DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 1
Status of Claims
Claims 1-22 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I and below species in the reply filed on 11/13/2025 is acknowledged.
Claims 1-10 and 15, 17, 19-22 are under examination. The examined species are 1) The hygroscopic material is the desiccant silica gel in a partially hydrated state, and 2) There is no humectant.
Claims 11-14, 16 and 18 are withdrawn. Claims 11-14 are withdrawn as members of non-elected Group II. Claims 16 and 18 are withdrawn as they are directed to species of a humectant.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-10, 15, 17 and 19-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over
Box et al. (US Patent, 7 361 787, issued April 22, 2008) cited on applicant’s IDS dated Nov 7 2022, in view of Taylor et al. (WO 01/98174, published December 27, 2001) cited on applicant’s IDS dated Nov 7 2022 and Portier et al. (WO 2008/135570, published November 13, 2008, cited by applicant on IDS dated Nov 7 2022.
Claims 1 and 10 are directed to a drug product comprising:
a dry powder inhalation device containing one or more pharmaceutical
compositions present therein (two pharmaceutical compositions present therein), wherein the one or more pharmaceutical compositions comprise active ingredients (I) vilanterol2, or a salt thereof, and (II) fluticasone furoate3, or a solvate thereof;
a hygroscopic material; and
a package which encompasses the dry powder inhalation device and the
hygroscopic material defining an enclosed volume therein;
wherein each of the active ingredients (I) and (II) are present in the same
or different pharmaceutical compositions, and wherein the enclosed volume
within the package exhibits a Relative Humidity of from 20% to 40%.
Regarding claims 1 and 10, Box teaches applicant’s long acting beta 2 adrenergic agonist vilanterol both generically (compound of formula I) and specifically, see abstract; Figures 1-4 for XRPD; see columns 1-4; column 4, line 58-59; claims 1-25.
Box exemplifies vilanterol as a preferred compound, see column 9, lines 38-45; see also Figures 1-4 for XRPD of vilanterol (especially Figure 1 for XRPD data for the triphenylacetate salt), and see claim 4 where vilanterol is 1 of 6 exemplified/preferred compounds.
Box teaches that compounds of formula I are combined with other compounds such as corticosteroids (columns 11-12; column 15, lines 10-13; and claim 7), preferably fluticasone propionate, see column 12, lines 4-5.
Box teaches the use of excipients such as lactose for use with compounds of formula I as inhaled dry powders, see column 17, line 35 to line 67; column 18, lines 32-39. See also column 17, line 35 bridging to column 18, line 31.
Box teaches that its claimed compound of formula I (such as vilanterol) is administered by (dry powder inhaler) DPI devices, column 17, lines 35-67.4
While Box teaches the claimed drug products/combination, a long acting beta 2 adrenergic receptor agonist drug (vilanterol) with an inhaled corticosteroid (fluticasone) of claim 15, it does not specifically recite sachets of desiccant (silica gel) in packaging with the claimed relative humidity.
Although Box teaches such a combination in the claimed DPI device and in a package as claimed with a hygroscopic material, it does not explicitly teach the claimed desiccant packet, in a packaging with the claimed relative humidity. However, use of desiccants such as silica gel in sachet packets, enclosed in packaging with DPIs administering inhaled drugs at the claimed relative humidity are known in the art as per Taylor and Portier.
Regarding the limitations of claims 1 and 10, i.e., a hygroscopic material, Taylor, discloses a package (a "sachet") for a medicament powder that comprises a desiccant such as silica gel, teaches that the preferred level of moisture content varies from medicament to medicament, and expressly suggests determining the optimal moisture content for a given medicament using routine laboratory testing (Abstract and page 6). A preferred medicament powder comprises a fluticasone ester (page 22, 2nd full paragraph), thus furoate esters are obvious. Taylor teaches that packaging the medicament powder can prevent an egress of moisture into the powder, which may lead to undesirable changes to the medicament such as degradation of the medicament, increase in particle size, or adherence of the particles to the walls of the carrier device resulting in reduced uptake via inhalation by the patient (page 2, 1st paragraph). Taylor teaches that the desiccant (i.e. moisture control agent) is partially hydrated, see abstract. It is noted that neither Box or Taylor teaches a container system with moisture control capacity as claimed.
Portier teaches a container system with moisture control capacity; the vessel is designed to hold pharmaceutical products such as dry powder inhalers (DPI), where the vessel includes an outer vessel and a moisture control material (silica gel or clay) blended with a plastic material placed within the vessel, see claims 15 and 16), see abstract; and page 1, lines 10-30; see also claims 1-2.
Regarding claims 1 and 10 and the limitations of packaging with preferred relative humidity of between 20 and 40%, Portier teaches there are many products, which enhanced by the maintenance of pre-determined levels of relative humidity within containers for these products; including pharmaceutical products, such as dry powder inhalers (DPI), see page 1, lines 25-30.
Regarding claims 1 and 10, Portier teaches a preferred range of relative humidity for the moisture control material is between 5% relative humidity and 40% relative humidity, see page 9, lines 14-16. It is noted that Portier teaches a range that encompasses applicant’s claimed range with significant overlap that lie within the prior art range.5
Prior to the filing of the present patent application, it would have been prima facie obvious to a PHOSITA following the teachings of the Box to form a drug product comprising a dry powder inhalation device comprising vilanterol and fluticasone furoate, as modified by Taylor and Portier, into a dry powder inhaler (DPI), with humectant/desiccant type powder in packaging to retain moisture in the claimed relative humidity of 20-40%. The PHOSITA would have a reasonable expectation of success as it would have been prima facie obvious to arrive at the combination of prior art elements (vilanterol/fluticasone drug combination in a DPI in packaging to retain the desired relative humidity).
Regarding claims 2-3 and the limitation of lactose excipient, Box teaches lactose as an excipient. See column 17, lines 35-42; column 18, lines 32-39.
Regarding claim 4 and the limitation of (I) vilanterol and (II) fluticasone furoate, as detailed above, these active ingredients are taught by Box as detailed above, see rejection of claim 1.
Regarding claims 5-6 that discloses a desiccant such as silica gel in an enclosure, Taylor discloses a package (a "sachet") for a medicament powder that comprises a desiccant such as silica gel, teaches that the preferred level of moisture content varies from medicament to medicament, and expressly suggests determining the optimal moisture content for a given medicament using routine laboratory testing (Abstract and page 6). See also Portier that teaches silica gel and clay as moisture control substances. Regarding the presence of silica gel within an enclosure, Taylor teaches that packaging the medicament powder can prevent an egress of moisture into the powder, (page 2, 1st paragraph). Taylor teaches that its desiccant (i.e. moisture control agent) is partially hydrated, see abstract. A PHOSITA would routinely optimize silica gel as a desiccant in the enclosure (packaging of Taylor and silica gel of Portier) with silica gel is present in such an enclosure.
Regarding claim 7 wherein the silica gel is present within a packet, Taylor discloses a package (a "sachet") for a medicament powder that comprises a desiccant such as silica gel, teaches that the preferred level of moisture content varies from medicament to medicament, and expressly suggests determining the optimal moisture content for a given medicament using routine laboratory testing (Abstract and page 6).
Regarding claims 8-9 and the limitations of unit-dose and multi-dose devices, Box teaches the use of unit-dose or multi-dose containers for drug formulations. See column 17, lines 26-27.
Claim 15 is directed to a process of producing a drug product comprising:
subjecting a hygroscopic material to moisture exposure sufficient to attain
a predetermined relative humidity;
combining the hygroscopic material with a dry powder inhalation device containing one or more pharmaceutical compositions therein, wherein the one or more pharmaceutical compositions comprise active ingredients
(I), vilanterol or a salt thereof, and
(II) (fluticasone furoate or a solvate thereof; wherein each of the active ingredients (I) and (II) are present in the same or different pharmaceutical compositions, and
enclosing the dry powder inhalation device and hygroscopic material within a package to define an enclosed volume therein forming a drug product and wherein the hydration level of the hygroscopic material is such that enclosed volume has a Relative Humidity of from 20% to 40%.
Regarding claim 15 and the process of producing a drug product by subjecting a hygroscopic material to attain sufficient relative humidity, as Portier teaches the preferred and claimed relative humidity, see page 9, lines 14-16, a PHOSITA would routinely optimize the sufficient relative humidity as claimed. Further, regarding the claimed step of combining the hygroscopic material with a dry powder device and enclosing the dry powder inhalation device and hygroscopic material within a package with the claimed relative humidity, as detailed above, the combined teachings of Box, Taylor and Portier teach the elements of the drug product, a PHOSITA would routinely optimize the art teachings into a process of producing the claimed drug product.
Regarding claim 17 and the hygroscopic packet in a packet, and claim 19 where the desiccant is silica gel or clay, Taylor discloses a package (a "sachet") for a medicament powder that comprises a desiccant such as silica gel, teaches that the preferred level of moisture content varies from medicament to medicament, and expressly suggests determining the optimal moisture content for a given medicament using routine laboratory testing (Abstract and page 6). See also Portier that teaches silica gel and clay as moisture control substances.
Regarding claims 20-21 wherein the packet is loose within the drug product or fixed, Portier teaches where the moisture control substance (such as silica gel or clay), is placed within an outer vessel, i.e., the drug product packaging. See abstract. As there are limited alternatives to place the packet loose within the drug product, or fix it with respect to the inhalation device, a PHOSITA would routinely optimize packets of desiccant as being loose within the drug product or fixed within the drug product, with respect to the inhalation device within, claim 20 is obvious per the teachings of Portier.
Regarding 22 directed to a drug product produced by the process of claim 15, as claim 22 is product by process claim producing a drug product identical to the drug product of claim 1, regardless of the process limitations to produce it, claim 15 is rendered obvious by the teachings of Box, Taylor and Portier.
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 1-10 and 15, 17, 19-22 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-27 of US 11116721 B2 in view of Taylor et al. (WO 01/98174, published December 27, 2001 - cited on applicant’s IDS dated 02/26/2013) and Portier et al. (WO 2008/135570, published November 13, 2008 - cited by applicant on IDS).
Claims 1, 10 and 22 are generally directed to a drug product comprising a dry powder inhaler comprising vilanterol and fluticasone furoate; hygroscopic material, a package encompassing the device and hygroscopic material, where the volume in the package exhibits a RH of from 20% to 40 %.
Regarding claims 1, 10 and 22, the conflict patent discloses a pharmaceutical product. See claims 1 and 12.
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As per claims 1, 10 and 22, Portier teaches the use of DPI devices, where the claimed vilanterol and fluticasone combination would be dispensed from, see page 1, lines 25-30.
Regarding the limitations of claims 1, 10 and 22, i.e., a hygroscopic material, Taylor, however, discloses a package (a "sachet") for a medicament powder that comprises a desiccant such as silica gel, teaches that the preferred level of moisture content varies from medicament to medicament, and expressly suggests determining the optimal moisture content for a given medicament using routine laboratory testing (Abstract and page 6). A preferred medicament powder comprises a fluticasone ester (page 22, 2nd full paragraph). Taylor teaches that packaging the medicament powder can prevent an egress of moisture into the powder, which may lead to undesirable changes to the medicament such as degradation of the medicament, increase in particle size, or adherence of the particles to the walls of the carrier device resulting in reduced uptake via inhalation by the patient (page 2, 1st paragraph). Taylor teaches that the desiccant (i.e. moisture control agent) is partially hydrated, see abstract.
Portier teaches a container system with moisture control capacity; the vessel is designed to hold pharmaceutical products such as dry powder inhalers (DPI), where the vessel includes an outer vessel and a moisture control material (silica gel or clay) blended with a plastic material placed within the vessel, see claims 15 and 16), see abstract; and page 1, lines 10-30; see also claims 1-2.
Regarding claims 1, 10 and 22 and the limitations of packaging with preferred relative humidity of between 20 and 40%, Portier teaches there are many products, which enhanced by the maintenance of pre-determined levels of relative humidity within containers for these products; including pharmaceutical products, such as dry powder inhalers (DPI), see page 1, lines 25-30.
Regarding claims 1, 10 and 22, Portier teaches a preferred range of relative humidity for the moisture control material is between 5% relative humidity and 40% relative humidity, see page 9, lines 14-16. It is noted that Portier teaches a range that encompasses applicant’s claimed range with significant overlap that lie within the prior art range.6
Prior to the filing of the present patent application, it would have been prima facie obvious to a PHOSITA following the teachings of US 11116721 to form a drug product comprising a dry powder inhalation device comprising vilanterol and fluticasone furoate, as modified by the secondary and tertiary references, Taylor and Portier, into a dry powder inhaler (DPI), with humectant/desiccant type powder in packaging to retain moisture in the claimed relative humidity of 20-40%. The PHOSITA would have a reasonable expectation of success as it would be obvious to arrive at the combination of prior art elements (vilanterol/fluticasone drug combination in a DPI in packaging to retain the desired relative humidity) according to known methods to predictably arrive at the instantly claimed subject matter.
Regarding claims 2-3 and the limitation of lactose excipient, the conflict patent teaches lactose as an excipient. See claims 1 and 12.
Regarding claim 4 and the limitation of (I) vilanterol and (II) fluticasone furoate, as detailed above, these active ingredients are taught by the conflict patent as detailed above, see above rejection of claim 1.
Regarding claims 5-6 that discloses a desiccant such as silica gel in an enclosure, Taylor discloses a package (a "sachet") for a medicament powder that comprises a desiccant such as silica gel, teaches that the preferred level of moisture content varies from medicament to medicament, and expressly suggests determining the optimal moisture content for a given medicament using routine laboratory testing (Abstract and page 6). See also Portier that teaches silica gel and clay as moisture control substances. Regarding the presence of silica gel within an enclosure, Taylor teaches that packaging the medicament powder can prevent an egress of moisture into the powder, (page 2, 1st paragraph). Taylor teaches that its desiccant (i.e. moisture control agent) is partially hydrated, see abstract. A PHOSITA would routinely optimize silica gel as a desiccant in the enclosure (packaging of Taylor and silica gel of Portier) with silica gel is present in such an enclosure.
Regarding claim 7 wherein the silica gel is present within a packet, Taylor discloses a package (a "sachet") for a medicament powder that comprises a desiccant such as silica gel, teaches that the preferred level of moisture content varies from medicament to medicament, and expressly suggests determining the optimal moisture content for a given medicament using routine laboratory testing (Abstract and page 6).
Regarding claims 8-9 and the limitations of unit-dose and multi-dose devices, Taylor teaches the use of unit-dose or multi-dose containers for drug formulations. See page 3, lines 8-11.
Claim 15 is directed to a process of producing a drug product comprising:
subjecting a hygroscopic material to moisture exposure sufficient to attain
a predetermined relative humidity;
combining the hygroscopic material with a dry powder inhalation device containing one or more pharmaceutical compositions therein, wherein the one or more pharmaceutical compositions comprise active ingredients
(I), vilanterol or a salt thereof, and
(II) (fluticasone furoate or a solvate thereof; wherein each of the active ingredients (I) and (II) are present in the same or different pharmaceutical compositions, and
enclosing the dry powder inhalation device and hygroscopic material within a package to define an enclosed volume therein forming a drug product and wherein the hydration level of the hygroscopic material is such that enclosed volume has a Relative Humidity of from 20% to 40%.
Regarding claim 15 and the process of producing a drug product by subjecting a hygroscopic material to attain sufficient relative humidity, as Portier teaches the preferred and claimed relative humidity, see page 9, lines 14-16, it would a PHOSITA would routinely optimize the sufficient relative humidity as claimed. Further, regarding the claimed step of combining the hygroscopic material with a dry powder device and enclosing the dry powder inhalation device and hygroscopic material within a package with the claimed relative humidity, as detailed above, the combined teachings of the conflict patent, Taylor and Portier teach the elements of the drug product, a PHOSITA would routinely optimize the art teachings into a process of producing the claimed drug product.
Regarding claim 17 and the hygroscopic packet in a packet, and claim 19 where the desiccant is silica gel or clay, Taylor discloses a package (a "sachet") for a medicament powder that comprises a desiccant such as silica gel, teaches that the preferred level of moisture content varies from medicament to medicament, and expressly suggests determining the optimal moisture content for a given medicament using routine laboratory testing (Abstract and page 6). See also Portier that teaches silica gel and clay as moisture control substances.
Regarding claims 20-21 wherein the packet is loose within the drug product or fixed, Portier teaches where the moisture control substance (such as silica gel or clay), is placed within an outer vessel, i.e., the drug product packaging. See abstract. As there are limited alternatives to place the packet loose within the drug product, or fix it with respect to the inhalation device, a PHOSITA would routinely optimize packets of desiccant as being loose within the drug product or fixed within the drug product, with respect to the inhalation device within, claim 20 is obvious per the teachings of Portier.
Regarding 22 directed to a drug product produced by the process of claim 15, as claim 22 is product by process claim producing a drug product identical to the drug product of claim 1, regardless of the process limitations to produce it, claim 15 is rendered obvious by the teachings of the conflict patent, Taylor and Portier.
Conclusion and Correspondence
In summary, no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a CON of 16/829,484 03/25/2020 ABN
16/829,484 is a CON of 13/819,184 02/26/2013 ABN
13/819,184 is a 371 of PCT/EP2011/065056 08/31/2011
PCT/EP2011/065056 has PRO 61/378,412 08/31/2010
2 4-{(1 R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino ]-1-hydroxyethyl}-2-(hydroxymethyl)phenol
3 (6α, 11β, 16α, 17α)-6,9-difluoro-17-{[(fluoromethyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1 ,4-dien-17-yl 2- furancarboxylate
4 See also dry powder compositions of vilanterol in capsules and cartridges (gelatin or blisters of laminated aluminum foil for use in inhaler); unit dose administration of DPI medicament packs (disk shape or elongated strip, DISKHALERTM and DISKUSTM); DPI bulk reservoir inhalation device (TURBUHALERTM); and metered doses of a DPI composition (ROTOHALERTM), Id.
5 Per 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). Therefore, a prima facie case of obviousness has been established in light of the prior art as the claimed range (20-40% versus 5 to 40% of Portier), overlaps or lies within that of the cited reference.
6 Per 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). Therefore, a prima facie case of obviousness has been established in light of the prior art as the claimed range (20-40% versus 5 to 40% of Portier), overlaps or lies within that of the cited reference.