DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-8 are pending and are being examined on the merits.
Applicant’s preliminary amendment to the claims filed 10/18/2023 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Priority
The instant application is a national stage filing under 35 U.S.C. 371 of international application PCT/JP2022/018185 filed 04/19/2022, which claims foreign priority to Japanese Application No. 2021-070615 filed 04/19/2021.
Should the applicant desire to obtain the benefit of foreign priority under 35 USC 119(a)-(d), a certified English translation of the foreign priority application must be submitted. Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 01/12/2024 and 09/09/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs have been considered by the examiner.
Non-Patent Literature document 2 in the IDS filed 01/12/2024 has been lined through because there is no English copy of the document in the application file.
Objections to Specification
The disclosure is objected to because of the following informalities.
The use of the terms TRITON X-100, ROCHE, HITACHI, and OLYMPUS which are trade names or marks used in commerce, have been noted in this application in paragraphs 0036-0039 and 0077. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to for the phrase “and contains polyoxyethylene monostyrenated phenyl ether” in line 10. In the interest of improving claim form, Applicant should consider an amendment to recite “and wherein the reagent composition contains polyoxyethylene monostyrenated phenyl ether”.
Claim 1 is objected to for the phrase “wherein the reagent composition has one or two or more activities selected from the group”. In the interest of improving claim form, Applicant should consider an amendment to recite “wherein the reagent composition has one, two, or three activities selected from the group”.
Claim 2 is objected to for the phrase “wherein a degree of polymerization n of polyoxyethylene”. In the interest of improving claim form, Applicant should consider an amendment to recite “wherein a degree of polymerization of polyoxyethylene”, by removing the term “n”.
Claim 8 is objected to for the phrase “wherein the first reagent composition contains any one of a hydrogen donor and a coupler and does not contain the other, and the second reagent composition does not contain the one of the hydrogen donor and the coupler and contains the other”. In the interest of improving claim form, Applicant should consider an amendment to recite “wherein (a) the first reagent composition contains a hydrogen donor and not a coupler, and the second reagent composition contains a coupler and not a hydrogen donor, or (b) the first reagent composition contains a coupler and not a hydrogen donor, and the second reagent composition contains a hydrogen donor and not a coupler”.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-8 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1 (claims 2-8 dependent therefrom) and 3-5 are indefinite for the phrase “wherein the reagent composition has one or two or more activities selected from the group consisting of cholesterol esterase activity, cholesterol oxidase activity, and sphingomyelinase activity, and contains polyoxyethylene monostyrenated phenyl ether” in claim 1 and the recitation of “the reagent composition” in claims 3-5. As written, it is unclear as to whether the recited “reagent composition” is in reference to the “first reagent composition,” “the second reagent composition,” or the first and second reagent compositions.
Claim Interpretation
The claims are drawn to a reagent composition used as a first reagent composition for a method of quantifying sdLDL-C, the method comprising: causing the first reagent composition to act on a sample, and applying a second reagent composition for quantifying sdLDL-C to quantify cholesterol, wherein the reagent composition has one or two or more activities selected from the group consisting of cholesterol esterase activity, cholesterol oxidase activity, and sphingomyelinase activity, and contains polyoxyethylene (POE) monostyrenated (MS) phenyl ether (PE).
In view of the indefiniteness of the reagent composition being modified by the recited activity or activities and inclusion of POE-MS-PE, the recited activity or activities and POE-MS-PE can be reasonably interpreted to correspond to the second reagent composition, wherein the second reagent composition is limited as part of the method of quantifying sdLDL-C. As the claims are drawn to a reagent composition, the method of quantifying sdLDL-C in a sample in the preamble of claim 1 is considered an intended use of the claimed reagent composition, and does not impart any structural limitations on the reagent composition (see MPEP 2111.02). Therefore, the limitations on the method of quantifying sdLDL-C, which include structural limitations on a second reagent composition, are considered to further limit the intended use and similarly do not impart structural limitations on the claimed reagent composition that is indicated as distinct from the second reagent composition. As such, given a broadest reasonable interpretation, the claimed or recited reagent composition is structurally unlimited.
Claim Rejections - 35 USC § 112(a)
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.
A. Claims 1-8 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention.
MPEP § 2163.II.A.3.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163.II.A.3.(a).ii) states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
According to § MPEP 2163.II.A.3.(a).ii), “[s]atisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’”
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention. According to MPEP § 2163, “Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient."
The claims are drawn to or recite a genus of reagent compositions. As stated above, the genus of reagent compositions is structurally unlimited. In this case, the genus of recited reagent compositions encompasses species that are considered to be widely variant with respect to structure.
The specification discloses the following representative species of the genus of recited reagent compositions:
a composition comprising PIPES buffer, cholesterol esterase, cholesterol oxidase, sphingomyelinase, peroxidase, bovine serum albumin, TOOS, 4AA, and a surfactant that is either (1) POE-MS-PE with degree of polymerization of 11-33, (2) POE-MS-PE with degree of polymerization of 13-37, or (3) POE-MS-PE with degree of polymerization of 50-80, and
a composition comprising PIPES buffer, cholesterol esterase, cholesterol oxidase, sphingomyelinase, catalase, ascorbate oxidase, bovine serum albumin, TOOS, and a surfactant that is either (1) POE-MS-PE with degree of polymerization of 11-33, (2) POE-MS-PE with degree of polymerization of 13-37, or (3) POE-MS-PE with degree of polymerization of 50-80.
Regarding the level of skill and knowledge in the art of cholesterol quantification, Li et al. (J Food Drug Anal, 2019, 27:375; cited on the attached Form PTO-892; herein Li) reviews various methods of quantifying cholesterol including classical chemical methods, fluorometric and colorimetric enzymatic assays, and analytical instrumental approaches each with distinctive advantages [p 378, col 1, para 1], and that each utilize reagent compositions comprising structurally variable components, for example, chemicals such as hydroxide, hexane, acetic anhydride-sulfuric acid, acetyl chloride, betaine aldehyde, or enzymes such as cholesterol esterase, cholesterol oxidase [Table 1]. While the methods reviewed by Li include examples of well-known reagent compositions comprising distinct chemicals or enzymes, Li acknowledges that for enzymatic assays, for example, the assays may not be strictly selective for cholesterol determination as they can act with other sterols, and additionally that chemicals present in the sample might interact with hydrogen peroxide that is intended to generate the required fluorescence to be measured in the method, which can result in bias for cholesterol determination [p 379, col 1, para 1]. As a result, Li discloses methods using gas and liquid chromatography that are more commonly used for cholesterol quantification as they are widely accepted to be more reliable, sensitive and accurate than other methods [p 379, beginning col 1, para 2], therefore indicating the high level of unpredictability in the field of cholesterol quantification with different reagent compositions.
In view of the high level of unpredictability in the art of cholesterol quantification, because the genus of reagent compositions is widely variant with respect to structure, and the specification discloses the actual reduction to practice of only six representative species among a widely variant genus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the recited genus of reagent compositions. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
B. Claims 1-8 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a reagent composition as described in Examples 1 and 3, does not reasonably provide enablement for all reagent compositions as encompassed by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
“The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.” In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)) as follows: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01(a). The Factors considered to be most relevant to the instant rejection are addressed in detail below.
The nature of the invention: According to the specification “LDL cholesterol can be simply and inexpensively quantified without requiring a lipoprotein aggregating agent that increases the turbidity of the reaction solution, without limitation on the enzymes to be used, and without the need to add another new enzyme in the step of reacting LDL cholesterol” at para 0002, and “The present invention provides a technique for measuring sdLDL-C with excellent accuracy” at para 0005.
The object of the invention is therefore to provide a simple and inexpensive quantification method for accurate measurement of sdLDL-C.
The breadth of the claims: The claims recite (in relevant part) a reagent composition used as a first reagent composition for a method of quantifying sdLDL-C. As stated above, the reagent composition is considered to be structurally unlimited.
The state of the prior art; The level of one of ordinary skill; and The level of predictability in the art: According to MPEP 2164.03, “…what is known in the art provides evidence as to the question of predictability” and “[I]f one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art.”
As noted above, the reagent composition is considered to be structurally unlimited. The reference of Li reviews various methods of quantifying cholesterol including classical chemical methods, fluorometric and colorimetric enzymatic assays, and analytical instrumental approaches each with distinctive advantages [p 378, col 1, para 1], and utilize reagent compositions comprising structurally variable components, for example, chemicals such as hydroxide, hexane, acetic anhydride-sulfuric acid, acetyl chloride, betaine aldehyde, or enzymes such as cholesterol esterase, cholesterol oxidase [Table 1]. While the methods reviewed by Li include examples of well-known reagent compositions comprising distinct chemicals or enzymes, Li acknowledges that for enzymatic assays, for example, the assays may not be strictly selective for cholesterol determination as they can act with other sterols, and additionally that chemicals present in the sample might interact with hydrogen peroxide that is intended to generate the required fluorescence to be measured in the method, which can result in bias for cholesterol determination [p 379, col 1, para 1]. As a result, Li discloses methods using gas and liquid chromatography that are more commonly used for cholesterol quantification as they are widely accepted to be more reliable, sensitive and accurate than other methods [p 379, beginning col 1, para 2], therefore indicating the high level of unpredictability in the field of cholesterol quantification with different reagent compositions.
As such, one of skill in the art would recognize a high level of unpredictability that all reagent compositions as encompassed by the claims would maintain the desired activity/utility.
The amount of direction provided by the inventor and The existence of working examples: The specification discloses the following working examples of the recited reagent compositions:
a composition comprising PIPES buffer, cholesterol esterase, cholesterol oxidase, sphingomyelinase, peroxidase, bovine serum albumin, TOOS, 4AA, and a surfactant that is either (1) POE-MS-PE with degree of polymerization of 11-33, (2) POE-MS-PE with degree of polymerization of 13-37, or (3) POE-MS-PE with degree of polymerization of 50-80, and
a composition comprising PIPES buffer, cholesterol esterase, cholesterol oxidase, sphingomyelinase, catalase, ascorbate oxidase, bovine serum albumin, TOOS, and a surfactant that is either (1) POE-MS-PE with degree of polymerization of 11-33, (2) POE-MS-PE with degree of polymerization of 13-37, or (3) POE-MS-PE with degree of polymerization of 50-80.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: While methods of making reagent compositions for the determination of cholesterol were known at the time of the invention, it was not routine in the art to make all reagent compositions as broadly encompassed by the claims.
In view of the overly broad scope of the claims, the lack of guidance and working examples provided in the specification, the high level of unpredictability, and the state of the prior art, undue experimentation would be necessary for a skilled artisan to make and use the entire scope of the claimed invention. Applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
Claim Rejections - 35 USC § 102
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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2010/035288 (cited on the IDS filed 09/09/2024; herein Denka).
The claims are drawn to a reagent composition and have been interpreted as stated above.
Regarding claim 1, Denka discloses a reagent for the quantitative determination of small dense LDLs [title] used in a method for determining cholesterol in sdLDLs [abstract]. As the limitation in claim 1 of “wherein the reagent composition has one or two or more activities selected from the group consisting of cholesterol esterase activity, cholesterol oxidase activity, and sphingomyelinase activity, and contains POE-ME-PE” can be interpreted as limiting the second reagent composition recited in the claim, and the claimed reagent composition is indicated as distinct from the second reagent composition, the disclosure of Denka is considered to satisfy the structural limitations of the claimed reagent composition.
Regarding claim 2, the limitation on the degree of polymerization of the POE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the rejection of claim 2 is included in the rejection of claim 1 above.
Regarding claim 3, the limitation on the content of POE-MS-PE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the rejection of claim 3 is included in the rejection of claim 1 above.
Regarding claim 4, the limitation of “the reagent composition further has at least one activity…” is considered to further limit the second reagent composition in view of the interpretation that the activity functionally limits the second reagent composition as stated above. Therefore, the rejection of claim 4 is included in the rejection of claim 1 above.
Regarding claim 5, Denka discloses a reagent composition comprising 4-aminoantipyrine [para 0046], which is understood as a coupler according to the specification at [para 0055].
Therefore Denka anticipates claims 1-5.
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 (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 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 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Denka.
Claims 6-8 are drawn to a kit used for quantifying the sdLDL-C in the sample, comprising:
a first reagent composition consisting of the reagent composition according to claim 1; and
a second reagent composition for quantifying the sdLDL-C.
The teachings of Denka as applied to claims 1-5 are discussed above. Denka does not teach the inclusion of reagent compositions in a kit.
The phrase “used for quantifying small sdLDL-C in the sample” in claim 6 is considered an intended use, as the method for using the claimed kit does not further define the structure of the claimed kit (see MPEP 2111.02). Additionally, the phrase “for quantifying the sdLDL-C” in line 5 of claim 6 is similarly considered an intended use, as the phrase does not impart any structural limitations on the second reagent composition.
Regarding claim 6, Denka teaches reagents for quantitative determination of sdLDL [title], and methods of quantitatively determining cholesterol in sdLDLs comprising a step of eliminating lipoproteins by adding a surfactant and a step of quantifying the remaining sdLDLs [claim 1] by adding an enzyme [claim 6], which are considered to correspond to a first reagent composition and a second reagent composition.
In view of Denka, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the first and second reagent compositions into a kit to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to combine the reagent compositions of Denka into a kit, because Denka teaches the use of a first and second reagent composition for the quantification of sdLDL-C, and it was routine in the art before the effective filing date to combine reaction compositions into a kit for convenience. One of ordinary skill in the art would have had a reasonable expectation of success because of the express teachings of Denka set forth above.
Regarding claim 7, Denka teaches a first and second reagent composition in example 2, wherein the second reagent composition comprises peroxidase [para 0053].
Regarding claim 8, Denka teaches a first and second reagent composition in example 2, wherein the first reagent composition comprises TOOS [para 0052] which is an aniline derivative that acts as a hydrogen donor [para 0035], and the second reagent composition comprises 4-aminoantipyrine [para 0053] which is understood to be a coupler [see Specification para 0055].
Therefore, the invention of claims 6-8 would have been obvious to one of ordinary skill in the art before the effective filing date.
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.
A. Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,209,270 (cited on the attached Form PTO-892; herein “patent”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following.
Regarding instant claim 1, claim 1 of the patent recites a kit to fractionate sdLDL-C comprising a first reagent composition. As the limitation in instant claim 1 of “wherein the reagent composition has one or two or more activities selected from the group consisting of cholesterol esterase activity, cholesterol oxidase activity, and sphingomyelinase activity, and contains POE-ME-PE” can be interpreted as limiting the second reagent composition recited in the claim, and the claimed reagent composition is indicated as distinct from the second reagent composition, the claims of the patent are considered to satisfy the structural limitations of reagent composition of instant claim 1.
Regarding instant claim 2, the limitation on the degree of polymerization of the POE in instant claim 2 is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the reagent composition of instant claim 2 is considered to encompass the kit of claim 1 of the patent.
Regarding instant claim 3, the limitation on the content of POE-MS-PE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the reagent composition of instant claim 3 is considered to encompass the kit of claim 1 of the patent.
Regarding instant claim 4, the limitation of “the reagent composition further has at least one activity…” is considered to further limit the second reagent composition in view of the interpretation that the activity functionally limits the second reagent composition as stated above. Therefore, the reagent composition of instant claim 4 is considered to encompass the kit of claim 1 of the patent
Regarding instant claim 5, claim 1 of the patent recites the first reagent composition comprises a coupler.
Regarding instant claim 6, claim 1 of the patent recites a kit comprising a first reagent composition and a second reagent composition.
Regarding instant claim 7, claim 1 of the patent recites a second reagent composition comprises peroxidase activity.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,209,270 as applied to claims 1-7 above, and further in view of Denka.
The claims of the patent as applied to claims 1-7 are discussed above. The claims of the patent do not recite a hydrogen donor in either the first or second reagent composition.
Denka relates to reagents for quantitative determination of sdLDL [title], and methods of quantitatively determining cholesterol in sdLDLs [claim 1], and discloses that the addition of a reagent containing a specific surfactant to a sample containing lipoproteins, sdLDLs among lipoproteins can be directly and selectively measured without carrying out separation using a filter or centrifugation.
Regarding claim 8, Denka discloses a first and second reagent composition in example 2, wherein the first reagent composition comprises TOOS [para 0052] which is an aniline derivative that acts as a hydrogen donor [para 0035], and the second reagent composition comprises 4-aminoantipyrine [para 0053] which is understood to be a coupler [see Specification para 0055].
In view of Denka, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using a hydrogen donor in the first reagent composition to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to use a hydrogen donor in the first reagent composition because Denka discloses that the addition of a first and second reagent compositions to a sample containing lipoproteins, sdLDLs among lipoproteins can be directly and selectively measured without carrying out separation using a filter or centrifugation. One of ordinary skill in the art would have had a reasonable expectation of success because the patent and Denka relate to compositions comprising reagents for measuring sdLDLs.
B. Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application 17/641689 (herein “reference application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following.
Regarding instant claim 1, claim 1 of the reference application recites a kit to quantify sdLDL-C comprising a first reagent composition. As the limitation in instant claim 1 of “wherein the reagent composition has one or two or more activities selected from the group consisting of cholesterol esterase activity, cholesterol oxidase activity, and sphingomyelinase activity, and contains POE-ME-PE” can be interpreted as limiting the second reagent composition recited in the claim, and the claimed reagent composition is indicated as distinct from the second reagent composition, the claims of the reference application are considered to satisfy the structural limitations of the claimed reagent composition.
Regarding instant claim 2, the limitation on the degree of polymerization of the POE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the reagent composition of instant claim 2 is considered to encompass the the kit of claim 1 of the reference application .
Regarding instant claim 3, the limitation on the content of POE-MS-PE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the reagent composition of instant claim 3 is considered to encompass the kit of claim 1 of the reference application.
Regarding instant claim 4, the limitation of “the reagent composition further has at least one activity…” is considered to further limit the second reagent composition in view of the interpretation that the activity functionally limits the second reagent composition as stated above. Therefore, the reagent composition of instant claim 4 is considered to encompass the kit of claim 1 of the reference application.
Regarding instant claim 5, claim 1 of the reference application recites the first reagent composition comprises a coupler.
Regarding instant claim 6, claim 1 of the reference application recites a kit comprising a first reagent composition and a second reagent composition.
Regarding instant claim 7, claim 1 of the reference application recites a second reagent composition comprises peroxidase activity.
Regarding instant claim 8, claim 1 of the reference application recites the first and second reaction compositions comprise a coupler and electron donor, wherein the coupler and electron donor are not allowed to be present in the same reaction composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
C. Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application 18/007690 (herein “reference application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following.
Regarding instant claim 1, claim 1 of the reference application recites a kit to fractionate cholesterol comprising a first reagent composition. As the limitation in instant claim 1 of “wherein the reagent composition has one or two or more activities selected from the group consisting of cholesterol esterase activity, cholesterol oxidase activity, and sphingomyelinase activity, and contains POE-ME-PE” can be interpreted as limiting the second reagent composition recited in the claim, and the claimed reagent composition is indicated as distinct from the second reagent composition, the claims of the reference application are considered to satisfy the structural limitations of the claimed reagent composition.
Regarding instant claim 2, the limitation on the degree of polymerization of the POE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the reagent composition of instant claim 2 is considered to encompass the composition of claim 1 of the reference application.
Regarding instant claim 3, the limitation on the content of POE-MS-PE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the reagent composition of instant claim 3 is considered to encompass the composition of claim 1 of the reference application.
Regarding instant claim 4, the limitation of “the reagent composition further has at least one activity…” is considered to further limit the second reagent composition in view of the interpretation that the activity functionally limits the second reagent composition as stated above. Therefore, the reagent composition of instant claim 4 is considered to encompass the composition of claim 1 of the reference application.
Regarding instant claim 5, claim 7 of the reference application recites the first reagent composition comprises a coupler.
Regarding instant claim 6, claim 1 of the reference application recites a kit comprising a first reagent composition and a second reagent composition.
Regarding instant claim 7, claim 1 of the reference application recites a second reagent composition comprises peroxidase activity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application 18/007690 as applied to claims 1-7 above, and further in view of Denka.
The claims of the reference application as applied to claims 1-7 are discussed above. The claims of the reference application do not recite a hydrogen donor in either the first or second reagent composition.
Denka relates to reagents for quantitative determination of sdLDL [title], and methods of quantitatively determining cholesterol in sdLDLs [claim 1], and discloses that the addition of a reagent containing a specific surfactant to a sample containing lipoproteins, sdLDLs among lipoproteins can be directly and selectively measured without carrying out separation using a filter or centrifugation.
Regarding claim 8, Denka discloses a first and second reagent composition in example 2, wherein the first reagent composition comprises TOOS [para 0052] which is an aniline derivative that acts as a hydrogen donor [para 0035], and the second reagent composition comprises 4-aminoantipyrine [para 0053] which is understood to be a coupler [see Specification para 0055].
In view of Denka, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the reference application by using a hydrogen donor in the first reagent composition to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to use a hydrogen donor in the first reagent composition because Denka discloses that the addition of a first and second reagent compositions to a sample containing lipoproteins, sdLDLs among lipoproteins can be directly and selectively measured without carrying out separation using a filter or centrifugation. One of ordinary skill in the art would have had a reasonable expectation of success because the reference application and Denka relate to reagent compositions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
D. Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application 18/007689 (herein “reference application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following.
Regarding instant claim 1, claim 1 of the reference application recites a kit to quantify cholesterol comprising a first reagent composition. As the limitation in instant claim 1 of “wherein the reagent composition has one or two or more activities selected from the group consisting of cholesterol esterase activity, cholesterol oxidase activity, and sphingomyelinase activity, and contains POE-ME-PE” can be interpreted as limiting the second reagent composition recited in the claim, and the claimed reagent composition is indicated as distinct from the second reagent composition, the claims of the reference application are considered to satisfy the structural limitations of the claimed reagent composition.
Regarding instant claim 2, the limitation on the degree of polymerization of the POE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the reagent composition of instant claim 2 is considered to encompass the kit of claim 1 of the reference application.
Regarding instant claim 3, the limitation on the content of POE-MS-PE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the reagent composition of instant claim 3 is considered to be encompassed by the kit of claim 1 of the reference application.
Regarding instant claim 4, the limitation of “the reagent composition further has at least one activity…” is considered to further limit the second reagent composition in view of the interpretation that the activity functionally limits the second reagent composition as stated above. Therefore, the reagent composition of instant claim 4 is considered to be encompassed by the kit of claim 1 of the reference application.
Regarding instant claim 5, claim 1 of the reference application recites the first reagent composition comprises a coupler.
Regarding instant claim 6, claim 1 of the reference application recites a kit comprising a first reagent composition and a second reagent composition.
Regarding instant claim 7, claim 1 of the reference application recites a second reagent composition comprises peroxidase activity.
Regarding instant claim 8, claim 1 of the reference application recites the first and second reagent compositions comprise a coupler and a hydrogen donor, and the coupler and hydrogen donor are not allowed to be present together in the same reagent composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
E. Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 and 10-11 of copending Application 18/855879 (herein “reference application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following.
Regarding instant claim 1, claim 1 of the reference application recites a first reagent composition. As the limitation in instant claim 1 of “wherein the reagent composition has one or two or more activities selected from the group consisting of cholesterol esterase activity, cholesterol oxidase activity, and sphingomyelinase activity, and contains POE-ME-PE” can be interpreted as limiting the second reagent composition recited in the claim, and the claimed reagent composition is indicated as distinct from the second reagent composition, the claims of the reference application are considered to satisfy the structural limitations of the claimed reagent composition.
Regarding instant claim 2, the limitation on the degree of polymerization of the POE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the reagent composition of instant claim 2 is considered to encompass the composition of claim 1 of the reference application.
Regarding instant claim 3, the limitation on the content of POE-MS-PE is considered to further limit the second reagent composition in view of the interpretation that the POE-MS-PE is a structural limitation of the second reagent composition as stated above. Therefore, the reagent composition of instant claim 3 is considered to encompass the composition of claim 1 of the reference application.
Regarding instant claim 4, the limitation of “the reagent composition further has at least one activity…” is considered to further limit the second reagent composition in view of the interpretation that the activity functionally limits the second reagent composition as stated above. Therefore, the reagent composition of instant claim 4 is considered to encompass the composition of claim 1 of the reference application.
Regarding instant claim 5, claim 7 of the reference application recites the first reagent composition comprises a coupler.
Regarding instant claim 6, claim 10 of the reference application recites a kit comprising a first reagent composition and a second reagent composition.
Regarding instant claim 7, claim 11 of the reference application recites a second reagent composition comprises peroxidase activity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 and 10-11 of copending Application 18/855879 as applied to claims 1-7 above, and further in view of Denka.
The claims of the reference application as applied to claims 1-7 are discussed above. The claims of the reference application do not recite a hydrogen donor in either the first or second reagent composition.
Denka relates to reagents for quantitative determination of sdLDL [title], and methods of quantitatively determining cholesterol in sdLDLs [claim 1], and discloses that the addition of a reagent containing a specific surfactant to a sample containing lipoproteins, sdLDLs among lipoproteins can be directly and selectively measured without carrying out separation using a filter or centrifugation.
Regarding claim 8, Denka discloses a first and second reagent composition