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 because the Item descriptions are in a foreign language particularly in figures 4A and 4C. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 3 (Fenestrated Speculum). 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. 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.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 2 objected to because of the following informalities: the phrase "and their administration through the use of instruments or tools of appropriate design, whose patentability is also claimed" should read " and the use of instruments of appropriate design.". Appropriate correction is required.
Claim 4 objected to because of the following informalities: the phrase "and a grimace or notcha at 12 o'clock" should be "a notch at 12 o'clock". Appropriate correction is required.
Claim 4 objected to because of the following informalities: the phrase "windows" should be windows. Appropriate correction is required. Examiner also recommends for the removal of the phrase “two fenestrations or lateral and longitudinal” to aid in claim clarification.
Claim 10 objected to because of the following informalities: the phrase "we proceed to make" should be "proceed to make".
Claim8 objected to because of the following informalities: the phrase "for the lengthening of the elongation of the vulvar vestibule" should be for the lengthening of the vulvar vestibule. 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 1-11 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Regarding Claim 1, 2, 8-11: the claim is considered indefinite as it is unclear which of the statutory categories the claim is referencing. Recognized categories include process, machine, manufacture, or composition of matter. Correction is required.
Regarding Claim 2: The claim is considered indefinite as it is unclear where the PCL and PDO threads are being utilized in the device. Clarification is required.
Claims 3-7: These claims are directed to a structural claim but depend upon a method claim. Clarity is needed as to which of the statutory classes are being claimed.
Claim 4 recites the limitation "the operator guide". There is insufficient antecedent basis for this limitation in the claim.
The term “12 o'clock” in claim 4 is a relative term which renders the claim indefinite. The term “12 o'clock ” 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 notch is made indefinite by the limitation "12 o'clock".
Claims 4 recites the transitional phrase “Characterized by” which broadens the scope of the previous “consisting of” transitional phrase of the claim in which claim 4 depends on. Examiner recommends replacing “characterized by” with “consisting of”. Correction is required
The term “appropriate” in claim 5 is a relative term which renders the claim indefinite. The term “appropriate” 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 word appropriate makes the limitations of shape and measurement indefinite because the applicant does not define appropriate.
Claim 6 recites the limitation "needle or thread-holding cannula". There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the previous placement of the introducer". There is insufficient antecedent basis for this limitation in the claim.
Regarding Claim 8: The claim is considered indefinite as it is unclear what is being elevated for lengthening. Clarification is required.
Regarding Claim 9: The claim is considered indefinite as the limitation “execution of two entrance holes” is unclear. Clarification is required.
Regarding Claim 9: The claim is considered indefinite as it is unclear what “one of them” is referencing.
Regarding Claim 10: The phrase “then it opens itself” is unclear as to what element is being opened.
Regarding Claim 10: The phrase “we proceed” consists of narrative language and it is unclear as to who is included in “we”. Examiner recommends removing phrase from claim.
The term “12 o'clock” in claim 10 is a relative term which renders the claim indefinite. The term “12 o'clock” 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 term rotation is rendered indefinite by the use of the term "12 o'clock".
Regarding Claim 11: The claim is considered indefinite as it is unclear to what degree is the tree consecutive rotations being completed. Clarification is required.
Claim 11 recites the limitation "edge". There is insufficient antecedent basis for this limitation in the claim.
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.
(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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2002/0147382 hereinafter Neisz.
In regards to Claim 1: A technique for the treatment of stress urinary incontinence in women (Neisz, Paragraph 14), characterized by the placement of a network of resorbable threads (Neisz, Paragraph 116) in the sub urethral and urethrovaginal spaces (Neisz, Paragraph 60).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0147382 hereinafter Neisz in view of US 2006/0195011 hereinafter Arnal in view of US 2010/0087861 hereinafter Lechmann.
In regards to Claim 2: Neisz teaches all of claim 1 and the administration through the use of instruments or tools of appropriate design, whose patentability is also claimed (Neisz, Paragraph 60). But does not teach polycaprolactone (PCL) and polydioxanone (PDO) threads, mesh threads, pluri yarns and mono screw threads (Lechmann, Paragraph 21).
Arnal teaches polycaprolactone (PCL) (Arnal, Paragraph 67) and polydioxanone (PDO) threads, mesh threads (Arnal, Paragraph 65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the use of PCL as a material to make a surgical mesh as taught by Arnal to the method taught in Neisz, the motivation being to provide a material that is biocompatible.
Lechmann teaches pluri yarns and mono screw threads (Lechmann, Paragraph 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the mono screws taught in Lechmann to the method taught in Neisz, the motivation being to provide a way to secure the mesh inside the body.
Claim(s) 3, 5, 6, & 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0147382 hereinafter Neisz in view of US 2006/0195011 hereinafter Arnal in view of US 2010/0087861 hereinafter Lechmann in further view of 2011/0245812 hereinafter Blocher in furthest view of 2011/0077500 hereinafter Shakiba.
In regards to Claim 3: A modified Neisz teaches all of claims 1, 2, the introducer element (Neisz, Figure 7), and the thread holder (Neisz, Paragraph 217; “the needle may comprise a needle or ligature carrier that includes a retractable suture holder for securely holding the suture to the needle while the needle and sling assembly are drawn up through the body”) but does not teach a fenestrated speculum, and a bayonet.
Blocher teaches of a bayonet (Blocher, Figure 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the bayonet taught in Blocher to the method taught in a modified Neisz, the motivation being to provide a tool to manipulate the thread accurately in the vaginal space.
Shakiba teaches of a fenestrated speculum (Shakiba, Figure 1; Paragraph 44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the fenestrated speculum taught by Shakiba to the method of Neisz, the motivation being to provide a better access to the surgical field.
In regards to Claim 5: A modified Neisz teaches all of claims 1, 2 , 3, and consisting of a handle or clamp and a hook at its end (Neisz, Figure 7 Items 50, 52, & 54; Paragraph 91), of appropriate shape and measurements for its entry into the urethra through and from the urethral meatus to the bladder.
In regards to Claim 6: A modified Neisz teaches all of claim 1, 2, 3, and consisting of a handle and a rod in the shape of an italic "S" (Blocher, Figure 4 and 5), which ends with a pointer adaptable to pressure to the rear part of the needle or thread-holding cannula (Blocher, Figure 4 and 5 Item 50).
In regards to Claim 7: A modified Neisz teaches all of claim 1, 2, 3, and consisting of a cylindrical body and an adaptable pressure pointer, intended for handling and placing the mesh threads (Neisz, Paragraph 217; “the needle may comprise a needle or ligature carrier that includes a retractable suture holder for securely holding the suture to the needle while the needle and sling assembly are drawn up through the body”).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0147382 hereinafter Neisz in view of 2010/0197999 hereinafter Deegan.
In regards to Claim 8: Neisz teaches all of claim 1, but does not teach the previous placement of the introducer through the urethral meatus, and elevation of the same for the lengthening of the elongation of the vulvar vestibule.
Deegan teaches the previous placement of the introducer through the urethral meatus, and elevation of the same for the lengthening of the elongation of the vulvar vestibule (Deegan, Paragraph 133; Figure 23 Item 1100).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the location in which the sling is placed taught in Deegan to the method taught in Neisz, the motivation being to ensure a state of continence immediately after implantation.
Conclusion
The examiner notes that, though no art has been applied against claims 4, 9-15 at this time, they are not presently allowable and the question of prior at will be revisited once the 112B issues have been addressed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.R.D./Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791