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 .
DETAILED ACTION
Status of the Claims
Claims 1-20 are pending. Claims 1-7 are the subject of this FINAL Office Action.
Claim Interpretations
In an effort to clarify the claims and overcome the prior art, Applicants have added more intended use language to the product claims. Specifically, Applicants add the following italicized intended use language: “an armor strand that includes a complementary section and a 3' modification, the complementary section being complementary to the 3' section of the first primer such that when the armor strand hybridizes to the first primer, the 3' section of the first primer becomes sequestered while the 5' section of the first primer is free to hybridize to a first target location of a target nucleic acid, wherein hybridization of the 5' section of the first primer to the first target location initiates branch migration and strand displacement that releases the armor strand from the first primer.” As is clear from this language, this describes how the parts of the composition are used. It completely fails to provide any structural description. Applicants must claim the structures that directly achieve this result in use; otherwise, the uses of the structures of the composition fail to distinguish over prior art structures in the prior art compositions.
In claim 1, Applicants use intended use language of the claimed products at the potential point of novelty, which fail to distinguish over prior art products. Specifically, the following intended uses fail to distinguish the claimed double-stranded primers:
“such that when the armor strand hybridizes to the first primer, the 3' section of the first primer becomes sequestered while the 5' section of the first primer is free to hybridize to a first target location of a target nucleic acid”; and
“to enable, with the first primer, amplification of the target nucleic acid, wherein during the amplification, the 3' modification of the armor strand prevents polymerase extension of the armor strand.”
Thus, the claims amount to the following composition:
A first primer, with a strand of nucleic acid hybridized to any part of the 3’-half of the first primer and including a “modification” at 3’-end; and
A second primer “associated” with the first primer.
Response to Arguments
Applicants assert that “[t]he sequestration clause defines how the armor strand is architecturally positioned relative to the first primer, and the de-armoring mechanism, in which target hybridization at the 5' section proceeds through branch migration and strand displacement to release the armor strand, is the core operative feature that distinguishes the claimed composition from the prior art” (Reply, pg. 11). This is inaccurate. The sequestration clause describes how the “armor strand” is used. It completely fails to describe any structural features of the armor strand. Regardless whether the “sequestration clause” “de-armoring mechanism” is “the core operative feature that distinguishes the claimed composition from the prior art,” yet it is described by how it is used, not what it is. Furthermore, Applicants’ assertion that “the core operative feature that distinguishes the claimed composition from the prior art” means that it is even more imperative that clarity is provided at this point of potential novelty and non-obviousness. See Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs “when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty”) (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)); MPEP §2173.05(g) (“For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”); In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997) (“It is the applicants’ burden to precisely define the invention, not the PTO’s. See 35 U.S.C. § 112,12. . . . [T]his section puts the burden of precise claim drafting squarely on the applicant.”); Ex Parte Miyazaki, 89 U.S.P.Q.2d 1207, 1210-11 (B.P.A.I. 2008) (“the applicant has an opportunity and a duty to amend the claims during prosecution to more clearly and precisely define the metes and bounds of the claimed invention and to more clearly and precisely put the public on notice of the scope of the patent.”); Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008) (“We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.”)
New Grounds of Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by PIEPENBURG (US 2005/0112631).
As to claims 1-2, PIEPENBURG teaches the following double-stranded primer just like in instant Figure 1A:
PNG
media_image1.png
202
734
media_image1.png
Greyscale
PIEPENBURG, Fig. 34A
PNG
media_image2.png
190
596
media_image2.png
Greyscale
INSTANT Fig. 1A
As is clear, PIEPENBURG teaches the exact same double-stranded primer structure with 3’-end block on the second strand hybridized to the 3’-portion of the first strand primer. PIEPENBURG further teaches another primer associated with a second target location of the target nucleic acid (e.g. reverse primer, or second target primer, or nested primers; Figs. 2-4).
As to claim 3, the amplification is an isothermal amplification with two or more primers (recombinase polymerase amplification, or RPA; e.g. Abstract and Fig. 2).
As to claim 4, nothing in claim 4 recites any structural features of the claimed primers of the composition; rather, it describes how the primers are used. This fails to distinguish over PIEPENBURG.
As to claim 5, this claim recites more uses of the composition: “wherein the downstream amplification reaction comprises a LAMP isothermal amplification reaction, wherein the composition further comprises a set of LAMP primers that lacks at least one primer required for the LAMP reaction to proceed independently, the transduction product functioning as the lacking primer to the downstream amplification reaction.” Moreover, the composition curiously can “lack[] at least one primer,” which encompasses lacking all primers. Thus, the claim encompasses no “LAMP primers.”
As to claims 6-7, the RPA reaction can include DNA polymerase and reverse transcriptase (e.g. Abstract and Figs. 2-3; para. 0063 (“RNA can be turned into double stranded DNA by one of skill in the arts using known methods”)).
Response to Arguments
Applicants argue that the purpose of PIEPENBURG is different from their own. This is immaterial. The oligos of PIEPENBURG meet the claimed oligos’ structures as broadly claimed. This is all that matters.
As to claim 2, a “3’ block” means “such as a dideoxy sugar, or other 3′ blocking group” (para. 0261). Any skilled artisan would recognize that “3’ block” includes the other listed options as well.
As to claim 3, all that is required is “a forward inner primer, a backward inner primer, a forward outer primer, a backward outer primer”; in other words four primers; which is met by a nested amplification with two inner primer and two outer primers.
As to claim 7, when PIEPENBURG states RNA can be the target, and “RNA can be turned into double stranded DNA [AKA cDNA] by one of skill in the arts using known methods,” a skilled artisan with any experience in the lab would fully and immediately comprehend that this means reverse transcription using reverse transcriptase. See MPEP § 2144.03(A) (“Official notice unsupported by documentary evidence may be taken by the examiner where the facts asserted to be well-known, or to be common knowledge in the art, are ‘capable of such instant and unquestionable demonstration as to defy dispute.’”).
Prior Art
The following prior art also teaches double-stranded primers: US 2013/0274135; US20100279295.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aaron Priest whose telephone number is (571)270-1095. The examiner can normally be reached 8am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at (571) 272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AARON A PRIEST/Primary Examiner, Art Unit 1681
Prosecution Insights