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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/05/2022 and 01/31/2024 have been considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites “detects the presence of analyte” in line 2. This should read “detects the presence of the analyte”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
• “detection element” first recited in claim 1.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for “detection element” is identified as any element or assay for the detection of analytes, as described in par. [0017] of the published specification of the instant application.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-5 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, the claim recites the limitation "the second opening" in line 2. There is insufficient antecedent basis for this limitation in the claim.
For the purposes of examination, the claim is interpreted as “a second opening”.
Further regarding claims 1 and 5, claim 1 recites the phrase “the detection element is mounted closer to the second opening” in lines 5-6. 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. Claim 5 recites a similar phrase in lines 5-6 “a pregnancy element mounted closer to the second opening”. Clarification is requested.
For the purposes of examination, the claim 1 is interpreted as “the detection element is mounted proximate the second opening” and claim 5 is interpreted as “a pregnancy detection element mounted proximate the second opening”.
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 opening comprising a narrower end 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 (pregnancy detection element 118), wherein the detection element is mounted closer 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 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 human chorionic gonadotropin (hCG) (Abstract; the pregnancy detection element immunologically detects human chorionic gonadotropin (hCG)), 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), a pregnancy detection element (pregnancy detection element 118) 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 pregnancy 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 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 ([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”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2015/0223783 by Eschete et al. – cited by Applicant teaches a device for the collection of urine comprising a protruding member for gripping the device.
US Patent 9,931,103 by DeLaRosa et al. – cited by Applicant teaches a urinary funnel comprising a detection element that narrows from the first end to the second end.
US Patent 5,605,161 by Cross et al. teaches a collapsible urinary funnel that narrows from a first end to a second end comprising a detection element proximate the second end.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791