DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on August 20, 2025 has been entered. The claims pending in this application are claims 1-4 and 7-10. The objections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on August 20, 2025. Claims 1-4 and 7-10 will be examined.
Claim Objections
Claim 1 is objected to because of the following informalities: “an algal toxin synthesis gene, microcystin synthestase A (mcyA), and a gas vesicle synthesis gene, gas vesicle protein C (gvpC)” step (2) should be “a gene for microcystin synthestase A (mcyA) and a gene for gas vesicle protein C (gvpC)” in view of original filed claim 1.
Appropriate correction is required.
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
This rejection has been modified from the rejection under 35 U.S.C. 112(a) mailed on May 20, 2025.
Claims 1-4 and 7-10 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 collecting water samples from different locations of a lake, does not reasonably provide enablement for defining the stages of development of a cyanobacterial bloom in any kind of lake using the methods recited in claims 1-4 and 7-10. 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 for defining the stages of development of a cyanobacterial bloom in a lake. 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 1-4 and 7-10 encompass a method for defining the stages of development of a cyanobacterial bloom in any kind of lake, wherein the method comprises dividing the development of a cyanobacterial bloom into five stages: a cyanobacteria wintering period, are a resuscitation period, a rapid growth period, an outbreak period and a cyanobacteria decline period; and the steps are as follows: step (1): collect mixed water samples of water columns, collect overlying water samples, and collect bottom lake sediment samples from different locations of the lake, wherein the each of the different locations each location of the lake is a monitoring point, wherein each of the mixed water samples of water columns is a water sample formed by mixing a water sample from the upper layer of the lake, a water sample from the middle layer of the lake and a water sample from the lower layer of the lake from the same location; determine the concentrations/contents of algocyan and chlorophyll a in the mixed water samples of the water columns, the overlying water samples and the bottom lake sediment samples respectively; calculate the concentration/content ratios of algocyan/chlorophyll a in the mixed water samples of water columns, the overlying water sample and the bottom lake sediment sample respectively; and define the time as a cyanobacteria wintering period when the concentration/content ratios of algocyan/chlorophyll a in the sediment samples, the overlying water samples and the mixed water samples of water columns from each of the different locations of the lake are all less than 1; step (2): during the cyanobacteria wintering period, collect surface sediment samples from the different locations of the lake, extract RNA from the surface sediment samples and determine the relative RNA expression levels of a phycocyanin synthesis gene, phycocyanin intergenic spacers (PC-IGS), a gene for microcystin synthestase A, and a gene for gas vesicle protein C (gvpC); and define that the cyanobacteria enter a resuscitation period when the relative RNA expression levels of the genes satisfy relative expression level of PC- IGS>3, relative expression level of mcyA>0.03 and relative expression level of gvpC>0.004 at the same time; step (3): during the cyanobacterial resuscitation period, collect the mixed water samples of water columns from the different locations of the lake, extract RNA from the cyanobacteria in the mixed water samples of water columns and determine the relative RNA expression level of the ftsZ gene; isolate microcystis from the cyanobacteria in the mixed water samples of water columns, indoor culture the microcystis, establish a regression equation of microcystis growth rate y and the relative RNA expression level of the ftsZ gene, determine a rapid growth period of microcystis, obtain the relative RNA expression level of the ftsZ gene at a moment as a threshold of a cyanobacteria rapid growth period window, and define that the cyanobacteria enter a lake cyanobacteria rapid growth period if the relative RNA expression level of the ftsZ gene is greater than this threshold, wherein when the value of the relative expression of the ftsZ gene > 0.5, the cyanobacterium are determined to have entered the rapid growth period; step (4): during the cyanobacteria rapid growth period, monitor the wind speed of each of monitoring points in the lake, wherein each of the monitoring points is one location of the lake, use 3.1m/s as a threshold for defining an outbreak period and define the time as a cyanobacteria decline period when the wind speed is less than 3.1m/s; and step (5): during the cyanobacteria rapid growth period, collect the mixed water samples of the water columns column from each of different monitoring points point, determine the relative RNA expression level of the nbIA gene and the ratio of glucose to neutral polysaccharides, and define that the cyanobacteria enter a decline period when the relative RNA expression level of the nbiA gene reaches 2.4 and the ratio of dissolved glucose to neutral polysaccharides in the lake is greater than 30%.
Working Examples
The specification does not provide any working example for defining the stages of development of a cyanobacterial bloom in in any kind of lake using the methods recited in claims 1-4 and 7-10.
The Amount of Direction or Guidance Provided and The State of The Prior Art
The specification provides no guidance for defining the stages of development of a cyanobacterial bloom in in any kind of lake using the methods recited in claims 1-4 and 7-10. During the process of the prior art search, the examiner has not found any prior art which is related to define the stages of development of a cyanobacterial bloom using the methods recited in claims 1-4 and 7-10.
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 the stages of development of a cyanobacterial bloom in any kind of lake can be defined using the methods recited in claims 1-4 and 7-10.
Although the specification teaches that “the relative expression level of the gene is expressed with 2−ΔΔCt. The calculation formula of ΔΔCt is as follows:
ΔΔCt= (Cttarget gene-Ct16S rRNA)field−(Cttarget gene−Ct16S rRNA) control” (see paragraph [0052] of US 2021/0348211 A1, which is US publication of this instant case), since step (2) of claim 1 does not indicate that relative RNA expression levels of PC-IGS, mcyA, and gvpC are relative to which RNA, step (3) of claim 1 does not indicate that relative RNA expression level of ftsZ is relative to which RNA, and step (4) of claim 1 does not indicate that relative RNA expression level of nblA is relative to which RNA, it is unpredictable how the cyanobacteria enter a resuscitation period can be defined in step (2) of claim 1, how the cyanobacteria enter a lake cyanobacteria rapid growth period can be defined in step (3) of claim 1, and how the cyanobacteria enter a decline period can be defined in step (5) of claim 1. Furthermore, since the specification teaches that “[F]inally, linear regression is performed on the growth rate μ of each sample and the relative expression level of corresponding ftsZ gene to obtain a regression equation of the growth rate of microcystis and the relative expression level of the ftsZ gene Y=0.059+0.093X (as shown in FIG. 8)”, “[A]ccording to the regression equation of the growth rate μ of microcystis and the relative expression level of the ftsZ gene, the in situ growth rate of microcystis at the sampling points in different lake areas of the Taihu Lake is obtained”, and “[F]rom the change law of in situ growth rate of microcystis from March to May in different lake areas of the Taihu Lake (FIG. 9), it can be seen that the growth rate of microcystis begins to increase from early April till May and then the growth begins to decline, so it is believed that the growth in the microcystis rapid growth period is about 0.13 d-1. This value is used as a threshold for cyanobacteria rapid growth period, and the cyanobacteria rapid growth period is judged to be early April to the first ten days of May. According to FIG. 8, it can be obtained that the relative expression level of the ftsZ gene now is 0.5. This value is used as a threshold for cyanobacteria rapid growth period” (see paragraph [0067] to [0069] and Figure 8 of US 2021/0348211A1, which is US publication of this instant case), the growth rate in the microcystis rapid growth period appears to be a growth rate in an early stage of a linear regression curve (see Figure 8). Since step (3) of claim 1 does not indicate what is a threshold of a cyanobacteria rapid growth period window, it is unpredictable how the cyanobacteria can be determined to have entered a lake cyanobacteria rapid growth period when the value of the relative expression of the ftsZ gene > 0.5 as recited in step (3) of claim 1. In addition, the specification teaches that “[S]amples are collected at the sampling points from the end of autumn to the beginning of spring, generally from November to March each year according to the meteorological conditions”, “[T]he planktonic algae communities in the water body of the Taihu Lake will undergo succession each year, diatoms are dominant in winter and green algae are dominant in spring, so the concentration ratio of algocyan/chlorophyll in the entire water columns is relatively low from October to next April, less than 1 in all the investigated lake areas. Compared with other types of algae, cyanobacteria are more suitable to grow in water with higher temperature. In May, cyanobacteria enter a rapid growth period. The concentration ratio of algocyan/chlorophyll in the water columns increases rapidly”, “[T]he expressions of the phycocyanin gene (PC-IGS), the algal toxin gene (mcyA) and the gas vesicle gene (gvpC) all start in winter and reach a maximum in spring, but the expressions of these three genes also differ in time. The expression of the gas vesicle gene is earlier than the expression of phycocyanin gene because with the increase in the expression level of the gas vesicle gene, cyanobacteria quickly synthesize gas vesicles, thereby driving the cyanobacteria to float from the bottom sediment up to the surface of the water body and subsequently enabling the cyanobacteria to acquire suitable growth conditions and nutritive salts. Only by then does the phycocyanin gene begin to be expressed rapidly”, “nblA is a gene encoding phycobilisome degradation protein. Phycobilisome degradation protein can degrade phycobilisome and affect the normal capture of light energy by algal cells. The annual change law of the relative ratio of nblA gene expression between wild cyanobacteria in the Taihu Lake and microcystis under the best indoor culture conditions shows that the ratio is low in winter and spring, about 0.8, but begins to increase in August at the end of summer, and reaches a peak in October, suggesting that the expression level of cyanobacteria phycobilisome degradation protein gene is the highest currently and the algae begin to decline rapidly. Then the relative expression level of the nblA gene begins to decrease (FIG. 10)” (see paragraphs [0034], [0041], [0054], and [0093] of US 2021/0348211A1, which is US publication of this instant case). Although it is known that the cyanobacteria wintering period starts from September (see paragraph [0042] of US 2021/0348211A1, which is US publication of this instant case), since claim 1 does not indicate when mixed water samples of water columns, collect overlying water samples, and collect bottom lake sediment samples from different locations of the lake are collected, if the mixed water samples of water columns, collect overlying water samples, and collect bottom lake sediment samples from different locations of the lake are collected before September, the cyanobacteria wintering period cannot be defined. Although it is known that ftsZ gene expression in cyanobacteria starts to increase in early spring to early summer (see page 1 of CN 201810400286.2), since claim 1 does not indicate when the cyanobacteria in the mixed water samples of water columns is collected in order to determine the relative RNA expression level of the ftsZ gene in the cyanobacteria, if the cyanobacteria in the mixed water samples of water columns is collected before early spring, a cyanobacteria rapid growth period cannot be determined. Although it is known that the relative ratio of nblA gene expression between wild cyanobacteria in the Taihu Lake and microcystis begins to increase in August at the end of summer and reaches a peak in October (see paragraph [0093] of US 2021/0348211A1, which is US publication of this instant case), since claim 1 does not indicate when the cyanobacteria in the mixed water samples of water columns is collected in order to determine the relative RNA expression level of the nbIA gene in the cyanobacteria and when the wind speed in the Taihu Lake is monitored, if the cyanobacteria in the mixed water samples of water columns is collected before August or the wind speed in the Taihu Lake is monitored before August, a cyanobacteria decline period cannot be determined. It is known that wind patterns over large lakes can be spatially and temporally variable while they are typically uniform in small lakes even though non-uniform wind patterns in small lakes can occur due to sheltering from a bluff topography or tree canopy (see page 112, right column from Brunet et al., Journal of Great Lakes Research 49, 112-121, 2023), cyanobacterial blooms in Taihu Lake are dominated by Microcystis aeruginosa, Microcystis flos-aquae, and Microcystis wesenbergii which have contributed more than 40% and up to 98% of total algal bio-volumes between May and October (see page 712, left column, second paragraph from Ma et al., Limnol. Oceanogr., 61, 711–722, 2016) and dominant cyanobacteria in different lakes are different. For example, the dominant species of cyanobacteria in Nansi lake are Pseudanabaena (32.94%) and Merismopedia (19.85%), not the bloom-forming algae such as Microcystis and Anabaena (Tian et al., Journal of Environmental Sciences, 24, 1394-1402, 2012). Although all results obtained in steps (1) to (5) of claim 1 is collected from Taihu Lake, since the claims do not limit that a lake is Taihu Lake, if the lake in claim 1 is any kind of lake such as Nansi lake which has different dominant species of cyanobacteria and is much smaller than Taihu Lake, it is unpredictable whether the stages of development of a cyanobacterial bloom in any kind of lake can be defined using the methods recited in claims 1-4 and 7-10.
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 the stages of development of a cyanobacterial bloom in any kind of lake can be defined using the methods recited in claims 1-4 and 7-10.
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 4, third paragraph bridging to page 7, first paragraph of applicant’s remarks, applicant argues that “the combination of the working examples provided in the detailed description and the direction provided in the claims and specification (as well as corresponding references, including Zhang et al, 2015) as well as the known predictability of the methods (e.g., water sampling, RNA purification, reverse transcription and fluorescent quantitative PCR), it would not require undue experimentation to identify the stages of cyanobacterial blooms in a lake”.
These arguments have been fully considered but they are not persuasive toward the
withdrawal of the rejection. Although the specification teaches that “the relative expression level of the gene is expressed with 2−ΔΔCt. The calculation formula of ΔΔCt is as follows:
ΔΔCt= (Cttarget gene-Ct16S rRNA)field−(Cttarget gene−Ct16S rRNA) control” (see paragraph [0052] of US 2021/0348211 A1, which is US publication of this instant case), since step (2) of claim 1 does not indicate that relative RNA expression levels of PC-IGS, mcyA, and gvpC are relative to which RNA, step (3) of claim 1 does not indicate that relative RNA expression level of ftsZ is relative to which RNA, and step (4) of claim 1 does not indicate that relative RNA expression level of nblA is relative to which RNA, it is unpredictable how the cyanobacteria enter a resuscitation period can be defined in step (2) of claim 1, how the cyanobacteria enter a lake cyanobacteria rapid growth period can be defined in step (3) of claim 1, and how the cyanobacteria enter a decline period can be defined in step (5) of claim 1. Furthermore, since the specification teaches that “[F]inally, linear regression is performed on the growth rate μ of each sample and the relative expression level of corresponding ftsZ gene to obtain a regression equation of the growth rate of microcystis and the relative expression level of the ftsZ gene Y=0.059+0.093X (as shown in FIG. 8)”, “[A]ccording to the regression equation of the growth rate μ of microcystis and the relative expression level of the ftsZ gene, the in situ growth rate of microcystis at the sampling points in different lake areas of the Taihu Lake is obtained”, and “[F]rom the change law of in situ growth rate of microcystis from March to May in different lake areas of the Taihu Lake (FIG. 9), it can be seen that the growth rate of microcystis begins to increase from early April till May and then the growth begins to decline, so it is believed that the growth in the microcystis rapid growth period is about 0.13 d-1. This value is used as a threshold for cyanobacteria rapid growth period, and the cyanobacteria rapid growth period is judged to be early April to the first ten days of May. According to FIG. 8, it can be obtained that the relative expression level of the ftsZ gene now is 0.5. This value is used as a threshold for cyanobacteria rapid growth period” (see paragraph [0067] to [0069] and Figure 8 of US 2021/0348211A1, which is US publication of this instant case), the growth rate in the microcystis rapid growth period appears to be a growth rate in an early stage of a linear regression curve (see Figure 8). Since step (3) of claim 1 does not indicate what is a threshold of a cyanobacteria rapid growth period window, it is unpredictable how the cyanobacteria can be determined to have entered a lake cyanobacteria rapid growth period when the value of the relative expression of the ftsZ gene > 0.5 as recited in step (3) of claim 1. In addition, the specification teaches that “[S]amples are collected at the sampling points from the end of autumn to the beginning of spring, generally from November to March each year according to the meteorological conditions”, “[T]he planktonic algae communities in the water body of the Taihu Lake will undergo succession each year, diatoms are dominant in winter and green algae are dominant in spring, so the concentration ratio of algocyan/chlorophyll in the entire water columns is relatively low from October to next April, less than 1 in all the investigated lake areas. Compared with other types of algae, cyanobacteria are more suitable to grow in water with higher temperature. In May, cyanobacteria enter a rapid growth period. The concentration ratio of algocyan/chlorophyll in the water columns increases rapidly”, “[T]he expressions of the phycocyanin gene (PC-IGS), the algal toxin gene (mcyA) and the gas vesicle gene (gvpC) all start in winter and reach a maximum in spring, but the expressions of these three genes also differ in time. The expression of the gas vesicle gene is earlier than the expression of phycocyanin gene because with the increase in the expression level of the gas vesicle gene, cyanobacteria quickly synthesize gas vesicles, thereby driving the cyanobacteria to float from the bottom sediment up to the surface of the water body and subsequently enabling the cyanobacteria to acquire suitable growth conditions and nutritive salts. Only by then does the phycocyanin gene begin to be expressed rapidly”, “nblA is a gene encoding phycobilisome degradation protein. Phycobilisome degradation protein can degrade phycobilisome and affect the normal capture of light energy by algal cells. The annual change law of the relative ratio of nblA gene expression between wild cyanobacteria in the Taihu Lake and microcystis under the best indoor culture conditions shows that the ratio is low in winter and spring, about 0.8, but begins to increase in August at the end of summer, and reaches a peak in October, suggesting that the expression level of cyanobacteria phycobilisome degradation protein gene is the highest currently and the algae begin to decline rapidly. Then the relative expression level of the nblA gene begins to decrease (FIG. 10)” (see paragraphs [0034], [0041], [0054], and [0093] of US 2021/0348211A1, which is US publication of this instant case). Although it is known that the cyanobacteria wintering period starts from September (see paragraph [0042] of US 2021/0348211A1, which is US publication of this instant case), since claim 1 does not indicate when mixed water samples of water columns, collect overlying water samples, and collect bottom lake sediment samples from different locations of the lake are collected, if the mixed water samples of water columns, collect overlying water samples, and collect bottom lake sediment samples from different locations of the lake are collected before September, the cyanobacteria wintering period cannot be defined. Although it is known that ftsZ gene expression in cyanobacteria starts to increase in early spring to early summer (see page 1 of CN 201810400286.2), since claim 1 does not indicate when the cyanobacteria in the mixed water samples of water columns is collected in order to determine the relative RNA expression level of the ftsZ gene in the cyanobacteria, if the cyanobacteria in the mixed water samples of water columns is collected before early spring, a cyanobacteria rapid growth period cannot be determined. Although it is known that the relative ratio of nblA gene expression between wild cyanobacteria in the Taihu Lake and microcystis begins to increase in August at the end of summer and reaches a peak in October (see paragraph [0093] of US 2021/0348211A1, which is US publication of this instant case), since claim 1 does not indicate when the cyanobacteria in the mixed water samples of water columns is collected in order to determine the relative RNA expression level of the nbIA gene in the cyanobacteria and when the wind speed in the Taihu Lake is monitored, if the cyanobacteria in the mixed water samples of water columns is collected before August or the wind speed in the Taihu Lake is monitored before August, a cyanobacteria decline period cannot be determined. It is known that wind patterns over large lakes can be spatially and temporally variable while they are typically uniform in small lakes even though non-uniform wind patterns in small lakes can occur due to sheltering from a bluff topography or tree canopy (see page 112, right column from Brunet et al., Journal of Great Lakes Research 49, 112-121, 2023), cyanobacterial blooms in Taihu Lake are dominated by Microcystis aeruginosa, Microcystis flos-aquae, and Microcystis wesenbergii which have contributed more than 40% and up to 98% of total algal bio-volumes between May and October (see page 712, left column, second paragraph from Ma et al., Limnol. Oceanogr. 61, 711–722, 2016) and dominant cyanobacteria in different lakes are different. For example, the dominant species of cyanobacteria in Nansi lake are Pseudanabaena (32.94%) and Merismopedia (19.85%), not the bloom-forming algae such as Microcystis and Anabaena (Tian et al., Journal of Environmental Sciences, 24, 1394-1402, 2012). Although all results obtained in steps (1) to (5) of claim 1 is collected from Taihu Lake, since the claims do not limit that a lake is Taihu Lake, if the lake in claim 1 is any kind of lake such as Nansi lake which has different dominant species of cyanobacteria and is much smaller than Taihu Lake, it is unpredictable whether the stages of development of a cyanobacterial bloom in any kind of lake can be defined using the methods recited in claims 1-4 and 7-10.
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 8 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 8 is rejected as vague and indefinite because it is unclear that a culture circle is used for culturing what. Please clarify.
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 October 24, 2025