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 disclosure is objected to because of the following informalities:
“…By providing the staples in a pre-assembled chain, the spacing between adjacent staples can be more accurately controlled to thereby fixating the distance between the single staples that will withstand intraluminal pressure, residual gastric, intestinal and alike, from enabling the creation of passages between individual staples and staple rows, and reduce the likelihood of leakage…” in para.[0012] needs to be corrected. More specifically, the language “fixating the distance between the single staples that will withstand intraluminal pressure, residual gastric, intestinal and alike, from enabling the creation of passages between individual staples and staple rows, and reduce the likelihood of leakage” needs to clarified to render it more comprehensible.
The listing of references in the specification such as in para. [0016] is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
Appropriate correction is required.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 1 line 6 “the region” and line 8 “the tissue surface” needs to be corrected. A suggested correction is – [[the]] a region – and – [[the]] a tissue surface—respectively in light of lack of any antecedent for respective term in the claim.
Claim 6 line 2 “a curved configuration” needs to be corrected. A suggested correction is – [[a]] the curved configuration—in light of its antecedent “a curved configuration” in claim 1 line 8.
Claim 1 lines 6-13 “said staple being designed to allow said two legs to become bent toward each other once the pointed lower ends have penetrated the tissue surface so as to assume a curved configuration and gather tissue below said surface and constrict same as a part of the pre-assembled chain of staples; and a plurality of rings, each of the rings configured for receiving adjacent legs of an adjacent pair of the staples to restrict movement of the adjacent legs of the adjacent pair of the staples away from each other so that the chain of staples is held together by the rings” needs to be corrected. A suggested correction is – said staple being designed to allow said two legs to become bent toward each other once the pointed lower ends have penetrated the tissue surface [[so]] in a manner as to assume a curved configuration and gather tissue below said surface and constrict same as a part of the pre-assembled chain of staples; and a plurality of rings, each of the rings configured for receiving adjacent legs of an adjacent pair of the staples to restrict movement of the adjacent legs of the adjacent pair of the staples away from each other [[so]] in a manner that the chain of staples is held together by the rings—to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “so that” and “so as to” is even required or not required.
Claim 2 “wherein at least some of the rings are sized so that movement of the adjacent legs of the adjacent pair of staples is minimized” needs to be corrected. A suggested correction is – wherein at least some of the rings are sized [[so]] in a manner that movement of the adjacent legs of the adjacent pair of staples is minimized — or -- wherein at least some of the rings are sized to minimize movement of the adjacent legs of the adjacent pair of staples
Claim 6 “allowing the legs of each of the staples to become bent toward each other so as to assume a curved configuration” needs to be corrected. A suggested correction is – allowing the legs of each of the staples to become bent toward each other [[so]] in a manner as to assume a curved configuration — or -- allowing the legs of each of the staples to become bent toward each other into a curved configuration-- to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “so as to” is even required or not required.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 1-11 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Each of claim 1 in line 9 and claim 6 in line 3 recite the limitation “constrict same” which renders this claim unclear. More specifically, it is unclear as to what is meant by “constrict same” and what preceding structure or feature the term “constrict same” is referencing or qualifying.
Claim 5 in line 1 recites “staples” “tissue” “a surgery” and “a bariatric surgery” which renders this claim unclear. More specifically, it is whether each of claim 5 line 1 “staples” “tissue” “a surgery” and “a bariatric surgery” is the same as, different than or in addition to respective corresponding terms recited in claim 1 line 1 “staples”, claim 1 line 1 “surgery”, claim 1 line 1 “bariatric surgery”, claim 1 line 9 “tissue”. Additionally, it is unclear as to whether claim 5 line 1 “staples” are encompassed by claim 1 line 1 “staples”.
Claim 5 in line 5 recites “the tissue” which renders this claim unclear. More specifically, it is unclear as to whether claim 5 line 5 “the tissue” is referencing claim 5 line 1 “tissue” and/or claim 1 line 9 “tissue”.
Claim 6 in line 3 recites “tissue” which renders this claim unclear. More specifically, it is unclear as to whether claim 6 line 3 “tissue” is referencing claim 5 line 1 “tissue” and/or claim 1 line 9 “tissue” or whether claim 6 line 3 “tissue” is in addition to those recited in base claim 5 and claim 1 and if different in what way do the two differ.
Regarding claim 5, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). More specifically, it is unclear whether the limitations “a bariatric surgery” following the phrase are part of the claimed invention or not part of the claimed invention.
Claim 5 recites the limitation “…inserting, preferably sequentially, the pointed ends of each of the legs of the staples of the pre-assembled chain of staples into the tissue...". The use of the word preferably in the claim language renders the claim indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention since it raises a "range within a range" or "broader limitation followed by narrow limitation" indefiniteness type issue. At line 4 of claim 5, it is not clear whether you have to have any form of insertion of the pointed ends of each of the legs of the staples of the pre-assembled chain of staples into the tissue or whether you have to have the specific type of insertion i.e. inserting, sequentially, the pointed ends of each of the legs of the staples of the pre-assembled chain of staples into the tissue.
Claim 11 recites the limitation “…the connector includes a central bar, preferably linear...". The use of the word preferably in the claim language renders the claim indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention since it raises a "range within a range" or "broader limitation followed by narrow limitation" indefiniteness type issue. At line 2-3 of claim 11, it is not clear whether you have to have connector including a central bar of any shape/configuration or whether you have to have the specific shaped central bar i.e. the connector includes a linear central bar.
Dependent claims 2-11 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-11 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification para. [0013], [0016].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
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 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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Milo; Simcha (Pub. No.: US 20110034953 A1, hereinafter referred to as "Milo") in view of Thompson et al. (Pub. No.: US 20170172571 A1, hereinafter referred to as “Thompson”).
As per independent Claim 1, Milo discloses a pre-assembled chain of staples suitable for use in surgery (Milo in at least abstract, fig. 1-7, [[0010-0012], [0025-0027], [0030-0031], [0034-0037], [0046] for example discloses relevant subject-matter. More specifically, Milo in at least abstract, [0011-0012], fig. 4 for example discloses pre-assembled chain of staples suitable/capable of being for use in surgery. See at least Milo abstract, “Interengaging surgical staples (11, 31, 51, 71) are provided that are useful in systems for the surgical correction … supporting weaknesses in abdominal regions. The staples are constructed with at least one ring (21, 41, 61, 81) extending laterally from the upper end of one staple leg (15, 35, 55, 75), which once implanted provides for interengagement with the next staple by passage of the other leg (13, 33, 53, 73) of it therethrough… the two staple legs to curve respectively toward each other once having penetrated the tissue, thus gathering and constricting the tissue in a region below the surface thereof”), the chain of staples comprising:
a plurality of staples, each of the staples having two spaced apart legs and a crown connector which joins the two legs to each other at upper ends thereof and spaces the two legs a predetermined fixed distance apart from each other at their upper ends (Milo in at least fig. 2, fig. 4, [0011-0012], [0025-0027], [0030] for example discloses a plurality of staples 11, each of the staples having two spaced apart legs 13, 15 and a crown connector 19 which joins the two legs to each other at upper ends thereof and spaces the two legs a predetermined fixed distance apart from each other at their upper ends. See at least Milo [0025] “surgical staples of a design that they will both constrict tissue and interconnect with one another, so as to instantly create a chain that can be used to reconfigure a tissue region, particularly …support a region of weakness in a body cavity… surgical staples have, at the time of penetration of the tissue surface, a pair of substantially parallel legs with pointed lower ends that are interconnected at their upper ends by a central connector bar or crown connector which spaces the upper ends of the legs a fixed predetermined distance apart”; [0030] “a surgical staple 11 which includes a pair of legs 13, 15 which have pointed bottom ends 17. The legs are interconnected at their upper ends through a crown connector 19. At the upper end of the leg 15, there is a ring 21 that is connected thereto …connector 19 includes a central linear bar 25 that is flanked by a pair of ears 27, 29.”),
said legs having a substantially constant cross section in the region above their lower ends which are pointed, said staple being designed to allow said two legs to become bent toward each other once the pointed lower ends have penetrated the tissue surface so as to assume a curved configuration and gather tissue below said surface and constrict same as a part of the pre-assembled chain of staples (Milo in at least fig. 2, fig. 4, [0011-0012], [0025-0027], [0030] for example discloses said legs 13, 15 having a substantially constant cross section in the region above their lower ends which are pointed 17, said staple being designed to allow said two legs to become bent toward each other once the pointed lower ends have penetrated the tissue surface as seen in fig. 4 so as to assume a curved configuration and gather tissue below said surface and constrict same as a part of the pre-assembled chain of staples. See at least Milo [0011] “said legs having a substantially constant cross section in the region above their lower ends which are pointed…said staple being designed to allow said two legs to become bent toward each other once said pointed lower ends have penetrated the tissue surface so as to assume a curved configuration and gather tissue below said surface and constrict same”; [0031] “staple has … a substantially constant circular cross section, except for the pointed ends 17”); and
a plurality of rings, each of the rings configured for receiving adjacent legs of an adjacent pair of the staples to restrict movement of the adjacent legs of the adjacent pair of the staples away from each other so that the chain of staples is held together by the rings (Milo in at least fig. 2, fig. 4, [0011-0012], [0017], [0025], [0030], [0034] for example discloses a plurality of rings 21, 21a, each of the rings configured for receiving adjacent legs of an adjacent pair of the staples as seen in fig. 4 to restrict movement of the adjacent legs of the adjacent pair of the staples away from each other so that the chain of staples is held together by the rings as seen in fig. 4. See at least Milo [0025] “surgical staples of a design that they will both constrict tissue and interconnect with one another, so as to instantly create a chain that can be used to reconfigure a tissue region, particularly …support a region of weakness in a body cavity… surgical staples have, at the time of penetration of the tissue surface, a pair of substantially parallel legs with pointed lower ends that are interconnected at their upper ends by a central connector bar or crown connector which spaces the upper ends of the legs a fixed predetermined distance apart”).
Milo does not explicitly disclose bariatric surgical staples feature.
However, in an analogous surgical staples field of endeavor, Thompson discloses the well-known use of staples in bariatric surgery (Thompson in at least fig. 1-2, [0152], [0154] for example discloses well-known use of staples in bariatric surgery. See at least Thompson [0154] “bariatric surgeries… staple line 12 therefore traverses the stomach 10 … desired location of the staple line 12 is about 0.5 cm to about 2 cm away from the gastroesophageal junction 22 and about 2 cm to about 10 cm away from the pylorus 32”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pre-assembled chain of staples suitable for use in surgery as taught by Milo, by extending application to bariatric surgery, as taught by Thompson. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of extending surgical benefits of pre-assembled chain staples (Milo [0025]) to other surgical procedures that employ staples such as bariatric surgery (Thompson [0152]).
As per dependent Claim 2, the combination of Milo and Thompson as a whole further discloses pre-assembled chain of staples wherein at least some of the rings are sized so that movement of the adjacent legs of the adjacent pair of staples is minimized (Milo in at least [0025] for example discloses at least some of the rings 21, 21a,are sized so that movement of the adjacent legs of the adjacent pair of staples is minimized. Milo [0025] “surgical staples of a design that they will both constrict tissue and interconnect with one another, so as to instantly create a chain that can be used to reconfigure a tissue region, particularly …support a region of weakness in a body cavity… surgical staples have… legs with pointed lower ends that are interconnected at their upper ends by a central connector bar or crown connector which spaces the upper ends of the legs a fixed predetermined distance apart, which distance does not change”).
As per dependent Claim 3, the combination of Milo and Thompson as a whole further discloses pre-assembled chain of staples wherein at least some of the rings have a racetrack or ovular shape (Milo in at least fig. 6 for example discloses an alternate embodiment wherein at least some of the rings have a racetrack or ovular shape in perspective shown in fig. 6).
As per dependent Claim 4, the combination of Milo and Thompson as a whole further discloses pre-assembled chain of staples wherein at least some of the rings have a round shape (Milo in fig. 2 for example discloses at least some of the rings 21, 21a have a round shape).
As per dependent Claim 5, the combination of Milo and Thompson as a whole further discloses a method of inserting a row of staples into tissue as part of a surgery, such as a bariatric surgery (Milo in at least [0011-0012] for example discloses method of inserting a row of staples into tissue as part of a surgery. See at least Milo [0012] “method of implanting surgical staples to form a ring-like arrangement …which method comprises implanting a first staple having two spaced apart legs and a crown connector which joins said legs to each other at upper ends thereof and spaces said legs a predetermined fixed distance apart from each other at their upper ends, with at least one of said legs being formed with … apertured ring …implanting a second surgical staple, which also has first and second such legs joined by a crown connector that spaces them a predetermined fixed distance apart at their upper ends and has …. ring extending laterally from said second leg, by passing said first leg through the aperture in the ring of said first implanted staple so as to interengage the two staples, and implanting a plurality of additional staples similar to said second staple with the first leg of each passing through the aperture in the ring of the last implanted staple to create an incomplete or complete ring-like arrangement in the tissue … said respective legs of each said staple becoming bent toward each other below the surface of the tissue to achieve a curved configuration toward each other and thereby gather tissue below the surface and constrict same”), the method comprising: providing the pre-assembled chain of staples of claim 1 (see claim 1); and inserting, preferably sequentially, the pointed ends of each of the legs of the staples of the pre-assembled chain of staples into the tissue (Milo in at least [0011-0012] for example discloses inserting the pointed ends of each of the legs of the staples of the pre-assembled chain of staples into the tissue. See at least [0011] “staple being designed to allow said two legs to become bent toward each other once said pointed lower ends have penetrated the tissue surface so as to assume a curved configuration and gather tissue below said surface and constrict same.”; [0012] “by passing said first leg through the aperture in the ring of said first implanted staple so as to interengage the two staples, and implanting a plurality of additional staples similar to said second staple with the first leg of each passing through the aperture in the ring of the last implanted staple … said respective legs of each said staple becoming bent toward each other below the surface of the tissue to achieve a curved configuration toward each other and thereby gather tissue below the surface and constrict same”).
As per dependent Claim 6, the combination of Milo and Thompson as a whole further discloses method further comprising allowing the legs of each of the staples to become bent toward each other so as to assume a curved configuration and gather tissue below said surface and constrict same as a part of the pre-assembled chain of staples (Milo in at least fig. 4, [0011-0012], [0034] . See at least Milo [0011] “said staple being designed to allow said two legs to become bent toward each other once said pointed lower ends have penetrated the tissue surface so as to assume a curved configuration and gather tissue below said surface and constrict same”; [0012] “said respective legs of each said staple becoming bent toward each other below the surface of the tissue to achieve a curved configuration toward each other and thereby gather tissue below the surface and constrict same”; [0034] “individual legs 13 and 15 are shown as having curved from their substantially parallel orientations at the time of delivery (shown in FIG. 1) to now lie juxtaposed with each other. “).
As per dependent Claim 7, the combination of Milo and Thompson as a whole further discloses method, further comprising restricting lengthening of the chain of staples (Milo in at least [0011-0012] for example discloses restricting lengthening of the chain of staples via interengaging staples with each staple comprising a crown connector that spaces the legs apart a predetermined fixed distance apart from each other. See at least [0011] “surgical staple which comprises two spaced apart legs, and a crown connector which joins said legs to each other at upper ends thereof and spaces said legs a predetermined fixed distance apart from each other at their upper ends,”).
As per dependent Claim 8, the combination of Milo and Thompson as a whole further discloses method, wherein the step of restricting lengthening of the chain of staples further comprises using the rings to restrict lengthening of the chain (Milo in at least [0011-0012] for example discloses using the rings to restrict lengthening of the chain via interengaging staples with each staple comprising a crown connector that spaces the legs apart a predetermined fixed distance apart from each other. See at least Milo [0012] “method of implanting surgical staples to form a ring-like arrangement …which method comprises implanting a first staple having two spaced apart legs and a crown connector which joins said legs to each other at upper ends thereof and spaces said legs a predetermined fixed distance apart from each other at their upper ends, with at least one of said legs being formed with … apertured ring …implanting a second surgical staple, which also has first and second such legs joined by a crown connector that spaces them a predetermined fixed distance apart at their upper ends and has …. ring extending laterally from said second leg, by passing said first leg through the aperture in the ring of said first implanted staple so as to interengage the two staples, and implanting a plurality of additional staples similar to said second staple with the first leg of each passing through the aperture in the ring of the last implanted staple to create an incomplete or complete ring-like arrangement in the tissue … said respective legs of each said staple becoming bent toward each other below the surface of the tissue to achieve a curved configuration toward each other and thereby gather tissue below the surface and constrict same”).
As per dependent Claim 9, the combination of Milo and Thompson as a whole further discloses method wherein the row of staples is a line (see Milo fig. 4).
As per dependent Claim 10, the combination of Milo and Thompson as a whole further discloses method wherein the row of staples is curved or circular (Milo in [0010] “implantation of a series of interengaging surgical staples, wherein each one at the time of its implantation interengages with the last implanted staple as a step in creating a ring “).
As per dependent Claim 11, the combination of Milo and Thompson as a whole further discloses pre-assembled chain of staples wherein the connector includes a central bar, preferably linear, that is flanked by a pair of ears configured for receiving the rings (Milo in at least fig. 2, fig. 4, [0030] for example discloses the connector 19 includes a central bar 25, preferably linear, that is flanked by a pair of ears 27, 29 configured for receiving the rings as seen in fig. 4. See at least Milo [0025] “surgical staples of a design that they will both constrict tissue and interconnect with one another, so as to instantly create a chain that can be used to reconfigure a tissue region, particularly … surgical staples have, at the time of penetration of the tissue surface, a pair of substantially parallel legs with pointed lower ends that are interconnected at their upper ends by a central connector bar or crown connector which spaces the upper ends of the legs a fixed predetermined distance apart”; [0030] “a surgical staple 11 which includes a pair of legs 13, 15 which have pointed bottom ends 17. The legs are interconnected at their upper ends through a crown connector 19. At the upper end of the leg 15, there is a ring 21 that is connected thereto …connector 19 includes a central linear bar 25 that is flanked by a pair of ears 27, 29”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
US 20040236419(see at least abstract, fig. 4, 16, 20-21, [0011-0016]);
US 20060291981 (see at least abstract, fig. 1, [0008-0011]);
US 20070010854(see at least abstract, fig. 7, [0011-0013]);
US 5246443(see at least abstract, fig. 11-14, col. 2);
US 5947999 (see at least abstract, col. 3);
US 20020042621 (see at least abstract, [0010-0044], fig. 4-6, 16, 19, 22-24);
US 5484451 (see at least abstract, fig. 18-20, col. 3-4);
US 20120111920 (see at least abstract, fig. 2, 11-12, 14, 16, [0007-0014]);
US 20150351762(see at least abstract, fig. 31C, 80A-80C, 81-85, [0009-0059]);
US 20040220682 (see at least abstract, fig. 2, 3A, [0010-0025]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791