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 .
Information Disclosure Statement
The information disclosure statement filed 11 January 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the cited foreign patent document and two non-patent literature publications referred to therein have not been considered.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 2, 4, 5, and 16-21 are objected to because of the following informalities:
In claim 2, line 1: “include” should apparently read --includes--.
In claim 4, line 1: “1/10” should apparently read --0.1--.
In claim 5, line 1: “3/10” should apparently read --0.3--.
In claim 5, line 1: “3/2” should apparently read --1.5--.
In claim 16, line 1: “frame” should apparently read --the frame--.
In claim 16, line 1: “figure of eight” should apparently read --figure-eight--.
In claim 16, line 2: there should be a comma following “loops.”
In claim 17, line 1: “cranial end” should apparently read --the cranial end--.
In claim 18, line 1: “of the device” should apparently read be deleted.
In claim 19, line 2: “POLYURETHANE, SILICONE” should not be capitalized.
In claim 20, line 3: there should be a comma or semi-colon following “mucosa.”
In claim 20, line 4: the comma following “cranial end” should be deleted.
In claim 20, line 4: “open frame” should read --frame-- for consistency throughout the claim; alternatively, the recitations of “the frame” in line 3 and line 5 (as well as the dependent claims) should read “the open frame.”
In claim 21, line 2: “posterior caudal end” should apparently read --a posterior caudal end--.
Appropriate correction is required.
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 4, 5, 10, 11, and 25-28 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 4 recites the limitation "the filament" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the filament" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the filament" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 is rejected by virtue of its dependence upon claim 10.
Claim 25 recites the limitation “gradually” in line 1. This term is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the amount of time for the placing required to be “gradual[ly]” are not readily apparent.
Claims 26 and 27 are rejected by virtue of their dependence upon claim 25.
Claim 28 recites the limitation “wherein an anterior portion of the caudal end of the device rests on the pubic symphysis.” This does not recite a step of the claimed method. It is not clear if this is merely an intended result of the “resting” step recited in claim 20 or if it is meant to be an actively practiced step (e.g., meant to be read along the lines of --resting an anterior portion of the caudal end of the device on the pubic symphysis--).
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.
Claims 1-4, 6-15, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hou et al. (U.S. Pub. No. 2012/0136199 A1; cited in the IDS filed 11 January 2023; hereinafter known as “Hou”).
Regarding claim 1, Hou discloses an intravaginal device 10 (Abstract; Figs. 1-6) comprising: a hollow elastic filament frame 22 configured for intimate contact with vaginal walls, a cranial end 36a/b configured for supporting a vaginal dome and a caudal end 34a/b/c/d configured for resting on a pelvic floor for preventing dislodgment ([0033]-[0034]; [0040]; [0050]). Hou incorporates by reference (in paragraph 0033) the shapes of devices from three other prior art references. These references teach intravaginal devices with diameters/widths of 20-170 mm before insertion and 5-40 mm after insertion, as well as lengths of 15-60 mm. These dimensions overlap with those taught by the present invention. Further, these references show the devices implanted in the same general area as that of the present invention. Thus, while Hou does not expressly teach that its cranial end supports a vaginal dome and its caudal end rests on a pelvic floor, its device is taken herein to be capable of being so positioned and providing such intended use/results.
Regarding claim 2, Hou discloses that said cranial end include members running in an anterior-posterior direction positioned to contact the vaginal dome on opposite lateral sides of a cervix (Figs. 1, 2; 36a and 36b may contact the vaginal dome on opposite sides of the cervix).
Regarding claim 3, Hou discloses that said caudal end includes one or more lateral running elements 34a/b/c/d configured for resting on the pelvic floor and inhibiting dislodgment of the device.
Regarding claim 4, Hou discloses that the filament has a diameter between 1/10 to 5 mm ([0038]).
Regarding claims 6 and 7, Hou discloses that the caudal end is configured to rest on a perineal body or a pubic symphysis (again, taken to be capable of doing so).
Regarding claim 8, Hou discloses that the caudal end configured to rest on the pubic symphysis is provided with a notch to prevent pressure on a urethra (Figs. 1, 2; notch between 34a/b or between 34c/d).
Regarding claim 9, Hou discloses that the frame delineates an axial passage 15 for permitting unhindered sexual intercourse (Fig. 6; [0040]).
Regarding claims 10 and 11, Hou discloses that the filament is made of a super-elastic material selected from at least one of Nitinol and an elastic polymer ([0034]).
Regarding claim 12, Hou discloses that the frame is made of a nitinol wire ([0025]-[0026]; [0030]; [0034]).
Regarding claim 13, Hou discloses that the frame is cut from a sheet ([0034]; such materials are capable of forming such a device by being cut from a sheet; this is a product-by-process claim and determination of patentability is based on the product itself; the process does not impart distinctive structural characteristics to the final product).
Regarding claim 14, Hou discloses that the frame is formed from a bent ring (Figs. 3, 4).
Regarding claim 15, Hou discloses that the frame is saddle shaped with two caudal extensions (Fig. 1).
Regarding claim 17, Hou discloses that cranial end forms an arc (Fig. 1).
Regarding claim 18, Hou discloses that the cranial end of the device comprises two lateral wires 36a/b, that are configured to support on opposite lateral sides of a uterine cervix (Figs. 1, 2).
Regarding claim 19, Hou discloses that the frame is coated with a biocompatible material chosen from a group of: PTFE, POLYURETHANE, SILICONE ([0043]).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hou as applied to claim 1 above. Hou discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the filament has a diameter between 3/10 to 3/2 mm. However, as cited supra, Hou teaches that most preferably the filament has a diameter of less than 3 mm, as well that the filament has a small cross-section to fit into an applicator and be comfortable. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hou with the recited dimensions because this would have been a matter of routine experimentation/optimization within the guideposts and motivation provided by Hou.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Hou as applied to claim 1 above, as further in view of Sopher et al. (U.S. Pub. No. 2019/0091062 A1; hereinafter known as “Sopher”). Hou discloses the invention as claimed, see rejection supra, but fails to expressly disclose that frame has a figure of eight shape including two loops each loop having a crossing point and two arched extensions connecting between the two crossing points. Sopher discloses a similar device (Abstract) comprising a frame with a figure of eight shape including two loops each loop having a crossing point and two arched extensions connecting between the two crossing points (Figs. 39-40; [0127]; [0135]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hou with the frame shape taught by Sopher because this would have been a simple substitution of one known prior art element for another with predictable results, as both frame shapes provide intravaginal support to internal organs.
Claims 20, 21, 23-25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Hou, in view of Zedland (IL86078A; cited in the IDS filed 11 January 2023).
Regarding claim 20, Hou discloses a method capable of treating vaginal prolapse (Abstract) comprising: inserting an open frame 22 into a vagina and placing the frame into intimate contact with vaginal walls and mucosa ([0009]; [0050]), wherein the frame comprises a cranial end 36a/b and a caudal end 34a/b/c/d. Hou fails to expressly disclose supporting a vaginal vault with the cranial end and resting the caudal end of the frame on a pelvic floor. Hou does incorporate by reference (in paragraph 0033) the shapes of devices from three other prior art references, which teach intravaginal devices with dimensions that overlap with those taught by the present invention. Further, these references show the devices implanted in the same general area as that of the present invention. Zedland discloses a similar method for controlling incontinence and vaginal prolapse (Abstract; p. 3, lines 1-4) comprising placing a frame into intimate contact with vaginal walls and mucosa and supporting a vaginal vault with a cranial end 12 and resting a caudal end 18/22 of the frame on a pelvic floor (Fig. 4; p. 6, lines 19-37) in order to aid in controlling prolapse and incontinence and retain the device in the vagina (p. 4, lines 4-6; p. 4a, lines 20-21; p. 6, lines 27-28). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hou by supporting a vaginal vault with the cranial end and resting the caudal end of the frame on a pelvic floor, as taught by Zedland, in order to aid in controlling prolapse and incontinence and retain the device in the vagina.
Regarding claim 21, the combination of Hou and Zedland discloses the invention as claimed, see rejection supra, and Zedland further discloses resting posterior caudal end of the frame on a perineal body (p. 6, lines 25-28).
Regarding claim 23, the combination of Hou and Zedland discloses the invention as claimed, see rejection supra, and Hou further discloses compressing said frame before said inserting and expanding said frame before said placing (Fig. 8; [0048]).
Regarding claim 24, the combination of Hou and Zedland discloses the invention as claimed, see rejection supra, and Hou further discloses introducing said frame into a delivery tube 32 prior to said inserting (Fig. 8; [0048]).
Regarding claim 25, the combination of Hou and Zedland discloses the invention as claimed, see rejection supra, and Hou further discloses that said placing is done gradually ([0046]-[0048]).
Regarding claim 28, the combination of Hou and Zedland discloses the invention as claimed, see rejection supra, and Zedland further discloses that an anterior portion of the caudal end of the device rests on the pubic symphysis (p. 6, lines 35-36).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hou and Zedland as applied to claim 20 above, as further in view of Schuman et al. (U.S. Pub. No. 2015/0305844 A1; hereinafter known as “Schuman”). The combination of Hou and Zedland discloses the invention as claimed, see rejection supra, but fails to expressly disclose incorporating said frame into vaginal walls. Schuman discloses a similar device (Abstract) comprising a frame that includes tips that allow incorporating of the frame into vaginal walls in order to resist rotational movement ([0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hou and Zedland with such tips and incorporating said frame into vaginal walls, as taught by Schuman, in order to resist rotational movement.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hou and Zedland as applied to claim 25 above, as further in view of Hastings et al. (U.S. Pub. No. 2011/0190870 A1; cited in the IDS filed 11 January 2023; hereinafter known as “Hastings”). The combination of Hou and Zedland discloses the invention as claimed, see rejection supra, but fails to disclose that said placing is controlled using a collapsing element that includes a filament wrapped around the frame. Hastings discloses a similar method (Abstract; Hou’s device is also described as a stent) that controls placing of a frame 12 using a collapsing element that includes a filament 52 wrapped around the frame in order to retain the frame in an expanded configuration until deployment and easily allow for deployment from outside the body ([0060]-[0062]; [0087]-[0088]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Hou and Zedland by controlling placing of the frame with a filament wrapped around the frame, as taught by Hastings, in order to retain the frame in an expanded configuration until deployment and easily allow for deployment from outside the body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ziv et al. (U.S. Pub. No. 2010/0217068 A1), Kresch et al. (U.S. No. 5,785,640), and Reimer (U.S. No. 5,618,256) teach similar devices and methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791