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 .
Applicant’s response filed 6/9/2026 have been entered.
Claims 1, 4, 6, 9, 11, 12, 15-25 are pending.
The outstanding rejection under 35 USC 103a is withdrawn in view of the amendments filed 6/9/2026 as the claims are directed to a specific way to synthesize the herein claimed composition.
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-disclaimes
Claims 1, 4, 6, 9, 11, 12, 15-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 8, -11, 14-24 of copending Application No. 19/059823 (‘823) (reference application) in view of ‘056. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘823 teaches a method of administering hormone through the herein claimed composition comprising the same hormones (estradiol and testosterone) and the hormones are being encapsulated by the polymer. The polymer is formed by photocrosslink the HAMA and sodium hyaluronate *see claims 1 and 8 for example). ‘823 teaches the dual chamber syringe also (see claim 8). ‘823 teaches the particle size and the treatment of hypogonadism (see claims 23-24). ‘823 teaches the herein claimed chelating agents (see claim 15).
‘823 does not expressly teach the hormone replenishing therapy. ‘823 does not expressly teach the forming of alginate shell and the removal of the same using chelators.
‘056 teaches a method of encapsulating biological material in a 3-dimensional hydrogel matrix, said method comprising: 1) providing a hydrogel precursor solution, said solution comprising a hydrogel precursor compound, said biological material, and a divalent cation selected from the group consisting of calcium, barium, strontium, and combinations thereof, dispersed or dissolved in a solvent system; 2) combining said hydrogel precursor solution with alginate to yield core/shell microparticles, each core/shell microparticle comprising an alginate shell and a liquid core comprising said hydrogel precursor solution; 3) crosslinking said hydrogel precursor compound in said liquid core to yield core/shell crosslinked microparticles, each core/shell crosslinked microparticle comprising said alginate shell and a core comprising a 3-dimensional hydrogel matrix and said biological material, said biological material being entrapped in said hydrogel matrix; and 4) removing said alginate shell to yield self-sustaining hydrogel microbeads, each hydrogel microbead comprising said 3-dimensional hydrogel matrix and biological material entrapped therein (see claim 1). ‘056 teaches the alginate shell is removed by chelating agent (see [0031]). ‘056 teaches UV light as one of the suitable initiators for the cross-linking of the precursor for forming the hydrogel microbeads (see [0028]). ‘056 teaches that such manufacturing method would “improve biocompatibility of the implanted biological material, reducing fibrosis. In addition, the microbeads allow for enhanced control and support of cell and tissue function in the microbeads, improving the bioactivity of any implants created using such microbeads” (see [0035]).
It would have been obvious to one of ordinary skill in the art at the time of filing to use the method of forming alginate shell and the removal thereof to manufacture the hydrogel microbeads composition. It would have been obvious to one of ordinary skill in the art at the time of filing to employ a dual chamber- syringe to deliver the composition of ‘823 for hormone replenishing therapy.
One of ordinary skill in the art would have been motivated to employ the method of ‘823 for hormone replenishing therapy because it would be reasonably expected to be effective in hormone replenishing for it can deliver the hormone to the patient effectively. One of ordinary skill in the art would have been motivated to use the method of forming alginate shell and the removal thereof to manufacture the hydrogel microbeads composition because it would be reasonably expected to impart the beneficial effects and properties of the hydrogel microbeads composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 6, 9, 11, 12, 15-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 7, 9, 11-13, 16, 18-21 of copending Application No. 19/059, 162 (‘162) in view of ‘059. ‘162 teaches a hydrogel composition comprising a crosslinked MHA polymers in a form of microbeads encapsulating hormones such as testosterone and estradiol in a dual chamber syringe (see claims 1, 6-8). ‘162 teaches the forming of alginate shell and the removal of the same using chelators (see claim 18). ‘162 teaches the herein claimed chelators (see claim 19). ‘162 teaches the particle size and the controlled release pf the hormone extending over a period from one week to one month (see claims 20-21).
‘162 does not expressly teach the hormone replenishing therapy. ‘162 does not expressly teach the use of UV light for initiate the cross-linking process.
‘056 teaches a method of encapsulating biological material in a 3-dimensional hydrogel matrix, said method comprising: 1) providing a hydrogel precursor solution, said solution comprising a hydrogel precursor compound, said biological material, and a divalent cation selected from the group consisting of calcium, barium, strontium, and combinations thereof, dispersed or dissolved in a solvent system; 2) combining said hydrogel precursor solution with alginate to yield core/shell microparticles, each core/shell microparticle comprising an alginate shell and a liquid core comprising said hydrogel precursor solution; 3) crosslinking said hydrogel precursor compound in said liquid core to yield core/shell crosslinked microparticles, each core/shell crosslinked microparticle comprising said alginate shell and a core comprising a 3-dimensional hydrogel matrix and said biological material, said biological material being entrapped in said hydrogel matrix; and 4) removing said alginate shell to yield self-sustaining hydrogel microbeads, each hydrogel microbead comprising said 3-dimensional hydrogel matrix and biological material entrapped therein (see claim 1). ‘056 teaches the alginate shell is removed by chelating agent (see [0031]). ‘056 teaches UV light as one of the suitable initiators for the cross-linking of the precursor for forming the hydrogel microbeads (see [0028]). ‘056 teaches that such manufacturing method would “improve biocompatibility of the implanted biological material, reducing fibrosis. In addition, the microbeads allow for enhanced control and support of cell and tissue function in the microbeads, improving the bioactivity of any implants created using such microbeads” (see [0035]).
It would have been obvious to one of ordinary skill in the art at the time of filing to use the method of forming alginate shell and the removal thereof to manufacture the hydrogel microbeads composition. It would have been obvious to one of ordinary skill in the art at the time of filing to employ the composition of ‘162 for hormone replenishing therapy.
One of ordinary skill in the art would have been motivated to employ the composition of ‘162 for hormone replenishing therapy because it would be reasonably expected to be effective in hormone replenishing for it can deliver the hormone to the patient effectively. One of ordinary skill in the art would have been motivated to use the method of forming alginate shell and the removal thereof to manufacture the hydrogel microbeads composition because it would be reasonably expected to impart the beneficial effects and properties of the hydrogel microbeads composition.
Furthermore, one of ordinary skill in the art would have been motivated to employ UV radiation to initiate the cross-linking HAMA polymer-encapsulated estrogen for hormone replenishing treatment. Using a well-known cross-linking method such as UV radiation to form the polymer and encapsulating the hormone for replenish treatment would be reasonably expected to be effective.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4, 6, 9, 11, 12, 15-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-6, 8-13, 15-17, 20-26 of copending Application No. 19/059, 216 (‘216) in view of ‘059 and US 6,692,468 (‘468). ‘216 teaches a hydrogel composition comprising a crosslinked MHA polymers in a form of microbeads encapsulating hormones such as testosterone and estradiol (see claims 1, 3). ‘216 teaches the forming of alginate shell and the removal of the same using chelators (see claim 21). ‘216 teaches the herein claimed chelators (see claim 22). ‘216 teaches the use of UV light for initiate the cross-linking process as well as the phtoinitiator LAP (see claims 16 and 17). ‘216 teaches the microbead particle size as 100 to 1400 µm (see claim 20). ‘216 teaches the controlled release pf the hormone extending over a period from one week to one month (see claim 23).
‘216 does not expressly teach the hormone replenishing therapy. ‘216 does not expressly teach the dual-chamber to deliver the hormone composition.
‘056 teaches a method of encapsulating biological material in a 3-dimensional hydrogel matrix, said method comprising: 1) providing a hydrogel precursor solution, said solution comprising a hydrogel precursor compound, said biological material, and a divalent cation selected from the group consisting of calcium, barium, strontium, and combinations thereof, dispersed or dissolved in a solvent system; 2) combining said hydrogel precursor solution with alginate to yield core/shell microparticles, each core/shell microparticle comprising an alginate shell and a liquid core comprising said hydrogel precursor solution; 3) crosslinking said hydrogel precursor compound in said liquid core to yield core/shell crosslinked microparticles, each core/shell crosslinked microparticle comprising said alginate shell and a core comprising a 3-dimensional hydrogel matrix and said biological material, said biological material being entrapped in said hydrogel matrix; and 4) removing said alginate shell to yield self-sustaining hydrogel microbeads, each hydrogel microbead comprising said 3-dimensional hydrogel matrix and biological material entrapped therein (see claim 1). ‘056 teaches the alginate shell is removed by chelating agent (see [0031]). ‘056 teaches UV light as one of the suitable initiators for the cross-linking of the precursor for forming the hydrogel microbeads (see [0028]). ‘056 teaches that such manufacturing method would “improve biocompatibility of the implanted biological material, reducing fibrosis. In addition, the microbeads allow for enhanced control and support of cell and tissue function in the microbeads, improving the bioactivity of any implants created using such microbeads” (see [0035]).
‘468 teaches a dual-chamber syringe with needle to mix and administer drugs (see the abstract for example).
It would have been obvious to one of ordinary skill in the art at the time of filing to use the dual-chamber to deliver the hormone composition. It would have been obvious to one of ordinary skill in the art at the time of filing to employ the composition of ‘216 for hormone replenishing therapy.
One of ordinary skill in the art would have been motivated to employ the composition of ‘216 for hormone replenishing therapy because it would be reasonably expected to be effective in hormone replenishing for it can deliver the hormone to the patient effectively. One of ordinary skill in the art would have been motivated to use the dual-chamber to deliver the hormone composition because using a well-known device to deliver the hormone for replenish treatment would be reasonably expected to be effective.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4, 6, 9, 11, 12, 15-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/059, 219 (‘219) in view of ‘059 and US 6,692,468 (‘468). ‘219 teaches a hydrogel composition comprising a crosslinked MHA polymers in a form of microbeads encapsulating hormones such as testosterone and estradiol (see claims 1, 4). ‘219 teaches the forming of alginate shell and the removal of the same using chelators (see claim 7). ‘219 teaches the herein claimed chelators (see claim 8). ‘219 teaches the microbead particle size as 50 to 2000 µm (see claim 10 and 20). ‘219 teaches the controlled release pf the hormone extending over a period from one week (see claim 1).
‘219 does not expressly teach the hormone replenishing therapy. ‘219 does not expressly teach the dual-chamber to deliver the hormone composition. ‘219 does not expressly teach the use of UV light for initiate the cross-linking process.
‘056 teaches a method of encapsulating biological material in a 3-dimensional hydrogel matrix, said method comprising: 1) providing a hydrogel precursor solution, said solution comprising a hydrogel precursor compound, said biological material, and a divalent cation selected from the group consisting of calcium, barium, strontium, and combinations thereof, dispersed or dissolved in a solvent system; 2) combining said hydrogel precursor solution with alginate to yield core/shell microparticles, each core/shell microparticle comprising an alginate shell and a liquid core comprising said hydrogel precursor solution; 3) crosslinking said hydrogel precursor compound in said liquid core to yield core/shell crosslinked microparticles, each core/shell crosslinked microparticle comprising said alginate shell and a core comprising a 3-dimensional hydrogel matrix and said biological material, said biological material being entrapped in said hydrogel matrix; and 4) removing said alginate shell to yield self-sustaining hydrogel microbeads, each hydrogel microbead comprising said 3-dimensional hydrogel matrix and biological material entrapped therein (see claim 1). ‘056 teaches the alginate shell is removed by chelating agent (see [0031]). ‘056 teaches UV light as one of the suitable initiators for the cross-linking of the precursor for forming the hydrogel microbeads (see [0028]). ‘056 teaches that such manufacturing method would “improve biocompatibility of the implanted biological material, reducing fibrosis. In addition, the microbeads allow for enhanced control and support of cell and tissue function in the microbeads, improving the bioactivity of any implants created using such microbeads” (see [0035]).
‘468 teaches a dual-chamber syringe with needle to mix and administer drugs (see the abstract for example).
It would have been obvious to one of ordinary skill in the art at the time of filing to use the dual-chamber to deliver the hormone composition. It would have been obvious to one of ordinary skill in the art at the time of filing to employ the composition of ‘216 for hormone replenishing therapy.
One of ordinary skill in the art would have been motivated to employ the composition of ‘216 for hormone replenishing therapy because it would be reasonably expected to be effective in hormone replenishing for it can deliver the hormone to the patient effectively. One of ordinary skill in the art would have been motivated to use the dual-chamber to deliver the hormone composition because using a well-known device to deliver the hormone for replenish treatment would be reasonably expected to be effective.
Furthermore, one of ordinary skill in the art would have been motivated to employ UV radiation to initiate the cross-linking HAMA polymer-encapsulated estrogen for hormone replenishing treatment. Using a well-known cross-linking method such as UV radiation to form the polymer and encapsulating the hormone for replenish treatment would be reasonably expected to be effective.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s remarks with regard to the double patenting rejection are acknowledged. Accordingly, the obviousness double patenting rejections are maintained.
No claims are allowed.
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 SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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