DETAILED ACTION
Claims 1-20 are pending and under consideration on the merits.
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 .
Status of the Rejections
The claim objections are withdrawn in view of the amendment.
The 112(b) rejections are withdrawn in view of the amendment.
The 103 rejections are revised in view of the amendment and expanded to newly added claims.
The provisional double patenting rejection is replaced with a nonprovisional rejection in light of the issuance of the reference application.
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 1-20 are rejected under 35 U.S.C. 103 as unpatentable over Omar (“Impregnation of Active Pharmaceutical Ingredients Into Porous Carriers”; Dissertation of Thamar A. Omar (October 2019); of record in IDS) in view of Vialpando et al. (WO 2020/234675; of record in IDS).
As to claims 1-20, Omar discloses a method for making porous carrier particles impregnated with an API (claim 12), the method comprising continuously conveying a solution comprising an API and a porous carrier into a continuous impregnation device, and continuously and simultaneously mixing and evaporating (claim 8) to form impregnated porous carrier particles (page 21, 2nd-3rd paragraphs and page 23, 1st paragraph). A specific concentration of the API in the solution is selected such that there is a controlled ratio between the API and the porous carrier (page 36, last full paragraph). In one embodiment, the Omar porous carrier particles are NEU carrier particles formed from magnesium aluminometasilicate (page 94, last paragraph). Omar further discloses that it is also known to use porous carrier particles comprising silica dioxide (claim 4), such as SBA-15 (page 6, 1st paragraph). Omar teaches that the surface area of the porous carrier plays a crucial role in the impregnation process, since high surface area results in a high loading of API into the carrier (page 24, last paragraph). Omar also discloses that blend uniformity of the porous carrier particles is an important parameter, and that it can be difficult to get highly uniform blends due to insufficient mixing of ingredients (paragraph bridging pages 38-39). Omar teaches that the impregnated particles showed high uniformity with a standard deviation of less than 5%, which reads on the recited ranges of claims 1 and 5 (page 67, 1st paragraph).
As to claims 2-3 and 19, Omar discloses that the NEU carrier particles have an average size of 124 microns and a pore size of 5 nm, which are within the recited ranges (Table 2.8 on page 54; page 66, 1st full paragraph).
Regarding claim 7, Omar discloses the use of a continuous tubular mixer as the continuous impregnation device (page 137, 1st paragraph).
As to claims 10-11 and 14-15, Omar teaches that the impregnated porous carrier particles can improve drug stability or solubility and increase the dissolution rate when processed into pharmaceutical solid dosage forms comprising a mixture of pharmaceutical excipients (Section 1.1 on pages 1-4).
Regarding 13, Omar discloses embodiments wherein the API content of the impregnated particles is within the recited less than 50 wt% range, for example, 21 wt% (paragraph bridging pages 38-39).
As to claims 1-20, Omar does not further expressly disclose that the API loading is higher than 10% (claim 1) or the amounts of 16-18, that the specific surface area of the porous carrier particles is at least 400 m2/g as recited by claim 1, or that the API loading is higher compared to the loading of porous particles having a specific surface area of less than 400 m2/g as recited by claim 6. Nor does Omar expressly teach that the mean residence time of the porous carrier in the continuous impregnation device is less than 10 minutes as recited by claim 9, nor the average particle size of claim 20.
Vialpando discloses mesoporous silica particles (a “silicon dioxide porous carrier” of claim 4) having a specific surface area of 1000 m2/g, and having a particle size of 2-250 microns which encompasses the range of claim 20, and wherein the particles are impregnated with an API (paragraphs 57, 64, 67-68).
As to claims 1-20, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Omar method by selecting silicon dioxide particles having a specific surface area of greater than 400 m2/g, such as 1000 m2/g, as the porous carrier, because Omar expressly teaches that the surface area of the porous carrier plays a crucial role in the impregnation process, since high surface area results in a high loading of API into the carrier, such that the skilled artisan would have had a motivation to select a porous carrier with a high surface area to allow for higher loading of the API, and further because Vialpando expressly teaches that porous particles having a surface area within the claimed range are suitable for use as a carrier for an API via impregnation of the carrier with the API, such that the skilled artisan reasonably would have expected that said porous carrier could be used as the type of porous carrier in the Omar method. Such a modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Regarding claim 9, it further would have been prima facie obvious to select a mean residence time of the porous carrier in the continuous impregnation within the recited range, since Omar expressly teaches that achieving high uniformity of the impregnated porous carrier particles is important but can be difficult to achieve due to insufficient mixing, and the amount of time that the drug solution and the porous carrier spend in the continuous impregnation device (which is where the mixing occurs) is directly related to the mixing time such that the mean residence time is a result effective variable that will affect the degree of uniformity of the impregnated carrier particles which Omar identifies as an important parameter, thereby motivating the skilled artisan to optimize the mean residence time with a reasonable expectation of success in arriving at the claimed time range. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, it further would have been prima facie obvious to select a particle size that is within the claimed range, because Vialpando expressly teaches that mesoporous silica particles that are impregnated with an API suitably may have particle sizes within the recited range, such that the skilled artisan reasonably would have expected that the Omar mesoporous particles impregnated with an API also could have such particle sizes.
The method of Omar and Vialpando as combined supra will result in an API loading within the ranges of claims 1 and 16-18 and a higher loading of the API relative to a porous carrier having a lower specific surface area within the range of claim 6 because it comprises the same steps of processing the same ingredients in the same way recited by the claims. The skilled artisan would recognize that using porous carriers having a higher specific surface area would result in higher loading of the API in light of Omar’s express teaching that the surface area of the porous carrier plays a crucial role in the impregnation process, since high surface area results in a high loading of API into the carrier.
Claims 1-20 are rejected under 35 U.S.C. 103 as unpatentable over Muzzio et al. (US Pat. No. 2023/0000776; of record in IDS) in view of Omar (“Impregnation of Active Pharmaceutical Ingredients Into Porous Carriers”; Dissertation of Thamar A. Omar (October 2019); of record in IDS) and Vialpando et al. (WO 2020/234675; of record in IDS).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The teachings of the cited secondary references are relied upon as discussed above.
As to claims 1-20, Muzzio discloses a continuous process for manufacturing API-impregnated porous carriers comprising feeding continuously a controlled amount of the porous carrier into a continuous blender (“continuous impregnation device”) such as a tubular mixer (claim 7), continuously spraying a solution comprising a controlled amount of API into the continuous blender, and continuously drying (“evaporating”) the impregnated porous carrier (claims 1, 8), wherein the carrier is granulated silicon dioxide (claim 4)(paragraphs 8-10, 51), the particles having a relative standard deviation of 3% or less (paragraph 13) which reads on the ranges of claims 1 and 5, and a pharmaceutical solid dosage form made by the method comprising the impregnated porous carrier mixed with pharmaceutical excipients (paragraphs 11, 26)(claims 10-11, 12, 14-15). The carrier has an average pore size of 100-2000 nm, which is above the ranges of claims 2 and 19 (paragraph 45). The mean residence time in the continuous impregnation device may be about 1-10 minutes (paragraph 56)(claim 9). The porous carriers have a particle size of about 112 microns, which is within the range of claim 3 but above the range of claim 20 (Table 3 at paragraph 89).
As to claims 1-20, Muzzio does not further expressly disclose that the API loading is higher than 10% (claim 1) or the amounts of 16-18, that the specific surface area of the porous carrier particles is at least 400 m2/g as recited by claim 1, nor that the pores size is in the ranges of claims 2 and 19, or that the API loading is higher compared to the loading of porous particles having a specific surface area of less than 400 m2/g as recited by claim 6, nor the average particle size of claim 20. .
As to claims 1-20, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Muzzio method by selecting particles having a specific surface area of greater than 400 m2/g, such as 1000 m2/g, as the porous carrier, because Omar expressly teaches that the surface area of the porous carrier plays a crucial role in the impregnation process, since high surface area results in a high loading of API into the carrier, such that the skilled artisan would have had a motivation to select a porous carrier with a high surface area to allow for higher loading of the API, and further because Vialpando expressly teaches that porous particles having a surface area within the claimed range are suitable for use as a carrier for an API via impregnation of the carrier with the API, such that the skilled artisan reasonably would have expected that said porous carrier could be used as the type of porous carrier in the Omar method. Such a modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Regarding claims 2 and 19, it further would have been prima facie obvious to select a pore size within the recited range, because Omar discloses that API-impregnated carrier particles may have a pore size of 5 nm, which is within the recited range, such that the skilled artisan reasonably would have expected that the pore size of the Muzzio particles also could be of this size. Such a modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143. Additionally, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, it further would have been prima facie obvious to select a particle size that is within the claimed range, because Vialpando expressly teaches that mesoporous silica particles that are impregnated with an API suitably may have particle sizes within the recited range, such that the skilled artisan reasonably would have expected that the Muzzio mesoporous particles impregnated with an API also could have such particle sizes.
The method of Muzzio, Omar, and Vialpando as combined supra will result in an API loading within the ranges of claims 1 and 16-18 and higher loading of the API relative to a porous carrier having a lower specific surface area within the range of claim 6 because it comprises the same steps of processing the same ingredients in the same way recited by the claims. The skilled artisan would recognize that using porous carriers having a higher specific surface area would result in higher loading of the API in light of Omar’s express teaching that the surface area of the porous carrier plays a crucial role in the impregnation process, since high surface area results in a high loading of API into the carrier.
Response to Applicant’s Arguments
Applicant presented a combined argument against both 103 rejections. Applicant argues that the cited art does not teach a reasonable expectation of success in achieving an API loading of higher than 10% and the RSD of less than or equal to 0.5% as recited by the claims as amended.
In response, this argument is not persuasive because Omar and Muzzio expressly teach a range for the relative standard deviation that reads on the recited ranges as discussed in the rejections, and the skilled artisan would have recognized that using porous carriers having a higher specific surface area would result in higher loading of the API in light of Omar’s express teaching that the surface area of the porous carrier plays a crucial role in the impregnation process, since high surface area results in a high loading of API into the carrier. Therefore, there would have been a reasonable expectation of success in arriving at the high API loadings recited by the claims by using a porous carrier having high specific surface area as recited by the claims.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. No. 12,564,555 and in view of Omar (“Impregnation of Active Pharmaceutical Ingredients Into Porous Carriers”; Dissertation of Thamar A. Omar (October 2019)) and/or Vialpando et al. (WO 2020/234675 where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a continuous process for manufacturing API-impregnated porous carriers comprising feeding continuously the porous carrier into a continuous blender, continuously spraying a solution comprising an API into the continuous blender, and continuously drying the impregnated porous carrier, wherein the carrier is granulated silicon dioxide, the particles having a relative standard deviation of 3% or less, and a pharmaceutical solid dosage form comprising the carrier and excipients.
Although the reference claims do not recite the particle size or pore size of the carrier, it would have been obvious to select amounts within the recited ranges because Omar expressly teaches that such sizes are suitable for use as carriers for an impregnated active.
Although the reference claims do not recite the presently claimed specific surface area range, it would have been obvious to select amounts within the recited range because Vialpando expressly teaches that porous particles having a surface area within the claimed range are suitable for use as a carrier for an API via impregnation of the carrier with the API, such that the skilled artisan reasonably would have expected that said porous carrier could be used as the type of porous carrier in the reference method.
Although the reference claims do not recite the use of a tubular mixer, it would have been obvious to do so because Omar expressly teaches that a tubular mixer is a suitable device for continuously impregnating porous carrier particles with an active.
Although the reference claims do not recite the wt% of the API loading on the carrier, it would have been obvious to select amounts within the presently claimed range because Omar expressly teaches that loadings within the recited range are appropriate for porous carrier particles.
Although the reference claims do not recite the mean residence time of in the impregnation device, Omar expressly teaches that achieving high uniformity of the impregnated porous carrier particles is important but can be difficult to achieve due to insufficient mixing, and the amount of time that the drug solution and the porous carrier spend in the continuous impregnation device (which is where the mixing occurs) is directly related to the mixing time such that the mean residence time is a result effective variable that will affect the degree of uniformity of the impregnated carrier particles which Omar identifies as an important parameter, thereby motivating the skilled artisan to optimize the mean residence time with a reasonable expectation of success in arriving at the claimed time range. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The reference method as modified supra will result in an API loading within the ranges of claims 1 and 16-18 and higher loading of the API relative to a porous carrier having a lower specific surface area within the range of claim 6 because it comprises the same steps of processing the same ingredients in the same way recited by the claims. The skilled artisan would recognize that using porous carriers having a higher specific surface area would result in higher loading of the API in light of Omar’s express teaching that the surface area of the porous carrier plays a crucial role in the impregnation process, since high surface area results in a high loading of API into the carrier.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of 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 as of 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.
Response to Applicant’s Arguments
Applicant argues that neither the reference claims nor the cited secondary references teach an API loading of higher than 10% and the RSD of less than or equal to 0.5% as recited by the claims as amended.
In response, the reference claims recite a relative standard deviation that reads on the claims range, and the skilled artisan would have recognized that using porous carriers having a higher specific surface area would result in higher loading of the API in light of Omar’s express teaching that the surface area of the porous carrier plays a crucial role in the impregnation process, since high surface area results in a high loading of API into the carrier. Therefore, there would have been a reasonable expectation of success in arriving at the high API loadings recited by the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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