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 Amendments and Reply filed 30 June 2026. Claims 44-45, 55, and 57 have been amended and claims 58-61 have been added.
Independent claim 1 and its dependent claims 53-54 and 56 were previously allowed (see paragraph 3 of the Office action mailed 31 March 2026). Applicant has amended claim 55 (also dependent from claim 1) to correct a typographical error. Accordingly, the prior objection to that claim has been overcome by amendment, and all of claims 1 and 53-56 are now allowed.
Regarding claims 44-45 and claims dependent therefrom, Applicant’s amendments and arguments have been thoroughly reviewed and have overcome the following objections/rejections set forth in the prior Office action:
Several prior rejections of claims under 35 USC 112(b) in view of Applicant’s claim amendments (although claims 44-45 and claims dependent therefrom remain indefinite for the reasons indicated below);
The rejection of dependent claim 57 under 35 USC 102(a)(1) and 35 USC 102(a)(2) as being anticipated by Campana et al (in view of Applicant’s claim amendments); and
The rejection of dependent claim 57 under 35 USC 101 in view of Applicant’s claim amendments.
Claims 44-45 and 57-61 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 Any rejections and/or objections not reiterated in this action have been withdrawn.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.
Claim Interpretation
Regarding new dependent claims 58 and 60, each of which recites (in further limiting a product) that “each label is independently an agent that has been artificially attached via chemical manipulation”, it is noted that product-by-process claims are not limited to the manipulations of the recited steps (in this case, to artificial attachment “via chemical manipulation”) but rather only to the structure implied by the steps, with patentability being determined “based on the product itself”) (see MPEP 2113).
Claim Objections
Claims 44 and 57-59 are objected to because of the following informalities: independent claim 44 recites the limitation “the oligonucleotide primer of probe” where “the oligonucleotide primer or probe” is the intended language based on the context of the claim. Appropriate correction is required; it is noted that this language (which is indefinite for the reasons noted below) has been interpreted as reciting “the oligonucleotide primer or probe” (in the interest of compact prosecution).
Claim Rejections - 35 USC § 112(b)/second paragraph
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 44-45 and 57-61 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.
Claims 44 and 57-59 are indefinite over the recitation twice in independent claim 44 of the language “and at least one oligonucleotide primer or probe directly attached to a label, wherein the oligonucleotide primer or probe hybridizes to the MAP1LC3 transcript or cDNA thereof….and at least one oligonucleotide primer or probe directly attached to a label, wherein the oligonucleotide primer of [sic] probe hybridizes to the EHMT2 or EHMT1 transcript or cDNA thereof”. Both recitations of the language “the oligonucleotide primer or probe” are indefinite because the claims previously recite “at least one oligonucleotide primer or probe”, not a single, specific such probe that clearly constitutes “the” primer/probe (and it is thus not clear whether the further limitations apply to all of the “at least one” primer/probe, or to a particular such primer/probe, etc.). Additionally, the second usage of “the oligonucleotide primer of [sic] probe hybridizes to….” is confusing, because there are multiple potential primers/probes previously referenced in the claims (and it is not clear which of these alternatives is being referenced; it is noted that the claim previously specified an “at least one oligonucleotide primer or probe…that hybridizes to” the recited target, which was unambiguous in contrast to the present language). Accordingly, clarification is required; it is noted that Applicant may wish to consider using terms such as “first” and “second” if the intent is to require different primers/probes (similar to the terminology employed in claim 45, which references “first” and “second” oligonucleotides).
Claims 45 and 60-61 are indefinite over the language of independent claim 45, reciting a solid support “comprising, consisting, or consisting essentially of” a first primer or probe and a second primer or probe (having the features recited in the claims). While claim 45 previously referred to primers/probes “immobilized to the solid support” of the claims, references to the solid support in the body of the claim have been removed. Particularly given that the claim states that the solid support may “consist” or “consist essentially of” the recite primers/probes, it is no longer clear whether anything more than the recited probes/primers are actually required by the claims (“consisting of” in particular is closed transitional language that does not permit for inclusion of elements other than what is specified, which in this case is the first and second probe/primer). Accordingly, further clarification is required.
Claims 57-61 are each indefinite because it is unclear how the inclusion of the term “independently” in the claims further limits them. More particularly, claim 57 recites that “each label is independently selected from” a recited group; given that the claim specifies that “each label” is selected from the group, it is not clear what further limitation is added by use of the term “independently” in this context (and as the application as filed did not employ this terminology, and as it does not have an art recognized meaning when employed as used in the claim, the language is unclear). Similarly, claims 58 and 60 state that “each label is independently an agent that has been artificially attached….”, and it is not clear how this differs from the language “each label is an agent that has been…”, while claims 59 and 61 state “each label is independently other than a naturally-occurring nucleoside” (and it is not clear how this differs from a requirement for “each label” to be “other than a naturally-occurring nucleoside). Again, the specification does not employ this language (including in paragraph 62 of the disclosure, which Applicant has identified as providing basis for the new claim language; see also the new matter rejection below). Accordingly, further clarification is required.
Claim Rejections - 35 USC § 112(a)/first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 57-61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Applicant has amended claim 57, and added new claims 58-61, each of which employ the term “independently”. More particularly, claim 57 recites that “each label is independently selected from” a recited group; claims 58 and 60 state that “each label is independently an agent that has been artificially attached….”; and claims 59 and 61 state “each label is independently other than a naturally-occurring nucleoside”. While Applicant’s remarks point to paragraph 62 of the disclosure as providing basis for these amendments, claim 62 defines and describes the term “label” without any use of the term “independently”, nor does this term (or an apparently equivalent) appear elsewhere in the application in reference to labels or the manner in which they are selected, employed, etc. Accordingly, Applicant’s amendments of 30 June 2026 add new matter to the claims.
Claim Rejections - 35 USC § 102
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claim(s) 44-45 and 58-61 remain/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Campana et al (US 9,777,332 B2 [Oct. 2017; filed March 2012]; previously cited).
Campana et al disclose generating expression profiles for acute lymphoblastic leukemia (ALL) that include mRNA expression levels established using nucleic acid probes, which profiles include data for genes found to be overexpressed or underexpressed in ALL relative to healthy controls; see entire reference, particularly column 11, line 40-col 12, line 47, Tables 1-2; col 129, line 50-col 132, line 4 (it is noted that the terms “overexpressed” and “underexpressed” are defined at col 8, lines 9-28). Campana et al report that they found both MAP1LC3B and EHMT1 to be underexpressed in ALL (regarding MAP1LC3B, see Table 2 at cols 67-68, bottom half of the page; regarding EHMT1, see Table 2 at cols 103-104, top half of the page). Campana et al teach that a variety of different methods may be employed to achieve expression profiling, including methods in which probe microarrays are used to capture RNA transcripts and assess expression levels; see, e.g., col 110, line 38-col 111, line 18. Campana et al exemplify obtaining their data reported in Table 2 (as well as Table 1) by hybridizing transcripts generated from ALL samples (as well as controls) to Affymetrix HG-U133A oligonucleotide microarrays; see col 136, line 35-col 137, line 35). As such, Campana et al disclose a composition/ meeting all requirements of claims 44-45 and 58-61, and anticipate those claims. Specifically, the Affymetrix arrays taught by Campana et al include attached oligonucleotide probes that hybridize to all captured expression products (including those of MAP1LC3B and EHMT1, as evidenced by Table 2 of Campana et al), and the microarray/solid support as employed by Campana et al - with captured target nucleic acids hybridized to their corresponding probes (which probes necessarily include modifications achieving attachment to the solid support, as well as nucleic acid sequences that inherently function as “labels” embraced by the claims) - meets the requirements for a composition including such transcripts/cDNAs as recited in claim 44 (again see col 136, line 35-col 137, line 35).
Regarding the claim language “probe directly attached to a label”, it is reiterated that the amended claims are indefinite (as discussed above) and that a reasonable interpretation of the present claim language in light of the specification includes “labels” that are themselves nucleic acid fragments that hybridize to target sequences. Regarding dependent claims 58 and 60, it is reiterated that these claims (see the Claim Interpretation above) do not require actual processes, but rather structures implied by what is recited (such that the probes taught by Campana et al satisfy the requirements of the claims. Regarding claims 59 and 61, the probes of Campana et al include nucleotides/nucleic acid fragments functioning as labels (which are not precluded by the claim language). Finally, with regard to the preamble and “wherein” language of claims 44-45, it is noted that these recitations do not impart any apparent further requirements applicable to the actual structure of the products being claimed, but rather simply state an intended use for the claimed products that does not result in any structural difference in the claimed product as compared to the prior art product disclosed by Campana et al (see MPEP 2111.02 and 2111.04).
The reply of 30 June 2026 traverses the prior rejection of claims based upon Campana et al on the following grounds.
The reply briefly summarizes the claims and the manner in which the rejection relies upon Campana et al, focusing on the interpretation of the term “label” (Reply page 7). Applicant asserts that the rejection is “based on an overly broad and artificial mapping of the gene expression profiling system of Campana et al (Reply page 7 bridging to page 8), urging that the invention ‘is directed to a specific and purpose-built diagnostic composition comprising a defined set of biomarker-specific probes”, with the specification emphasizing “that invention is based on a minimal, biologically meaningful biomarker profile” (Reply page 8). Applicant urges that the term “label” as used “has a clear and specific meaning: it refers to a detectable moiety, such as a fluorophore, enzyme or chromophore, that is artificially linked to a molecule and is capable of generating a detectable signal”, urging that the Office’s interpretation of “label” is “inconsistent with this definition” (Reply page 8). Applicant also argues that “the Office’s position improperly conflates an analytical system with a composition”, while the claims are ’directed to a composition defined by its molecular constituents” (Reply page 9). Finally, Applicant argues that the rejection “appears to rely on the open-ended nature o the term ‘comprising’ to read the claim onto complex microarray systems containing many probes and targets”, and urges that the features required by the claims “are not disclosed in Campana et al in the manner required to establish anticipation” (Reply page 9).
These arguments have been thoroughly considered but are not persuasive. While the examiner does not disagree that the application discloses preferred diagnostic compositions specifically related to MAP1LC3 and EHMT2/EHMT1, Applicant’s claims are of such breadth that Campana et al anticipate the invention as claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Regarding interpretation of the term “label”, the examiner must rely on what is actually disclosed in the application itself for interpretation of the term (not on preferred embodiments referenced in Applicant’s arguments). The specification teaches a variety of types of labels (including those discussed in the Reply), but the fact remains that the specification itself states “the term ‘label’ and grammatical equivalents thereof, refer to any atom or molecule that can be used to provide a detectable and/or quantifiable signal” (paragraph 62). The discussion of labels in paragraph 62 also refers to labels that are “other than a naturally-occurring nucleoside” as corresponding to “specific embodiments”, such that it is readily apparent from Applicant’s own statements in the specification that the term is much broader than Applicant now argues. If the claims are in fact intended to be limited to the specific types of labels referenced in the Reply, the claims could be amended to require such labels (it is noted that claim 57 is no longer rejected under 35 USC 102, as that claim does recite types of labels corresponding to those referenced in Applicant’s arguments). Regarding the alleged differences between the “molecular constituents” of the claims and the composition of Campana et al, it is noted that the claims do not require anything other than the recited nucleic acids, and place no limits on their form (e.g., the claims – which embrace any products as specified therein – do not specify that the claimed materials must be present in separate tubes, packaged in a particular way, etc.). Thus, compositions formed during the practice of the methods of Campana et al that include all the components as required by the claims anticipate the claims. Again, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Regarding the term “comprising”, the examiner has interpreted the claims as encompassing compositions “comprising” the recited elements because the term “comprising” is employed by Applicant in the claims (and “comprising” is open transitional language, permitting for the inclusion of any other probes, targets, buffers, etc.). See MPEP 2111.03, which states that the term “comprising” is “synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Accordingly, this argument is also non-persuasive.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claim(s) 57 is rejected under 35 U.S.C. 103 as being unpatentable over Campana et al (US 9,777,332 B2 [Oct. 2017; filed March 2012]; previously cited), as evidenced by The Ohio State University (“OSU”) (Procedures and Recommendations for Quantitative PCR, ver. 1.2, 7 pages [April 2003]; cited herein).
Campana et al disclose generating expression profiles for acute lymphoblastic leukemia (ALL) that include mRNA expression levels established using nucleic acid probes, which profiles include data for genes found to be overexpressed or underexpressed in ALL relative to healthy controls; see entire reference, particularly column 11, line 40-col 12, line 47, Tables 1-2; col 129, line 50-col 132, line 4 (it is noted that the terms “overexpressed” and “underexpressed” are defined at col 8, lines 9-28). Campana et al report that they found both MAP1LC3B and EHMT1 to be underexpressed in ALL (regarding MAP1LC3B, see Table 2 at cols 67-68, bottom half of the page; regarding EHMT1, see Table 2 at cols 103-104, top half of the page). Campana et al teach that a variety of different methods may be employed to achieve expression profiling, including methods in which probe microarrays are used to capture RNA transcripts and assess expression levels; see, e.g., col 110, line 38-col 111, line 18. Campana et al exemplify obtaining their data reported in Table 2 (as well as Table 1) by hybridizing transcripts generated from ALL samples (as well as controls) to Affymetrix HG-U133A oligonucleotide microarrays; see col 136, line 35-col 137, line 35). As such, Campana et al disclose a composition/ meeting all requirements of claim 44, from which instant claim 57 depends. Specifically, the Affymetrix arrays taught by Campana et al include attached oligonucleotide probes that hybridize to all captured expression products (including those of MAP1LC3B and EHMT1, as evidenced by Table 2 of Campana et al), and the microarray/solid support as employed by Campana et al - with captured target nucleic acids hybridized to their corresponding probes - meets the requirements for a composition including such transcripts/cDNAs as recited in claim 44 (again see col 136, line 35-col 137, line 35).
Claim 57 is directed to the composition of claim 44, “wherein each label is independently selected from a radioisotope, fluorophore, quencher, or chromophore”; thus, the compositions discussed above fail to meet all requirements of claim 44. However, Campana et al further teach that there are alternative methods “for determining the level of marker mRNA in a sample”, such as via the use of RT-PCR, with a preferred embodiment being “quantitative fluorogenic RT-PCR (i.e., the TaqMan® System” (see “RNA Expression Profiling” at columns 129-131, particularly col 130, line 54-col 131, line 8). As evidenced by OSU, the alternative methods suggested by Campana et al employ probes having attached fluorophores and quenchers (see entire reference, particularly page 2, the section “ii) Probes”). Accordingly, Campana et al suggest alternative methods employing probes labeled in the manner required by claim 57. Further, the practice of such methods in detecting transcripts as disclosed by Campana et al (i.e., substituting quantitative fluorogenic RT-PCR/TaqMan for the microarray methodology exemplified by Campana et al) would necessarily result (during the process of amplification and detection) in compositions meeting all requirements of the present claims. In view of Campana et al’s own teachings (as evidenced by OSU), it would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have prepared a composition meeting the requirements of claim 57. Such a composition results from substituting the noted alternative technique of Campana et al for the exemplified methodology of Campana et al, which is a modification suggested by Campana et al’s own teachings (as noted above), and which an ordinary artisan would also have recognized as the simple substitution of one prior art method for determining mRNA levels for another to achieve a predictable result. (It is also reiterated that the language of claim 44 is indefinite, and that the specific requirements of the probes/primers being claimed are unclear for that reason).
Claim Rejections - 35 USC § 101
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 44-45 and 58-61 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.
Independent claim 44 as amended recites a composition including two types of nucleic acid transcripts/cDNAs and either one or two probes/primers “directly attached to a label”, while independent claim 45 recites a solid support comprising/consisting of/consisting essentially of two types of primers/probes, each of which is “directly attached to a label”. The nucleic acids of these claims are broadly recited, and encompass portions/fragments of naturally occurring nucleic acids present together in a composition or on a support. While it is noted that each of claims 44 and 45 includes language stating that the primers/probes as claimed are “directed attached to a label”, this encompasses - based on a literal interpretation of the claim language and the broad definition of “label” in the specification, which states “the term ‘label’ and grammatical equivalents thereof, refer to any atom or molecule that can be used to provide a detectable and/or quantifiable signal” (paragraph 62) - a “label” that is simply a further nucleotide/nucleotide sequence; thus, the claims continue to embrace oligonucleotides that are nothing more than fragments of naturally occurring nucleic acids. Again, it is reiterated that the specification defines the term “label” as referring to “any atom or molecule that can be used to provide a detectable and/or quantifiable signal” (paragraph 62 at page 16); the specification further teaches that a label or marker may be “any radioactive, fluorescent, biological or enzymatic tags or labels of standard use in the art” (paragraph 109 at page 28). Thus, the present claim language, based on the guidance provided in Applicant’s disclosure, does not preclude the use of naturally occurring nucleotides that function as a “label”. Accordingly, these nucleic acid materials as claimed are not markedly different from their naturally occurring counterparts, nor does their presence together render them markedly different from a product of nature.
With further regard to claims 44 and 58-59, nothing beyond nucleic acids themselves is required by independent claim 44, such that nothing providing integration into a practical application, or potentially adding something “significantly more” than a judicial exception, is required. New dependent claim 58 as written states that “each label is independently an agent that has been artificially attached via chemical manipulation”; however, the claim is to a product (not a process in which, e.g., chemical manipulation is actually performed), and nucleic acids that are structurally identical to naturally occurring nucleic acids may be produced by the process recited in the claim (see also the Claim Interpretation above). Thus, there is no requirement for anything “markedly different” than a naturally occurring nucleic acid, as well as nothing amounting to a practical application, or something “significantly more”, than a JE. Regarding claim 59, while this claim precludes use of “a naturally occurring nucleoside” as an attached label, the claim language does not exclude nucleotides, nucleic acid fragments, etc. (such that the analysis that applies to claim 44 also applies to this claim; it is also noted that the recitation in the specification [see again paragraph 62] of a label that “is other than a naturally-occurring nucleoside” supports the position that the claims embrace naturally occurring nucleotides/nucleic acid fragments functioning as labels). While it is noted that these claims also encompass alternative embodiments requiring different types of labels that would render the claimed molecules markedly different from their naturally occurring counterparts (such as, e.g., an attached fluorophore or radioisotope, etc.), when the broadest reasonable interpretation of a claim encompasses both statutory and nonstatutory embodiments, the claim is directed to nonstatutory subject matter (see MPEP 2106.03(II)).
Regarding claims 45 and 60-61, while the preamble of claim 45 refers to a “solid support”, the claim as presently written states that the “solid support” may comprise/consist/consist essentially of the first and second recited primer/probe (i.e., the claim as written appears to embrace at least some embodiments in which no solid support per se is required, and language related to probes/primers being “immobilized to the solid support” have been removed from the claim). Thus, claim 45 as amended does not clearly require any alteration of the oligonucleotides that would render them “markedly different” (it is noted that the language “attached to a label” is not sufficient to allow for interpretation of the claim as not embracing nucleotides that function as a label, again given the definition and teachings regarding “labels” provided in the specification). Even to the extent that the claims may require “immobilized” probes, the term immobilized/immobilization encompasses, e.g., the fixing of probes to a support “by electrostatic forces, hydrophobic or hydrophilic interactions or Van-der-Waals forces” (see paragraph 62). This amounts to providing the probes on any type of generic support in a manner in which they are not necessarily permanently attached/fixed, with the support constituting a nominal or token extra solution component that is nothing more than an attempt to generally link a product of nature to a particular technological environment. Further, the claims do not require anything clearly corresponding to a practical application, or adding anything “significantly more”, than a product of nature (again, the analysis of the limitation “directly attached to a label” discussed above with respect to claim 44 also applies to claim 45). Regarding dependent claim 60, the claim as written states that “each label is independently an agent that has been artificially attached via chemical manipulation”; however, the claim is to a product (not a process in which, e.g., chemical manipulation is actually performed), and nucleic acids that are structurally identical to naturally occurring nucleic acids may be produced by the process recited in the claim (see also the Claim Interpretation above). Thus, there is no requirement for anything “markedly different” than a naturally occurring nucleic acid, as well as nothing amounting to a practical application, or something “significantly more”, than a JE. Regarding claim 61, while this claim precludes use of “a naturally occurring nucleoside” as an attached label, the claim language does not exclude nucleotides, nucleic acid fragments, etc. (such that the analysis that applies to claim 45 also applies to this claim; it is also noted that the recitation in the specification [see again paragraph 62] of a label that “is other than a naturally-occurring nucleoside” supports the position that the claims embrace naturally occurring nucleotides/nucleic acid fragments functioning as labels). While it is noted that these claims also encompass alternative embodiments requiring different types of labels that would render the claimed molecules markedly different from their naturally occurring counterparts (such as, e.g., an attached fluorophore or radioisotope, etc.), when the broadest reasonable interpretation of a claim encompasses both statutory and nonstatutory embodiments, the claim is directed to nonstatutory subject matter (see MPEP 2106.03(II)).
Accordingly, claims 44-45 and 58-61 are not directed to patent eligible subject matter.
The reply of 30 June 2026 traverses the prior rejection of claims under 35 USC
101 on the grounds that the claims do not encompass labels that are further nucleotide sequences, and that this would be recognized by a person of ordinary skill in the art (Reply page 10). Applicant further states that the “specification consistently describes labels as detectable moieties, including radioisotopes, fluorophores, quenchers, and chromophores, which are used to generate a measurable signal” (referring to paragraph 62 of the specification), and proper claim construction precludes interpreting the claims as embracing naturally occurring nucleic acid sequences (Reply page 10 bridging to page 11).
These arguments have been thoroughly considered but are not persuasive because – as discussed in the above rejection – the examiner’s interpretation of the claims relies on Applicant’s own definition of “label” (provided in paragraph 62). The claims certainly do embrace preferred labels such as fluorophores, radioisotopes, etc. (and it is noted that claim 57, which requires such label types, has not been included in the rejection of claims under 35 USC 101); however, given that the application clearly states that a label may be “any atom or molecule that can be used to provide a detectable and/or quantifiable signal”, the claims (other than claim 57) are clearly not limited to the preferred label types referenced in Applicant’s arguments. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is also noted that the statement in paragraph 62 that “In specific embodiments, the label is other than a naturally-occurring nucleoside” makes clear that there are embodiments of the claims that encompass the use of naturally occurring nucleic acids/nucleotides/nucleosides, etc., as labels. Thus, the claims when interpreted in light of the specification cannot reasonably be interpreted as being limited in the manner urged by Applicant.
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.
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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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