NON-FINAL OFFICE ACTION
Notice of Pre-AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 9,848,858 (“the ‘858 patent”) is or was involved. These proceedings would include any AIA proceedings, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Maintenance Fees
Review of the file indicates that applicant’s window for the 7.5 year maintenance fee without surcharge opened 26 December 2024 and will close 26 June 2025. Payment of the maintenance fee with surcharge begins 27 June 2025 and will close 26 December 2025. Applicant is encouraged to ensure all payments are current and proper. See 37 CFR §1.362(d) and (e).
As per MPEP §2504(I)(B),
Effective January 16, 2018, the original patent requires a separate maintenance fee payment if at least one reissue application based on the original patent is pending on the maintenance fee due date (i.e., the 3½, 7½, or 11½ year date) even if a maintenance fee payment is made in reissue patent(s) that have issued from the same original patent.
35 U.S.C. 251 permits reissue only for "the unexpired part of the term of the original patent." An original patent is not surrendered under 35 U.S.C. 252 until a reissue application, based on the original patent, issues as a reissue patent and no other reissue application, based on the same original patent, is still pending. Because it is the granting of the reissue patent – and not the filing of the reissue application - that effectuates surrender of the original patent under 35 U.S.C. 252, maintenance fees remain due in the original patent whenever an application for reissue of the original patent is pending on the maintenance fee due date. Specifically, when one or more reissue patents have issued and at least one application for reissue of the same original patent remains pending, the original patent is not surrendered and maintenance fees remain due in the original patent until the last remaining reissue application issues as a reissue patent or becomes abandoned. In other words, while there is an application for reissue pending in a reissue patent family, maintenance fee payments will be required in both the original patent and the corresponding reissue patent(s). (emphasis added).
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Applicant is reminded that maintenance fees are required in both the original ‘858 patent and reissue patent # RE49359.
35 U.S.C. 251
The reissue oath/declaration filed with this application is a copy from reissue application #16/722,094 and is improper because it fails to identify an error being corrected by this continuation reissue application. See 37 CFR 1.175 and MPEP § 1414 II (D)(1). The error statement must be a new error statement supporting a continuation reissue since the original error from reissue application #16/722,094 is considered to have been corrected in the issuance of the previous reissue application (RE49359). As set forth in MPEP § 1414 II (D)(1),
Where a continuation reissue application is filed with a copy of the reissue oath/declaration from the parent reissue application, and the parent reissue application is not to be abandoned, the reissue oath/declaration should be accepted by the Office of Patent Application Processing (OPAP) without further evaluation, because it is an oath/declaration, albeit improper under 35 U.S.C. 251. The examiner should, however, reject the claims of the continuation reissue application under 35 U.S.C. 251 as being based on an oath/declaration that does not identify an error being corrected by the continuation reissue application, and should require a new oath/declaration that identifies a new error or a statement explaining compliance with 37 CFR 1.175(f)(2) if appropriate. If the same error corrected in the parent is also being corrected in the continuation reissue application, but the error is being corrected in a different way, a statement is needed to explain compliance with 37 CFR 1.175(f)(2) for a reissue application filed on or after September 16, 2012. For these applications, a petition under 37 CFR 1.183 is not needed. For a reissue application filed before September 16, 2012, a petition under 37 CFR 1.183 will be needed to waive pre-AIA 37 CFR 1.175(e) in order to rely on the same error identified in the parent but being corrected in a different way. See 37 CFR 1.175(f)(2) for reissue applications filed on or after September 16, 2012, and pre-AIA 37 CFR 1.175(e) for reissue applications filed before September 16, 2012. One of form paragraphs 14.01.01, 14.01.02, or 14.01.03 may be used.
Claims 1-6 and 8-17 are rejected as being based upon a defective reissue oath/declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175. Applicant must provide a new signed Declaration with new error statement or a statement in compliance with 37 CFR 1.175(f)(2) explaining how the error is being corrected in a different way. Applicant is also reminded that the error cannot be based on surrendered subject matter from the original patent application. See Recapture below.
Specification
The specification is objected to as not containing the notice that more than one reissue application has been filed for the ‘858 patent.
As per 37 C.F.R. 1.177(a),
The Office may reissue a patent as multiple reissue patents. If applicant files more than one application for the reissue of a single patent, each such application must contain or be amended to contain in the first sentence of the specification a notice stating that more than one reissue application has been filed and identifying each of the reissue applications by relationship, application number and filing date. The Office may correct by certificate of correction under § 1.322 any reissue patent resulting from an application to which this paragraph applies that does not contain the required notice.
It is requested that applicant amend the first sentence of the specification in order to list both reissue applications (16/722,094 and 17/988,830) filed for the ‘858 patent. Additionally, it is requested that applicant also include the reissue patent # RE49359 for the 16/722,094 application in the amended first sentence since it has already issued.
Claim Objections
Original claims 1-12 have already been reissued in RE49359. Therefore, the claims in this reissue application need to be renumbered to start at new claim number 13.
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 1-5 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-13 of U.S. Patent No. RE49359. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader versions of the claims issued in RE49359 (see chart below).
17/988,830
RE49359
1. (Currently amended) An instrument for at least one of endoscopic applications, mechanical applications, and electronic applications, comprising
1. An instrument for at least one of endoscopic applications, mechanical applications, and electronic applications, comprising
a tube like member having a handling end portion having at least a first rigid zone, a first flexible handling portion, a second rigid zone and a second flexible handling portion, and having actuating means located at an other, actuating end portion,
a tube like member having a handling end portion having at least a first rigid zone, a first flexible handling portion, a second rigid zone and a second flexible handling portion, and having actuating means located at an other actuating end portion,
at least an inner layer, an outer layer and a first intermediate layer comprising [said tube like member comprising at least an inner cylindrical element, a first outer cylindrical element and first] longitudinal elements
at least an inner cylindrical element, an outer cylindrical element and a first cylinder, said inner cylindrical element, outer cylindrical element and first cylinder being coaxially arranged, the first cylinder comprising longitudinal elements
for transferring a movement of the actuating means to the handling end portion resulting in a change of orientation of at least one of the first flexible portion handling portion and the second flexible handling portion,
for transferring a movement of the actuating means to the handling end portion resulting in a change of orientation of at least one of the first flexible handling portion and the second flexible handling portion,
said longitudinal elements being formed by portions of the first intermediate layer, and wherein said inner layer and said outer layer are continuous layers each of which having at least flexible portions that coincide with respective ones of said first flexible handling portion and said second flexible handling portion
said longitudinal elements being formed by portions of the first cylinder, and wherein said inner cylindrical element and said outer cylindrical element are continuous cylindrical elements each of which having a tube wall that comprises rigid and flexible portions that coincide with respective ones of said first rigid zone, said first flexible handling portion, said second rigid zone and said second flexible handling portion,
wherein said inner layer[cylindrical element] and said [first] outer layer [cylindrical element] are continuous layers [cylindrical elements] each of which having at least [a tube wall that comprises rigid and] flexible portions that coincide with respective ones of [said first rigid zone,] said first flexible handling portion[, said second rigid zone] and said second flexible handling portion (these limitation are duplicate to the previous limitations)
Same as limitations listed above
wherein said flexible portions are obtained by locally providing slits in the respective tube walls of said inner cylindrical element and said outer cylindrical element.
2. (Currently amended) The instrument according to claim 1, wherein the actuating means comprises a tube like section containing a number of alternating flexible and rigid actuating zones,
2. The instrument according to claim 1, wherein the actuating means comprises a tube like section containing a number of alternating flexible and rigid actuating zones,
said longitudinal elements are arranged in sets, and each set of longitudinal elements is connecting one of the rigid zones with a corresponding flexible handling portion
said longitudinal elements are arranged in sets, and each set of longitudinal elements is connecting one of the rigid actuating zones with a corresponding flexible handling portion.
3. (Currently amended) The instrument according to claim [1]2, wherein each set [of said first and second sets]of longitudinal elements comprises at least three longitudinal elements.
3. The instrument according to claim .[.1.]. .Iadd.2.Iaddend., wherein each set .[.of said first and second sets.]. of longitudinal elements comprises at least three longitudinal elements.
4. (currently amended) The instrument according to claim 1, wherein [each element of the first longitudinal elements is cable shaped] the instrument comprises a second intermediate layer arranged coaxially with the inner layer, outer layer, and first intermediate layer, said longitudinal elements are arranged in sets, each set of said longitudinal elements being configured to control said change of orientation of one flexible handling portion, and each one of the first intermediate layer and second intermediate layer comprising one or more sets of longitudinal elements.
4. The instrument according to claim 1, wherein .[.each element of the first longitudinal elements is cable shaped.] the instrument comprises a second cylinder arranged coaxially with the inner cylindrical element, outer cylindrical element, and first cylinder, said longitudinal elements are arranged in sets, each set of said longitudinal elements being configured to control said change of orientation of one flexible handling portion, and several sets of longitudinal elements are located in at least one of the first and second cylinders.
5. (Currently amended) The instrument according to claim 1, wherein the instrument comprises a second intermediate layer arranged coaxially with the inner layer , outer layer, and first intermediate layer, said longitudinal elements are arranged in sets, each set of said longitudinal elements being configured to control said change of orientation of one flexible handling portion, and each set of longitudinal elements is located in a separate one of the first and second cylinders.
5. The instrument according to claim 1, wherein the instrument comprises a second cylinder arranged coaxially with the inner cylindrical element, outer cylindrical element, and first cylinder, said longitudinal elements are arranged in sets, each set of said longitudinal elements being configured to control said change of orientation of one flexible handling portion, and each set of longitudinal elements is located in a separate one of the first and second cylinders.
8. (Granted claim) An instrument according to claim 1, wherein the tube like section of the actuating means has a diameter which is different from the diameter of the remaining tube like member.
8. The instrument according to claim 1, wherein the tube like section of the actuating means has a diameter which is different from the diameter of the remaining tube like member.
9. (Currently amended)] An instrument according to claim 1, wherein the actuating means at the actuating end portion comprises at least one rigid disc, said longitudinal elements are arranged in sets, each set of said longitudinal elements being configured to control said change of orientation of one flexible handling portion, and at least one set of longitudinal elements is connected to said at least one rigid disc of which the orientation [of which] can be changed with respect to a plane perpendicular to the longitudinal axis of the instrument.
9. The instrument according to claim 1, wherein the actuating means at the actuating end portion comprises at least one rigid disc, said longitudinal elements are arranged in sets, each set of said longitudinal elements being configured to control said change of orientation of one flexible handling portion, and .Iaddend.at least one set of longitudinal elements is connected to said at least one rigid disc of which the orientation .[.of which.]. can be changed with respect to a plane perpendicular to .[.the.]. a longitudinal axis of the instrument.
10. (Currently amended) The instrument according to claim 9, wherein the at least one rigid disc is mounted on a ball-and-socket joint connected to the instrument and in that the orientation of the at least one rigid disc is controlled by means of two linear actuators.
10. The instrument according to claim 9, wherein the at least one rigid disc is mounted on a ball-and-socket joint connected to the instrument and in that the orientation of the at least one rigid disc is controlled by means of two linear actuators.
11. (Currently amended) An instrument according to claim 9, [characterized in that]wherein the rigid disc is supported by means of three linear actuators.
11. The instrument according to claim 9, wherein the rigid disc is supported by means of three linear actuators.
12. (Currently amended) The instrument according to claim 1, wherein the actuating means at the actuating end portion comprises at least one set of linear actuators, said longitudinal elements are arranged in sets, each set of said longitudinal elements being configured to control said change of orientation of one flexible handling portion, and at least one set of longitudinal elements is connected to said at least one set of linear actuators.
12. The instrument according to claim 1, wherein the actuating means at the actuating end portion comprises at least one set of linear actuators, said longitudinal elements are arranged in sets, each set of said longitudinal elements being configured to control said change of orientation of one flexible handling portion, and at least one set of longitudinal elements is connected to said at least one set of linear actuators.
13. (New) The instrument according to claim1, wherein the instrument is flexible between the handling end portion and the actuating end portion.
13. The instrument according to claim 1, wherein the instrument is flexible between the handling end portion and the actuating end portion.
Recapture
Claims 1-5 and 8-14 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984). A broadening aspect is present in the reissue which was not present in the application for patent. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
As stated in M.P.E.P. § 1412.02,
In Clement, 131 F.3d at 1468-70, 45 USPQ2d at 1164-65, the Court of Appeals for the Federal Circuit set forth a three step test for recapture analysis. In North American Container, 415 F.3d at 1349, 75 USPQ2d at 1556, the court restated this test as follows:
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We apply the recapture rule as a three-step process:
(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims;
(2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and
(3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In North American Container, the court cited Pannu, 258 F.3d at 1371, 59 USPQ2d at 1600; Hester, 142 F.3d at 1482-83, 46 USPQ2d at 1649-50; and Clement, 131 F.3d at 1468, 45 USPQ2d at 1164-65 as cases that lead to, and explain the language in, the North American Container recapture test.
Step 1: Independent claim 1 and 14 and thereby their dependent claims are broader than original patent claims 1-12. Amended claim 1 and new claim 14 do not include the claim limitations of “said first longitudinal elements being located in a first intermediate layer between said inner cylindrical element and said first outer cylindrical element and being connected to both the actuating means and to the handling end portion,” “wherein the actuating means have at least a first and a second actuating means and the first longitudinal elements comprise at least a first and second set of longitudinal elements, the first set of longitudinal elements having respective handling ends connected to a first rigid ring, said first rigid ring being connected to at least one of said inner cylindrical element and said first outer cylindrical element in said first rigid zone, the second set of longitudinal elements having respective handling ends connected to a second rigid ring, said second rigid ring being connected to at least one of said inner cylindrical element and said first outer cylindrical element in said second rigid zone, and said first set of longitudinal elements being guided through openings in said second rigid ring, the first actuating means being connected to an actuating end of said first set of longitudinal elements, and the second actuating means being connected to an actuating end of said second set of longitudinal elements,”Reissue application for U.S. Pat. No. 9,848,858 Amendment dated: December 20, 2019 -3-“wherein said inner cylindrical element and said first outer cylindrical element are continuous cylindrical elements each of which having a tube wall that comprises rigid and flexible portions that coincide with respective ones of said first rigid zone, said first flexible handling portion, said second rigid zone and said second flexible handling portion, and wherein said flexible portions are obtained by locally providing slits in the respective tube walls of said inner cylindrical element and said first outer cylindrical element” which was part of original patent claim 1.
Therefore step 1 of the three-step test is met for claims 1-6 and 8-14.
Step 2: In the prosecution of US Application 14/221,710 (“the ‘710 application”), applicant relied upon the above claim language in order to gain allowance of the claims; these limitations are not included in the amended or new claims submitted for reissue.
In this case, Applicant’s response of 1/17/17 in the ‘710 application resulted in the incorporation of the above claim language into claim 1. Subsequently, a notice of allowance was mailed. Further, Applicant stated in their 1/17/17 response that the prior art did not teach these limitations. See the ‘710 application, response of 1/17/17, pp. 6-8. Furthermore, the examiner cited to this claim language in the reasons for allowance mailed 3/14/17 in the ‘710 application.
Therefore, the claim language removed from original patent claim 1 which resulted in the broadening of claims 1-5 and 8-14 is the exact claim language of the surrendered subject matter by applicant.
Therefore, step 2 of the three-step test is met for claims 1-5 and 8-14.
Step 3: It is impermissible recapture for a reissue claim to be as broad as, or broader in scope than any claim that was canceled or amended in the original prosecution to define over the art. Claim scope that was canceled or amended is deemed surrendered and therefore barred from reissue. Clement, 131 F.3d at 1470, 45 USPQ2d at 1165. It must be determined whether the reissue claim omits or broadens any limitation that was added or argued during the original prosecution to overcome an art rejection. Such an omission in a reissue claim, even if it is accompanied by other limitations making the reissue claim narrower than the patent claim in other aspects, is impermissible recapture. Pannu, 258 F.3d at 1371-72, 59 USPQ2d at 1600. In any broadening reissue application, the examiner will determine, on a claim-by-claim basis, whether the broadening in the reissue application claim(s) relates to subject matter that was surrendered during the examination of the patent for which reissue is requested) by an amendment narrowing claim scope in order to overcome a rejection and/or argument relying on a claim limitation in order to overcome a rejection.
Claims 1-5 and 8-14 entirely eliminate the surrendered subject matter. During the prosecution of the ‘858 patent, the Applicant specifically argued that the prior art did not disclose these limitations. Therefore, the Applicant is not permitted to remove these limitation without invoking impermissible recapture.
Additionally, Applicant is reminded that they are barred from pursuing “different inventions” or “other aspects” in this reissue application. The parent application to the ‘710 application contained a restriction requirement including an election of species. See US Patent application 12/933,703, Requirement for Restriction/Election mailed 8/14/12. Therefore, any patentably distinct invention or species should have been pursued in subsequent divisional applications. Reissue is not a vehicle for recovering restricted inventions or species. See MPEP § 1412.01 I and II.
Therefore, step 3 of the three-step test is met for claims 1-5 and 8-14.
The omission of the above cited limitation from amended claims 1-5 and 8-12 and new claims 13-14 invokes impermissible recapture of surrendered subject matter as detailed above by the three step test. Therefore, claims 1-5 and 8-14 are rejected under 35 U.S.C. 251 as indicated above.
Claim Rejections - 35 USC § 112
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.
Claims 1-5 and 8-14 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.
Claim 1 recites duplicate limitations at the end of the claim. Claim 1 reads in part,
…and wherein said inner layer and said outer layer are continuous layers each of which having at least flexible portions that coincide with respective ones of said first flexible handling portion and said second flexible handling portion [thereof, wherein the actuating means have at least a first and a second actuating means and the first longitudinal elements comprise at least a first and second set of longitudinal elements, the first set of longitudinal elements having respective handling ends connected to a first rigid ring, said first rigid ring being connected to at least one of said inner cylindrical element and said first outer cylindrical element in said first rigid zone, the second set of longitudinal elements having respective handling ends connected to a second rigid ring, said second rigid ring being connected to at least one of said inner cylindrical element and said first outer cylindrical element in said second rigid zone, and said first set of longitudinal elements being guided through openings in said second rigid ring, the first actuating means being connected to an actuating end of said first set of longitudinal elements, and the second actuating means being connected to an actuating end of said second set of longitudinal elements], wherein said inner layer[cylindrical element] and said [first] outer layer [cylindrical element] are continuous layers [cylindrical elements] each of which having at least [a tube wall that comprises rigid and] flexible portions that coincide with respective ones of [said first rigid zone,] said first flexible handling portion[, said second rigid zone] and said second flexible handling portion[, and wherein said flexible portions are obtained by locally providing slits in the respective tube walls of said inner cylindrical element and said first outer cylindrical element]. (Emphasis Added.)
It is noted that the added claim language to claim 1 in the amendment filed 11/17/2022 is duplicate to original claim language already included in the claim which is highlighted in italics above. Appropriate correction is required.
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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1, 8-9 and 13 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by US 2008/0234545 to Breedveld et al. (“Breedveld”).
Regarding claims 1 and 13, Breedveld teaches an instrument for at least one of endoscopic applications, mechanical applications, and electronic applications (see ¶ [0001]), comprising a tube like member (see figs. 2A and 2B) having a handling end portion (see portion “B” in fig. 2B); having two rigid zones (3 and 9); having at least two flexible handling portions (see fig. 2B regions “A” and “B”) and actuating means located at an other, actuating end portion (4); at least a cylindrical inner layer (10) and a cylindrical outer layer (11), said first cylinder and second cylinder being coaxially arranged (see figs. 1A and 1B), and first intermediate layer (12) having longitudinal elements (6) for transferring a movement of the actuating means to the handling end portion (see ¶ [0036]) resulting in a change of orientation of the flexible handling portions (see ¶ [0051]); the longitudinal element (5 or 6) being formed by portions of the first intermediate layer (cables 6 form the ring of cables 5 in the intermediate layer slot 12) and wherein the inner layer and out layer are continuous layers (they each extend continuously from proximal to distal end see Figs. 2A and 2B) each of which having at least flexible portions that coincide with respective ones of said first flexible handling portion and said second flexible handling portion (see Fig. 2B specifically).
Regarding claim 8, Breedveld fig. 2B having portion labeled “C” which has a different diameter than the rest of the device.
Regarding claim 9, Breedveld teaches that at the actuating end portion at least one set of longitudinal elements is connected to a rigid disc (9, fig. 2B) the orientation of which can be changed with respect to a plane perpendicular to the longitudinal axis of the instrument (fig. 2A versus 2B).
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 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 negatived by the manner in which the invention was made.
Claims 4-5 and 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Breedveld in view of US Pub. No. 2005/0107667 to Danitz (hereinafter “Danitz ‘667”).
Regarding claim 4-5, Breedveld meets the claim limitations as described above for claim 1, but fails to teach a second intermediate layer comprising at least one second longitudinal element for transferring a movement of the actuating means to the handling end portion resulting in a change of orientation of the other one of the first flexible handling portion and the second flexible handling portion, said at least one second longitudinal element being formed by portions of the second intermediate layer.
Regarding claim 14, Breedveld teaches an instrument for at least one of endoscopic applications, mechanical applications, and electronic applications (see ¶ [0001]), comprising a tube like member (see figs. 2A and 2B) having a handling end portion (see portion “B” in fig. 2B); having two rigid zones (3 and 9); having at least two flexible handling portions (see fig. 2B regions “A” and “B”) and actuating means located at an other, actuating end portion (4); at least a cylindrical inner layer (10) and a cylindrical outer layer (11), said first cylinder and second cylinder being coaxially arranged (see figs. 1A and 1B) continuous layers each of which having at least flexible portion (coils Figs. 2A and 2B) that coincide with respective ones of said first flexible handling portion and the second flexible handling portion (regions “A” and “B”), and first intermediate layer (12) having longitudinal elements (cables 6) for transferring a movement of the actuating means to the handling end portion (see ¶ [0036]) resulting in a change of orientation of the flexible handling portions (see ¶ [0051]); the longitudinal element (5 or 6) being formed by portions of the first intermediate layer (cables 6 form the ring of cables 5 in the intermediate layer slot 12) and wherein the inner layer and out layer are continuous layers (they each extend continuously from proximal to distal end see Figs. 2A and 2B) each of which having at least flexible portions that coincide with respective ones of said first flexible handling portion and said second flexible handling portion (see Fig. 2B specifically). Breedveld meets the claim limitations but fails to teach a second intermediate layer comprising at least one second longitudinal element for transferring a movement of the actuating means to the handling end portion resulting in a change of orientation of the other one of the first flexible handling portion and the second flexible handling portion, said at least one second longitudinal element being formed by portions of the second intermediate layer.
However, Danitz ‘667 teaches a similar invention and discloses two intermediate layers of cables. See Figs. 1F and 5A-5B. Specifically, Danitz ‘667 teaches “articulating mechanism 101 of FIG. 1F has nine pairs of links with three cable sets each providing for movement in 27 degrees of freedom.” See para. [0082]. At the time of the invention, it would have been obvious by one skilled in the art to arrange the cylinder/longitudinal elements as taught by Breedveld into two layers as taught by Danitz ‘667. The references are analogous in the art of medical devices that have steering capabilities; therefore, a combination is proper. Additionally, the motivation for the incorporation would have been in order to increase degrees of freedom and flexibility as taught by Danitz ‘667 (“providing for movement in 27 degrees of freedom,” para. [0082]).
Claims 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Breedveld in view of US 2006/0111616 to Danitz et al (“Danitz ‘616”).
Breedveld meets the claim limitations as provided above for claim 1 but the combination fails to include a number of alternating flexible and rigid zones where the longitudinal elements are arranged in sets and each set is connected to one of the rigid zones with a corresponding flexible handling portion.
Regarding claim 2, Danitz ‘616 teaches a similar invention which converts movements of the proximal end into corresponding movements of the distal end (see fig. 1A and ¶¶ [0031] and [0042]) and which has a plurality of actuating means (101, 103 and 105, fig. 1A) connected to a plurality of rigid rings (102, 104 and 106, fig. 1A) via a plurality of sets of longitudinal elements (202, 204 and 206). Danitz ‘616 teaches that the number of rigid and flexible zones can be increased, along with a corresponding increase in set(s) of longitudinal elements/wire/cables, thereby giving the device increased degrees of freedom and flexibility.
At the time of the invention, it would have been obvious by one skilled in the art to arrange the cylinder/longitudinal elements as taught by Breedveld into “sets” as taught by Danitz ‘616. The references are analogous in the art of medical devices that have steering capabilities; therefore, a combination is proper. Additionally, the motivation for the incorporation would have been in order to increase degrees of freedom and flexibility as taught by Danitz ‘616.
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Breedveld in view of Danitz and in further view of US 2007/0299424 to Cumming et al. (“Cumming”).
Breedveld in view of Danitz meets the claim limitations as described above for claim 2. However, the combination fails to teach wherein each set of longitudinal elements comprises at least three longitudinal elements.
However, Cumming discloses a flat pull wire steering mechanism that includes flat pull wires (30) attached to a cylindrical steering ring (90). See figs. 2 and 9-10. As disclosed, these two elements together provide a mechanism for steerability. See ¶¶ [0058-0059]. Cumming teaches that any number of flat wires may be employed and are arranged in sets. See ¶ [0045] and fig. 9).
At the time of the invention, it would have been obvious for one skilled in the art to incorporate the pull wires and cylindrical steering ring of Cumming into the invention of Breedveld in view of Danitz. All three inventions are analogous in the art of medical devices that have steering capabilities; therefore, a combination is proper. Additionally, the motivation for the incorporation would have been in order to provide a low profile steering mechanism for reducing the overall wall thickness or outer diameter of the medical device.
Claims 10-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Breedveld as applied to claims 1 and 9 above, and further in view of US 2004/0138700 to Cooper et al (“Cooper”).
Breedveld meets the claim limitations as described above but fail to include the at least one rigid disc is mounted on a ball-and-socket joint connected to the instrument and in that the orientation of the at least one rigid disc is controlled by means of two linear actuators.
However, Cooper teaches a similar device in which separate linear actuators may be used to provide tension to each set of a plurality of sets of longitudinal elements.
At the time of the invention, it would have been obvious to modify the combination of Breedveld in view of Cumming, Thompson, Danitz ‘667 and Danitz ‘616 to include at least four linear actuators (at least one for each set of longitudinal elements), as taught by Cooper, to provide automated control to the device which allows the device to be moved in all possible degrees of freedom.
The combination fails to teach that the rigid disc is mounted on a ball and socket joint; however, Danitz ‘616 teaches that rigid discs in the instrument are mounted on ball-and-socket joints 160 which allows then to move flexibly in a wide variety of directions while still being properly retained within the device. It would have been obvious to one skilled in the art to modify the combination of Breedveld in view of Cumming, Thompson, Danitz ‘667 and Danitz ‘616 to use ball-and-socket joint(s) for any rigid discs in the instrument to allow those discs to become flexible while also still being retained in the device is a controllable manner.
Conclusion
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/CATHERINE S WILLIAMS/Primary Examiner, Art Unit 3993
Conferees:
/SARAH B MCPARTLIN/Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993