DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
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 prior art rejection set forth below 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.
Status of the Application
2. Claims 1 and 2 are pending and examined on the merits herein.
Information Disclosure Statement
3. The Information Disclosure Statement filed on April 17, 2024 has been considered.
Drawings
4. The drawings filed on April 17, 2024 are acceptable.
Substitute Specification
5. The substitute specification filed on April 29, 2024 has been entered.
The substitute specification is objected to because the continuity information in the first paragraph should be updated to state that prior-filed Application Serial No. 17/249,896 has issued as US 11,987,851.
Claim Objections
6. Claim 2 is objected to because original claims should not contain markings, such as underlining or strike-throughs. See 37 CFR 1.121(c)(2). In this case, line 1 of claim 1 contains underlining.
Claim Interpretation
7. Two aspects of the instant claims merit discussion in this section: (1) the definition of the terms “active fragment” and “amplification reaction,” which are used in the claims; and (2) the interpretation of claim 2.
(1a) The application defines the term “active fragment,” when used in reference to an oligonucleotide (i.e., as in the instant claims 1 and 2) as follows (see [0014] on pages 3-4): any nucleic acid molecule which includes fewer nucleotides than the full-length oligonucleotide, and retains at least one biological property of the full-length oligonucleotide (e.g., priming ability). Para [0014] goes on to state that active fragments may be “10, 15, 20, 25, 30 or more nucleotides in length and can be used as a primer in an HCV amplification reaction.”
(1b) The application defines the term “amplification reaction” as “any in vitro process for exponentially increasing the number of copies of a nucleotide sequence or sequences” (para. [0015] on page 4; emphasis added). This explicit definition in the specification excludes linear amplification methods such as reverse transcription.
(2) Claim 2 depends from claim 1 and requires the forward primers to “comprise a primer comprising SEQ ID NO: 11 or an active fragment thereof, SEQ ID NO: 12 or an active fragment thereof, SEQ ID NO: 13 or an active fragment thereof, SEQ ID NO: 14 or an active fragment thereof, and SEQ ID NO: 15 or an active fragment thereof.” The claim also requires the reverse primers to “comprise SEQ ID NO: 16 or an active fragment thereof, SEQ ID NO: 17 or an active fragment thereof, SEQ ID NO: 18 or an active fragment thereof, SEQ ID NO: 19 or an active fragment thereof, and SEQ ID NO: 20 or an active fragment thereof.”
As discussed below, claim 2 is indefinite because it is not clear whether the claim requires substituting the recited forward and reverse primers for the forward and reverse primers recited in claim 1 or if the claim requires performing the amplification reaction using the primers recited in both of claims 1 and 2. It is also not clear whether claim 2 was intended to be an independent claim since the bulk of the specification describes using the primers recited in claims 1 and 2 in separate amplification reactions (see, e.g., para. [0009] on pages 2-3 as well as para. [0041] on page 14 and pages 25-28; see also Examples 1 and 2 on pages 32-34).1
For examination purposes, the following interpretations have been used: (1) claim 2 was intended to be an independent claim; (2) claim 2 was intended to depend from claim 1 and encompasses substituting the primers of claim 1 with those of claim 2; (3) claim 2 was intended to depend from claim 1 and requires using the primers recited in both claims in the amplification reaction.
Claim Rejections - 35 USC § 112
8. 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 2 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 2 depends from claim 1 and requires the forward primers to “comprise a primer comprising SEQ ID NO: 11 or an active fragment thereof, SEQ ID NO: 12 or an active fragment thereof, SEQ ID NO: 13 or an active fragment thereof, SEQ ID NO: 14 or an active fragment thereof, and SEQ ID NO: 15 or an active fragment thereof.” The claim also requires the reverse primers to “comprise SEQ ID NO: 16 or an active fragment thereof, SEQ ID NO: 17 or an active fragment thereof, SEQ ID NO: 18 or an active fragment thereof, SEQ ID NO: 19 or an active fragment thereof, and SEQ ID NO: 20 or an active fragment thereof.”
Claim 2 is indefinite because it is not clear whether the claim requires (i) substituting the recited forward and reverse primers for the forward and reverse primers recited in claim 1 or (ii) performing the amplification reaction using the primers recited in claims 1 and 2. It is also not clear whether claim 2 was intended to be an independent claim since the bulk of the specification describes using the primers recited in claims 1 and 2 in separate amplification reactions (see, e.g., para. [0009] on pages 2-3, pages 25-28, and Examples 1-2).
As noted above in the “Claim Interpretation” section, the following interpretations have been used for examination: (1) claim 2 was intended to be an independent claim; (2) claim 2 was intended to depend from claim 1 and encompasses substituting the primers of claim 1 with those of claim 2; (3) claim 2 was intended to depend from claim 1 and requires using the primers recited in both claims in the amplification reaction.
Claim Rejections - 35 USC § 112
9. 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 from claim 1. As discussed above, claim 2 is indefinite, but one possible interpretation is that the claim requires substituting the primers recited in claim 1 with those recited in claim 2. If this interpretation is correct, claim 2 is not further limiting because it no longer requires all of the elements of the claim from which it depends. See also MPEP 608.01(n)(III).
Applicant may cancel the claim, amend the claim to place it in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
10. 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.
11. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
12. Claims 1 and 2 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dean et al. (US 2003/0118998 A1; IDS reference) in view of Lipson et al. (US 2010/0159533 A1).
The instant claims are drawn to a method for amplifying nonstructural protein 3 (NS3) from hepatitis C (HCV) in a sample. The method comprises performing an amplification reaction using a plurality of primers.
Regarding claims 1 and 2, Dean discloses an amplification method, described as “Reverse Transcription Multiple Displacement Amplification” (RT-MDA) in paras. 173-174 that comprises the following steps: (i) reverse transcription of RNA in a nucleic acid sample; (ii) removal of RNA (e.g., by nuclease digestion using, e.g., RNase H); and (iii) multiple displacement amplification of the reverse transcribed DNA. Dean further teaches that the nucleic acid sample may be a bodily fluid sample (e.g., blood). As evidenced by the specification of the instant application at, for example, paras. 3 and 28, HCV may be present in blood samples. Dean additionally teaches that MDA preferably uses random primers (e.g., random hexamers) (see, e.g., paras. 8 and 52). The random hexamers used by Dean necessarily contain active fragments of each of the instant SEQ ID NOs: 1-20 since random hexamers are necessarily capable of being used to amplify DNA transcribed from HCV NS3. As well, the MDA method of Dean is an exponential amplification method (see, e.g., para. 202).
Dean does not specify the conditions under which the reverse transcription step in RT-MDA is performed.
Lipson, though, teaches that random hexamers are commonly used for reverse transcription (see, e.g., para. 15).
It would have been prima facie obvious for one of ordinary skill in the art at the time of the invention to practice the reverse transcription step in the RT-MDA method of Dean using random hexamers. In view of the teachings of Lipson cited above, the ordinary artisan would have recognized that random hexamers were suitable for use as primers for reverse transcription and would have selected this commonly used option with a reasonable expectation of success. See also MPEP 2144.07, which notes that, in the absence of unexpected results, which have not been presented in this case, it is prima facie obvious to select a known material or method based on its suitability for the intended purpose. As well, since MDA step in the RT-MDA method disclosed by Dean is preferably performed with nonspecific primers (i.e., random hexamers), the ordinary artisan would have recognized that it would also be desirable to conduct the preceding reverse transcription step using nonspecific random hexamers since doing so would result in a consistently nonspecific, whole genome amplification method.
Further regarding claims 1 and 2, as noted above, Dean teaches that the disclosed methods may be practiced using any of a variety of samples, including samples that may include HCV nucleic acids (i.e., blood samples). As well, as noted above, the random hexamers used in the exponential MDA step of RT-MDA include active fragments of each of the instant SEQ ID NOs: 1-20. Therefore, when the RT-MDA method suggested by Dean in view of Lipson is conducted using a blood sample, it is capable of amplifying HCV as required by the preamble of claim 1.
Thus, the methods of claims 1 and 2 are prima facie obvious over Dean in view of Lipson.
Statutory Double Patenting
13. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 10 of prior U.S. Patent No. 9,528,163 B2 (IDS reference). This is a statutory double patenting rejection.
Nonstatutory Double Patenting
14. 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.
15. Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 10,982,294 B2 (IDS reference).
Initially, it is noted that the rejection is based on the interpretation that claim 2 was intended to be an independent claim.
Although the instant claim 2 and claim 14 of the ‘294 patent are not identical, they are not patentably distinct from each other because the method set forth in claim 14 of the ‘294 patent recites all of the limitations of the instant claim 2 as well as additional requirements concerning the length of the primers. Thus, claim 14 of the ‘294 patent is a species of the method more generically recited in the instant claim 2, and as discussed in MPEP 804 II.B.2, a more specific claim anticipates a more generic claim. Thus, the instant claim 2 is not patentably distinct from claim 14 of the ‘294 patent.
16. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,987,851 B2.
Although the instant claim 1 and the claims of the ‘851 patent are not identical, they are not patentably distinct from each other because the method set forth in independent claim 1 of the ‘851 patent, from which claims 2-16 of the ‘851 patent depend, recites all of the limitations of the instant claim 1 as well as additional requirements concerning the length of the primers and the use of PCR for the amplification step. Thus, claim 1 of the ‘851 patent is a species of the method more generically recited in the instant claim 1, and as discussed in MPEP 804 II.B.2, a more specific claim anticipates a more generic claim. Thus, the instant claim 1 is not patentably distinct from claims 1-16 of the ‘851 patent.
Conclusion
17. No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Angela Bertagna whose telephone number is (571)272-8291. The examiner can normally be reached 8-5, M-F.
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/ANGELA M. BERTAGNA/Primary Examiner, Art Unit 1637
1 It is noted that the specification provides support for using the primers recited in claims 1 and 2 together at least at pages 25-26.
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