FINAL ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is responsive to the Amendment and Response filed 02 June 2026. Claims 26, 33, and 48 have been amended and claims 51-59 have been added. Claims 49 and 51-56 remain/are withdrawn (see also paragraph 4 below). Applicant’s amendments and arguments have been thoroughly reviewed, and Applicant’s clarifying amendments to claim 26 have overcome the remaining rejections of that claim and claims dependent therefrom; accordingly, claims 26 and 30-47 are allowed (with claim 36 and additional embodiments of claims 44-45 having been rejoined, as noted below). Claims 48, 50, and 57-59 remain/are rejected for the reasons given below, which include new grounds of rejection necessitated by Applicant’s amendments. Any rejections and/or objections not reiterated in this action have been withdrawn. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions, Rejoinder, and Status of Claims
Claim 49 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 15 November 2023. Additionally, while new claims 57-59 depend from claim 50 and correspond to the elected species under consideration herein, new claims 51-56 are directed to alternative species of the product/kit claims that would have been identified as separate species had these claims been originally presented. As the kit/product of the invention is not allowable, these claims are withdrawn (although it is noted that the claims will, like claim 49, be eligible for rejoinder upon allowance of independent claim 48).
Claim 26 is allowable. Claim 36, previously withdrawn from consideration as a result of a species election requirement, requires all the limitations of an allowable claim, as do the (previously withdrawn) alternative embodiments of claims 44-45. Pursuant to the procedures set forth in MPEP § 821.04(a), the species election requirement between species of methods (originally related to method claims 35-36 and 44-45) as set forth in the Office action mailed on 15 September 2023, is hereby withdrawn and dependent claim 36, as well as the further embodiments of claims 44-45, is/are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
The current status of the claims is as follows: claims 26 and 30-47 are allowed; claims 48, 50, and 57-59 are rejected; and claims 49 and 51-56 are withdrawn.
Claim Interpretation
Independent claim 48 as amended now recites a kit comprising an FIP and a BIP (as specified in the claim), “wherein the FIP or BIP is configured to anneal to a target region comprising one or more nucleotides from each of two repeat units in a tandem repeat” (see text of claim 48). While the claim is no longer indefinite, the specification teach that “configured to anneal” may refer to a “capacity to anneal or hybridize”, and/or simply be equivalent to “complementary to a target” (see paragraph 72 of the published application). It is also noted that the specification does not define “FIP” or “BIP” primers as requiring any minimum lengths (see also the interpretation of these terms set forth in the Office action mailed 06 March 2024). With regard to “primers” in general, while the specification teaches that a primer of the invention “typically contains 13 to 30 or more nucleotides” (see paragraph 73 of the published application), the specification does not define the term in such a way that it requires any particular minimum length. It is also noted that that the specification teaches that repeat units in a tandem repeat may be as short as 2 base pairs in length (see, e.g., paragraphs 128-130 of the published application), such that the target repeat sequences of the FIP and BIP of the claims may be as short as 4 nucleotides in length.
Claim Objections
Claim 59 is objected to because of the following informalities: the claim recites the abbreviation “CMOS” without first providing the complete terminology. Appropriate correction is required.
Claim Rejections - 35 USC § 112
THE FOLLOWING ARE NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 57-59 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 57 (from which claims 58-59 depend) recites the “kit of claim 50, wherein the liquid medium is contained within a reaction chamber” (with claims 58-59 reciting further limitations that pertain to the “reaction chamber”). Claim 50 itself recites “wherein the FIP and BIP” (i.e., the two required primers of the kit recited in independent claim 48) “are present in a liquid medium reaction mixture”; thus, claim 50 requires primers in a “liquid medium reaction mixture”, but contains no other reference to a “liquid medium”. The language of claim 57 thus does not make clear how the claim further limits the product of claim 50, particular with regard to the referenced “liquid medium”. It is not clear whether this is an unclear reference to the reaction mixture of claim 50, or a reference to the source of “liquid medium”, etc. Further, as the product of claim 50 requires primers present in a “liquid medium reaction mixture”, it is unclear whether claims 57-59 are actually further limiting of the product of claim 50; even to the extent that claim 57 may be intended to further limit the “reaction mixture”, requiring the mixture to be present in a specified location would not clearly further limit the product actually being claimed. Accordingly, further clarification is required.
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.
THE FOLLOWING ARE NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 57-59 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. It is reiterated that new claims 57-59 are indefinite for the reasons given above, and it is presently unclear how, and whether, the claims actually further limit claim 50, from which they depend; as such, the claims as presently written are not proper dependent claims. 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 § 102
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 rejection 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.
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 –
(a)(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claim(s) 48, 50, and 57-59 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Reeve et al (WO9947706A1 [Sept 1999]; cited herein).
Reeve et al teach compositions, including arrays, comprising all possible “N mer” oligonucleotides or subsets thereof “where N is preferably from 5 to 10, particularly 8 or 9” (see entire reference, particularly pages 4-5; quotation from page 5, lines 10-11). Reeve et al teach that their N mers may be DNA, RNA, PNA or “mimetics or mixtures thereof” (see page 5, lines 12-13), and state that the molecules may be in solution (page 4) or "immobilised at a spaced location on a surface of a support” (page 5). Reeve et al disclose the use of their reagents in sequencing by hybridization, and particularly in determining difference between target and reference sequences (see entire reference, particularly, e.g., pages 2-3). As the products of Reeve et al include all possible oligonucleotides/primers of a particular length – and thus include primers complementary to – “configured to anneal” to – any target nucleic acid over the length of the oligonucleotides/primers - the oligonucleotides taught by Reeve et al meet all the requirements of the FIP and BIP primers of the instant claims (i.e., the combinations of all possible 5mers-10mers taught by Reeve et al comprise molecules that inherently constitute complements of any target nucleic acid, including the targets as specified in the claims). Reeve et al further teach kits comprising the materials disclosed as used in their methods (including their oligonucleotide compositions)(see, e.g., claim 11), and thus anticipate the claims. With further regard to claims 50 and 57-59 (which are indefinite, and which simply require that the primers as claimed be present in a “liquid medium reaction mixture”), Reeve et al also teach kits comprising their materials present in solution, including while incubating under “hybridization conditions”, which constitutes a type of “liquid medium reaction mixture” (see, e.g., claims 1-11); thus, these claims are also anticipated by Reeve et al.
Claim Rejections - 35 USC § 101
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 48, 50, and 57-59 remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon/law of nature without significantly more. The claim(s) recite(s) “FIP” and “BIP” primers without clearly specifying any particular required structures/sequences for these primers. As fragments of naturally occurring nucleic acids may function as such primers, these claims recite products of nature that fall under the law of nature/natural phenomenon judicial exception. Nothing recited in the claims necessarily renders the primers of the claims markedly different from their naturally occurring counterparts, nor does their presence together in a kit or “liquid” reaction mixture (as in claim 50 and new claims 57-59) necessarily do so. While it is noted that independent claim 48 require a primer including a region (either F2 of FIP or B2 of BIP) that “anneals to the target region” and has “one or more mismatched nucleotides with respect to the target region”, the “target region” of the claim is merely a target region “comprising one or more nucleotides from each of two repeat units” to which either FIP or BIP ‘is configured to anneal”. Given the broad definition of “tandem repeat” (both in the specification and in the claim itself), and the breadth of the terminology “configured to anneal”, the claims continue to embrace at least some embodiments directed to fragments of naturally occurring nucleic acids. This judicial exception is not integrated into a practical application because placing a product of nature into a generic container/kit or “medium” does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim, and is nothing more than an attempt to generally link the product of nature to a particular technological environment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the packaging of oligonucleotide primers into kits (or their placement into a reaction mixture/medium for use, whether inside a kit or not) was well-understood, routine, and conventional in the art before the effective filing date of the claimed invention.
Thus, claims 48, 50, and 57-59 are not directed to patent eligible subject matter (with regard to new claims 57-59, it is also reiterated that the product being claimed does not clearly require the “reaction chamber” or cartridge, etc., as is discussed above in the rejections under 35 USC 112(b) and 35 USC 112(d)).
The Reply of 02 June 2026 traverses the prior rejection of claims under 35 USC 101 on the following grounds.
Applicant summarizes the “markedly different characteristics analysis” and urges that claims 48 and 50 “recite primers with specific structural and functional characteristics that render them markedly different from any naturally occurring nucleic acid fragments”, pointing in particular to features of the F2/B2 regions relative to a target region, and urging that the claimed primers have a “junction-spanning design” (Reply page 11 bridging to page 12). Applicant discusses benefits of “strategic placement of mismatches” that are urged as imparting a “markedly different functional characteristic” and reflecting “a fundamentally different behavior of the assay” (Reply page 12). The Reply also urges that the claimed primers “are human-designed molecular tools with specific structural modifications…that confer specific functional characteristics” (Reply page 12). The Reply also discusses additional features recited in the new dependent claims that are urged as clarifying “the marked differences between the claimed primers and naturally occurring nucleic acids” (Reply page 12 bridging to page 13).
These arguments have been thoroughly considered but are not persuasive. While the examiner agrees that some embodiments of FIP and BIP primers encompassed by the claims are markedly different than naturally occurring nucleic acids, given the breadth of the claims and the fact that the claims encompass primers lacking even a required minimum length, which primers must simply be complementary to a target including a tandem repeat as short as 4 nucleotides, the claims also embrace nucleic acids that fail the “markedly different characteristics” analysis. As stated in MPEP 2106.03(II): “A claim whose BRI covers both statutory and non-statutory embodiments embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter”; thus, properties that further limit only some embodiments of the claimed invention cannot be relied upon in the manner urged by Applicant.
With regard to Applicant’s discussion of mismatches and features of the F2/B2 regions, it is also noted that the claimed products do not require any particular target sequences or target regions, etc.; rather, the claims recite primers “configured to anneal” to a broadly recited target region comprising “one or more nucleotides from each or two repeat units in a tandem repeat” (which thus may include as few as four nucleotides). Again, while Applicant’s arguments could potentially be persuasive with regard to some preferred embodiments embraced by the claims, the breadth of the claims precludes them being persuasive with regard to the claims actually under consideration.
Regarding the alleged benefits of the primers in detection/”behavior of the assay”, the rejected claims are directed to products having the limitations specified in the claims; the claims are not drawn to a method in which those primers are required to be used (and a practitioner could choose to use the claimed product in any manner).
Regarding Applicant’s statements that the claimed primers “are human-designed molecular tools with specific structural modifications…”, it is again noted that these features do apply to some embodiments embraced by the claims, but the claims at present are not limited to primers having such features.
Finally, with regard to the newly added dependent claims, it is noted that claims 57-59 are addressed above in the rejections of those (new) claims, and are considered patent ineligible for the reasons given.
Conclusion
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 DIANA B JOHANNSEN whose telephone number is (571)272-0744. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm EST.
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, Wu-Cheng Winston Shen can be reached at (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANA B JOHANNSEN/Primary Examiner, Art Unit 1682
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