DETAILED ACTION
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 .
Status of the Claims
It is acknowledged that the Applicant amended claims 1, 3, 5, 6, 9-12, 14, 15, 18, and 20 and cancelled claim 17 in their response.
Claims 1-3, 5-15, 18 and 20-23 are currently pending. Claims 14-15, 18, and 20-23 were withdrawn as drawn to an unelected invention in the previous action.
Claims 1-3 and 5-13 have herein been examined.
Summary of Response to Applicant’s Arguments
This action is in response to the papers filed July 24, 2026. Applicant’s remarks and amendments have been fully and carefully considered but are not found to be persuasive. Detailed responses are documented on pages 7-8, 13, and 16-17 of this office action. Any new grounds of rejection presented in this Office Action are necessitated by Applicant’s amendments. Any rejections or objections not reiterated herein have been withdrawn. This action is made FINAL.
As a result of amendments to the claims, objection to claim 11 has been withdrawn. The rejection of claim 5 under 35 U.S.C. 112(b) has similarly been withdrawn. However, claim amendments have necessitated a new rejection under 35 U.S.C. 112(b), which is set forth below.
As a result of amendments to the claims, rejections under 35 U.S.C. 101, 35 U.S.C. 103, and double patenting rejections have been modified, as set forth below.
As claim 1 has not been found allowable, Applicant’s request to rejoin the withdrawn claims is denied.
Priority
Applicant’s claim to the benefit of provisional application 63/411,973 is acknowledged, and the effective filing date of the instant application is considered to be 9/30/22.
Claim Rejections - 35 USC § 112
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.
Claims 1-3 and 5-13 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 1-3 and 5-13 are rejected for the recitation of “wherein amplifying the nucleic acid template generates inorganic pyrophosphate (PPi) with each successive NTP incorporation event” in claim 1 because it is unclear how the wherein clause is intended to limit the claims. The claims are directed to a composition, and compositions are analyzed with respect to their structure. However, the clause is limiting the intended use of the composition (i.e. amplifying nucleic acid templates) and not its structure. As a result, one of skill in the art would not be able to determine the metes and bounds of the claimed subject matter. If the limitation is intended to require that a particular element is present in the composition, the claims must be amended to reflect that meaning.
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.
Claims 1-3 and 5-13 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.
Claim 1 recites “the first plurality of amplification primers being orthogonal to the second plurality of amplification primers.” In this case, the specification as originally filed provides for first and second pluralities of amplification primers, including a specific embodiment of P5 and P7 lawn primers (par. 48-49, 53, 64 of PGPub). The amplification primers “may be specific for a particular target nucleic acid that it is desired to amplify, but in other embodiments these sequences may be ‘universal’ primer sequences which enable amplification of any target nucleic acid… which has been modified to enable amplification with the universal primers” (par. 49). Thus, the original disclosure supports a first and second plurality of amplification primers which are configured to amplify or hybridize to different targets. However, the specification does not support ‘orthogonal’ primers, i.e. primers engineered to be entirely non-interacting with other primers so as to bind only to their precise target sequence.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 5-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims have been evaluated using the 2019 Revised Patent Subject Matter Eligibility Guidance (see Federal Register Vol. 84, No. 4, Monday, January 7, 2019).
Step 1: The claims are directed to the statutory category of a composition.
Step 2A, prong one: Evaluate Whether the Claim Recites a Judicial Exception
The claims are drawn to a composition comprising the naturally occurring enzymes and biomolecules including amplification primers, nucleic acid template, NTPs, polymerase, and inorganic pyrophosphatase. Claim 3 additionally requires at least one of a recombinase, a single-stranded nucleotide binding protein, an ATP-generating substrate, and an ATP-generating enzyme (all encompassing natural products). Claim 5 restricts the polymerase to DNA Polymerase I. Claims 9 and 10 require either a thermophilic or mesophilic inorganic pyrophosphatase. Claims 11 requires metal cofactors and claim 12 requires magnesium ions.
The markedly different characteristics analysis has been used to determine if the nature-based products are a judicial exception. The nature-based products have been compared to their natural counterparts.
The claims broadly encompass naturally occurring enzymes and biomolecules and there is no indication that the natural products – inorganic pyrophosphatase, NTPs, polymerase, nucleic acid templates, amplification primers, single-stranded nucleotide binding protein, recombinase, or magnesium ions – of the instant claims have any characteristics that are different from the naturally occurring enzymes or biomolecules. There is no difference in function, structure, or other properties from the recited generic enzymes and biomolecules and those found in nature.
It is noted that the natural products are recited as being in a “composition.” There is no indication that these elements being present in the composition changes their function, structure, or other properties. Claims 11 and 12 are directed toward the composition in the form of a “kit.” The natural products do not interact with other elements of the composition in the “kit.” There is no indication that their presence in a “kit” changes their structure, function, or other properties. Because the claimed natural products do not have markedly different characteristics, they are a product of nature exception.
It is noted that the natural products are recited as being in a composition alongside non-natural products such as a solid substrate coupled to pluralities of amplification primers which are orthogonal to one another and hybridize to the nucleic acid template. There is no indication that these elements being present in the composition changes the function, structure, or other properties of the natural products. It is noted that in claim 13, the natural products are recited as lacking primers having a length between 18 to 22 base pairs. There is no indication that the lack of these elements changes the function, structure, or other properties of the natural products. It is noted that the natural products are recited as being in a “composition.” There is no indication that the natural products being present in the composition changes the function, structure, or other properties of the natural products. Because the claimed natural products do not have markedly different characteristics, they are a product of nature exception.
Step 2A, prong two: Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application
In addition to the natural products, the claims recite “a solid substrate having first and second pluralities of amplification primers coupled thereto, the first plurality of amplification primers being orthogonal to the second plurality of amplification primers” and that the nucleic acid template is “bound to the solid substrate through hybridization to an amplification primer of the first plurality of amplification primers.” These limitations are insufficient to make the claims eligible, as they do not alter the characteristics of the natural products and merely limit the nature-based products to a particular technological environment.
In addition to the natural products, the claims recite intended uses and other functional language. As product claims are analyzed relative to their structure, these limitations do not limit the scope of the claims. These limitations do not practically integrate the judicial exceptions and are the equivalent of adding the words “apply it” to the judicial exceptions.
In addition to the natural products, Claim 6 recites the additional element of a lack of PEG and claim 13 recites the lack of primers having a length between 18 to 22 base pairs. The absence of these elements does not provide integration. These limitations fail to meaningfully limit the claims and is the equivalent of adding the words “apply it” to the judicial exception.
In addition to the natural products, claim 7 recites the additional element of a buffer. This element does not practically integrate the judicial exceptions and is the equivalent of adding the words “apply it” to the judicial exception.
In addition to the natural products, Claims 11 and 12 recite the additional element of a “kit.” A “kit” broadly encompasses a collection of reagents. It fails to meaningfully limit the claims and is the equivalent of adding the words “apply it” to the judicial exception.
Step 2B: Evaluate Whether the Claim Provides and Inventive Concept
In addition to the natural products, the claims recite “a solid substrate having first and second pluralities of amplification primers coupled thereto, the first plurality of amplification primers being orthogonal to the second plurality of amplification primers” and that the nucleic acid template is “bound to the solid substrate through hybridization to an amplification primer of the first plurality of amplification primers.” At the time the invention was made, these elements were well-known, routine, and conventional in the art. Thus, the claims as whole do not amount to significantly more than each “product of nature” by itself, and the claims do not qualify as eligible subject matter.
In addition to the natural products, the claims recite intended uses and other functional language. As product claims are analyzed relative to their structure, these limitations do not limit the scope of the claims. Thus, the claims as whole do not amount to significantly more than each “product of nature” by itself, and the claims do not qualify as eligible subject matter.
In addition to the natural products, Claim 6 recites the additional element of a lack of PEG and claim 13 recites the lack of primers having a length between 18 to 22 base pairs. In addition to the natural products, claim 7 recites the additional element of a buffer. In addition to the natural products, Claims 11 and 12 recite the additional element of a “kit.” A “kit” broadly encompasses a collection of reagents. At the time the invention was made, enzyme compositions lacking PEG and/or primers having lengths between 18-22 base pairs, buffers in enzymes compositions, and including enzyme compositions in kits were all well-established, routine, and conventional. Thus, the claims as whole do not amount to significantly more than each “product of nature” by itself, and the claims do not qualify as eligible subject matter.
Response to Arguments
In the response filed July 24, 2026, Applicant stated that the amendments to claim 1 recite an arrangement of elements that is made by man and not found in nature and clarify the inventive function of the polyphosphate and polyphosphate kinase in such an arrangement. Applicant argued that the amended claim is therefore directed to patentable subject matter.
This argument has been considered but is not found to be persuasive. As explicated in the modified rejection above, the inclusion of non-natural elements in the composition and intended use language does not change the characteristics of the natural product and does not provide sufficient integration into a practical application or an inventive concept such that the claims qualify as eligible subject matter. See the modified rejection above for further discussion.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-3, 5-8, and 10-13 are rejected under 35 U.S.C. 103 as unpatentable over Tabor et al. (published Jul 28, 2005; Patent Application Publication No. US2005/0164213) in view of Gunderson (published May 24, 2018; Patent Application Publication US 20180141020).
Regarding claims 1 and 8, Tabor teaches compositions comprising nucleic acid templates bound to a solid substrate (par. 37), a polymerase (Abstract, par. 35), a plurality of NTPs (par. 26), and an inorganic pyrophosphatase (par. 23, 83).
Although the instant claims are directed to a “clustering” composition, as noted in MPEP 2111.02, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the
purpose or intended use of the invention, rather than any distinct definition of any of the claimed
invention’s limitations, then the preamble is not considered a limitation and is of no significance
to claim construction.” Accordingly, the claim language of “clustering” merely sets forth the intended use of the claimed composition, but does not limit the scope of the claims. Similarly, although Tabor does not explicitly teach that the composition is a ”resynthesis” composition, this limitation is an intended use of the composition. Since compositions are analyzed with respect to their structure, intended uses do not limit the scope of the claims.
Regarding claim 1, Tabor does not explicitly teach that the composition comprises a solid substrate having first and second pluralities of amplification primers coupled thereto, the first plurality of amplification primers being orthogonal to the second plurality of amplification primers; or a nucleic acid template bound to the solid substrate through hybridization to an amplification primer of the first plurality of amplification primers.
Gunderson teaches compositions which comprise a solid substrate having first and second pluralities of amplification primers coupled thereto, the first plurality of amplification primers being orthogonal to the second plurality of amplification primers; and a nucleic acid template bound to the solid substrate through hybridization to an amplification primer of the first plurality of amplification primers (par. 38, 41, 67, 77; Figure 2).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of Gunderson and Tavanti. One would have been motivated to do so in order to prevent or reduce seeding and amplification from non-target polynucleotides (par. 179). One would have had reasonable expectation of success because Gunderson demonstrates that appropriate solid substrate compositions may be formulated and support nucleic acid amplification (par. 238; Figure 10).
Regarding claim 1, the combined references do not explicitly teach that the inorganic pyrophosphatase is present to increase clustering kinetics, inhibit polymerase stalling, improve clustering of structured genomic regions, and increase sequencing signal intensity by substantially removing inorganic pyrophosphate, nor that the polymerase is present to amplify the nucleic acid template using the NTPs and the first plurality of amplification primers. The combined references do not teach that amplifying the nucleic acid template generates inorganic pyrophosphate with each successive NTP incorporation event. However, compositions are analyzed with respect to their structure. Therefore, these limitations represent intended uses which do not limit the scope of the claims.
Nevertheless, note that Gunderson teaches that polymerases possess the property of amplifying nucleic acid templates using primers (Gunderson: par. 184) and Tabor teaches that inorganic pyrophosphate accumulates as a product of DNA synthesis reactions and that inorganic pyrophosphatase can prevent inhibition of DNA synthesis by reducing inorganic pyrophosphate (par. 56).
Regarding claim 2, Tabor teaches adding 20ng of inorganic pyrophosphatase to a 50µL reaction (par. 83). With a molar mass of approximately 71 kDa for the enzyme in Saccharomyces cerevisiae, the concentration of the inorganic pyrophosphatase is approximately 0.006 µM. Claim 2 broadly encompasses this value, given the recitation of “about.” Therefore, the limitation is considered to have been met.
Regarding claim 3, Tabor teaches compositions additionally comprising: single-stranded nucleotide binding protein (par. 35, 51), and an ATP-generating substrate and enzyme (par. 57-58, 79).
Regarding claim 5, Tabor does not teach that the polymerase is DNA Polymerase I. Instead, Tabor teaches DNA polymerases generally with a preferred embodiment of T7 DNA polymerase.
Gunderson teaches DNA Polymerase I is one of many DNA polymerases (par. 145).
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to substitute a generic polymerase or T7 with DNA Polymerase I because Gunderson demonstrates that the two are functional equivalents (par. 145). One would have had reasonable expectation of success because Tabor demonstrates that factors such as which accessory proteins should be used with a particular DNA polymerase are well-known (par. 44-45).
Regarding claim 6, Tabor teaches a composition which does not comprise PEG (Examples 1, 2). Here, Tabor is silent regarding use of polyethylene glycol in the composition and uses a different macromolecular crowding agent in the form of dextran. Therefore, the limitation is considered to have been met.
Regarding claim 7, Tabor teaches that the composition comprises a buffer, and that the composition is buffered to a pH of 7.5 (par. 69). As pH 7.5 lies within the claimed range of 7.0 to 8.5, the limitation is considered to have been met.
Regarding claim 10, Tabor teaches a composition comprising a mesophilic inorganic pyrophosphatase (par. 83).
Regarding claims 11 and 12, Tabor teaches kits comprising inorganic pyrophosphatase (par. 35). Tabor also teaches inorganic pyrophosphatase compositions comprising a metal cofactor composition, wherein the metal cofactor composition comprises magnesium ions (par. 63). Although Tabor does not explicitly teach that the metal cofactor composition is used with a kit, the term “kit” broadly encompasses a collection of reagents. Therefore, the limitation of “kit” is considered to be anticipated.
Regarding claim 13, Tabor teaches that the composition does not comprise primers having a length between 18 to 22 base pairs (par. 50, Abstract).
Claims 2 and 9 are rejected under 35 U.S.C. 103 as unpatentable over Tabor et al. (published Jul 28, 2005; Patent Application Publication No. US2005/0164213) in view of Gunderson (published May 24, 2018; Patent Application Publication US 20180141020), as applied to claim 1 above, and further in view of Park et al. (published Oct 31, 2009; Park et al. Appl Microbiol Biotechnol. 2010 Jan;85(3):807-12).
Tabor and Gunderson teach the limitations of claim 1, as discussed above.
Regarding claim 2, Tabor teaches a concentration of inorganic pyrophosphatase of 0.006 µM. Given the language of “about 0.01 µM to about 1000 µM,” this teaching can be interpreted to meet the limitations of claim 2. However, because Tabor does not explicitly teach a concentration which lies precisely between 0.01 µM and 1000 µM, and in the interests of compact prosecution, the limitation is also addressed in view of Park.
Regarding claim 9, Tabor doesn’t teach a thermophilic inorganic pyrophosphatase.
Park teaches a thermophilic inorganic pyrophosphatase (pg. 807, col. 2). Park teaches adding the inorganic pyrophosphatase to a composition at a concentration of 0.2 µM (pg. 808, col. 2, par. 2). This concentration lies within the range of 0.01 µM and 1000 µM, and therefore meets the limitation of claim 2.
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of Tabor and Gunderson with the teachings of Park. One would have been motivated to do, in order to utilize a thermostable enzyme in a biotechnological application (pg. 807, col. 2), such as in produce a higher yield in PCR (pg. 811, col. 2). One would have had reasonable expectation of success because Park successfully utilized the thermostable enzyme in nucleic acid amplification (Fig. 3).
Response to Arguments
In the response filed July 24, 2026, Applicant argued that Tabor does not disclose, teach, or suggest the arrangement of elements recited in amended claim 1, and that Tabor is silent regarding the uses of an inorganic pyrophosphatase to provide the recited improvements to clustering on a solid substrate. Applicant argued that none of the combined references (Piepenburg or Park) correct these deficiencies.
These arguments have been fully and carefully considered. However, as a result of amendments to the claims, rejections were modified and rely on a different combination of references which teach all the limitations of the amended claims. Please see the rejections above.
Double Patenting
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.
Claims 1-3 and 5-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of co-pending Application No. 18/475,939, in view of Tabor et al. (published Jul 28, 2005; Patent Application Publication No. US2005/0164213).
Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims are drawn to compositions (ref claims 1-19). Both sets of claims require:
a solid substrate having first and second pluralities of amplification primers coupled thereto, the first plurality of amplification primers being orthogonal to the second plurality of amplification primers (claim 1)
a nucleic acid template bound to the solid substrate through hybridization to an amplification primer of the first plurality of amplification primers (claim 1)
Amplification compositions (ref claims 1-17), resynthesis, or clustering compositions (ref claim 17)
ATP-generating substrate and ATP-generating enzyme (ref claims 1-21)
Recombinase, single-stranded binding protein, polymerase, and NTPs (ref claims 1-4)
that the polymerase is present to amplify the nucleic acid template using the NTPs and the first plurality of amplification primers (claim 1)
The absence of PEG (ref claim 14)
The reference application does not explicitly require inorganic pyrophosphatase. However, it would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to add an inorganic pyrophosphatase to the composition in order to reduce inhibition of DNA synthesis due to pyrophosphate accumulation (Tabor: par. 56).
The combined references do not explicitly state that the inorganic pyrophosphatase is present to increase clustering kinetics, inhibit polymerase stalling, improve clustering of structured genomic regions, and increase sequencing signal intensity by substantially removing inorganic pyrophosphate or that amplifying the nucleic acid template generates inorganic pyrophosphate. However, compositions are analyzed with respect to their structure. Therefore, these limitations do not limit the scope of the claims.
This is a provisional nonstatutory double-patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In the response filed July 24, 2026, Applicant asserted that the reference application and Tabor do not disclose, teach, or suggest the arrangement of elements recited in amended claim 1, and that they are silent as to uses of an inorganic pyrophosphatase to provide the recited improvements on a solid substrate. Applicant requested that the rejections therefore be withdrawn or held in abeyance.
These arguments have been fully considered and not found to be persuasive. The amended elements of the instant application are either present in the amended claims of the reference application (e.g. solid substrate) or Tabor (e.g. inorganic pyrophosphatase), or are intended use or functional language which does not limit the scope of the composition/product claims. Please see the modified rejection above.
Regarding the request to hold the claims in abeyance, the request has been fully considered. MPEP 804(I)(B)(1) states that “[a] complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers)... As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance.”
Because Applicant did not file a terminal disclaimer or show that the claims subject to the rejection are patentably distinct from the reference application’s claims, the rejections are maintained.
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.
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/C.M.J./Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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