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
Claims 21-40 are currently pending and a preliminary amendment to the claims filed on 07/19/2024 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The two (2) information disclosure statements (IDS) submitted on 07/19/2024 were filed before the mailing date of the instant first action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies are enclosed herewith.
Specification
The abstract of the specification is objected to a minor informality.
In the instant case, the abstract is written as follows:
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The claimed invention is directed to a flowable dry powder comprising several essential ingredients while the abstract refers to a method of manufacturing a flowable dispersible powder. That is, the current abstract is not descriptive to represent the invention. Accordingly, a substitute abstract is respectfully requested.
Claim Objections
Claim 28 is objected to a minor informality.
Claim 28 recites “a tap density greater than 0.1g/cm”, but which should be corrected to “a tap density greater than 0.1g/cm3”.
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
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.
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.
Claims 35-40 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 35 recites “an insoluble or slightly soluble component” in line 2 and the dry powder composition comprises between about 0.01 and 50% w/w of the insoluble or slightly soluble component” in lines 10-11. Further, claim 35 additionally “the dry powder composition comprises between about 1% and 60% collectively by weight of the one or both of a plant derived or synthesized cannabinoid drug substance” in lines 5-7. Here, the cannabinoid drug substance is seen as an insoluble or slightly soluble substance as supported by e.g., [0004], [0031] and [0071] of instant publication. The cannabinoid drug substance is present in “60%” at the maximum while the insoluble or slightly soluble component is present in “50%” at the maximum. The insoluble or slightly soluble component cannot exceed 50%. However, the maximum amount 60% of cannabinoid drug substance exceeds the maximum amount 50%of insoluble or slightly soluble component in the dry powder composition, which is unclear. Does applicant intend to recite additional insoluble or slightly soluble component between about 0.01 and about 50% other than the cannabinoid drug substance? If so, proper correction is requested.
The remaining claims are also rejected due to the rejection of base claim 35.
Claim 22 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 21 recites “the dry composition comprises between about 0.01 and 50% w/w of the insoluble or slightly soluble component”. Its dependent claim 22 recites “the dry powder composition comprises between about 1% and 60% of cannabinoid”. Here, the cannabinoid is seen as insoluble or slightly soluble substance as supported by e.g., [0004], [0031] and [0071] of instant publication. Thus, scope of dependent claim 22 is broader than claim 21. It may not be said that claim 22 further limits claim 21 in a proper manner.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(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.
Claims 21 and 25 are rejected under 35 U.S.C. 102(a)(1) as being are anticipated by Gordon et al. (US2002/0132011A1).
Applicant claims the below claim 21 filed on 07/19/2024:
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Prior Art
Gordon discloses dry powders having hydrophobic and hydrophilic components (abstract); the hydrophobic components include budesonide, testosterone, hydrocortisone, prednisone (claim 9 of prior art), peptide, retinoid, vitamin D, E, K, prostaglandin, THC (tetrahydrocannabinol), hydrophobic antibiotic, and chemotherapeutic drug (claim 10 of prior art); the hydrophilic component includes lactose, pectin, etc. (claim 12 of prior art); and the dry powders are pulmonary delivered via a dry powder inhaler (DPI) (e.g., [0002], [0004], [0019], [0024], Fig. 6, etc.).
In the below embodiment ([0060] - Table 2: e.g., formulation B-38), Gordon discloses a dry powder contains budesonide 187.5mg (= about 1.1% - obtained from 187.5mg/1562.5mg) which reads on the claimed insoluble component or slightly soluble component and its amount is within the claimed range of between about 0.01 and 50%, and lactose which reads on the claimed disaccharide and/or bulking agent as supported by instant publication at [0073], and the powder composition contains 0.81% moisture content which is within the claimed moisture content below about 10%, and therefore, the dry powder of Gordon reads on the claimed flowable dry powder (instant claim 21); and the powder has a mass median aerosol diameter (MMAD) of 2.41 microns which is within the claimed range of between 0.5 and 5 microns (instant claim 25).
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In light of the foregoing, instant claims 21 and 25 are anticipated by Gordon.
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 21, 22, 24 and 25 are rejected under 35 USC 103 as being obvious over Gordon et al. (US2002/0132011A1) as applied to instant claims 21 and 25.
Applicant claims the below claim 21 filed on 07/19/2024:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical dry powder research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Gordon was discussed with respect to instant claims 21 and 25. That is, Gordon discloses a dry powder containing hydrophobic drug such as Budesonide, THC, etc., and hydrophilic component lactose which reads on the claimed disaccharide/bulking agent, and the powder has a moisture content of below 10%.
Further, Gordon discusses the hydrophobic drug includes THC (claim 9 of prior art) which reads on the claimed cannabinoid; and such drug can be present in an amount of 0.01 to 95% ([0014]) which overlaps the instant range of about 1 and 60%. MPEP 2144.05 : “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”(instant claim 22); and the dry particles produced by spray drying method has a uniform size distribution with a mean particle size below 5 microns ([0009]), and although Gordon does not expressly teach a mean granule diameter between 0.05 mm and 3 mm of instant claim 24, the granule size is generally larger than the micronized powder particle size, and therefore, the size of granule would be milled or optimized to obtain desired powder particle size as a matter of design or choice depending on the intended purpose, formulation type (e.g., powder), spray-drying technique, etc. It is also noted that since it has been held that changing the size or range of an article is not ordinarily a matter of invention, appropriate selection of size, weight, ratios, etc. is considered routine, and is typically a matter of design choice. See In re Rose 105 USPQ 237 (CCPA 1955) and also In re Yount (36 C.C.P.A. (Patents) 775, 171 F.2d 317, 80 USPQ 141(instant claim 24).
In light of the foregoing, instant claims 21, 22, 24 and 25 are obvious over Gordon.
Claims 23 and 26-27 are rejected under 35 USC 103 as being obvious over Gordon et al. (US2002/0132011A1) as applied to instant claims 21 and 25 in view of Whitfield et al. (US2010/0316724A1).
However, Gordon does not expressly teach nicotine of instant claim 23; fine particle fraction (FPT) and delivery efficiency (DE) of instant claim 26; and tap density of dry powder of instant claim 27. The deficiencies are cured by Whitfield.
Whitfield discloses microparticles in the form of free-flowing dry powder ([0029] and [0205]) having a moisture content of less than about 5% ([0151]) for the treatment of asthma, chronic obstructive pulmonary disease (COPD), and other lung disease ([0054]); and the microparticles contain as therapeutic agent tacrolimus, cyclosporin, cannabinoid, budesonide, nicotine, etc. ([0089]) which reads on the claimed insoluble or slightly soluble component nicotine, and polysaccharide such as lactose, trehalose, raffinose, or cyclic oligosaccharides such as cyclodextrins ([0065]); and the microparticles has a fine particle fraction (FPF) of less than 6.5 or 5.8 microns that reads on the claimed FPF, which is from about 70 or 80-90% of the delivered dose ([0188]-[0189]) that overlaps the instant delivery efficiency (DE) range of greater than 60%. MPEP 2144.05 above. (instant claim 26); and the microparticles have a tap density of less than or equal to about 0.3g/cm3 (abstract, [0041] and [0159]) which overlaps the instant range of between about 0.1 g/cm3 and 0.6 g/cm3. MPEP 2144.05 above (instant claim 27). Such low density of the microparticles can provide less weight for the same volume and therefore allow a low dose to be provided in a container without a carrier ([0208]) and additionally gives rise to plugs aerosolized in an inhaler with far greater friability than those obtained with the standard formulation friable plugs ([0280]-[0281]).
It would have been obvious to modify the teachings of Gordon with addition of nicotine and parameters of FPF/DE and tap density of Whitfield.
One of the ordinary artisan would have been motivated to do so because both references are directed to providing free-flowing dry powder for e.g., pulmonary drug delivery and require the similar ingredients of cannabinoid, steroid, nicotine, lactose, etc. and they are in analogous art; and accordingly, replacing or defining insoluble or slightly soluble component including THC of Gordon with nicotine would be a matter of choice or design depending on the intended purpose and thus selection of nicotine would be obvious from the standpoint of the ordinary artisan’s skill and knowledge; combining FPF/DE of Whitfield art would provide enhanced delivery because when greater than 60% of the powder’s mass consists of fine particles having less than 5.8 microns, such small particle range is enough to reach the lower airways and lungs when delivered, and combining low tap density of Whitfield with Gordon would allow less weight for the same volume and therefore a low dose without carrier as taught by Whitfield.
In light of the foregoing, instant claims 23 and 26-27 are obvious over Gordon in view of Whitfield.
Claims 28-34 are rejected under 35 USC 103 as being obvious over Gordon et al. (US2002/0132011A1) in view of Whitfield et al. (US2010/0316724A1).
Level of Ordinary Skill in the Art (MPEP 2141.03) as noted above.
Applicant claims the below claim 28 filed on 07/19/2024:
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Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Gordon discloses dry powders having hydrophobic and hydrophilic components (abstract); the hydrophobic components include steroid such as budesonide, testosterone, hydrocortisone, prednisone (claim 9 of prior art), peptide, retinoid, vitamin D, E, K, prostaglandin, hydrophobic antibiotic, and chemotherapeutic drug, THC (tetrahydrocannabinol), (claim 10 of prior art) which reads on the claimed lipophilic component; the hydrophilic component includes lactose which reads on the claimed disaccharide, pectin, etc. (claim 12 of prior art), and are present in an amount of about 0.01 to about 95% or about 0.05 to about 25% ([0032]) which overlaps or is within the instant range of between about 0.01 and 50% of insoluble or slightly insoluble component; the dry powders have a moisture content of below 10%, 5%, 3% or lower ([0030]) which is identical to the claimed moisture content of below 10% (instant claim 28, in part and instant claim 31); and the dry powders are pulmonary delivered via a dry powder inhaler (DPI) (e.g., [0002], [0004], [0019], [0024], Fig. 6, etc.); further the hydrophobic component includes cyclosporin, budesonide, fluticasone, vitamin E (=tocopherol), amphotericin B ([0026]), etc. which reads on the claimed lipophilic component species(instant claim 29); and the dry powder composition further comprises sodium citrate ([0009]) which reads on the claimed stabilizing additive (instant claim 34).
However, Gordon does not expressly teach a tap density of instant claim 28; other species of instant claim 29; nicotine of instant claim 30; mannitol, trehalose, raffinose or maltodextrin of instant claim 32; and specific amino acid of instant claim 33; and other species of stabilizing additive of instant claim 34. The deficiencies are cured by Whitfield.
Whitfield discloses microparticles in the form of dry powder ([0029]) having a moisture content of less than about 5% ([0151]); the microparticles has a tap density of less than or equal to about 0.3g/cm3 (abstract and [0041]) which overlaps the instant range of greater than about 0.2 g/cm3 (instant claim 28 – tap density); the microparticles contain tacrolimus, cyclosporin, cannabinoid, budesonide, nicotine, etc. ([0089]) which reads on the claimed lipophilic component nicotine (instant claims 29-30); buffer such as citrate ([0146]), carriers, excipients or bulking agent ([0055]) such as mannitol or trehalose ([0075]), raffinose ([0106]), etc., which reads on the claimed one or more additive (instant claim 32); and the microparticles contain amino acid such as leucine, phenylalanine, tryptophan, etc. ([0074], [0089], and [0225]) which reads on the claimed amino acid(instant claim 33), and surfactants ([0146] and [0203]) including lecithin or phospholipid (e.g., DPPC) ([0237]), fatty acids, phosphatidylcholine, etc. ([0227]) which reads on the claimed stabilizing additive (instant claim 34).
It would have been obvious to modify the teachings of Gordon with a tap density of Whitfield because both references are directed to providing free-flowing dry powder for e.g., inhalation and require the similar ingredients of cannabinoid, steroid, nicotine, additive, etc. and they are in analogous art; and accordingly, combining low tap density of Whitfield art would provide less weight for the same volume and therefore allow a low dose without carrier as taught by Whitfield.
It would have been obvious to modify the teachings of Gordon with certain additives including amino acid, saccharide additive, and stabilizing agent of Whitfield in order to enhance the properties of the dry powder composition.
In light of the foregoing, instant claims 28-34 are obvious over Gordon in view of Whitfield.
Claims 35-40 are rejected under 35 USC 103 as being obvious over Gordon et al. (US2002/0132011A1) in view of Whitfield et al. (US2010/0316724A1).
Level of Ordinary Skill in the Art (MPEP 2141.03) as noted above.
Applicant claims the below claim 35filed on 07/19/2024:
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For examination purpose, please note that “plant derived or synthesized” cannabinoid is a product-by-process limitation which is not limiting because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, when the prior art teaches “cannabinoid”, it reads on the claimed cannabinoid.
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Gordon discloses dry powders having hydrophobic and hydrophilic components (abstract); the hydrophobic components include steroid such as budesonide, testosterone, hydrocortisone, prednisone (claim 9 of prior art), peptide, retinoid, vitamin D, E, K, prostaglandin, THC (tetrahydrocannabinol), hydrophobic antibiotic, and chemotherapeutic drug (claim 10 of prior art) which reads on the claimed insoluble or slightly soluble component; the hydrophilic component includes lactose which reads on the claimed disaccharide, pectin, etc. (claim 12 of prior art), and the hydrophobic drugs in the dry powder composition are present in an amount of about 0.01 to about 95% or about 0.05 to about 25% ([0032]) which overlaps or within the instant range of between about 1 and 60% or between about 0.01 and 50% of insoluble or slightly insoluble component; the dry powders have a moisture content of below 10%, 5%, 3% or lower ([0030]) which is identical to the claimed moisture content of below 10% (instant claim 35 (in part), and claim 36); and the dry powders have a particle size of below 10 microns or preferably below 5 microns ([0016]); and the powder has a mean geometric diameter of from below 10 microns or preferably below 5 microns ([0016] and [0028]) which is within the instant range of from 0.01 to about 20 microns (instant claim 38).
However, Gordon does not expressly teach hydroxypropylmethylcellulose (HPMC) or methylcellulose (MC) of instant claim 37; distearoylphosphatidylcholine (DSPC) of instant claim 39; and bulk density of instant claim 40. The deficiencies are cured by Whitfield.
Whitfield discloses microparticles in the form of dry powder ([0029]) having a moisture content of less than about 5% ([0151]); the microparticles contain cannabinoid, nicotine, etc. ([0089]); buffer such as citrate ([0146]), carriers, excipients or bulking agent ([0055]) such as mannitol or trehalose ([0075]), raffinose ([0106]), etc.; and amino acid such as leucine, phenylalanine, tryptophan, etc. ([0074], [0089], and [0225]); the microparticles contain polysaccharide such as cellulose (e.g., methyl cellulose (MC) and hydroxypropymethyl cellulose (HPMC))([0110] and [0145]) (instant claim 37); and surfactants ([0146] and [0203]) including lecithin or phospholipid (e.g., DPPC) ([0237]), fatty acids, phosphatidylcholine, DPPC, etc. ([0227]). Although Whitfield does not expressly teach DSPC (=diasteroylphosphatidylcholine) of instant claim 39, this prior art teaches fatty acid, phosphatidylcholine, dipalmitoylphosphatidylcholine, and therefore, it would be obvious to modify the surfactants of Whitfield with DSPC, and such replacement would have yielded no more than the predictable results of surfactant, absent evidence to the contrary is given (instant claim 39); the microparticles have a bulk density of no more than about 0.2g/cm3 ([0041]) which overlaps the instant range between about 0.05g/cm3 and 0.30 g/cm3. MPEP 2144.05 above(instant claim 40).
Further, it would have been obvious to modify the teachings of Gordon with cellulose additives of Whitfield in order to enhance the properties of the dry powder composition.
It would have been obvious to modify the teachings of Gordon with bulk density of Whitfield because both references are directed to providing free-flowing dry powder for e.g., pulmonary delivery and require the similar ingredients of cannabinoid, steroid, nicotine, saccharides etc. and they are in analogous art; and accordingly, combining low bulk density of Whitfield art would allow a low dose drug without carrier as taught by Whitfield.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,328,216B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because US ‘216 is directed to a method of manufacturing a flowable and dispersible powder and the claimed invention is directed to a flowable dry powder. However, both claim sets require lipophilic substance (=insoluble or slightly insoluble substance), identical MMAD, FPF and DE, tap density, bulk density, moisture content, same one or more additives. Further, patent ‘216 disclosure has the same composition for use in the method. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘216 subject matter.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,833,118B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because US ‘118 is directed to a method of manufacturing a flowable and dispersible powder and the claimed invention is directed to a flowable dry powder. However, both claim sets require lipophilic substance (=insoluble or slightly insoluble substance), identical MMAD, FPF and DE, tap density, bulk density, moisture content, same one or more additives including surfactant DSPC, amino acid. Further, patent ‘216 disclosure has the same composition for use in the method. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘118 subject matter.
Conclusion
All examined clams are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613