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 .
Election/Restrictions
Applicant's election with traverse of group I, claims 1-8, in the reply filed on 07/22/2026 is acknowledged. The traversal is on the ground(s) that the common technical features shared by inventions I, II, and III include the use of galactose dehydrogenase stabilized by trehalose for reacting with a biological sample, and that inventions I, II and III are technically interrelated and that therefore there is no undue burden on the examiner to consider all claims in the single application. This is not found persuasive because the issue as to the meaning and intent regarding “independent and distinct” as used in 35 U.S.C 121 and 37 CFR 1.41 has been adequately addressed in MPEP §802.01. Therein, it is stated that the legislative intent was to maintain the substantive law on the subject of restriction practice prior to enactment of 35 USC 121. Such practice permitted restriction between distinct, albeit dependent inventions. If the intent had been otherwise, then only the term “independent” would have been used. Thus, restriction between the distinct inventions set forth in this application is proper even though these inventions are clearly related.
With regard to applicants allegation that joinder of these distinct inventions would not present a serious burden to the U. S. Patent and Trademark Office, such allegations relied on the unsupported assumption that the search and the examination of both the invention would be coextensive. Further, while there may be some overlap in the searches of the two inventions, there is no reason to believe that the searches would be identical. Please see the restriction mailed 05/22/2026 page 4 which sets forth the burden.
Further, with regards to the claims sharing a technical feature it is noted that the restriction is under normal US practices and not 371 national stage practices.
Therefore, based on the additional work involved in searching and examining both distinct inventions together, restriction of the distinct inventions is clearly proper and is therefore made FINAL.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/22/2026.
Status of Claims
Claims 1-20 remain pending in the application, with claims 1-8 being examined and claims 9-20 being withdrawn pursuant to the election filed 07/22/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Figures 1a and 1b mentioned on page 9.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 146, 148, 152, 154 seen in Figure 5 and Table 5 mentioned twice on page 19 where the table is not seen in either the specification or Figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-3 are objected to because of the following informalities:
Claim 2 appears to be an improper Markush group as it recites “the buffer is selected from a group consisting of… and triethanolamine buffer.”
Please see MPEP 2117 which states that alternatives may be set forth as "a material selected from the group consisting of A, B, and C" or "wherein the material is A, B, or C"
Therefore, it is suggested that claim 2 be amended to recite “the buffer is selected from [[a]] the group consisting of… and triethanolamine buffer.”
Claim 3 similarly appears to be an improper Markush group as it recites “the antioxidant is selected from a group consisting of… and NTA-Nitrilotriacetate acid (NTA).”
Please see above for suggestion on how to amend.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-8 are 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 1 recites “the galactose dehydrogenase concentration is 4% or more, the trehalose concentration is 0.01% or more” on lines 8-9 where it is unclear what the percentage is of. Currently, the test strip comprises an enzyme and a stabilizer where the stabilizer is trehalose and the enzyme is galactose dehydrogenase, and it is described that the galactose dehydrogenase is solidified and dried on the test strip. Is it the percentage of the total mixture (galactose dehydrogenase and stabilizer) that is applied to the test strip?
Claims 2-8 are rejected by virtue of being dependent on a rejected claim.
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.
The factual inquiries 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 nonobviousness.
Claim(s) 1-3, 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over translated Hu (TW-I292478-B) in view of translated Huang (CN-204008654-U), translated Svorc (IT-MI971216-A1), Balasubramanian (US-2014/0262831-A1), and Abulhaj (US-2014/0018655-A1).
Regarding claim 1, Hu teaches a galactose rapid quantitative detection system, comprising:
a galactose solution composition including a galactose, a buffer and a 0-99% antioxidant, which enters a body and produces a biological sample after metabolism by the liver (page 4 paragraph 3 see purpose of the invention is to provide a specimen preparation method and sampling test paper for liver function determination, page 4 paragraph 4 see inject a galactose composition into the subject, after a certain interval draw an appropriate amount of blood and drop it on a suitable filter paper, page 4 paragraph 5 see galactose composition contains 1%-50% galactose powder, a buffer, and an antioxidant);
Hu describes on page 4 paragraph 4 that the method involves injecting the galactose into the test subject, after a certain interval draw blood from the subject and drop it onto a suitable filter paper to air dry, where the air-dried blood on the filter paper is then dissolved to prepare a test sample. Page 7 paragraph 3 describes where measuring liver function uses a microplate reader to measure the absorbance of the sample, where the absorbance value is then used to indirectly calculate the galactose concentration using a galactose concentration-absorbance measurement line.
Hu therefore does not teach a test strip comprising an enzyme nor a meter.
In the same problem solving area of measuring active substances such as blood glucose, Huang teaches a biological test strip and a biometer (Huang; [0002], [0024], [0075]).
Specifically, Huang teaches:
a test strip (biological test strip 100), comprising an enzyme, the enzyme reacts with the biological sample producing an electrochemical information (Huang; [0066] and see biological test strip 100 is an electrochemical test strip where types of biological test strips 100 and items measured are not limited, [0073] see reaction layer 150 contains at least one active material and conductive medium for chemically reacting with a sample where the active substance includes immobilized or unimmobilized enzymes such as glucose oxidase, [0092] see where a calculation unit is for concentration conversion, Figures 1A-B); and
a meter (biometer 10) comprising (Huang; [0091], Figure 3):
a power supply unit (power supply unit 16) for providing a signal (Huang; [0092], Figure 3);
a connector (connector 11) for receiving the signal provided by the power supply unit (16) and transmitting the signal to the test strip (100), wherein the signal reacting with the electrochemical information produce a corresponding response signal, and the connector (11) transmits the corresponding response signal to the meter (10) (Huang; [0092], Figure 3);
a calculation unit (calculation unit 12) for calculating the corresponding response signal (Huang; [0092], Figure 3);
an A/D convertor (analog-to-digital converter 13) for receiving the corresponding response signal from the calculation unit (12), transforming the corresponding response signal calculated by the calculation unit (12) into a digital reaction signal (Huang; [0092], Figure 3);
a processor (processor 14) for processing the digital reaction signal (Huang; [0092], Figure 3);
a display (display 15) for displaying the digital reaction signal (Huang; [0092], Figure 3); and
It would have been obvious to one skilled in the art to modify the system as taught by Hu such that the blood sample, after injection of galactose solution, is analyzed with the test strip and meter system of Huang because Huang teaches that the test strip and meter allows for the measurement of analytes in blood and the interpretation of test results (Huang; [0066], [0091]).
Examiner further finds that the prior art contained a device/method/product (i.e., a galactose solution to be injected, placed on a filter paper, and then absorbance is read to calculate galactose concentration) which differed from the claimed device by the substitution of component(s) (i.e., filter paper and absorbance measurement) with other component(s) (i.e., test strip and meter), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., the filter paper and absorbance measurement for the test strip and meter), and the results of the substitution (i.e., determination of the concentration of analyte) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the filter paper and absorbance measurement of reference Hu with the test strip and meter of reference Huang, since the result would have been predictable.
Therefore, the galactose solution will be administered to the subject, and the blood sample will then be placed on the biological test strip and inserted into the meter of Huang.
Huang teaches that the enzyme used can include glucose oxidase, where [0073] of Huang recites “Its composition may include, but is not limited to, enzymes (such as glucose saccharifying enzyme),…”. However Huang does not teach that the enzyme is galactose dehydrogenase. Huang further does not teach a stabilizer for maintaining the enzyme stability where the stabilizer comprises trehalose.
In the analogous art of electrochemical biosensors, Svorc teaches biosensors with high stability (Svorc; [0004], [0025]).
Specifically, [0014] of Svorc describes that the biosensitive elements consist of electrically conductive material in the form of powder or granules, substances capable of absorbing the chemical mediator, a biocatalyst, and one or more solid compounds with a binding function. Svorc teaches that an enzyme can be used as a biocatalyst, and various enzymes that can be used in the biosensor including glucose oxidase and galactose dehydrogenase (Svorc; [0067], [0069]). Additionally, Svorc teaches that the biosensor contains a stabilizing modification such as the presence of a stabilizer incorporated into a matrix, coating with an airtight material, treatment with high-energy particles, treatment with buffer solutions, and application of a pre-working potential (Svorc; [0020]). [0045] of Svorc describes where stabilizers are selected from a sugar group such as trehalose and [0079] that the stabilizer is 0.05%-30% by weight (see [0075] of Svorc that states the various elements that make up the biosensitive element are present in the following proportions by weight).
Examiner finds that the prior art contained a device/method/product (i.e., a biological test strip) which differed from the claimed device by the substitution of component(s) (i.e., enzyme being for example glucose oxidase) with other component(s) (i.e., the enzyme being galactose dehydrogenase), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., glucose oxidase for galactose dehydrogenase), and the results of the substitution (i.e., functioning of the test strip and meter for detecting an analyte of interest) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the glucose oxidase of reference Huang with galactose dehydrogenase of reference Svorc, since the result would have been predictable.
Additionally, it would have been obvious to one skilled in the art to modify the biological test strip of Huang to include trehalose as a stabilizer as taught by Svorc because Svorc teaches that the stabilizer allows for greater reliability, portability, and versatility of use of the biosensor even under non-ideal measurement conditions, and increases the lifetime and stability of the electrical signal produced by the biosensor (Svorc; [0021], [0045]).
While Svorc does teach that the stabilizer is 0.05%-30% by weight, Svorc nor Huang teach the concentration of enzyme present.
In the analogous art of electrochemical sensor systems, Balasubramanian teaches a hemolysis sensor that includes at least one enzyme that is stabilized (Balasubramanian; [0008], [0072]).
Specifically, Balasubramanian teaches that the hemolysis sensor includes glutaraldehyde, bovine serum albumin, and an enzyme stabilizer such as polyethyleneimine, and lactate oxidase, where the percentages by weight are: 45% lactate oxidase, 45% bovine serum albumin, 5% stabilizer, and 5% glutaraldehyde where it is described that the weight fractions can vary (Balasubramanian; [0073]).
It would have been obvious to one skilled in the art at the time the invention was filed, to determine, through routine experimentation, the optimum concentration of enzyme for the test strip to a range of 4% or more, which would allow for the enzymatic reaction to occur because it is taught by Balasubramanian that varying the weight fractions of the components such as the enzyme and stabilizer is effective when developing sensors.
Huang does not teach a digital terminal for receiving the digital reaction signal.
In the analogous art of blood glucose meters, Abulhaj teaches where blood glucose meter data can be transmitted to a memory storage cloud for later review and/or manipulation by a user, doctor and/or the like (Abulhaj; [0015]).
Specifically, Abulhaj teaches where blood glucose readings are taken using a test strip receiving device 10, computing or communication device 12, and blood glucose meter application (Abulhaj; [0019]). [0019] of Abulhaj describes where data collected using the test strip receiving device 10, computing or communication device 12, and blood glucose meter application is transferred to a network 30 via long-range or short-range wireless capabilities of the computing or communication device 12 where the data is stored in a provider server 40 and/or external media.
It would have been obvious to one skilled in the art to modify the system of Huang such that it further includes a server and/or external media and to modify the biometer such that it can send data to the server and/or external media as taught by Abulhaj because Abulhaj teaches that this allows for a patient and/or doctor to review historical results (Abulhaj; [0019]).
Regarding claim 2, modified Hu teaches the system according to claim 1. Hu further teaches wherein the buffer is selected from a group consisting of citrate buffer, phosphate buffer, acetate buffer, carbonate buffer, and triethanolamine buffer (Hu; page 4 paragraph 5).
Regarding claim 3, modified Hu teaches the system according to claim 1. Hu further teaches wherein the antioxidant is selected from a group consisting of sodium bisulfite (Hu; page 4 paragraph 5).
Regarding claim 5, modified Hu teaches the system according to claim 1. Hu further teaches wherein the galactose composition is administrated through injection (Hu; page 4 paragraph 4).
Regarding claim 6, modified Hu teaches the system according to claim 1.
The limitations of claim 6 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Hu and the galactose solution of Hu is capable of being administered through oral administration. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Hu (see MPEP §2114).
Please note that Hu has been modified such that after galactose solution is injected, waiting a time interval, the sample of blood is disposed onto the biological test stirp of Huang.
Regarding claim 7, modified Hu teaches the system according to claim 1. Hu further teaches wherein the galactose solution composition is administrated through injection, wherein the way of injection is to let users inject the galactose solution composition into the body in advance, then a content of galactose in the body is measured by measuring the content of galactose in the biological sample (Hu; page 4 paragraph 4).
Please note that Hu has been modified such that after galactose solution is injected, waiting a time interval, the sample of blood is disposed onto the biological test stirp of Huang.
Regarding claim 8, modified Hu teaches the system according to claim 1.
Hu has been modified such that it will now have the biological test strip of Huang, where the enzyme will be galactose dehydrogenase as taught by Svorc. Svorc teaches that a stabilizer, such as trehalose, is 0.05%-30% by weight. Balasubramanian teaches where the enzyme present in a electrochemical sensor can have its weight fractions vary.
Therefore, it would have been obvious to one skilled in the art at the time the invention was filed, to determine, through routine experimentation, the optimum ratio of trehalose to galactose dehydrogenase to a range of 0.05 - 10:10 - 30, which would allow for the enzymatic reaction to occur because it is taught by Balasubramanian that varying the weight fractions of the components such as the enzyme and stabilizer is effective when developing sensors.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over translated Hu (TW-2006/17391-A), translated Huang (CN-204008654-U), translated Svorc (IT-MI971216-A1), Balasubramanian (US-2014/0262831-A1), and Abulhaj (US-2014/0018655-A1), and as evidenced by NIST, see NPL printout.
Regarding claim 4, modified Hu teaches the system according to claim 1. Hu teaches 1%-50% galactose powder.
It is evidenced by NIST that another name for galactose includes D-(+)-Galactose. Therefore, the galactose powder of Hu is understood to be D-(+)-Galactose.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hu (US-544954-B1) teaches a stable galactose injection solutions containing 1 to 50% by weight galactose, 0.01 to 1 M of a buffer solution and 0.01 to 5% of an antioxidant (Hu; abstract).
Translated Shinozuka (WO-2010/070719-A1) teaches where a biosensor has an enzyme such as galactose dehydrogenase (Shinozuka; [0052]).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
