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 Group I, claims 1-6 in the reply filed on is acknowledged. Currently, claims 1-7 are pending. Claim 7 is withdrawn as being directed to a non-elected invention. Accordingly, claims 1-6 are under examination.
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 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 1-6 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, step iv), the recitation “the color development intensity” there is insufficient antecedent basis for this limitation.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (US 2021/0003568) in view of Nazareth et al (US 8,999,728)
Chang et al discloses an immunodiagnostic device comprising a sample pad for receiving a sample, a conjugate pad (area) connected to the sample region and comprising probes conjugated with anti-I-hCG, anti-Bcf hCG and mouse IgG (e.g. abstract, para’s 0031-0032, 0035, 0041, 0056). Chang et al discloses that the device comprises a signal detection region that comprises a first test line having an anti-I-hCG antibody immobilized to the first test line, a second test line having an anti-Bcf hCG antibody immobilized to the second test line, and a control line comprising goat anti-mouse (e.g. abstract, para’s 0031, 0056, 0064-0071). Chang et al discloses that the device comprises a wicking region located downstream of the signal detection region which absorbs the test sample for which a signal detection reaction has terminated (e.g. abstract, para’s 0013, 0031, 0060, Fig. 1). Chang et al discloses that the antibodies in the test lines can be monoclonal antibodies (e.g. para 0054). Chang et al discloses that the probe can be gold nanoparticles (e.g. para 0035). Chang et al discloses that the signal detection area can be a nitrocellulose membrane (e.g. para 0037). Chang et al discloses that the wicking region may include a porous support and an absorbent dispersed in pores of the porous support or adsorbed or coated on a fiber of the porous support (e.g. para 0017).
Chang et al differs from the instant invention in failing to teach the conjugate pad comprises a multi-binding anti-hCG monoclonal antibody that recognized Intact hCG and Bcf hCG bonded to a probe material (cl. 1). Chang et al fails to teach an analyzer (as in claim 2). Chang et al also fails to teach the Bcf-hCG is in the first test line and the Intact hCG is in the second test line.
Nazareth et al teaches that it is known and conventional in the art to use an antibody that recognizes all isoforms and binds to intact hCG and hCG-Bcf (e.g. col 7, lines 18-27). Nazareth et al teaches that this antibody can be a monoclonal antibody (e.g. col 3, lines 24-36). Nazareth et al also teaches that it is known and conventional in the art to use a reader (analyzer) to quantify the color intensity (e.g. col 24, lines 57-67).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate the multi-binding antibody of Nazareth et al with a probe for the separate probe conjugated anti-I hCG and hCG-Bcf antibodies of Chang et al because Nazareth shows that one can use a multi-purpose antibody and one of ordinary skill in the art would recognize that this would provide for the use of less reagents in an assay and Nazareth et al further teaches that this may provide enhanced sensitivity of an assay (e.g. col 2, lines 16-26). It would have also been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate the use of an analyzer such as taught by Nazareth et al into the device of Chang et al because Nazareth et al shows that it is known and conventional. Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating the multi-binding antibody of Nazareth et al with a probe for the separate probe conjugated anti-I hCG and hCG-Bcf antibodies of Chang et al and to also incorporate an analyzer such as taught by Nazareth et al with the device of Chang et al.
With respect to the Bcf hCG in the first test line and the Intact hCG in the second test line. It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to rearrange the first and second antibodies in the test line of Chang et al, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
With respect to the recitations “for determining normal and abnormal pregnancy” and “wherein a case in which a ratio of the color development intensity of Bcf hCG with respect to the color intensity of Bcf hCG and Intact hCG, measured in the deterineation….. as recited in claim 1. This is intended use of the device and a recitation of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art and since Chang et al and Nazareth et al disclose the same components as the instantly recited claims, the combination of Chang et al and Nazareth et al reads on the instantly recited claims and is capable of use for determining normal and abnormal pregnancies and is capable of a ratio measurement when used in an equation and is capable of checking a number of weeks of pregnancy (cl. 6).
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Nam et al., (US 2009/0208983) in view of Chang et al (US 7,332,350) (Chang 1) and Nazareth et al (US 8,999,728) and further in view of Chang et al (US 2021/0003568) (Chang 2)
Nam et al discloses a device for measuring the ratio of similar structural molecules comprising a sample application pad connected to a pad containing antibody-detection marker conjugate (conjugate area) (e.g. abstract, para’s 0018, 0048, Fig 2a-2b). Nam et al discloses that the marker can be a latex bead (e.g. para 0015). Nam et al discloses that the conjugate area comprises a monoclonal antibody which recognizes both intact hCG and modified hCG (e.g. para’s 0018, 0024). Nam et al discloses the device comprises a detection area having immobilized probes in spatially separate positions from each other wherein the immobilized probes could be Intact hCG monoclonal antibody and anti-modified hCG monoclonal antibody which respectively recognize specific site on each of intact hCG and modified hCG. (e.g. para’s 0018, 0024, Figs 2a-2b). Nam et al discloses that detection area comprises nitrocellulose (e.g. para 0039). Nam et al also discloses the detection area comprises test end line (control line) (e.g. para 0039, 0047-0048, 0074). Nam et al discloses that the device comprises a sample absorbent pad (e.g. para 0018, 0048, 0074, Fig. 2b). Nam et al teaches this immunochromatographic device is used for determining a ratio in normal and ectopic pregnancies (e.g. Figs 6-7).
Nam et al differs from the instant invention in failing to teach the modified hCG is Bcf hCG. Nam et al also differs from the instant invention in failing to teach the specific order of the immobilized antibodies in the detection area. Nam et al and Chang fail to specifically teach that the conjugate antibody binds to both Intact hCG and Bcf hCG and the use of antibodies which bind specifically to Bcf hCG.
Chang 1 teaches that it is known in the art that modified hCG includes beta-core fragment and that modified hCG and Intact hCG appear differently in normal and ectopic pregnancies (e.g. col 2, lines 35-55). Chang et al teaches that antibodies can be interchanged in these assays (e.g. col 7, lines 29-39).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate beta core fragment hCG such as taught by Chang 1 for the modified hCG of Nam et al because both Nam et al and Chang et al are directed to modified hCG in normal and ectopic pregnancies and one would apply beta core fragment such as taught by Chang in the device of Nam.
It would have also been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to place antibodies for beta core fragment in the first detection line and antibodies for Intact hCG in the second detection line in Nam et al because Chang et al shows that antibodies can be interchanged in an assay. It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to rearrange the first and second antibodies in the test line of Nam et al, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Nam et al and Chang 1 fail to specifically teach that the conjugate antibody binds to both Intact hCG and Bcf hCG and the use of antibodies which bind specifically to Bcf hCG. Nam et al and Chang 1 et al also fails to teach an analyzer (as in claim 2)
Nazareth et al teaches that it is known and conventional in the art to use an antibody that recognizes all isoforms and binds to intact hCG and hCG-Bcf (e.g. col 7, lines 18-27). Nazareth et al teaches that this antibody can be a monoclonal antibody (e.g. col 3, lines 24-36). Nazareth et al also teaches that it is known and conventional in the art to use a reader (analyzer) to quantify the color intensity (e.g. col 24, lines 57-67).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate the multi-binding antibody of Nazareth et al into the modified device of Nam et al because Nazareth shows that one can use a multi-purpose antibody for bind to both Intact hCG and Bcf hCG. It would have also been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate the use of an analyzer such as taught by Nazareth et al into the modified device of Nam et al because Nazareth 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 the multi-binding antibody of Nazareth et al into the modified device of Nam et al and an analyzer such as taught by Nazareth et al.
Nam et al., Chang 1 and Nazareth et al differ from the instant invention in failing to specifically teach antibodies which bind specifically to Bcf hCG. Nam et al., Chang 1 and Nazareth et al also differ from the instant invention in failing to teach the absorption region comprises an absorbent dispersed in a pore of a porous support or adsorbed or coated on a fiber yarn of the porous support.
Chang 2 teaches that it is known and conventional in the art to use anti-Bcf hCG antibodies which specifically bind to beta core fragment hCG (e.g. abstract, 0031-0032). Chang 2 also teaches that it is known and conventional that the wicking region (absorbent region) may include a porous support and an absorbent dispersed in pores of the porous support or adsorbed or coated on a fiber of the porous support (e.g. para 0017).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate anti-Bcf hCG antibodies such as taught by Chang 2 for the immobilized antibodies in the modified device and method of Nam et al because Chang 2 shows it is known and conventional and one of ordinary skill in the art would use the appropriate antibody for the desired substance, in this case beta core fragment hCG. It would have also been obvious to one of ordinary skill in the art to incorporate a porous support such as taught by Chang 2 into the modified device of Nam et al because Chang 2 shows that it is known and conventional in the art. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating anti-Bcf hCG antibodies such as taught by Chang 2 for the immobilized antibodies in the modified device and method of Nam et al and to also include a porous support such as taught by Chang 2 into the modified device of Nam et al.
With respect to the recitations “for determining normal and abnormal pregnancy” and “wherein a case in which a ratio of the color development intensity of Bcf hCG with respect to the color intensity of Bcf hCG and Intact hCG, measured in the deterineation….. as recited in claim 1. This is intended use of the device and a recitation of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art and since Chang et al and Nazareth et al disclose the same components as the instantly recited claims, the combination of Chang et al and Nazareth et al reads on the instantly recited claims and is capable of use for determining normal and abnormal pregnancies and is capable of a ratio measurement when used in an equation and is capable of checking a number of weeks of pregnancy (cl. 6).
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lim et al (US 20220146509) discloses a chromatography strip for diagnosing pregnancy and discloses the strip comprises a sample pad, test lines 1 & 2, a control line and an absorbent pad (e.g. abstract).
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
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