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 .
Response to Amendment
Applicant’s amendments to claims 1-14 filed on 07/11/2025 are acknowledged by the examiner.
Claims 1-14 are currently pending and are under examination.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Vardy in view of Sopher is now disclosed in light of the arguments made, and Zipper is still disclosed in this office action only to teach the coupling element in claims 4-5.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“coupling element” in claims 4-5
“actuation mechanism” in claim 11
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1, 3, 7-8, 11, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardy (WO 2018/213187 A1) in view of Sopher et al. (referred to as “Sopher”) (US 2019/0091062 A1).
Regarding claim 1, Vardy discloses a vaginal device (600) for pelvic organ prolapse treatment (see Fig. 7 and [0049]; pessary 600 is a vaginal device for pelvic organ prolapse treatment), comprising:
an elongated base element (602) (see Fig. 7 and [0049]; pessary 600 comprises a stem 602 which is an elongated base element as it is long and is the foundation for pessary 600),
an inflatable element (702) for placement in a fornix posterior and attached to a distal end part of the elongated base element (602) (see Fig. 7 and [0049]; annular balloon 702 is an inflatable element as it may be selectively inflatable for placement in a fornix posterior, and the annular balloon 702 may be attached to a distal end part of the stem 602, as the positioning of the annular balloon 702 about stem 602 can be varied depending on the desired placement of the pessary device 600, as shown in Fig. 7 via the different placements of the annular balloon 702, and thus can be attached at a distal end part as shown in the very first image of Fig. 7).
Vardy is silent on a support element attached to a proximal end part of the elongated base element the support element comprising at least two support members, the at least two support members extending away from the proximal end part of the elongated base element, wherein the at least two support elements are arranged to support lower parts of prolapsed compartments, and wherein the support element comprises an adjustable connector for fixing the position of the support element along the proximal end part of the elongated base element.
However, Sopher teaches an analogous vaginal device (4800) for pelvic organ prolapse treatment (see Figs. 48-51A and [0005]) and an analogous elongated base element (4814) (see Figs. 48-51A; central stem 4814 is an analogous elongated base element as it is long and is the foundation for pessary 4800), and a support element (4802) attached to a proximal end part of the elongated base element (4814) (see Fig. 50 and [0145]; petal members 4802 are support elements as the petal members 4802 are attached to a proximal end part of the central stem 4814, as the petal members 4802 are attached to an upper end part of the central stem 4814), the support element (4802) comprising at least two support members (see Fig. 50 and [0145]; the petal members 4802 have three petal members 4802 shown in Fig. 50 and thus is at least two support members), the at least two support members (4802) extending away from the proximal end part of the elongated base element (4814) (see Fig. 50 and [0145]; each of the petal members 4802 extend away from the proximal end part of the central stem 4814, as the petal members 4802 extend radially outwardly in a deployed state, see [0146]), wherein the at least two support members (4802) are arranged to support lower parts of prolapsed compartments (see Fig. 50 and [0145]; the petal members 4802 are capable of supporting lower parts of prolapsed compartments), and wherein the support element (4802) comprises an adjustable connector (4812+5102) for fixing the position of the support element (4802) along the proximal end part of the elongated base element (4814) (see Fig. 50-51A and [0145]-[0147]; sliding ring 4812 + locking bumps 5102 make up an adjustable connector, as the sliding ring 4812 is able to slide along the central stem 4814 in order to adjust the position of the petal members 4802, and the position is locked in place or fixed via locking bumps 5102, and thus locking the petal members 4802 along the proximal end part of the central stem 4814, as Applicant’s specification discloses that the adjustable connector may be implemented in various manners, such as using a sliding and locking mechanism, see Pg. 7 lines 13-15 of Applicant’s specification), providing support members that help to retain the pessary in a user and help to support the prolapsed organs, while also being adjustable so that inserting/removing the pessary is easier.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a proximal end part of the elongated base element (602) in the device of Vardy with a support element comprising at least two support members (petal members 4802) that extend away from the proximal end part, and wherein the at least two support members are arranged to support lower parts of prolapsed compartments, and an adjustable connector (sliding ring 4812+locking bumps 5102) for fixing the position of the support element along the proximal end part of the elongated base as taught by Sopher to have provided an improved vaginal device that provides support members that help to retain the pessary in a user and help to support the prolapsed organs, while also being adjustable so that inserting/removing the pessary is easier.
Regarding claim 3, Vardy in view of Sopher discloses the invention as discussed in claim 1. Vardy in view of Sopher further discloses a valve (704 of Vardy) in fluid communication with the inflatable element (702 of Vardy) (see Fig. 7 of Vardy and [0049] of Vardy; valve 704 of Vardy is in fluid communication with the annular balloon 702 of Vardy).
Regarding claim 7, Vardy in view of Sopher discloses the invention as discussed in claim 1. Vardy in view of Sopher further discloses wherein the at least two support members (4802 of Sopher) comprise three support members (see Fig. 50 of Sopher; as previously modified above, see claim 1, the petal members 4802 of Sopher comprises three support members as seen in Fig. 50 of Sopher).
Regarding claim 8, Vardy in view of Sopher discloses the invention as discussed in claim 1. Vardy in view of Sopher further discloses wherein the at least two support members (4802 of Sopher) comprise an end part having a support surface (4808 of Sopher) (see Fig. 50 of Sopher; the petal members 4802 of Sopher each have an end part which is where hinge 4808 of Sopher is located, and hinge 4808 of Sopher is interpreted to be a support surface as this structure is capable of providing less peak pressure on small internal surfaces during use, as the hinge 4808 of Sopher is rounded and not sharp, as Applicant’s specification discloses that the support surface provides for less peak pressure on small internal surfaces during use, see Pg. 5 lines 32-34 of Applicant’s specification).
Regarding claim 11, Vardy in view of Sopher discloses the invention as discussed in claim 1.
Sopher further teaches in another embodiment an analogous pessary (4100), and wherein the support element comprises an actuation mechanism (4302) connected to the at least two support members (4102, 4104) (see Fig. 41, 43, and [0141]; the support element is shown in Fig. 43 and the upper petal 4102 and the lower petal 4104 are analogous at least two support members, and compression spring 4302 is an actuation mechanism, as Applicant’s specification discloses that the actuation mechanism may be a metal spring, see Pg. 7 lines 20-21 of Applicant’s specification, that is connected to the upper petal 4102 and lower petal 4104), providing an easy mechanism that biases pessary into a deployed state (see [0138]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the support element in the device of Vardy in view of Sopher with an actuation mechanism (spring) connected to the at least two support members as taught by Sopher in another embodiment to have provided an improved vaginal device that provides an easy mechanism that biases the pessary into a deployed state (see [0138]).
Regarding claim 13, Vardy in view of Sopher discloses the invention as discussed in claim 1.
Sopher further teaches in another embodiment an analogous vaginal device (pessary 1800), and an insertion aid (1900), the insertion aid (1900) surrounding at least the elongated base element (1810) and the support element (1820) (see Figs. 18-19B, [0103]-[0105]; in another embodiment of Sopher, an analogous pessary 1800 is shown in Figs. 18-19B, and stem 1810 is analogous elongated base element and petal members 1820 are analogous support elements, and applicator 1900 is an insertion aid as the applicator 1900 is used during the insertion process to place the pessary 1800 into the vaginal canal of a user, and the applicator 1900 surrounds the stem 1810 and the petal members 1820 via applicator housing 1904 as best seen in Fig. 19A when the pessary is in a collapsed state), providing an applicator to assist with the insertion process of the pessary.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the vaginal device in the device of Vardy in view of Sopher with an insertion aid (1900) that surrounds at least the elongated base element and the support element as taught by Sopher in another embodiment to have provided an improved vaginal device that has an applicator to assist with the insertion process of the pessary.
Regarding claim 14, Vardy in view of Sopher discloses the invention as discussed in claim 1.
Sopher further teaches in another embodiment an analogous vaginal device (pessary 300), and wherein one or more components of the vaginal device (300) is a biocompatible material (see Figs. 3-5 and [0084]; pessary 300 is an analogous vaginal device as it is placed in the vagina of a user, and the pessary 300 can be a biocompatible FDA approved material, and thus the petal members 310 which are analogous support members and hollow stem 320 which is an analogous elongated base element are made of a biocompatible material), providing a material that is safe and nontoxic for a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vaginal device in the device of Vardy in view of Sopher to comprise a biocompatible material as taught by another embodiment of Sopher to have provided an improved vaginal device that has a material that is safe and nontoxic for a user.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardy in view of Sopher further in view of Booher, SR. (referred to as “Booher”) (US 2015/0265456 A1).
Regarding claim 2, Vardy in view of Sopher discloses the invention as discussed in claim 1.
Vardy in view of Sopher is silent on wherein the inflatable element comprises an inflatable ring at an outer circumference of the inflatable element.
However, Booher teaches an analogous inflatable element (880) (see Fig. 8 and [0053]; the inner balloon 880 is an analogous inflatable element as inner balloon 880 is configured to be inflated), and wherein the inflatable element (880) comprises an inflatable ring (890) at an outer circumference of the inflatable element (880) (see Fig. 8 and [0053]-[0054]; the inner balloon 880 has an outer balloon 890 that goes around the inner balloon 880, as seen in Fig. 8), providing a double inflatable element configuration which offers a greater array of options for materials and sufficiently allows for the inflatable elements to remain in contact with a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the inflatable ring (702 of Vardy) in the device of Vardy in view of Sopher with an inflatable ring at an outer circumference of the inflatable element as taught by Booher to have provided an improved vaginal device that has a double inflatable element configuration which offers a greater array of options for materials and sufficiently allows for the inflatable elements to remain in contact with a user (see [0054]).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardy in view of Sopher further in view of Zipper (US 2009/0216071 A1).
Regarding claim 4, Vardy in view of Sopher discloses the invention as discussed in claim 1.
Vardy in view of Sopher is silent on wherein the elongate base element further comprises a coupling element in fluid communication with the inflatable element.
However, Zipper teaches an analogous elongate base element (110) and an analogous inflatable element (120), and wherein the elongate base element (110) further comprises a coupling element (200) in fluid communication with the inflatable element (120) (see Figs. 1 and 5-7, and [0045]; the cap 200 is a coupling element as the cap 200 may be hinged back to expose an access port which provides a point of communication between the pessary device 100 and conventional syringes/tubing, such that fluid/gas may be input through the access port of cap 200 through valve 140 to inflate the inflatable bladder 120, as Applicant’s specification discloses that the coupling element allows the use of a filling tube with a syringe to inflate/deflate the inflatable element, see Pg. 6 lines 27-30 of Applicant’s specification, thus cap 200 is in fluid communication with the inflatable bladder 120), providing an easy mechanism to selectively inflate the inflatable element (see [0045]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elongate base element (602 of Vardy) in the device of Vardy in view of Sopher to comprise a coupling element (200) in fluid communication with the inflatable element as taught by Zipper to have provided an improved vaginal device that provides an easy mechanism to selectively inflate the inflatable element (see [0045]).
Regarding claim 5, Vardy in view of Sopher further in view of Zipper discloses the invention as discussed in claim 4.
Zipper further teaches wherein the coupling element (200) is positioned in the proximal end part of the elongated base element (110) (see Fig. 1; the cap 200 is positioned in a proximal end part of the main stem 110 as the cap 200 is positioned at the end portion of main stem 110 where it is nearest the point of attachment to syringes/IV tubing for inflation of the device), providing an easy mechanism to selectively inflate the inflatable element (see [0045]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal end part of the elongate base element (602 of Vardy) in the device of Vardy in view of Sopher further in view of Zipper to have provided an improved vaginal device that provides an easy mechanism to selectively inflate the inflatable element (see [0045]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardy in view of Sopher further in view of Whitehead et al. (referred to as “Whitehead”) (US 3,512,528).
Regarding claim 6, Vardy in view of Sopher discloses the invention as discussed in claim 1.
Vardy in view of Sopher is silent on wherein the inflatable member comprises a permeable material.
However, Whitehead teaches an analogous inflatable member (tampon 10 is an analogous inflatable member as tampon 10 may be inflated via filler tube 17), and wherein the inflatable member (10) comprises a permeable material (see Fig. 1; tampon 10 may be inflated via filler tube 17, and tampon 10 has a semi-permeable liner 13, and thus comprises a permeable material to a degree, see Col. 3 lines 71-73), providing a material that is semi-permeable such that certain substances/drugs may be administered through the vaginal device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the inflatable member (702 of Vardy) in the device of Vardy in view of Sopher to comprise a permeable material as taught by Whitehead to have provided an improved vaginal device that has a material that is semi-permeable such that certain substances/drugs may be administered through the vaginal device.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardy in view of Sopher in view of Burbank et al. (referred to as “Burbank”) (US 2005/0113852 A1) further in view of Blurton et al. (referred to as “Blurton”) (US 2015/0066048 A1).
Regarding claim 9, Vardy in view of Sopher discloses the invention as discussed in claim 1.
Vardy in view of Sopher is silent on wherein the support surface is provided with a load sensor.
However, Burbank teaches an analogous support surface (14, 15) (leading edges 14,15 are analogous support surfaces of support members 42 as they are end parts/portions of the support members 42), and wherein the support surface (14, 15) is provided with a sensor (18, 19) (see Fig. 1; the leading edges 14,15 are provided with sensors 18,19), providing sensors on the support surfaces such that the sensors are able to properly sense the information needed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the support surfaces (4808 of Vardy) in the device of Vardy in view of Sopher with sensors as taught by Burbank to have provided an improved vaginal device that provides sensors on the support surfaces such that the sensors are able to properly sense the information needed.
Vardy in view of Sopher further in view of Burbank discloses the invention as discussed above.
Vardy in view of Sopher further in view of Burbank is silent on the sensor being a load sensor.
However, Blurton teaches an analogous sensor (252,254) (see Fig. 6), the sensor being a load sensor (252,254) (see Fig. 6; the strain gauges 252,254 make up the pressure detecting system 250 and thus are load sensors, as the strain gauges 252,254 detects changes in pressure, stress, or strain that may be indicative of the amount of pressure being applied on the support system 100 or by the support system 100, see [0082], and thus are load sensors as Applicant discloses that the load sensor monitors loads on the support surfaces 5b, see Pg. 6 lines 6-8 of Applicant’s specification), providing a load sensor to monitor the amount of pressure being applied to the support members to make sure the device is properly positioned.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor in the device of Vardy in view of Sopher further in view of Burbank to be a load sensor as taught by Blurton to have provided an improved vaginal device that provides a load sensor to monitor the amount of pressure being applied to the support members to make sure the device is properly positioned.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardy in view of Sopher further in view of Heinen et al. (referred to as “Heinen”) (US 2019/0060044 A1).
Regarding claim 10, Vardy in view of Sopher discloses the invention as discussed in claim 1.
Vardy in view of Sopher is silent on wherein the at least two support members comprise material having a hardness of less than Shore 40A.
However, Heinen teaches analogous at least two support members (28) (see Figs. 2-4; supporting arms 28 are analogous at least two support members as they are legs that extend outwardly and there are at least two supporting arms 28), and wherein the at least two support members (28) comprise material having a hardness of less than Shore 40A (see [0068] and Figs. 2-4; the core 12, which is made up of supporting arms 28, can be constructed of a material which exhibit a Shore A hardness of 30-80, and thus can have a hardness of less than 40, as claimed), providing a material with a suitable hardness that is still comfortable for a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the at least two support members (4802 of Sopher) to comprise a hardness of less than Shore 40A as taught by Heinen to have provided an improved vaginal device that provides a material with a suitable hardness that is still comfortable for a user.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardy in view of Sopher further in view of Choo (US 2019/0336324 A1).
Regarding claim 12, Vardy in view of Sopher discloses the invention as discussed in claim 1.
Vardy in view of Sopher is silent on wherein the elongated base has a length between 4 and 12 cm.
However, Choo teaches an analogous elongated base (1) (see Fig. 2; the vaginal barrier device 10 has a flexible stem 1 which is an analogous elongated base), and wherein the elongated base (1) has a length between 4 and 12 cm (see [0034]; the flexible stem 1 has a length of 6cm to 7cm, and thus falls within the claimed range), providing an elongated barrier that is sufficient in length for proper insertion and retainment in the vagina of a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the elongated base (110 of Vardy) in the device of Vardy in view of Sopher to be between 4 and 12 cm as taught by Choo to have provided an improved vaginal device that is sufficient in length for proper insertion and retainment in the vagina of a user.
Conclusion
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/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786