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 .
Applicant’s amendment and argument of 9/3/26 are entered.
Claims 5, 8-11, 17-19, 22-23, 25, 27, 31 and 33 are amended.
Claims 1-33 are pending and are considered herein.
Claim Objections
In light of the argument to other kingdoms of cell, the warnings against Claims 2 and 16 are withdrawn.
In light of amendments, the advisories against Claims 5, 30, 19 and 33 are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
In light of the amendment to Claim 9, the rejections under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, is withdrawn.
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.
In light of the amendment, no longer claiming the dyes of Claim 9 as hydrophobic, the rejections of Claims 1-33 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, are withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2020/0256854 A1 to Arab, et al., published 8/13/20 (i.e., more than a year prior to Applicant’s earliest filing date: 10/6/21); and U.S. Patent Application Publication No. 2018/0216171 A1 to Xue, et al (published 8/2/18).
Claims 1 and 15: Arab teaches stable water-in-oil emulsions containing droplets made by emulsification with an immiscible fluid (e.g., Arab, paragraph 30), the droplet may be an aqueous solution containing living cells (e.g., Arab, paragraph 56 and 15) and a fluorescent molecule (e.g., Arab, paragraph 16). The immiscible (continuous) phase may use fluorocarbons, fluorosurfactants, hydrocarbon, mineral or silicone oils (e.g., Arab, paragraph 20). These methods result in obtaining the compositions.
Claims 2 and 16: the cells include bacteria, fungi, plant cells, animal cells, or cells from any other cellular organism (e.g., Arab, paragraph 56).
Claims 3 and 17: bacterial cells are taught (e.g., Arab, paragraph 56).
Claims 4 and 18: Arab, Paragraph 7 teaches the difficulty of nucleic acid techniques while paragraphs 9-10 indicate the methods have advantages versus the NATs in the art. Further Figure 1 teaches patients, in the context of humans. Thus, the Artisan would understand the method and compositions include human cells.
Claim 5 and 19: Arab, paragraph 56, teaches “The cells may be obtained directly from an organism or from a biological sample obtained from an organism, e.g., from sputum, saliva, urine, blood, cerebrospinal fluid, seminal fluid, stool, and tissue.” Further, Arab is particularly interested in pathogens (e.g., paragraph 11).
Claims 6-7 and 20-21: Arab, paragraph 57 teaches the continuous phase may be a fluorocarbon oil.
Claims 8-9 and 22-23: Arab, paragraph 16 teaches the fluorescent reporter may “include a resazurin dye, a tetrazolium dye, coumarin dye, an anthraquinone dye, a cyanine dye, an azo dye, a xanthene dye, an arylmethine dye, a pyrene derivative dye, a ruthenium bipyridyl complex dye or a derivative thereof.”. Further, for multiplexing, several dyes may be required (e.g., paragraph 63).
Claims 11 and 25: Arab, paragraph 22, teaches that the reporters include viability dye, and metabolic activity determination with dye, e.g., resorufin. Noting the need to be non-toxic to the cells. Thus, the limitations of not impeding viability or metabolic activity are met. Clearly, this would be extended to the other components of the composition, as impeding these would work against the dyes requirements.
Claim 12: Arab teaches 30-40 deg. C (e.g., paragraph 23).
Claims 13-14 and 26-27: Arab, paragraph 57 indicates the oil may comprise a surfactant or a fluorocarbon surfactant.
Claims 28 and 31: Arab, paragraph 7, teaches diagnosing the source of a pneumonia infection, and thus, these bacterial cells are taught.
Claims 29 and 32: Arab, paragraph 6, teaches Staph aureus, and paragraph 63 teaches Escherichia coli.
Claims 30 and 33: The teaching of sampling pneumonia infection in patients (e.g., Arab, paragraph 7) also necessarily teaches the cells derived from a tissue infected with the bacterial cells. These cells may be pathogens (e.g., paragraph 11).
However, while Arab teaches all these limitations as noted above, Arab does not teach the use of alpha/beta/gamma-cyclodextrins (Applicant’s claims 10 and 24) in such W/O compositions.
On the other hand, Xue teaches w/o emulsion droplets comprising alpha, beta, and/or gamma cyclodextrins (e.g., paragraph 47), which may also contain cells (e.g., paragraph 44) and fluorescent dyes (e.g., paragraph 45). It is taught that the cyclodextrin-containing emulsions are stabilized by the presence of a cyclodextrin (e.g., section “Examples”, under “Droplet Stabilization With Poloxamer: Cyclodextrin Emulsions).
Thus, at the time of invention, it would have been obvious to modify the emulsions of Arab, to further include alpha, beta, and/or gamma cyclodextrins. The Artisan would do so to stabilize the droplets in the emulsion. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Response to Argument – 103, Arab and Xue
Applicant’s argument of 9/3/26 has been considered but is not found persuasive.
Applicant argues that Arab doesn’t teach or suggest the use of cyclodextrins and submits that Xue is to PCR methods and there is no reasonable expectation of success that Xue’s methods of PCR would be successfully applied to the processing and analysis of intact living cells (pp. 12-13, paragraph bridging).
Such is not persuasive. Xue isn’t used for performing PCR, Xue is utilized for stabilizing the emulsions, to which Xue teaches the stabilization of the emulsions. The Examiner is lost as to why PCR must be performed. This is a 103 rejection, not a 102 rejection.
Applicant argues that Xue doesn’t teach the PCR can be performed on living cells, and the instant methods advantageously avoid high temperature thermal cycling (p. 13, paragraph 2).
Such is not persuasive. PCR is not required, and thus, high temperature thermal cycling is not required.
Applicant avers that there is no reasonable expectation of success, in applying stabilizing effects of the cyclodextrins of Xue to the methods of Arab (pp. 13-14, paragraph briding).
Such is not persuasive. The stabilizing effects are there, regardless of temperature. Otherwise, Xue’s PCR would lead to breakdown regardless.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2020/0256854 A1 to Arab, et al., published 8/13/20 (i.e., more than a year prior to Applicant’s earliest filing date: 10/6/21); and Li, et al. (2015) “Optimization of Microencapsulation of Fish Oil with Gum Arabic/Casein/Beta-Cyclodextrin Mixtures by Spray Drying”, Journal of Food Science,: 80(7): C1445-52.
Claims 1 and 15: Arab teaches stable water-in-oil emulsions containing droplets made by emulsification with an immiscible fluid (e.g., Arab, paragraph 30), the droplet may be an aqueous solution containing living cells (e.g., Arab, paragraph 56 and 15) and a fluorescent molecule (e.g., Arab, paragraph 16). The immiscible (continuous) phase may use fluorocarbons, fluorosurfactants, hydrocarbon, mineral or silicone oils (e.g., Arab, paragraph 20). These methods result in obtaining the compositions.
Claims 2 and 16: the cells include bacteria, fungi, plant cells, animal cells, or cells from any other cellular organism (e.g., Arab, paragraph 56).
Claims 3 and 17: bacterial cells are taught (e.g., Arab, paragraph 56).
Claims 4 and 18: Arab, Paragraph 7 teaches the difficulty of nucleic acid techniques while paragraphs 9-10 indicate the methods have advantages versus the NATs in the art. Further Figure 1 teaches patients, in the context of humans. Thus, the Artisan would understand the method and compositions include human cells.
Claim 5 and 19: Arab, paragraph 56, teaches “The cells may be obtained directly from an organism or from a biological sample obtained from an organism, e.g., from sputum, saliva, urine, blood, cerebrospinal fluid, seminal fluid, stool, and tissue.” Additionally, pathogens are specifically taught (e.g., paragraph 11).
Claims 6-7 and 20-21: Arab, paragraph 57 teaches the continuous phase may be a fluorocarbon oil.
Claims 8-9 and 22-23: Arab, paragraph 16 teaches the fluorescent reporter may “include a resazurin dye, a tetrazolium dye, coumarin dye, an anthraquinone dye, a cyanine dye, an azo dye, a xanthene dye, an arylmethine dye, a pyrene derivative dye, a ruthenium bipyridyl complex dye or a derivative thereof.”. Further, for multiplexing, several dyes may be required (e.g., paragraph 63).
Claims 11 and 25: Arab, paragraph 22, teaches that the reporters include viability dye, and metabolic activity determination with dye, e.g., resorufin. Noting the need to be non-toxic to the cells. Thus, the limitations of not impeding viability or metabolic activity are met. Clearly, this would be extended to the other components of the composition, as impeding these would work against the dyes requirements.
Claim 12: Arab teaches 30-40 deg. C (e.g., paragraph 23).
Claims 13-14 and 26-27: Arab, paragraph 57 indicates the oil may comprise a surfactant or a fluorocarbon surfactant.
Claims 28 and 31: Arab, paragraph 7, teaches diagnosing the source of a pneumonia infection, and thus, these bacterial cells are taught.
Claims 29 and 32: Arab, paragraph 6, teaches Staph aureus, and paragraph 63 teaches Escherichia coli.
Claims 30 and 33: The teaching of sampling pneumonia infection in patients (e.g., Arab, paragraph 7) also necessarily teaches the cells derived from a tissue infected with the bacterial cells. Moreover, paragraph 11 teaches pathogens.
However, while Arab teaches all these limitations as noted above, Arab does not teach the use of alpha/beta/gamma-cyclodextrins (Applicant’s claims 10 and 24) in such W/O compositions. On the other hand, it is known in the Art that Cyclodextrins stabilize W/O emulsions. For example, Li teaches that the use of beta-cyclodextrin can be used forming stable water-in-oil emulsions due to it hydrophilic outer surface and hydrophobic cavity (e.g., p. C1445, col. 2, paragraph 1).
Thus, at the time of invention, it would be obvious to modify the W/O emulsions of Arab, by adding the cyclodextrin of Li. The Artisan would do so to stabilize the water droplets in the oil. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Response to Argument – 103, Arab and Li
Applicant’s argument of 9/3/26 has been considered but is not found persuasive.
Applicant argues that Li is directed to fish oil microencapsulation using gum/Arabic/casein/cyclodextrin mixtures to form a protective barrier that reduces oxidation and slows escape of volatile compounds, and there is no reasonable expectation of success that Li’s product could be successfully applied to the formation of the wo emulsions containing intact living cells (pp. 14-15, paragraph bridging).
Such is not persuasive. It is not clear how stabilizing effects only apply to o/w emulsions, as the cyclodextrin clearly helps with the partitioning.
Applicant argues that Li teaches various conditions for their methods that are distinct from the present claimed invention, e.g., temperatures no greater than 40 degrees (p. 14, paragraph 2).
Such is not persuasive. If it is stabilized, it is not clear how it works only when utilized in the methods of Li. The stabilization is not limited to Li’s methods, as far as the Examiner can see.
Applicant argues that the materially distinct methods provide no reasonable expectation of success (pp. 15-16, paragraph bridging).
Such is not persuasive. The rejection does not require the methods of Li be used. Only that the cyclodextrins are utilized for stabilization.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638
