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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the treatment rendering portion described in claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the Abstract includes the legal phraseology “comprising”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 3-8 and 13-14are 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 3 recites the limitation "the upper tube and the lower tube" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the lower element" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends on claim 3; in order to obviate the 112(b) rejection the dependency of claim 4 should have been claim 2.
As to claim 5, the limitation “…shaped like a sphere…” renders the claim vague and indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting “…sphere-shaped…” instead.
As to claim 6, the limitation “…shaped like a pear…” renders the claim vague and indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting “…pear-shaped…” instead.
As to claim 7, the limitation “…shaped like an ovoid…” renders the claim vague and indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting “…ovoid-shaped…” instead.
As to claim 8, the limitation “…shaped like a cuboid…” renders the claim vague and indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting “…cuboid-shaped…” instead.
Claim 13 recites the limitation "the three or more arms" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the three or more arms" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 5-7, 9-10 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harmanli U.S/ Publication No. (20090283099 A1).
With respect to claim 1, Harmanli discloses a device (as shown in figs.1-3) sized and shaped for alleviating pelvic organ prolapse when inserted into a vagina (Abstract), comprising:
a prolapse treatment rendering portion (12) configured to be adjustable between a collapsed state and an expanded state, where the expanded state extends substantially in three dimensions [0048] and (figs.1-3).
wherein the device has a distal dome (18 and 20, fig.1, note: the dome structure is described in [0061] as element 54 which is the same referenced structure as to the embodiment of figs.1-3) disposed at a distal end of the prolapse treatment rendering portion (12) to ease insertion of the device into the vagina.
With respect to claim 5, Harmanli discloses the treatment rendering portion is shaped like a sphere (as shown in fig.1).
With respect to claim 6, Harmanli discloses the treatment rendering portion is shaped like a pear (as shown in fig.2).
With respect to claim 7, Harmanli discloses the treatment rendering portion is shaped like an ovoid (as shown in fig.2).
With respect to claim 9, Harmanli discloses the treatment rendering portion is rotationally symmetric (as shown in fig.1).
With respect to claim 10, Harmanli discloses at least a portion of the treatment rendering portion is provided with padding [0048 a protective cover or sleeve 26 for partially encasing the frame member 12] and [0046, a protective cover or sleeve may be used to partially encase the frame member, covering the spokes while leaving the upper and lower hubs exposed. The protective cover or sleeve may be made of a flexible, resilient and impermeable biocompatible material (i.e., materials that do not incite toxic reactions). Suitable materials include silicone rubber].
With respect to claim 15, Harmanli discloses a system for alleviating pelvic organ prolapse when inserted into a vagina, comprising: (a) a device according to claim 1; and, (b) an applicator (42, fig.4) which exhibits a larger exterior diameter than the device (when the device is inserted).
With respect to claim 16, Harmanli discloses the distal dome (18 or 20) has a larger exterior diameter than the applicator (as shown in fgi.1).
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) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Harmanli.
With respect to claim 8, Harmanli substantially discloses the invention as claimed except the treatment rendering portion is shaped like a cuboid. It would have been an obvious matter of design choice to make the treatment rendering portion of whatever form or shape was desired or expedient based on the targeted organ intended for treatment. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim(s) 12-14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Harmanli as applied to claim 15 above, and further in view of Sopher et al. U.S. Publication No. (2020/0306077 A1).
With respect to claim 12, Harmanli substantially discloses the treatment rendering portion comprises three or more arcs (24, fig.3) except connected to two orthogonal rings.
Sopher et al., however, teaches a collapsable pessary comprising petal members (310) connected to ring (318, fig.4). While Sopher et al., did not teach (1) two orthogonal rings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide an additional ring for connecting the three or more arcs, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ. Furthermore, it would have been an obvious matter of design choice to make the different portions of the ring of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
With respect to claim 13, the combination of Harmanli/Sopher et al. substantially discloses the invention as claimed. Harmanli further discloses the three or more arms are equally spaced apart angularly (as shown in fig.3).
With respect to claim 14, the combination of Harmanli/Sopher et al. substantially discloses the invention as claimed except the three or more arms are not equally spaced apart angularly. Based on the shape and size of the dropped pelvic organ to which the device is being used to hold, it would have been obvious to provide the three or more arms are not equally spaced apart angularly.
With respect to claim 17, Harmanli substantially discloses the invention as claimed except the applicator comprises a holder and a pusher.
Sopher et al., however, teaches a collapsible pessary (Abstract) and (figs.3-4) comprising an applicator (1900) and a plunger or pusher (1906) to eject the pessary out of the applicator housing (1904) and [0127] and (fig.19A).
In view of the teachings of Sopher et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the applicator of Harmanli by incorporating a pusher for ejecting and inserting the pessary into the anatomy of the user.
With respect to claim 18, the combination of Harmanli/Sopher et al. substantially discloses the invention as claimed. Sopher et al. further teaches the device is nested within the holder of the applicator when in the collapsed state (as shown in fig.19A) and [0127].
With respect to claim 19, the combination of Harmanli/Sopher et al. substantially discloses the invention as claimed. Sopher et al. further teaches the pusher is disposed within the holder and proximally of the device (as shown in figs.19A-B).
With respect to claim 20, the combination of Harmanli/Sopher et al. substantially discloses the invention as claimed. Sopher et al. further teaches the pusher is slidable within the holder (as shown in fig.19B).
Allowable Subject Matter
Claims 2 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The prior art of record fails to show or make obvious the claimed combinations of elements particularly the limitations as set forth in dependent claims 2 and 11which recite features not taught or suggested by the prior art of record, in combination with the other elements (or steps) of the apparatus and method recited in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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, Alireza Nia can be reached at 5712703076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
