DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The IDS received on December 17, 2024 is proper and is being considered by the Examiner. The citations pertaining to provisional applications have been lined-through as they are not publicly available application, having no publication date.
Drawings
The drawings received on September 18, 2024 are acceptable.
Claim Interpretation
The term, “conjugate release pad” has been construed as defined in section [0100] of the instant specification:
“The sample pad is situated within the device such that it is in physical contact with the conjugate release pad, a matrix composed of a material with minimal nucleic acid binding capacity and of a physical composition which allows dried detection particles to be liberated into solution with minimal residual binding to the matrix.”
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 3-7 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 3 is indefinite for reciting the phrase, “detection zone matrix is additionally patterned with sites comprising a localized concentration of … negative controls” because it is unclear how a detection zone matrix is patterned for the detection of a negative control. While a positive and negative detection result could occur in a test zone (e.g., two lines for true positive (control + test-positive) vs one line for negative (control + test-negative), it is unclear what is meant by a detection zone that is patterned with sites that comprises a localized concentration of negative controls). In addition, the application as originally filed does not appear to provide any guidance for such a configuration. For example, section [0044] of the instant specification appears to discuss negative controls but this is made in reference to a gel-run on an amplification reaction (see Fig. 1, left gel-run, lane 2), but there is no pattern that is observed from the localized concentration that is produced from “negative controls” on the right side of the Figure that contains a lateral flow assay.
Claims 4-7 are indefinite by way of their dependency on claim 3, and no additional interpretation could be made for these claims for the purposes of prior art.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 2, and 8-10 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Ebersole et al. (U.S. Patent No. 6,037,127, issued March 13, 2000).
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With regard to claim 1, Ebersole et al. teach a test device comprising the below depicted configuration (from FIGs. 1A and 10A, left to right, respectively):
As seen, the device comprises:
a sample receiving zone for receiving an aliquot of a sample, said receiving zone comprising sample zone matrix with minimal nucleic acid binding properties (see the left region where the samples are loaded, also “sample application zone”, “application zone which receives a liquid sample containing nucleic acid analytes”, column 11, lines 6-8; the strip is nitrocellulose membrane which has minimal nucleic acid binding properties as the nucleic acid is allowed to migrate); and
a detection zone in lateral flow contact with the sample zone, said detection zone comprising a detection zone matrix containing a pattern of an immobilized capture oligonucleotide formed on the detection zone matrix (see capture zone above, also “at least one capture moiety irreversibly affixed to the test strip at a specific capture zone”, column 3, lines 56-57; also “immobilized capture nucleic acid located in the capture zone”, column 11, lines 3-4).
With regard to claim 2, see the pattern of the immobilized capture reagents (above Fig. 10A).
With regard to claim 8, the sample zone and the detection zone matrix are absorbent materials (the sample applied from sample zone is migrated toward the detection zone via capillary migration that results from absorbance of the aqueous solution, see “test strip comprising a chromatographic material capable of moving the test sample laterally from the first end to the second end of the test strip by capillary migration”, column 3, lines 53-55).
With regard to claims 9 and 10, the test strip is made of nitrocellulose membrane (see column 28, lines 13-16, “lateral flow buffer was applied to the application zone of the prepared nitrocellulose test strip”).
Therefore, the invention as claimed is anticipated by Ebersole et al.
Claims 1 and 11-18 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Gerdes et al. (US2004/0110167, published June 10, 2004).
With regard to claim 1, Gerdes et al. teach a lateral flow device comprising: (a) a sample receiving zone (102, Figure 4A) and a detection zone (108, Figure 4B) (see also below):
“sample receiving zone 102 serves to receive a fluid sample which may contain the target nucleic acid and begin the flow of the sample along the test strip …” (section [0082)
“receiving zone for receiving an aliquot of … sample” (section [0024])
“binding partner (A) can be coupled to the target nucleic acid … Ligand (A’) is designed to specifically recognize and bind to binding partner (A) coupled to the target nucleic acid … capture zone 108 containing capture moiety (B’) is designed to specifically recognize and bind to binding partner (B) coupled to the oligonucleotide probe.” (section [0105])
Gerdes et al. teach that the term, “binding partner” refers to member of a pair molecules capable of recognizing a specific structural aspect of another molecule, wherein the artisans explicitly contemplate the binding partner being complementary nucleic acid fragments:
“the term, ‘binding partner’ refers to a member of a pair of molecules and/or compositions capable of recognizing a specific structural aspect of another molecule or composition, wherein the binding partners interact with each other by means of specific, noncovalent or covalent interactions. Examples of such binding partners and corresponding molecules or compositions include, but are not limited to … complementary nucleic acid fragments …” (section [0088])
With regard to claim 11, the lateral flow device further comprises a labeling zone (see 104, Fig. 4A) in lateral flow contact with the sample receiving zone, said labeling zone comprising a labeling zone matrix embedded with a detection oligonucleotide coupled to a detection label, wherein the detection zone is in lateral flow contact with the labeling zone (the labeled product from zone 104 migrates through migration region 106 toward the detection zone 108).
With regard to claims 12 and 13, the labeling zone matrix is an absorbent material (“labeling zone comprising a porous material having at least first visible moiety”, section [0019]; also “labeling zone material include, but are not limited to, porous or microporous materials such as glass (e.g., borosilicate glass fiber), cotton, cellulose, polyester …”, section [0089]).
With regard to claims 14 and 15, the detectable label is colloidal gold (“visible moieties according to this invention are microparticles … such as dyed particle … Any suitable insoluble particle may be employed for purposes of this invention, including but not limited to … polystyrenes … colloidal gold … colored dye”, section [0129]; also “first and second visible moieties contain microparticles of different colors (e.g., blue and yellow) …”, section [0092]).
With regard to claim 16, the labeling zone matrix and the detection zone matrix form a lateral flow matrix that transports the sample from sample receiving zone to the detection zone (see above, also Fig. 4A and 4B).
With regard to claim 17, the lateral flow device comprises zones that are made of sample pad (i.e., pad that receives the aliquot of the sample), a conjugate release pad (labeling zone where the label is released to bind to the target, also “sample wicks sequentially from said sample receiving zone to a labeling zone and to a capture zone … probes are released from said test strip and specifically hybridizes to said target nucleic acid upon contact … at least a first visible moiety coupled to a first ligand and reversibly bound to said test strip, wherein said first ligand specifically binds said first binding partner”, section [0030]) and a microporous membrane strip (“capture zone comprises a capture moiety immobilized to a portion of said test strip”, section [0030], all made of the same material).
With regard to claim 18, the flow matrix comprises a wicking pad at the end to help flow the sample down from the sample receiving end to the sample detection end (see 112, Fig. 4A, also “absorbent pad or zone 112 is an absorbent material … helps to draw a test sample from the sample receiving zone to the distal end of the test strip by capillary action”, section [0094]).
Therefore, Gerdes et al. anticipate the invention as claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 19 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gerdes et al. (US2004/0110167, published June 10, 2004) in view of Glynou et al. (Analytical Chemistry, 2003, vol. 75, pages 4155-4160).
The teachings of Gerdes et al. have already been discussed above.
While Gerdes et al. teach a lateral flow device comprising a sample pad and the conjugate release pad overlapping the microporous membrane strip by 1-2 mm (see 106 overlap with 102 and 104, Fig. 4B), the artisans do not each that the sample zone being laminated to the conjugate release pad and conjugate release pad laminated to microporous membrane strip.
Glynou et al. teach a well-known configuration of having overlap of various regions in a lateral flow test device wherein the artisans expressly teach an absorbent pad being positioned above a flow membrane, overlapping by 2mm, conjugate pad overlapping by 2 mm and in being placed below the membrane:
“absorbent pad … was placed above the membrane, overlapping by 2 mm … conjugate pad … was placed below the membrane, overlapping by 2 mm …” (page 4157, 1st column)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Gerdes et al. with the teachings of Glynou et al., thereby arriving at the invention as claimed for the following reasons.
Combinations of elements of prior art known element that do not yield more than a predictable outcome is deemed obvious as such combination results from incorporating elements that have been well-known and incorporated for reasons known, or as an industry standard.
“[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395.
“In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
As evidenced by Glynou et al., the overlap of different regions of a lateral flow membrane in the amount of 2 mm had been known to be employed in the art long before the time the invention was made, as well as their overlap. And while neither Gerdes et al. nor Glynou et al. explicitly teach that the different zones are “laminated”, the lamination of such regions in adjacent arrangement would have simply produced a predictable result of allowing the different regions of Gerdes et al. to maintain its orientation and allow for the flow direction of the disclosed device.
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 August 17, 2026
/YJK/
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