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 .
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 Rejections - 35 USC § 112
3. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
4. Claims 2 and 3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claims 2 and 3, while the disclosure provides support for a first polymer portion that covers the upper arm of the clamp as suggested at [0172], and the polymer overmold overlaying recesses formed in the substrate members at [0284]-[0287] of the instant publication, the disclosure does not provide support for a first polymer portion that completely fills the one or more suture passageways or partially fills the one or more suture passageways.
5. 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.
6. Claims 8, 12, 13, 18 and 19 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.
7. At line 3 of claim 8, it is unclear if “each of the recessed suture portions” is intended to reference “a second plurality of suture portions that are recessed” as recited at line 2 of claim 8, or “a plurality of recessed suture portions” recited at lines 13-14 of claim 1.
8. At lines 4-5 of claim 12, it is unclear in both instances which “the suture portions” are being referenced as lines 2-3 recites “one or more suture portions”. A suggested amendment to lines 4-5 is –the one or more suture portions--.
9. At lines 3-4 of claim 13, it is unclear in both instances which “the suture portions” are being referenced as line 2 recites “one or more suture portions”. A suggested amendment to lines 3-4 is –the one or more suture portions--.
10. Claim 18 at line 6 recites the limitation "the polymer portion that is penetrable by a suture needle". There is insufficient antecedent basis for this limitation in the claim.
11. Claim 19 at line 3 recites the limitation "the first suture portion". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
12. 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.
13. 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.
14. Claims 1, 4-12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jacobs et al. (U.S. Pub. No. 2011/0190791). Regarding claim 1, Jacobs et al. (hereinafter Jacobs) teaches a bariatric clamp (Fig. 1) comprising:
a first elongated portion 104A (Fig. 2(a)) including a first substrate member [0076] at least partly overmolded by a first polymer portion 700 (Figs. 19-20 and [0095]-[0096]), the first elongated portion 104a having a first proximal end and a first distal end opposite the first proximal end, and an inner surface and an outer surface (Fig. 2(a));
a second elongated portion 104B (Fig. 2(a)) including a second substrate member at least partially overmolded by a second polymer portion ([0096]; and [0079]: “sleeves…can be slid over the arms of the clamp”), the second elongated portion 104B having a second proximal end and a second distal end opposite the second proximal end, and an inner surface and an outer surface (Fig. 2(a)); and
a bight portion 106 including a flexible hinge (Fig. 2(a) and [0063]-[0064], [0071]), the flexible hinge joining the first elongated portion at the first proximal end thereof and joining the second elongated portion at the second proximal end thereof (Fig. 2(a));
wherein the first elongated portion 104A includes a plurality of recessed suture portions 612D,E that are recessed from at least one of the inner surface and the outer surface of the first elongated portion (Fig. 14 and [0087]), each recessed suture portion including one or more suture passageways through the first substrate member such that the one or more suture passageways have a perimeter at least partially defined by the first substrate member (sutures placed through suture holes as described at [0097] and claim 46).
Regarding claim 4, Jacobs discloses that the first polymer portion can completely cover the one or more suture passageways of the recessed suture portions ([0096]: “…silicone sleeve 700 can have tubular section 702…that…can be manipulated into position to encapsulate the…bight portion of the clamp”).
Regarding claim 5, the bight portion 106 includes an opening 108 through a portion of the flexible hinge (Figs. 2(b)-2(c) and [0063], [0066], [0068]).
Regarding claim 6, the opening 108 in the bight portion 106 is configured to form a suture connection as it can be configured to have other engagement features such as “a socket, a loop, a hook, a clasp, a string, magnetic, etc” [0066] or receive a T-bar 118 [0068] which can form a suture connection.
Regarding claim 7, the bight portion 106 includes a substrate member 702 at least partially surrounding the opening in the flexible hinge (Figs. 19-27 and [0096]).
Regarding claim 8, the second elongated portion 104B includes a second plurality of suture portions that are recessed from at least one of the inner surface and the outer surface of the second elongated portion (Figs. 14 and 15(a); [0087]: “additional suture holes 612 provided in the lower rigid member 608”), each of the recessed suture portions including one or more suture passageways through the second substrate member (sutures placed through suture holes as described at [0097] and claim 46).
Regarding claim 9, the clamp further comprises a closure mechanism [0076]-[0077] and Figs. 5, 6B, 7A-7B and 9A) comprising: an engagement portion disposed adjacent the first distal end of the first elongated portion 104A; and a fastener portion 220 disposed adjacent the second distal end of the second elongated portion comprising one or more openings (“loop”) to receive at least a portion of the engagement portion ([0076] and [0079]) to retain the bariatric clamp in a closed position ([0077] and [0079]).
Regarding claim 10, the first substrate member includes a first bend adjacent the first proximal end of the first elongated portion and the second substrate member includes a second bend adjacent the second proximal end of the second elongated portion (“bends” shown in the first/second substrate members in Figs. 6C and 6D) such that, when the bariatric clamp is positioned on a stomach, the flexible hinge of the bight portion forms an aperture 108 through which fluid contained within the stomach may flow (Fig. 2(b)-2(i); [0063] and [0066]; fluid is capable of flowing through the aperture).
Regarding claim 11, Jacobs teaches a bariatric clamp (Fig. 1) comprising:
a first elongated portion 104A (Fig. 2(a)) that includes a first substrate member [0076];
a second elongated portion 104B (Fig. 2(a)) that includes a second substrate member [0076]; and
a bight portion 106 including a flexible hinge (Fig. 2(a) and [0063]-[0064], [0071]), the flexible hinge joining the first elongated portion and the second elongated portion (Fig. 2(a));
wherein the first elongated portion 104A includes one or more suture portions 612A-E configured to facilitate formation of a suture connection with a patient’s stomach (Fig. 14 and [0087]),
wherein each suture portion comprises a first suture passageway through the first substrate member (sutures placed through suture holes as described at [0097] and claim 46) and is at least partially overlaid by a first polymer portion 700 ([0095]-[0096] and Figs. 19-20), and wherein the first polymer portion 700 is penetrable by a suture needle (silicone, which makes up the first polymer portion 700 [0087], is penetrable by a needle).
Regarding claim 12, the second substrate member of the second elongated portion 104B includes one or more suture portions (Figs. 14 and 15(a); [0087]: “additional suture holes 612 provided in the lower rigid member 608”), and wherein the one or more suture portions of the first elongated portion are aligned with the one or more suture portions of the second elongated portion when the bariatric clamp is in a substantially closed position (Fig. 15(a) and [0087]).
Regarding claim 14, the first polymer portion 700 comprises a polymer overmold of at least a portion of the bariatric clamp ([0095]-[0096] and Figs. 19-27).
15. Claims 15-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Santilli et al. (U.S. Pub. No. 2007/0149989). Regarding claim 15, Santilli et al. (hereinafter Santilli) teaches a bariatric clamp (Figs. 1 and 4) comprising:
a first elongated member 32 having a first proximal end 12b and a first distal end 12a opposite the first proximal end, and a first longitudinal axis that is defined between the first distal end and the first proximal end of the first elongated member (Figs. 7-8 and [0034]);
a second elongated member 34 having a second proximal end 14b and a second distal end 14a opposite the second proximal end, and a second longitudinal axis that is defined between the second distal end and the second proximal end of the second elongated member (Figs. 7-8 and [0034]); and
a bight portion 16 including a flexible hinge ([0029] and [0035]) joining the first elongated member 32 at the first proximal end 12b thereof and joining the second elongated member 34 at the second proximal end 14b thereof (Fig. 7);
wherein, when the bariatric clamp is in a closed position, the bight portion 16 at least partially forms a passage-forming section (as shown in Fig. 2), wherein the first elongated member 32 and the second elongated member 34 form a partition-forming section that, when the bariatric clamp is positioned on a stomach of a patient, partitions a portion of the stomach into a first partitioned volume and a second partitioned volume (as shown in Fig. 4), and
wherein at least a portion of the first elongated member 32 includes a first curve that is positioned between the first distal end 12a and the first proximal end 12b of the first elongated member 32 (as shown in Fig. 8 and described at [0034]) and curved away from the second elongated member 34 along the first longitudinal axis thereby defining a curved separation in the partition-forming section of the bariatric clamp (“curved away from the second elongated member 34” being interpreted as Santilli’s teaching of the first elongated member 32 being “disposed away from an operative site” at [0035]).
Regarding claim 16, when the bariatric clamp is positioned on the stomach of the patient, the passage-forming section of the bariatric clamp permits gastric fluids within the stomach to flow from the first partitioned volume to the second partitioned volume (as shown in Fig. 2, the various levels of teeth 15 allows various levels of compression, which would still allow fluid to flow [0030] and [0032]).
Regarding claim 17, at least a portion of the second elongated member 34 includes a second curve along the second longitudinal axis (also has “arc-shaped feature” as the first elongated member [0035]) that is curved away from the first elongated member (“curved away from the first elongated member” being interpreted as Santilli’s teaching of the first and second members being “disposed away from an operative site” at [0035]), the second curve positioned between the second distal end and the second proximal end of the second elongated member ([0034]-[0035] and Fig. 8).
Regarding claim 18 and in view of its indefinite nature, the first elongated member includes a suture portion 20 configured to facilitate formation of a suture connection with a patient's stomach ([0033]-[0034] and Figs. 1 and 8), and wherein the suture portion 20 comprises an aperture (“opening”) formed through the first elongated member ([0033] and Fig. 1) and at least a portion of the aperture of the suture portion is capable of being overlaid by a polymer portion 18 that is penetrable by a suture needle (polyester mesh 18 is penetrable by a suture needle [0033]).
Regarding claim 20, the clamp further comprises a closure mechanism comprising: an engagement portion 13 disposed adjacent the first distal end of the first elongated member 32; and a fastener portion disposed adjacent the second distal end of the second elongated member 34 comprising one or more openings (of teeth 15) to receive at least a portion of the engagement portion 13 to retain the bariatric clamp in the closed position ([0029]-[0030]; and Figs. 1-4, 7 and 8).
Claim Rejections - 35 USC § 103
16. 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.
17. 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.
18. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobs et al. (U.S. Pub. No. 2011/0190791). Regarding claim 13, Jacobs discloses wherein the second substrate member of the second elongated portion includes one or more suture portions (Figs. 14 and 15(a); [0087]: “additional suture holes 612 provided in the lower rigid member 608”); however Jacobs fails to explicitly disclose wherein the suture portions of the first elongated portion are not aligned with the suture portions of the second elongated portion when the bariatric clamp is in a substantially closed position. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the device wherein the suture portions of the first elongated portion are not aligned with the suture portions of the second elongated portion when the bariatric clamp is in the substantially closed position, since rearranging parts of an invention involves only routine skill in the art. The motivation for doing so would be to create dispersed pressure across the tissue when the device is in a closed position as discussed at [0084]-[0086] of Jacobs.
19. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Santilli et al. (U.S. Pub. No. 2007/0149989). Regarding claim 19, while Santilli discloses that the first elongated member includes a suture portion 20 ([0033]-[0034] and Figs. 1 and 8), and wherein the suture portion 20 comprises an aperture (“opening”) formed through the first elongated member ([0033] and Fig. 1), Sanitilli fails to disclose explicitly that the second elongated member includes a second suture portion, wherein the first suture portion is aligned with the second suture portion when the bariatric clamp is in a substantially closed position. However, placing a suture portion/aperture on the second elongated member would constitute a mere duplication of parts, which would be obviated by Santilli’s teaching of parallel elongated members, both of which are necessitating coverage by the cover 18, and the teaching of sewing the cover to the elongated member to retain it on the clamp when in the closed position [0033]. Providing another opening on the second elongated member would enabling retaining the cover on the second elongated member sufficiently, in addition to its retention on the first elongated member ([0033]-[0035]).
Double Patenting
20. 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.
21. Claims 1, 4-8, 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, 12, 16-19, 25 and 26 of U.S. Patent No. 10,420,664. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose:
“a bariatric clamp comprising: a first elongated portion including a first substrate member at least partly overmolded by a first polymer portion, the first elongated portion having a first proximal end and a first distal end opposite the first proximal end, and an inner surface and an outer surface; a second elongated portion including a second substrate member at least partially overmolded by a second polymer portion, the second elongated portion having a second proximal end and a second distal end opposite the second proximal end, and an inner surface and an outer surface; and a bight portion including a flexible hinge, the flexible hinge joining the first elongated portion at the first proximal end thereof and joining the second elongated portion at the second proximal end thereof; wherein the first elongated portion includes a plurality of recessed suture portions that are recessed from at least one of the inner surface and the outer surface of the first elongated portion, each recessed suture portion including one or more suture passageways through the first substrate member such that the one or more suture passageways have a perimeter at least partially defined by the first substrate member”; and
“a bariatric clamp comprising: a first elongated portion that includes a first substrate member; a second elongated portion that includes a second substrate member; and a bight portion including a flexible hinge joining the first elongated portion and the second elongated portion; wherein the first elongated portion includes one or more suture portions configured to facilitate formation of a suture connection with a patient's stomach, wherein each suture portion comprises a first suture passageway through the first substrate member of the first elongated portion and is at least partially overlaid by a first polymer portion, and wherein the first polymer portion is penetrable by a suture needle”.
22. Claims 1, 9, 11-15 and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 8 and 13-19 of U.S. Patent No. 11,723,786. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose:
“a bariatric clamp comprising: a first elongated portion including a first substrate member at least partly overmolded by a first polymer portion, the first elongated portion having a first proximal end and a first distal end opposite the first proximal end, and an inner surface and an outer surface; a second elongated portion including a second substrate member at least partially overmolded by a second polymer portion, the second elongated portion having a second proximal end and a second distal end opposite the second proximal end, and an inner surface and an outer surface; and a bight portion including a flexible hinge, the flexible hinge joining the first elongated portion at the first proximal end thereof and joining the second elongated portion at the second proximal end thereof; wherein the first elongated portion includes a plurality of recessed suture portions that are recessed from at least one of the inner surface and the outer surface of the first elongated portion, each recessed suture portion including one or more suture passageways through the first substrate member such that the one or more suture passageways have a perimeter at least partially defined by the first substrate member”; and
“a bariatric clamp comprising: a first elongated portion that includes a first substrate member; a second elongated portion that includes a second substrate member; and a bight portion including a flexible hinge joining the first elongated portion and the second elongated portion; wherein the first elongated portion includes one or more suture portions configured to facilitate formation of a suture connection with a patient's stomach, wherein each suture portion comprises a first suture passageway through the first substrate member of the first elongated portion and is at least partially overlaid by a first polymer portion, and wherein the first polymer portion is penetrable by a suture needle”; and
“a bariatric clamp comprising: a first elongated member having a first proximal end and a first distal end opposite the first proximal end, and a first longitudinal axis that is defined between the first distal end and the first proximal end of the first elongated member; a second elongated member having a second proximal end and a second distal end opposite the second proximal end, and a second longitudinal axis that is defined between the second distal end and the second proximal end of the second elongated member; and a bight portion including a flexible hinge joining the first elongated member at the first proximal end thereof and joining the second elongated member at the second proximal end thereof; wherein, when the bariatric clamp is in a closed position, the bight portion at least partially forms a passage-forming section, wherein the first elongated member and the second elongated member form a partition-forming section that, when the bariatric clamp is positioned on a stomach of a patient, partitions a portion of the stomach into a first partitioned volume and a second partitioned volume, and wherein at least a portion of the first elongated member includes a first curve that is positioned between the first distal end and the first proximal end of the first elongated member and curved away from the second elongated member along the first longitudinal axis thereby defining a curved separation in the partition-forming section of the bariatric clamp.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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, Charles A Marmor, II can be reached at (571) 272-4730. 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.
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
Prosecution Insights