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 and cancellation of claim 3 filed 07/29/2025 is acknowledged by the examiner.
Claims 4-6 remain withdrawn.
Claims 1-2 and 4-6 are currently pending and claims 1-2 are currently under examination.
Response to Arguments
Applicant's arguments filed 07/29/2025 have been fully considered but they are not persuasive.
Applicant’s argument: Applicant contends that Raje does not disclose or suggest all the limitations as depicted in Applicant’s amended claim 1. Particularly, Raje at [056] teaches that the string is provided with markings that are optional, whereas in the Applicant’s invention the markings are necessary to aid the skilled surgeon to achieve objective trimming of the thread. Contrastingly, the optional markings of Raje is merely for the purpose of leaving 2 to 3 cm string in the vaginal cavity. With regards to 1 mm markings, Applicants contend that these markings at the specified length is critical for the correct positioning of the IUD device inside the vaginal cavity where the intended IUD is used by a skilled surgeon.
Examiner’s response: Although Raje discloses that the gradation markings on the IUD thread is optional, this still means that there is an embodiment of an IUD with gradation markings, which is shown in Fig. 15 of Raje and thus still reads on the amended claim. Further, this embodiment of the IUD may be formed during manufacturing of the string as stated in [0056] of Raje and thus would be necessarily provided with the IUD. It is stated in [0056] of Raje that the markings help a surgeon in cutting a right length of the thread, which is the same purpose as Applicant’s invention, as Applicant stated the markings are necessary to aid the skilled surgeon to achieve objective trimming of the thread.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, “graduation markings” in line 8 should be recited as “gradation markings”.
Appropriate correction is required.
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 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raje et al. (referred to as “Raje”) (US 2018/0147085 A1) in view of Widenhouse et al. (referred to as “Widenhouse”) (US 2008/0287974 A1) in view of Tran et al. (referred to as “Tran”) (US 2005/0274384 A1) further in view of Wildemeersch (US 2020/0008972 A1), as extrinsically evidenced by MIKKONEN (WO 2021/175880 A1), Taylor (US 2022/0176619 A1), Ostendorf-Kunststoffe, and P. Gregory for claim 1.
Regarding claim 1, Raje discloses a monofilament retrieval thread for use with intracavitary devices comprising intrauterine devices (IUD’s) (see Fig. 15 and [0002] and [0056]; the IUD 20 in Fig. 15 and all of the embodiments of the IUDs in Figs. 1-14 of Raje has a monofilament thread or string for use, and these IUDs are intracavitary device as they are placed in the uterus of a user), wherein the IUD’s comprising one or more tails necessarily provided with gradation markings at uniform intervals (see Fig. 15 and [0056]; the IUD 20 shown in Fig. 15 has a tail provided with gradation markings at uniform intervals, as [0056] states there are a plurality of identification marks at measured intervals),
the thread comprising, two contrasting colors, alternatingly, one of the colors forming the gradation markings at uniform intervals that are configured to be visible to the naked eye (see Fig. 15 and [0056]; the thread 18 comprises two contrasting colors that alternate as seen in Fig. 15, and the darker color forms a plurality of gradation marks that are visible to the naked eye, as a surgeon is able to see the markings, as discussed in [0056]).
Raje is silent on the thread comprising, two contrasting colors, alternatingly, the thread forming the gradation markings at uniform intervals that are radio- and sono-opaque; and the thread comprising 1 mm long graduation markings at specified intervals on the thread and additional 1 mm long gradation markings at specified intervals for convenient identification of the measurable length at each such specific marked interval on the thread; and wherein the thread and the markings are inert to biological fluids of the human body and stable at a pH range of 1-9.
However, Widenhouse teaches analogous gradation markings (28, 30) (see Fig. 2) comprising two contrasting colors, alternatingly, one of the colors forming gradation markings that are radio-opaque (see Fig. 2 and [0035]; tube 24 has both visually clear sections 28 and radiopaque, white colored sections 30, which are two contrasting colors, that alternate as seen in Fig. 2, and the white colored sections 30 are radiopaque), providing visual markings that are easy to visualize and understand.
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 thread of Raje to have two contrasting colors (28, 30) that alternate, and one of the colors forming gradation markings that are radio-opaque as taught by MIKKONEN to have provided an improved retrieval thread with visual markings that are easy to visualize and understand.
Raje in view of Widenhouse discloses the invention as discussed above.
Raje in view of Widenhouse is silent on the thread forming gradation markings that are sono-opaque; and wherein the thread and the markings are inert to biological fluids of the human body and stable at a pH range of 1-9.
However, Tran teaches an analogous marking (102) that is radio- and sono-opaque (see [0090]; marker 102 is an analogous marker as it may be colored and is for use with an intracavitary device, and marker 102 may be an ultrasound marker, meaning it is visible in an ultrasound image, and thus is sono-opaque), providing colored markings that are visible in various imaging techniques so that a medical professional is able to easily identify the location/placement of the markings.
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 one of the colors forming gradation markings in the device of Raje in view of Widenhouse to be sono-opaque as taught by Tran to have provided an improved monofilament retrieval thread that has colored markings that are visible in various imaging techniques so that a medical professional is able to easily identify the location/placement of the markings.
Raje in view of Widenhouse further in view of Tran discloses the invention as discussed above.
Raje in view of Widenhouse further in view of Tran is silent on the thread comprising 1mm long graduation markings at specified intervals on the thread and additional 1mm long gradation markings at specified intervals for convenient identification of the measurabale length at each such specific marked interval on the thread; and wherein the thread and the markings are inert to biological fluids of the human body and stable at a pH range of 1-9.
Although Raje in view of Widenhouse further in view of Tran does not explicitly disclose the thread comprising 1mm long gradation markings at specified intervals on the thread and additional 1mm long gradation markings at specified intervals for convenient identification of the measurable length at each such specific marked interval on the thread, it is noted that the applicant does not indicate that the claimed dimension is otherwise critical (see Page 9 of Applicant’s specification, which describes the intervals for the gradation markers capable of being various other units of measurement, e.g. centimeters, millimeters, inches, etc.). Therefore, in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device, and thus 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 gradation markings of Raje in view of Widenhouse further in view of Tran to be 1 mm long at specified intervals on the thread additional 1mm long gradation markings at specified intervals for convenient identification of the measureable length at each such specific marked interval on the thread in order to have a sufficient number of identification markings to aid the surgeon in cutting a right length of the thread, as Raje also discloses the markings to be at measured intervals (see [0056] of Raje).
Raje in view of Widenhouse further in view of Tran is silent on wherein the thread and the markings are inert to biological fluids of the human body and stable at a pH range of 1-9.
However, Wildemeersch teaches an analogous intracavitary device (see Abstract) with an analogous thread (see [0104]-[0105] which discusses the IUD having an extraction wire which is a monofilament polypropylene strand and thus is an analogous thread), and color (see [0105] which discusses the extraction wire comprising a coloring agent), wherein the thread and the color are inert to biological fluids of the human body and stable at a pH range of 1-9 (see [0104]-[0105]; the thread is a monofilament polypropylene strand, which is known in the art to be inert to biological fluids of the human body, as evidenced by WO 2017/175880 MIKKONEN which states on Pg. 7 lines 12-15, how polypropylene is biocompatible with the human body, definition of biocompatibility is “compatibility with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection,” https://www.merriam-webster.com/dictionary/biocompatible, and thus is inert or chemically inactive to biological fluids of the human body, and polypropylene is also known in the art to be stable at a pH of 1-13, which falls within the range of 1-9, as evidenced by https://www.ostendorf-kunststoffe.com/en/quality/polypropylene/, and the coloring agent is Cu-phtalocyanine dye, which is also known in the art to be biocompatible and thus is inert or chemically inactive to biological fluids of the human body, as evidenced by US 2022/0176619 A1 Taylor in paragraph [0249] of Taylor, which discusses copper phthalocyanine as a biocompatible colorant), providing to use materials that are biocompatible so that it is safe for use.
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 materials of the thread and the markings in the device of Raje in view of Widenhouse further in view of Tran to be inert to biological fluids of the human body and stable at a pH range of 1-9 as taught by Wildemeersch to have provided an improved monofilament thread for use with intracavitary devices that uses materials that are biocompatible so that it is safe for use.
Raje in view of Widenhouse in view of Tran further in view of Wildemeersch discloses the invention as discussed above.
Although Raje in view of Widenhouse in view of Tran further in view of Wildemeersch does not explicitly disclose the markings being stable at a pH range of 1-9, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the markings are stable at a pH range of 1-9, as copper phthalocyanine as taught by Wildemeersch, which forms the markings, are known in the art for their high chemical stability, as evidenced by P. Gregory on Page 4 in the highlighted text, in order to provide a material that is safe for use with the human body.
Regarding claim 2, Raje in view of Widenhouse in view of Tran further in view of Wildemeersch discloses the invention as discussed in claim 1. Raje in view of Widenhouse in view of Tran further in view of Wildemeersch further discloses colored and uncolored segments contrasting alternatingly (see Fig. 2 of Widenhouse and [0036] of Widenhouse; as previously modified above, see claim 1, the thread of Raje comprises two contrasting colors, which have been modified to be clear sections 28 of Widenhouse and white colored sections 30 of Widenhouse that alternate as seen in Fig. 2 of Widenhouse, and the clear sections 28 of Widenhouse are uncolored, as they are clear, and the white colored sections 30 of Widenhouse are colored).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBIN HAN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786