DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (directed to claims 1-5 and 7-9) in the reply filed on 21 July 2026 is acknowledged. The traversal is on the ground(s) that neither Sitton nor Fischer discloses an aqueous composition that has a pH greater than 7.7 and less than 8.45, as recited in claim 1 (Group I) and that the claims of Group III recite a kit comprising the composition of claim 1. This is not found persuasive because, firstly, an aqueous composition having a pH greater than 7.7 and less than 8.45 is not a shared technical feature between any of the Groups. While this technical feature is recited in claim 1 (Group I), it is not recited in Group II, and Group III’s recitation in claim 15 “wherein said buffer has a buffering region at 20° C that extends from a pH of 7.8 or lower to a pH of 8.2 or higher” is not the same as this technical feature, so Group III also does not require this technical feature. Secondly, Examiner notes that Group III does not make reference to the composition of claim 1.
In the traversal, Applicant also states:
If the Office maintains the objection to the unity of invention over Sitton and Fischer, then the Office must use Sitton and Fischer in a rejection under 35 U.S.C. §§ 102 or 103 (see 35 U.S.C. § 372) or withdraw the restriction requirement and rejoin the claims of Group III to Group I.
Examiner is not aware of such a requirement and 35 U.S.C. 372 only states the following with no reference to a requirement to use references used to break unity of invention in a restriction requirement in later prior art rejections:
35 U.S.C. 372 National stage: Requirements and procedure.
(a) All questions of substance and, within the scope of the requirements of the treaty and Regulations, procedure in an international application designating the United States shall be determined as in the case of national applications regularly filed in the Patent and Trademark Office.
(b) In case of international applications designating but not originating in, the United States—
(1) the Director may cause to be reexamined questions relating to form and contents of the application in accordance with the requirements of the treaty and the Regulations;
(2) the Director may cause the question of unity of invention to be reexamined under section 121, within the scope of the requirements of the treaty and the Regulations; and
(3) the Director may require a verification of the translation of the international application or any other document pertaining to the application if the application or other document was filed in a language other than English.
Therefore, in the interest of compact prosecution, Examiner will use the strongest art identified during a complete search in order to formulate any prior art rejections under 35 U.S.C. 102 or 103 in this action without being beholden to formulating a rejection specifically using Sitton and/or Fischer. Examiner requests that Applicant provide a precise quotation of any such requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-5, 7-11, 15-16, and 18-21 are pending.
Claims 6, 12-14, and 17 are canceled.
Claims 10-11, 15-16, and 18-21 are withdrawn.
Claims 1-5 and 7-9 are under examination.
Specification
The use of terms including, but not limited to, 3M, Molecular Detection System, and Zeta sizer (which appears to refer to the trademarked Zetasizer), which are trade names or marks used in commerce, has been noted in this application. 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 term.
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.
Claim Objections
Claim 7 is objected to because of the following informalities: claim 7 recites “The aqueous composition of any of claim 1”, the phrase “any of” should be removed so that it reads “The aqueous composition of claim 1”. Claim 7 also recites “comprising ferric ion”. Examiner suggests that “comprising a ferric ion” or “comprising ferric ions” would be more grammatically appropriate, or that Applicant may have indented to recite “comprising ferric iron” because page 5 lines 22-27 of the instant specification filed 1 March 2024 recites the composition including ferric iron. Appropriate correction is required.
Claim Interpretation
Claim 1 recites “optionally 7.8-8.3 when measured at 20° C” on lines 10-11 with regard to the pH of the composition. As this limitation is recited as being optional, this limitation is not required by claim 1 (and claims 2-9 that depend upon claim 1).
Claim 2 recites “further optionally having a concentration of 40 mM to about 200 mM, and still further optionally having a concentration of 40 mM to 150 mM” on lines 3-4. As this limitation is recited as being optional, this limitation is not required by claim 2 (and claim 3 that depends upon claim 2).
Claim 5 recites “optionally wherein the magnesium salt is magnesium sulfate or a hydrate thereof, and further optionally magnesium sulfate heptahydrate” on lines 2-3. As this limitation is recited as being optional, this limitation is not required by claim 5.
Claim 8 recites “optionally no more than 250 nm, optionally no more than,” on lines 2-3. As this limitation is recited as being optional, this limitation is not required by claim 8.
Claim 8 recites “wherein the zirconium oxide particles have a mean particle size of no more than 500 nm […] in each case as measured by photon correlation spectroscopy as described herein”. As the claim is for a product, specifically a composition comprising the zirconium oxide particles, the phrase “in each case as measured by photon correlation spectroscopy as described herein” only defines a process by which the size of the particles is measured, but does not materially limit the composition. Therefore, this recitation only requires that the zirconium oxide particles have a mean particle size of no more than 500 nm.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites “optionally no more than,” in line 3 with no value following the recitation, so the metes and bounds of this limitation would be unclear to one of ordinary skill in the art.
Claim Rejections - 35 USC § 112(d) - Dependency
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 depends upon claim 1 and only requires that “the buffer comprises at least one zwitterionic compound, wherein said buffer has a concentration of 40mM or greater” (see Claim Interpretation section above regarding the optional limitations not being required), which is equivalent to the limitation in claim 1 that “said buffer comprises at least one zwitterionic compound and has a concentration of 40mM or greater”. Therefore, claim 2 fails to further limit claim 1 upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Sitton et al. (US 2018/0142280, published 24 May 2018), herein Sitton, in view of Ho. (US 2017/0022493, published 26 January 2017).
Regarding claim 1, Sitton teaches an aqueous composition comprising: zirconium oxide particles; a surfactant at a concentration greater than or equal to 0.005% (mass/volume); an organic, iron-chelating reagent having a first affinity constant greater than or equal to 104.2 with respect to ferric iron and a second affinity constant less than 103.8 with respect to magnesium, wherein the first affinity constant and the second affinity constant are determined in 20° C deionized water at pH 8.45 (claims 1 and 9, note that EGTA is such an organic iron-chelating reagent per [0067]); and a buffer (“wherein the composition further comprises a buffering agent” claim 11). Sitton also teaches that the composition has a pH greater than 7.7 and less than 8.45 (“the composition has a pH of about 8.45 to 8.85” claim 1; also recited in identical or equivalent terms in the Abstract, [0009], [0011], [0012], [0051], [0074], [0075], [0098], [0103], [0136], and [0185]; because the phrase “about” when describing a number would be understood by one of ordinary skill in the art to include similar values that are less than and greater than the value modified by “about”, one of ordinary skill in the art would understand Sitton to teach the composition having a pH less than 8.45).
However, regarding claim 1, Sitton does not teach that the buffer comprises at least one zwitterionic compound having a concentration of 40 mM or greater. This deficiency is made up for in the teachings of Ho.
Regarding claim 1, Ho teaches the use of various buffers in lysis solutions at concentrations of 40 mM or greater (“In certain embodiments, the concentration of the buffer ranges from about 10 mM up to about 100 mM, or from about 20 mM up to about 50 mM, or is about 50 mM” [0118]) wherein the buffer comprises at least one zwitterionic compound and buffers pHs in the range of 7.7 to 8.45 (page 7 Table 2, note that TAPS, Bicine, Tricine, TAPSO, HEPES, TES, and MOPS are all zwitterionic and all include pHs within the range of 7.7 to 8.45 in their buffer range in the third column). Furthermore, similar to the lysis solution taught by Sitton, the lysis solution taught by Ho includes a surfactant at a concentration greater than or equal to 0.005% (mass/volume) (page 7 Table 1, Tween 20 1%; section following [0127]) and a chelating agent (page 7 Table 1, EDTA; section following [0122]).
Regarding claim 2, the combination of Sitton and Ho teach the aqueous composition of claim 1 (see 35 U.S.C. 103 rejection of claim 1 above), wherein the buffer comprises at least one zwitterionic compound, wherein said buffer has a concentration of 40 mM or greater (see the teachings of Ho with regard to claim 1 above).
Regarding claim 3, the combination of Sitton and Ho teach the aqueous composition of claim 2 (see 35 U.S.C. 103 rejection of claim 2 above), and Ho further teaches using bicine as a zwitterionic compound in a lysis buffer (page 7 Table 2).
Regarding claim 4, the combination of Sitton and Ho teach the aqueous composition of claim 1 (see 35 U.S.C. 103 rejection of claim 1 above), and Sitton further teaches the composition further comprising citric acid or a salt thereof (“The aqueous composition of claim 1, further comprising a nanoparticle dispersion stabilizer” claim 5; “A particularly-preferred dispersion stabilizer that can be used in a composition of the present disclosure includes […] (citric acid) or salts thereof” [0055]).
Regarding claim 5, the combination of Sitton and Ho teach the aqueous composition of claim 1 (see 35 U.S.C. 103 rejection of claim 1 above), and Sitton further teaches the composition further comprising a magnesium salt (“a composition according to the present disclosure optionally can comprise magnesium or salts thereof” [0071]).
Regarding claim 7, the combination of Sitton and Ho teach the aqueous composition of claim 1 (see 35 U.S.C. 103 rejection of claim 1 above), and Sitton further teaches the composition further comprising ferric ions or ferric iron (“the composition can comprise ferric ions” [0051]”; “further comprising ferric iron” claim 4).
Regarding claim 8, the combination of Sitton and Ho teach the aqueous composition of claim 1 (see 35 U.S.C. 103 rejection of claim 1 above), and Sitton further teaches the composition wherein the zirconium oxide particles have a mean particle size of no more than 500 nm (claim 2).
Regarding claim 9, the combination of Sitton and Ho teach the aqueous composition of claim 1 (see 35 U.S.C. 103 rejection of claim 1 above), and Sitton further teaches the composition further comprising at least one of an indicator dye, a preservative, an enhancer of a LAMP reaction, an enhancer of a qPCR reaction, or a fluorosurfactant (“further comprising an indicator dye” claim 8; “Embodiment X is the composition of any one of the preceding Embodiments, wherein the composition further comprises an effective amount of a preservative” [0126], note that Embodiment A in [0103] is equivalent to claim 1; “the composition further comprises […] an enhancer for facilitating a LAMP-BART nucleic acid amplification reaction or an enhancer for facilitating a qPCR reaction” claim 11; “the composition may comprises a non-ionic polymeric fluorochemical surfactant” [0035]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform the simple substitution of a zwitterionic buffer, such as bicine, as taught by Ho for the Tris buffer used in the aqueous composition suitable for lysis and nucleic acid amplification taught by Sitton (MPEP §2143 I. B.). One of ordinary skill in the art could have performed this substitution and would have found the results of this substitution predictable because both buffers are taught to be used in lysis solutions for obtaining nucleic acids (see Sitton claim 9, see Ho Abstract), the solutions taught by both Sitton and Ho contain similar reagents such as buffers, chelators, and surfactants/detergents, and because Ho teaches that the zwitterionic buffer, such as bicine, is able to buffer pHs about 8.45. Note that though Ho’s specific solution is only taught with regard to a wide pH range (“pH ranging from about pH 4 to about pH 9” Abstract) or specific embodiments that are less than the claimed 7.7-8.45 range (see [0111]), Sitton provides the teaching of a greater than 7.7 and less than 8.45 (due to reciting “about 8.45”) and buffers used in lysis solutions such as bicine can buffer this pH as taught by Ho. Therefore, the invention as a whole of claims 1-5 and 7-9 would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
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 1-5 and 7-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 (regarding instant claims 1-5 and 7-8) and 22 or 25 (regarding instant claim 9) of U.S. Patent No. 10,604,787, herein ‘787, in view of Sitton et al. (US 2018/0142280, published 24 May 2018), herein Sitton, and in view of Ho (US 2017/0022493, published 26 January 2017).
Regarding instant claim 1, claim 14 of ‘787 claims an aqueous composition comprising a non-ionic surfactant anticipating the surfactant of instant claim 1 and an organic iron-chelating reagent anticipating the organic iron-chelating reagent of instant claim 1, wherein the aqueous composition has a pH of about 8.45-8.85, anticipating the claimed composition having a pH greater than 7.7 and less than 8.45 because “about 8.45” includes values near to but less than 8.45. However, claim 14 of ‘787 does not teach the aqueous composition comprising zirconium oxide particles or a buffer wherein the buffer comprises at least one zwitterionic compound. These deficiencies are made up for in the teachings of Sitton and Ho.
Regarding instant claim 1, Sitton teaches that including zirconium oxide particles in aqueous compositions for lysing cells and analyzing nucleic acids, such as that of claim 14 of ‘787, provides the advantage of neutralizing inhibitory proteins without the need for a protease digestion step (Sitton [0043]).
Regarding instant claim 1, Ho teaches formulating lysis solutions using buffers comprising zwitterionic compounds such as bicine with a concentration of 40 mM or greater (see discussion of Ho in the 35 U.S.C. 103 rejection of claim 1 above). Therefore, the combination of Sitton and Ho with claim 14 of ‘787 teaches an aqueous composition meeting all limitations of instant claim 1.
Regarding instant claim 2, instant claim 2 does not further limit instant claim 1 (see 35 U.S.C. 112(d) rejection of claim 2 above) so the teachings so claim 14 of ‘787 in view of Sitton and Ho, as discussed with regard to instant claim 1 above, also teach all required limitations of instant claim 2.
Regarding instant claim 3, Ho teaches the buffer comprising bicine (see discussion of Ho with regard to claims 1 and 3 in the 35 U.S.C. 103 rejections of claims 1 and 3 above).
Regarding instant claim 4, Sitton teaches the inclusion of citric acid in the aqueous compositions (see discussion of Sitton in the 35 U.S.C. 103 rejection of claim 4 above).
Regarding instant claim 5, Sitton teaches the inclusion of a magnesium salt in the aqueous compositions (see discussion of Sitton in the 35 U.S.C. 103 rejection of claim 5 above).
Regarding instant claim 7, claim 14 of ‘787 claims the aqueous composition comprising ferric iron.
Regarding instant claim 8, Sitton teaches the that the zirconium oxide particles have a mean particle size of no more than 500 nm (see discussion of Sitton in the 35 U.S.C. 103 rejection of claim 8 above).
Regarding instant claim 9, claim 22 of ‘787 claims the composition of claim 14 of ‘787 further comprising an indicator dye, and claim 25 claims that the composition of claim 14 (through claim 25 depending upon claim 23, which recites the composition of claim 14) further comprises an enhancer of a LAMP reaction.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the teachings of Sitton with claim 14 of ‘787 because Sitton teaches a similar composition for use in isolating and amplifying nucleic acids and teaches that the inclusion of zirconium oxide particles provides the advantage of not requiring protease digestion (MPEP §2143(I)(G)). One of ordinary skill in the art would have a reasonable expectation of success in this combination because Sitton and claim 14 of ‘787 are both concerned with the formulation of aqueous compositions for isolating and amplifying nucleic acids. Further, it would have been obvious to combine the teachings of Ho with the combination of Sitton and claim 14 of ‘787 for the same reasons that it would be obvious to combine Ho with Sitton as discussed in the 35 U.S.C. 103 rejection above. Therefore, the invention as a whole of claims 1-5 and 7-9 are prima facie obvious variations of claims 14 and 22 or 25 of ‘787.
Claims 1-5 and 7-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 (regarding instant claims 1-5), 2 (regarding instant claim 8), 4 (regarding instant claim 7), and 8 (regarding instant claim 9) of U.S. Patent No. 10,619,189, herein ‘189, in view of in view of Ho (US 2017/0022493, published 26 January 2017) or in view of Ho and further in view of Sitton et al. (US 2018/0142280, published 24 May 2018), herein Sitton.
Regarding instant claim 1, claim 1 of ‘189 claims an aqueous composition comprising a plurality of zirconium oxide particles anticipating the zirconium oxide particles of instant claim 1, a non-ionic surfactant anticipating the surfactant of instant claim 1, and an organic iron-chelating reagent anticipating the organic iron-chelating reagent of instant claim 1, wherein the aqueous composition has a pH of about 8.45-8.85, anticipating the claimed composition having a pH greater than 7.7 and less than 8.45 because “about 8.45” includes values near to but less than 8.45. However, claim 1 of ‘189 does not teach the aqueous composition a buffer wherein the buffer comprises at least one zwitterionic compound. This deficiency is made up for in the teachings of Ho.
Regarding instant claim 1, Ho teaches formulating lysis solutions using buffers comprising zwitterionic compounds such as bicine with a concentration of 40 mM or greater (see discussion of Ho in the 35 U.S.C. 103 rejection of claim 1 above). Therefore, the combination of Ho with claim 1 of ‘189 teaches an aqueous composition meeting all limitations of instant claim 1.
Regarding instant claim 2, instant claim 2 does not further limit instant claim 1 (see 35 U.S.C. 112(d) rejection of claim 2 above) so the teachings so claim 1 of ‘189 in view of Ho, as discussed with regard to instant claim 1 above, also teach all required limitations of instant claim 2.
Regarding instant claim 3, Ho teaches the buffer comprising bicine (see discussion of Ho with regard to claims 1 and 3 in the 35 U.S.C. 103 rejections of claims 1 and 3 above).
Regarding instant claim 4, claim 1 of ‘189 claims the composition comprising a nanoparticle dispersion stabilizer, which may be citric acid (see ‘189 col 9 lines 48-58), but does not specifically claim the composition further comprising citric acid or a salt thereof. This deficiency is made up for in the teachings of Sitton. Sitton teaches aqueous compositions for lysing cells and analyzing nucleic acids and the use of citric acid as a nanoparticle dispersion stabilizer for zirconium oxide particles (see discussion of Sitton in the 35 U.S.C. 103 rejection of claim 4 above).
Regarding instant claim 5, Sitton teaches the inclusion of a magnesium salt in the aqueous compositions (see discussion of Sitton in the 35 U.S.C. 103 rejection of claim 5 above).
Regarding instant claim 7, claim 4 of ‘189, depending upon claim 1 of ‘189, claims the aqueous composition further comprising ferric iron.
Regarding instant claim 8, claim 2 of ‘189, depending upon claim 1 of ‘189, claims the aqueous composition wherein the zirconium oxide particles have a mean particle size of less than or equal to 100 nm, anticipating the limitation of instant claim 8 of a mean particle size of no more than 500 nm.
Regarding instant claim 9, claim 8 of ‘189 claims the composition of claim 1 of ‘189 further comprising an indicator dye.
It would have been obvious to combine the teachings of Ho with the claim 1 of ‘189 for the same reasons that it would be obvious to combine Ho with Sitton as discussed in the 35 U.S.C. 103 rejection above because the composition of claim 1 of ‘189 is the same as that of Sitton discussed in the 35 U.S.C. 103 rejection above. Further, it would have been obvious to combine the teachings of Sitton with the combination of the teachings of Ho and claim 1 of ‘189 because Sitton teaches similar aqueous compositions for the purpose of isolating and amplifying nucleic acids comprising citric acid, which provides the advantage of being a dispersion stabilizer for the zirconium oxide particles present in both the composition of Sitton and the composition of claim 1 of ‘189. One of ordinary skill in the art would have a reasonable expectation of success in this combination because Sitton and claim 1 of ‘189 both teach aqueous compositions for the purpose of isolating and amplifying nucleic acids comprising zirconium oxide particles. Therefore, the invention as a whole of claims 1-5 and 7-9 are prima facie obvious variations of claims 1, 2, 4, and 8 of ‘189.
Claims 1-5 and 7-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11,168,352, herein ‘352, in view of Sitton et al. (US 2018/0142280, published 24 May 2018), herein Sitton, and in view of Ho (US 2017/0022493, published 26 January 2017).
Regarding instant claim 1, claim 7 of ‘352, via its dependency on claim 1 of ‘352, claims a method that involves an aqueous composition contacted with a water-insoluble material (and therefore the composition can be interpreted as comprising said material) that comprises a plurality of zirconium oxide particles, thereby anticipating the zirconium oxide particles of instant claim 1, and an organic iron-chelating reagent anticipating the organic iron-chelating reagent of instant claim 1, wherein the aqueous composition has a pH of about 8.45-8.85, anticipating the claimed composition having a pH greater than 7.7 and less than 8.45 because “about 8.45” includes values near to but less than 8.45. Furthermore, claim 3 of ‘352, which also depends on claim 1 of ‘352, teaches that the lysis buffer that makes up part of the aqueous composition may further comprise a non-ionic surfactant. Since both claims 3 and 7 and ‘352 depend on claim 1 of ‘352, it would be obvious to combine the teaching of the inclusion of a surfactant of claim 3 of ‘352 with the composition of the method of claim 7 of ‘352. However, the claims of ‘352 do not teach that the surfactant has a concentration greater than or equal to 0.005% (mass/volume) or that the aqueous composition a buffer wherein the buffer comprises at least one zwitterionic compound. These deficiencies are made up for in the teachings of Sitton and Ho.
Regarding instant claim 1, Sitton teaches aqueous compositions for lysing cells and analyzing nucleic acids including a surfactant and that the surfactant has a concentration greater than or equal to 0.005% (mass/volume) (see discussion of Sitton in the 35 U.S.C. 103 rejection of claim 1 above).
Regarding instant claim 1, Ho teaches formulating lysis solutions using buffers comprising zwitterionic compounds such as bicine with a concentration of 40 mM or greater (see discussion of Ho in the 35 U.S.C. 103 rejection of claim 1 above). Therefore, the combination of Sitton and Ho with claim 7 of ‘352 teaches an aqueous composition meeting all limitations of instant claim 1.
Regarding instant claim 2, instant claim 2 does not further limit instant claim 1 (see 35 U.S.C. 112(d) rejection of claim 2 above) so the teachings so claim 7 of ‘352 in view of Sitton and Ho, as discussed with regard to instant claim 1 above, also teach all required limitations of instant claim 2.
Regarding instant claim 3, Ho teaches the buffer comprising bicine (see discussion of Ho with regard to claims 1 and 3 in the 35 U.S.C. 103 rejections of claims 1 and 3 above).
Regarding instant claim 4, Sitton teaches the inclusion of citric acid in the aqueous compositions (see discussion of Sitton in the 35 U.S.C. 103 rejection of claim 4 above).
Regarding instant claim 5, claim 3 of ‘352, which depends upon claim 1 of ‘352, teaches that the lysis buffer that makes up part of the aqueous composition may further comprise an magnesium sulfate heptahydrate, which is a magnesium salt. Since both claims 3 and 7 and ‘352 depend on claim 1 of ‘352, it would be obvious to combine the teaching of the inclusion of magnesium sulfate heptahydrate of claim 3 of ‘352 with the composition of the method of claim 7 of ‘352.
Regarding instant claim 7, claim 2 of ‘352, which depends upon claim 1 of ‘352, teaches that the lysis buffer that makes up part of the aqueous composition may further comprise ferric iron. Since both claims 2 and 7 and ‘352 depend on claim 1 of ‘352, it would be obvious to combine the teaching of the inclusion of ferric iron of claim 2 of ‘352 with the composition of the method of claim 7 of ‘352.
Regarding instant claim 8, Sitton teaches that the zirconium oxide particles in similar aqueous compositions have a mean particle size of no more than 500 nm (see discussion of Sitton in the 35 U.S.C. 103 rejection of claim 8 above).
Regarding instant claim 9, claim 3 of ‘352, which depends upon claim 1 of ‘352, teaches that the lysis buffer that makes up part of the aqueous composition may further comprise an indicator dye or a fluorosurfactant. Since both claims 3 and 7 and ‘352 depend on claim 1 of ‘352, it would be obvious to combine the teaching of the inclusion of an indicator dye or a fluorosurfactant of claim 3 of ‘352 with the composition of the method of claim 7 of ‘352.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform the simple substitution of the specific concentration of surfactant in an aqueous solution for isolating and amplifying nucleic acids taught by Sitton for the surfactant of undisclosed concentration in an aqueous solution for amplifying nucleic acids of claim 7 of ‘352 (MPEP §2143(I)(B)). One of ordinary skill in the art would have a reasonable expectation of success in this combination because Sitton and claim 7 of ‘352 are both concerned with the formulation or use of aqueous compositions for isolating and amplifying nucleic acids. Further, it would have been obvious to combine the teachings of Ho with the combination of Sitton and claim 7 of ‘352 for the same reasons that it would be obvious to combine Ho with Sitton as discussed in the 35 U.S.C. 103 rejection above. Therefore, the invention as a whole of claims 1-5 and 7-9 are prima facie obvious variations of claims 7 of ‘352.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fischer et al. (US 2017/0073738, published 16 March 2017) teaches compositions for collecting and lysing cells for downstream nucleic acid analysis that comprise zwitterionic compounds such as bicine wherein the solution has the buffer present at a pH of about 6.5 to about 9.0 and the concentration of the buffer ranges from about 1 mM to about 1 M.
Zegrati et al. (US 2018/0258467, published 13 September 2018, effectively filed 7 April 2015), Zegrati teaches lysis buffer formulations similar to the composition of claim 1 where options for formulations include surfactants in the concentration range 0.2% to 20% (w/v), the organic iron-chelating reagent EGTA, and a buffer that may be bicine of disclosed pH values including 8.0 and disclosed concentrations greater than 40 mM.
Conclusion
Claims 1-5 and 7-9 are rejected. Claims 10-11, 15-16, and 18-21 are withdrawn. Claims 6, 12-14, and 17 are canceled. No claims are allowed.
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/JEFFREY BELLAH/Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
