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 .
Response to Amendment
This office action is responsive to the amendment filed on 12/01/2025. As directed by the amendment: no amendment was made to the claims. Thus, claims 1, 2, and 4 – 22 are presently pending in this application, with claims 8 – 22 currently withdrawn from consideration.
Election/Restriction
Applicant’s election without traverse of Group I (claims 1, 2, and 4 – 7) in the reply filed on 12/01/2025 is acknowledged.
Claims 8 – 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/01/2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the feature “a filling port having: docking means at a first end, and a tube extending from a second end” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 150-6 (paragraph [0062]), 150-8 (paragraph [0062]), and 150-8c (paragraph [0062]). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 7 is 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.
Claim 7 recites the limitation "the first jaw end" in line 5. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to amend the limitation to read “the first distal jaw end”.
Claim 7 recites the limitation “the first extension” in line 10. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to amend the limitation to read “the first jaw extension”.
Claim 7 recites the limitation “the second extension” in line 12. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to amend the limitation to read “the second jaw extension”.
Claim 7 recites the limitation "the first distal end of the first jaw" in line 16. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to amend the limitation to read “the first distal jaw end of the first jaw”.
Claim 7 recites the limitation "the second distal end of the second jaw" in lines 16 and 16. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to amend the limitation to read “the second distal jaw end of the second jaw”.
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.
Claim(s) 1, 2, and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kauper (U.S. 2015/0073381) in view of Elmaleh (U.S. 2020/0353233).
Regarding claim 1, Kauper teaches a medical device system comprising:
an analyte diffusive implantable device (ADID) (see cartridge as shown in Figure 1, see discussion of implantable cartridge in paragraph [0073]) which comprises:
a cavity (the inner space of each chambers that contain the core which function as a reservoir as discussed in paragraph [0094]);
a cell-scaffolding material (CSM) arranged within the cavity and configured to hold or otherwise retain a plurality of living cells (a matrix disposed in the core where the encapsulated cells are distributed (paragraph [0094]);
and a porous membrane at least partially enclosing the cavity (the surrounding semi-permeable membrane is formed into a porous structure in each chamber as discussed in paragraph [0102]),
wherein at least a portion of the membrane is adhered to the CSM by a high durometer adhesive which creates a hemispheric seal at both ends of the membrane (see paragraph [0104] discussing sealing the capsules by polymer adhesives to form a hermetic seal at each end of the device);
and a filling port (access port as discussed in paragraphs [0091] and [0092] and shown in Figure 3, see annotated Figure 3 below) having:
docking means at a first end (see annotated Figure 3 below), and a tube extending from a second end (see annotated Figure 3 below), wherein the tube is sealed at a distal end to the filling port and at a proximal end to the cavity of the ADID, so as to establish an integral, cell-filling pathway there-within (see annotated Figure 3 below and discussion of accessing chambers within the cartridge through an access port in paragraphs [0091] and [0092]). Examiner notes that the tube as shown in the annotated Figure 3 below connect the chambers within the cartridge with the filling port and therefore is sealed at the chambers/cavity of the ADID at one end and the filling port at the other end.
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However, Kauper does not specify that the tube of the filling port is a micro-diameter tube.
Elmaleh teaches a device similar to Kauper and the current application, further including a filling port having a micro-diameter tube (see micro tube extension 301, Figure 1, paragraphs [0035] and [0036]).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Elmaleh with the system of Kauper in order to allow fast filling (paragraph [0029] of Elmaleh).
Regarding claim 2, Kauper teaches that the system further comprises at least one anchor arranged on at least one end of the device (see anchor as shown in the annotated Figure 3 above and discussion of tether including anchor loop in paragraph [0103]).
Regarding claim 4, Kauper teaches that the anchor is configured to affix the device to tissue (see discussion of securing the device to target region such as an ocular structure by an anchor loop in paragraph [0103]).
Claim(s) 5 – 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kauper (U.S. 2015/0073381) in view of Elmaleh (U.S. 2020/0353233), and in view of Calderon (U.S. 2014/0074047)
Regarding claim 5, Kauper and Elmaleh teach claim 2 as seen above.
Kauper further teaches that the anchor is configured to be held by a clip (see discussion of a tether such as the anchor as shown in the annotated Figure 3 above for aids in maintaining the device placement during implant and aids in retrieval in paragraph [0103]). Examiner notes that the anchor as taught by Kauper is capable of being held by a clip for aids in device placement or retrieval.
However, Kauper and Elmaleh do not specify a clip.
Calderon teaches a device similar to Kauper, Elmaleh, and the current application, including a clip (clamp 30, Figures 2 – 5) capable of holding an tube (see Figure 5). Examiner notes that the clip as disclosed by Calderon is capable of holding the anchor of the combined device of Kauper and Elmaleh as discussed above.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Calderon with the combined system of Kauper and Elmaleh in order to maintain adequate compression of the tubing/anchor and withstand pressure challenge that would cause the clamp to deform and compromise the system (paragraph [0037] of Calderon). Further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 6, Kauper, Elmaleh, and Calderon teach claim 5 as seen above.
Kauper further discloses that the anchor as shown in Figure 3 and annotated Figure 3 above can be used to aids in device placement or retrieval in paragraph [0103]. Calderon discloses a clip that is capable of holding the anchor as discussed above.
Therefore, in the combined system of Kauper, Elmaleh, and Calderon as discussed above, the clip as taught by Calderon is capable of enabling transfer of the device as taught by Kauper and Elmaleh.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Calderon with the combined system of Kauper, Elmaleh, and Calderon in order to maintain adequate compression of the tubing/anchor and withstand pressure challenge that would cause the clamp to deform and compromise the system (paragraph [0037] of Calderon). Further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time the application was filed.
Regarding claim 7, Kauper, Elmaleh, and Calderon teach claim 5 as seen above.
However, Kauper and Elmaleh does not specify that the clip comprises: a proximal end and a distal end; a first jaw having a corresponding first distal jaw end; a second jaw having a corresponding second distal jaw end configured for movement relative to the first jaw end; a first jaw extension integral with the first jaw; a second jaw extension integral with the second jaw; and at least two proximal extensions integral with the first jaw; wherein the first extension includes a first projection, a first receiving area and a second receiving area; the second extension includes a flexible projection; the first receiving area being configured to receive an end of the flexible projection; the second receiving area being configured to receive the second jaw extension and move therein; and the first distal end of the first jaw is closed with respect to the second distal end of the second jaw in a resting position.
Calderon teaches a device similar to Kauper, Elmaleh, and the current application, further including that the clip (clamp 30, Figures 2 – 7) comprises:
a proximal end and a distal end (as shown in the annotated Figure 2 below);
a first jaw (leg 36, Figure 2) having a corresponding first distal jaw end (tooth 74, Figure 4);
a second jaw (leg 38, Figure 2) having a corresponding second distal jaw end (tooth 76, Figures 5 and 6) configured for movement relative to the first jaw end (see Figures 4 and 5 showing tooth 74 at different positions relative to tooth 76);
a first jaw extension (arm 68, gap 70, cutout 112, Figure 4) integral with the first jaw ;
a second jaw extension (arms 104) integral with the second jaw;
and at least two proximal extensions (see annotated Figure 2 below) integral with the first jaw;
wherein the first extension includes a first projection (arm 68, Figure 2), a first receiving area (gap 70, Figure 4) and a second receiving area (cut out 112, Figure 4);
the second extension includes a flexible projection (arm 72, Figure 4);
the first receiving area being configured to receive an end of the flexible projection (gap 70 receives arm 72 as shown in Figure 5 and discussed in paragraph [0041]);
the second receiving area being configured to receive the second jaw extension and move therein (cut out 112 receives arms 104 as shown in Figure 5 and discussed in paragraph [0044]);
and the first distal end of the first jaw is closed with respect to the second distal end of the second jaw in a resting position (tooth 74 and tooth 74 are engaged as shown in the resting position of Figure 5).
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It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Calderon with the combined system of Kauper, Elmaleh, and Calderon in order to maintain adequate compression of the tubing/anchor and withstand pressure challenge that would cause the clamp to deform and compromise the system (paragraph [0037] of Calderon). Further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time the application was filed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH T BUI whose telephone number is (571)270-1028. The examiner can normally be reached M - F 8 - 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANH T. BUI
Examiner
Art Unit 3783
/Anh Bui/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783