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 1-14 in the reply filed on 19 November 2025 is acknowledged.
Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 November 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 30 May 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 24 January 2024. These drawings are not acceptable.
The two replacement sheets separating Figures 1 and 2 should be labeled as “NEW Sheet” rather than “Replacement Sheet” because the original drawing sheet 1/2 contained both Figures 1 and 2. A replacement sheet replaces the same sheet; however, in this case, the sheets each containing a single figure is new.
Specification
The lengthy 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 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 1-14 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.
Claims 1-3 appear to cover all products having the mentioned characteristic or property, whereas the application provides support for only a very limited number thereof, namely products comprising polyacrylamide (PAAM) and polyethylene oxide (PEO) as linear, nonionic polymers (page 15, lines 4-8 of the description as filed). Applicant appears to be claiming a genus menstrual fluid simulant composition, while the specification discloses a more specific menstrual fluid simulant composition. Thus, it appears that Applicant does not have possession of the genus menstrual fluid simulant composition; and therefore, 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.
Claims 1-14 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In the present case, the application as a whole additionally lacks disclosure. There is no teaching in the application how to obtain the desirable characteristics or properties mentioned in claims 1-3 for other linear, nonionic polymers than those mentioned in the description. In the absence of a general teaching, the skilled person has to prepare and measure compositions containing each other type of linear polymer and each quaternary ammonium compound falling under the broad definition of formulae (I) and (II) and measure the above-mentioned parameters. This amounts to an undue burden, which fails to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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 1-14 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.
Re claim 1, claim lines 2, 14, 17, 19, and 22: Each occurrence of the term “about” is a relative term which renders the claim indefinite. Each occurrence of the term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 2, claim lines 2, 15, 18, 20, and 24: Each occurrence of the term “about” is a relative term which renders the claim indefinite. Each occurrence of the term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 3, claim lines 2, 14, 17, 19, and 22: Each occurrence of the term “about” is a relative term which renders the claim indefinite. Each occurrence of the term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 4, claim line 2: The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 6, claim lines 2-3: The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 7, claim line 2: The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 10, claim line 2: The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 11, claim line 2: The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 12, claim line 2: The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 13, claim line 2: The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 13, claim line 3: The term “low” is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear which alcohols specifically may be used and which may be excluded. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Re claim 14, claim line 2: The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how close or far away from the value the value can be and still be deemed to be about the value. The specification fails to disclose the threshold or the percentage to the specific value. Since the metes and bounds of the term is unknown, then the term and therefore the claim is deemed to be indefinite.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Prior art was not relied upon to reject claims 1-14 because the prior art of record fails to teach and/or make obvious a menstrual blood simulating liquid comprising a quaternary ammonium compound of Formula (i) or Formula (II) in combination with all of the remaining limitations of the claim.
The closest prior art, CN 106908367, discloses a menstrual blood simulating liquid, comprising 820-950 parts of water, 40-50 parts of inorganic sodium salt, 9-12 parts of acid-base regulator, 1-3 parts of thickener, 75-90 parts of simulated modifier, 0.05-0.3 part of simulated regulator, 0.5-1.5 parts preservative, and 2-3 parts of red pigment. The thickener is selected from glycerine, sodium carboxymethyl-cellulose, gelatin, polyvinyl alcohol, and gum arabic. CN 106908367 fails to teach a quaternary ammonium compound of Formula (i) or Formula (II).
Claims 1-14 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL SEAN LARKIN whose telephone number is 571-272-2198. The examiner can normally be reached M-F 9:00 AM - 5:30 PM.
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/DANIEL S LARKIN/Primary Examiner, Art Unit 2855