DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of group I, imidazolidinyl and EDTA in the reply filed on 1/22/2026 is acknowledged. Upon reconsideration group II has been rejoined.
Claims 33-37 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/22/2026.
Priority
The instant application was filed 04/25/2023 and is a continuation of 12689370 , filed 01/19/2010, which claims priority from provisional application 61227529 , filed 07/22/2009 and claims priority from provisional application 61146065 , filed 01/21/2009.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/20/2024 are being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 21, 23-26 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Ryan (US 2004/0137417 A1).
While claim 21 recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
With regards to claim 21, Ryan teaches an evacuated collection container (0015). Ryan teaches an anticoagulant and imidazolidinyl urea (0017). Thus Ryan teaches a evacuated collection container comprising an anticoagulant and imidazolidinyl urea.
With regards to claim 23, Ryan claims imidazolidinyl urea as a fixative agent (claim 14) and , wherein concentration of said fixative agent is less than about 1 g/ml.(claim 16)
With regards to claim 24, Ryan teaches EDTA (0018)
With regards to claim 25, Ryan teaches EDTA (0018) and imidazolidinyl urea (0017).
With regards to claim 26-27, Ryan claims imidazolidinyl urea as a fixative agent (claim 14) and , wherein concentration of said fixative agent is less than about 1 g/ml.(claim 16). Ryan claims wherein concentration of said anticoagulant agent is less than about 0.3 g/ml. (claim 17).
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 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 negated by the manner in which the invention was made.
Claims 21-32 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ryan (US 2004/0137417 A1), Ryan (US patent (5,849,517), Garcia-Blanco (US2004/0014107).
Ryan (US 2004/0137417 A1) is referred to as Ryan 1. Ryan (US patent is (5,849,517) as Ryan 2.
While claim 21 recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
With regards to claim 21, Ryan 1 teaches an evacuated collection container (0015). Ryan teaches an anticoagulant and imidazolidinyl urea (0017). Thus Ryan teaches a evacuated collection container comprising an anticoagulant and imidazolidinyl urea. Ryan 1 teaches the use of glycine as part of a protective agent.
While Ryan 1 teaches imidazolidinyl urea, EDTA, and glycine, Ryan does not specifically teach a concentration of glycine.
However, Ryan 1 teaches, “in yet another aspect of the invention, it has been found that the addition of glycine, or other formaldehyde reactive compounds, is useful in removing any free formaldehyde which may be an equilibrium component of the compositions of the instant invention. It should be noted, however, that the preferred compositions of the instant invention contain only trace amounts of formaldehyde in equilibrium.“(column 5, lines 54-60).”
Garcia Blanco teaches, “[0015] Upon completion of the crosslinking step, the
reaction can be quenched. Glycine or other appropriate compound with a primary amine
can be used as the quencher when crosslinking is effected using formaldehyde. For
example, glycine (e.g. pH 7) can be added to a final concentration roughly equal to that
of the formaldehyde used, e.g., about 0.25M, and the resulting solution incubated
briefly, e.g. about 5 min at room temperature.” Garcia Blanco further teaches, “It is
important to note that the buffers did not contain primary or secondary amines, since
formaldehyde could crosslink these amines to proteins or nucleic acids. Crosslinking
reactions were quenched by the addition of glycine (pH 7.0) to a final concentration of
0.25 M followed by incubation at room temperature for 5 min.” The 0.25M glycine is
about 20 g/L.
As stated in the MPEP, 2144.05 II, “[W]here the general conditions of a claim
are disclosed in the prior art, it is not inventive to discover the optimum or workable
ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235
(CCPA 1955)."
MPEP 2144.05 IIB states, “In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because “obvious to try” is not a valid rationale for an obviousness finding. In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that “obvious to try” was a valid rationale for an obviousness finding, for example, when there is a “design need” or “market demand” and there are a “finite number” of solutions. 550 U.S. at 421 (“The same constricted
analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be
proved obvious merely by showing that the combination of elements was ‘[o]bvious to
try.’ ... When there is a design need or market pressure to solve a problem and there
are a finite number of identified, predictable solutions, a person of ordinary skill has
good reason to pursue the known options within his or her technical grasp. If this leads
to the anticipated success, it is likely the product not of innovation but of ordinary skill
and common sense. In that instance the fact that a combination was obvious to try
might show that it was obvious under §103.”). Thus, after KSR, the presence of a known
result-effective variable would be one, but not the only, motivation for a person of
ordinary skill in the art to experiment to reach another workable product or process. “
MPEP 2144.05 III states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence
indicating such concentration or temperature is critical. “[W]here the general conditions
of a claim are disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ
233, 235 (CCPA 1955) (Claimed process which was performed at a temperature
between 40°C and 80°C and an acid concentration between 25% and 70% was held to
be prima facie obvious over a reference process which differed from the claims only in
that the reference process was performed at a temperature of 100°C and an acid
concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The
normal desire of scientists or artisans to improve upon what is already generally known
provides the motivation to determine where in a disclosed set of percentage ranges is
the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ
809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope
of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).
Therefore it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to optimize the amount of glycine, IDU and EDTA in a nucleic acid protective agent comprising imidazolidinyl urea (IDU), ethylenediamine tetraacteic acid, glycine of IDU between about 300g/L and about 700g/L, glycine between about 20g/L and about 60g/L and EDTA between about 60g/L and about 100g/l or the ratios of claim 22, 28 as suggested by Ryan 2 and Ryan 1 in a tube to an evacuated collection container. The teachings of Ryan 1 and Ryan 2 present general teachings to the use of preserving blood. Ryan1 specifically teaches fixative, anticoagulant and suggests glycine and suggests the use of a fixative agent (IDU) at less than about 1 g/ml as well as suggesting, "In yet another aspect of the invention, it has been found that the addition of glycine, or other formaldehyde reactive compounds, is useful in removing any free formaldehyde which may be an equilibrium component of the compositions of the instant invention.” Thus it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to optimize the ratio glycine to remove free formaldehyde which is dependent on the amount of IDU and glycine obvious in view of the teaches of Garcia-Blanco with respect to 0.5M glycine being used to quench formaldyde. The art recognizes IDU and glycine as art result effective variables. The artisan would have a reasonable expectation of success as the artisan is merely optimizing the concentrations of a nucleic acid stabilizer, a free formaldehyde quencher and anticoagulant in known samples.
With regards to claim 23, Ryan 1 claims imidazolidinyl urea as a fixative agent (claim 14) and , wherein concentration of said fixative agent is less than about 1 g/ml.(claim 16)
With regards to claim 24, Ryan1 teaches EDTA (0018)
With regards to claim 25, Ryan1 teaches EDTA (0018) and imidazolidinyl urea (0017).
With regards to claim 26-27, Ryan1 claims imidazolidinyl urea as a fixative agent (claim 14) and , wherein concentration of said fixative agent is less than about 1 g/ml.(claim 16). Ryan claims wherein concentration of said anticoagulant agent is less than about 0.3 g/ml. (claim 17).
.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 21-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims1- 17 of U.S. Patent No. 12378543 and Ryan (US 2004/0137417 A1) . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
While the independent claims recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
The instant claims are drawn to an evacuated collection container comprising: a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample comprising: a formaldehyde releaser, and an anticoagulant.
The claims of 543 are drawn to a composition comprising: (i) a component capable of releasing an aldehyde; (ii) an anticoagulant comprising citric acid, trisodium citrate, and dextrose; and (iii) α-cyclodextrin, wherein the component capable of releasing an aldehyde is imidazolidinyl urea.
Ryan teaches an evacuated collection container (0015). Ryan teaches an anticoagulant and imidazolidinyl urea (0017). Thus Ryan teaches a evacuated collection container comprising an anticoagulant and imidazolidinyl urea. Ryan teaches the use of glycine as part of a protective agent.
Therefore it would have been prima facie obvious to one of ordinary skill in the art to provide the composition of 543 in an evacuated container. The artisan would be motivated as blood is normally drawn into an evacuated contained. The artisan would have a reasonable expectation of success as Ryan demonstrates evacuated containers were known.
Claims 21-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims1- 20 of U.S. Patent No. 11647743 and Ryan (US 2004/0137417 A1) . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
While the independent claims recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
The instant claims are drawn to an evacuated collection container comprising: a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample comprising: a formaldehyde releaser, and an anticoagulant.
The claims of 743 are drawn to A method comprising: a) providing a device including: i) a tube having an open end and a closed end, a closure inserted in the open end of the tube, and a vacuum drawn to a predetermined level inside the tube; and ii) preloaded compounds loaded into an interior portion of the tube prior to insertion of the closure and the vacuum draw, such that in an upright position the majority of the interior portion of the tube is substantially free of contact with the preloaded compounds, wherein the preloaded compounds include diazolidinyl urea and/or imidazolidinyl urea, and ethylenediamine tetraacetic acid (EDTA); b) drawing a blood sample into the tube such that the blood sample contacts the preloaded compounds to yield a final composition, wherein a ratio of a volume of the preloaded compounds to a volume of the final composition is from about 1:100 to about 2:100; c) transporting, at ambient temperature, the device including the blood sample to an analysis site; d) puncturing the closure, wherein the puncturing takes place at least three days after the blood sample draw; e) handling the blood sample in a low-toxicity environment wherein the preloaded compounds have an inhalation toxicity amount of zero; and f) transferring at least a portion of the blood sample from the device to another substrate and analyzing cells and cellular components present in the transferred blood sample for disease diagnosis; and wherein the preloaded compounds prevent in vitro cell clumping of the cells in the blood sample; and wherein the method is free of diluting the final composition.
Therefore it would have been prima facie obvious to one of ordinary skill in the art to provide the composition of 743 in an evacuated container. The artisan would be motivated as blood is normally drawn into an evacuated contained. The artisan would have a reasonable expectation of success as Ryan demonstrates evacuated containers were known.
Claims 21-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims1- 19 of U.S. Patent No. 10091984 and Ryan (US 2004/0137417 A1) . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
While the independent claims recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
The instant claims are drawn to an evacuated collection container comprising: a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample comprising: a formaldehyde releaser, and an anticoagulant.
The claims of 984 are drawn to A method for blood sample treatment comprising: locating about 50 μl to about 400 μl of a protective agent into a tube, the protective agent including imidazolidinyl urea, EDTA and glycine; drawing a blood sample having a first circulating tumor cell concentration into the tube, whereby it contacts the protective agent; isolating circulating tumor cells from the contacted blood sample at least 24 hours after the blood draw, the contacted blood sample having a second circulating tumor cell concentration, wherein the second circulating tumor cell concentration is not lower or higher than the first circulating tumor cell concentration by any statistically significant value; and wherein the concentration of the imidazolidinyl urea after the contacting step is greater than 5 mg/ml; wherein the concentration of the glycine after the contacting step is below about 0.03 g/ml; wherein the protective agent is present in an amount that is less than about 5% of an overall mixture volume of the protective agent and the drawn blood sample; wherein the method is free of any step of refrigerating the contacted blood sample to a temperature below room temperature after it has been contacted with the protective agent composition; and wherein as a result of metabolic inhibition of the circulating tumor cells in the treated blood sample, apoptotic and necrotic pathways are inhibited and the circulating tumor cells are protected from cell degradation.
Therefore it would have been prima facie obvious to one of ordinary skill in the art to provide the composition of 984 in an evacuated container. The artisan would be motivated as blood is normally drawn into an evacuated contained. The artisan would have a reasonable expectation of success as Ryan demonstrates evacuated containers were known.
Claims 21-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims1- 18 of U.S. Patent No. 10674721 and Ryan (US 2004/0137417 A1) . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
While the independent claims recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
The instant claims are drawn to an evacuated collection container comprising: a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample comprising: a formaldehyde releaser, and an anticoagulant.
The claims of 721 are drawn A method for blood sample treatment comprising: locating a protective agent into a tube, the protective agent including imidazolidinyl urea (“IDU”), glycince, and EDTA; drawing the blood sample having a first circulating tumor cell concentration into the tube, whereby the blood sample contacts the protective agent; isolating circulating tumor cells from the blood sample after the blood draw, the contacted blood sample having a second circulating tumor cell concentration, wherein the second circulating tumor cell concentration is not lower or higher than the first circulating tumor cell concentration by any statistically significant value; and wherein a concentration of the IDU prior to the contacting step is between about 0.1 g/mL and about 3 g/mL; wherein a concentration of the protective agent after the contacting step is less than about 0.8 g/mL; and wherein a concentration of the glycine after the contacting step is below about 0.03 g/mL..
Therefore it would have been prima facie obvious to one of ordinary skill in the art to provide the composition of 721 in an evacuated container. The artisan would be motivated as blood is normally drawn into an evacuated contained. The artisan would have a reasonable expectation of success as Ryan demonstrates evacuated containers were known.
Claims 21-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims1- 22 of U.S. Patent No. 11547111 . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
While the independent claims recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
The instant claims are drawn to an evacuated collection container comprising: a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample comprising: a formaldehyde releaser, and an anticoagulant.
The claims of 111 are A device comprising: an evacuated tube containing less than 10 mL of a mixture, the mixture including: a. a blood sample including one or more tumor-based nucleic acid fragments present within the blood sample in a first concentration; b. a protective agent in an amount of from about 50 to about 400 μl comprising imidazolidinyl urea, EDTA, and glycine, the protective agent present in an amount that is less than 5% by volume of the mixture, but greater than 1 part by volume protective agent to 300 parts by volume mixture, the glycine present in an amount of 1% to 10% by weight of the protective agent and the imidazolidinyl urea present in an amount of about 0.1 g/ml of the protective agent; wherein at least 24 hours after contact between the protective agent and the blood sample, the one or more tumor-based nucleic acid fragments are present in a second concentration that is not lower or higher than the first concentration by any statistically significant value...
Therefore it would have been prima facie obvious to one of ordinary skill in the art at the time the method was claimed the claims of 111 are encompassed by the instant claims and thus at least obvious variants.. .
Claims 21-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 20 of U.S. Patent No. 12114654 . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
While the independent claims recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
The instant claims are drawn to an evacuated collection container comprising: a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample comprising: a formaldehyde releaser, and an anticoagulant.
The claims of 654 are A device comprising: an evacuated tube that includes: (i) a blood sample including one or more tumor-based nucleic acid fragments present within the blood sample in a first concentration; (ii) a protective agent in an amount of at least about 300 μl comprising a preservative composition selected from imidazolidinyl urea, diazolidinyl urea, or a combination thereof and an anticoagulant; wherein the preservative composition is present in an amount of from 10 mg/ml to 20 mg/ml of the total blood sample and protective agent and less than 60% by weight of the protective agent, and the anticoagulant being present in an amount of less than 10% by weight of the protective agent; and wherein at least 24 hours after contact between the protective agent and the blood sample, the one or more tumor-based nucleic acid fragments are present in a second concentration that is not lower or higher than the first concentration by any statistically significant value..
Therefore it would have been prima facie obvious to one of ordinary skill in the art at the time the method was claimed the claims of 654 are encompassed by the instant claims and thus at least obvious variants.. .
Claims 21-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims1- 20 of U.S. Patent No. 9657227 and Ryan (US 2004/0137417 A1) . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
While the independent claims recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
The instant claims are drawn to an evacuated collection container comprising: a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample comprising: a formaldehyde releaser, and an anticoagulant.
The claims of 227 are drawn direct blood draw tube for stabilization of cell-free nucleic acid within a plasma sample comprising: a composition including: a) one or more preservative agents including imidazolidinyl urea; b) one or more enzyme inhibitors; and c) one or more solvents; and wherein the one or more enzyme inhibitors are selected from the group consisting of EDTA, aurintricarboxylic acid, and combinations thereof; wherein an amount of the one or more preservative agents relative to an amount of the one or more enzyme inhibitors is about 3 to about 6 parts by weight of preservative agent to about 2 parts by weight of enzyme inhibitors; wherein the composition contains less than, or about 30% by weight of the one or more enzyme inhibitors; wherein the composition includes some formaldehyde but less than 500 parts per million of formaldehyde; and wherein a concentration of the preservative agent is less than, or about 1000 g/l of the composition; and wherein the direct blood draw tube including the composition and a blood sample located therein is storable at room temperature...
Therefore it would have been prima facie obvious to one of ordinary skill in the art to provide the composition of 227 in an evacuated container. The artisan would be motivated as blood is normally drawn into an evacuated contained. The artisan would have a reasonable expectation of success as Ryan demonstrates evacuated containers were known.
Claims 21-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims1- 108 of U.S. Patent No. 9926590 and Ryan (US 2004/0137417 A1) . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
While the independent claims recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
The instant claims are drawn to an evacuated collection container comprising: a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample comprising: a formaldehyde releaser, and an anticoagulant.
The claims of 590 are drawn to a direct blood draw tube comprising: a composition formulated for stabilizing cell-free nucleic acids within a blood sample including: a) one or more formaldehyde releaser preservative agents; b) ethylenediaminetetraacetic acid (EDTA); c) one or more solvents; d) about 1% formaldehyde; wherein the composition is free of separately added formaldehyde but contains the formaldehyde as a result of the one or more formaldehyde releaser preservative agents; wherein an amount of composition within the direct blood draw tube prior to blood draw is less than, or about 1000 g/liter and is in an amount sufficiently small so that any consequential dilution of the blood sample is avoided; and wherein the direct blood draw tube including the composition: facilitates storage of the blood sample collected in the direct draw blood tube at room temperature for at least, or about 14 days without cell lysis and without cell-free nucleic acid degradation of the blood sample due to DNase and RNase activity after blood draw....
Therefore it would have been prima facie obvious to one of ordinary skill in the art to provide the composition of 590 in an evacuated container. The artisan would be motivated as blood is normally drawn into an evacuated container. The artisan would have a reasonable expectation of success as Ryan demonstrates evacuated containers were known.
Claims 21-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims1- 20 of U.S. Patent No. 10144955 and Ryan (US 2004/0137417 A1) . Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
While the independent claims recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
The instant claims are drawn to an evacuated collection container comprising: a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample comprising: a formaldehyde releaser, and an anticoagulant.
The claims of 955 are drawn to A method comprising: preparing a blood collection tube including at least, or about, 200 grams per liter of a composition formulated for stabilizing cell-free nucleic acids within a blood sample, the composition including: a) about 50 to about 500 grams per liter of at least one formaldehyde releaser preservative agent; b) ethylenediaminetetraacetic acid (EDTA); and c) one or more solvents; wherein the presence of the at least one formaldehyde releaser preservative agent results in release of at least some formaldehyde and up to, or about, 1% formaldehyde into the composition; and sending the blood collection tube and composition located therein to a remote location for collection of a blood sample that contains cell-free nucleic acids that are stabilized by the composition..
Therefore it would have been prima facie obvious to one of ordinary skill in the art to provide the composition of 955 in an evacuated container. The artisan would be motivated as blood is normally drawn into an evacuated container. The artisan would have a reasonable expectation of success as Ryan demonstrates evacuated containers were known.
Claims 21-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-37of copending Application No. 18/373,793 in view of Ryan (US 2004/0137417 A1).
This is a provisional nonstatutory double patenting rejection.
While the independent claims recites, “a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample.” This appears to only provide an intended use of the claim and does not specifically change the composition of the protective agent.
The instant claims are drawn to an evacuated collection container comprising: a protective agent formulated for stabilizing fetal cell-free nucleic acid within a maternal blood sample comprising: a formaldehyde releaser, and an anticoagulant
The claims of 793 are drawn to A method of stabilizing a biological sample for analysis, comprising: obtaining in a sample collection container containing a biological sample from a subject, the biological sample comprising circulating cell-free nucleic acids from the subject; admixing the biological sample while within the sample collection container with a protective agent composition to form a mixture of the protective agent composition and the sample, the protective agent composition comprising: at least one preservative, an anticoagulant, and a quenching agent; and quenching any free formaldehyde that may be present with the quenching agent from the protective agent composition such that the free formaldehyde reactos to form a reaction product that is inert to the nucleic acids of the biological sample, hereby stabilizing the biological sample such that nucleic acids within themixture are suitable for polymerase chain reaction and DNA sequencing, wherein the sample for at least 7 days after collection in the collection container is substantially devoid of aldehyde induced cross-linking.
Therefore it would have been prima facie obvious to one of ordinary skill in the art to provide the composition of 793 in an evacuated container. The artisan would be motivated as blood is normally drawn into an evacuated container. The artisan would have a reasonable expectation of success as Ryan demonstrates evacuated containers were known.
Summary
No claims are allowed.
Conclusion
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/Steven Pohnert/ Primary Examiner, Art Unit 1683
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