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 Arguments
The amendments and remarks, filed on 3/20/2025, has been entered. The claim amendments overcome the previous prior art rejection, and a new prior art rejection is applied to address the claim amendments.
The amendments and remarks, filed on 6/11/2025, has been entered. The claim amendments overcome the previous 112(b) rejection of claim 13.
Claim Status
Claims 11-20 are pending and being examined.
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 13 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 13 recites the limitation " a single absorbent element extending along the longitudinal axis, the single absorbent element comprising the biological liquid deposition portion and the diffusion band, the single absorbent element being of a blotting paper type" in lines 1-4. The limitation is unclear as the absorbent assembly is recited to comprises a single absorbent element, but further recites the “single” absorbent element comprising the biological liquid deposition portion and a diffusion band which would require two separate structures. Thus, is the applicant claiming that the absorbent assembly comprises the diffusion band and the single blotting paper? Is the single blotting paper independent/different from the diffusion band. For purpose of prosecution, the examiner interprets that the single blotting paper is either a diffusion blotting paper or a reservoir blotting paper, as set forth in paragraphs 11 and 42 of the specification.
The term “blotting paper type” in claim 13 is a relative term which renders the claim indefinite. The term “blotting paper type” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purpose of prosecution, the examiner interprets that the blotting paper type is either a diffusion blotting paper or a reservoir blotting paper, as set forth in paragraphs 11 and 42 of the specification.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al (US 20040082878 A1; hereinafter “Baldwin”; already of record) in view of Ren (US 20210156856 A1; hereinafter “Ren”; priority filed on 6/16/2018; already of record).
Regarding claim 11, Baldwin teaches a device to collect a sample of a biological liquid to be inserted into a portable reader to analyze the biological liquid1 (Baldwin; Abstract; An oral fluid collection and transfer device), the device comprising:
a strip extending along a longitudinal axis (Baldwin; Fig. 8, 13; para [56, 57, 58]; nitrocellulose membrane 152) and comprising, on an upper face of the strip (Baldwin; Fig. 8, 13; para [56]; The upper surface of a flat, elongate nitrocellulose membrane), a plurality of color-changing reactive elements arranged one after the other along the longitudinal axis (Baldwin; Fig. 8; para [58]; nitro-cellulose membrane 152, capture reagents 162 such as drug-protein derivatives or antibody or receptor or protein or enzyme are biochemically bound to the nitro-cellulose membrane 152…Multiple zones 162 may be used on each test strip to allow testing of more than one analyte on each strip);
an absorbent assembly (Baldwin; Fig. 12, 13; examiner interprets the absorbent assembly comprising the absorbent pad 12 and the sample pad 158) extending along the longitudinal axis (Baldwin; Fig. 13; sample pad 158 extends longitudinally) and comprising: a biological liquid deposition portion (Baldwin; Fig. 12; examiner interprets this portion as the contact point between the absorbent sample pad 158 and the absorbent pad 12) and a diffusion band to diffuse the biological liquid arranged facing the plurality of color-changing reactive elements (Baldwin; para [56]; When fluid is applied to the sample pad 158 it is drawn along the sample pad 158 by capillary action, through the conjugate release pad 156 and nitrocellulose membrane 152; examiner interprets the diffusion band as the sample pad 158. The sample pad of Baldwin which is interpreted as the diffusion band is positioned in front/before the plurality of color-changing reactive elements, thus the limitation of “facing” the plurality of reactive elements is met as seen in Figure 8 of Baldwin.);
a housing extending along the longitudinal axis between two lateral ends (Baldwin; Fig. 7; para [41]; test cartridge 100), the housing comprising:
a housing bottom (Baldwin; Fig. 8; para [50]; The test cartridge 100 is formed from a top moulding 106 and a base moulding 108), the strip being arranged on the housing bottom, transparency or translucency of the strip enables each reactive element to be arranged facing an opening of the housing bottom (Baldwin; Fig. 8; as seen in Fig. 8 the strip is positioned in front of the openings of the base);
a cover (Baldwin; Fig. 8; para [50]; The test cartridge 100 is formed from a top moulding 106 and a base moulding 108) arranged over a top of the diffusion band (Baldwin; Fig. 8, 12; Fig. 8 and 12 show that the diffusion band interpreted as sample pad 158 is enclosed by the top moulding 106), and comprising at least one protruding pattern forming a first pressing surface configured to press the diffusion band into contact with the plurality of color-changing reactive elements (Baldwin; Fig. 12; para [51]; a number of protrusions 138 which extend downwardly from the cover portion 112…The protrusions 138 act to securely hold the various components of the test strip 150 together); and
an access opening configured to provide access to the biological liquid deposition portion (Baldwin; Fig. 7, 8; para [50]; The top moulding 106 has a collection chamber 110 which extends vertically from one end of an elongate rectangular cover section 112 of the top moulding 106).
Baldwin does not teach the strip being transparent or translucent.
However, Ren teaches an analogous art of a lateral flow assay device (Ren; Abstract) comprising a transparent or translucent strip (Ren; para [44]; The membrane 104 can be transparent in the visible region) comprising, on an upper face of the strip, a plurality of color-changing reactive elements arranged one after the other along the longitudinal axis (Ren; para [44]; Capture agent may be immobilized on or within the membrane 104 using any suitable method including, for example, depositing). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the strip of Baldwin to be transparent as taught by Ren, because Ren teaches that the transparent membrane minimizes undesirable reads and increases accuracy (Ren; para [44]).
1 The limitation “to be inserted into a portable reader to analyze the biological liquid” is an intended use of the device. Functional language does not add any further structure to the device beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the preamble. Further, the limitation of the “portable reader” is not a positively recited component of the device and not required to be part of the device.
Regarding claim 12, modified Baldwin teaches the device of claim 11, wherein the biological liquid deposition portion is arranged through the access opening (Baldwin; Fig. 10, 12).
Regarding claim 13, modified Baldwin teaches the device of claim 11, wherein the absorbent assembly comprises a single absorbent element extending along the longitudinal axis, the single absorbent element comprising the biological liquid deposition portion and the diffusion band (Baldwin; para [56]; When fluid is applied to the sample pad 158 it is drawn along the sample pad 158 by capillary action, through the conjugate release pad 156 and nitrocellulose membrane 152; examiner interprets the diffusion band as the sample pad 158), the single absorbent element being of a blotting paper type (Baldwin; para [36]; the absorbent pad 12 is generally oblong in shape and made from an absorbent foam such as medical grade foam, or cellulose material).
Regarding claim 14, modified Baldwin teaches the device of claim 11, wherein the biological liquid deposition portion comprises an absorbent reservoir band distinct from the diffusion band (Baldwin; para [36]; the absorbent pad 12 is generally oblong in shape and made from an absorbent foam such as medical grade foam, or cellulose material); and wherein the housing comprises a second pressing surface configured to press at least one contact portion of the absorbent reservoir band into contact with a contact pad of the diffusion band (Baldwin; Fig. 12; para [50, 51]; the collection device 10 is inserted into the collection chamber 110… the test strip 150 which lies directly beneath the collection chamber 110 when oral fluid is transferred from the collection device 10 to the test cartridge 100).
Regarding claim 15, modified Baldwin teaches the device of claim 14, wherein the absorbent reservoir band and the diffusion band are arranged longitudinally one after the other (Baldwin; Fig. 9, 12; examiner notes that the absorbent pad 12, interpreted as the absorbent reservoir band, extends longitudinally over the sample pad 158, interpreted as the diffusion band), the reservoir band being configured to be movable in translation along the longitudinal axis; and wherein said at least one contact portion is arranged at an end of the absorbent reservoir band2, said at least one contact portion being configured to hit the second pressing surface by pushing, along the longitudinal axis, of the absorbent reservoir band and into contact with the contact pad of the diffusion band (Baldwin; Fig. 12; examiner interprets the contact portion as the area when the absorbent is compressed to release the sample onto the sample pad)3.
2 The limitation is directed to the function and/or the manner of operating the reservoir band, all the structural limitations of the claim has been disclosed by Baldwin in view of Ren and the reservoir band of modified Baldwin is capable of “being movable in translation along the longitudinal axis”. As such, it is deemed that the claimed reservoir band is not differentiated from the reservoir band of modified Baldwin (see MPEP §2114). Specifically, the orientation of the test cartridge can be positioned vertically, thus the collection device 10 which holds the sample pad, interpreted as the absorbent reservoir band, can be translated longitudinally/horizontally. Additionally, the collection device 10 may translate longitudinally when inserted vertically, because the collection device is locked into the test cartridge until the notches 133 fix the top moulding 106.
3 The limitation is directed to the function and/or the manner of operating the one contact portion, all the structural limitations of the claim has been disclosed by Baldwin in view of Ren and the one contact portion of modified Baldwin is capable of “hit[ing] the second pressing surface by pushing, along the longitudinal axis, of the absorbent reservoir band and into contact with the contact pad of the diffusion band”. As such, it is deemed that the claimed one contact portion is not differentiated from the one contact portion of modified Baldwin (see MPEP §2114). Specifically, the orientation of the test cartridge can be positioned vertically, thus the collection device 10 which holds the sample pad, interpreted as the absorbent reservoir band, can be translated longitudinally/horizontally.
Regarding claim 16, modified Baldwin teaches the device of claim 14, wherein the diffusion band and the absorbent reservoir band respectively comprise a diffusion blotting paper and a reservoir blotting paper distinct from the diffusion blotting paper (Baldwin; para [36, 56]; absorbent pad 12 is generally oblong in shape and made from an absorbent foam such as medical grade foam, or cellulose material…an absorbent sample pad 158), the reservoir blotting paper comprising a liquid absorption feature greater than that of the diffusion blotting paper (Baldwin; para [66]; As the absorbent pad 12 becomes compressed, an excess of oral fluid which had previously been absorbed in the absorbent pad 12 is squeezed out. The excess fluid runs downwards onto the sample pad 158). Examiner notes that reservoir blotting paper has a lower liquid absorption feature as the liquid is compressed, thus transferred to the sample pad.
Regarding claim 17, modified Baldwin teaches the device of claim 11, wherein the diffusion band comprises a plurality of mounting pads arranged successively along the longitudinal axis (Baldwin; Fig. 13; para [56, 57]; conjugate release pad 156 is overlapped by an absorbent sample pad 158 and is bonded at its upper surface to the lower surface of the absorbent sample pad 158…The conjugate release pad 156 holds a mobile and visible label, or marker, such as colloidal gold or coloured latex particles (or by other labels such as fluorescent or chemiluminescent label) attached to the revealing agent or ligand such as anti-drug antibody, and is in contact with the nitro-cellulose membrane 152), each reactive element being arranged under a single mounting pad, the diffusion band comprising a material recess between each of the mounting pads (Baldwin; Fig. 13; examiner interprets the recess as the area/space under the elevated portion of sample pad 158, interpreted as the diffusion band, which connects the sample pad 158 and nitro-cellulose membrane 152, which comprises the reactive elements).
Regarding claim 18, modified Baldwin teaches the device of claim 11, wherein the access opening is arranged on one of lateral ends of the housing (Baldwin; Fig. 7, 8, 9; para [53]; collection chamber 110).
Regarding claim 19, modified Baldwin teaches the device of claim 18, wherein the housing comprises two opposite longitudinal walls inside the housing forming a guideway cooperating with a removable support of the absorbent assembly (Baldwin; para [53]; he base moulding 108 contains a pair of wedge shaped notches 133), the removable support being configured to be inserted into the housing through the access opening (Baldwin; para [53]; The notches 133 help to securely fix the top moulding 106 to the base moulding 108 when the force resulting from pushing the collection device 10 into the collection chamber 110).
Regarding claim 20, modified Baldwin teaches the device of claim 11, wherein the access opening is arranged on the cover of the housing or on the housing bottom (Baldwin; Fig. 7, 8, 9; para [50]; the top moulding 106 has a collection chamber 110).
Regarding claim 21, modified Baldwin teaches a system to analyze a sample of biological liquid comprising the device of claim 11, and a reader to analyze the sample of the biological liquid (Baldwin; para [17]; The oral fluid transferred from the collection device to the test cartridge is conveyed to a test strip which is subsequently analysed by a compatible analysis device).
Response to Arguments
In the Applicant’s arguments, on page 1, the Applicant argues that Baldwin fails to teach the diffusion band facing the plurality of color-changing reactive elements. The examiner respectfully disagrees. The applicant argues that the sample pads are not facing the nitrocellulose membrane, because they are arranged one after the other. The broadest reasonable interpretation of the term “facing” is interpreted to be positioned with the face or front toward something. The sample pad of Baldwin which is interpreted as the diffusion band is positioned in front/before the plurality of color-changing reactive elements, thus the limitation of “facing” the plurality of reactive elements is met as seen in Figure 8 of Baldwin.
In the Applicant’s arguments, on page 2, the Applicant argues that the transparency or translucency of the strip enables the reactive elements to be arranged facing an opening. The examiner notes that reactive elements face the opening because the broadest reasonable interpretation of the term “facing” could be interpreted as being positioned with the face or front toward something. Thus, the nitrocellulose membrane comprising the plurality of color-changing reactive elements is positioned in front/top of the opening of the housing bottom which comprises the opening slots as seen in Fig. 8. If applicants disagree with the examiner’s interpretation. The examiner notes that Baldwin does not teach the transparency of the film, but relies on Ren. Thus, modified Baldwin teaches the film being transparent which would face the opening. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the Applicant’s arguments, on page 2-3, the Applicant argues that Baldwin does not teach the nitrocellulose membrane being transparent/translucent, thus it would not be arranged facing an opening of the housing bottom. The examiner respectfully disagrees. The broadest reasonable interpretation of the term “facing” could be interpreted as being positioned with the face or front toward something. The nitrocellulose membrane comprising the plurality of color-changing reactive elements are positioned in front/top of the opening of the housing bottom. The opening is interpreted as the slots that hold the strip as seen in Fig. 8.
In the Applicant’s arguments, on page 3, the Applicant argues that Baldwin does not teach the cover of the housing comprises protruding patters forming a pressing surface configured to press the diffusion band into contact with the plurality of color-changing reactive elements. The examiner respectfully disagrees. The limitations are directed to the function and/or the manner of operating the cover, all the structural limitations of the claim has been disclosed by Baldwin in view Ren and the cover of modified Baldwin is capable of “press[ing] the diffusion band into contact with the plurality of color-changing reactive elements”. As such, it is deemed that the claimed cover is not differentiated from the cover of modified Baldwin (see MPEP §2114).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796