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 .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/19/24 has been entered.
Claims 1-14 are pending.
Claim Rejections - 35 USC § 102
3. 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 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.
4. 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.
5. Claim(s) 1-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bohannon et al (US 7,319,032; herein referred to as Bohannon) in light of Thermo Scientific Sodium Deoxycholate Detergent.
Bohannon et al disclose a lateral flow test device comprising an analyte binding
zone with a mobile detectable analyte binding reagent, an assay zone with immobilized
assay reagent that binds to the analyte, and a sample release zone with a bulking
material having a non-sugar sweetener compound. The sample release zone is
upstream of and in fluid communication with the assay zone (Col. 3, lines 15-37, Col.
10, lines 58-67, and Col. 11, lines 1-7). In some embodiments, the sample release zone
and analyte binding zone may form a single zone (i.e. a sample addition part that
comprises a reagent necessary for an antigen-antibody reaction) (Col. 11, lines 56-64,
and Col. 20, lines 47-57). The bulking material in the sample release zone includes a
non-sugar sweetener and optionally other reagents including surfactants, such as
sodium deoxycholate (Col. 20, lines 58-67, and Col. 21, lines 1-67 (especially line 17)). The sample release pad can be made of glass fiber (Col. 28, lines 57-59) which is defined as a “nonwoven fabric” by the instant specification (see [0013]).
With respect to claim 1, Examples 1 and 2 of Bohannon et al (Cols. 28-30) show
methods for application of the bulking material with labeled antibodies to a pad (a
sample release zone analogous to a sample addition part) where the antibodies and bulking material are applied to the pad and then baked. Page 8 of the instant
specification teaches an analogous method where surfactant is applied to a porous
support and then dried leaving a white powder of surfactant on the porous support and
page 6 lists sodium deoxycholate as a surfactant. Thus, the method thought by
Bohannon et al in Example 1 and 2 will also leave a white powder of surfactant on the
sample release zone since Bohannon et al is performing the same application and
drying steps taught by the instant specification and Bohannon et al lists sodium
deoxycholate as a surfactant.
With respect to the amendments to claim 1 which add limitations directed to the
device that the sample addition part is to be incorporated into, such limitations to the
device (separate sample addition part and labeled substance part) are considered an
intended use for the sample addition part that is made by the method of claim 1. How
the sample addition part is intended to be used after it is made has no bearing on the method that makes the sample addition part and thus does not further limit the claimed
method of making the sample addition part. Bohannon teaches the claimed sample
addition part and the method for making it.
With respect to claims 2 and 6, Thermo Scientific Sodium Deoxycholate
Detergent shows the surfactant claimed by the applicant, sodium deoxycholate, being a
water-soluble anionic surfactant, whose molecular weight is 414.6 which falls within the
range of 200 to 900 recited in claims 2 and 6.
With respect to claim 5, claim 5 has been amended to recite a device with a
separate sample addition part and a separate labeled substance part. Bohannon
teaches a device comprising a chromatographic medium that, upon wetting, allows a
sample to migrate through various zones that are in fluid communication. The
chromatographic medium includes a sample release zone with bulking material having a
non-sugar sweetener compound and other reagents including surfactants, blocking
agents, or flow reagents (i.e. a sample application part) and an analyte binding zone
with a mobile detectable analyte binding reagent (i.e. a labeled substance part) (Col. 3,
lines 15-37). Bohannon teaches that in some embodiments the sample application part
and labeled substance part overlap to form a single zone (Col. 11, lines 56-60) but in
other embodiments the sample application part and labeled substance part are separate
and distinct.
With respect to new claims 9 and 10, the blocking agents or flow reagents taught
by Bohannon in the sample application zone can be considered “sample developing
ingredients”.
In response to this rejection, Applicants argue that:
a.) The surfactant being in a white powder form under normal conditions is physical feature of the claimed surfactant. Bohannon is totally silent about applying a white powder surfactant to a sponge or nonwoven fabric pad.
b.) Bohannon describes embodiments wherein the sample release zone and analyte binding zone partially of fully overlap or form a single zone. But nowhere does the reference actually describe any embodiment wherein the sample application part and labeled substance part are separate and distinct
Applicant’s arguments have been considered but are not convincing.
a.) Claims 1 and 14 recite applying the surfactant to a sample addition part…wherein said at least one surfactant is in white powder form under normal conditions. However, the claims do not recite apply the surfactant to the sample addition part in white powder form. Claims 1 and 14 can be interpreted as applying the surfactant to the sample addition part and the surfactant is subsequently present on the sample addition part in a white powder form. Paragraphs [0017] to [0019] of the instant specification teach a method where surfactant is applied to a porous support in dissolved or aqueous solution form and then dried leaving a white powder of surfactant on the porous support and page 6 lists sodium deoxycholate as a surfactant. Examples 1 and 2 of Bohannon et al (Cols. 28-30) show analogous methods for application of the bulking material (which can include surfactants) with labeled antibodies to a pad (a sample release zone analogous to a sample addition part) where the antibodies and bulking material are applied to the pad and then baked. Thus, the method thought by Bohannon et al in Examples 1 and 2 will also leave a white powder of surfactant on the sample release zone since Bohannon et al is performing the same application and drying steps taught by the instant specification and Bohannon et al lists sodium deoxycholate as a surfactant. Following the drying step, the surfactant (i.e. sodium deoxycholate) is at normal conditions or room temperature and pressure when the pad is assembled into the complete test strip.
b.) Bohannon teaches a device comprising a chromatographic medium that, upon wetting, allows a sample to migrate through various zones that are in fluid communication. The chromatographic medium includes a sample release zone with bulking material having a non-sugar sweetener compound and other reagents including surfactants, blocking agents, or flow reagents (i.e. a sample application part) and an analyte binding zone with a mobile detectable analyte binding reagent (i.e. a labeled substance part) (Col. 3, lines 15-37). Bohannon teaches that in some embodiments the sample application part and labeled substance part overlap to form a single zone (Col. 11, lines 56-60) but in other embodiments the sample application part and labeled substance part are separate and distinct. Thus, Bohannon specifically teaches a distinct sample application part that does not contain a labeled substance.
Claim Rejections - 35 USC § 103
6. 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.
7. Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehra et al (US 2010/0136566 A1, herein referred to as Mehra) in view of Bohannon et al (US 7,319,032; herein referred to as Bohannon) in light of Thermo Scientific Sodium Deoxycholate Detergent.
Mehra teaches an immunochromatographic device comprising a sample pad (i.e.
a sample application part), a reagent pad with labeled detection reagent (i.e. a labeled
substance part), a detection zone, and an absorbent pad (see Fig. 1). The sample pad
can contain dried detergents/surfactants, such as Tween-20, Triton X-100, CHAPS, and
blocking agents, such as BSA ([0033], [0034]).
The sample pad of Mehra can be made of glass fibers (see [0027]) which is defined as a “nonwoven fabric” by the instant specification (see [0013]).
Mehra differs from the instant invention in failing to teach sodium deoxycholate
as the surfactant in the sample pad.
See above for the teachings of Bohannon and Thermo Scientific Sodium Deoxycholate Detergent. Bohannon lists sodium deoxycholate, Tween-20, and Triton X-100, CHAPS, as exemplary surfactants suitable for use in the sample application part (Col. 21, lines 12-39)
It would have been obvious to a person of ordinary skill in the art before the
effective filing date of the claimed invention to use sodium deoxycholate, as taught by
Bohannon, as a surfactant in the sample pad of Mehra because Mehra teaches Tween-
20, Triton X-100, and CHAPs as examples of surfactants in the sample pad and
Bohannon teaches that sodium deoxycholate, Tween-20, and Triton X-100, and CHAPS
are functionally equivalent surfactants. Furthermore, Mehra teaches the surfactant in
the sample pad as being in a dry form and Bohannon teaches drying surfactants, such
as sodium deoxycholate on a sample pad. A person of ordinary skill in the art
reasonably would have expected success because both Mehra and Bohannon are
directed to lateral flow device with sample pads that contain surfactants.
With respect to claims 2 and 6, Thermo Scientific Sodium Deoxycholate
detergent shows the surfactant claimed by the applicant, sodium deoxycholate, being a water-soluble anionic surfactant, whose molecular weight is 414.6 which falls within the
range of 200 to 900 recited in claims 2 and 6.
With respect to claims 9 and 10, Mehra teaches including a blocking agent, such
as BSA, with the surfactant in the sample pad. Page 13 of the instant specification
refers to BSA as a sample developing ingredient.
In response to this rejection Applicants argue that Mehra and Bohannon fail to disclose applying a surfactant (which is a white powder under normal conditions) to the sample application part.
Applicant’s arguments have been considered but are not convincing. As pointed out above, the claims do not recite apply the surfactant to the sample addition part in white powder form. Claims 1 and 14 can be interpreted as applying the surfactant to the sample addition part and the surfactant is subsequently present on the sample addition part in a white powder form. Mehra teaches the sample pad can contain dried detergents/surfactants, such as Tween-20, Triton X-100, CHAPS, and blocking agents, such as BSA ([0033], [0034]). Adding the sodium deoxycholate of Bohannon to the dried reagents in Mehra for the reasons set forth above will yield a white powder on the sample addition part as in the instant invention.
Conclusion
8. All claims are either identical to or patentably indistinct from claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 extension fee 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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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, Bao-Thuy Nguyen can be reached on 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
9/13/25