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 .
Status of the claims
The Preliminary Amendment filed 09/06/23 is acknowledged and has been entered. Claims 1-95, 97-100, 102-105, 107-111, 113 and 115-121 have been canceled. Claims 96, 106, 112, 114, 122-123 and 125-128 have been amended. New claims 129-136 have been added. Accordingly, claims 96, 101, 106, 112, 114 and 122-136 are under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The instant abstract utilized implied phrases see “The present disclosure relates to”. This language should be avoided.
Specification
The disclosure is objected to because of the following informalities: The specification on page 1 should indicate the current status of all nonprovisional parent application references. For example, after the disclosure “is a divisional application of U.S. Application No. 16/965,989, filed on July 29, 2020,”. Applicant should delete the recitation “now pending” and replace it with --now abandoned--.
Appropriate correction is required.
The use of the term Tween 20 (e.g. page 16, paragraph 0054), which is a trade name or a mark used in commerce, has been noted in this application. It should be capitalized wherever it appears and be accompanied by the generic terminology.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 96, 101, 106, 112, 114 and 122-136 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 96, the recitation "e.g." renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See deficiencies throughout the claim.
Claim 96, line 6 the recitation “a sample liquid from a subject” is vague and indefinite because it is unclear if the Applicant is referring to the sample and subject recited in line 3 or if the Applicant intends another sample or subject. Please clarify.
Claim 106, the recitation "e.g." renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 112 the recitation “a subject” is vague and indefinite because it is unclear which sample the Applicant is referring to. It is unclear if the Applicant is referring to the sample in line 3 or line 6 of claim 96. Also, it is unclear if the Applicant is referring to the subject in claim 96 or not.
Claims 122-125 provides for the use of the method of claim 96, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claims 122-125 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim 126 the recitation “the HIV infection duration” there is insufficient antecedent basis for this limitation.
Claim 128, the recitation "e.g." renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See deficiencies throughout the claim.
Claim 129, the recitation "e.g." renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See deficiencies throughout the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 96, 101, 106, 112, 114 and 122-136 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The claims directed to a naturally occurring correlation of antibody avidity of anti-HIV antibody and HIV infection duration.
Step 2A, Prong 2
The additional elements of contacting a sample from a subject with a lateral test flow device comprising a porous matrix; a sample application site and a first test location comprising an immobilized first binding reagent that specifically binds to anti-HIV antibody wherein saif first binding reagent is limiting and said anti-HIV antibody is in excess, and said sample liquid flows laterally along the lateral flow test device and passes the first location to form a first detectable signal comprising multiple signal pixels and a reader does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation “assessing average antibnody avidity of said anti-viral antibody, e.g., anti-HIV antibody, is said sample liquid and/or viral, e.g., HIV infection…”. The “assessing” statement at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the average antibody avidioty being correlated HIV infection duration. No active method steps are invoked or clearly required; the “assessing” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
With respect to the “treating a subject that has been infected with HIV in the past about …” as recited in claim 127. Although the claim invokes administering a treatment to the patient, the claim as currently recited allows for a scenario wherein the subject has not been infected during the recited days and in this scenario no treatment step would be administered. Therefore, this scenario does not recite something significantly more than the judicial exception. Further, the instant claims allow for a generic treatment with any and all treatments already known in the art including rest.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by the art below it is well known routine and conventional in the art to contact a sample with a lateral flow test device and use a reader to measure signals as recited.
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
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.
Claims 96, 101, 112, 114 and 125-136 are rejected under 35 U.S.C. 103 as being unpatentable over Granade et al (“Development of a Novel Rapid HIV Test for Simultaneous Detection of Recent or Long-Term HIV Type 1 Infection Using a Single Testing Device”, AIDS Research and Human Retroviruses, 2013) in view Ehrenkranz (US 2014/0213468 A1).
Granade et al discloses a system and method for assessing HIV infection duration in a subject (abstract, p. 62, col. 1, par. 2). Granade et al discloses contacting a system with a sera sample from an individual (e.g. abstract, pgs. 62, 64). The system comprises a lateral flow test device comprising a porous matrix (nitrocellulose strips, p. 63, col. 2, par. 1, see Fig. 2) that comprises, from upstream to downstream, a sample application site configured to receive a sample liquid from a subject (sample application pad, p. 63, col. 2, par. 1; see Fig. 2), and a first test location comprising an immobilized first binding reagent that specifically binds to an anti-HIV antibody in the sample liquid having a first average antibody avidity, wherein relative to the anti-HIV antibody in the sample liquid, the first binding reagent is limiting and the anti-HIV antibody is in excess (rapid I-P assay was configured with two rIDR-M lines at different antigen concentrations (high and low) and a Protein A control line; recent and long-term infections is such that individuals with long-term infections have high antibody avidity that reacts with both the low and high rIDR-M antigen concentration lines, whereas those who are recently infected have weak avidity antibodies that react only with the high concentration rIDR-M line, p. 63, col.1-col. 2, Fig. 2), a second test location comprising an immobilized second binding reagent that specifically binds to an anti-HIV antibody in the sample liquid having a second average antibody avidity, wherein relative to the anti-HIV antibody in the sample liquid, the second binding reagent is in excess and the anti-HIV antibody is limiting, and the first average antibody avidity is higher than the second antibody avidity (p. 63, col.1-col. 2, Fig. 2).
Granade et al discloses the sample liquid flows laterally along the lateral flow test device and passes the first test location to form a first detectable signal and passes the second test location to form a second detectable signal (Fig. 2; p. 63, col. 1-col. 2). It is noted that Granade et al discloses the system comprising a lateral flow device comprising a porous matrix comprising a sample application site, a first test location comprising an immobilized first binding reagent that specifically binds to an anti-HIV antibody, and a second test location comprising an immobilized second binding reagent that specifically binds to an anti-HIV antibody as required by the claim and is considered capable of having a sample liquid flow laterally along the lateral flow test device, pass the first test location to form a first detectable signal comprising multiple signal pixels, and pass the second test location to form a second detectable signal comprising multiple signal pixels. Granade et al discloses the first detectable signal and second detectable signal are used to assess average antibody avidity of the anti-HIV antibody in the sample liquid and/or HIV infection duration in the subject (p. 63, col. 2, par. 3). Granade et al discloses the system is configured for assessing HIV infection duration from about 10 days to about 450 days (the system is configured to analyze samples characterized as recent (<180 days) or long-term (in this case >1 year) and thus reads on “configured for assessing HIV infection duration from about 10 days to about 450 days”, p. 63, col. 1, par. 3-p. 63., col. 1, par. 1; Fig. 2B).
Granade et al fails to teach a reader configured to measure both the number of the signal pixels and the intensities of the signal pixels in the first detectable signal to generate a first quantitative signal readout and to measure both the number of the signal pixels and the intensities of the signal pixels in the second detectable signal to generate a second quantitative signal readout.
Ehrenkranz et al teaches a system comprising a lateral flow immunoassay apparatus and a reader/detector device (e.g., abstract, par. 6, 12-38, 68). Ehrenkranz et al teaches the reader is configured to measure both the number of the signal pixels and the intensities of the signal pixels in a detectable signal to generate a quantitative signal readout (e.g., par. 37). Ehrenkranz et al teaches the reader is an image sensor, wherein in the image sensor is an active pixel sensor (external digital imager e.g., CCD or CMOS chip, par. 6, 68, 78, 112). Ehrenkranz et al teaches the quantitative signal readout uses an intensity count produced by taking an integrative value based on a pre- determined area and adding the intensity values (0-255) of each of the pixels (par. 112), thereby reading on “integrated pixel density unit” when this term is given its broadest reasonable interpretation.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in the system of Granade et al a reader configured to measure both the number and intensities of the signal pixels as in Ehrenkranz et al in order to provide quantitative results (Ehrenkranz, par. 5) that can be used to assess average antibody avidity and/or viral infection. One having ordinary skill in the art would have a reasonable expectation of success because both prior art references are similarly drawn to systems comprising lateral flow immunochromatographic strips that include optical signals.
With respect to claim 101, Granade et al discloses that the test device comprises a conjugate pad (labeling reagent) and that the conjugate is in dried form until use (e.g. page 63-64).
With respect to claims 114 and 130-132, Granade et al discloses the first binding reagent comprises a polypeptide that specifically binds to an anti-HIV-1 antibody and the second binding reagent comprises a polypeptide that specifically binds to an anti-HIV-1 antibody (multisubtype gp41 recombinant protein (rIDR-M) to identify recent HIV-1 infection, p. 61, col. 2, par. 2; p. 62, col. 1, par. 2; p. 63, col. 1, par. 3- p. 63, col. 2, par. 3). Accordingly, Grenade et al teaches both the first binding reagent and the second binding reagent specifically bind to an antibody against the same type of HIV (p. 61, col. 2, par. 2; p. 62, col. 1, par. 2; p. 63, col. 1, par. 3- p. 63, col. 2, par. 3).
With respect to claim 126 as currently recited. The combination of Granade et al and Ehrenkranz et al teach method steps, systems, lateral flow devices and a reader consonant to the instantly recited claims and therefore it is deemed that the HIV infection duration in the subject would be a false recency rate (FRR) of less than 10% relative to a given MDRI.
With respect to claim 127 Granade et al teaches that the identification of the HIV infection allows for treating the subject (e.g. page 66).
Claim 106 is rejected under 35 U.S.C. 103 as being unpatentable over Granade et al in view of Ehrenkranz et al as applied to claims 96, 101, 112, 114 and 125-136 above, and further in view of Galli et al (WO 2008/104081).
See above for the teachings of Granade et al and Ehrenkranz et al.
Granade et al and Ehrenkranz et al differ from the instant invention in failing to explicitly teach the subject is a human.
Galli et al teaches that it is known and conventional in the art of antibody testing for HIV diagnosis that the subject to be tested can be a human (e.g. pgs 1 and 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a human such as taught by Galli et al into the modified method of Granade et al because Galli et al shows that it is known and conventional. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a human subject such as taught by Galli et al into the modified method of Granade et al.
Claims 122-124 are rejected under 35 U.S.C. 103 as being unpatentable over Granade et al in view of Ehrenkranz et al as applied to claims 96, 101, 112, 114 and 125-136 above, and further in view of Duong et al (PLOS ONE, February 24, 2015, pages 1-15).
See above for the teachings of Granade et al and Ehrenkranz et al.
Granade et al and Ehrenkranz et al differ from the instant invention in failing to teach the use of mean duration of recent infection (MDRI) and cutoffs to assess the HIV infection duration.
Duong et al teaches that it is known and conventional in the art to apply meanduration of recent infection (MDRI) and cutoff values to assess HIV infection and Duong et al teaches that these parameters are critical for laboratory-based assays (e.g. pgs 1-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate MDRI and cutoffs such as taught by Duong et al into the modified method of Granade et al because Duong et al shows that it is known and conventional in the art ant that these parameters are critical for laboratory-based assays. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating MDRI and cutoffs such as taught by Duong et al into the modified method of Granade et al.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678