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 .
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.
Status of Claims
Claims 1-37 are pending. Claims 1-25 and 27 are withdrawn. Claims 26-36 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 26-36) in the reply filed on 08/07/2026 is acknowledged.
Claims 1-25 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse.
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 27 and 36 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 27 recites a kit but does not set forth what elements are part of the claimed kit. In particular, the claim recites “using the method according to claim 1” does not provide any context to the elements that are part of the kit. In other words, is the sample also included as part of the kit? Thus, the claim is unclear to the metes and bounds of the claimed kit from a claimed process.
Claim 36 does not clearly invoke a method nor product claim. In particular, the claim recites the limitation of “the workflow of the kit of claim 32, which involves” does not properly provide positive recitation of active steps in performing the kit nor directed to a structure of the product. Because the claim appears to invoke instructions or intentions of a kit, the interpretation is that it is instructions to the kit. Also, the recitations in claim 36 lack antecedent basis of claim 32. For example, the claim recites gold nanoparticle in a tube which has not been identified in claim 32, which makes it unclear what is part of the kit.
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.
Claims 29-31 and 33-36 are rejected 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.
With respect to claims 29-31 and 33-35, these claims have recitations that are directed to the sample. However, the independent claims, which these claims are dependent upon, do not further limit the structure of the claimed kit. The intended use of different samples has not changed the structures of the claimed kit from the independent claims. Thus, these recitations do not further limit the claimed products.
With respect to claim 36, the “instructions for use” (as interpreted below in the 103 rejection, i.e., “the workflow of the kit of claim 32, which involves”) is not found to be limiting in such a case as this; where the only difference between a prior art’s product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP 2112.01. Again, printed matter has not changed the structures of the claimed kit from the independent claim 32. Thus, these recitations do not further limit the claimed kit.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claims 26-27 and 32-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peng et al. (“Multiplex lateral flow immunoassay for five antibiotics detection based on gold nanoparticle aggregations”, RSC. Adv., 2016, vol. 6, pgs. 7798-7805, published 01/11/2016).
Peng teaches an immunochromatographic assay was developed and five mAbs were conjugated to colloidal gold nanoparticle, forming AuNP-labeled antibodies which were placed in a microtiter well after freeze-drying (abstract). Fig. 1 shows at least one later flow test strip, wherein the lateral flow matrix comprises at least one sample zone (i.e., sample pad) and at least one detection zone (i.e., test and control lines). Peng teaches the end of the test strip sample pad was placed into the microtiter wells and 100 µL of extracts with and without standards was added to the wells with the five freeze-dried antibody-AuNP conjugates (at pg. 7803, left col., section 3.3). Peng teaches the strips were cut and stored in a sealed bag together with the mAb-AuNP conjugates, which were freeze-dried using a vacuum freeze dryer (at pg. 7800, left col. para. 1). Note the recitation of “for detecting an analyte in a sample” is directed to intended use. The intended use must result in a structural difference between the claimed structures and prior art’s structures to patentably distinguish the claimed invention.
With respect to claim 27, Peng does not specifically teach the phrase “kit”. However the phrase is not found to further limit the scope of the claims beyond the phrase kit. This terminology of a “kit” does not clearly invoke any additional ingredients or provide antecedent basis (such as specific packaging or container elements, for example). Consequently, when the claim is given their broadest reasonable interpretation, the teachings of the reference are anticipatory even though the reference does not employ the word "kit" in describing their invention, as the reference teaches all necessary reagents of the claimed “kit”. See also MPEP 2111.02.
With respect to claim 32, Peng teaches the strips were cut and stored in a sealed bag together with the mAb-AuNP conjugates, which were freeze-dried using a vacuum freeze dryer (at pg. 7800, left col. para. 1). Fig. 1 shows a lateral flow test strip dipstick.
With respect to claims 33-35, the sample is part of the intended use, which is not part of the kit comprising at least one container with dried antibody nanoparticle conjugate, and at least one lateral flow test strip dipstick. Thus, the kit still contains at least one container with dried antibody nanoparticle conjugate, and at least one lateral flow test strip dipstick.
With respect to claim 36, the claim is interpreted as part of the kit claim that contains merely instructions for the workflow that involves the intended use. As stated in the indefiniteness rejection, the claim lacks antecedent basis to the structure of the kit. Because this claim is dependent from a kit, these limitations are intended use if/when the liquid sample is applied.
Claims 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parnsubsakul et al. (“Selection of cryoprotectants for freezing and freeze-drying of gold nanoparticles towards further uses in various applications”, Colloids and Surfaces B: Biointerfaces, vol. 217 (2022), 112702, pgs. 1-10, published 07/14/2022).
With respect to claim 26, Parnsubsakul teaches cryopreservation of AuNPs without aggregation for long-term stability and all cryoprotectants for preventing citrate-capped AuNPs from irreversible aggregation under freezing (at abstract). Parnsubsakul teaches for freeze-drying, the samples were frozen by fast immersion in liquid nitrogen, followed by connecting immediately to a freeze-dryer and the resulting AuNP lyophilizates were stored in a desiccator (at pg. 2, right col., para. 1 of section 2.2), which would read on a device comprising at least one container with dried nanoparticle conjugate. Note that the claimed invention only requires one container with dried nanoparticle conjugate as the device. Also, the recitation of “for detecting an analyte in a sample” is directed to intended use. The intended use must result in a structural difference between the claimed structures and prior art’s structures to patentably distinguish the claimed invention. Parnsubsakul’s citrate-capped AuNPs stored in desiccator would read on all the claimed device comprising a container with dried nanoparticle conjugate.
With respect to claim 27, Parnsubsakul’s citrate-capped AuNPs stored in desiccator would read on a kit. Parnsubsakul does not specifically teach the phrase “kit”. However the phrase is not found to further limit the scope of the claims beyond the phrase kit. This terminology of a “kit” does not clearly invoke any additional ingredients or provide antecedent basis (such as specific packaging or container elements, for example). Consequently, when the claim is given their broadest reasonable interpretation, the teachings of reference are anticipatory even though the reference does not employ the word "kit" in describing their invention, as the reference teaches all necessary reagents of the claimed “kit”. See also MPEP 2111.02.
Claims 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mirica et al. (“Latest Trends in Lateral Flow Immunoassay (LFIA) Detection Labels and Conjugation Process”, Frontiers in Bioengineering and Biotechnology, vol. 10, June 2022, Article 922772, pgs. 1-22).
Mirica teaches LFIA tests consist of individual segments, namely pads, made of various materials and the sample is placed on a pre-treated sample pad, and the dried conjugate is applied to the conjugation pad, which is usually made of fiberglass or polyester and interacts with the analyte present in the sample (at pg. 2, right col., para. 2 and Fig. 1). Also, Fig. 1 shows at least one lateral flow test strip, wherein the lateral flow matrix comprises at least one sample zone and at least one detection zone. Note the recitation of “for detecting an analyte in a sample” is directed to intended use. The intended use must result in a structural difference between the claimed structures and prior art’s structures to patentably distinguish the claimed invention.
With respect to claim 27, Mirica does not specifically teach the phrase “kit”. However the phrase is not found to further limit the scope of the claims beyond the phrase kit. This terminology of a “kit” does not clearly invoke any additional ingredients or provide antecedent basis (such as specific packaging or container elements, for example). Consequently, when the claim is given their broadest reasonable interpretation, the teachings of the reference are anticipatory even though the reference does not employ the word "kit" in describing their invention, as the reference teaches all necessary reagents of the claimed “kit”. See also MPEP 2111.02.
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:
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.
Claims 26-36 are rejected under 35 U.S.C. 103 as being unpatentable over Peng et al. (“Multiplex lateral flow immunoassay for five antibiotics detection based on gold nanoparticle aggregations”, RSC. Adv., 2016, vol. 6, pgs. 7798-7805, published 01/11/2016) in view of Porter et al. (WO2021186003A1, published 09/23/2021).
Peng has been discussed in the above rejection. Also, Peng teaches an immunochromatographic assay was developed and five mAbs were conjugated to colloidal gold nanoparticle, forming AuNP-labeled antibodies which were placed in a microtiter well after freeze-drying (abstract and see above). Fig. 1 shows at least one later flow test strip, wherein the lateral flow matrix comprises at least one sample zone (i.e., sample pad) and at least one detection zone (i.e., test and control lines). Peng teaches the end of the test strip sample pad was placed into the microtiter wells and 100 µL of extracts with and without standards was added to the wells with the five freeze-dried antibody-AuNP conjugates (at pg. 7803, left col., section 3.3). Peng also teaches the test strips are stored in a sealed bag with the mAb-AuNP conjugates, which were freeze-dried using a vacuum freeze dryer (at pg. 7800, left col. para. 1).
Although Peng teaches the freeze-dried AuNP-labeled antibodies are stored with the test strips in a sealed bag, the reference does not teach that the container with dried nanoparticle conjugate does not contain the lateral flow test strip in a device (claim 26), a lateral flow cassette kit (claim 28) and a lateral flow dipstick kit (claim 32).
Porter teaches a lateral flow device (at abstract). Porter teaches the later flow device is placed into a container (at Fig. 1 and pg. 28, lines 12-20). Porter teaches the lateral flow device comprises a cassette or dipstick (at pg. 16, lines 5-10). Porter teaches a test strip (at pg. 13, lines 1-5). Porter teaches nitrocellulose, cellulose acetate or paper (at pg. 16, lines 1-5). Porter teaches gold nanoparticle are used in the lateral flow device (at pg. 11, lines 5-15).
Thus, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have stored the freeze-dried AuNP-labeled antibodies in a container as taught by Peng separately from the lateral flow device as taught by Porter because Peng teaches the freeze-dried AuNP-labeled antibodies are mixed in the sample solution for specific antibody conjugation and Porter teaches the sample solution is in a container. Thus, it would have been obvious to have stored the freeze-dried AuNP-labeled antibodies in a container separated from the test strip in the seal bag of Peng because the container would provide the ability to store the freeze-dried AuNP-labeled antibodies and the sample can be added to the container for activating antibody detection on the gold nanoparticles.
Additionally, it would have been obvious to have used the lateral flow device of Peng in a lateral flow test strip cassette or a dipstick as taught by Porter because Porter teaches its lateral flow device includes a cassette or dipstick. Meanwhile, it would have been obvious to have used Peng’s device in a cassette because Peng and Porter both recognize dipping lateral flow device in a container to perform the assay detection.
The person would have a reasonable expectation of success in containing the freeze-dried AuNP-labeled antibodies in a container separate from the test strips within a sealed bag because it has been well understood in the art to perform the assay reaction in a solution container at the time the sample is added.
With respect to claim 27, Peng does not specifically teach the phrase “kit”. Porter teaches Kit (at pg. 17, lines 30-35). However, the phrase is not found to further limit the scope of the claims beyond the phrase kit. This terminology of a “kit” does not clearly invoke any additional ingredients or provide antecedent basis (such as specific packaging or container elements, for example). Consequently, when the claim is given their broadest reasonable interpretation, the teachings of the reference are anticipatory even though the reference does not employ the word "kit" in describing their invention, as the reference teaches all necessary reagents of the claimed “kit”. See also MPEP 2111.02.
With respect to claims 28-31, Note that the recitation of “for identifying fentanyl and analogs in a sample using the device” is intended use. The intended use must result in a structural difference between the claimed structures and prior art’s structures to patentably distinguish the claimed invention. Meanwhile, the sample is part of the intended use, which is not part of the kit comprising at least one container with dried antibody nanoparticle conjugate, and at least one lateral flow test strip dipstick. Thus, the kit still contains at least one container with dried antibody nanoparticle conjugate, and at least one lateral flow test strip cassette.
With respect to claim 32, Peng teaches the strips were cut and stored in a sealed bag together with the mAb-AuNP conjugates, which were freeze-dried using a vacuum freeze dryer (at pg. 7800, left col. para. 1). Fig. 1 shows a lateral flow test strip dipstick.
With respect to claims 33-35, the sample is part of the intended use, which is not part of the kit comprising at least one container with dried antibody nanoparticle conjugate, and at least one lateral flow test strip dipstick. Thus, the kit still contains at least one container with dried antibody nanoparticle conjugate, and at least one lateral flow test strip dipstick.
With respect to claim 36, the claim is interpreted as part of the kit claim that contains merely instructions for the workflow that involves the intended use. As stated in the indefiniteness rejection, the claim lacks antecedent basis to the structure of the kit. Because this claim is dependent from a kit, these limitations are intended use if the liquid sample is applied.
Thus, “instructions for use” is not found to be limiting in such a case as this; where the only difference between a prior art’s product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). See MPEP 2112.01.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAM P NGUYEN whose telephone number is (571)270-0287. The examiner can normally be reached Monday-Friday (8-4).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
