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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 clamping part is affixed with a woven flexible material” of claim 13 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.
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 1-15 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.
Clim 1 recites “a discoid structure deployed on an atrial side” and “a split structure…deployed on a ventricular side”. It is unclear the scope required by the claim as claim 1 is directed to an apparatus claim and not a method of use. The prior art is not required to teach where the device is deployed. Instead, Applicant should amend the language to functionally recite where the device is capable of being deployed.
Claim 1 recites “a split structure with different tapers”. It is unclear what is meant by “different tapers”. It is unclear if Applicant is intending to claim the split structure comprises segments of different degrees of tapers (one taper is grater or lesser than another), or, if Applicant is intending to claim the split structure comprises different segments (split segments), each having its own taper. The instant specification does not provide further details about the split structure and the detail other than what is annotated as reference number (30) and mentioned in paragraph [0064] of the published application. The specification does not further describe or label the “different tapers” of the device. Therefore, the scope of the term “different tapers” cannot be ascertained.
Claim 1 recites “depending on original valve leaflets”. It is unclear what is meant by this recitation as it appears to leave the scope of the claim open ended. In other words, it is unclear what is required by this claim language.
Claim 2 recites “a prosthesis”. The claimed prosthesis appears to be separate from the prosthetic valve device. However, the original disclosure discusses the barbs as configured to anchor the prosthetic heart valve to a natural cardiac valve annulus ([0063] of the published application). Therefore, it is unclear if the claimed “prosthesis” is in reference to the prosthetic heart valve device, or another separate prosthesis.
The term “special-shaped” in claim 4 is a relative term which renders the claim indefinite. The term “special” 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.
Claim 4 recites the “annular side”. There is a lack of antecedent basis for this limitation.
Claim 5 recites “the special-shaped structure”. However, this term was used twice in claim 4. Therefore, it is unclear which special-shaped structure claim 5 is referring to or if claim 5 is referring to both special-shaped structures.
Claim 6 recites “the split structure with different tapers is distributed at 60°-120°, with the split structure of the prosthetic valve device adapted for the mitral valve distributed at 120°.” There is a lack of antecedent basis for “the mitral valve”. It is further unclear the scope of this claim. It is unclear if the distribution is at 60°-120°, or if 120° is required.
Claim 8 recites “the inner stent can be deployable or self-expanding.” It is unclear what is meant by this limitation since a self-expanding stent is a deployable stent (in other words the stent is deployed via a self-expanding mechanism).
Claim 11 recites “covered with biocompatible material to avoid leakages of blood flow between a prosthesis and a natural annulus”. The claimed prosthesis appears to be separate from the prosthetic valve device. However, the original disclosure discusses the biocompatible material as configured to avoid leakages of blood flow between the prosthetic heart valve and a natural annulus ([0060] of the published application). Therefore, it is unclear if the claimed “prosthesis” is in reference to the prosthetic heart valve device, or another separate prosthesis.
Claim 13 recites “the clamping part”. However, claim 1 recites a plurality of clamping parts. It is unclear which clamping part is being referred to in claim 12 or if claim 12 is referring to all the clamping parts.
Claim 14 recites “the prosthetic valve device adapted for use with the mitral valve”. There is a lack of antecedent basis for this limitation as the prosthetic valve device was never defined as adapted for use with a mitral valve.
Claim 14 recites “the prosthetic valve device…comprises two clamping parts, with a front anchoring part used to capture a natural anterior leaflet and fix a prosthesis, and a rear anchoring part used to capture a natural posterior leaflet and fix a prosthesis”. It is unclear if these two clamping parts are the same clamping parts as recited in claim 1, or additional clamping parts. It is further unclear if the front anchoring part and rear anchoring part are of the clamping parts, or if they are in addition to the clamping parts. If the anchoring parts are different from the clamping parts, then this would necessitate a drawing objection for claimed subject matter not being shown as the drawings have only showed two clamping parts (40).
Claim 14 recites similarly to above, “the prosthetic valve device…comprises three clamping parts, with one of the clamping parts used to capture a natural anterior leaflet and fix a prosthesis, a rear clamping part used to capture a natural posterior leaflet and fix a prosthesis, and another clamping part used to capture a natural septal leaflet and fix a prosthesis.” It is unclear if these three clamping parts are the same clamping parts as recited in claim 1, or additional clamping parts. It is further unclear if the one of the clamping part, a ear clamping part, and another clamping part are part of the previously defined clamping parts or if they are in addition to the three clamping parts. If they are of the same clamping parts, this limitation should be amended to recite - - one of the clamping parts of the clamping parts used to capture a natural anterior leaflet and fix a prosthesis, a rear clamping part of the clamping parts used to capture a natural posterior leaflet and fix a prosthesis, and another clamping part of the clamping parts used to capture a natural septal leaflet and fix a prosthesis.
It is further unclear in claim 14 whether both the two clamping parts and the three clamping parts are required, therefore totaling five clamping parts; or if only one of two clamping parts or three clamping parts is required. There is no embodiment showing five clamping parts.
Claim 14 further repeatedly recites “a prosthesis”. The claimed prosthesis appears to be separate from the prosthetic valve device. However, the original disclosure discusses the clamping parts as configured to fix the prosthetic heart valve with a leaflet ([0065], [0071] of the published application). Therefore, it is unclear if the claimed “prosthesis” is in reference to the prosthetic heart valve device, or another separate prosthesis.
Claim(s) 3, 7, 9, 10, 12 and 15 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 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, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
Prosecution Insights