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 .
Response to Amendment
The amendment filed January 23rd, 2026 is acknowledged. Regarding the Office Action mailed October 24th, 2025:
The rejection set forth under 35 U.S.C. 112(b) is withdrawn in view of the amendments.
The rejection of claims 1, 2, 5, and 10 set forth under 35 U.S.C. 102 is withdrawn in view of the cancellation of these claims.
The rejection of claims 3 and 4 set forth under 35 U.S.C. 103 is withdrawn in view of the cancellation of these claims.
Maintained or modified rejections are set forth below, as necessitated by the amendments. Responses to arguments, if necessary, follow their respective rejection sections.
Claim Summary
Claims 6-7, 13, and 14 have been amended. Claims 1-5, 10, 12, and 15-16 have been canceled. Claims 6-9, 11, and 13-14 are pending. Claims 6-9, 11, and 13-14 are under examination and discussed in this Office action.
Claim Rejections - 35 USC § 112(a) – Modified – Necessitated by Amendment
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 6-9, 11, and 13-14 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.
In making a determination of whether the application complies with the written description requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is claiming and what Applicant has possession of.
Claims 6, 7, 13, and 14 all recite variations on a method of screening a subject for a cancer selected from a breast, pancreatic, liposarcoma, or colorectal cancer and treating the subject for the cancer comprising: extracting cfDNA from a sample from the subject, determining lengths of cfDNA in the sample, comparing to a reference, and treating the subject with a breast, pancreatic, liposarcoma, or colorectal anti-cancer treatment selected from radiotherapy, chemotherapy, and/or immunotherapy when the levels in the sample differ from the reference. These limitations are broadly addressed to screening for breast, pancreatic, liposarcoma, or colorectal cancer and treating with an unspecified radiotherapy, chemotherapy, and/or immunotherapy treatment. Therefore, these limitations are understood to mean that the method can be used to screen for breast, pancreatic, liposarcoma, or colorectal cancer, and then treat with an unspecified radiotherapy, chemotherapy, and/or immunotherapy based on the level of cfDNA fragments of a particular size. However, how to apply this method to breast, pancreatic, liposarcoma, or colorectal cancer and treating with unspecified radiotherapy, chemotherapy, and/or immunotherapy is not further defined or described in the claims.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). See MPEP § 2163.
Regarding claims 6, 7, 13, and 14, the specification does not clearly describe or define screening for a cancer selected from a breast, pancreatic, liposarcoma, or colorectal cancer based on the level of cfDNA fragments of a particular size, and then treating with a breast, pancreatic, liposarcoma, or colorectal anti-cancer treatment selected from radiotherapy, chemotherapy, and/or immunotherapy based on the level of cfDNA fragments of a particular size. The specification does clearly define many methods for screening for a cancer and concluding that a subject suffers from cancer using variations on the general method as described above. A representative example of these methods can be found on pages 10-29 of the instant specification. However, in terms of then treating based on this screening, there is a minimal amount of description. Therapeutic applications are generally discussed (starting page 35); however, it is stated that the screening methods are “suitable for determining whether a subject is eligible or not to an anti-cancer treatment” (Page 35). This is equivalent to saying that because a subject has cancer, they should be treated for it, not necessarily that a treatment is actively administered. Furthermore, it is generally understood that treatments are tailored to the type of cancer that a subject may have. This is exemplified in Chabner (Cancer Chemotherapy, Immunotherapy and Biotherapy Principles and Practice, 6th edition, 2006, Chapter 1, 20-39; previously cited), where Table 1.2 gives various examples of treatment options for cancer, all specifically tailored to the type and location of the cancer. While it may be claimed that anti-cancer therapy for breast, pancreatic, liposarcoma, or colorectal cancer is selected from radiotherapy, chemotherapy, and/or immunotherapy, there is a distinct lack of description of treatments tailored to each of these cancers. As stated above, therapeutic methods are generally discussed (starting Page 35), and while there are treatments that could reasonably be considered as specific immunotherapies for breast (see Page 40) and colorectal (see Page 40, 41) cancer, there are no specific chemotherapies or radiotherapies directed to breast and colorectal cancer, and no specific treatments of any kind directed to pancreatic cancer and liposarcoma.
While the method screens for a cancer selected from a breast, pancreatic, liposarcoma, or colorectal cancer based on levels of cfDNA fragments, there is no description of if there are differences in cfDNA fragment lengths that may then provide information on the type of cancer. The art indicates that more information is necessary to associate fragments with a particular tissue, which may then be related to a particular cancer. Cristiano (Genome-wide cell-free DNA fragmentation in patients with cancer, Nature, May 2019, 385-389 plus extended data; cited on the IDS filed February 1st, 2022; previously cited) teaches that, when examining whole genome sequencing data of cfDNA fragments, the median overall length of fragments from cancer patients is smaller than that of healthy individuals (Page 386, column 2, paragraph 2). However, this is just a median, with Cristiano also teaching that fragment size can increase and decrease depending on the examined region in the genome (Page 387, column 1, paragraph 2). Cristiano teaches that it is examination of the changes in cfDNA fragmentation profiles that allows for determination of the tissue of origin, not measuring a level of a specific length of fragment, which can then be related to a specific type of cancer (Page 388). This analysis is improved through the addition of mutation detection (Page 388, column 2, paragraph 2). In the instant disclosure, the Applicant has at most provided description for a specific cancer in that they developed their screening method using cfDNA size profiles of patients known to have colorectal cancer (see examples starting page 52). This was then applied to the other claimed cancers (see page 62, where breast cancer, liposarcoma, and pancreatic cancer are introduced), but using the same size profile that the Applicant has generally associated with cancer. These examples do not provide specificities on being able to determine a specific cancer from those claimed, only generally screening for cancer based on the described cfDNA size profile. Furthermore, the examples do not provide a description for then treating cancer patients using this size profile. Therefore, it is unpredictable to match the claimed levels of particular cfDNA fragment lengths to all the claimed cancers, and further a treatment selected from chemotherapy, radiotherapy, and/or immunotherapy without specificity for the claimed cancers.
Overall, there is a lack of description connecting the screening method and treating the subject as a result of this screening, and therefore there is a lack of support for the methods of claims 6, 7, 13, and 14 as a whole. Claims and 8-9 and 11, which depend from claims 6 and 7, lack written description since they do not further describe the identified issue.
Response to Arguments
Applicant's arguments filed January 23rd, 2026 have been fully considered but they are not persuasive.
The Applicant first summarizes the amendments and support for the amendments to claims 6-7 and 13-14 such that the claims no longer encompass the screening and treatment of any type of cancer (Page 7 of the Remarks filed January 23rd, 2026). The Applicant then argues that there is support for the active step of treating, and provides examples and citations from the instant specification (Pages 7-8 of the Remarks filed January 23rd, 2026). The Applicant finally states that the treatment has been limited to treating the specific cancer types being screened (Page 8 of the Remarks filed January 23rd, 2026).
In response to these arguments, the Examiner would like to note that even with the amendment to specific cancer types, there still appears to be a lack of support for active treatment, and particularly for treatments related to the specific cancers claimed (pancreatic cancer and liposarcoma most particularly). It is still noted that “determining whether a subject is eligible or not to an anti-cancer treatment” (Page 35) does not convey treatment is actively being applied, nor does “the physician can take the choice to administer the subject with a chemotherapeutic agent/radiotherapeutic agent/immunotherapeutic agent” (Pages 35, 38, 42). Furthermore, while the specification does name many treatments for cancer, with a few immunotherapies that may be considered specific for breast and colorectal cancer, there are no descriptions directed toward specific chemotherapies or radiotherapies for breast and colorectal cancer, and no specific treatments at all for liposarcoma and pancreatic cancer. Furthermore, the Applicant has failed to address the rejection as it pertains to how cfDNA fragment length can be used to differentiate types of cancer, as it currently appears to be claimed. While the claims have been amended to specific types of cancer that the Applicant has Examples directed towards, there is no indication of specificities on being able to determine a specific cancer from those claimed, only generally screening for cancer based on the described cfDNA size profile. There is also no description for then treating cancer patients using this size profile. For these reasons, the Applicant’s arguments are not considered persuasive and the rejection under 35 U.S.C 112(a) is maintained.
Claim Rejections - 35 USC § 101 – Modified – Necessitated by Amendment
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 6-9, 11 and 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon and abstract ideas without significantly more. While the claims are directed to processes, and therefore meet step 1 of the subject matter eligibility test (see MPEP 2106.03), the claims recite the natural correlation between levels of cell free DNA (cfDNA) fragments and cancer, and the mental processes of determining a level and comparing levels. The correlation is a natural phenomenon because it describes a consequence of natural processes in the human body, and the mental processes are abstract ideas because they can reasonably be performed in the human mind.
While the Applicant has amended the claims to recite “wherein the subject is treated with a breast, pancreatic, liposarcoma, or colorectal anti-cancer therapy selected from radiotherapy, chemotherapy, and/or immunotherapy”, this is claimed with enough generality as to not satisfy an integration into a practical application. Furthermore, as currently claimed, there is an option where the subject is not treated, meaning that the treatment cannot serve as a practical application for this option and still constitutes an issue under 35 U.S.C. 101. The rejection is as follows:
Step 2A of the subject matter eligibility test requires a two-pronged analysis. Prong One asks: does the claim recite an abstract idea, law of nature or natural phenomenon? As discussed in MPEP 2106.04(II)(A)(1), the meaning of “recites” is “set forth” or “describes”. That is, a claim recites a judicial exception when the judicial exception is “set forth” or “described” in the claim. In the instant case, the claims describe a natural phenomenon and abstract ideas: natural correlation between levels of cell free DNA (cfDNA) fragments and cancer, and the mental processes of determining a level and comparing levels.
Prong Two of the analysis under step 2A asks: does the claim recite additional elements that integrate the judicial exception into a practical application of the judicial exception? As discussed in MPEP 2106.04(II)(A)(2), “Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B.” The considerations to be used are set forth at MPEP 2106.05(a) through (c) and (e) through (h). Turning to those sections of the MPEP:
MPEP 2106.05(a) has to do with improvements to the functioning of a computer or to any other technology or technical field. The claims at issue do not improve the functioning of a computer or other technology. While the instant claims recite steps of screening for a cancer selected from breast, pancreatic, liposarcoma, or colorectal by extracting cell free DNA (cfDNA) from a sample obtained from a subject, wherein the sample is serum or plasma, dividing the sample into samples s1 and s2, determining the level of the dsDNA having a specific length, denaturing s2 into single stranded DNA (ssDNA) and determining the level of ssDNA having a specific length, determining a ratio between the dsDNA and ssDNA levels, comparing the ratio to a reference obtained from healthy subjects, and treating for cancer based on the comparison, wherein the subject is treated with a breast, pancreatic, liposarcoma, or colorectal anti-cancer treatment selected from radiotherapy, chemotherapy, and/or immunotherapy; and implementing a similar dsDNA and ssDNA method that compares the levels by plotting a cumulative size frequency, determining a gain and a loss of fragments, comparing the gain and loss to a reference obtained from healthy subjects, and treating for cancer based on the comparison, wherein the subject is treated with a breast, pancreatic, liposarcoma, or colorectal anti-cancer treatment selected from radiotherapy, chemotherapy, and/or immunotherapy, the claims do not improve upon cfDNA extraction techniques, techniques to determine levels of DNA fragments, or comparison techniques. The claims merely use existing methods for these steps. Note that MPEP 2106.05(a) indicates that “[u]sing well-known standard laboratory techniques to detect enzyme levels in a bodily sample” is an example that the courts have indicated may not be sufficient to show an improvement to technology.
MPEP 2106.05(b) has to do with whether the claims involve the use of a particular machine. In this case, the claims do not involve the use of a particular machine. While the instant claims recite steps of screening for a cancer selected from breast, pancreatic, liposarcoma, or colorectal by extracting cell free DNA (cfDNA) from a sample obtained from a subject, wherein the sample is serum or plasma, dividing the sample into samples s1 and s2, determining the level of the dsDNA having a specific length, denaturing s2 into single stranded DNA (ssDNA) and determining the level of ssDNA having a specific length, determining a ratio between the dsDNA and ssDNA levels, comparing the ratio to a reference obtained from healthy subjects, and treating for cancer based on the comparison, wherein the subject is treated with a breast, pancreatic, liposarcoma, or colorectal anti-cancer treatment selected from radiotherapy, chemotherapy, and/or immunotherapy; and implementing a similar dsDNA and ssDNA method that compares the levels by plotting a cumulative size frequency, determining a gain and a loss of fragments, comparing the gain and loss to a reference obtained from healthy subjects, and treating for cancer based on the comparison, wherein the subject is treated with a breast, pancreatic, liposarcoma, or colorectal anti-cancer treatment selected from radiotherapy, chemotherapy, and/or immunotherapy, no such machines are required by the claim, and certainly no particular machines. Even if some conventional machine were recited in the claims, like a DNA sequencer, further considerations such as the particularity or generality of the recited machine must be taken into account, as well as whether the involvement of the machine is merely extra-solution activity. MPEP 2106.05(g) describes “extra-solution activity”, noting that “[d]etermining the level of a biomarker in blood” is an example of “mere data gathering” which the courts have found to be insignificant extra-solution activity.
MPEP 2106.05(c) has to do with whether the claims involve a particular transformation. Here, none of the limitations of the claims involve a particular transformation. For example, the extraction of cfDNA does not transform that cfDNA into something else. Similarly, determining a level of the cfDNA does not transform the cfDNA into something else.
MPEP 2106.05(e) has to do with “other meaningful limitations”. The additional limitations imposed upon the natural correlation between levels of cell free DNA (cfDNA) fragments and cancer, and the mental processes of determining a level and comparing levels in the instant case have to do with screening for a cancer selected from breast, pancreatic, liposarcoma, or colorectal by extracting cell free DNA (cfDNA) from a sample obtained from a subject, wherein the sample is serum or plasma, dividing the sample into samples s1 and s2, determining the level of the dsDNA having a specific length, denaturing s2 into single stranded DNA (ssDNA) and determining the level of ssDNA having a specific length, determining a ratio between the dsDNA and ssDNA levels, comparing the ratio to a reference obtained from healthy subjects, and treating for cancer based on the comparison, wherein the subject is treated with a breast, pancreatic, liposarcoma, or colorectal anti-cancer treatment selected from radiotherapy, chemotherapy, and/or immunotherapy; and implementing a similar dsDNA and ssDNA method that compares the levels by plotting a cumulative size frequency, determining a gain and a loss of fragments, comparing the gain and loss to a reference obtained from healthy subjects, and treating for cancer based on the comparison, wherein the subject is treated with a breast, pancreatic, liposarcoma, or colorectal anti-cancer treatment selected from radiotherapy, chemotherapy, and/or immunotherapy. These limitations are not considered “meaningful limitations”. MPEP 2106.05(e) states: “The phrase "meaningful limitations" has been used by the courts even before Alice and Mayo in various contexts to describe additional elements that provide an inventive concept to the claim as a whole.” In addition, as has been discussed, they represent insignificant extra-solution activity, i.e. “data gathering”.
MPEP 2106.05(f) raises the question as to whether the additional elements recited in the claim represent “mere instructions to apply an exception”. Here, the judicial exceptions are the natural correlation between levels of cell free DNA (cfDNA) fragments and cancer, and the mental processes of determining a level and comparing levels. The additional elements recited in the claims (i.e. screening for a cancer selected from breast, pancreatic, liposarcoma, or colorectal by extracting cell free DNA (cfDNA) from a sample obtained from a subject, wherein the sample is serum or plasma, dividing the sample into samples s1 and s2, determining the level of the dsDNA having a specific length, denaturing s2 into single stranded DNA (ssDNA) and determining the level of ssDNA having a specific length, determining a ratio between the dsDNA and ssDNA levels, comparing the ratio to a reference obtained from healthy subjects, and treating for cancer based on the comparison, wherein the subject is treated with a breast, pancreatic, liposarcoma, or colorectal anti-cancer treatment selected from radiotherapy, chemotherapy, and/or immunotherapy; and implementing a similar dsDNA and ssDNA method that compares the levels by plotting a cumulative size frequency, determining a gain and a loss of fragments, comparing the gain and loss to a reference obtained from healthy subjects, and treating for cancer based on the comparison, wherein the subject is treated with a breast, pancreatic, liposarcoma, or colorectal anti-cancer treatment selected from radiotherapy, chemotherapy, and/or immunotherapy) does amount to mere instructions to apply the correlation, since the collection of particular biological samples from particular subjects, extracting cfDNA from those samples and determining levels of cfDNA serve as mere conventional steps taken for the purpose of gathering data about the cfDNA levels in a subject, which any practical use of the natural correlation would require.
MPEP 2106.05(g) has to do with whether the additional elements of the claim amount to insignificant extra-solution activity. MPEP 2106.05(g) notes that “[d]etermining the level of a biomarker in blood” is an example of “mere data gathering” which the courts have found to be insignificant extra - solution activity. Likewise, MPEP 2106.05(g) notes that “[p]erforming clinical tests on individuals to obtain input for an equation” also represents insignificant extra-solution activity. This aligns closely with the instant claims, where the additional elements of the claims amount to gathering samples, extracting cfDNA from those samples, and determining levels of cfDNA those samples.
MPEP 2106.05(h) has to do with whether the additional elements amount to more than generally linking the use of a judicial exception to a particular technological environment or field of use. Here, the present invention relates to a method for screening a subject for a cancer by determining the level of double stranded DNA fragments in a sample, which is considered a “field of use”. However, as MPEP 2106.05(h) indicates, such limiting to a particular “field of use” does not confer patentability on otherwise ineligible subject matter.
In addition, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions (as set forth in step 2B of the subject matter eligibility test; see MPEP 2106-III) because it was known in the prior art to ascertain cfDNA levels of particular sizes from a subject’s sample, compare the level to that of a reference, and treat using this information. Thierry (US9580755B2; previously cited) teaches a method for screening a subject for a cancer and treating the subject for the cancer (Page 31, column 6, lines 3-19) comprising the steps of: i. extracting the cell free nucleic acids (cfDNA) from a sample obtained from the subject (Page 37, column 17, lines 45-55); ii. determining, within the cfDNA, the level of at least one double stranded DNA fragment having a length from 40 to 250 bp (Page 37, column 17, lines 45-55); iii. comparing the level determined at step ii) with a predetermined reference value (Page 37, column 17, lines 45-55) and; iv. treating the subject for the cancer when the level determined at step iii) differs from the predetermined reference value (Page 31, column 6, lines 47-67 and Page 32, column 7, lines 1-11).
Having considered the factors discussed in MPEP 2106.05 (a)-(c) and (e)-(h), as well as the prior art of Thierry, it is clear that the additional elements recited in the claims, whether considered individually or as a combination, do not integrate the judicial exceptions into a practical application of those exceptions in such a way as to provide meaningful limits on the use of the judicial exceptions. Therefore, claims 6-9, 11, and 13-14 are rejected here under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed January 23rd, 2026 have been fully considered but they are not persuasive.
The Applicant first reiterates the amendment wherein the subject is treated with a breast, pancreatic, liposarcoma, or colorectal anti-cancer therapy selected from radiotherapy, chemotherapy, and/or immunotherapy (Page 8 of the Remarks filed January 23rd, 2026). The Applicant then cites various examples from the June 7th, 2018 Memorandum related to related to Vanda Pharmaceuticals v. West-Ward Pharmaceuticals directed to methods of treatment and their use as practical applications (Pages 8-9 of the Remarks filed January 23rd, 2026). The Applicant further cites an additional example of a patent eligible method of treatment released in October of 2019 directed towards treating NAS-3 (Page 9 of the Remarks filed January 23rd, 2026). The Applicant argues that the present claims are method of treatment claims that are not directed to a judicial exception given their similarity to the presented examples (Page 9 of the Remarks filed January 23rd, 2026).
In response to these arguments, it is noted that while the Applicant now claims radiotherapy, chemotherapy, and/or immunotherapy as anti-cancer therapy for breast, pancreatic, liposarcoma, or colorectal cancer, this is still claimed with generality such that it does not integrate the judicial exceptions into a practical application. There are no treatments identified that align with the method provided, they are only claimed generally as a treatment when a subject has a different ratio of cfDNA fragments as compared to a healthy subject. Furthermore, there is an option for the subject to not be treated if the ratio is not different as currently claimed, meaning this option is not integrated into a practical application as there is no applicable treatment step. Given these considerations, the Applicant’s arguments are not persuasive and the rejection under 35 U.S.C. 101 is modified as necessitated by amendment and maintained.
Conclusion
All claims are rejected.
THIS ACTION IS MADE FINAL. 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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/ALLISON E SCHLOOP/ Examiner, Art Unit 1683
/ANNE M. GUSSOW/ Supervisory Patent Examiner, Art Unit 1683