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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Republic of India on 31 October 2023. It is noted, however, that applicant has not filed a certified copy of the Republic of India application as required by 37 CFR 1.55.
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 1-20 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.
Claims 1 and 15 recite the limitation "the menstrual fluid" in line 3. There is insufficient antecedent basis for this limitation in the claim. Previously, menstrual blood was disclosed.
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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Naseri et al. (10,993,645).
With respect to claim 1, Naseri discloses a diagnostic arrangement to detect analytes in menstrual fluid, as shown in figure 3 and described in column 2, lines 25-30. The arrangements comprises a top layer 110 to collect menstrual fluid, a middle layer 151, and a sensor layer 300, as shown in figure 3. The middle layer 1015 has a plurality of parallelly placed vertical columns 160/170 having a shape, as shown in figure 4. One or more detection marker are coated on an inner surface, as disclosed in column 13, lines 55-59, to react with one or more analytes in the collected menstrual fluid, as disclosed in column 9, lines 48-50. The sensor layer 300 has a plurality of spots 200 corresponding to the columns 160/170, as shown in figure 4, that sense a concentration of one or more analytes, as disclosed in column 10, lines 65. A transmitter wirelessly transmits the sensed concentration to a user device, as shown in figure 19, and the user device compares the sensed concentration to a normal concentration to determine a health condition, as shown in figure 21 and disclosed in column 10, line 59, to column 11, line 13.
With respect to claim 2, the shapes are a cylindrical shape, as shown in figure 3.
With respect to claim 3, the detection markers include antibodies, as disclosed in column 9, lines 13-14.
With respect to claim 4, the size-based separation forms a first region of a larger size and a second region of a smaller size, as shown as element 170 in figure 7A.
With respect to claim 5, the analytes include endometrial cells, as disclosed in column 5, lines 47-49.
With respect to claim 6, the analytes include bacteria, nucleic acid, and proteins, as disclosed in column 3, lines 43-44, and column 9, lines 13-14 and 48-51.
With respect to claim 7, the sensor layer has an impedance-based sensor on each of the plurality of spots, such that coupling of an antigen with the detection marker leads to a change in impedance, as disclosed in column 22, lines 8-14.
With respect to claim 8, the change in impedance is associated with a concentration of a corresponding analyte, as disclosed in column 10, lines 61-66.
With respect to claim 9, the analyte facilitates the detection of infection disease conditions including at least one or candidiasis based on fungi Candida albicans and gonorrhea, as disclosed in column 9, lines 18-22.
With respect to claim 10, the arrangement is in a sanitary napkin, as shown in figure 3, or tampon, as disclosed in column 2, lines 31-33.
With respect to claim 11, Naseri discloses a sanitary napkin having a diagnostic arrangement to detect analytes in menstrual fluid, as shown in figure 3 and described in column 2, lines 25-30. The arrangements comprises a top layer 110 to collect menstrual fluid, a middle layer 151, and a sensor layer 152, as shown in figure 3. The middle layer 1015 has a plurality of parallelly placed vertical columns 160 having a shape, as shown in figure 4. One or more detection marker are coated on an inner surface, as disclosed in column 13, lines 55-59, to react with one or more analytes in the collected menstrual fluid, as disclosed in column 9, lines 48-50. The sensor layer 152 has a plurality of spots 161 corresponding to the columns 160, as shown in figure 4, that sense a concentration of one or more analytes, as disclosed in column 10, lines 65. A transmitter wirelessly transmits the sensed concentration to a user device, as shown in figure 19, and the user device compares the sensed concentration to a normal concentration to determine a health condition, as shown in figure 21 and disclosed in column 10, line 59, to column 11, line 13. A bottom layer 140 sandwiches the middle layer 151 and sensor layer 152 with the top layer 110, as shown in figure 3.
Naseri discloses all aspects of the claimed invention with the exception of the detection markers being coated on an inner surface of the vertical columns.
With respect to claim 12, the shapes are a cylindrical shape, as shown in figure 3.
With respect to claim 13, the detection markers include antibodies, as disclosed in column 9, lines 13-14.
With respect to claim 14, the size-based separation forms a first region of a larger size and a second region of a smaller size, as shown as element 170 in figure 7A.
With respect to claim 15, the analytes include endometrial cells, as disclosed in column 5, lines 47-49.
With respect to claim 16, the analytes include bacteria, nucleic acid, and proteins, as disclosed in column 3, lines 43-44, and column 9, lines 13-14 and 48-51.
With respect to claim 17, the sensor layer has an impedance-based sensor on each of the plurality of spots, such that coupling of an antigen with the detection marker leads to a change in impedance, as disclosed in column 22, lines 8-14.
With respect to claim 18, the change in impedance is associated with a concentration of a corresponding analyte, as disclosed in column 10, lines 61-66.
With respect to claim 19, the analyte facilitates the detection of infection disease conditions including at least one or candidiasis based on fungi Candida albicans and gonorrhea, as disclosed in column 9, lines 18-22.
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naseri et al. (10,993,645).
With respect to claim 20, the bottom layer is made of a waterproof material, plastic, to prevent passing of menstrual blood, as disclosed in column 12, lines 26-27. Naseri discloses all aspects of the claimed invention with the exception of the top layer having an adhesive for application. The use of adhesive to attach layers of a sanitary napkin is well-known in the art. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the top layer of Naseri with an adhesive for application to achieve the predictable result of using a known method to securely attach the layers of the sanitary napkin together.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patents and Publications 11,612,356; 7,141,715; 3,918,433; 2009/0082745; 2008/0344296; and 2004/0133090 disclose diagnostic arrangements for absorbent articles.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNNE ANDERSON whose telephone number is (571)272-4932. The examiner can normally be reached Monday-Friday 10-6.
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/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781