polyanionic
`
`compound and a bivalent cationic compound, and one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol.
`
`Likewise, the rejection recognizes that claim 19 of co-pending US. Patent
`
`Application No. 14/877,663 fails to require the claimed reagent. Roblin et al. do not remedy
`
`the deficiencies of claim 19 of co-pending US. Patent Application No. l4/877,663. Roblin
`
`et al. merely discuss a reagent mixture containing excipients that stabilize the reagent
`
`mixture, wherein the excipients in Roblin et al. include mannitol or glycine. In fact, Roblin
`
`et al. are silent as to an analysis reagent including one substance or one compound of the
`
`substance as an additive, wherein the substance is at least one selected from the group
`
`consisting of succinic acid, gluconic acid, valine, histidine, and maltitol, as required by claim
`
`15. Korey merely discusses effects of excipients on the crystallization of pharmaceutical
`
`l6
`
`

`

`S/N: 14/479,936
`In Reply to Office Action mailed 11/06/2015
`
`compounds during lyophilization, where the excipients can be glycine, alanine, etc., and does
`
`not remedy the deficiencies of claim 19 of co-pending US. Patent Application No.
`
`14/877,663 and Roblin et al.
`
`For at least these reasons, claim 15 is patentable over claim 19 of co-pending US.
`
`Patent Application No. 14/877,663in view of Roblin et al. Applicant does not concede the
`
`relevance of the rejection to the remaining features of the claim.
`
`In view of the above, favorable reconsideration in the form of a notice of allowance is
`
`respectfully requested. Any questions regarding this communication can be directed to the
`
`undersigned attorney, Douglas P Mueller, Registration No. 30,300, at (612) 455-3 804.
`
`Respectfully submitted,
`
`HAMRE, SCHUMANN, MUELLER &
`
`LARSON, PC.
`45 s. 7th St, Suite 2700
`Minneapolis, MN 55402
`(612) 455-3800
`
`/Douglas P. Mueller/
`By:
`Name: Douglas P. Mueller
`Reg. No. 30,300
`
`Dated: July 21, 2016
`
`DPM/CY
`
`17
`
`