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 .
Claims Status
Claims 1-15 are pending and under current examination.
Information Disclosure Statements
Information Disclosure Statement (IDS) filed 05/22/2025 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claim Rejections - 35 USC § 102
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.
(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.
Claims 9-10, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brough et al. (Use of Polyvinyl Alcohol as a Solubility-Enhancing Polymer for Poorly Water Soluble Drug Delivery (Part 1))-2015).
Brough et al. teach PVA 4-88 powders which have a hydrolysis of 88% and viscosity of 4mPa.s., see abstract, intro and results and discussion. Such powders are sintered as higher viscosity PVA behaved differently due to sintering properties or crystalline nature of the high viscosity PVA, thus the PVA 4-88 is also sintered. The PVA 4-88 is taught to enhance solubility of poorly soluble drugs, see abstract. Regarding the hydrolysis, Brough et al. teach a hydrolysis of 88% and that the viscosity of PVP 4-88 is 4 mPa.s of a 4% solution at 20 degrees Celsius, see introduction.
Regarding “for selective laser sintering” 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, since Brough et al. teach a sinter powder, the prior art is capable of being used for selective laser sintering.
Regarding the recitation “produced by selective laser sintering” at claim 13, E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
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.
Claims 1-7 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Propplewell et al. (United States Patent 10993466) and Brough et al. (Use of Polyvinyl Alcohol as a Solubility-Enhancing Polymer for Poorly Water Soluble Drug Delivery (Part 1))-2015) as evidenced by Lurie Raz (United States Patent 6090788).
Propplewell teaches methods of preparing delivery systems which comprise an active, see abstract. To prepare the delivery system a 3D printer is suitable including for selective laser sintering where a layer of light curable polymer powder is dispersed to a base, see column 1, lines 45-51, column 6, lines 31-37, and column 7, lines 7-18. A high power laser beam is directed to locally fuse the polymeric powder to bind it to base, see column 7, lines 7-18. Thus, Propplewell suggests operating SLS apparatuses for a sinter powder. The powders that are not sintered are removed at the end of the process, see column 7. Examples of polymers include polyvinyl alcohol, see column 8, lines 9-16 and claims 1-8. The composition can further comprise pigments or colorants including gold, see column 16 at lines 13-30. Active materials include itraconazole, see column 12, lines 24-35 and column 15, lines 9-11.
Propplewell does no teach that the PVA (polyvinyl alcohol) is inclusive of PVA- 4-88 (instant claim 3).
However, Brough et al. teach that polyvinyl alcohol including PVA 4-88 is effective at enhancing solubility and bioavailability of poorly soluble drugs such as itraconazole, see abstract. PVA has a hydrolysis of about 88%. The viscosity of PV 4-88 is 4mPa.s, see introduction
It would have been prima facie obvious to substitute the polyvinyl alcohol (PVA) of Propplewell for PVA 4-88.
One of ordinary skill in the art would have been motivated to do so because PVA 4-88 enhances solubility and bioavailability of poorly soluble drugs.
There would have been a reasonable expectation of success as Propplewell teaches PVA polymers and both Propplewell and Brough teach drugs inclusive of itraconazole.
Regarding the hydrolysis, Brough teaches a hydrolysis of 88% and that the viscosity of PVP 4-88 is 4 mPa.s of a 4% solution at 20 degrees Celsius.
Regarding the limitation of further comprising a light absorbing material, the composition of Propplewell can contain light absorbing materials such as gold. As evidenced by Lurie Raz (U.S. Patent 6090788), gold is considered a light absorbing material, see claim 3. Therefore, Propplewell can further comprise light absorbing materials.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Propplewell et al. (United States Patent 10993466) and Brough et al. (Use of Polyvinyl Alcohol as a Solubility-Enhancing Polymer for Poorly Water Soluble Drug Delivery (Part 1))-2015) as evidenced by Lurie Raz (United States Patent 6090788) as applied to all claims above, and further in view of Dadbakhsh et al. (Effect of Powder Size and Shape on the SLS Processability and Mechanical Properties of a TPU Elastomer-2016).
Neither Propplewell et al. nor Brough teach that the sinter powder has a particle size of D50 of 200 microns or lower.
Dadbakhsh et al. teach that fine powders of smaller particle sizes have improved packing density for SLS process. A powder with a D50 of 63 microns yields good tensile strength and it was found that the fine powder is better processable at significantly higher powder bed temperatures allowing for lower optimum laser energy input thus minimizing smoking and degradation of the polymer see abstract and section 3.1 and entire document.
It would have been prima facie obvious to provide the sinter powder of Propplewell with a D50 of 63 microns in order to provide sintered powders with optimal processability and good strength as powders of these size range are taught to be advantageous in Dadbakhsh.
There would have been a reasonable expectation of success because Propplewell teaches a selective laser sintering process.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,6-7 and 14 of copending Application No. 18881106 (reference application) in view of Propplewell et al. (United States Patent 10993466) and Brough et al. (Use of Polyvinyl Alcohol as a Solubility-Enhancing Polymer for Poorly Water Soluble Drug Delivery (Part 1))-2015).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Both the instant claims and that of Application ‘106 claim a selective laser sintering process having an active ingredient. Both the instant claims and that of ‘106 comprise a light absorbing material wherein the size of the sinter powder is from D50-200 microns.
The difference between the instant claims and that of Application ‘106 is that ‘106 claims poloxamer whereas the instant claims claim the laser sintering of sinter powder which comprises polyvinyl alcohol including PVA 4-88 having a hydrolysis from 70-90% and viscosity of 3-8 mPas.
Propplewell teaches methods of preparing delivery systems which comprise an active, see abstract. To prepare the delivery system a 3D printer is suitable including for selective laser sintering where a layer of light curable polymer powder is dispersed to a base, see column 1, lines 45-51, column 6, lines 31-37, and column 7, lines 7-18. A high power laser beam is directed to locally fuse the polymeric powder to bind it to base, see column 7, lines 7-18. Thus, Propplewell suggests operating SLS apparatuses for a sinter powder. The powders that are not sintered are removed at the end of the process, see column 7. Examples of polymers include polyvinyl alcohol, see column 8, lines 9-16 and claims 1-8.The composition can further comprise pigments or colorants including gold, see column 16 at lines 13-30. Active materials include itraconazole, see column 12, lines 24-35 and column 15, lines 9-11.
Brough et al. teach that polyvinyl alcohol including PVA 4-88 is effective at enhancing solubility and bioavailability of poorly soluble drugs such as itraconazole, see abstract. PVA has a hydrolysis of about 88%. The viscosity of PV 4-88 is 4mPa.s, see introduction
It would have been obvious to substitute the poloxamer of Application ‘106 for the polyvinyl alcohol (PVA) of PVA 4-88. One of ordinary skill in the art would have been motivated to do so because PVA 4-88 enhances solubility and bioavailability of poorly soluble drugs and Propplewell teaches that polymers for selective laser sintering to form dosage formulations can comprise polyethylene oxide or polypropylene oxide copolymers (i.e. poloxamers).
Regarding the hydrolysis, Brough teaches a hydrolysis of 88% and that the viscosity of PVP 4-88 is 4 mPa.s of a 4% solution at 20 degrees Celsius.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19476797 (reference application) in view of Dadbakhsh et al. (Effect of Powder Size and Shape on the SLS Processability and Mechanical Properties of a TPU Elastomer-2016)
Claims 1-15 are directed to an invention not patentably distinct from claim 1-14 of commonly assigned Application No. 19476797.
Both the instant claims and that of ‘797 claim compositions comprising sintered PVA powder made by selective laser sintering. The sinter powder comprises light absorbing material and polymer wherein the polymer comprises polyvinyl alcohol having a hydrolysis from 70-90 and viscosity from 3-8 mPas. Both Application ‘797 and the instant claims can comprise PVA 4-88.
Although Application ‘797 does not claim a particle size, Dadbakhsh et al. teach that fine powders of smaller particle sizes have improved packing density for SLS process. A powder with a D50 of 63 microns yields good tensile strength and it was found that the fine powder is better processable at significantly higher powder bed temperatures allowing for lower optimum laser energy input thus minimizing smoking and degradation of the polymer see abstract and section 3.1.
It would have been obvious to provide the Application ‘797 with PVA having a particle size D50 of 200 microns or less in order to have improved packing density and better processability to allow optimum laser energy during selective laser sintering.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 19476797 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, 12, 13 and 15-16 of Application 18034260 (recently issued) in view of Propplewell et al. (United States Patent 10993466) and of Dadbakhsh et al. (Effect of Powder Size and Shape on the SLS Processability and Mechanical Properties of a TPU Elastomer-2016).
Claims 1-15 are directed to an invention not patentably distinct from claim 1, 7, 8, 12, 13 and 15-16 of commonly assigned Application No. 18034260.
Both the instant claims and that of ‘260 claim compositions comprising PVA and an active agent where the PVA can comprise PVA 3-80, PVA 3-82.
The difference between the instant claims and that of Application ‘260 is that the instant claims utilize a selective laser sintering process to form a sinter powder, the size of the powder and the presence of a light absorbing material.
Propplewell teaches methods of preparing delivery systems which comprise an active, see abstract. To prepare the delivery system a 3D printer is suitable including for selective laser sintering where a layer of light curable polymer powder is dispersed to a base. A high power laser beam is directed to locally fuse the polymeric powder to bind it to base. The powders that are not sintered are removed at the end of the process. Examples of polymers include polyvinyl alcohol. The composition can further comprise pigments or colorants including gold. Active materials include itraconazole.
Dadbakhsh et al. teach that fine powders of smaller particle sizes have improved packing density for SLS process. A powder with a D50 of 63 microns yields good tensile strength and it was found that the fine powder is better processable at significantly higher powder bed temperatures allowing for lower optimum laser energy input thus minimizing smoking and degradation of the polymer see abstract and section 3.1.
It would have been obvious to prepare the dosage form of Application ‘260 via a selective laser sintering process to fuse polymer powder to base and form a pharmaceutical dosage form and to provide such particles with a D50 of 200 microns or lower and to provide a light absorbing material such as gold taught in Propplewell.
One of ordinary skill would have recognized that laser sintering of particles having a D50 of less than 200 microns offers better strength and processability and per the teachings of Propplewell, gold can be added as a colorant to the formulation.
There would have been a reasonable expectation of success because both Application ‘260 and the instant claims utilize PVA polymers having the same hydrolysis and viscosity with active agent.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18034260 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
Currently, claims 1-15 are rejected and no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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