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 .
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 1 and 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 1 recites the limitation "a cartridge port" in line 12. It is unclear if it is a new port or the cartridge entry port from line 5. Appropriate clarification is required.
Claim 7 recites the limitation " the first machine-readable code” and “the second machine-readable optical code” in lines 5 and 6. There is insufficient antecedent basis for this limitation in the claim.
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 (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.
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.
Claim(s) 1-5, 10-11, 13, 17, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al (2017/0113221), hereinafter "Hoffman" in view of Anderson et al (US 20040241752).
Regarding claim 1, Hoffman teach a portable point of care device for use in testing a biological sample (Fig. 1 and 10-14, Fig. 8; claim 36; para. 1-4), the device comprising: a sample collection member (Para. 0130; Fig. 1: cartridge sample port 1104), a test cartridge (see Fig. 1, cartridge 1100, a reader (Fig. 1, host instrument 5000 and see Fig. 10-14) , and an alignment pin (Fig. 13: pin connector 1304 connecting first PCB 1302 and second PCB 1301); the test cartridge (1100) comprising a housing within which is a test strip (Fig. 14, Ref. 1403; see also Fig. 9, "PCR well layer 1250"), a distal end (1103) and a proximal end (1106), the proximal end (1106) adapted to engage with a cartridge entry port of the reader (port 5030 of reader 5000); and the reader (Fig. 13: 5000) comprising a casing within which is housed an optical chassis stack (Fig. 10: detector head 311/1300; Fig. 13, housing 1303; Fig. 11, the two housing halves 312, 313 of detector head 311), and the cartridge entry port configured to accept the test cartridge (Para. 0123: docking bay 5030 of reader 5000); wherein the optical chassis stack further comprises a first printed circuit board (PCB) (Fig. 13 and 14, PCB 1302) in communication with a lens holder, which accommodates a lens (Fig. 13 and 14; Para. 0149: lens 1330), a second PCB (Fig. 13 and 14, PCB 1301) in communication with the lens holder (the holder of lens 1300; see Fig. 14, whereby both PCBs 1302 and 1301 are in optical and mechanical communication with lens 1330), a chassis in communication with the second PCB (Fig. 13 internal support elements together with some or even all internal support structures for mounting for example the PCBs 1301 and 1302 represent the "chassis"), a cartridge port with springs in communication with the chassis (Fig. 12, Para. 0147: the port formed beneath the clamping mechanism 500), and a linear sensor array in communication with the first PCB (Fig. 14, para. 0154: photo-sensors 1317 and 1337 and para 0110, "CCD'); wherein the optical chassis stack (detector head 1300/331 of Fig. 11 or 13 in combination with the support structure as shown in Fig. 11/12) further comprises a shaft traversing therethrough from the first PCB to the chassis, and configured to accommodate the alignment pin (Fig. 13: pin connector 1304) .
Hoffman teach the user inserts the sample but is silent to the sample collection member comprising a distal end, a sample chamber and a proximal end adapted to connect to the distal end of the test cartridge.
Anderson teach a point of care device having a test strip, where the sample is applied to the test strip using a standard plastic pipet (Para. 0131: pipet reads on "the sample collection member comprising a distal end, a sample chamber and a proximal end adapted to connect to the distal end of the test cartridge" as the pipet is adapted to deliver sample with two ends, the one end to connect to the test strip). Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the plastic pipet of Anderson to the system of Anderson to provide the above advantage of delivering sample to the test strip.
Regarding claim 2, Hoffman/Anderson teach the shaft (Fig. 13: pin connector) comprises at least three or four engagement mechanisms, wherein a first engagement mechanism is an aperture at the entrance to the shaft on the first PCB; a second engagement mechanism is an aperture located on the second PCB; and a third engagement mechanism and, a fourth engagement mechanism are snap-fit elements located on the chassis that engage with the alignment pin. (Fig. 13: pin connector has multiple engagement mechanisms to the aperture on the first and second PCB, it is noted that the fourth engagement mechanism is not required)
Regarding claim 3, Hoffman/Anderson teach the second PCB comprises an aperture and an illuminating light source (Fig. 13: second PCB comprises light source 1331/1332).
Regarding claim 4, Hoffman/Anderson teach the illuminating light source sits below and to one side of the linear sensor array (Fig. 13: light source 1331 sits "below" sensor array 1337 (" below" is a relative term and depends on the orientation/positioning of the sensor head 1300)
Regarding claim 5, Hoffman/Anderson teach the light emitted from the light source is directed to the test strip at an angle via sloped sides on a cartridge window (Fig. 14: light from light source 1331 is directed to the test strip 1402 via sloped sided of mirror element 1334)
Regarding claim 10, Hoffman/Anderson teach the lens is in the form of a lens array. (Fig. 13, the two lenses 1310 and 1330;)
Regarding claim 11, Hoffman/Anderson teach the lens is a rod lens ((Fig. 13, the two lenses 1310 and 1330, it is noted that "rod lens" is sufficiently broad to read on a cylindrical lens)
Regarding claim 13, Hoffman teach a cartridge to detect nucleic acid with membranes (Para. 0012), Hoffman is silent to test strip comprises a sample pad, a conjugate pad, a testing membrane and a wicking pad; the test strip is impregnated with one or more reagents that react with one or more target molecules in the test sample, wherein the reagent is selected from an antibody, a labelled antibody, a nucleic acid, a labelled nucleic acid, a protein scaffold, a labelled protein scaffold, a peptide aptamer, a labelled peptide aptamer, and RNA aptamer, a labelled RNA aptamer, or a combination thereof; the test strip is in a sandwich format and consists of a nitrocellulose membrane upon which an antibody to the target molecule and a control antibody have been immobilised.
Anderson teach test strip for nucleic acid assays (Para. 0009) comprises a sample pad, a conjugate pad, a testing membrane and a wicking pad (Para. 0107); the test strip is impregnated with one or more reagents that react with one or more target molecules in the test sample, wherein the reagent is selected from an antibody, a labelled antibody, a nucleic acid, a labelled nucleic acid, a protein scaffold, a labelled protein scaffold, a peptide aptamer, a labelled peptide aptamer, and RNA aptamer, a labelled RNA aptamer, or a combination thereof (Para. 0107) ; the test strip is in a sandwich format and consists of a nitrocellulose membrane upon which an antibody to the target molecule and a control antibody have been immobilised (Para. 0014; 0061). It is advantageous to provide the lateral flow assay to specifically detect analytes such as nucleic acids. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the arrangement of Anderson to the device of Hoffman to provide the above advantage of detecting nucleic acids with specificity.
Regarding claim 17, Hoffman/Anderson teach the sample collection member collects bodily fluid by capillary action, aspiration or under vacuum. (Para. 0092)
Regarding claim 28, Hoffman/Anderson teach use in (i) monitoring an immune status of an individual, or (ii) for assessing an infection status of an individual, or (iii) for predicting a health event in an individual, or (iv) for determining whether an individual is suffering from a disease, or a combination thereof. (Para. 0005,0052:analysis of test samples with target infectious agents)
Claim(s) 6-7, 14, 16, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman/Anderson in view of Markart (USP 5281395).
Regarding claims 6-7, 14, 16 Hoffman/Anderson teach using a code for information stored (Anderson Para. 0084), but are silent to a first machine-readable optical code comprising timing data and a second machine-readable optical code comprising a batch identifier; the linear sensor array comprises at least two optical readers in the form of a first optical reader and a second optical reader; wherein the first optical reader is configured to determine a speed that the test cartridge is inserted into the reader by reading and interpreting the first machine-readable code, and the second optical reader is configured to read and interpret the second machine-readable optical code on the test cartridge.
Markart teach a first machine-readable optical code comprising timing data and a second machine-readable optical code comprising a batch identifier; the linear sensor array comprises at least two optical readers in the form of a first optical reader and a second optical reader; wherein the first optical reader is configured to determine a speed that the test cartridge is inserted into the reader by reading and interpreting the first machine-readable code, and the second optical reader is configured to read and interpret the second machine-readable optical code on the test cartridge. (col. Fig. 3: clock track 15 and data track 17 read by first and second reader units 43 and 44). It is advantageous to provide a both clock and data codes to aid in high degree of reading reliability irrespective of the speed of the movement of the code (col. 3 lines 25-35) Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the codes and readers of Markart to the system of Hoffman/Anderson to provide the above advantage of providing reading reliability irrespective of the speed of the movement of the code.
Regarding claim 18, Hoffman/Anderson/Markart teach the test cartridge further comprises at least one machine-readable optical code encoding information that is read by the at least one optical reader in the linear sensor array (Markart: Fig. 3: data track 17).
Regarding claim 19, Hoffman/Anderson/Markart teach wherein result data from the test cartridge can be transmitted to a remote device over a wireless communication means for display by the remote device, and wherein the remote device is a mobile phone device or electronic tablet device (Hoffman: Para. 0127).
Claim(s) 21, 30, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman/Anderson in view of Taran (WO 2020/016616)
Regarding claims 21, 30, and 31, Hoffman/Anderson teach the reader further comprises a microcontroller and a memory coupled with the microcontroller, (Para. 0127: controller 10003 and ROM and RAM). Hoffman/Anderson are silent to wherein the memory comprises executable program instructions to configure the microcontroller to perform the steps of: receiving by the reader via wireless communication, batch data from an application associated with the reader residing on a mobile device; and storing the received batch data in the memory; a cloud database for storing batch data obtained during manufacture of a batch of the test cartridges ; and an application associated with the reader downloadable to a mobile user device, wherein the application is configured to receive batch data transmitted from the cloud database and result data transmitted by the reader and to transmit batch data to the reader; batch data obtained during manufacture of a batch of the test cartridges is uploaded to the cloud database, wherein the application is further configured to send result data to the cloud database.
Taran teach the memory comprises executable program instructions to configure the microcontroller to perform the steps of: receiving by the reader via wireless communication, batch data from an application associated with the reader residing on a mobile device; and storing the received batch data in the memory (p. 12 lines 1-16: QR codes with batch data; p. 27 line 14-15 mobile application); a cloud database for storing batch data obtained during manufacture of a batch of the test cartridges ; and an application associated with the reader downloadable to a mobile user device, wherein the application is configured to receive batch data transmitted from the cloud database and result data transmitted by the reader and to transmit batch data to the reader (P. 27 line 14-15); batch data obtained during manufacture of a batch of the test cartridges is uploaded to the cloud database, wherein the application is further configured to send result data to the cloud database (p. 27 lines 20: cloud platform includes batch data). It is advantageous to provide the cloud and wireless communication with the batch data to ensure the system is connected to up to date information in the cloud. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the system above of Taran to the system of Hoffman/Anderson to provide the above advantage of ensuring the system is connected to up to date information in the cloud.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman/Anderson in view of Hart et al (US 20170023457)
Regarding claim 12, Hoffman/Anderson teach sensor, but are silent to the inner surfaces of the optical chassis stack are coated with, or are partly formed with, a light-absorbing paint or a light-absorbing material.
Hart et al teach a portable sensor having the enclosure of the optical system coated with light absorbing paint (para. 0029). It is advantageous to provide the coating of light absorbing paint to sensors to avoid stray light from reaching the sensor. (Para. 0029). Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the light absorbing paint of Hart to Hoffman/Anderson system to provide the above advantage of avoiding stray light from reaching the sensor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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, Maris R. Kessel can be reached at (571) 270-7698. 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.
/Dennis White/Primary Examiner, Art Unit 1758