DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on July 20, 2026 has been entered. The claims pending in this application are claims 1, 2, 4, 16, 19, 22, 24, 53-56, 59, 64, 65, 69, 71, 84, 85, 95-97, and 142 wherein claims 53, 95-97, and 142 have been withdrawn due to the restriction requirement mailed on May 23, 2025. The objections and rejections not reiterated from the previous office action is hereby withdrawn in view of applicant’s amendment filed on July 20, 2026. Claims 1, 2, 4, 16, 19, 22, 24, 54-56, 59, 64, 65, 69, 71, 84, and 85 will be examined.
Drawings
New Figures 8A, 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 13A, 13B, 14A, 14B, 15A, 15B, 16A, 16B, 17A, 17B, 18A, 18B, 19A, 19B, 20A, and 20B filed on July 20, 2026 have been accepted and entered by the office.
Claim Rejections - 35 USC § 112
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.
Scope of Enablement
Claims 1, 2, 4, 16, 19, 22, 24, 54-56, 59, 64, 65, 69, 71, 84, and 85 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for performing steps (a) to (c) of claim 1, does not reasonably provide enablement for detecting or quantifying a sense and an antisense strand of an oligonucleotide duplex in a sample using the methods recited in claims 1, 2, 4, 16, 19, 22, 24, 54-56, 59, 64, 65, 69, 71, 84, and 85.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The Nature of The Invention
The claims are drawn to a method of detecting or quantifying a sense and an antisense strand of an oligonucleotide duplex in a sample. The invention is a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The Breadth of The Claims
Claims 1, 2, 4, 16, 19, 22, 24, 54-56, 59, 64, 65, 69, 71, 84, and 85 encompass a method of detecting or quantifying a sense and an antisense strand of an oligonucleotide duplex in a sample, the method comprising: (a) contacting the sample with a composition comprising a set of probes, wherein the set of probes comprises: (i) a sense probe comprising a first single stranded oligonucleotide tag that is complementary to at least a portion of a first capture oligonucleotide immobilized on a support surface, a sense binding portion capable of hybridizing to a nucleotide sequence of the sense strand of the oligonucleotide duplex, and a first label; and (ii) an antisense probe comprising a second single stranded oligonucleotide tag that is complementary to at least a portion of a second capture oligonucleotide immobilized on the support surface, an antisense binding portion capable of hybridizing to a nucleotide sequence of the antisense strand of the oligonucleotide duplex, and a second label, wherein the length of the sense binding portion of the sense probe is shorter than the length of the sense strand, and wherein the length of the antisense binding portion of the antisense strand is shorter than the length of the antisense strand; and (b) incubating the probes with the sample to form a hybridization mixture comprising hybridization complexes comprising: (i) a sense complex comprising the sense probe hybridized with the sense strand of the oligonucleotide duplex; and (ii) an antisense complex comprising the antisense probe hybridized with the antisense strand of the oligonucleotide duplex; and (c) contacting the support surface with the hybridization mixture in which the first and second oligonucleotide tags of the sense and antisense probes hybridize to the first and second capture oligonucleotides immobilized on the support surface and contacting the hybridization complexes in the hybridization mixture with a single-strand specific nuclease; and (d) detecting or quantifying the sense and antisense strands of the oligonucleotide duplex based on the presence of the first label and the second label on the support surface.
Working Examples
The specification provides 18 examples (see pages 26-38 of US 2023/0141860 A1, which is US publication of this instant case). However, the specification provides no working example for detecting or quantifying a sense and an antisense strand of an oligonucleotide duplex in a sample using the methods recited in claims 1, 2, 4, 16, 19, 22, 24, 54-56, 59, 64, 65, 69, 71, 84, and 85.
The Amount of Direction or Guidance Provided and The State of The Prior Art
The specification provides 18 examples (see pages 26-38 of US 2023/0141860 A1, which is US publication of this instant case). However, the specification provides no working example for detecting or quantifying a sense and an antisense strand of an oligonucleotide duplex in a sample using the methods recited in claims 1, 2, 4, 16, 19, 22, 24, 54-56, 59, 64, 65, 69, 71, 84, and 85. Furthermore, there is no experimental condition and/or experimental data in the specification to support the claimed invention. During the process of the prior art search, the office has not found a prior art related to detect or quantify a sense and an antisense strand of an oligonucleotide duplex in a sample using the methods recited in claims 1, 2, 4, 16, 19, 22, 24, 54-56, 59, 64, 65, 69, 71, 84, and 85.
Level of Skill in The Art, The Unpredictability of The Art, and The Quantity of Experimentation Necessary
While the relative skill in the art is very high (the Ph.D. degree with laboratory experience), there is no predictability whether a sense and an antisense strand of an oligonucleotide duplex in a sample can be detected or quantified using the methods recited in claims 1, 2, 4, 16, 19, 22, 24, 54-56, 59, 64, 65, 69, 71, 84, and 85.
Although claim 1 requires that a sense probe comprises a first label and an antisense probe comprises a second label, since claim 1 does not indicate that the first label and the second label are different labels which can generate different signals and it is known that different fluorescent dyes are excited in different wavelengths and produce different fluorescent signals (see pages 5 and 6 of “Fluorophore” from Wikipedia), if the first label and the second label are an identical label such as an identical fluorescent dye which produces an identical fluorescent signal, it is unpredictable how the signals from the first label and the second label on the support surface can be differentiated from each other such that the sense strand and the antisense strand of the oligonucleotide duplex in the sample cannot be differentiated only based on the presence of the first label and the second label on the support surface. Furthermore, since claim 1 does not require that the sense probe and the antisense probe can hybridize to 100% sense strand and 100% antisense strand of the oligonucleotide duplex, if the sense probe and the antisense probe do not have enough amounts and only hybridize to portions of the sense strand and the antisense strand of the oligonucleotide duplex such as 70% of the sense strand and 70% the antisense strand of the oligonucleotide duplex in the sample, some portions of the sense strand and the antisense strand of the oligonucleotide duplex such as 30% of the sense strand and 30% the antisense strand of the oligonucleotide duplex in the sample do not hybridize to the sense probe and the antisense probe such that some portions of the sense strand and the antisense strand of the oligonucleotide duplex such as 30% of the sense strand and 30% the antisense strand of the oligonucleotide duplex in the sample cannot be quantified and it is unpredictable how the sense strand and the antisense strands of the oligonucleotide duplex in the sample can be quantified only based on the presence of the first label and the second probe on the support surface. In addition, Tables 8 and 10 in pages 75 and 76 of the specification teach that, when the concentrations of a sensor probe and an antisense probe of an oligonucleotide duplex is 0.610 pg/ml, after the sensor probe and the antisense probe hybridize to the oligonucleotide duplex, ECL signals of the hybridized sensor probe and the hybridized antisense probe are less than the background signal of a negative control sample and these results clearly indicate that a limit of detection of the method recited in claim 1 is more than 0.610 pg/ml such that it is unpredictable how the method recited in claim 1 can have a limit of detection of less than about 0.16 pg/ml as recited in claim 84.
Case law has established that “(t)o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright 990 F.2d 1557, 1561. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) it was determined that “[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art”. The amount of guidance needed to enable the invention is related to the amount of knowledge in the art as well as the predictability in the art. Furthermore, the Court in Genentech Inc. v Novo Nordisk 42 USPQ2d 1001 held that “[I]t is the specification, not the knowledge of one skilled in the art that must supply the novel aspects of the invention in order to constitute adequate enablement”.
In view of above discussions, the skilled artisan will have no way to predict the experimental results. Accordingly, it is concluded that undue experimentation is required to make the invention as it is claimed. The undue experimentation at least includes to test whether a sense and an antisense strand of an oligonucleotide duplex in a sample can be detected or quantified using the methods recited in claims 1, 2, 4, 16, 19, 22, 24, 54-56, 59, 64, 65, 69, 71, 84, and 85.
Conclusion
In the instant case, as discussed above, the level of unpredictability in the art is high, the specification provides one with no guidance that leads one to claimed methods. One of skill in the art cannot readily anticipate the effect of a change within the subject matter to which the claimed invention pertains. Thus given the broad claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the large quantity of research required to define these unpredictable variables, the lack of guidance provided in the specification, the absence of any working example related to claimed invention and the no teaching in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation for one of skill in the art to perform the method of the claim as broadly written.
Response to Arguments
In page 13, last paragraph bridging to page 16, first paragraph of applicant’s remarks, applicant argues that “(i) The Office alleges that the specification provides eighteen examples but provides no working example for detecting or quantifying a sense and an antisense strand of an oligonucleotide duplex in a sample using the methods recited in the claims. OA, p. 8. The standard for determining whether the specification meets the enablement requirement is whether the experimentation needed to practice the invention is undue or unreasonable. MPEP § 2164.01. The test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures coupled with information known in the art without undue experimentation. Id. Applicant respectfully disagrees with the Office that the application does not have a working example of detecting a sense and antisense strand of oligonucleotide duplex in a sample using the claimed methods. Example 1 in the specification describes the detection of sense oligonucleotides as well as the detection of antisense oligonucleotides (ASO), using a label, e.g., SULFO-TAGᵀM streptavidin, wherein the plate was washed, a read buffer was added, and the plates were read using an imager for detection and quantification. See Application as filed, p. 71, para. 4. The method of Example 1 uses the recited method steps for detecting or quantifying the sense and antisense strands of the oligonucleotide duplex in the sample using electrochemiluminescence (ECL) with a MSD SULFO-TAG label. Thus, the present specification properly describes ‘how to make and how to use the invention’, including for detecting or quantifying a sense and an antisense strand of an oligonucleotide duplex in a sample using the methods recited in the claims without undue experimentation and therefore enables the invention. (ii) The Office alleges that although claim 1 requires that a sense probe comprises a first label and an antisense probe comprises a second label, claim 1 does not indicate whether the first label and the second label are different labels which can generate different signals. OA, p. 9. The Office further argues that if the first label and the second label are an identical label, it is not evident how the first label and the second label on the support surface can be differentiated from each other. Id. Applicant submits that the claim is not required to recite whether the first and second label are the same or different to identify different analytes and/or strands because the specification enables the claimed invention without this requirement”, and in view of “[A]pplication as filed, p. 54, para. 3 (emphasis added).The specification therefore enables a person of ordinary skill in the art to distinguish between the detection of the sense and antisense strand at least by the position and precise location of each binding domain on the surface. This is illustrated, e.g., in FIG. 4. Whether the first and second label are the same or different has no bearing on the ability of a person of ordinary skill in the art to make and use the claimed methods at the time of the invention. Thus, the present specification properly describes ‘how to make and how to use the invention’ without undue experimentation and therefore enables the invention, in view of the disclosure in the specification. (iii) The Office alleges that since claim 1 does not require that the sense probe and the anti- sense probe hybridize to all of the sense strand and the antisense strand of the oligonucleotide duplex, if the sense probe and the antisense probe only hybridize to a portion of the sense strand and the antisense strand of the oligonucleotide duplex such as 70% of the sense strand and the antisense strand of the oligonucleotide duplex, it is unclear how the sense strand and the antisense strands of the oligonucleotide duplex in the sample can be quantified based on the presence of the label on the support surface. OA, p. 9.
It is not required that the sense probe and the anti-sense probe hybridize to all of the sense strand and the antisense strand of the oligonucleotide duplex to carry out the claimed method. The Examples in the application disclose the hybridization of shortened probes (e.g., 10-mer, 11-mer, 12-mer, 13-mer, and 14-mer) alongside full-length probes (16-mer) to the antisense and/or sense
strand, with measurable ECL signal detection. See, e. g., FIG. 7-10, and 17-20 and Tables in Examples 1-18. The Office has not provided a clear reason why the sense probe and the anti-sense probe need to hybridize to all of the sense strand and the antisense strand of the oligonucleotide duplex for quantification or detection. The present specification properly describes and enables the invention to quantify the sense strand and the antisense strands of the oligonucleotide duplex in the sample based on the presence of the label on the support surface without undue experimentation”.
The above arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection.
First, although applicant argues that “[E]xample 1 in the specification describes the detection of sense oligonucleotides as well as the detection of antisense oligonucleotides (ASO), using a label, e.g., SULFO-TAGᵀM streptavidin, wherein the plate was washed, a read buffer was added, and the plates were read using an imager for detection and quantification. See Application as filed, p. 71, para. 4. The method of Example 1 uses the recited method steps for detecting or quantifying the sense and antisense strands of the oligonucleotide duplex in the sample using electrochemiluminescence (ECL) with a MSD SULFO-TAG label. Thus, the present specification properly describes ‘how to make and how to use the invention’, including for detecting or quantifying a sense and an antisense strand of an oligonucleotide duplex in a sample using the methods recited in the claims without undue experimentation and therefore enables the invention”, since claim 1 does not indicate that the first label and the second label are different labels which can generate different signals and it is known that different fluorescent dyes are excited in different wavelengths and produce different fluorescent signals (see pages 5 and 6 of “Fluorophore” from Wikipedia), if the first label and the second label are an identical label such as an identical fluorescent dye which produces an identical fluorescent signal, it is unpredictable how the signals from the first label and the second label on the support surface can be differentiated from each other such that the sense strand and the antisense strand of the oligonucleotide duplex in the sample cannot be differentiated only based on the presence of the first label and the second label on the support surface.
Second, although applicant argues that in view of “[A]pplication as filed, p. 54, para. 3 (emphasis added).The specification therefore enables a person of ordinary skill in the art to distinguish between the detection of the sense and antisense strand at least by the position and precise location of each binding domain on the surface. This is illustrated, e.g., in FIG. 4. Whether the first and second label are the same or different has no bearing on the ability of a person of ordinary skill in the art to make and use the claimed methods at the time of the invention. Thus, the present specification properly describes ‘how to make and how to use the invention’ without undue experimentation and therefore enables the invention, in view of the disclosure in the specification”, claim 1 does not require to “distinguish between the detection of the sense and antisense strand at least by the position and precise location of each binding domain on the surface” as argued by applicant. 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).
Third, although applicant argues that “[I]t is not required that the sense probe and the anti-sense probe hybridize to all of the sense strand and the antisense strand of the oligonucleotide duplex to carry out the claimed method. The Examples in the application disclose the hybridization of shortened probes (e.g., 10-mer, 11-mer, 12-mer, 13-mer, and 14-mer) alongside full-length probes (16-mer) to the antisense and/or sense strand, with measurable ECL signal detection. See, e. g., FIG. 7-10, and 17-20 and Tables in Examples 1-18. The Office has not provided a clear reason why the sense probe and the anti-sense probe need to hybridize to all of the sense strand and the antisense strand of the oligonucleotide duplex for quantification or detection. The present specification properly describes and enables the invention to quantify the sense strand and the antisense strands of the oligonucleotide duplex in the sample based on the presence of the label on the support surface without undue experimentation”, since claim 1 does not require that the sense probe and the antisense probe can hybridize to 100% sense strand and 100% antisense strand of the oligonucleotide duplex, if the sense probe and the antisense probe do not have enough amounts and only hybridize to portions of the sense strand and the antisense strand of the oligonucleotide duplex such as 70% of the sense strand and 70% the antisense strand of the oligonucleotide duplex in the sample, some portions of the sense strand and the antisense strand of the oligonucleotide duplex such as 30% of the sense strand and 30% the antisense strand of the oligonucleotide duplex in the sample do not hybridize to the sense probe and the antisense probe such that some portions of the sense strand and the antisense strand of the oligonucleotide duplex such as 30% of the sense strand and 30% the antisense strand of the oligonucleotide duplex in the sample cannot be quantified and it is unpredictable how the sense strand and the antisense strands of the oligonucleotide duplex in the sample can be quantified only based on the presence of the first label and the second probe on the support surface.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 84 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 84 is rejected as vague and indefinite because the phrase “a limit of detection
of less than about 200 pg/mL to about 0.16 pg/mL” does not make sense since it is unclear that a limit of detection is less than about 200 pg/mL or less than about 0.16 pg/mL. Furthermore, it is unclear that about 200 pg/mL or about 0.16 pg/mL is a concentration of what. Please clarify.
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, 2, 4, 16, 19, 54, and 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/035,358 (reference application). Although the conflicting claims are not identical, they are not patentably distinct from each other because the examined claims in this instant application are either anticipated by, or would have been obvious over, the reference claims. See 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); and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). Although claims 1, 2, 4, 16, 19, 54, and 71 in this instant application are not identical to claims 1-20 of copending Application No. 19/035,358, since the content of copending Application No. 19/035,358 teaches that “[I]n one aspect, the single-strand specific
nuclease includes a single-strand specific RNase”, “[I]n one aspect, (a)-(c) are performed concurrently. In one aspect, (a)-(c) are performed sequentially” and “[I]n one aspect, the sample is a biological sample obtained or derived from a source of interest. In one aspect, a sample is an organism or is obtained from an organism. In one aspect, a sample is a plant or is obtained from a plant. In one aspect, the sample is an animal or is obtained from an animal. In one aspect, the sample is obtained from a mammal. In one aspect, the sample is obtained from a human. In one aspect, the source of interest includes a bioreactor. In one aspect, the sample is a manufacturing process sample. In one aspect, the sample is an environmental sample” (see paragraphs [0039], [0040], and [0230] of US 2025/0243529 A1, which is US Publication of case 19/035,358), claims 1-20 of copending Application No. 19/035,358 are directed to the same subject matter and fall entirely within the scope of claims 1, 2, 4, 16, 19, 54, and 71 in this instant application. In other words, claims 1, 2, 4, 16, 19, 54, and 71 in this instant application are anticipated by claims 1-20 of copending Application No. 19/035,358.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In page 17, fifth to seventh paragraphs of applicant’s remarks, applicant argues that “[U]S Application No. 19/035,358 has a patent term filing date of January 23, 2025, which is later than the patent term filing date of the instant application, September 8, 2022. The Office is respectfully reminded of the following: (i) Application under examination has the earlier patent term filing date If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent. See MPEP 804 (emphasis added). Applicant respectfully submits that the nonstatutory double patenting rejections over US Application No. 19/035,358 should be withdrawn”.
The above arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection because the provisional nonstatutory double patenting rejection is not only rejection remaining in this instant application (for other rejections, see above rejections under 35 U.S.C 112 (a) and (b)).
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.
No claim is allowed.
Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993)(See 37 CAR § 1.6(d)). The CM Fax Center number is (571)273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph.D., whose telephone number is (571)272-0746. The examiner can normally be reached on Monday-Friday from 9 A.M. to 5 P.M.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Dr. Anne Gussow, Ph.D., can be reached on (571)272-6047.
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/FRANK W LU/Primary Examiner, Art Unit 1683
September 24, 2026
