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 .
DETAILED ACTION
This action is in response to papers filed August 18, 2025. Applicant’s reply to the restriction/election requirement of April 17, 2025 has been entered. Claims 1, 10, 13, 15, 18, 20-23, 25, and 26 have been amended; claims 17 and 24 have been canceled; and claim 27 has been newly added. Claims 1-16, 18-23, and 25-27 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/US2021/027558, filed April 15, 2021 under 35 U.S.C. 365(c), which claims the benefit of prior-filed U.S. Provisional Patent Application No. 63/010,628, filed April 15, 2020 under 35 U.S.C. 119(e), is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-18, is acknowledged. Applicant’s elections of i) “around the periphery only” as the species of region to which the second binding liquid is applied to the intermediate layer, ii) “both the first and third powder compositions” as the species of powder composition that does not contain an API/sensitive API/sensitive particle containing an API, iii) “coated API” as the species of form of the aqueous sensitive particle comprising the API, iv) “drying one or more of the wetted lase layer, the wetted intermediate layer, or the wetted cap layer” as the species of further active step, v) “the wetted cap layer” as the species of powder composition layer that undergoes drying”, and vi) “aqueous sensitive particle comprising API” as the species of further constituent of the second powder composition are all also acknowledged. The Examiner has determined that claims 1-3 and 5-10 read on the elected subject matter.
All of Applicant’s elections have been made without traverse, except for the election of the single disclosed species of further active step. Applicant contends that “the two alleged species…are not connected in any of design, operation, or effect” and thus “are not species of a common genus”.
The Examiner, however, would like to point out that they are, in fact, species of further active step. As Applicant has pointed out, the various species of further active step are quite different in design, operation, or effect, and thus Applicant’s statement supports the requirement to elect a single disclosed species of further active step.
Accordingly, claims 4, 11-16, 18-23, and 25-27 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on August 18, 2025. Claims 1-3 and 5-10 are currently under examination.
Claim Objections
Claims 1-3 and 5-10 are objected to because of the following:
i) In claim 1, step 4, there should be an “and” between the last two wherein clauses, i.e. between “rim of the depression” and “wherein the intermediate powder composition”.
ii) For claims 2, 3, and 5-10, there should be a comma between the preamble and the wherein clause.
iii) For claim 8, there should be a comma between “coated with a coating material” and “or an agglomerated”.
iv) In claim 9, the expressions “a same liquid” and “a same powder” should be “the same liquid” and “the same powder”, respectively.
Appropriate correction is required.
Obviousness-Type 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 1-3 and 5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,278,501.
Applicant’s elected subject matter is directed to a method of making a dosage form within a portion of the packaging for the dosage form, comprising forming in situ within at least one depression of the packaging a first powder composition into a base powder layer having a uniform thickness, depositing a first binding liquid in a continuous pattern on the base powder layer to form a base wetted powder layer, forming in situ within the at least one depression a second powder composition into an intermediate powder layer having a uniform thickness, depositing a second binding liquid along the periphery only of the intermediate powder layer to form an intermediate wetted powder layer, forming within the at least one depression a third powder composition into a cap powder layer having a uniform thickness, depositing a third binding liquid in a continuous pattern on the cap powder layer to form a cap wetted powder layer, and drying the cap powder layer; wherein the second powder composition contains an aqueous sensitive coated API, and both the first and third powder layers do not contain an API/sensitive API/sensitive particle containing an API; and wherein the first and third powder compositions are the same, and the first and third binding liquids are the same.
Claims 1-15 of U.S. Patent No. 11,278,501 disclose a method of making a dosage form within a portion of the packaging for the dosage form, comprising depositing a first powder material within at least one depression of the packaging to form a first powder layer having a uniform thickness, depositing a first binding liquid in a pattern on the first powder layer to form a first wetted powder layer, depositing a second powder material within the at least one depression to form a second powder layer having a uniform thickness, depositing a second binding liquid in a pattern on the second powder layer to form a second wetted powder layer, optionally forming within the at least one depression a third powder composition into a third powder layer having a uniform thickness, depositing a third binding liquid in a pattern on the third powder layer to form a third wetted powder layer; wherein a wetted powder composition layer can be evaporatively dried.
Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 11,278,501 discloses that the binding liquid can be applied only at the peripheral portions of the second substantially uniform layer of powder, leaving a central portion of unwetted/unbound powder. Moreover, U.S. Patent No. 11,278,501 discloses that the “powder material” can include an API, and that the powder materials and binding liquids can be the very same for select separate powder layers (e.g. such as the first and third powder layers).
Claim Rejections - 35 USC § 112(b)
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.
Claims 2, 3, and 5-8 are 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 2 stipulates in a wherein clause that “the base powder layer and the intermediate powder layer have a uniform thickness”. One of ordinary skill in the art would understand that the base powder layer itself has a uniform thickness, and also that the intermediate powder layer itself has a uniform thickness. However, from the presentation of the claim, one of ordinary skill in the art cannot definitively ascertain whether the base powder layer thickness is necessarily precisely the very same as the intermediate powder layer thickness, or whether the two layers can have different thicknesses, even though the thickness is uniform within each layer.
Claims 5-8 contain the acronym “API”, which is not defined by the claim. Claims musty stand alone to define the invention, and should not reply on the specification, drawings, or extraneous materials to give them meaning. Applicant is advised to first define “API” by its formal name, and then the acronym can be employed.
Claims 5 and 6 stipulate that the API or the particle comprising the API are “sensitive”, which renders the claims indefinite. The term “sensitive” is not defined by the claim, and is an arbitrary, subjective, and relative property. “Sensitive” to what? Sensitive in what way and to what degree? Sensitive compared to what? For example, one of ordinary skill in the art cannot definitively ascertain whether the API is necessarily “sensitive” to heat? If so, how is the API “sensitive”, e.g. the API changes conformation, or e.g. the API degrades to another compound, or e.g. the API explodes? Further, what constitutes being “sensitive” to heat, e.g. the API is “sensitive” to temperatures exceeding 3000 F, or e.g. the API is “sensitive” at room temperature? Hence, one of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 7 and 8 stipulate that the API, or the particle comprising the API, is “aqueous-sensitive”, which renders the claims indefinite. The term “aqueous-sensitive” is not defined by the claim, and is an arbitrary, subjective, and relative property. Does “aqueous-sensitive” mean “sensitive” to water molecules themselves, or perhaps sensitive to pH, or to ions from salts dissolved in water, or to certain reactions that can proceed in the presence of water, or to moisture generally, or what? Sensitive in what way and to what degree? Sensitive compared to what? How is the API “aqueous-sensitive”, e.g. the API changes conformation, or e.g. the API degrades to another compound, or e.g. the API explodes? Hence, one of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 3 is indefinite for depending from an indefinite claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10, which depends from claim 1, stipulates in a wherein clause that “the placing of the first powder composition comprises depositing the first powder composition as the base powder layer”. Claim 1 appears to already provide that the first powder composition is deposited as the base powder layer. Claim 10, therefore, does not appear to further limit claim 1 from which it depends.
Potentially Patentable Subject Matter
No prior art rejection is being applied to the elected subject matter. It is noted that the International Searching Authority, in their written opinion completed September 1, 2021, found the elected claims currently under examination to be both novel and inventive. Moreover, U.S. Patent No. 11,278,501, issued to the same assignee, and sharing some common inventors with the present application, has claims directed to a method that is not patentably distinct from the presently claimed method. For U.S. Patent Application No. 17/285,186, from which U.S. Patent No. 11,278,501 issued, a first action allowance was mailed, and the Examiner explained in the statement of reasons for allowance that while Patel et al. (U.S. Patent Application Pub. No. 2018/0141275) disclose methods of preparing a 3D printed article, such as a tablet, by forming layers of powder in a receptacle/cavity, and depositing a binding liquid on the powder layers, Patel et al. first manufactures the articles, and then, only after the articles have been completely manufactured, are they placed into the packaging, such as a blister pack. There is no teaching or suggestion to manufacture the articles in situ directly in the depressions of the blister pack. The present claims also require that the dosage form be manufactured in situ directly in the depressions of the packaging, such as a blister pack.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617