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 .
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, 6-8, 11-16, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/672,594 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘594 anticipates:
Claim 1. A medical device for applying a sheet-shaped delivery object to a target site, the medical device comprising: a main body having an elongated shaft portion and a holding portion provided at a distal end of the shaft portion, the holding portion configured to hold the sheet-shaped delivery object; and wherein the holding portion has a tapered portion widening in a tapered manner from the distal end of the shaft portion and a placement portion extending from the tapered portion, and end portions of the placement portion are folded back inward at least on a proximal end side (claims 1 and 9).
Claim 6. The medical device according to claim 1, wherein the holding portion is configured to be bendable at an angle with respect to an axial direction of the shaft portion (claim 2).
Claim 7. The medical device according to claim 1, wherein the shaft portion is hollow (claim 8).
Claim 8. The medical device according to claim 1, further comprising: an elongated sliding body configured to slide on one or more of the holding portion and an elongated cylindrical body (claim 1, 12, 13).
Claim 11. A method for applying a sheet-shaped delivery object to a target site, the method comprising: providing the medical device of claim 1 (sclaim 1 and 9); placing the sheet-shaped delivery object on the holding portion (claim 1); accommodating the medical device in the cylindrical body; delivering the medical device to the target site; and applying the sheet-shaped delivery object to the target site (claims 12 and 13).
Claim 12. The method according to claim 11, wherein the delivery to the target site is performed by inserting the medical device into the cylindrical body intraperitoneally inserted into a body cavity (claim 13).
Claim 13. The method according to claim 11, wherein the sheet-shaped delivery object is intraperitoneally inserted into a body cavity and applied to the target site (claim 12 and 13).
Claim 14. A method for applying a sheet-shaped delivery object to a target site, the method comprising: placing a sheet-shaped delivery object on a holding portion of a medical device, the medical device including an elongated shaft portion and the holding portion provided at a distal end of the shaft portion, the holding portion having a tapered portion widening in a tapered manner from the distal end of the shaft portion and a placement portion extending from the tapered portion, and wherein end portions of the placement portion are folded back inward at least on a proximal end side (claims 1 and 9); accommodating the medical device in an elongated cylindrical body; delivering the medical device to the target site; and applying the sheet-shaped delivery object to the target site (claims 12 and 13).
Claim 15. The method according to claim 14, wherein the delivery to the target site is performed by inserting the medical device into the cylindrical body intraperitoneally inserted into a body cavity (claims 12 and 13).
Claim 16. The method according to claim 14, wherein the sheet-shaped delivery object is intraperitoneally inserted into a body cavity and applied to the target site (claims 12 and 13).
Claim 20. The method according to claim 14, wherein the holding portion is configured to be bendable at an angle with respect to an axial direction of the shaft portion (claim 2).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 11-20 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.
In re claim 1, it is unclear what the structure scope of “sheet-shaped” are. It seems any structure could be interpreted as sheet-shaped.
It is unclear what metes and bounds of “a proximal end side” are. This “a proximal end side” is on which apparatus? The placement portion or the shaft portion, or anything else? It seems from the Spec., this “a proximal end side” is a proximal end side of the placement portion 122.
In re claim 6, it is unclear what the metes and bounds of “bendable” are. Anything can be bendable depends on the force being applied. But something is more bendable than others, or flexible than others. The Examiner will interpret that “the holding portion is configured to be
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 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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Knight et al. (US 5,667,480, hereinafter Knight ‘480).
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In re claim 1, Knight ‘480 teaches a medical device for applying a sheet-shaped delivery object to a target site, the medical device comprising: a main body having an elongated shaft portion (fig. 1&4, 12; fig. 2&5, 21) and a holding portion provided at a distal end of the shaft portion (fig. 1&4, 16 & 18; fig. 2&5, 26 & 28), the holding portion configured to hold the sheet-shaped delivery object (fig. 1&4, 16 & 18; fig. 2&5, 26 & 28, it is capable of; note that sheet-shaped delivery object is not being limited to a particular sheet shape and size); and wherein the holding portion has a tapered portion widening in a tapered manner from the distal end of the shaft portion and a placement portion extending from the tapered portion, and end portions of the placement portion are folded back inward at least on a proximal end side (fig. 1&4, 16 & 18; fig. 2&5, 26 & 28).
In re claim 2, Knight ‘480 teaches wherein a folding angle of the end portions of the placement portion with respect to the placement portion is configured to increase from a distal end side to the proximal end side (fig. 1&4, 16 & 18; fig. 2&5, 26 & 28).
In re claim 3, Knight ‘480 teaches wherein at least the distal end side of the placement portion on which the sheet-shaped delivery object is placed is configured to be a planar surface (fig. 1&4, 16 & 18; fig. 2&5, 26 & 28, note that 16 is a plane, and that a plane does not have to be flat).
In re claim 4, Knight ‘480 teaches wherein the folding angle of the end portions of the placement portion with respect to the placement portion is configured to be 60 degrees to 180 degrees (col. 5, lines 43-46).
In re claim 5, Knight ‘480 teaches wherein the folding angle of the end portions of the placement portion with respect to the placement portion is configured to be 90 degrees to 180 degrees (col. 5, lines 43-46).
In re claim 6, Knight ‘480 teaches wherein the holding portion is configured to be bendable at an angle with respect to an axial direction of the shaft portion (figs 4 & 5, it is at an angle zero, or angle 180).
In re claim 7, Knight ‘480 teaches wherein the shaft portion is hollow (figs. 4 & 5, 13 and 23 are lumens to receive endoscope, col. 4, lines 52-55; col. 5, lines 10-15).
In re claim 8, Knight ‘480 teaches further comprising: an elongated sliding body configured to slide on one or more of the holding portion and an elongated cylindrical body (figs. 4 & 5, 13 and 23 are lumens to receive endoscope 6, col. 4, lines 52-55; col. 5, lines 10-15).
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 (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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight ‘480 in view of Mathis et al. (US 2006/0167416, hereinafter Mathis ‘416).
In re claim 11, Knight ‘480 teaches a method for applying a sheet-shaped delivery object to a target site, the method comprising: providing the medical device of claim 1 (see claim 1 rejection above); but fails to teach placing the sheet-shaped delivery object on the holding portion; accommodating the medical device in the cylindrical body; delivering the medical device to the target site; and applying the sheet-shaped delivery object to the target site.
Mathis ‘416 teaches teach placing the sheet-shaped delivery object on the holding portion; accommodating the medical device in the cylindrical body; delivering the medical device to the target site; and applying the sheet-shaped delivery object to the target site (0096, 0144-0149, note that film is a sheet shaped delivery object).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Knight ‘480 to include the features of Mathis ‘416 in order to provide additional therapeutic treatment to the desired location.
In re claim 12, Mathis ‘416 teaches wherein the delivery to the target site is performed by inserting the medical device into the cylindrical body intraperitoneally (0141) inserted into a body cavity (0096, 0144-0149).
In re claim 13, Mathis ‘416 teaches wherein the sheet-shaped delivery object is intraperitoneally (0141) inserted into a body cavity and applied to the target site (0096, 0144-0149).
In re claim 14, Knight ‘480 teaches a method for applying a sheet-shaped delivery object to a target site, the method comprising:
Knight ‘480 fails to teach placing a sheet-shaped delivery object on a holding portion of a medical device …, and delivering the medical device to the target site; and applying the sheet-shaped delivery object to the target site.
Mathis ‘416 teaches placing a sheet-shaped delivery object on a holding portion of a medical device …, and delivering the medical device to the target site; and applying the sheet-shaped delivery object to the target site (0096, 0144-0149, note that film is a sheet shaped delivery object).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Knight ‘480 to include the features of Mathis ‘416 in order to provide additional therapeutic treatment to the desired location.
In re claim 15, Mathis ‘416 teaches wherein the delivery to the target site is performed by inserting the medical device into the cylindrical body intraperitoneally (0141) inserted into a body cavity (0096, 0144-0149)..
In re claim 16, Mathis ‘416 teaches wherein the sheet-shaped delivery object is intraperitoneally (0141) inserted into a body cavity and applied to the target site (0096, 0144-0149).
In re claim 17, Knight ‘480 teaches wherein a folding angle of the end portions of the placement portion with respect to the placement portion is configured to increase from a distal end side to the proximal end side (fig. 1&4, 16 & 18; fig. 2&5, 26 & 28)..
In re claim 18, Knight ‘480 teaches wherein the folding angle of the end portions of the placement portion with respect to the placement portion is configured to be 60 degrees to 180 degrees (col. 5, lines 43-46).
In re claim 19, Knight ‘480 teaches wherein at least the distal end side of the placement portion on which the sheet-shaped delivery object is placed is configured to be a planar surface (fig. 1&4, 16 & 18; fig. 2&5, 26 & 28, note that 16 is a plane, and that a plane does not have to be flat).
In re claim 20, Knight ‘480 teaches wherein the holding portion is configured to be bendable at an angle with respect to an axial direction of the shaft portion (figs 4 & 5, it is at an angle zero).
Allowable Subject Matter
Claims 9-10 allowed.
The following is a statement of reasons for the indication of allowable subject matter: Closet prior art fails to teach “end portions of the placement portion are configured to be wound such that back surfaces of the end portion of the placement portion are pressed against each other” when combined with the rest of claim 9 structures.
Knight ‘480 teaches a medical device for applying a sheet-shaped delivery object to a target site, the medical device comprising: a main body having an elongated shaft portion and a holding portion provided at a distal end of the shaft portion, the holding portion configured to hold the sheet-shaped delivery object; the holding portion having a tapered portion widening in a tapered manner from the distal end of the shaft portion and a placement portion extending from the tapered portion; and when the main body is accommodated in a cylindrical body configured to accommodate the main body so as to be movable forward and backward (figs. 4 & 5, 13 and 23 are lumens to receive endoscope 6, col. 4, lines 52-55; col. 5, lines 10-15) but fails to teach end portions of the placement portion are configured to be wound such that back surfaces of the end portion of the placement portion are pressed against each other.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3797
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