DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application claims priority from provisional application 61/551,728, filed 10/26/2011.
However, numerous application between the current application and the provisional do not include the current figures and are directed at wholly different inventions. For example parent application 16/881579 does not include any of the current figures. It appears to support the independent claim, but fails to disclose any of the tab or break features. This lack of disclosure continues for several applications within the family including application 14051787 which is a continuation in part of application 13658050, which is the only disclosure of the tabs. Therefore the chain of priority is broken for those features and they will be given the filing date of this application for their priority date, 09/07/2023.
Confirmation and clarification by the applicant is required for all applications within the family as to if they are actually continuations and not continuations in part.
Status of Claims
Claims 1-18 are pending.
Claims 9 and 18 have been withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Species 1 (Figures 1-6) in the reply filed on 05/01/2026 is acknowledged.
Information Disclosure Statement
The Information Disclosure Statement filed on 12/13/2023 has been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: missing/outdated priority information. Since the filing of this application at least one of the parent applications have been issued patent numbers. The priority information within the first line of the specification must be amended to disclose these patent numbers. Also see note above under priority for confirmation as to the proper status for the parent cases.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 5-7 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 5,071,431. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued patent is more specific and would anticipate the current broader claims.
Claim 1 of the pending application is only different from Patented claim 1 within the preamble. Pending claim 1 refers to a prosthetic and Patented claim 1 is a sizing ring. A prosthetic would qualify as a sizing ring as evidenced by the intended use defined in Pending claim 10. Therefore the sizing ring would read upon the claimed prosthetic.
Claim 2 of the pending application is only different from Patented claim 2 because it doesn’t not call the break a defect. However they both require the same structure regardless of it being called a defect or not.
Pending and Patented Claims 3 are identical.
Claim 5 of the pending application is only different from Patented claim 4 because it doesn’t say the tab is gripped by forceps. However they both require the same structure regardless of the intended use.
Pending claim 6 and Patented Claim 5 are identical.
Claim 7 of the pending application is only different from Patented claim 6 because it doesn’t say the tab is gripped by forceps. However they both require the same structure regardless of the intended use.
Claims 10-13 and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 5,071,431 in view of Aklog US 2005/0004665 A1.
The patented claims disclose all the same structural features as those in pending claims 10-12 and 14-16, which will be outlined below in more detail. However, the Patented claims do not disclose the use of a system comprising a plurality of the ring assemblies in different sizes.
Aklog discloses that it is old and well known in the art of annuloplasty rings to provide a system including a kit with multiple sets of the annuloplasty devices in different sizes [0093] in order to provide an optimal fit for each patient.
Therefore it would have been obvious at the time of filing to provide the annuloplasty ring assemblies of the patented case in the form of a kit with multiple assemblies in varied sizes in order to provide the patient with the optimal sized ring.
In view of the modification, Claim 10 of the pending application is only different from Patented claim 1 within the preamble. Pending claim 1 refers to a prosthetic and Patented claim 1 is a sizing ring. A prosthetic would qualify as a sizing ring as evidenced by the intended use defined in Pending claim 10. Therefore the sizing ring would read upon the claimed prosthetic.
In view of the modification, Claim 11 of the pending application is only different from Patented claim 2 because it doesn’t not call the break a defect. However they both require the same structure regardless of it being called a defect or not.
In view of the modification, Pending claim 12 and Patented Claim 3 are identical.
In view of the modification, Claim 14 of the pending application is only different from Patented claim 4 because it doesn’t say the tab is gripped by forceps. However they both require the same structure regardless of the intended use.
In view of the modification, Pending claim 15 and Patented Claim 5 are identical.
In view of the modification, Claim 16 of the pending application is only different from Patented claim 6 because it doesn’t say the tab is gripped by forceps. However they both require the same structure regardless of the intended use.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-2 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Tremulis et al (Tremulis) US Patent No. 7,101,395 B2.
1. Tremulis discloses a heart valve prosthetic ring assembly (Figure 7B), comprising:
an outer ring 12; and an inner ring 14 configured and arranged to couple to the outer ring (Figure 7B and described in 2:18-29 and 5:22-43); and
the outer ring and inner ring having a pair of complementary mating surfaces configured (near 40 Figure 7B) and arranged to grip sutures therebetween when coupled together (Tremulis discloses the rings grip tissue so therefore they are inherently capable of gripping some type of known suture).
2. Tremulis discloses the outer ring further comprises a break in the outer ring (the rings of Tremulis are delivered straight and coiled at the implant site so they inherently have a break).
Claim(s) 2 and 5-8 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Dobrilovic US Patent No. 9,889,009 B2.
In view of the later priority date for the tab features explained above, Dobrilovic qualifies as prior art for these claims. Dobrilovic discloses:
1. Dobrilovic discloses a heart valve prosthetic ring assembly (Figures 1-6), comprising:
an outer ring 12; and an inner ring 14 configured and arranged to couple to the outer ring (Figure 6); and
the outer ring and inner ring having a pair of complementary mating surfaces configured (Figure 6) and arranged to grip sutures therebetween when coupled together (Figure 5).
2. Dobrilovic discloses the outer ring further comprises a break 15 in the outer ring.
5. Dobrilovic discloses a tab 26 extending from the outer ring.
6. Dobrilovic discloses the tab is angled outwardly from the outer ring (Figure 1).
7. and 8. Dobrilovic discloses a tab 24 extending from the inner ring.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tremulis.
Tremulis discloses the invention substantially as claimed being described above and further comprising snap fitting concave and convex surfaces (near 40 Figure 7B). However, the concave and convex surfaces are reversed compared to the claimed configuration (Figure 7B).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to switch the concave and convex surfaces of Figure 7B because merely reversing the working parts of a device involves only routine skill in the art and does not, by itself, establish patentability. In this case the surfaces would still lock together to secure any tissue or sutures therebetween. This modification would not change any functionality or produce any new effects. Furthermore, the applicant’s disclosure has not provided any specific need or unexpected result from this configuration.
4. Tremulis discloses the outer ring further comprises a break in the outer ring (the rings of Tremulis are delivered straight and coiled at the implant site so they inherently have a break).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tremulis in view of Aklog US 2005/0004665 A1.
Tremulis discloses the invention substantially as claimed being described above. However, Tremulis does not disclose the rings are part of a system comprising a plurality of the paired rings of different sizes.
Aklog discloses that it is old and well known in the art of annuloplasty rings to provide a system including a kit with multiple sets of the annuloplasty devices in different sizes [0093] in order to provide an optimal fit for each patient.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the annuloplasty ring assemblies of Tremulis in the form of a kit with multiple assemblies in varied sizes in order to provide the patient with the optimal sized ring.
10. Tremulis further discloses each of his paired prosthetic ring assemblies may be utilized for determining proper sizing and then permanently secured in place as a permanent implanted ring prosthetic (it is a prosthetic valve not a trial, which if the surgeon determines has the right dimensions it will be permanently implanted).
11. and 13. Tremulis discloses each outer ring further comprises a break in the outer ring (See rejection of claim 2 above).
12. Tremulis discloses each outer ring has a concave surface on an inner portion thereof and each inner ring has a convex surface on an outer portion thereof that snap-fit together (See rejection of claim 3 above).
Claims 11 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Dobrilovic in view of Aklog US 2005/0004665 A1.
Dobrilovic discloses the invention substantially as claimed being described above. However, Dobrilovic does not disclose the rings are part of a system comprising a plurality of the paired rings of different sizes.
Aklog discloses that it is old and well known in the art of annuloplasty rings to provide a system including a kit with multiple sets of the annuloplasty devices in different sizes [0093] in order to provide an optimal fit for each patient.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the annuloplasty ring assemblies of Dobrilovic in the form of a kit with multiple assemblies in varied sizes in order to provide the patient with the optimal sized ring.
10. Dobrilovic as modified discloses a heart valve prosthetic ring system, comprising: a plurality of paired ring prosthetic ring assemblies (see Aklog [0093]) , each of said plurality of paired ring prosthetic ring assemblies comprising and outer ring 12, and an inner ring 14 configured and arranged to couple to the outer ring (Figure 1), and the outer ring and inner ring having a pair of complementary mating surfaces (Figures 3-6) configured and arranged to grip sutures therebetween when coupled together (Figures 4-5), each of said plurality of paired ring prosthetic ring assemblies having a different size (see Aklog [0093]) wherein each of the plurality of paired ring prosthetic ring assemblies may be utilized for determining proper sizing (see Aklog [0093]) and then permanently secured in place as a permanent implanted ring prosthetic (Figure 5).
11. and 13. Dobrilovic discloses each outer ring further comprises a break 15 in the outer ring.
14. Dobrilovic discloses a tab 26 extending from each outer ring
15. Dobrilovic discloses the tab is angled outwardly from the outer ring (Figure 1).
16. and 17. Dobrilovic discloses a tab 24 extending from each inner ring.
Examiner’s Note
It is noted that in related application 13/658,050, the board overturned a similar rejection, but the reasoning is not applicable here because this application specifically calls the invention a prosthetic ring. Therefore the leaflets would not render the invention unable to perform the intended use. Furthermore claim 10, supports the prosthetic being left in place which would be the case for Sauter. This art has not been used is would anticipate at least some of the pending claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
Prosecution Insights