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 .
Status of Claims
Receipt of Arguments/Remarks filed on 12/08/2025 is acknowledged. Claims 9-11, 13-14, and 16-28 are pending. Claims 9 and 11 were amended. Claims 1-8, 12, and 15 were canceled. New claims 17-28 were added.
Withdrawn Objections
The objection to the specification is withdrawn.
New and modified objections and rejections necessitated by amendment
Claim Objections
Claim 21 is objected to because of the following informalities: claim 21 recites “liprotein” in line 1. This should instead be “lipoprotein”. Appropriate correction is required.
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 9-11, 13-14, and 16-28 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.
Claim 9 recites “(ii) wherein the second reagent composition does not satisfy one or two of Condition 1, Condition 2, or Condition 3, but satisfies all other conditions”. It is unclear what all other conditions are. Under broadest reasonable interpretation, this limitation reads on a second reagent which satisfies any one or two of the conditions, regardless of the conditions satisfied by the first reagent.
The negative limitation “does not satisfy one or two” makes the scope unclear. Specifically, it is not clear if the one or two conditions not satisfied by the second reagent must be the same one or two conditions that are satisfied by the first reagent, or if the one or two conditions not satisfied by the second reagent may be any of the three conditions.
If the second reagent can satisfy any of the conditions regardless of the conditions satisfied by the first reagent, the claim should be amended to positively recite this, i.e. “the second reagent composition satisfies one or two of Condition 1, Condition 2, and Condition 3”. If the second reagent is meant to be dependent on the composition of the first reagent, the claim should be amended to more clearly state this and indicate how the two reagents are related, and to clearly specify which components are in each reagent.
For the purposes of examination, the claim is being interpreted to mean that both the first reagent and the second reagent may satisfy any one or two of the three conditions, or that they are independent of one another.
Claim 26 recites “wherein the lipoprotein as a measurement target is the sd LDL”. However, claim 9, upon which claim 26 depends, is directed to a method of quantifying cholesterol (lipoprotein C) in a lipoprotein other than small dense small dense low density lipoprotein (sd LDL) (emphasis added). Therefore, it appears that the limitation in claim 26, wherein the measurement target is sd LDL, is contradictory to the independent claim upon which it depends, which requires that the lipoprotein target is NOT sd LDL. It is requested that applicant amend the claims to clarify this issue.
Claim 26 additionally recites the limitation “the apoE containing HDL”. There is insufficient antecedent basis for this limitation in the claim. Claim 26 depends on claim 24, which depends on claim 9. Neither claim 9 nor claim 24 recite “an apoE containing HDL”. Thus, it is unclear what this limitation in claim 26 is referring to.
Claims 10-11, 13-14, and 16-25, and 27-28 are included in this rejection because they depend on a rejected claim and do not clarify the issue.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 9-11, 13-14, 16, 18-21, 24, 25, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al., CN1888863A.
Regarding claims 9, 10, and 13, Zhang teaches methods and reagents for quantitative determination of high-density lipoprotein cholesterol (Zhang p. 1). Zhang teaches that the method involves causing a first reagent (reagent I) to act on a sample, then causing a second reagent (reagent II) to act on the sample (Zhang p. 16 para. 57).
Zhang teaches that reagents I and II contain cholesterol lipase, cholesterol oxidase and peroxidase, and that the three enzymes can be all contained in reagent I (Zhang p. 11 para. 31).
Zhang teaches that reagent I comprises a dispersible surfactant, including polyoxyethylene-polyoxypropylene condensates or polyoxyethylene alkyl ether sulfates (Zhang p. 9 para. 25). The instant specification provides examples of surfactants that act on a lipoprotein other than the lipoprotein as a measurement target, and these include polyoxyethylene-polyoxypropylene condensates and sodium polyoxyethylene alkyl ether sulfate (see specification p. 22-23). Therefore, Zhang teaches that reagent I comprises a surfactant wherein the surfactant acts on a lipoprotein other than the lipoprotein to be quantified.
Regarding Condition 1, Zhang teaches that reagent I or reagent II may comprise 4-aminoantipyrine, which is a coupler as set forth on p. 28 of the instant specification (Zhang p. 9-11 para. 26, para. 30).
Regarding condition 2, Zhang teaches that reagent I or reagent II may comprise potassium ferrocyanide, which is an iron complex as set forth on p. 32 of the instant specification (Zhang p. 9-11 para. 26, para. 30).
Regarding condition 3, Zhang teaches that reagent I or reagent II may have peroxidase activity (Zhang p. 11 para. 31).
Therefore, Zhang teaches a first reagent composition that satisfies one or two of Conditions 1, 2, or 3; and a second reagent composition that does not satisfy one or two of Conditions 1, 2, or 3 but satisfies all other conditions. For example, reagent I may comprise a coupler, 4-aminoantipyrine, and an iron complex, potassium ferrocyanide, satisfying conditions 1 and 2 but not condition 3; and reagent II may comprise peroxidase activity, satisfying condition 3 but not conditions 1 and 2.
The “wherein” clauses of claims 9, 10, and 13 regarding absorption recite limitations to characterize the properties of the first and second reagents after storage for 2 weeks. These limitations do not result in a manipulative difference in the method steps. The method does not require that the reagents be stored for any amount of time prior to carrying out the method steps. As Zhang teaches the active method steps recited in claim 9, i.e. causing the first and second reagents to act on a lipoprotein sample, Zhang anticipates the method of claim 9 and dependent claims 10 and 13.
Regarding claim 11, Zhang teaches that the first reagent may comprise peroxidase activity (Zhang p. 11 para. 31).
Regarding claim 14, Zhang teaches that the second reagent comprises styrene-phenol polyoxyethylene (16) ether, which is a known commercially available surfactant (Zhang p. 9 para. 29). Zhang teaches that the soluble surfactant, or reaction promoter, in reagent II has a high affinity for the hydrophilic groups in HDL particles (Zhang p. 5 para. 11). As HDL is the measurement target in the method of Zhang, this is a surfactant that acts on the lipoprotein as a measurement target.
Regarding claim 16, Zhang teaches that the lipoprotein as a measurement target is HDL cholesterol (p. 7 para. 16).
Regarding claims 18 and 19, Zhang teaches that the first reagent comprises peroxidase activity (Zhang p. 11 para. 31).
Regarding claims 20 and 21, Zhang teaches that the first reagent comprises cholesterol (lipoprotein) lipase (Zhang p. 11 para. 31).
Regarding claim 24, Zhang teaches that the surfactant is polyoxyethylene-polyoxypropylene condensates or polyoxyethylene alkyl ether sulfates (Zhang p. 9 para. 25), which are nonionic surfactants.
Regarding claim 25, Zhang teaches that the measurement target is HDL and the surfactant is polyoxyethylene-polyoxypropylene condensates (Zhang p. 1; p. 9 para. 25).
Regarding claim 28, Zhang teaches that the coupler is 4-aminoantipyrine (Zhang p. 9-11 para. 26, para. 30).
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.
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 17, 22, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. as applied to claims 9-11, 13-14, 16, 18-21, 24, 25, and 28 above, in view of Sato et al., US 2016/0161512 A1.
Zhang teaches the method according to claim 9 as set forth above. Zhang teaches that the surfactant is a non-ionic surfactant and is a polyoxyethylene alkyl ether as recited in claims 26-27 (Zhang p. 9 para. 25).
Zhang does not teach that the first reagent comprises both cholesterol esterase and cholesterol oxidase activity (claim 17), that the first reagent comprises the cholesterol esterase activity, the cholesterol oxidase activity, a catalase activity, a peroxidase activity, a sphingomyelinase activity, and a lipoprotein lipase activity (claim 22), or that the lipoprotein as the measurement target is sdLDL or apoE containing HDL (claims 26-27).
Regarding claim 17, Sato teaches a method of quantifying cholesterol in high-density lipoprotein 3, or HDL3 (Sato “Technical Field”). Sato teaches a first reagent, Reagent A, is added to serum fractions containing CM-VLDL, LDL, HDL2, and HDL3 (Sato Example 1; pg. 4 para. 50). Reagent A was added to the lipoprotein samples and reacted, or caused to act on the sample (Sato para. 50). Sato teaches a second reagent, Reagent B, is then reacted with the sample after the rection of Reagent A, followed by absorbance measurements to quantify cholesterol (Sato para. 50). Sato teaches that Reagent A contains cholesterol oxidase and cholesterol esterase, i.e. that the reagent has cholesterol esterase and oxidase activity (Sato pg. 4 para. 51).
Regarding claim 22, Sato teaches that the first reagent includes cholesterol esterase and cholesterol oxidase (Sato p. 4 para. 45; para. 51), a catalase (Sato p. 3 para. 39; p. 4 para. 51), and a combination of sphingomyelinase and phospholipase that acts on lipoproteins, or lipoprotein lipase (Sato p. 3 para. 40-42; p. 4 para 51).
Regarding claims 26 and 27, Sato teaches that HDL can be divided based on the content of apolipoprotein E (apoE), wherein HDLs having higher contents of apoE are defined as apoE-rich HDLs (Sato p. 1 para. 3). Sato teaches that that CETP deficiency causes an increase in apoE-rich HDL, and that, since apo-E-rich HDL has a strong cholesterol-efflux ability and antiplatelet action, it is a better HDL among HDLs (Sato p. 1 para. 4). Sato teaches that surfactants that react with lipoproteins other than HDL or HDL3 include, but are not limited to,
nonionic surfactants such as polyoxyethylene sorbitan derivatives, polyoxyethylene-polyoxypropylene condensates and polyoxyethylene-stearylamine (Sato p. 3 para. 33).
It would have been obvious for a skilled artisan, before the effective filing date, to modify the teachings of Zhang and utilize a first reagent that has both cholesterol oxidase and cholesterol esterase activity. Zhang teaches that the first reagent used in a method of quantifying cholesterol in HDL has cholesterol oxidase activity (Zhang p. 11 para. 31). Both Zhang and Sato are directed to methods of quantifying cholesterol in HDL. It would have been obvious to use a cholesterol esterase in addition to the cholesterol oxidase, as taught by Sato for the same purpose of cholesterol quantification. Similarly, based on the teachings of Sato, it would have been obvious to use a first reagent comprising cholesterol esterase and oxidase activity, a catalase activity, a peroxidase activity, a sphingomyelinase activity, and a lipoprotein lipase activity. Sato teaches a reagent with all of these activities except peroxidase activity, and Zhang teaches a reagent with cholesterol oxidase and peroxidase activity for HDL cholesterol quantification. It would have been obvious that all of these enzymes could be combined in a first reagent. A skilled artisan would have also found it obvious to use apoE-containing HDL, given that both references exemplify measuring cholesterol in HDL, and apoE-HDL is a type of HDL.
A person of ordinary skill in the art would have been motivated to modify the reagents of Zhang to incorporate cholesterol esterase, catalase, and sphingomyelinase because cholesterol esterase hydrolyzes ester-type cholesterol in lipoprotein to produce free cholesterol and a fatty acid (Sato p. 2 para. 27), catalase decomposes the hydrogen peroxide produced by cholesterol esterase and oxidase into water and oxygen (Sato p. 3 para. 37), and sphingomyelinase and phospholipase allow for more accurate quantification of HDLs (Sato p. 3 para. 40). Thus, it is considered advantageous to incorporate these reagents in Zhang’s method of quantifying HDL cholesterol as they perform relevant functions. A skilled artisan would have been motivated to use apoE-containing HDL as the measurement target as apoE-HDL is increased in CETP deficiency and it is therefore of interest to develop methods to quantify apoE-HDL cholesterol.
A skilled artisan would have had a reasonable expectation of success in modifying the teachings of Zhang to incorporate the additional components taught by Sato because both Zhang and Sato teach similar methods for quantifying cholesterol in the same type of lipoprotein, HDL, and Sato teaches that these enzymes are successfully used and are beneficial in this method. An ordinary artisan would expect success in using apoE-HDL as the measurement target as this is a type of HDL and the methods of Zhang and Sato are successful in measuring cholesterol in HDL.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. as applied to claims 9-11, 13-14, 16, 18-21, 24, 25, and 28 above, in view of Hama et al., WO9740376A1.
Zhang teaches the method according to claim 9 as set forth above.
Zhang does not teach that the first reagent composition comprises a protein with no enzymatic activity (claim 23).
Regarding claim 23, Hama teaches method for measuring cholesterol in high-density lipoprotein (HDL) using cholesterol ester hydrolase and cholesterol oxidase (Hama p. 11 para. 13). Hama teaches that when the biological sample, HDL, is contacted with cholesterol esterase
and cholesterol oxidase, a nonenzymatic protein, albumin, is used as a blocker that does not affect the reaction of these enzymes with HDL cholesterol but inhibits the reaction of these enzymes with LDL cholesterol and VLDL cholesterol (Hama p. 16 para. 25).
It would have been obvious for a skilled artisan, before the effective filing date, to modify the first reagent in the method of Zhang and incorporate a protein with no enzymatic activity, such as albumin, as taught by Hama. Both Zhang and Hama are directed to methods of quantifying cholesterol in HDL using enzymes such as cholesterol oxidase and peroxidase. It would have been obvious to a skilled artisan that albumin could be incorporated in the reagent taught by Zhang given its use in a similar reagent for a similar method taught by Hama.
A person of ordinary skill in the art would have been motivated to use a protein with no enzymatic activity such as albumin, because Hama teaches that it is beneficial when quantifying HDL cholesterol to use albumin as a blocker to inhibit reaction of the cholesterol oxidase or esterase with LDL and VLDL cholesterol (Hama p. 16 para. 25). As such, it would be considered advantageous to include albumin in a reagent according to Zhang for quantifying cholesterol in HDL.
A skilled artisan would have had a reasonable expectation of success in making this modification to the method of Zhang because Hama teaches that albumin is successfully used and is beneficial in a similar method of quantifying HDL cholesterol.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-11 and 13-14, and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 18, 23-24, 27, and 29-30 of copending Application No. 18/007,689 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
Regarding instant claims 9, 10, and 13, claim 14 of copending ‘689 recites a method for quantification of cholesterol in a sample comprising step 1 of applying a cholesterol oxidase and cholesterol esterase, then step 2 of quantifying cholesterol. Claim 14 of ‘689 recites that the first step for quantification of lipoprotein cholesterol comprises cholesterol esterase and oxidase, and the second step is for quantifying the analyte lipoprotein cholesterol. Claim 23 of ‘689 recites that the first step involves the use of a surfactant that acts on lipoproteins other than the analyte. Claim 14 of ‘689 recites that the first step utilizes a peroxidase and the second step utilizes a coupler and iron complex (meeting conditions 1-3).
The “wherein” clauses of instant claims 9, 10, and 13 recite limitations to characterize the properties of the first and second reagents after storage for 2 weeks. These limitations do not result in a manipulative difference in the method steps. The method does not require that the reagents be stored for any amount of time prior to carrying out the method steps. Thus, the claims of copending ‘689 read on instant claims 9, 10, and 13.
Regarding instant claims 11, 14, and 16-19, the limitations of these dependent claims are recited in claims 1, 3-11, 14, and 16-28 of copending ‘689.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 20-21 and 24-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 18, 23-24, 27, and 29-30 of copending Application No. 18/007,689 in view of Zhang et al., CN1888863A.
The teachings of ‘689 regarding instant claim 9 are set forth above.
Regarding instant claims 24-27, claim 30 of ‘689 recites that the analyte lipoprotein is apoE-containing HDL cholesterol. Claim 29 of ‘689 recites the use of surfactants.
Regarding instant claim 28, claim 14 of ‘689 recites the use of a coupler.
Copending ‘689 does not recite that the first reagent comprises a lipoprotein degrading enzyme, lipoprotein lipase (claims 20-21), the specific surfactants of claims 24-27, or the specific coupler of claim 28. However, these features are taught by Zhang.
Zhang teaches methods and reagents for quantitative determination of high-density lipoprotein cholesterol (Zhang p. 1). Zhang teaches that the method involves causing a first reagent (reagent I) to act on a sample, then causing a second reagent (reagent II) to act on the sample (Zhang p. 16 para. 57).
Regarding instant claims 20 and 21, Zhang teaches that the first reagent comprises cholesterol (lipoprotein) lipase (Zhang p. 11 para. 31).
Regarding instant claim 24-27, Zhang teaches that the surfactant is polyoxyethylene-polyoxypropylene condensates or polyoxyethylene alkyl ether sulfates (Zhang p. 9 para. 25), which are nonionic surfactants. Zhang teaches that the measurement target is HDL and the surfactant is polyoxyethylene-polyoxypropylene condensates (Zhang p. 1; p. 9 para. 25).
Regarding instant claim 28, Zhang teaches that the coupler is 4-aminoantipyrine (Zhang p. 9-11 para. 26, para. 30).
It would have been obvious for a skilled artisan to combine the teachings of Zhang and copending ‘689 to arrive at the instant invention. ‘689 teaches various enzymes for the purpose of quantifying cholesterol in a sample such as HDL cholesterol. It would have been obvious to incorporate a lipoprotein degrading protein such as the lipase taught by Zhang in a similar method of HDL cholesterol quantification. Further, ‘689 recites that the method uses a surfactant and coupler. It would have been obvious to use the specific surfactant and couplers taught by Zhang, with a reasonable expectation of success, as both methods are used for the same purpose of HDL cholesterol quantification.
This is a provisional nonstatutory double patenting rejection.
Claims 22 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 18, 23-24, 27, and 29-30 of copending Application No. 18/007,689 in view of Zhang et al., CN1888863A and Sato et al., US 2016/0161512 A1.
The teachings of ‘689 and Zhang regarding instant claim 9 are set forth above.
Regarding instant claim 22, claim 14 of copending ‘689 recites a method for quantification of cholesterol in a sample comprising step 1 of applying a cholesterol oxidase, cholesterol esterase, and peroxidase. Claim 27 of copending ‘689 teaches that the first step uses a catalase.
‘689 and Zhang do not recite the sphingomyelinase activity of claim 22.
Regarding claim 22, Sato teaches that the first reagent includes cholesterol esterase and cholesterol oxidase (Sato p. 4 para. 45; para. 51), a catalase (Sato p. 3 para. 39; p. 4 para. 51), and a combination of sphingomyelinase and phospholipase that acts on lipoproteins, or lipoprotein lipase (Sato p. 3 para. 40-42; p. 4 para 51).
It would have been obvious for a skilled artisan to combine the teachings of Zhang, Sato, and copending ‘689 to arrive at the instant invention. All of these are directed to methods for quantifying HDL cholesterol. ‘689 teaches using cholesterol oxidase and esterase, catalase, and peroxidase. Zhang and Sato teach using a lipoprotein degrading enzyme, such as a lipase. A skilled artisan would have been motivated, with a reasonable expectation of success, to use an additional enzyme in the method of ‘689 taught by Sato, sphingomyelinase, as sphingomyelinase/phospholipase allow for more accurate quantification of HDLs (Sato p. 3 para. 40).
This is a provisional nonstatutory double patenting rejection.
Claim 23 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 18, 23-24, 27, and 29-30 of copending Application No. 18/007,689 in view of Zhang et al., CN1888863A and Hama et al., WO1997040376A1.
The teachings of ‘689 and Zhang regarding instant claim 9 are set forth above.
‘689 and Zhang do not recite that the first reagent composition comprises a protein with no enzymatic activity (claim 23).
Regarding instant claim 23, Hama teaches method for measuring cholesterol in high-density lipoprotein (HDL) using cholesterol ester hydrolase and cholesterol oxidase (Hama p. 11 para. 13). Hama teaches that when the biological sample, HDL, is contacted with cholesterol esterase and cholesterol oxidase, a nonenzymatic protein, albumin, is used as a blocker that does not affect the reaction of these enzymes with HDL cholesterol but inhibits the reaction of these enzymes with LDL cholesterol and VLDL cholesterol (Hama p. 16 para. 25).
It would have been obvious for a skilled artisan, to combine the teachings of Zhang, Hama, and ‘689 and incorporate a protein with no enzymatic activity, such as albumin, as taught by Hama. All of these references are directed to methods of quantifying cholesterol in HDL using enzymes such as cholesterol oxidase and peroxidase. It would have been obvious to a skilled artisan that albumin could be incorporated in the method of ‘689, with a reasonable expectation of success, given its use in a similar reagent for a similar method taught by Hama, and would have been motivated to do so given the benefits of albumin in HDL cholesterol quantification taught by Hama.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Rejections under 35 U.S.C. § 112
Regarding applicant’s argument that the elements of dependent claim 15 that were
added to independent claim 9 further clarify the second reagent composition, it is the examiner’s position that the requirements of the second reagent in claim 9 are still unclear. Specifically, it is not clear if the “one or two” conditions not satisfied by the second reagent are the same one or two conditions satisfied by the first reagent, or if this refers to any of the two conditions, as discussed above. The rejection under 35 U.S.C. § 112 is maintained.
Rejections under 35 U.S.C. § 102
In light of amendments to the claims, the rejections of claims 9-11 and 13-16 under 35 U.S.C. § 102 in view of Wang; and of claims 9-14 and 16 under 35 U.S.C. § 102 in view of Sato, have been withdrawn. However, upon further consideration, new grounds of rejection of claims 9-11, 13-14, and 16-28 are made as set forth above. Given these new grounds of rejection, the arguments presented regarding claims rejected under 35 U.S.C. § 102 in view of Wang or Sato are moot.
Non-statutory double patenting
Regarding the request that the Office follow the procedure described in MPEP § 804(1)(B)(1), as quoted by applicant, this section states that:
If "provisional" ODP rejections in two applications are the only rejections
remaining in those applications, the examiner should withdraw the ODP rejection
in the earlier filed application
However, the provisional double patenting rejections are not the only rejections remaining in the application, and therefore this does not apply.
Regarding the request that non-statutory double patenting rejections be held in abeyance, applicants are reminded that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer. Only objections or requirements as to form not necessary to further consideration of the claims may be requested to be held in abeyance until allowable subject matter is indicated. Non-statutory double patenting rejections may not be held in abeyance. See MPEP § 804(I)(B)(1).
Therefore, the rejections on the grounds of non-statutory double patenting are maintained and modified as set forth above.
Conclusion
Claims 9-11, 13-14, and 16-28 are rejected. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY F EIX/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653