Notice of Pre–AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Information Disclosure Statement
2. No information disclosure statement was present at the time of this office action.
Specification
3. The use of the terms Cobas® and ThinPrep®, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever it 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
4. Claims 1 and 9 are objected to because of the following informalities:
In claim 1, line 4, the phrase, “a unaltered” is grammatically incorrect and should be “an unaltered”;
In claim 1, line 2, the “HPV” acronym is not defined in the claim. An acronym should be defined the first time it appears in the claims. For the purposes of examination, the “HPV” is interpreted to mean “Human Papillomavirus”, as defined in the specifications;
In claim 9, line 2, “form” should be “from”;
In claims 9, 10, and 12, the “PCR” acronym has previously been defined in claim 1. An acronym should only be defined the first time it appears in the claims.
Appropriate correction is required.
Claim Rejections – 35 USC § 112
35 USC § 112(d)
5. 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.
6. Claim 17 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 17 requires that the clinically validated PCR assay of claim 16 correlate with clinical significance. The results from a clinically validated assay would have clinical significance. Thus, claim 17 fails to further limit the subject matter of claim 17. 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.
35 USC § 112(b)
7. 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.
8. Claims 1, 5 – 7, 10 – 12, 15, and 16 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.
9. Claims 1, 6, 10, and 12 contain the trademark/trade name Cobas® in claim 1, line 8; claim 6, line 3; claim 10, line 2; and claim 12, line 7. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre–AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an HPV test/assay and, accordingly, the identification/description is indefinite.
10. Claim 5 contains the relative term “good concordance”, which renders the claim indefinite. The term “good concordance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “Good concordance” is not defined in the specification. Thus, one having ordinary skill in the art would be unable to determine what level of concordance was considered "good".
11. Claim 7 recites the limitation "detecting of HPV 16 and HPV 18...with an average Ct value of 37 and 35.6" in lines 1 and 2 of the claim. There is ambiguity and insufficient antecedent basis for this limitation in the claim due to the lack of an adverb, such as “respectively” or “correspondingly”, at the end of the list to delineate which HPV pairs with which Ct value. In the interest of compact prosecution, it will be interpreted that HPV 16 has a Ct value of 37, whereas HPV 18 has a Ct value of 35.6, as described in the specifications. However, an appropriate amendment is required.
12. Claim 15 recites the limitation "clinically validated assay" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. The phrase “clinically validated assay” is not defined in claim 12, upon which claim 15 depends. Since there is no earlier recitation of a “clinically validated assay”, it cannot be determined where or not the phrase is a recited limitation.
13. The terms "male, non–binary, and transgender patient" in claim 16 and "a non–binary woman, a non–binary male" in claim 11 render the claims indefinite. The term nonbinary is defined as “relating to or being a person who identifies with or expresses a gender identity that is neither entirely male nor entirely female” in the specification. Moreover, the term transgender is defined as a “person whose gender identity differs from the sex the person had or was identified as having at birth especially, relating to, or being a person whose gender identity is opposite the sex the person had or was identified as having at birth” in the specification. Thus, it is contradictory for an individual to be male and non–binary; woman and non–binary; or male, non–binary, and transgender. In the interest of compact prosecution, it will be interpreted that the patient is “male, non–binary, or transgender” in claim 16, as defined in claim 1. However, an appropriate amendment is required for both claims 11 and 16.
Claim Rejections – 35 USC § 103
14. 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.
15. Claims 1 – 4 and 7 – 12 are rejected under 35 U.S.C. 103 as being unpatentable over Vibat, C. R. (US20150376725A1, Published December 31, 2015) in further view of Yang, W., et. al. (CA3119710A1, Published July 7, 2020).
Vibat, C. R. teaches a method for the detection of nucleic acids (DNA) from one or more high–risk forms of HPV, namely HPV 16, HPV 18, and HPV 68 (page 5, paragraph 0057, lines 1 – 9), as mentioned in instant claims 2 and 18. It is further taught that the detected nucleic acids are obtained from a urine sample (abstract, lines 2 – 5, claim 1) of a female or male subject (page 1, paragraph 0006, lines 3 and 4), wherein there is no processing of the urine (page 1, paragraph 0007, lines 3 – 9), as recited in instant claims 1, 11, and 12. Sample preparation, page 11, paragraph 0083 and 0084 goes on to teach that nucleic acids are extracted/isolated from the urine, as required in instant claims 1 and 12. It is further taught that isolated nucleic acids are subsequently PCR amplified, wherein the amplifying technique is real time PCR, PCR–SSRP, LCR, and nested PCR (page 3, paragraph 0007, lines 1 – 6, claim 9; page 8, paragraph 0069, lines 1 – 6), as recited in instant claims 9 and 10. Vibat, C. R. goes on to teach that detection of HPV nucleic acid molecules in a urine sample indicates the presence of an HPV infection in a subject (page 2, paragraph 0011, lines 3 – 5), as recited in instant claims 1 and 12; wherein the method has a sensitivity greater than 90% for HPV 16, HPV 18, and HPV 68 (page 8, paragraph 0068, lines 2 – 9), as recited in instant claims 3 and 4.
Vibat, C. R. fails to teach testing the isolated nucleic acids with the Cobas HPV test using the Cobas 6800 or 8800 assay, as required in instant claims 1, 10, and 12; the specificity of the method, as recited in instant claims 3; and the minimum concentration and average Ct value for detecting HPV, as mentioned in instant claims 7 and 8. However, Yang, W., et. al. teaches that real–time fluorescent quantitative PCR is one of the most widely used HPV nucleic acid detection technology, namely the Cobas HPV detection method (page 2, paragraph 006, lines 1 – 6), as recited in instant claims 1, 10, and 12. It is further taught that employing the method of HPC detection in urine analyte has a specificity of at least 99% or more (page 33, paragraph 121, lines 1 – 7), as required in instant claims 3 and 9. Yang, W., et. al. also teaches that the positive control is a plasmid containing the high risk HPV gene with a concentration of 10~105 copies/µL prepared (page 11, paragraph 044, lines 1 – 3) and that each plasmid is 103 copies/mL (page 54, paragraph 229, bullet point 4) wherein the Ct value associated of the test sample is no more than about 35 or less (page 33, paragraph 118, lines 1 – 4), as mentioned in instant claims 7 and 8.
Vibat, C. R. and Yang, W., et. al. are considered to be analogous to the claimed invention because both are in the same field of detecting HPV in urine analyte. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the urine analyte detection method of Vibat, C. R. with the Cobas HPV test mentioned in Yang, W., et. al. to provide a less invasive and easier method to test for HPV in both sexes without compromising accuracy, sensitivity, or specificity (page 3, paragraph 009, lines 1 – 16). All the claimed elements were known in the prior art. It would have been obvious to a person having ordinary skill in the art to have combined the elements as claimed by known methods with no change in their respective functions. The combination would have yielded nothing more than predictable results to one having ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143A and 2143.02.
16. Claim(s) 5, 6, and 13 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Vibat, C. R. (US20150376725A1, Published December 31, 2015) and Yang, W., et. al. (CA3119710A1, Published July 7, 2020), and in further in view of the cobas HPV package insert (Published April 2020) – hereby referred to as Cobas.
From the prior teachings of Vibat, C. R., and Yang, W., et. al. above in paragraph 15, Vibat, C. R. further teaches that the nucleic acids of the high-risk HPV types are extracted by applying the urine to a silica–based affinity column (reagents, kits, and usage, page 10, paragraph 0077), as required in claim 16, 18, and 19. Additionally, Vibat, C. R. teaches that a thermostable DNA polymerase is employed during the PCR amplification (page 4, paragraph 0044, lines 1 – 6), as recited in claim 16. Moreover, Vibat, C. R. teaches that the disclosed reagents and materials are packaged as a diagnostic kit for detecting HPV, wherein instructions relating to usage of the kit and containers for collection or transfer of a urine sample are included (page 2, paragraph 0017, lines 1 – 3; page 11, paragraph 0078, lines 1 – 11), as required in instant claims 15 and 20.
Vibat, C. R. and Yang, W., et. al. fail to teach the clinical significance of the taught method, as recited in instant claims 5, 6, and 17; the coefficient of variation, as required in instant claim 13; and the automation of the results, as mentioned in instant claims 14 and 16. However, Cobas teaches that the cobas HPV test has similar performance to an FDA–approved HPV test in terms of sensitivity and specificity for detecting disease (page 32, table 25), wherein the specimens were collected using the ThinPrep Pap Test (clinical performance, page 30), as recited in instant claims 5, 6, and 17. Cobas further teaches that the overall CV(%) in positive panel members ranged from 1.09% to 4.61% for HPV 16 (page 24, table 16), 1.23% to 3.76% for HPV 18 (page 24, table 17), and 4.32% to 6.19% for other high risk HPV (page 24, table 15), as required in instant claim 13. It is further taught in Cobas that automated data management is performed by the cobas software (principles of the procedure, page 6), as mentioned in instant claims 14 and 16.
Vibat, C. R., Yang, W., et. al., and the cobas HPV product brochure are considered to be analogous to the claimed invention because all are in the same field of detecting HPV. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the urine analyte detection method of Vibat, C. R. and Yang, W., et. al. with the cobas HPV product to have fully automated sample preparation for determining the presence of HPV (page 6). All the claimed elements were known in the prior art. It would have been obvious to a person having ordinary skill in the art to have combined the elements as claimed by known methods with no change in their respective functions. The combination would have yielded nothing more than predictable results to one having ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143A and 2143.02.
Allowable Subject Matter
17. No claims are allowed.
Conclusion
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Hallie N. Pennington, Ph.D. whose telephone number is (571)272–6781. The examiner can normally be reached M–Th 7:30–5:30 ET.
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/HALLIE NICOLE PENNINGTON, PH.D./Examiner, Art Unit 1671
/JANET L ANDRES/Supervisory Patent Examiner, Art Unit 1671