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 .
Pro-Se Applicant
It appears the inventor(s) filed the current application pro se (i.e., without the benefit of representation by a registered patent practitioner). While inventors named as applicants in a patent application may prosecute the application pro se, lack of familiarity with patent examination practice and procedure may result in missed opportunities in obtaining optimal protection for the invention disclosed. The inventor(s) may wish to secure the services of a registered patent practitioner to prosecute the application, because the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting a patent practitioner.
A listing of registered patent practitioners is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent practitioners located in their area by writing to Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
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.
Claim 1 (or alternatively claims 1-4) 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.
Claim 1 (or alternatively claims 1-4) are rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The claim(s) are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited below in the prior art section.
The indefinite issue with the claims stems from whether the claims is 4 elements of a single claims, or 4 separate claims with a general statement of the invention preceding the claims. The general form of a claim includes a preamble followed by a transitional phrase, and then the body of the claim laying out what the applicant wishes to seek protection for. As noted above, please see the claims listed in the cited prior art applications/patents which are cited in the prior art rejections and the pertinent prior art section in the conclusion.
The claim(s) submitted on 12/14/2023 and 2/16/2024 include what appears to be a preamble: “A one-time ready to use method, to indicate the position in menstruation cycle using pH characteristic due to LH surges in the vaginal discharge, consisting of:”, and then is followed by 4 numbered sections. Each of these numbered sections appears as if they could be drawn to a different aspect of the invention, and it is unclear if each of these numbered sections are (1) part of the body of a single claim with the previously identified preamble; or (2) individual claims which are preceded by a narrative statement of the general thrust of the invention.
In light of this issue, it is unclear as to how the claim(s) should be interpreted for the purpose of applying prior art. For example, is it a single claim with 4 different aspects, or is it 4 separate claims to different inventions? Either of these interpretations have drastically different metes and bounds which determine the scope of the invention. This is further complicated as each of the 4 numbered sections have additional indefinite issues that need to be addressed.
Some of these indefinite issues include:
Regarding the section numbered 1; the recitation of an “organic” pH sensitive solution is indefinite, as the specification does not outline what qualifies a dye as “organic”. The term “organic” has different meanings in different context (i.e in the food industry, in the textile industry, etc…), and the specification is silent to even the recitation of the work “organic”, and as such, it is unclear as to what organic means in the context of “an organic pH sensitive solution” (i.e. is a solution considered organic if a part of the solution is made of an organic material? Does the dye have to be naturally occurring? Is it dyes derived from material which was not treated with synthetic pesticides? Etc…). In the absence of a description of what constitutes and organic pH sensitive solution. The examiner is ignoring the term organic for the purpose of interpreting the claim over prior art (see recreated claim below). However the examiner does note that reference US 4,029,597 to Neisius et al (cited in the additional prior art made of reference section in the Conclusion) does disclose at least some form of organic dye for testing/determining pH.
Further regarding section 1; the recitation of “the underwear crotch panel” renders the claim indefinite as it is unclear as to what underwear crotch panel it is referring to. For the purpose of examination the examiner will interpret the limitation as “a crotch panel on women’s underwear”.
Further regarding section 4a and b; the claims recite “to report the change in color of a product” and or “a self-report method”, but it is unclear in the light of the specification what report means in the context of the claim. Said another way, what constitutes reporting? Is it merely recording the data to a database, is it calling a doctor to report the change? Is it alerting a partner to the change in color” There are a variety of possibilities of what constitutes reporting, and absent any description in the specification (the word report is not used once in the specification), it is unclear as to what would be required to meet the claim limitation of “report the change in color of the product” or “a self-report method”, and thus the claim is indefinite. For the purpose of advancing prosecution, the examiner is interpreting reporting as recording the color change in a database.
As the claims are replete with indefinite issues, and it is unclear as to the scope of the claims, in order to advance examination on the basis of prior art and practice compact prosecution, the examiner will interpret the provided claim set as a single claim as follows:
Examiner’s interpretation of Claim 1 for the purpose of applying prior art:
A one-time ready to use method, to indicate the position in menstruation cycle using pH characteristics due to luteinizing hormone (LH) surges in the vaginal discharge, comprising:
providing a self-diagnostic product to monitor the change in pH level due to LH surges in vaginal discharge indicating a fertility window comprising:
a substrate shaped for positioning on a crotch panel of women’s underwear including a color changing pH sensitive solution sensitive to different pH levels disposed on one side of the substrate;
an adhesive disposed on the other side of the substrate configured to adhere the substrate to a crotch panel the underwear
attaching the self-diagnostic product on a crotch panel of underwear using the adhesive so that the side having the color changing pH sensitive solution is positioned adjacent the vagina
wearing the underwear with the self-diagnostic product adhered thereto
observing color change in the color changing pH sensitive solution indicated by increase in pH value of vaginal discharge
comparing the color change to a color chart indicating if the user is ovulating or not
removing and disposing the self-diagnostic product after vaginal discharge has been received and color change has been observed
recording color changes in a database to indicate the position in the menstruation cycle.
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.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Crespo (included foreign publication WO 2006/042871 A1, wherein examiner refers to provided English translation for citation) in view of Catt et al (US 2007/0015285 A1) and Chen et al (US 2013/0273666 A1), at least as best understood.
Examiner’s Note: As indicated in the 35 USC 112(b) rejection above, the examiner has provided an interpretation of the claim as best understood for the purpose of examination over prior art.
Regarding claim 1; Crespo discloses A one-time ready to use method, to indicate the position in menstruation cycle using pH characteristics due to luteinizing hormone (LH) surges in the vaginal discharge (figure 1), comprising:
providing a self-diagnostic product (compress, element 1) to monitor the change in pH level due to LH surges in vaginal discharge indicating a fertility window (claim 1 comprising:
a substrate (element 2) shaped for positioning on a crotch panel of women’s underwear including a color changing pH sensitive solution (indicator) sensitive to different pH levels disposed on one side of the substrate (indicator can be indicate the acidity or pH; see Preferred embodiment of the invention section);
an adhesive disposed on the other side of the substrate configured to adhere the substrate to a crotch panel the underwear (film adhesive for immobilization on an intimate garment; see Preferred embodiment of the invention section)
attaching the self-diagnostic product on a crotch panel of underwear using the adhesive so that the side having the color changing pH sensitive solution is positioned adjacent the vagina (positioned on intimate garment for receiving vaginal secretions)
wearing the underwear with the self-diagnostic product adhered thereto (worn in the intimate garment)
observing color change in the color changing pH sensitive solution indicated by increase in pH value of vaginal discharge (indicator reveals the measurement or state of fertility through total or partial color change of the compress; see Description of Invention section)
removing and disposing the self-diagnostic product after vaginal discharge has been received and color change has been observed (discloses discarding the compress when done; see Description of Invention section)
recording color changes to indicate the position in the menstruation cycle (uses the color to determine the state of their fertility; claim 1).
However, Crespo does not explicitly disclose comparing the color change to a color chart indicating if the user is ovulating or not or recording the color change in a database.
Catt teaches in a similar system for determining fertility via observing changes in color of a reactive chemical with a bodily fluid to include a color chart which allows the daily result to be compared to a stand LH surge to allow for comparison and determination of the onset of a fertility cycle using the supplied chart (paragraph [0114]).
Regarding claim 1; Crespo discloses monitoring the change of color of the compress in order to determine the state of fertility/ovulation. Catt further teaches utilizing a color chart to enable to user to compare the color to standard reference values so as to determine the state with the naked eye. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further provide Crespo’s method with a color chart as taught by Catt in order to help the user easily identify the stage of fertility/ovulation associated with the color change with the provided the color chart indicating what the colors mean.
Further regarding claim 1; the Crespo/Catt combination teaches obtaining the result of the color change to monitor the position in the ovulation cycle, but is silent to recording the color change in a database. Chen teaches a system and method of monitoring color changes in a diagnostic test using a color chart wherein the color changes can be detected with a mobile phone application and are recorded and stored in a database for later viewing (paragraphs [0025], [0030], [0058]-[0059]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Crespo/Catt combination to utilize a mobile phone application to identify the correct color and store the data in a database for later viewing/historical context.
of diagnostic testing when comparing to a color chart, teaches storing
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 4,029,597 to Neisius et al; discloses organic pH sensitive dye indicators (section 1 of claims)
US 2025/0387104 A1 to Zhou et al; discloses a system for testing female reproductive health and diagnostic method.
US 2016/0066894 A1 to Barton-Sweeney; discloses a health state monitoring device which can detect onset of ovulation.
US 2017/0265789 A1 to Naseri et al; discloses a system and method for non-invasive analysis of bodily fluid.
US 5,823,953 to Roskin et al; discloses a secretion analysis apparatus and method.
US 6,627,394 B2 to Kritzman et al; discloses a diagnostic feminine pad.
US 5,468,236 to Everhart et al; discloses a disposable absorbent product incorporating chemically reactive substance.
US 2007/0015285 A1 to Catt et al;
US 2022/0291132 A1 to Heron et al; discloses a bodily fluid testing method.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 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, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791