DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant amendments filed 06/23/2026 have been entered.
Applicant amendments overcomes the previous double patenting rejections set forth in the Office Action mailed 03/23/2026, the previous double patenting rejections are withdrawn.
Applicant amendments to the drawing overcomes the previous drawing objection set forth in the Office Action mailed 03/23/2026, the previous drawing objection is withdrawn.
Applicant amendments do not overcome each and every claim objection set forth in the Office Action mailed 03/23/2026, please see claim objections section below.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Republic of Korea on 08/05/2022. It is noted, however, that applicant has not filed a certified copy of the KR10-2022-0097738 application as required by 37 CFR 1.55.
Status of Claims
Claims 1, 3-4, 8, 10 remain pending in the application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A measurement unit and a determination unit in claim 1.
A measurement unit and a determination unit in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 8 are objected to because of the following informalities:
Claim 1 line 14 recites “the material array” where it is suggested for consistency to amend it to recite “the metamaterial array”
Claim 8 line 1 recites “(SRAS-CoV-2)” which appears to be a typo and should be “(SARS-CoV-2)”
Line 19 recites “the material array” where it is suggested that for consistency it be amended to recite “the metamaterial array”
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.
Claim 10 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 10 recites “The device of claim 9” where because claim 9 has been cancelled the dependency of claim 10 is unclear.
It appears that claim 10 should be dependent on claim 8, and should be amended as such. For examination, claim 10 will be dependent on claim 8.
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, 3-4, 8, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seo (US-2017/0081695-A1) in view of Seo (US-10288560-B1) herein Seo 2019.
Regarding claim 1, Seo teaches a device for determining a coronavirus mutation, comprising:
a metamaterial array (sensing chip 1) that includes a metamaterial (meta unit 11), wherein a surface of the metamaterial array (1) includes a nanogap (pattern 111) configured to amplify an electromagnetic wave of a specific frequency ([0026] see meta unit 11 in which a pattern is formed to amplify a frequency corresponding to an absorption frequency of an avian influenza virus of interest, [0030] see pattern 111 for selectively amplifying a frequency of interest and the slits are in the range of width 10 nm to 1 µm, length from 10 µm to 1 mm, with gaps of 1 nm to 1 mm in both widthwise direction and lengthwise direction, Figures 1-2);
an electromagnetic wave irradiation unit (irradiator) configured to irradiate a terahertz electromagnetic wave toward the metamaterial array (1) ([0028], [0031]);
a measurement unit configured to measure one or more measurement factors selected from the group consisting of a frequency shift and a transmittance of the irradiated electromagnetic wave ([0031]); and
a determination unit ([0031]),
From [0031], the detector measures the transmittance or frequency change of the terawaves passing through the sensing chip 1 to specify subtypes of avian influenza viruses, and determines concentrations of the specified avian influenza viruses. Therefore, the detector described will have both a measurement unit as well as a determination unit.
The limitations “a determination unit configured to determine a mutation of the coronavirus based on the measured measurement factor” and “wherein some amino acids amplified by the material array are part of an amino acid sequence constituting a receptor binding protein (RBD) of a spike (S) region of the coronavirus” 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 Seo and the apparatus of Seo is capable of determining a coronavirus mutation and the material array is capable of amplifying some amino acids. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Seo (see MPEP §2114).
With regards to amplifying some amino acids, please see [0026] which describes amplifying a frequency corresponding to an absorption frequency of an avian influenza virus, and [0027] that the target biological sample in a liquid state can be selectively specified for subtypes among various avian influenza viruses. It is therefore understood that Seo would be capable of amplifying amino acids.
Additionally, the limitation regarding the amino acids is directed to the material worked upon by the apparatus, all the structural limitations of the claim has been disclosed by Seo and the apparatus of Seo is capable of working on some amino acids constituting a receptor binding protein (RBD) of a spike (S) region of the coronavirus. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Seo (see MPEP §2115).
Additionally, please note that the amino acids have not been positively recited in the claim, and are therefore not a part of the claimed device.
While Seo does teach that the sensing chip 1 may be designed to amplify a specific frequency by adjusting the spec (shape, size, and gap of the slits) of pattern 111 to set the resonance transmitting frequencies (Seo; [0030]) it is unclear if this would be a natural vibration mode.
In the analogous art of observing the conformational change in a protein, Seo 2019 teaches a sensing element (Seo 2019; column 4 lines 19-26).
Specifically, Seo 2019 teaches where the sensing element 120 includes a substrate 121 and a film 122, where film 122 is subjected to intaglio patterning such that an electromagnetic wave of a specific frequency is amplified (Seo 2019; column 4 lines 35-39). Further, Seo 2019 describes that the slot in film 122 may be adjusted in width, length, height, and distances between adjacent slots so that resonance occurs at a frequency in the natural vibration mode of a target protein in which the conformational change is observed (Seo 2019; column 4 lines 43-48, Figure 2). Additionally, Seo 2019 describes that the electromagnetic wave irradiation unit 130 corresponds to terahertz (Seo 2019; column 4 lines 52-56).
It would have been obvious to one skilled in the art to adjust the slits of Seo with respect to one or more selected from the group consisting of a length, a width, and thickness as taught by Seo 2019 such that resonance occurs at a frequency of a natural vibration mode because Seo 2019 teaches it is effective to adjust these parameters depending on the target protein to be analyzed (Seo 2019; column 4 lines 43-48).
It is again noted that the amino acids that are part of an amino acid sequence constituting a RBD of a spike region of the coronavirus have not been positively recited in the claim, and therefore are not part of the claimed device.
Regarding claim 3, modified Seo teaches the device of claim 1.
The limitations of claim 3 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 modified Seo and the apparatus of modified Seo is capable of amplifying some amino acids, where the some amino acids are part of amino acid sequence constituting a receptor binding protein (RBC) of a spike (S) region of the coronavirus, where the some amino acids include leucine and asparagine. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Seo (see MPEP §2114).
Further, these limitations are directed to the material worked upon by the apparatus, all the structural limitations of the claim have been disclosed by modified Seo and the apparatus of modified Seo is capable of working on some amino acids, where the some amino acids are part of amino acid sequence constituting a receptor binding protein (RBC) of a spike (S) region of the coronavirus, where the some amino acids include leucine and asparagine. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Seo (see MPEP §2115).
Further, please note that the amino acids have not been positively recited in the claim, and are therefore not a part of the claimed device.
Regarding claim 4, modified Seo teaches the device of claim 1.
The limitations of claim 4 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 modified Seo and the apparatus of modified Seo is capable of having a sample containing the coronavirus uniformly applied to a surface of the metamaterial. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Seo (see MPEP §2114).
Further, these limitations are directed to the material worked upon by the apparatus, all the structural limitations of the claim have been disclosed by modified Seo and the apparatus of modified Seo is capable of working on a sample containing the coronavirus. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Seo (see MPEP §2115).
See [0031] of Seo which describes that sample is loaded on the meta unit 11.
Regarding claim 8, Seo teaches a device, comprising:
a metamaterial array (sensing chip 1) that includes a metamaterial (meta unit 11), wherein a surface of the metamaterial array (1) includes a nanogap (pattern 111) configured to amplify an electromagnetic wave of a specific frequency ([0026] see meta unit 11 in which a pattern is formed to amplify a frequency corresponding to an absorption frequency of an avian influenza virus of interest, [0030] see pattern 111 for selectively amplifying a frequency of interest and the slits are in the range of width 10 nm to 1 µm, length from 10 µm to 1 mm, with gaps of 1 nm to 1 mm in both widthwise direction and lengthwise direction, Figures 1-2);
an electromagnetic wave irradiation unit (irradiator) configured to irradiate a terahertz electromagnetic wave toward the metamaterial array (1) ([0028], [0031]);
a measurement unit configured to measure one or more measurement factors selected from the group consisting of a frequency shift and a transmittance of the irradiated electromagnetic wave ([0031]); and
a determination unit ([0031]),
From [0031], the detector measures the transmittance or frequency change of the terawaves passing through the sensing chip 1 to specify subtypes of avian influenza viruses, and determines concentrations of the specified avian influenza viruses. Therefore, the detector described will have both a measurement unit as well as a determination unit.
wherein a biological sample separated from an object is uniformly applied to the surface of the metamaterial (11) ([0031] see sample is loaded on the meta unit 11),
The limitations “A device for diagnosing a coronavirus disease-19(SRAS- CoV-2)”, “a determination unit configured to determine a mutation of the coronavirus based on the measured measurement factor”, “wherein the device for determining a coronavirus disease-19 is configured to diagnose whether or not the object is infected with the coronavirus disease-19,” and “wherein some amino acids amplified by the material array are part of an amino acid sequence constituting a receptor binding protein (RBD) of a spike (S) region of the coronavirus,” 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 Seo and the apparatus of Seo is capable of diagnosing a coronavirus disease, determining a mutation of the coronavirus based on the measured measurement factor, and determining a coronavirus disease-19 diagnoses whether or not the object is infected with coronavirus disease-19 and capable of amplifying some amino acids. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Seo (see MPEP §2114).
With regards to amplifying some amino acids, please see [0026] which describes amplifying a frequency corresponding to an absorption frequency of an avian influenza virus, and [0027] that the target biological sample in a liquid state can be selectively specified for subtypes among various avian influenza viruses. It is therefore understood that Seo would be capable of amplifying amino acids.
Additionally, the limitation regarding the amino acids is directed to the material worked upon by the apparatus, all the structural limitations of the claim has been disclosed by Seo and the apparatus of Seo is capable of working on some amino acids constituting a receptor binding protein (RBD) of a spike (S) region of the coronavirus. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Seo (see MPEP §2115).
Additionally, please note that the amino acids constituting a coronavirus have not been positively recited in the claim, and are therefore not a part of the claimed device.
While Seo does teach that the sensing chip 1 may be designed to amplify a specific frequency by adjusting the spec (shape, size, and gap of the slits) of pattern 111 to set the resonance transmitting frequencies (Seo; [0030]) it is unclear if this would be a natural vibration mode.
In the analogous art of observing the conformational change in a protein, Seo 2019 teaches a sensing element (Seo 2019; column 4 lines 19-26).
Specifically, Seo 2019 teaches where the sensing element 120 includes a substrate 121 and a film 122, where film 122 is subjected to intaglio patterning such that an electromagnetic wave of a specific frequency is amplified (Seo 2019; column 4 lines 35-39). Further, Seo 2019 describes that the slot in film 122 may be adjusted in width, length, height, and distances between adjacent slots so that resonance occurs at a frequency in the natural vibration mode of a target protein in which the conformational change is observed (Seo 2019; column 4 lines 43-48, Figure 2). Additionally, Seo 2019 describes that the electromagnetic wave irradiation unit 130 corresponds to terahertz (Seo 2019; column 4 lines 52-56).
It would have been obvious to one skilled in the art to adjust the slits of Seo with respect to one or more selected from the group consisting of a length, a width, and thickness as taught by Seo 2019 such that resonance occurs at a frequency of a natural vibration mode because Seo 2019 teaches it is effective to adjust these parameters depending on the target protein to be analyzed (Seo 2019; column 4 lines 43-48).
It is again noted that the amino acids that are part of an amino acid sequence constituting a RBD of a spike region of the coronavirus have not been positively recited in the claim, and therefore are not part of the claimed device.
Regarding claim 10, modified Seo teaches the device of claim 8 (please see 112 section supra regarding claim 10’s dependency).
The limitations of claim 10 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 modified Seo and the apparatus of modified Seo is capable of amplifying some amino acids, where the some amino acids are part of amino acid sequence constituting a receptor binding protein (RBC) of a spike (S) region of the coronavirus, where the some amino acids include leucine and asparagine. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Seo (see MPEP §2114).
Further, these limitations are directed to the material worked upon by the apparatus, all the structural limitations of the claim have been disclosed by modified Seo and the apparatus of modified Seo is capable of working on some amino acids, where the some amino acids are part of amino acid sequence constituting a receptor binding protein (RBC) of a spike (S) region of the coronavirus, where the some amino acids include leucine and asparagine. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Seo (see MPEP §2115).
Further, please note that the amino acids have not been positively recited in the claim, and are therefore not a part of the claimed device.
Response to Arguments
Applicant arguments filed 06/23/2026 have been fully considered. Due to amendments to the claims, incorporating the limitations of claims 2, 5, 6, and 7 into claim 1 and incorporating the limitations of claims 9, 11, 12, and 13 into claim 8, the rejections in view of Seo (US-2017/0081695-A1) under 35 USC 102(a)(1) have been modified to address this amendment.
Applicant argues on page 7 of 8 that the amended claim specifically requires: that the amino acids amplified by the metal material are amino acids constituting the receptor binding protein (RBD) of the spike region of the coronavirus, that the device includes a measurement unit configured to measure frequency shift and/or transmittance and a determination unit for determining the coronavirus mutation based on the measured measurement factor, and that the nanogap geometry is configured such that resonance occurs at a frequency corresponding to a natural vibration mode of the amino acids constituting the coronavirus RBD. Applicant further argues that these features define structural and technical characteristics of the claimed device rather than merely reciting an intended use of a known terahertz sensor.
Examiner respectfully disagrees.
Currently as claim 1 is phrased, the some amino acids amplified by the material array have not been positively recited, and are thus not a part of the claimed device. Therefore, so long as the prior art is capable of amplifying the amino acids the prior art will read on the limitations. This is similar to the determination unit where a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Similarly, in claim 8 the some amino acids have not been positively recited and are thus not a part of the claimed device. The determination unit described in claim 8 is also a recitation of the intended use, where this must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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