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
1. Claims 1-16 filed 6/29/23 are pending. Claim 1 is an independent claim.
2. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which Applicant may become aware in the specification.
3. Claim interpretation: The specification discloses at [0041] that the term “about” in relation to a given numerical value is meant to include numerical values within 10% of the specified value. The specification discloses at [0054] that the terms “particle” or “particles” or “microparticles” are used interchangeably in the broadest sense, and refers to a discrete body or bodies, being circular, spheroidal and of controlled dispersity with a characteristic size from sub-micrometers to tens of micrometers in contrast to a porous monolithic cake which is typically produced during conventional lyophilization. The specification discloses at [0088] that the circularity of a particle can be described as the ratio of the smallest diameter of the particle to its largest diameter, and for a perfect circle this ratio is 1. With regard to the limitation “internal void space”, Applicant has stated on the record in the parent application serial no. 17/351,937 that “internal void space” has a well-established meaning in the art which distinguishes this term from the term “porosity”, and has cited Molecular Basis of Chromatographic Separation, Fogacs and Cserhati (IDS reference) at page 124, section “g”, i.e., “A pore is a hole, a cavity, or a channel connected to the surface of the solid…A cavity that does not communicate with the surface is called a closed pore or an internal void and will not contribute to porosity or specific surface area. Applicant also pointed to disclosure in the specification at [00345] that states “removal of the trapped second liquid can produce particles with internal void spaces and porosity, i.e., a citing of internal void spaces separately from porosity.
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not disclose how to make and/or use the instant invention, a particle comprising greater than about 70% antibody or a fragment thereof by weight, and an amino acid, wherein the particle has less than about 10% internal void space, a circularity of about 0.80 to about 1.00, and a diameter of about 10 um to about 50 um, and including the limitations recited in the dependent claims, wherein the particle does not further comprise all of a carbohydrate, a salt, and a surfactant. (Note that instant dependent claim 13 recites these components as alternatives in part.)
The specification has not enabled the breadth of the claimed invention because the claims encompass a particle that must incorporate high percentages of antibody or a fragment thereof by weight in addition to an amino acid, have less than about 10% internal void space, a particular range of circularity and a particular diameter, wherein it is unpredictable that the particle can be made without further incorporation with a carbohydrate, a salt, and a surfactant. This is because the specification discloses working examples wherein a human IgG antibody particle is made with a combination of an amino acid, a carbohydrate, a salt, and a surfactant, and wherein the specification at these working examples is silent as to the percentage of antibody present on the resulting particles.
The specification discloses a large multiplicity of working examples of making particles comprising an antibody and an amino acid that also comprise a carbohydrate, a salt, and a surfactant, but does not disclose the percentage of antibody present on the particles.
For example, the specification discloses at Example 2 ([00442]), Example 4 ([00444]), Example 6 ([00446]), Example 9 ([00449), Example 11 ([00451]), Example 12 ([00452]), Example 13 ([00453]), Examples 17 ([00457]), 18 ([00458]) ,19 ([00459]), 23 ([00463]), when making a particle, human IgG (antibody) powder was reconstituted in deionized water, desalted and quantities of an amino acid, a carbohydrate, a salt, and a surfactant were added.
The specification discloses a limited number of working examples of making a particle comprising an antibody and an amino acid plus (generic) excipients, but does not disclose the percentage of antibody present on the particles, nor the internal void space, circularity, diameter, or residual moisture by weight.
The specification at Example 15 ([00455]), disclose that a solution of human IgG was reconstituted in deionized water to three different concentrations, then desalted, and a quantity of an amino acid was added to each to control particle surface properties. The specification at Example 20 discloses that human IgG powder was reconstituted in deionized water, desalted and quantities of two excipients were added. However, this said disclosure does not evidence the percentage of antibody present on the particle, in concert with the percentage of internal void space, the circularity, or the diameter, or the residual moisture by weight.
The specification discloses at Example, 48 ([00489]) that human IgG was prepared, desalted and a quantity of a surfactant was added. This said disclosure does not evidence the percentage of antibody present on the particle, in concert with the percentage of internal void space, the circularity, or the diameter.
The instant specification evidences that surfactants and excipients are comprised in the antibody microparticles during synthesis.
Evidentiary reference Dutton, G. (www.genengnews.com, 2026, pages 1-7) teaches that these microparticles are produced using a protein therapeutic in liquid form (see entire reference).
There is insufficient guidance in the specification as to how to make the instant invention. Undue experimentation would be required of one skilled in the art to practice the instant invention. See In re Wands 8 USPQ2d 1400 (CAFC 1988).
6. 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.
7. Claim 16 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.
8. Claim 16 contains the trademark/trade name TRITONTM N-101. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a surfactant and, accordingly, the identification/description is indefinite.
9. 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.
10. Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 13-16 of U.S. Patent No. 11,717,488 (that issued from parent application serial no. 17/351,937).
The claims of U.S. Patent No. 11,717,488 are drawn to “A particle comprising at least one antibody or a fragment thereof, an amino acid, a carbohydrate, a salt, and a surfactant, wherein the circularity of the particle is from about 0.80 to about 1.00, and wherein the particle has less than about 10% internal void space, a diameter of about 10 um to about 50 um, and greater than about 70% antibody or a fragment thereof by weight, including wherein the particle further comprises a pH adjusting agent, a bactericide, or a combination thereof, including wherein the particle has less than about 5%, 3%, or 1% residual moisture by weight, including wherein the particle has greater than about 80%, 90% or 95% antibody/fragment thereof by weight, and including wherein the particle may comprise one or more of a carbohydrate, a salt, a surfactant, and including the species of amino acid, carbohydrate, salt, or polysorbate recited in dependent claims 13-16 of US 11,717,488.
11. Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,459,376 in view of US20120076800 A1 (IDS reference).
The claims of US 11,459,376 are drawn to a pharmaceutically effective composition comprising particles having the same antibody percentage, internal void space, circularity, and less than 3% residual moisture by weight (the latter, identical to that residual moisture recited in instant dependent claim 7), and wherein the particles may comprise a carbohydrate, an amino acid, a salt, a pH adjusting agent, a bactericide, or a combination thereof.
The claims of US 11,459,376 do not recite that the diameter of the particles is about 10 um to about 50 um.
US20120076800 A1 discloses a pharmaceutically effective non-aqueous, reduced viscosity composition comprising particles, the particles comprising at least about 70% antibody or fragment thereof by weight, and having a size of between 0.2-250 um, or 0.2-20 um, expressed as an average diameter. US20120076800 A1 discloses that mAbs have become important therapeutics for treating various human diseases (see entire reference, e.g., title, abstract, [0002]-[0026], [0053], [0063], and [0081]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made the diameter of the particles recited in the claims of US 11,459,376 the diameter of those disclosed by US20120076800 A1.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to make a particle that would be useful for treatment, particularly in light of the disclosure of a similarly high percent antibody particle in the disclosed range of average diameters.
12. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 18/827,595 case as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
Claims 1-5 and 9- 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/827,595 in view of US20120076800 A1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims 1, 2, 7, 9, 15, 17, 19, 20, 38, 39, 43, 55-57 and 100-102 of 18/827,595 are drawn to a particle/pharmaceutical composition thereof, the particle comprising a therapeutic biologic that is an antibody or fragment thereof at greater than about 60% therapeutic biologic by weight, an amino acid, pH adjusting agent, a salt, a carbohydrate, a surfactant, a bactericide or a combination thereof. The particle has a circularity of about 0.8 to about 1.00 and less than about 25% internal void spaces.
Claims 124, 132 and 191 of 18/827,595 are drawn to a method of treating a disease or condition in a subject in need thereof comprising administering to the subject a pharmaceutically effective amount of a composition comprising a plurality of particles.
The claims of 18/827,595 do not recite the diameter of the particles, nor do they recite species of amino acid, carbohydrate, salt or surfactant which appear in instant dependent claims 13-16.
US20120076800 A1 discloses a pharmaceutically effective non-aqueous, reduced viscosity composition comprising particles, the particles comprising at least about 70% antibody or fragment thereof by weight, and having a size of between 0.2-250 um, or 0.2-20 um, expressed as an average diameter. US20120076800 A1 discloses that sucrose, L-histidine, proline, polysorbate, sodium chloride, calcium chloride and/or magnesium chloride can be present in the particle, including them for the purpose of mitigating aggregation and oxidation, to enhance transition of the bioactive molecule from the non-aqueous vehicle into an environment of use or to improve formability of the particles, to maintain biological activity during formulation process (e.g., [0054]-[0057] [0063], [0079]). US20120076800 A1 discloses that mAbs have become important therapeutics for treating various human diseases (see entire reference, e.g., title, abstract, [0002]-[0026], [0053], [0063], and [0081]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made the diameter of the particles recited in the claims of 18/827,595 the diameter of those disclosed by US20120076800 A1,and to have included the salt, surfactant, amino acid, and carbohydrate disclosed by US20120076800 A1.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to make a particle that would be useful for treatment, particularly in light of the disclosure of a similarly high percent antibody particle in the disclosed range of average diameters, and because US20120076800 A1 discloses that it is advantageous to include such salt, surfactant, amino acid, and carbohydrate to facilitate particle formation, bioactivity and stability.
13. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6-12 and 14 of copending Application No. 18/659,740 in view of WO2012042274 A1 (IDS reference) and US20120076800 A1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of 18/659,740 are drawn to a composition comprising particles, wherein a plurality of the particles comprise an antibody or fragment thereof and one or more excipients, wherein the one or more excipients comprise a surfactant, have less than about 7% residual moisture by weight, have a loading of the antibody or fragment thereof from about 75 weight % to about 100 weight %, comprise less than about 0.1% internal void spaces, and wherein the composition comprises less than 5% aggregation of the antibody or fragment thereof; the particle may further comprise a sugar or an antioxidant, and have diameters from about 1 um to about 25 um.
The claims of 18/659,740 do not recite wherein the particle further comprises an amino acid, including wherein it further comprises a salt, a surfactant and/or a carbohydrate, nor do they recite a circularity of about 0.80 to about 1.00.
WO2012042274 A1 teaches circular solid particles (see entire reference).
US20120076800 A1 discloses a pharmaceutically effective non-aqueous, reduced viscosity composition comprising particles, the particles comprising at least about 70% antibody or fragment thereof by weight, and having a size of between 0.2-250 um, or 0.2-20 um, expressed as an average diameter. US20120076800 A1 discloses that sucrose, L-histidine, proline, polysorbate, sodium chloride, calcium chloride and/or magnesium chloride can be present in the particle, including them for the purpose of mitigating aggregation and oxidation, to enhance transition of the bioactive molecule from the non-aqueous vehicle into an environment of use or to improve formability of the particles, to maintain biological activity during formulation process (e.g., [0054]-[0057] [0063], [0079]). US20120076800 A1 discloses that mAbs have become important therapeutics for treating various human diseases (see entire reference, e.g., title, abstract, [0002]-[0026], [0053], [0063], and [0081]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made circular particles as taught by WO2012042274 A1 and to have included a species of salt, amino acid, surfactant, and carbohydrate disclosed by US20120076800 A1 in the particle recited in the claims of 18/659,740.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to make a particle that incorporates the components for better formation, therapeutic protein stability, and mitigating aggregation and oxidation as is disclosed by US20120076800 A1.
Instant dependent claim 4 is included in this rejection because the sodium chloride and other salt containing buffers disclosed by US20120076800 A1 are pH-adjusting agents.
14. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6-12 and 14 of copending Application No. 18/907,018 in view of US20120076800 A1. (Note that 18/907,018 is a continuing application of 18/659,740 which is a continuing application of the instant application. No group restriction requirements were made in the instant application, nor it its parent application, as the claims in both applications were exclusively drawn to a particle. The claims of ‘018 are not protected by the § 121 safe harbor provision noted above in this office action.)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims 1-30 of 18/907,018 are drawn to a method for making a plurality of particles comprising a therapeutic biologic that is an antibody at greater than about 60% by weight, wherein the particles comprise less than about 10% internal void spaces, have a circularity of from about 0.80 to about 1.00, comprise saline (sodium chloride, a pH adjusting agent) and dextrose (a sugar) and a surfactant; in addition, the particles have a water content of less than 10% by weight after drying (i.e., have less than 10% residual moisture by weight).
The claims of 18/907,018 do not recite wherein the particle has a diameter of about 20 um to about 40 um, comprises an amino acid, or comprises a specific sugar such as sucrose, a specific surfactant such as polysorbate, or a specific amino acid such as histidine or proline, or a specific salt besides sodium chloride such as calcium chloride.
US20120076800 A1 discloses a pharmaceutically effective non-aqueous, reduced viscosity composition comprising particles, the particles comprising at least about 70% antibody or fragment thereof by weight, and having a size of between 0.2-250 um, or 0.2-20 um, expressed as an average diameter. US20120076800 A1 discloses that sucrose, L-histidine, proline, polysorbate, sodium chloride, calcium chloride and/or magnesium chloride can be present in the particle, including them for the purpose of mitigating aggregation and oxidation, to enhance transition of the bioactive molecule from the non-aqueous vehicle into an environment of use or to improve formability of the particles, to maintain biological activity during formulation process (e.g., [0054]-[0057] [0063], [0079]). US20120076800 A1 discloses that mAbs have become important therapeutics for treating various human diseases (see entire reference, e.g., title, abstract, [0002]-[0026], [0053], [0063], and [0081]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made the particles in the sizes disclosed by US20120076800 A1, and to have incorporated the amino acid, salt, surfactant, and/or sugar ingredients disclosed by US20120076800 A1 when making the particle by the method recited in the claims of 18/907,018.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to mitigate aggregation and oxidation, to enhance transition of the bioactive molecule during production into an environment of use or to improve formability of the particles, or to maintain biological activity during formulation process as is disclosed by US20120076800 A1.
The particle recited in the method claims of 18/907,018 in view of US20120076800 A1 anticipates the instantly claimed particle.
15. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/906,489 in view of US20120076800 A1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-21 of 18/906,489 are drawn to a composition comprising particles, wherein a plurality of particles comprise greater than 65% of a therapeutic agent, including an antibody or fragment thereof, by weight, have less than 25% internal void space, have a circularity from 0.80 to 1.00, have less than 7% residual moisture by weight.
Claim 22 of 18/906,489 is drawn toa composition comprising particles wherein a plurality of the particles comprise greater than 65% of a therapeutic biologic or salt thereof by weight, and further comprise a surfactant, an amino acid, or a combination thereof.
The claims of 18/906,489 do not recite wherein the diameter of the particles is about 10 um to about 50 um, nor that the particles comprise a carbohydrate, nor a specific species of salt, surfactant, amino acid, or carbohydrate.
US20120076800 A1 discloses a pharmaceutically effective, reduced viscosity composition comprising particles, the particles comprising at least about 70% antibody or fragment thereof by weight, and having a size of between 0.2-250 um, or 0.2-20 um, expressed as an average diameter. US20120076800 A1 discloses that sucrose, L-histidine, proline, polysorbate, sodium chloride (a pH adjusting agent), calcium chloride and/or magnesium chloride can be present in the particle, including them for the purpose of mitigating aggregation and oxidation, to enhance transition of the bioactive molecule from the non-aqueous vehicle into an environment of use or to improve formability of the particles, to maintain biological activity during formulation process (e.g., [0054]-[0057] [0063], [0079]). US20120076800 A1 discloses that mAbs have become important therapeutics for treating various human diseases (see entire reference, e.g., title, abstract, [0002]-[0026], [0053], [0063], and [0081]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made the particles in the sizes disclosed by US20120076800 A1, and to have incorporated specific species of amino acid, salt, surfactant, and/or sugar ingredients disclosed by US20120076800 A1 into the particle.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to mitigate aggregation and oxidation, to enhance transition of the bioactive molecule during production into an environment of use or to improve formability of the particles, or to mitigate aggregation and oxidation and to maintain biological activity as is disclosed by US20120076800 A1.
16. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20, 39, 40 and 42 of copending Application No. 17/833,427 in view of US20120076800 A1. (With regard to the method claims of 17/833,427, the application was filed as a separate application from the instant application rather than a divisional of the instant application and is not entitled to the § 121 safe harbor provision that is noted above in this office action.)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20, 39 and 42 of 17/833,427are drawn to a pharmaceutically effective composition comprising particles , wherein the particles have a circularity from 0.8 to 1.00, less than 3% residual moisture by weight, have greater than 70% of at least one antibody or fragment thereof by weight, comprise at least one of a carbohydrate, a pH adjusting agent, a salt, a chelator, a mineral, a surfactant, an antiseptic, an amino acid, a bactericide or a combination thereof.
Claims 20 and 40 of 17/833,427 are drawn to a method of treating a disease or condition in a subject in need thereof comprising administering a pharmaceutically effective composition comprising a plurality of particles that comprise at least one antibody or fragment thereof greater than about 65% weight percent.
The claims of 17/833,427 do not recite the diameter of the particles, nor specific species of a carbohydrate, a salt, a surfactant, or an amino acid.
US20120076800 A1 discloses a pharmaceutically effective, reduced viscosity composition comprising particles, the particles comprising at least about 70% antibody or fragment thereof by weight, and having a size of between 0.2-250 um, or 0.2-20 um, expressed as an average diameter. US20120076800 A1 discloses that sucrose, L-histidine, proline, polysorbate, sodium chloride (a pH adjusting agent), calcium chloride and/or magnesium chloride can be present in the particle, including them for the purpose of mitigating aggregation and oxidation, to enhance transition of the bioactive molecule from the non-aqueous vehicle into an environment of use or to improve formability of the particles, to maintain biological activity during formulation process (e.g., [0054]-[0057] [0063], [0079]). US20120076800 A1 discloses that mAbs have become important therapeutics for treating various human diseases (see entire reference, e.g., title, abstract, [0002]-[0026], [0053], [0063], and [0081]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made the particles recited in the claims of 17/883,427 in the diameters disclosed by US20120076800 A1 and to have used the species of carbohydrate, salt, surfactant and/or amino acid disclosed by US20120076800 A1 such as sodium chloride, polysorbate, sucrose, and/or histidine.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, as the claims of 17/833,427 do not recite the diameter of the particles, nor specific species of the generic carbohydrate, a salt, a surfactant, and/or an amino acid.
17. No claim is allowed.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE DIBRINO whose telephone number is (571)272-0842. The examiner can normally be reached on M, T, Th, F.
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/Marianne DiBrino/
Marianne DiBrino, Ph.D.
Patent Examiner
Group 1640
Technology Center 1600
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641