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 .
Election/Restrictions
Applicant’s election without traverse of invention I, claims 1 and 3 in the reply filed on 06/16/2026 is acknowledged.
Claims 2 and 4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/16/2026.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 11,609,224 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the instant claim is anticipated by those of the noted patent.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of U.S. Patent No. 11,248,994 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the instant claim is anticipated by those of the noted patent.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,276,584 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the instant claim is anticipated by those of the noted patent.
Claim Objections
Claim 3 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim as it refers back to more than one previous claim and not in the alternative manner as required. “A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed.” See MPEP § 608.01(n). Claim 3 has been treated on the merits at this time due to the nature of it being a substantial duplicate of claim 1, merely in method form. However, if the issue is not resolved in a subsequent reply the claim will not be treated on the merits in being an improper multiple dependent claim.
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 3 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.
As to claim 3, the examiner is unclear which dependent claim that claim 3 depends from. As noted above in the claim objection, the claim is in improper multiple dependent form. Specifically, claim 3 depends currently both on claim 1 and 2 and not in the alternative form. As this is not permitted the examiner will interpret for examination purposes the claim merely to dependent from the elected claim 1.
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:
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.
Claim(s) 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (U.S. PGPub No. 2014/0170757 A1) in view of Chou et al. (WO 2017/027643 A1) further in view of Pan (U.S. Patent No. 7,538,922 B2).
As to claim 1, Tsai discloses and shows in figure 2B and 3, an adapter device for analyzing an analyte in a liquid sample, comprising:
a) an attachment member (306) configured to attach the adapter device (300) to an apparatus (204) that comprises a light source (206B) and a camera (208) ([0036]; [0038], ll. 1-8);
(b) a card slot (302) configured to accommodate a sample card (202), which contains a liquid sample (i.e. blood) that is compressed, wherein when the sample card inserted into the card slot, the sample is positioned under the view of the camera and the light source ([0004], [0038]; [0095]);
(c) the light source forms a first beam (explicitly shown in figure 3 via arrows) with a specific wavelength range (all light sources inherently have a wavelength range, no known source is capable of producing all wavelengths, even so that would still be a range encompassing all wavelengths), wherein a part of the first beam illuminates on the edge (i.e. via the top edge relative to page as explicitly shown) of the sample card and travels in the sample card to illuminate the sample (explicitly shown via arrow prior to reaching detector 208) ([0039]);
(d) a mirror (310) configured to deflect part of the first beam to form a second beam that back-illuminates (since no frame of reference is provided in the claim, the examiner is interpreting the surface of the sample impingement as the back of the test strip) the sample in an oblique angle (explicitly the angle of illumination is not 90 degrees and thus oblique) ([0039]; [0040]); and
Tsai does not explicitly disclose where the liquid sample is compressed into a layer of uniform thickness.
However, Chou does disclose in (page 5, ll. 19-33) the use of a similar sample holder that uses spacers with predefined dimension so that the sample under test can be compressed between two plates to form a uniform sample thickness layer.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsai where the liquid sample is compressed into a layer of uniform thickness in order to provide the advantage of increased accuracy as explicitly noted by Chou this sample holder formation ensures sample layer thickness is uniform so that the volume of the sample can be readily calculated with high accuracy, obviously having uniform thickness in an optical system provided the further advantage of predicable light/sample interaction analysis.
Tsai in view of Chou does not explicitly disclose an absorber configured to absorb at least a part of the first beam that is not deflected by the mirror.
However, Pan does disclose and show in figure 4 and in (col. 3, ll. 4-7; col. 4, ll. 8-10; col. 6, ll. 34-42) the use of light absorbing layers (122/152) the absorb unwanted scattered light or essentially any light in the enclosed area to remove potential optical noise from the system. The examiner notes that although Pan deals with spatial light modulators, the core concept and motivation remains the same for both optical system, particularly the removal of unwanted light (e.g. scattered or un-deflected) from the system.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsai in view of Chou with an absorber configured to absorb at least a part of the first beam that is not deflected by the mirror in order to provide the advantage of increased accuracy as noted explicitly by Pan using absorber layers is well-known in the optical art to mitigated unwanted light from reaching undesired areas, in other words using an absorber layer of Chou in Tsai would remove unwanted noise from the system by absorbing any light that wasn’t directly reflected by the mirror of Tsai.
As to claim 3, Tsai discloses and shows in figure 2B and 3, a method for analyzing an analyte in a liquid sample, comprising:
(a) obtaining the liquid sample (in the reaction area) ([0004]; [0034], ll. 10-16; [0095];
(c) inserting the sample card into the adaptor device, which is configured to be attached to an apparatus that comprises a light source and a camera ([0004]; [0038]);
(d) illuminating the sample with light from the light source ([0039]),
wherein i. the light forms a first beam with a specific wavelength range, part of the first beam illuminating on the edge of the sample card and travels in the sample card to illuminate the sample ii. part of the first beam is deflected by a mirror of the adapter device to form a second beam that back-illuminates the sample in an oblique angle ([0039], specific interpretations are already provided above in claim 1’s rejection);
Tsai does not explicitly disclose compressing at least part of the sample into a layer with the sample card.
However, Chou does disclose in (page 5, ll. 19-33) the use of a similar sample holder that uses spacers with predefined dimension so that the sample under test can be compressed between two plates to form a uniform sample thickness layer.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsai at least part of the sample into a layer with the sample card in order to provide the advantage of increased accuracy as explicitly noted by Chou this sample holder formation ensures sample layer thickness is uniform so that the volume of the sample can be readily calculated with high accuracy, obviously having uniform thickness in an optical system provided the further advantage of predicable light/sample interaction analysis.
Tsai in view of Chou does not explicitly disclose at least a part of the first beam that is not deflected by the mirror is absorbed by an absorber of the adapter device.
However, Pan does disclose and show in figure 4 and in (col. 3, ll. 4-7; col. 4, ll. 8-10; col. 6, ll. 34-42) the use of light absorbing layers (122/152) the absorb unwanted scattered light or essentially any light in the enclosed area to remove potential optical noise from the system. The examiner notes that although Pan deals with spatial light modulators, the core concept and motivation remains the same for both optical system, particularly the removal of unwanted light (e.g. scattered or un-deflected) from the system.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Tsai in view of Chou with at least a part of the first beam that is not deflected by the mirror is absorbed by an absorber of the adapter device in order to provide the advantage of increased accuracy as noted explicitly by Pan using absorber layers is well-known in the optical art to mitigated unwanted light from reaching undesired areas, in other words using an absorber layer of Chou in Tsai would remove unwanted noise from the system by absorbing any light that wasn’t directly reflected by the mirror of Tsai.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P LAPAGE whose telephone number is (571)270-3833. The examiner can normally be reached Monday-Friday 8-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur Chowdhury can be reached at 571-272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael P LaPage/Primary Examiner, Art Unit 2877
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