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 .
Information Disclosure Statement
The Information Disclosure Statements filed on 7/30/2025 have been entered and considered. Initialed copies of the form PTO-1449 are enclosed with this action.
Status of claims
Applicant’s response filed 7/30/2025 has been entered.
Claims 4 and 12 have been amended.
Claims 14-17 are newly added.
Note: on 3/14/2025, the applicant elected Group II, claims 4 and 12, without traverse. The applicant also elected species of MeJ inducer, without traverse.
In view of the claim amendment and the newly added claims requiring two or more species, upon further consideration, the species election is withdrawn. Accordingly, SNP, Mej, SA, and silver nitrate are examined in the office action.
In summary, claims 4, 12, 14-17 are examined in the office action. Non-elected claims are withdrawn.
All previous objections and rejections not set forth below have been withdrawn in view of the applicant’s amendment and/or upon further consideration. See “Response to Arguments” at the end of office action.
The following rejections are repeated, modified and/or added for the reasons of record as set forth in the last Office action of 5/1/2025, and/or necessitated by the applicant’s amendments. The applicant’s arguments filed 7/30/2025 have been thoroughly considered but are not deemed fully persuasive.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Amended claims 4 and new claim 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over, Jia (CN101773071, published 7/14/2010).
Note: English translation of the CN101773071 is used to cite the page and para numbers.
The amended claim 4 is drawn to an inducer for increasing a content of flavonoid phenylpropanoid compounds in a Saussurea involucrata cell culture (preamble), wherein the inducer is an aqueous solution comprising two or more inducer compounds selected from the group consisting of sodium nitroprusside (SNP), methyl jasmonate (MeJ), salicylic acid (SA), and silver nitrate.
According to Oxford dictionary, “aqueous” refers to of or containing water”.
Claim 14 limits claim 4, wherein the inducer comprises MeJ and SA, or SA and silver nitrate, or SA, silver nitrate, MeJ, and SNP.
Jia discloses a medium comprising elicitors sodium nitroprussiate (SNP), methyl jasmonate (MJ or MeJ) and salicylic acid (SA). The elicitors are the medium containing water (abstract in p2; p5, last para, p6, 1st para; claim 1 C).
The medium is used in Saussureae Involueratae (p5, whole page, p7, 3rd to last para; claim 1).
According to Oxford dictionary, an elicitor is a substance that induces the production of products in higher plants. Accordingly, an elicitor is a specific inducer.
Thus, Jia teaches the same structure of the claimed inducer,
except
does not explicitly teach for increasing a content of flavonoid phenylpropanoid compounds in a Saussurea involucrata cell culture, recited in the preamble.
However, according to MPEP 2111.02 A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
In this particular case, the preamble does not recite any structure, rather merely recites the purpose of a process or the intended use of the structure, thus, is not accorded any patentable weight.
In addition, according to MPEP 2112. I, SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Id.
According to MPEP 2112. III, A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC. Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103rejection is appropriate for these types of claims as well as for composition claims.
In this case, Jia teaches exactly the same structure of the claims, and teaches adding the solution to Saussurea involucrata cells. The for increasing a content of flavonoid phenylpropanoid compounds in a Saussurea involucrata cell culture is inherent in the structure of Jia. Even if such property or function is previously unappreciated, it does not render the old composition patentably new to the discoverer.
Therefore, the claims are anticipated by or, in the alternative, as obvious over, Jia.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jia et al, in view of Liu et al (Chapter 4. Saussurea medusa Cell Suspension Cultures for Flavonoid Production. Methods in Molecular Biology. 53-59, 2009), Guo et al (In vitro propagation of an endangered medicinal plant Saussurea involucrata Kar. et Kir. Plant Cell Rep. p26:261–265, 2007), Halder et al (Elicitation: A biotechnological tool for enhanced production of secondary metabolites in hairy root cultures. Eng Life Sci. p880-895, 2019.7), and Wang et al (Enhanced production of flavonoids by methyl jasmonate elicitation in cell suspension culture of Hypericum perforatum. Bioresources and Bioprocessing, p1-9, 2015).
Claim 12 is drawn to a method comprising the following steps:
1) inducing a callus in an explant that is a seed embryo of Saussurea involucrata or a plant germinated from a seed of Saussurea involucrata, in an induction medium, and performing repeated subculturing to obtain a Saussurea involucrata cell line;
2) incubating the Saussurea involucrata cell line obtained in step 1) in a first medium for culturing, under conditions including an inoculation amount of 1-50 g of cells (fresh weight) per liter of the first medium, an illumination amount of 1,000-3,000 lux, an illumination time of 12-24 h/day, and a shaker speed of 100-130 rpm;
performing subculturing one time every 7 days-20 days, and establishing a Saussurea involucrata suspension cell culture line after 3-4 rounds of subculturing; and
3) inoculating the Saussurea involucrata suspension cell culture obtained in step 2) in a second medium for culturing, under conditions including an inoculation amount of 10-80 g of cells (fresh weight) per liter of the second medium, and filtering and harvesting cells after suspension culturing for 14-20 days,
wherein the first medium and the second medium are the same or different, each comprising the inducer of claim 4.
for improving a content of flavonoid phenylpropanoid compounds in a Saussurea involucrata cell culture (preamble).
Interpretation of the “inoculating” in the claims: According to Oxford dictionary, “inoculating” means introducing (an infective agent) into an organism. However, in view of the specification (p7, line 31, p8, line 1-2), there is no infective agent like Agrobacterium introduced to the Saussurea cell culture. The cells are merely incubated in a sterile condition. Thus, by BRI, the “inoculating” is interpreted as what described in the specification—incubating.
As analyzed above, Jia et al teaches a medium comprising elicitors SNP, MeJ and SA, and the medium is used in Saussureae Involueratae.
Jia further teaches obtaining and selecting corpus/explant of Saussurea involucrate Kar.et Kir. (Saussurea involucratea, snow lotus) plant, which is germinated from a seed (p5, lines 6-7), and inducing callus in an induction medium (p5, B. callus induction are cultivated).
Jia teaches incubating the Saussurea involucrata callus obtained in a medium for culturing in a medium comprising inducers/elicitors of sodium nitroprussiate (SNP), methyl jasmonate (MJ) and salicylic acid (SA), reading on the claimed first medium and the same medium (that are the same or different). Light application time is 0-24 hour/day. The intensity of illumination includes 0-100 μ mol/m 2S (p5, last para; p6, 1st para). By using https://www.waveformlighting.com/horticulture/convert-ppfd-to-lux-online-calculator, 0-100 μ mol/m 2S is about 0-4348 lux, or 0-2891 lux, depending on the light source that is not specified in the claim. The 0-2891 or 4348 lux overlaps with the claimed 1000-3000 lux. The light application time also overlap with the claimed 12-24 hours/day. See more in Guo et al below.
Please note that “for improving a content of flavonoid phenylpropanoid compounds in a Saussurea involucrata cell culture” is only in the preamble, not in any method steps of the claim. As analyzed above, such preamble does not recite any structure or step, rather merely recites the purpose of a process or the intended use of the structure or step, thus, is not accorded any patentable weight.
Thus, Jia teaches the first and second medium and the same explant of Saussurea involucrata (structure), and teaches parts of step 1) and step 2) of claim 12,
except
does not teach a condition of a shaker speed of 100-130 rpm, performing repeated subculturing to obtain a cell line (part of step 1)), and an inoculation amount of 1-50 g of cells (fresh weight) per liter, and performing subculturing one time every 7 days-20 days, and establishing a suspension cell culture line after 3-4 rounds of subculturing (part of step 2)), and step 3).
Regarding the part of step 1), Liu et al teach a method of culturing Saussurea suspension cells for flavonoid production (p53, Title, Abstract). Liu et al teach germinating Saussurea seed, then inducing callus in a callus induction medium, and performing and repeating subcultures, to obtain Saussurea suspension cell line (Materials in p54-55; Methods in p55-56, 3.1, 1-5; p56, 3.2, 1).
Regarding the part of step 2), Liu et al teach incubating/inoculating the suspended cells on a shaker at 110 rpm (teaching 100-300 rpm), under 16 h light (teaching 12-24 h/day illumination time), and performing subculture every 14 days (teaching 7-20 days), and established and demonstrated a rapid growing suspension culture that had high yield production of flavonoid (p56, 3.1, 2-4). The cell density is 2.5 g in 250 ml (p56, 3.1, 1), or 10 g/L (teaching 1-50 g per liter). The high yield of flavonoids is from day 15 at least to day 30 and longer (p57, fig 4). The high production of flavonoids was demonstrated in p57, fig 4.
Regarding step 3), Liu et al teach incubating/inoculating the subculture at least 10x and the cell density reached 17.2 g/L in the medium (p56, 3.2, 3-4), teaching 10-80 g of cells per liter medium and large scale. Liu et al teach harvesting and filtering the cells for flavonoid contents (p55, 2.3 Analysis; p56, fig4). Fig 4 shows that and high flavonoid contents occurs on day 15 to day 30, overlapping with the claimed 14-20 days.
Thus, Liu et al not only teach the method steps, but also teach an advantage of suspension cell culture in high flavonoid production in the suspension cells.
Further regarding the lighting intensity and condition, Guo et al teach and demonstrated a method in detail of culturing cells of Saussurea involucrata, an endangered species of Saussurea, from callus (p261, Title, Abstract, p262-263, Materials and Methods, Results and Discussions in p262-265). Specifically, Guo et al teach incubating/inoculating the Saussurea involucrata cells 16 hours/day at light intensity of 30–40 μmolm−2 s−1, and demonstrated success (p262, left col, 2nd para, Materials and Methods). Using https://www.waveformlighting.com/horticulture/convert-ppfd-to-lux-online-calculator, 30–40 μmolm−2 s−1, 30–40 μmolm−2 s−1 is 1304-1739 lux, teaching 1000-3000 lux in the claim. Accordingly, Jia overlaps with the claimed parameters; Guo et al teach the parameters.
As analyzed above, “for improving a content of flavonoid phenylpropanoid compounds in a Saussurea involucrata cell culture” is only in the preamble, not in any method steps of the claim. Such preamble does not recite any structure or step, rather merely recites the purpose of a process or the intended use of the structure or step, thus, is not accorded any patentable weight. Nevertheless, for compact prosecution, the examiner provides the following analysis:
According to MPEP 2112. III, Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic.
In this particular case, Jia teaches using the combination of SA, MJ and SNP as inducers in Saussurea involucrate culture, but is silent on for improving a content of flavonoid phenylpropanoid compounds. Thus, the effect of the combination of SA, MJ and SNP on improving a content of flavonoid phenylpropanoid compounds is deemed inherent.
In addition, Halder et al cite multiple references teaching that the elicitors like MJ and/or SA have the effect of increasing flavonoids production including in plant hairy roots (p883, right col, 2nd to 3rd para; p884, whole page). Halder et al also teach that SNP, an elicitor, when added as combination with other elicitors, also has the effect on increasing secondary metabolites (flavonoid phenylpropanoid compounds are one of the secondary metabolites) production (p890, right col, 1st para). Halder et al further teach that combination of two or more elicitors/inducers, like MJ, SA, and/or SNP has the effect of increasing production of secondary metabolites (p890, left col, 2.3 in last 3 paras, whole right col; p891, left col, 1st to 5th paras).
Furthermore, Wang et al teach and demonstrated that treating plant suspension cell culture with methyl Jasmonate (MJ or MeJ) induced production of flavonoids to 2.1 times higher than in controlled culture (p1, Abstract; p6, left col, 1st para and whole right col).
Thus, improving a content of flavonoid phenylpropanoid compounds in a Saussurea involucrata cell culture is not only inherent in Jia, but also would have been highly expected, in view of the Halder et al and Wang et al.
Regarding dependent claim 17, Jia et al teach that for large scale culture, the concentration of SNP is 40～60 μ mol/L, the MJ (Mej) is 40～60 μ mol/L, and the concentration of SA is 40～60 μ mol/L.
The MW of SNP is 297.95 g/mol. 40～60 μ mol/L is equivalent to about 2.98-29.8 mg/L.
The MW of Mej is 224.30 g/mol, 40～60 μ mol/L is equivalent to about 2.24-22.4 mg/L.
The MW of salicylic acid is 138.1 g/mol. 40～60 μ mol/L is equivalent to about 1.28-13.8 mg/L.
Each of them is narrower than 1-50 mg/L, the limitation of claim 17.
An invention would have been obvious to one ordinary skill in the art if any teaching, suggestion or motivation in prior art leading the one to combine the teaching(s) or suggestion(s) of the cited references to arrive the claimed invention.
In this case, it would have been obvious for one ordinary skill in the art to modify the invention of Jia, such that the method including establishing Saussurea suspension cell lines, culturing the suspension cells, and producing flavonoids in the cells, as taught and demonstrated by Liu et al. One ordinary skill in the art would have been motivated to do so because Liu et al had demonstrated high flavonoid production in suspension cell line. It also would have been obvious for one ordinary skill in the art to slightly modify the invention of Jia, such that the lighting parameters are slightly modified as taught by Guo et al. One ordinary skill in the art would have been motivated to do so because Guo et al demonstrated success of using such light parameters in incubating Saussurea involucrata. The expectation of success would have been high, because the modifications had been taught and demonstrated, including the high production of flavonoids.
Again, Jia teaches using the combination of SA, MJ and SNP as inducers in Saussurea involucrate culture, but is silent on for improving a content of flavonoid phenylpropanoid compounds. Thus, the effect of the combination of SA, MJ and SNP on improving a content of flavonoid phenylpropanoid compounds is deemed inherent. Nevertheless, Halder et al teach that MJ, SA, and/or SNP, individually or as a combination, have the effect on increasing production of secondary metabolites and/or flavonoids. Wang et al demonstrated that treating plant suspension cell culture with MeJ leads to production of flavonoids to 2.1 times higher than in controlled culture. In sum, improving a content of flavonoids is not only inherent in Jia, but also highly expected in view of Halder et al and Wang et al.
Therefore, the invention would have been obvious to one ordinary skill in the art.
Claims 15-16 a rejected under 35 U.S.C. 103 as being unpatentable over Jia as applied to claim 4 above, and further in view of Halder et al.
Claim 4 and the teaching of Jia have been analyzed above.
New claim 15 limits claim 4, comprising SA and silver nitrate.
New claim 16 limits claim 4, comprising SA, silver nitrate, MeJ, and SNP.
As analyzed above, Jia teaches an aqueous solution comprising two or more inducer compounds SA, MeJ and SNP, but
Jia does not teach the aqueous solution comprising inducer silver nitrate, required by claims 15-16.
As analyzed above, Halder et al teach that the elicitors/inducers like MJ and/or SA have the effect of increasing flavonoids production including in plant hairy roots. Halder et al also teach that SNP, an elicitor, when added as combination with other elicitors, also has the effect on increasing secondary metabolites (flavonoid phenylpropanoid compounds are one of the secondary metabolites) production. Halder et al teach that combination of two or more elicitors/inducers, like MJ, SA, and/or SNP has the effect of increasing production of secondary metabolites.
More relevantly, Halder et al further teach that silver nitrate, like MJ (MeJ), has the effect on increasing production of secondary metabolites (p886, right col, last para).
In sum, MJ, SA, SNP, and silver nitrate, individually or as a combination, have the effect on increasing production of secondary metabolites and/or flavonoids.
In this case, it would have been obvious to one ordinary skill in the art to slightly modify the invention of Jia, such that such that the combination of two or more inducer compounds further includes silver nitrate, as suggested by Halder et al. One ordinary skill in the art would have been motivated to do so because MJ, SA, SNP, and silver nitrate, individually or as a combination, have the effect on increasing production of secondary metabolites and/or flavonoids. The expectation of success would have been high because MJ, SA, SNP, and silver nitrate had been proven to increasing production of secondary metabolites and/or flavonoids.
Therefore, the dependent claims would have been obvious to one ordinary skill in the art.
Response to Arguments
Priority
The applicant argues that the applicant submitted a certified English translation of the priority application and requests the acknowledgement of the priority date as 11/28/2019.
In view of such submission, the priority date is recognized as 11/28/2019.
Claim Objections
The previous objections are withdrawn in view of the claim amendments.
Rejections Under 35 U.S.C.§ 112
The rejections are withdrawn in view of the claim amendments.
Rejections Under 35 U.S.C.§ 102/103
In view of the claim amendments reciting/requiring “two or more inducer compounds” (a new ground of rejection), and new claims, the rejection is re-written by the examiner citing a new reference, as analyzed above. Thus, the arguments to the previous cited reference are no longer applicable.
Rejections Under 35 U.S.C.§ 103
In view of the claim amendments and new claims, the rejections are re-written by the examiner citing two new references, as analyzed above. Thus, the arguments to the previous cited references are no longer applicable.
Conclusion
No claim is allowed.
The 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). The 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 extension fee 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 date of this final action.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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/Wayne Zhong/
Examiner, Art Unit 1662