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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on April 17th, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/17/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Status of the Claims
Claims 124-125, 127, 133, 135-139, 144-148 are pending in this application. Claims 1-123, 126, 128-132, 134, and 140-143 have been cancelled by applicant. Claims 124-125, 127, 133, and 144-148 are under examination herein. Claims 135-139 are withdrawn from consideration (see election/restriction requirement from 07/16/2025)
Claim Objections
Claims 124 and 127 is objected to because of the following informalities:
In claim 124, the structure of Formula I is blurry and the variables are difficult to read.
In claim 127, the third and second to last lines should read: “n is selected from integers of 1-8, x is selected from integers greater than or equal to n, x is less than 10, and the value of z satisfies…” or something to that effect (note that a couple “ands” have been removed, and commas have been added to streamline language).
Appropriate correction is required.
Claim 148 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Interpretation
The preamble of the instant claims recite a “kit.” The specification, however, describes the kit as merely containing individually packed, known reagents, for use in nucleic acid molecule extensions (pages 18-22). The specification does not define this term “kit” further, and so it is being interpreted to encompass any collection of the compound of Formula 1, 1-2, 1-13, and/or 5, as indicated in the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter. See MPEP § 2112.01 I-III.
Examiner Notes
Claims 127 and 147-148 are free of the prior art, but stand rejected and/or objected over formal matters.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 127 and 147 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 127 states that “R3 is substituted or unsubstituted alkyl”, however, Formula 1-2 does not have an R3 group. It is unclear what applicant intended by this limitation.
Claim 147 is rejected for depending upon the limitations of claim 127. Claim 148 remedies the deficiencies of these claims by specifying a single compound and thus eliminating ambiguity. Thus, claim 148 is not included in this rejection.
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.
Claims 125 and 144-146 are 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.
Claims 125 and 144-146 rejected for failing to further limit claim 124, from which they depend. Claim 124 limits R3 to heteroaryls. Claims 125 and 144-146 expand this limitation to encompass R3 being cycloalkyl.
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.
Claims 125 and 144-146 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (Biosci. Biotechnol. Biochem., 2007, 71, 1970–1978) (“Ahmad”); in view of CAS 1184984-49-3 (10083-08-6), CAS Registry File Accessed April 27th, 2026 from STN, entered into STN Sep. 16th, 2009, (“STN1”).
Claim 125 is broader than claim 124, from which it depends. As it pertains to embodiments beyond the scope of claim 124, wherein R3 is cycloalkyl, this rejection applies (see 112(d)).
Regarding claims 125 and 144-146, Ahmed teaches all the chemicals used to prepare real time polymerase chain reaction (PCR) buffers are Tris-HCl buffer, MgCl2, dNTPs, and Taq polymerase (page 1971, Materials and Methods – section). Ahmed teaches that Tris-H3PO4 buffer (pH of 8.3) gave an expanded dynamic range for the detection of nucleic acids compared to Tris-HCl (abstract and page 1974, col. 1, last para.).
While Ahmed does not teach phytic acid as their phosphoric acid, phytic acid is a known compound in the art, as seen by STN1.
STN1 discloses Phytic acid, below, CAS 10083-08-6, was entered into STN on Sep. 16th, 2009, and it is a phosphoric acid.
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Therefore, regarding claims 125 and 144-146, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to put together a kit for routine PCR techniques comprising a polymerase, a dNTP, and a solution of phytic acid (a phosphoric acid) in view of Ahmed and the fact that phytic acid is a well-known phosphoric acid in the art. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Ahmed teaches the chemicals used to prepare PCR buffers, such as a Tris-HCl buffer, MgCl2, dNTPs, and Taq polymerase; further because Ahmed specifically teaches that phosphate titrated Tris buffers have an expanded dynamic range for the detection of nucleic acids compared to Tris-HCl; and further in view of the fact that phytic acid is a known phosphoric acid, which one of ordinary skill would have a reasonable expectation of success in using for titration of Tris to make the corresponding buffer.
Applicant is advised that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). In the present case, Applicant would be required to show an unprecedented property of the instantly claimed phytic acid or an unexpected result in the instant invention.
Applicant is further advised that the preamble of the instant claims recite a “kit.” The specification, however, describes the kit as merely containing individually packed, known reagents, for use in nucleic acid molecule extensions (pages 18-22). The specification does not define this term “kit” further, and so it is being interpreted to encompass any collection of the compound of Formula 1, a polymerase, and a dNTP, as indicated in the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter. See MPEP § 2112.01 I-III. Applicant is advised that products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Therefore, the instantly claimed kit comprising phytic acid, a polymerase, and a dNTP is prima facie obvious in view of the teachings from Ahmed and STN1, as outlined above.
Claim 124 is rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (Biosci. Biotechnol. Biochem., 2007, 71, 1970–1978) (“Ahmad”); in view of CAS 269484-26-5, CAS Registry File Accessed April 27th, 2026 from STN, entered into STN April 30th, 2021, (“STN2”).
Regarding claim 124, Ahmed teaches all the chemicals used to prepare real time polymerase chain reaction (PCR) buffers are Tris-HCl buffer, MgCl2, dNTPs, and Taq polymerase (page 1971, Materials and Methods – section). Ahmed teaches that Tris-H3PO4 buffer (pH of 8.3) gave an expanded dynamic range for the detection of nucleic acids compared to Tris-HCl (abstract and page 1974, col. 1, last para.).
While Ahmed does not teach the instantly claimed phosphoric acids; the teachings of STN2 are relied upon for these disclosures.
STN2 discloses the compound below, which anticipates the instant claim when n is 1; R1-2 are H; and R3 is a substituted heteroaryl.
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Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to put together a kit for routine PCR techniques comprising a polymerase, a dNTP, and a solution of a phosphoric acid of Formula 1, in view of Ahmed and STN2. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Ahmed teaches the chemicals used to prepare PCR buffers, such as a Tris-HCl buffer, MgCl2, dNTPs, and Taq polymerase; further because Ahmed specifically teaches that phosphate titrated Tris buffers have an expanded dynamic range for the detection of nucleic acids compared to Tris-HCl; and further in view of STN2’s disclosure of their phosphoric acid, which one of ordinary skill would have a reasonable expectation of success in using for titration of Tris to make the corresponding buffer, in view of Ahmed and STN2.
Applicant is reminded that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). In the present case, Applicant would be required to show an unprecedented property of the instantly claimed acids or an unexpected result in the instant invention.
Applicant is reminded that the preamble of the instant claims recite a “kit.” The specification, however, describes the kit as merely containing individually packed, known reagents, for use in nucleic acid molecule extensions (pages 18-22). The specification does not define this term “kit” further, and so it is being interpreted to encompass any collection of the compound of Formula 1, a polymerase, and a dNTP, as indicated in the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter. Applicant is reminded that products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Claims 133 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (Biosci. Biotechnol. Biochem., 2007, 71, 1970–1978) (“Ahmad”); in view of CAS 269484-26-5, CAS Registry File Accessed April 27th, 2026 from STN, entered into STN April 30th, 2021, (“STN2”); as applied to claim 124; further in view of Fadanka et al. (Obtained from protocols.io [retrieved on September 27th, 2025] <URL: https://www.protocols.io/view/preparation-of-pbs-solution-3byl4bxjrvo5/v1?u=%2Fview%2Fpreparation-of-pbs-solution-3byl4bxjrvo5%2Fv1> - Published June 14th, 2022 – previously cited) (“Fadanka”).
The teachings of Ahmed and STN2 are disclosed above and incorporated herein.
While Ahmed and STN2 do not specifically disclose a phosphoric acid concentration of 1-150 µmol/L, the teachings of Fadanka are relied upon for these disclosures.
Fadanka discloses a protocol for the preparation of a phosphate buffered saline (PBS) solution, commonly used in biological research (page 1, para. 1, line 1). Fadanka discloses a sodium phosphate dibasic solution with an initial concentration of 10 mmol/ L and a potassium phosphate solution with an initial concentration of 1.8 mmol/ L (Table at the bottom of page 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to prepare a solution comprising Ahmed in view of STN2’s phosphoric acid in any concentration desired, including 1-150 µmol/ L. One of ordinary skill would have been motivated to do so in view of Ahmed in view of STN2’s disclosure of their phosphoric acid solutions for titration of a Tris base to make a buffer. One of ordinary skill would have had a reasonable expectation of success in view of Fadanka’s disclosure of a protocol for preparing PBS, which is a commonly used phosphate buffer, containing phosphates at about 1.8 to 11.8 mmol/ L. A person with ordinary skill has good reason to pursue known options within his or her technical grasp. Note: MPEP 2143(E) KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Applicant is advised that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when 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 similar properties, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that where 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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05-II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been introduced.
Claim Objections
Applicant’s arguments, see page 7, filed 03/30/2026, with respect to objections to the claims have been fully considered and are persuasive. The objection of the claim has been withdrawn. However, upon further consideration, a new ground(s) of objection is made.
Claim Rejections - 35 USC § 112(b) and (d)
Applicant’s arguments, see page 7-8, filed 03/30/2026, with respect to 35 USC § 112(b) and (d) rejections have been fully considered and are persuasive. The 35 USC § 112(b) and (d) rejections of the claims has been withdrawn. However, upon further consideration, a new ground(s) of 35 USC § 112(b) and (d) rejections is made in view of amendments to claims.
Claim Rejections - 35 USC § 103
In view of claim amendments, the 35 USC § 103 rejections of the claims have been withdrawn. However, upon further consideration, and in view of claim amendments, a new ground of rejections is presented herein.
With regards to the definition of record, regarding a “kit”, Applicant states the following (para. Linking pages 10-11):
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Applicant argues that Fadanka doesn’t cure the deficiencies of Ahmed.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, and that the mere fact that components are known does not render the kits obvious, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Ahmed teaches all the chemicals used to prepare real time polymerase chain reaction (PCR) buffers are Tris-HCl buffer, MgCl2, dNTPs, and Taq polymerase (page 1971, Materials and Methods – section). Ahmed teaches that Tris-H3PO4 buffer (pH of 8.3) gave an expanded dynamic range for the detection of nucleic acids compared to Tris-HCl (abstract and page 1974, col. 1, last para.).
STN1 and STN2 disclose the phosphoric acids below:
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Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to put together a kit for routine PCR techniques comprising a polymerase, a dNTP, and a solution of a phosphoric acid, in view of Ahmed and STN1 and STN2. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Ahmed teaches the chemicals used to prepare PCR buffers, such as a Tris-HCl buffer, MgCl2, dNTPs, and Taq polymerase; further because Ahmed specifically teaches that phosphate titrated Tris buffers have an expanded dynamic range for the detection of nucleic acids compared to Tris-HCl; and further in view of STN1/ 2’s disclosure of their phosphoric acids, which one of ordinary skill would have a reasonable expectation of success in utilizing for the titration of Tris to make the corresponding buffer, in view of Ahmed and STN2.
Applicant is reminded that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). In the present case, Applicant would be required to show an unprecedented property of the instantly claimed acids or an unexpected result in the instant invention.
Applicant is reminded that the preamble of the instant claims recite a “kit.” The specification, however, describes the kit as merely containing individually packed, known reagents, for use in nucleic acid molecule extensions (pages 18-22). The specification does not define this term “kit” further, and so it is being interpreted to encompass any collection of the compound of Formula 1, a polymerase, and a dNTP, as indicated in the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter. Applicant is reminded that products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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