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 .
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-15, 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2013/0144322 (Callaghan).
1. Callaghan discloses a medical implant (FIG. 2A) adapted to be implantable within a gallbladder (FIG. 4A; P0114) in order to restrict movement of any gallbladder stones present within the gallbladder (FIG. 4A; P0114), the gallbladder defining an interior volume (e.g., see portion of interior volume filled by implant in FIG. 4A), the medical implant comprising:
an elongated resilient body (filtering mesh 110 of “shape memory” at P0031 and frame 105 of nitinol at P0095) adapted to fit within the interior volume of the gallbladder and to allow natural movement of the gallbladder (FIG. 4A-4B; P0099); and
a plurality of pores formed within the elongated resilient body (FIG. 2A-2B; P0096);
wherein the pores are adapted to allow bile to flow through the pores (FIG. 2B; P0096); and
where the elongated resilient body is adapted such that one or more of the medical implants at least substantially fill (or are at least capable of substantially filling) the interior volume of the gallbladder (e.g., the claim merely requires the implant to substantially fill an interior volume of the gallbladder such that the implant in FIG. 4A substantially fills the portion of the entirety of the interior volume occupied by the implant (substantially fills the portion of the interior volume)(FIG. 4A; P0192); alternatively, gallbladders are of varying sizes based on the size of the human or type of animal (i.e., hamster) such that the implant of Callaghan is fully capable of being inserted to substantially fill the entire interior volume based on the size of the gallbladder due to different size humans or animals).
2. The elongated resilient body has a length and a width, and the length is greater than the width (FIG. 4A; P0114).
3. The elongated resilient body is adapted to be compressed for delivery into the gallbladder, and to expand once present within the gallbladder (FIG. 13A-13B; P0031 and P0095).
4. The elongated resilient body has a length and a width, and the length is greater than the width (FIG. 4A; P0114).
5. The elongated resilient body is adapted such that two or more medical implants in combination are capable of at least substantially filling an interior volume of the gallbladder (e.g., capability at FIG. 4A and P0114).
6. The plurality of pores comprise an average pore size of about 2 millimeters (P0078).
7. At least some of the plurality of pores range from a minimum pore size of about 0.5 millimeters to a maximum pore size of about 5 millimeters (P0078).
9. The elongated resilient body has a substantially uniform density throughout the body (FIG. 2A-2B; P0094 and P0096).
10. The elongated resilient body has a hollow interior (e.g., conical mesh in FIG. 4A is “hollow”).
11. The medical implant has a material disposed within the resilient body or over an exterior surface of the elongated resilient body (e.g., see coating at P0100 or P0139).
12. The material is a pharmaceutical composition (P0139).
13. The material comprises a radiopaque material (e.g., nitinol at P0098).
14. The material comprises a protective coating that protects an interior of the gallbladder (P0100 or P0139).
15. Callaghan discloses a gallbladder implant (FIG. 2A), comprising:
an elongated resilient body (filtering mesh 110 of “shape memory” at P0031 and frame 105 of nitinol at P0095) adapted to substantially fill an interior volume of a gallbladder (see conical device FIG. 2A and P0114 substantially filling at least a portion (i.e., an interior volume) of a gallbladder) (or are at least capable of substantially filling) the interior volume of the gallbladder (e.g., the claim merely requires the implant to substantially fill an interior volume of the gallbladder such that the implant in FIG. 4A substantially fills the portion of the entirety of the interior volume occupied by the implant (substantially fills the portion of the interior volume)(FIG. 4A; P0192); alternatively, gallbladders are of varying sizes based on the size of the human or type of animal (i.e., hamster) such that the implant of Callaghan is fully capable of being inserted to substantially fill the entire interior volume based on the size of the gallbladder due to different size humans or animals), the elongated resilient body adapted to allow bile to flow through the resilient body while immobilizing any gallbladder stones present within the gallbladder (FIG. 4A; P0096 and P0114).
17. The elongated resilient body comprises a machined metallic or polymeric body (frame 105 of nitinol at P0095).
18. The elongated resilient body comprises an ovoid shape (FIG. 2A; P0114).
19. The elongated resilient body has a distal region and a proximal region, and the proximal region of the resilient body has a cross-sectional profile larger than a cross-sectional profile of the distal region (FIG. 4A; P0114).
20. Callaghan discloses a gallbladder implant (FIG. 2A) comprising:
an elongated resilient body (filtering mesh 110 of “shape memory” at P0031 and frame 105 of nitinol at P0095) adapted to substantially fill an interior volume of a gallbladder (FIG. 4A; P0114) (or are at least capable of substantially filling) the interior volume of the gallbladder (e.g., the claim merely requires the implant to substantially fill an interior volume of the gallbladder such that the implant in FIG. 4A substantially fills the portion of the entirety of the interior volume occupied by the implant (substantially fills the portion of the interior volume)(FIG. 4A; P0192); alternatively, gallbladders are of varying sizes based on the size of the human or type of animal (i.e., hamster) such that the implant of Callaghan is fully capable of being inserted to substantially fill the entire interior volume based on the size of the gallbladder due to different size humans or animals); and a plurality of void spaces formed within the elongated resilient body (FIG. 2A-2B; P0078), the plurality of void spaces adapted to allow bile to flow through the void spaces (P0096), the plurality of void spaces restricting intra-gallbladder movement of any gallbladder stones present within the gallbladder (FIG. 4A; P0114).
Claim Rejections - 35 USC § 103
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) 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0144322 (Callaghan), as applied above to claim 1.
Callaghan discloses the invention substantially as claimed as discussed above and further discloses the resilient body having void space (FIG. 7A; P0125) but is silent regarding the specific percentage of void space. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the void space of Callaghan to be at least about 10% since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Holman would not operate differently with the claimed void space percentage since Callaghan teaches the openings being modified in size to allow some sized stones to pass while blocking others thereby functioning appropriately having the claimed value (P0125). Further, applicant places no criticality on the range claimed, indicating the value “may” be or that the range forms one of many potential ranges (see P0056).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0144322 (Callaghan), as applied above to claim 15, and further in view of US 2023/0390046 (Holman).
Callaghan discloses the invention substantially as claimed as discussed above but does not disclose the resilient body being an open cell foam. Holman teaches a gallbladder implant in the same field of endeavor having a resilient body of open cell foam (P0028) for the purpose of expanding the implant while also retaining stones (P0028). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the resilient body of Callaghan to be an open cell foam as taught by Holman in order to expand the implant while also retaining stones.
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive. Applicant argues that the implant of Callaghan is not adapted to fill the interior volume of the gallbladder. Examiner respectfully disagrees. The implant of FIG. 4A of Callaghan is at least capable of substantially filling an interior volume of the gallbladder since the claim merely requires the implant to substantially fill an interior volume (e.g., a portion of an interior volume of an entirety of a gallbladder) of the gallbladder such that the implant in FIG. 4A substantially fills the portion of the entirety of the interior volume occupied by the implant (substantially fills the portion of the interior volume)(FIG. 4A; P0192). Alternatively, gallbladders are of varying sizes based on the size of the human or type of animal (i.e., hamster) such that the implant of Callaghan is fully capable of being inserted to substantially fill the entire interior volume based on the size of the gallbladder due to different size humans or animals. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the implant of Callaghan is fully capable of performing the intended use as described above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kelly Bekker can be reached on 571-272-2739. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771