Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Applicant’s submission filed on 09/13/2024 is duly acknowledged
Claims 1-16 (originally presented) have been canceled by applicants.
Claims 17-32 have been newly presented and are pending in this application, and have been examined on their merits in this action hereinafter.
Priority
This application is a CON of 16/989,545 (filed on 08/10/2020, now PAT 12116617), which is a CON of 16/036,340 (filed on 07/16/2018, now PAT 10738344), which is a CON of 13/724,839 (filed on 12/21/2012, ABN), which is a CON of 11/869,657 (filed on 10/09/2007, ABN).
Claim Objections
1. Claim 22 (as newly presented) is objected to because of the following informalities: Claim 22 is reproduced below:
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As presented, claim 22 does not end with a period (taken herein as a typographical error). Appropriate correction is required.
Claim Rejections - 35 USC § 112 – New Matter Issue
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
1. Claim 19 (as newly recited) is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 19 is reproduced below:
“19. (New) The method of claim 17, wherein the soluble protein is removed using liquid chromatography, acid precipitation, filtration, or centrifugation.”
It is noted that the disclosure of record (see parent application 11/869,657, p. 3-4, paragraphs [0007]-[0008] reproduced below) states the following:
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The disclosure of record generally provides the support for removal of soluble protein in step (i) as disclosed using an “acid precipitation” step, which may be followed by “filtration or centrifugation” in order to remove “acid insoluble protein” precipitate. However, does not provide support for removal of soluble protein “using liquid chromatography” per se.
Insertion of the limitations “wherein the soluble protein is removed using liquid chromatography” does not appear to have appropriate support in the as-filed specification. The insertion of this limitation is a new concept because it neither has literal support in the as-filed specification by way of generic disclosure, nor are there specific examples of the newly limited genus which would show possession of the concept of the use of “liquid chromatography” for removal of soluble proteins as per disclosure of record for the method as claimed. There is only one exemplified step of using “acid precipitation” followed by, “for example, filtration or centrifugation” in order to remove acid insoluble protein fraction. This is not sufficient support for the newly limited genus. This is a matter of written description, not a question of what one of skill in the art would or would not have known. The material within the four corners of the as-filed specification must lead to the generic concept. If it does not, the material is new matter. Declarations and new references cannot demonstrate possession of a concept after the fact. Thus, the insertion of limitations “wherein the soluble protein is removed using liquid chromatography” is considered to be the insertion of new matter for the above discussed reasons. Appropriate correction is required.
NOTE: In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
1. Claims 17-32 (as currently presented) are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mascher et al (1997; applicant’s IDS dated 09/26/2024, NPL citation 22) taken with Yamanaka et al (1994; applicant’s IDS dated 09/26/2024, citation no. 34), Careri et al (1998; applicant’s IDS dated 09/26/2024, NPL citation no. 7), Liu et al (2006; applicant’s IDS dated 09/26/2024, NPL citation no. 19), and Liu et al (1981; cited in applicant’s IDS dated 09/26/2024, NPL citation no. 20).
Claims 17, 18 and 27-32 as newly presented are reproduced below:
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NOTE: All citations for applicant’s original disclosure of record is for parent specification 11/869,657, from which this application has been ultimately derived as a CON (see section on priority above).
Mascher et al (1997) disclose a high-pressure liquid chromatographic (HPLC) method for determining the amount of total thiamine in a body fluid sample (such as plasma; see abstract and assay method on pages 83-85, in particular), comprising: removing soluble protein from said sample (using acid precipitation step such as with perchloric acid; see section “Sample Preparation” on pages 84-85, in particular); enzymatically treating said sample with an acid phosphatase (10 mg/ml enzyme solution) to convert phosphorylated thiamine to thiamine, wherein the incubation of acid phosphatase with the deproteinated sample is carried out at a pH of 4.6 (adjusted with acetate buffer solution; i.e. “under acidic condition”) at 40 degree C for 16 hours (see section “Sample Preparation” on pages 84-85, in particular), before purifying said thiamine from the aqueous supernatant by liquid chromatography (i.e. by HPLC; see section “Chromatographic Conditions” on page 84, in particular); wherein the total thiamine is determined after post-column chemical derivatization and fluorescence determination using various standards of thiamine, and its derivatives (see section “Preparation of Calibration Samples” on page 84, in particular) that were spiked in pooled plasma samples before sample preparation steps for HPLC. Mascher et al the fact that incubation with acid phosphatase at 40 degree C for 16 hours was "sufficient to separate all of the TMP and TDP, and leave only T…” (i.e. free thiamine; see page 85, section “Assay Results”, “Phosphate Separation”, in particular). However, after 3 hours of incubation with acid phosphatase, the phosphates (i.e. TDP and TMP) were only “partially separated”. Thus, they chose the incubation time of 16 hours at 40 degree C in order to achieve complete (i.e. 100%) conversion of phosphorylated thiamine to free thiamine (i.e. in order to determine “total thiamine” in plasma samples) for all of their experiments.
However, Mascher et al do not disclose- 1) the step of using “organic solvent extraction” (instant claim 17, step (iv) as recited); 2) the step of determination of thiamine amounts using liquid chromatography in combination with mass spectrometry (i.e. LC-MS) that uses electrospray ionization (ESI) in positive ion mode in SRM (see instant claims 24-26), wherein said step comprises ionizing said thiamine to a parent ion having a mass/charge ratio of 265.00 + 1.0, which further fragment into one or more daughter ions that comprise an ion having a mass/charge ratio of 144.00 + 1.0 or 121.94 + 1.0 (see instant claims 27-29); and 3) wherein pyrithiamine is used as an internal standard added to the body fluid sample (such as plasma or serum samples; see instant claims 18, 30), and its analysis and/or determination in terms of parent ions (m/z ratio of 259.04 +1.0) and/or fragmented daughter ion (see instant claims 31-32).
Yamanaka et al (1994) disclose the method step of performing an organic solvent extraction (using isobutanol as an organic solvent; see summary on page 91 and figure 1, flow chart for pretreatment of sample on page 92, in particular) of a yeast sample with or without spiked internal standards, wherein the result of said extraction is an organic solvent phase and an aqueous phase; and further purifying said thiamine from the aqueous phase and analyzing for the amount of thiamine present in said sample using atmospheric pressure chemical ionization-mass spectrometry (i.e. HPLC/APCI-MS; see summary, section "Experiments", and page 94, right column, in particular); wherein thiamine was determined as having mass to charge ratio (m/z. ratio) of 265.10 (see page 94, right column and figures 3-4, in particular); and wherein said APCI-MS in combination with HPLC is disclosed to be suitable to permit identification and determination of thiamine in various biological samples. Although, Yamanaka et al disclose additional steps after organic extraction of the sample before the HPLC steps for detection of thiamine, they nevertheless disclose the method step for pre-treatment or cleaning up and/or extracting the biological sample using suitable organic solvent, wherein thiamine is recovered in aqueous or “water layer” (see Figure 1, p. 92, in particular).
Careri et al (1998) disclose the fact that systems with combination of liquid chromatography with mass spectrometry (LC-MS), including systems such as electrospray/ion spray MS liquid interface, and tandem MS techniques provide sensitive and useful systems for analyses of various substances (charge neutral compounds) such as vitamins (including thiamine or vitamin B1) in food and beverage samples (see Abstract, introduction, section 2.3 “Vitamins”, and figure 10 on page 280, in particular); wherein they disclose the ionic chromatograms of thiamine having m/z ratio of 144 and 265 (albeit using a TSP interface, i.e. thermospray-based MS, LC-TSP-MS in a selected ion monitoring (SIM) acquisition/detection mode; see figure 10, in particular) in a commercial sample of health drink that was analyzed using LC-MS system. Although, Careri et al do not specifically disclose the mechanistic details and/or order of steps as to how the ionization and fragmentation of thiamine produce ions having m/z ratios of 265 and 144, as shown in figure 10, they do disclose the fact that both ions are detectable and/or identifiable characteristics of the presence of thiamine in the sample from which the amounts of thiamine can be calculated and/or suitably determined employing appropriate mass spectrometric analytic systems (i.e. using LC-MS, and/or LC-MS/MS or tandem MS techniques; see abstract and introduction, in particular). In addition, Careri et al disclose various systems that can be combined with LC-MS systems including systems that are interfaced with electrospray (ESP) and/or collision-induced dissociation (CID) MS (see page 264 right column, for example) for analyses of various vitamins and other naturally occurring substances in food and drink samples, and that for certain compounds, the ESP ionization may provide 1 to 2 fold better sensitivity compared to TSP ionization in positive ion detection mode (see page 289, left column, last paragraph, for instance).
Liu et al (2006), while studying the crystal structure of thiamine pyrophosphokinase enzyme in the presence of pyrithiamine pyrophosphate (see title, abstract and introduction, in particular), disclose the fact that pyrithiamine acts as a structural analog of thiamine, and can be successfully used as an internal standard along with thiamine in analyses using electrospray ionization mass spectrometry (ESI-MS) with detection/analysis in positive ion mode with a scan range of from 100 to 1000 (LCQ/MS; see page 6602, section “Mass Spectrometry Analysis”, in particular); wherein they disclose the fact that pyrithiamine was identified as a mass peak of 259 daltons (see page 6605, left column, 2nd paragraph, in particular) in the MS analysis of the reaction mixture, wherein the standard thiamine peak was identified as m/z ratio of 264.9 (i.e. 265 +1.0, as also demonstrated by Careri et al, above) in positive ion detection mode.
Thus, given the disclosure in the cited prior art for the use of method steps of extracting thiamine by organic solvents into an aqueous phase (see teachings from Yamanaka et al, above) and analyzing extracted thiamine (from samples of body fluids, such as plasma or serum samples) by further purifying it on suitable HPLC systems (see teachings from Mascher et al, discussed above), and combining it with sensitive mass spectrometry (MS) analytic systems such as thermospray, and other suitable systems that use electrospray and/or collision-induced dissociation systems for detection and/or quantification of thiamine in fluid samples (including samples of food and/or pharmaceutical formulations) in the presence of internal as well as other required controls and standards (see Careri et al in combination with Liu et al 2006, as discussed above), it would have been obvious to an artisan of ordinary skill in the art (at the time this invention was made) to modify the method of estimating thiamine in body fluids as disclosed by Mascher et al by combining (or interfacing it with) sensitive ESI-MS or tandem MS systems for efficient and sensitive analyses and determination of thiamine (including total thiamine, if desired) in plasma, serum (or other body fluids) with a reasonable expectation of success. The motivation for an artisan of ordinary skill in the art, being the extraordinary selectivity, sensitivity and high throughput capability of such combination of chromatographic systems as specifically disclosed by the combined teachings of Yamanaka et al when taken with Careri et al and Liu et al 2006 (see their respective summary and abstract, in particular). Thus, an artisan of ordinary skill in the art would have been able to successfully modify and/or combine the sample pre-treatment steps such as deproteination and acid phosphatase treatment of body fluid samples followed by organic solvent extraction and HPLC purification of thiamine (as disclosed by combined teachings of Yamanaka et al and Mascher et al), and the suitable MS systems (such as electrospray ionization-MS) as explicitly suggested and disclosed by combined teachings from Careri et al and Liu et al 2006, in order to achieve an even more sensitive, streamlined and efficient method for determining the amount of thiamine in the aqueous, HPLC purified extract obtained from a given body fluid such as plasma, serum, etc., as currently claimed.
The specific limitations of incubating the body fluid samples (such as deproteinated plasma or serum samples) with acid phosphatase enzyme for “about 1 to about 2 hours” (see instant claim 22), would have been obvious to an artisan of ordinary skill in the art, as evidenced by the fact that Mascher et al do provide reference incubation time of 16 hours at 40 degree C (i.e. a result-effective variable; wherein all, i.e. 100% of the thiamine phosphates are to be converted to free thiamine, for example; i.e. the goal is complete conversion to free thiamine in the sample), or a 3 hour incubation for partial conversion (it is to be noted that instant claim 17 does not require estimation of “total thiamine” per se), that can be further optimized by an artisan in the art depending on the specific activity and the amount of enzyme preparation “acid phosphatase” used in the reaction mix, and depending on the type of samples used such as serum, plasma, whole blood, or for that matter any other body fluid or tissue extract, etc., unless evidence/data provided by the applicants to the contrary (which is currently lacking on record). It is to be noted that instant claims as presented are not limited to any specific body fluid, and do not require any specific activity (and/or treatment conditions) of the acid phosphatase enzyme used in the process as claimed, and therefore, depending on the requirement at hand, an artisan of ordinary skill in the art would be able to successfully adjust such incubation periods (i.e. a result effective variable; given that the basic sample pre-treatment conditions have already been established by Mascher et al, such as incubation conditions, pH, temperature and duration, etc.) for efficient and total conversion of phosphorylated thiamines into free thiamine that can be further purified, detected and/or measured using downstream method steps of HPLC in combination with ESI-MS or MS/MS, etc., as demonstrated by the combined teachings of the cited prior art references of Careri et al and Liu et al 2006, as discussed above.
The specific limitations of claims 27-29, wherein thiamine is ionized into parent ion having m/z ratio of 265 + 1.0, and which is further fragmented to produce daughter ions having m/z ratio of 144+1.0, in order to determine the amount of total thiamine in a sample of body fluid, would have been obvious and fully contemplated by an artisan of ordinary skill in the art as evidenced by the detailed disclosure and/or suggestions by Careri et al (see page 280, figure 10, in particular, and discussion above) and Liu et al 2006 (as discussed above for use of ESI-MS) in order to achieve a highly sensitive assay or measurement procedure employing LC-MS or LC-MS/MS technique using electrospray ionization-detection (in positive ion mode, for instance) for thiamine-containing samples.
In addition, given the explicit teachings from Liu et al 2006 (for detection and/or analyses of thiamine and pyrithiamine in a given sample using ESI-MS in positive ion mode), a person of ordinary skill in the art, would have used pyrithiamine as an internal standard (i.e. substitution as a functional equivalent known in the art; that could be spiked into the sample of given body fluid such as plasma or serum to act as LC-MS control) in order to accurately detect and determine the amount of total thiamine in the method as disclosed by the combined teachings of Mascher et al taken with Yamanaka et al and Cereri et al. Such incorporation being an independent verification for the method in terms of accuracy and/or efficiency of the quantitative determination from biological samples as already eluded for the use of controls and internal standards by the cited prior art of Careri et al (see page 279, right column), albeit for estimation of various vitamins, in general using LC-MS techniques. The specific limitations of claim 32 (i.e. pyrithiamine’s daughter ion having a m/z ratio of 122.00+1.0) is taken to be intrinsic to the fragmentation pattern of the parent ion of pyrithiamine via electrospray ionization mass spectrometry (ESI-MS), which has already been disclosed in the cited prior art (see disclosure from Liu et al 2006, above for detection/analyses in ion scan range of 100 to 1000) to be having the same parent ion m/z ratio of 259 for pyrithiamine, as currently claimed by applicants, unless evidence/data provided by the applicants to the contrary.
Moreover, regarding the limitations of “wherein the one or more daughter ions comprises an ion having a mass/charge ratio of 121.94 + 1.0” (see instant claim 29), Liu et al (1981) while disclosing matrix-assisted secondary ion mass spectra of various biological compounds (see title, abstract, “Experimental section”, and right column on page 111), disclose thiamine parent as well as daughter fragmentation ions having m/z ratio of 265 for the parent ion, and 144, 122 and 123 for the daughter ions depending on the conditions of mass spectrometry and specific matrices used for mass analyses (see Liu et al 1981, page 111, right column, and positive ion SIMS spectrum of thiamine-HCl in figure 4, in particular), each one of which can be used by an artisan in the art to analyze, detect and/or determine the amount of thiamine in a given body fluid sample under appropriate conditions of mass spectrometry (see Liu et al 1981, page 112, left column, 1st paragraph, in particular, and cited references therein).
Also, evidenced by the fact that cited prior art references teach method for the determination of the amount of total thiamine using liquid chromatography-mass spectrometry with detection of thiamine ions having m/z ratio of 265 and 144 (as discussed above), wherein the method steps and conditions are clearly suitable to identify various fragments within the similar m/z range (see Careri et al, figure 10, in particular). Since, the claimed daughter ion having the m/z ratio of 121.94 + 1.0 for determining thiamine in said sample falls within the same range established by the prior art, it can be optionally used for determination of thiamine in a given sample by LC-MS using the same method steps as disclosed by the cited prior art, unless evidence/data provided by the applicants to the contrary. Since, instant claims do not recite any specific Mass Spectrometry methodology, specific matrix or conditions, and/or any other critical process step that is structurally different than the combined teachings and/or suggestions in the cited prior art for use of LC-MS for the determination of total thiamine in body fluids, the claimed method would have been obvious and fully contemplated by an artisan of ordinary skill in the art, at the time this invention was made. It is to be noted that m/z ratio of 122, 123 and 144 for thiamine fragmentation ions disclosed in the cited art of Liu et al, 1981 fall within the ranges for the m/z ratio being claimed and demonstrated by applicants in the instant disclosure (i.e. correspond to 121.94 + 1.0, and 144.00 + 1.0, for instance; see instant claims 17 and 29, in particular) of record.
In addition, applicants have not shown and/or demonstrated on the record (see specification, figure 3, in particular), as to why the use of any specific daughter ions including for example, the m/z ratio of 121.94 + 1.0 alone, is critical to the determination of thiamine in a body fluid sample per se, when as disclosed on the record, applicant’s invention employs both thiamine daughter ions (i.e. 121.94 + 1.0, and 144.00 + 1.0) along with the daughter ion from internal standard pyrithiamine (see parent Specification 11/869657, page 20, full paragraph [0088], in particular), in order to provide the “total thiamine” determination in a sample with reasonable accuracy and/or sensitivity (see parent specification 11/869,657, paragraph [0019], for instance). Therefore, the invention as broadly claimed fails to distinguish itself over the combined teachings and/or suggestions from the cited prior art references, as discussed above.
Thus, the claim as whole would have been prima facie obvious to a person of ordinary skill in the art at the time the claims invention was made.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless appellant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
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.
1. Claims 17-32 (as newly presented) are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 10,738,344 B2 (issued to common inventors and assignee, on 08/11/2020, from US application 16/036,340; a CON application in relationship). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claim 1 of the US patent '344 is deemed to be a species of the instant claims as generically presented in this application for examination. The issued claim 1 recites as follows:
“1. A method for determining the amount of total thiamine in a plasma or serum sample, comprising:
(i) performing an organic solvent extraction of a plasma or serum sample in the presence of an internal standard, wherein the result of the extraction is an organic solvent phase and an aqueous phase, and wherein the internal standard is pyrithiamine;
(ii) purifying thiamine with pyrithiamine internal standard from the aqueous phase by high performance liquid chromatography (HPLC);
(iii) ionizing and detecting the purified thiamine and pyrithiamine internal standard using electrospray ionization tandem mass spectrometry (ESI-MS/MS) with selected reaction monitoring (SRM) in positive ion mode; and
(iv) quantifying the amount of thiamine by analyzing fragmented ions using said mass spectrometry, wherein the amount of total thiamine in said sample is determined based on the comparative abundance of daughter ions generated from thiamine that have a mass-to-charge ratio of 144.03±1.0 and 121.94±1.0, relative to the abundance of a daughter ion generated from pyrithiamine internal standard that has a mass-to-charge ratio of 122.00±1.0.”
Thus, it is clear from the subject matter recited in the issued claim 1 (see also dependent claims 2-10 in the issued US patent '344) that the pending claims in this CON application are directed to essentially the same process with a broad generic scope for multiple limitations (i.e. in a genus-species relationship; see instant claim 1 under examination, in particular), and therefore, an ODP rejection is deemed proper (see also the 103(a) rejection over the cited prior art references discussed above).
2. Claims 17-32 (as newly presented) are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 12,116,617 B2 (issued to common inventors and assignee, on 10/15/2024, from US application 16/989,545; instant application is a CON of the parent issued as patent ‘617). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claim 1 of the US patent '617 is deemed to be a species of the instant claims as generically presented in this application for examination. The issued claim 1 in patent ‘617 recites as follows:
“1. A method for determining the amount of thiamine in a body fluid sample, comprising:
(i) adding a pyrithiamine internal standard to the sample;
(ii) purifying thiamine and the pyrithiamine internal standard from the body fluid sample by high performance liquid chromatography to form a purified thiamine and a purified pyrithiamine internal standard;
(iii) ionizing and detecting the purified thiamine and the purified pyrithiamine internal standard by electrospray ionization tandem mass spectrometry with selected reaction monitoring in positive ion mode; and
(iv) quantifying the amount of thiamine in the body fluid sample by analyzing fragmented ions using the tandem mass spectrometry, wherein the amount of total thiamine in the sample is determined based on the comparative abundance of daughter ions generated from thiamine that have a mass/charge ratio of 144.03+1.0 and 121.94+1.0, relative to the abundance of a daughter ion generated from pyrithiamine internal standard that has a mass/charge ratio of 122.00±1.0.”
Thus, it is clear from the subject matter recited in the issued claim 1 (see also dependent claims 2-9 in the issued US patent ‘617) that the pending claims in this CON application are directed to essentially the same process, albeit with a broad generic scope for multiple limitations (i.e. in a genus-species relationship; see instant claim 1 under examination), and therefore, an ODP rejection is deemed proper (see also the 103(a) rejection over the cited prior art references discussed above).
Conclusion
NO claims are currently allowed.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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