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 .
DETAILED ACTION
Amendment Entry
1. Applicant's amendment / response filed June 3, 2025 is acknowledged and has been entered. Claims 1-3 have been amended. Claims 4-6 have been cancelled. Accordingly. claims 1-6 are pending. Claims 1-3 are under examination.
Withdrawn Rejections / Objections
2. Any objection or rejection not reiterated herein, has been withdrawn.
Priority
3. Based on the filing receipt, the effective filing date of the instant application is March 16, 2021.
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.
4. Claims 1-3, as amended, stand 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 is vague and indefinite in being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. In this case, claim 1 recites “an apparatus for use with an apparel… comprising a disposable housing removably attached with the apparel, wherein the housing incorporates a fluid channel containing a chemical solution;” but fails to clearly define how the disposable housing is structured within the apparatus and configured so as to be removably attached in a manner that incorporates a fluid channel enabled to contain a chemical solution (i.e. reagent) which appears to be in fluid form, and so as to be capable for use in detecting seminal fluid.
Claim 1 is indefinite in reciting "apparel surfaces such as underwear, diapers… bedding accessories" because the phrase “such as” appears to imply examples of elements that may be intended although not an integral part of the claimed apparatus, thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Claim 2 remains indefinite for using parenthetical symbols in reciting “(disodium salt)” and “(A67-B/E3)” because it is unclear whether the limitations within the parentheses are part of the claimed invention.
Claim 2 is confusing in reciting “the chemical solution comprising … prostate-specific antigen (PSA)” because PSA is an antigen analyte released from prostate gland in certain conditions such as cancer, whereby it may be present in seminal fluid for capture and detection. Accordingly, it is unclear how PSA in claim 2 is comprised in the claimed apparatus as a chemical solution reagent used to detect PSA which may be present in seminal fluid for detection.
Claim 2 remains vague and indefinite in reciting “A67-B/E3” because it is unclear what is encompassed in the identification or nomenclature and what properties are encompassed in relation to the named prostate-specific antigen.
If Applicant intends “A67-B/E3” to identify a monoclonal antibody in claim 2, the properties of the named monoclonal antibody are not clearly defined absent deposit accession number or some other identification to set forth, without question, what antibodies are intended. Hence, the properties of the monoclonal antibody named A67-B/E3 are not clear.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
5. Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this case, the recitation of “comprises underwear, diapers, … and bedding accessories” which has been recited in claim 1 is not further limiting in failing to further limit the limitations recited in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
6. Claims 1-3 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 claims 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.
Claim 1 recites “an apparatus for use with an apparel… comprising a disposable housing removably attached with the apparel, wherein the housing incorporates a fluid channel containing a chemical solution to detect seminal fluid present on a surface of the apparel.” As set forth, inter alia, the specification does not provide sufficient descriptive support that shows distinguishing characteristics and identification structures that define the claimed disposable housing so as to be distinct from a lab-on-chip microfluidic device, cassette, or test strip). The structural components therein (adhesive, clamp, inlet, outlet), other than a common fluid channel are conventional and well-known in microfluidic devices, including characteristic parameters (housing composition, size, portability) and do not distinguish Applicant’s claimed apparatus from other devices taught in the prior art. None of the drawings show a representative illustration of what the patch-sized apparatus should look like. Figures 1-4 show perspective views of a diaper, a onesie, a bedding, and a frock, respectively, and corresponding locations of suspected surface areas upon which the apparatus may be applied or attached that may be contaminated with seminal fluid required for detection. Paragraph [0031] states that the patched-sized apparatus may utilize textile-based chemical and physical sensors to detect seminal fluid which may include humidity, respiration rate, temperature, and pressure sensors without showing their applicability, in form, to the claimed apparatus. Paragraph [0027] was amended to state that “the housing and fluid channel, … designed to be removed and replaced after detecting seminal fluid” but fails to provide how the claimed housing and fluid are designed so as to distinguish Applicant’s claimed apparatus from other devices taught in the prior art.
Paragraph [0032] states that “the disposable housing of the present patch-sized apparatus may include … a film-forming agent, a plasticizer, wetting agents, and indicators.” “The indicator includes bromothymol blue sodium salt, bromoxylenol blue, sodium alizarine sulfonate, and bromocresol purple” though their applications relative to the disposable housing, in question, is neither defined nor clearly recited in the claimed invention.
Although paragraph [0033] provides that Figure 5 “illustrates a flowchart of a method to detect the presence of seminal fluid in apparel, in accordance with an embodiment” and that “the disposable portion incorporates therein a fluid channel comprising a chemical solution to detect seminal fluid present on the surface of the apparel… comprising: 1-Naphthylphosphate (disodium salt) and prostate-specific antigen (PSA) (A67-B/E3)” which describes the chemical reagents used for incorporation into the apparatus, the structural configuration representative of the claimed apparatus comprising a disposable housing that is removably attached and which incorporates therein a fluid channel, is missing. As such, Applicant’s disclosure is deemed to lack written description of what the claimed apparatus is, by failing to provide any representative embodiment that defines what structural components and configurations encompass Applicant’s apparatus.
Accordingly, claims 1-3 fail to comply with the written description requirement set forth under the provisions of 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 103
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.
7. Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Ashburn (US 2009/0170147).
Ashburn discloses an apparatus (test strip kit) for use with an apparel (fabrics, garments) to detect seminal fluid (semen) (Abstract; [0008, 0016]). The apparatus comprises: a disposable housing (AP test strip, PSA test strip) removably attached to the apparel (AP strip is attached and pressed against the surface of the fabric and removed) which incorporates therein a fluid channel (syringe configured to dispense and extract) (Abstract; [0009, 0012, 0016, 0028]). The fluid channel comprises a chemical solution that detects seminal fluid present on a surface of the apparel (Abstract; [0012]). Ashburn teaches that the chemical reagent solution comprises 1-Naphthylphosphate disodium salt (disodium 1-Naphthylphosphate) used to detect acid phosphatase (AP) and prostate-specific antigen-specific antibody (anti-PSA antibody) used to detect prostate-specific antigen (PSA) in the seminal fluid (Abstract; [0006, 0008, 0009, 0011, 0012, 0016, 0028]). The apparel is a fabric comprised in any one of underwear, diapers (absorbent pad), pajamas, shirts, dresses (garments), and bedding accessories ([0004, 0010, 0012, 0016]; Figure 3).
Since claims 1-3 are so unclear as to how the claimed apparatus is structured, what structural components and configurations are encompassed so as to distinguish Applicant’s invention from those taught in the prior art; and since the essential structural and functional cooperative relationships of elements are not clearly defined and described in Applicant’s disclosure in a manner that renders the claimed apparatus distinct from the chemical reagents provided in paragraphs [0028-0031] shown to be conventional and well-known in the art, and the ELISA technique and sensors provided in paragraphs [0030] are shown to be conventional and well-known in the art; it is proper for purposes of this obviousness rejection to interpret the test strip, syringe, and reagents taught by Ashburn as encompassing the “apparatus”, “disposable housing”, “fluid channel”, and chemical solution recited in claim 1-3 because unpatented claims are given the broadest reasonable interpretation consistent with the specification.
Response to Arguments
8. Applicant’s arguments with respect to claims 1-3 have been considered but are moot in light of the new grounds of rejection necessitated by Applicant’s amendment and because the new grounds of rejection do not rely on any teaching or matter specifically challenged in the argument.
9. Applicant's arguments filed June 3, 2025 have been fully considered but they are not persuasive.
A) Applicant argues that claim 1 has been amended to address the 112(b) issues.
Contrary to Applicant’s argument, claim 1 has not been amended so as to substantially correct the pending 112(b) issues as set forth herein supra.
B) Applicant argues that the parenthetical symbols have been removed from claim 2; thus, overcoming the rejection.
Contrary to Applicant’s argument, it is noted that the parenthetical symbols remain in claim 2.
C) Applicant argues that claim 2 is definite and that the specification has been amended to clarify how PSA is incorporated and used as a reagent to detect seminal fluid.
As set forth herein supra, Examiner reiterates that the claimed PSA in claim 2 which stands for prostate-specific antigen is an antigen which appears to be the analyte detected to indicate the presence of seminal fluid as provided in paragraph [0027-0029] and is not a reagent in the form of a chemical solution. Although the claims may be interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
10. No claims are allowed.
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 GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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, Gregory S. Emch can be reached on (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
November 4, 2025