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 .
Claims Accounting
Applicant's arguments, filed 06/04/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 06/04/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 4, and 6 have been amended.
Claims 1-6 are the current claims hereby under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 6, claim 1 recites “a detection element to detect an analyte of interest using an antigen/receptor assay, which test for all pregnancy, disease, and illegal drugs” in lines 5-7. There is insufficient written description for this claim limitation. The written description recites the detection element being configured to provide a simple positive/negative indicator for the presence of an antigen being detected in par. [0017]. Paragraphs [0025-0031] describe the use of the detection element specifically in order to determine human chorionic gonadotropin (hCG), which can indicate pregnancy. The only recitations of illegal drugs are found in paragraphs [0003, 0017, and 0024], where the written description describes the general use of antigen/receptor assays. The recitation of “Generally, devices such as these are found in clinical testing systems, for example, pregnancy detection systems, disease detection systems, or apparatus for the detection of illegal drugs” does not indicate that the detection element is capable of the detection of illegal drugs. This recitation only indicates that there are generally devices capable of detecting illegal drugs.
The only recitations directed towards the detection of disease are found in paragraphs [0017 and 0024], and similarly do not teach the detection element of the invention being capable of detecting disease. Further, there is no recitation in the written description that states or implies that the detection element is capable of testing for pregnancy, disease, and illegal drugs.
Further, the current construction of the claim implies that every illegal drug can be detected, and every disease can be detected. There is insufficient written support in the identified paragraphs for the detection element being capable of testing for each of pregnancy, every disease, and every illegal drug.
Claim 6 recites “the detection element immunologically detects human chorionic gonadotropin (hCG), a disease, and illegal drugs” in lines 15-17. This recitation lacks support in the written description for the same reasons as stated above.
All paragraph numbers cited are with respect to the published application.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(a) are rejected by virtue of their dependency on a rejected base claim.
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.
Regarding claim 1, it is unclear how the recitations of “a detection element to detect an analyte of interest using an antigen/receptor assay, which test for all pregnancy, disease, and illegal drugs” of claim 1 is achieved. It is unclear what type of antigen/receptor assay and/or which analyte of interest is capable of screening for pregnancy, all types of disease, and all types of illegal drugs. Clarification is requested.
For the purposes of examination, the claim is interpreted as “a detection element to detect an analyte of interest using an antigen/receptor assay, which tests for one of: pregnancy, diseases, and illegal drugs”. Examiner posits this is the intended meaning of this recitation, as it is consistent with the preamble of amended claim 6. Further, claim 4 recites “the analyte of interest” indicating that the device is drawn to detecting a single analyte of interest.
Regarding claim 5, claim 5 recites the phrase “a pregnancy element mounted closer to the second opening” in lines 4-5. It is unclear, based on this phrase, what the positioning of the detection element is being compared to such that it is considered closer to the second opening. In order for the detection element to be mounted closer to the second opening, it must be mounted closer than something else. It is unclear what the other feature or element being compared is, and therefore it is unclear what the intended position of the detection element is. Clarification is requested.
For the purposes of examination, the claim is interpreted as “a pregnancy detection element mounted proximate the second opening”.
Regarding claim 6, the claim recites “A device comprising an antigen/receptor assay for detection of pregnancy, a disease, or illegal drugs” in lines 1-2 and recites “the detection element immunologically detects human chorionic gonadotropin (hCG), a disease, and illegal drugs” in lines 15-17. The first recitation indicates that the device can detect any of the three of pregnancy, a disease, or illegal drugs. However, the second recitation indicates that the device detects all three of pregnancy, a disease, or illegal drugs. Clarification is requested.
For the purposes of examination, the recitation of “the detection element immunologically detects human chorionic gonadotropin (hCG), a disease, and illegal drugs” in lines 15-17 is interpreted as “the detection element immunologically detects one of: human chorionic gonadotropin (hCG), a disease, and illegal drugs”. This interpretation is consistent with the interpretation of claim 1.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Publication 2020/0107820 by Gupta – cited by Applicant, hereinafter “Gupta”.
Regarding claim 1, Fig. 1 of Gupta teaches a device (device 100) comprising: a conical main body (central main body 102; [0027] “Essentially, the device as disclosed herein below is a funnel or a vessel or any other suitable shape”. It is noted that a funnel has a conical shape.) comprising a first end (first end 104) and a second end (second end 108), wherein the first end comprises a first opening (first opening 106) and the second end comprising a narrower second opening positioned opposite to the first opening (second opening 110 is opposite the first end and main body 102 tapers from the first end to the narrower second end), wherein the conical body includes an extended portion for holding the device (See annotated Fig. 1, the back portion of the first end can be considered an extended portion for holding the device), and wherein the conical body includes a detection element to detect an analyte of interest using an antigen/receptor assay, which tests for all of pregnancy, disease, and illegal drugs (pregnancy detection element 118 immunologically detects human chorionic gonadotropin (hCG), thereby defining a receptor assay for hCG indicating pregnancy), wherein the detection element is mounted adjacent to the second opening ([0032]; the detection element is mounted at an edge of the second opening).
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Annotated Fig. 1
Regarding claim 2, Gupta teaches the conical device of claim 1, further comprising a first longitudinal crease (upper longitudinal crease 112) and a second longitudinal crease (lower longitudinal crease 114), wherein the first longitudinal crease and the second longitudinal crease are capable of being folded to have a compact flattened effect ([0030]; “the upper longitudinal crease 112 and the lower longitudinal crease 114 are foldable and folded to have compact flattened packaging of the device 100.”).
Regarding claim 3, Gupta teaches the conical device of claim 1, wherein the first opening of the first end is configured to receive an analyte from a subject ([0033]; “the first opening 106 of the first end 104 is configured to receive urine from a female user.” Urine contains analytes, therefore receiving the urine is equivalent to receiving the analyte).
Regarding claim 4, Gupta teaches the conical device of claim 1, wherein when the analyte comes in contact with the detection element, the detection element detects the presence of the analyte ([0032]; The device tests the detects the analyte within the urine by immunologically detecting a plurality of morphological differences between human chorionic gonadotropin (hCG) and modified forms thereof, which are secreted into the body fluid (e.g. urine)) and indicates a positive or negative output if the analyte is present in the body fluid sample ([0011]; “the pregnancy detection element immunologically detects human chorionic gonadotropin (hCG) present in the urine of the female user and indicates a positive pregnancy result if the female user is pregnant.”).
Regarding claim 5, Gupta teaches a device (device 100) for a contactless pregnancy detection comprising a conical shaped main body (central main body 102; [0027] “Essentially, the device as disclosed herein below is a funnel or a vessel or any other suitable shape”. It is noted that a funnel has a conical shape.) including a first end (first end 104) having a first opening (first opening 106) and a second narrower end (second end 108; main body 102 tapers from the first end to the narrower second end) having a second opening (second opening 110), a first longitudinal crease (upper longitudinal crease 112) and a second longitudinal crease (lower longitudinal crease 114) opposite the first crease allow the conical body to lay flat when not in use ([0030]; “the upper longitudinal crease 112 and the lower longitudinal crease 114 are foldable and folded to have compact flattened packaging of the device 100.”) including a pregnancy detection element (pregnancy detection element 118) mounted closer to the second opening ([0032]; the detection element is mounted at an edge of the second opening) and a flap extending from the first end of the conical body to allow a user to hold the device (See annotated Fig. 1, the flap extends down from the first opening and is capable of being held by a user).
Regarding claim 6, Gupta teaches a device (device 100) for detection of pregnancy, a disease, or illegal drugs, (Abstract; the pregnancy detection element immunologically detects human chorionic gonadotropin (hCG), which indicates pregnancy), the device comprising: a conical main body (central main body 102; [0027] “Essentially, the device as disclosed herein below is a funnel or a vessel or any other suitable shape”. It is noted that a funnel has a conical shape.) comprising a first end (first end 104) and a second end (second end 108), wherein the first end comprises a first opening (first opening 106) and the second end comprises a second opening positioned opposite to the first opening in a narrowing manner (second opening 110 is opposite the first opening and main body 102 tapers from the first end to the narrower second end), an antigen/receptor detection element (pregnancy detection element 118 immunologically detects human chorionic gonadotropin (hCG), thereby defining a receptor assay for hCG indicating pregnancy) mounted proximate to the second opening ([0032]; the detection element is mounted at an edge of the second opening); and a first longitudinal crease (upper longitudinal crease 112) and a second longitudinal crease opposite the first crease (lower longitudinal crease 114 is opposite the first longitudinal crease), wherein the first longitudinal crease and the second longitudinal crease are capable of being folded to flatten the device ([0030]; “the upper longitudinal crease 112 and the lower longitudinal crease 114 are foldable and folded to have compact flattened packaging of the device 100.”), wherein the device is opened by applying simultaneous pressure to the first end of the first longitudinal crease and the second longitudinal crease ([0031]; “Additionally, the device 100 is opened by applying simultaneous pressure to the upper longitudinal crease 112 and the lower longitudinal crease 114.”), further comprising an extension proximate the first end to allow a subject to hold the device (See extended portion of Annotated Fig. 1. This portion is capable of being held by a user), wherein the first opening of the first end is configured to receive urine from a female user while the female user is in a standing position and enables the urine to pass through a detection element proximate the second opening ([0019]; “the first opening of the first end is configured to receive the urine from a female user while the female user is in a standing position and enables the urine to pass through the pregnancy detection element at the edge of the second opening”), and wherein when the urine comes in contact with the detection element, the detection element immunologically detects human chorionic gonadotropin (hCG), a disease, and illegal drugs present in the urine of the female user and indicates a positive pregnancy result if the female user is pregnant ([0019]; “when the urine comes in contact with the pregnancy detection element, the pregnancy detection element immunologically detects human chorionic gonadotropin (hCG) present in the urine of the female user and indicates a positive pregnancy result if the female user is pregnant”).
Response to Arguments
Applicant’s arguments, filed 06/24/2026 have been fully considered.
The amendments to claim 4 overcomes the objections of record.
The amendments to the claims do not overcome the rejections under 35 U.S.C. 112(b).
Applicant’s assertion regarding the rejection of claim 1 under 35 U.S.C. 102 is acknowledged. This assertion is moot as it is based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2014/0046215 by Hu et al. teaches that assays are commonly used to determine if a certain analyte, such as a drug or markers associated with disease are present in samples such as urine.
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 NELSON A GLOVER whose telephone number is (571)270-0971. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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