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 .
Status of the Claims
Claims 1-20 are pending in the application.
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 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)(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-6 and 8-16 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Shaviv (US 2021/0137725 A1) (Published 5/13/21; Priority to 5/3/18).
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As to claim 1, Shaviv teaches a menstrual cup 1600 (intravaginal device 1600 at least Fig.6A-C; [0117]-[0121)) comprising: a main body 1602/1622 (at least arms 1602 Fig.6A-C; [0118],ll.4; and covering 622; Fig.6A-C;[0120],ll.2-3) to hold menstrual fluid (menstrual discharge or blood [0120],ll.5-6), wherein the main body comprises a plurality of segments 1602/1622, adjacent segments are connected (where arms 1602 attached to cover 1622 [0120],ll.2-3) along a fold line (as fold at side edges of arms 1602 connected to cover 1622 that fold together in collapsed/undeployed state Fig.6A; [0119]); the cup is moveable between an expanded state (Fig.6B; [0119],ll.7- [0120],ll.5) and a collapsed state (Fig.6A; [0119],ll.2-7), the main body 1600 folds along the fold lines (fold lines at side edges of arms 1602 attached to covering 1622 Fig.6A) when the cup moves between the expanded (Fig.6B) and collapsed (Fig.6A) states ([0119]-[0120]), and the segments 1602 project outwardly (Fig.6B) beyond the fold lines (fold lines at side edges of arms 1602 attached to covering 1622 Fig.6A) when the cup is in the expanded state (Fig.6B; [0119],ll.7- [0120],ll.5).
As to claim 2, Shaviv teaches wherein the segments 1602/1622 are arranged about a central longitudinal axis (Fig.1A-C), and the segments 1602 project radially outward beyond the fold lines when the cup is in the expanded state (Fig.6B; [0119],ll.7- [0120],ll.5).
As to claim 4, Shaviv teaches wherein each of the fold lines has a depth that varies along the length of the main body (where main body forms a v-shape from bottom to top when expanded, such that the fold lines’ depth varies along length of main body as shown in Fig.6B).
As to claim 5, Shaviv teaches wherein each of the fold lines has a depth that decreases towards a base of the main body (where main body forms a v-shape from bottom to top when expanded, such that the fold lines’ depth decreases towards a base 1603 (Fig.6B; [0118],ll.1-3) of the main body 1600 as shown in Fig.6B).
As to claim 6, Shaviv teaches wherein the cup 1600 comprises a central longitudinal axis (through middle of cup 1600 at center of central tube 1608; Fig.6B; [0118],ll.6-8) and, when the cup 1600 is in the expanded state (Fig.6B), each of the fold lines has a maximum radial distance of R1, each segment has a maximum radial distance of R2, and R2 is greater than R1 (where fold line at edge of arms 1602 on covering 1622 is necessarily indented due to fold inward of covering 1622 when collapsed Fig.6A, such that radial distance R2 of segment 1602/1622 is greater than radial distance R1 of fold as shown in Fig.6B).
As to claim 8, Shaviv teaches wherein, when the cup is in the expanded state, the main body 1600 has a fold angle of no greater than 130 degrees at each of the fold lines (where folding in expanded state 6A from unexpanded state 6B is capable of being expanded to a fold angle of <130 degrees)
As to claim 9, Shaviv teaches wherein the fold angle is no less than 60 degrees (where folding in expanded state 6A from unexpanded state 6B is capable of being expanded to a fold angle of > 60 degrees).
As to claim 10, Shaviv teaches wherein an exterior surface (of cover 1622 Fig.6B) of the main body 1600 undulates about a central longitudinal axis when the cup 1600 is in the expanded state Fig.6B (where arms 1602 and attached cover 1622 are attached to central longitudinal tube 1608 via fixed length struts 1604 Fig.6B; [0118], such that main body undulates or folds about the central longitudinal axis defined by central longitudinal tube 1608 Fig.6B; [0118]).
As to claim 11-12, Shaviv teaches wherein the main body 1600 comprises a base 1603 (Fig.6B; [0118],ll.1-3), and a side wall (arms 1602 as presented above) upstanding from the base 1603 Fig.6B, the side wall comprises the plurality of segments 1602 (as presented above) Fig.6B, and the exterior surface of the side wall 1602 undulates about the longitudinal axis (Fig.6B); and (claim 12) the segments 1602 pivot relative to the base 1603 ([0118],ll.1-3) when the cup moves between the expanded Fig.6B and the collapsed Fig.6A states ([0118]-[0119]).
As to claim 13, Shaviv teaches wherein the main body 1600 comprises between five and eight segments 1602 (Fig.6B shows 6 segments 1602, but can be any number [0118],ll.3-4).
As to claim 14, Shaviv teaches wherein the main body 1600 is resiliently biased to the expanded state Fig.6B (e.g., where struts 1604 coupled to arms 1602 and central shaft 1606 pivot and are held in place in expanded state to provide increased rigidity Fig.6B; [0118],ll.12-13; [0118]).
As to claim 15, Shaviv teaches wherein the cup 1600 comprises a rim provided at an open end of the main body (where rim provided as upper edge of covering 1622 and arms 1602 Fig.6B), and the rim has an outer edge having an elliptical profile in a radial direction when the cup is in the expanded state (where covering 1622 flexible to fold between expanded and unexpanded state [0118]-[0120], such that the rim as upper edge of covering 1622 is capable of forming an elliptical profile Fig.6B).
As to claim 16, Shaviv teaches wherein the rim (at least upper edge of 1622 Fig.6A/B) folds as the cup moves between the expanded Fig.6B and collapsed Fig.6A states ([0118]-[0120]).
As to claim 17, Shaviv teaches wherein the rim (at least upper edge of 1622) folds along fold lines that are aligned radially with the fold lines in the main body (where rim as upper edge of covering 1622 is continuous with main body (rest of 1622) fixedly connected to segments 1602, such that the rim folds along fold lines aligned radially with fold lines of main body (as further presented above)).
As to claim 18, Shaviv teaches wherein the rim (upper edge of 1602 and 1622) is undulated when the cup is in the expanded state Fig.6B (where arms 1602 and attached cover 1622 are attached to central longitudinal tube 1608 via fixed length struts 1604 Fig.6B; [0118], such that main body undulates or folds about the central longitudinal axis defined by central longitudinal tube 1608 Fig.6B; [0118]).
As to claim 19, Shaviv teaches wherein an outer edge of the rim (upper edge of 1602/1622 Fig.6B): undulates in an axial direction (where arms 1602 and attached cover 1622 are attached to central longitudinal tube 1608 via fixed length struts 1604 Fig.6B; [0118], such that main body undulates or folds about the central longitudinal axis defined by central longitudinal tube 1608 Fig.6B; [0118]); and has an elliptical profile in a radial direction (where covering 1622 flexible to fold between expanded and unexpanded state [0118]-[0120], such that the rim as upper edge of covering 1622 is capable of forming an elliptical profile Fig.6B).
As to claim 20, Shaviv teaches wherein the rim (upper edge of 1602/1622) is funneled towards the main body 1600 when the cup is in the expanded state (as shown in Fig.6B as funnel shape of main body).
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Shaviv.
As to claim 3, Shaviv does not teach wherein each of the fold lines has a maximum depth of at least 5 mm when the cup is in the expanded state. However, Shaviv teaches wherein the expanded/deployed position has a maximum diameter of 40-90 mm [0067],ll.7-10; where the outer diameter of the device is wide enough to seal the device against the vaginal passageway [0032],ll.8-10; where the main body 1600 folds along the fold lines (fold lines at side edges of arms 1602 attached to covering 1622 Fig.6A) when the cup moves between the expanded (Fig.6B) and collapsed (Fig.6A) states ([0119]-[0120]), such that it would have been obvious to provide the device that is capable of providing each of the fold lines having a maximum depth of at least 5 mm, where any number of segments 1602 would include where the cover 1622 fold has a fold line max depth of at least 5 mm (Fig.6B). One of skill would have been motivated to do so, in order to provide the advantage of optimizing the maximum fold depth of at least 5 mm to provide sufficient depth in the expanded state to be capable of providing where the cup is not completely stretched in the expanded state due to flexibility in the covering 1622 and/or due to restrictions on the diameter caused by the diameter of the vagina where the menstrual cup is located in the expanded state Fig.6B; [0119],ll.7- [0120],ll.5).
As to claim 7, Shaviv does not specifically teach wherein R2/R1 is at least 1.2. However, Shaviv teaches R2 is greater than R1 (as presented above for claim 6), such that it would have been obvious before the effective filing date to provide a fold indentation of at least 20%, and one of skill would have been motivated to do so, where the expanded state would be capable of providing a 20% higher R2, e.g., where the cover 1622 is not under complete stretching (as shown by slack in 1622 in Fig.6B), and/or where the cup is not completely stretched in the expanded state due to restrictions on the diameter caused by the diameter of the vagina where the menstrual cup is located in the expanded state Fig.6B; [0119],ll.7- [0120],ll.5).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NICHOLAS WEISS, can be reached on 571-270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781