DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This application is a domestic application, filed 11 Oct 2023; and claims benefit as a CON of 17/380,900, filed 20 July 2021, issued as Patent 11,819,486; which claims benefit as a CON of 16/689,689, filed 20 Nov 2019, issued as Patent 11,103,476; which claims benefit as a CON of 14/928,369, filed 30 Oct 2015, issued as Patent 10,525,028; which claims benefit as a CON of 14/117,330, which is the 371 of PCT/JP2012/062114, filed 11 May 2012, issued as Patent 9,220,702; and claims benefit of foreign priority document JAPAN 2011-107512, filed 12 May 2011. This foreign priority document is not in English.
Claims 1-14 are pending in the current application and are examined on the merits herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 14/117330, filed on 12 Nov 2013.
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.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-7 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Horrobin et al. (US 6,177,470, issued 23 Jan 2001, provided by Applicant in IDS filed 11 Oct 2023).
Horrobin et al. teaches the use of gamma-linolenic acid (GLA) or dihomo-gamma-linolenic acid (DGLA) as their ascorbic-6-acid esters, referred to as Ascorbyl GLA and Ascorbyl DGLA, as medicaments for the purpose of treating conditions including rheumatoid arthritis, osteoarthritis, dermatitis and other inflammatory disorders. Uses also extend to cosmetic or skin care preparations (column 1, line 65 to column 2, line 20), meeting limitations of claims 1 and 7. The examined application at paragraph 44 as published states “The DGLA to be used for the purpose of the present invention may take on any form that contains it as a constituent fatty acid”, therefore the Ascorbyl DGLA of Horrobin et al. is interpreted to be a form of DGLA as claimed. The esters may be applied topically in creams, ointments, lotions, emulsions, pessaries, suppositories, sticks or other appropriate forms in which the compound is present in a concentration of 0.001% to 50%, preferably 0.1% to 20% and very preferably 1% to 10% by weight (column 2, lines 35-40), meeting limitations of claim 6. A particular appropriate formulation is for the ester to be dissolved or dispersed in free fatty acids or triglycerides in which one or more of GLA, DGLA and/or the further anti-inflammatory fatty acid EPA is an important constituent preferably 5% or more by weight (column 2, lines 45-50), meeting limitations of claims 2-3.
Regarding claim 2 reciting “wherein the dihomo-y-linolenic acid (DGLA) is in the form of any one of …”, claim 1 recites the open transitional phrase “comprising” therefore the claim is interpreted to be open to inclusion of additional DGLA in other forms such as the Ascorbyl DGLA disclosed in Horrobin et al.
Regarding claims 4-5, the claims recite further limitations of particular forms of the DGLA but do not require the DGLA to be these particular forms, therefore the claims are interpreted to encompass DGLA in the form of the glyceride or the free fatty acid as disclosed in Horrobin et al.
Therefore the disclosure of Horrobin et al. taken as a whole would have led one of ordinary skill in the art to the disclosed method meeting all structural limitations of claims 1-7.
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 negated 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 8-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Horrobin et al. (US 6,177,470, issued 23 Jan 2001, provided by Applicant in IDS filed 11 Oct 2023) as applied to claims 1-7 above, in view of Perricone (US 6,296,861, issued 02 Oct 2001, cited in PTO-892).
Horrobin et al. teaches as above.
Horrobin et al. does specifically disclose the type of dermatitis and other inflammatory disorders treated (claim 8). Horrobin et al. does specifically disclose the composition is applied continuously for at least 7, 10, or 14 consecutive days (claims 9-13). Horrobin et al. does specifically disclose the treatment suppresses the itch of the inflammatory disease (claim 14).
Perricone teaches a combination of conjugated linoleic acid and fatty acid esters of ascorbic acid is topically applied to treat skin damage, such as contact dermatitis, atopic dermatitis, xerosis, eczema, rosacea, seborrhea, psoriasis, thermal and radiation burns, other types of skin inflammation, and aging (abstract). Perricone teaches early suggestions for dealing with aging effects in skin were predominantly aimed at lubrications and emollients through use of topical compositions containing soothing agents, e.g., as exemplified by commercial hand lotion products and the like (column 2, lines 45-50). Perricone teaches generally in the practice of methods of the invention, the composition is topically applied to the affected skin areas in a predetermined or as-needed regimen either at intervals by application of a lotion or the like, it generally being the case that gradual improvement is noted with each successive application (column 5, lines 55-65).
It would have been obvious to one of ordinary skill in the art before the time of the invention to combine Horrobin et al. in view of Perricone in order to select the type of dermatitis and other inflammatory disorders treated and to select the optimum application regimen through routine experimentation. One of ordinary skill in the art would have been motivated to combine Horrobin et al. in view of Perricone with a reasonable expectation of success because both Horrobin et al. and Perricone are drawn to treatment of types of skin inflammation such as dermatitis comprising topical administration of a composition including fatty acid esters of ascorbic acid and a compound structurally related to linoleic acid, suggesting it would have been obvious to select the type of dermatitis and other inflammatory disorders treated to be contact dermatitis, atopic dermatitis, or psoriasis. Regarding the treatment regimen and the number of consecutive days applied, Perricone teaches generally the composition is topically applied to the affected skin areas in a predetermined or as-needed regimen either at intervals by application of a lotion or the like, it generally being the case that gradual improvement is noted with each successive application, suggesting it would have been routine experimentation by one of ordinary skill in the art to determine the optimum regimen based on the gradual improvement from successive applications. Regarding the treatment suppressing the itch of the inflammatory disease, one of ordinary skill in the art would have expected that treating the underlying inflammatory disease would suppress its symptoms such as itching as Perricone teaches commercial hand lotion products provide soothing treatment.
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,220,702.
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 1-8 and 11 of the reference patent are drawn to a method for treating inflammatory disease comprising administering topically, to the skin of a patient in need thereof, an effective amount of a composition consisting of dihomo-γ-linolenic acid (DGLA) in the form of a free fatty acid, a composition base, and optional components, meeting limitations of claims 1-2. Reference claims 9-10 are drawn to a method of suppressing itch of an inflammatory disease comprising administering topically, to the skin of a patient in need thereof, an effective amount of dihomo-γ-linolenic acid (DGLA) in the form of a free fatty acid, meeting limitations of claims 1-2 and 14. Reference claim 2 and 6 recites the composition contains 0.05 to 10 wt % or 0.05 to 7 wt % of the dihomo-γ-linolenic acid (DGLA), meeting limitations of claim 6, 9-13. Reference claims 3-4 recite diseases which correspond to claims 7-8. Reference claims 7-8 recite the composition is applied continuously for at least 10 or 14 consecutive days to an area affected by the inflammatory disease, meeting limitations of claims 9-13.
Regarding claims 4-5, the claims recite further limitations of particular forms of the DGLA but do not require the DGLA to be these particular forms, therefore the claims are interpreted to encompass DGLA in the form of the free fatty acid.
Therefore reference claims 1-11 of the reference patent would lead one of ordinary skill in the art to readily envision each and every limitation of the method of claims 1-14.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,525,028.
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 1-9 of the reference patent are drawn to a method of suppressing an itch of inflammatory disease comprising administering topically, to the skin of a patient in need thereof, an effective amount of dihomo-γ-linolenic acid (DGLA), addressing limitations of claims 1, and 9-14. Reference claims 2-5 recite the form of the DGLA corresponding to claims 2-5. Reference claim 6 recites the composition contains 0.01 to 50 wt % of the dihomo-γ-linolenic acid (DGLA), corresponding to claim 6 and 9-13. Reference claims 7-8 recite diseases which correspond to claims 7-8. Reference claims 7-8 recite the composition is applied continuously for at least 10 or 14 consecutive days to an area affected by the inflammatory disease, meeting limitations of claims 9-13.
Reference claims 1-9 do not specifically recite the administered composition comprising 0.05 to 10 wt % or 0.05 to 7 wt % of the DGLA (claims 10-11)
It would have been obvious to one of ordinary skill in the art before the time of the invention to modify Reference claims 1-9 in order to select the optimum concentration of the DGLA administered through routine experimentation. One of ordinary skill in the art would have been motivated to modify Reference claims 1-9 with a reasonable expectation of success because Reference claim 6 recites the composition contains 0.01 to 50 wt % of the dihomo-γ-linolenic acid (DGLA), and Reference claims 7-8 recite the treatment of the same diseases as claimed, suggesting it would have been routine experimentation for one of ordinary skill in the art to determine the optimum concentration of the DGLA administered in order to treat the same diseases as claimed within the scope of Reference claims 1-9.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,103,476 in view of Perricone (US 6,296,861, issued 02 Oct 2001, cited in PTO-892).
Reference claims 1-7 of the reference patent are drawn to a method of keeping skin in healthy condition, comprising administering topically, to the skin of a human, an effective amount of dihomo-γ-linolenic acid (DGLA) as an active ingredient in a cosmetic product, wherein the DGLA is applied continuously for at least 14 consecutive days to the skin. Reference claims 2-5 recite the form of the DGLA and correspond to claims 2-6. Reference claims 6 recite the DGLA is administered in a composition containing 0.01 to 50 wt % of the DGLA, corresponding to claim 6.
Reference claims 1-7 do not specifically recite the method for treating inflammatory disease (claim 1).
Perricone teaches as above. Perricone further teaches skin inflammation and aging are closely related phenomena. So similar are the processes involved with both, that aging is sometimes described dermatologically as a chronic low grade inflammatory condition (column 1, lines 25-30).
It would have been obvious to one of ordinary skill in the art before the time of the invention to combine Reference claims 1-7 in view of Perricone in order to select the treatment of dermatitis and other inflammatory disorders and to select the optimum concentration of the DGLA administered through routine experimentation. One of ordinary skill in the art would have been motivated to combine Reference claims 1-7 in view of Perricone with a reasonable expectation of success because both Reference claims 1-7 and Perricone are drawn to treatment the skin comprising topical administration of a composition including a compound structurally related to linoleic acid, and Perricone further teaches skin inflammation and aging are closely related phenomena and teaches treatment of known skin inflammation diseases using the same agent, suggesting it would have been obvious to select the method of keeping skin in healthy condition to include treatment of both particular skin inflammation diseases and aging. Regarding the concentration of the DGLA administered, Reference claim 6 recites the composition contains 0.01 to 50 wt % of the dihomo-γ-linolenic acid (DGLA), and Perricone teaches generally the composition is topically applied to the affected skin areas in a predetermined or as-needed regimen, suggesting it would have been routine experimentation to select the optimum concentration of the DGLA. Regarding the treatment suppressing the itch of the inflammatory disease, one of ordinary skill in the art would have expected that treating the underlying inflammatory disease would suppress its symptoms such as itching as Perricone teaches commercial hand lotion products provide soothing treatment.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,819,486.
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 1-9 of the reference patent are drawn to a method of treating inflammatory disease comprising administering topically, to the skin of a patient in need thereof, an effective amount of dihomo-γ-linolenic acid (DGLA), wherein the DGLA is applied continuously for at least 14 consecutive days to an area affected by the inflammatory disease, addressing limitations of claims 1, and 9-14. Reference claims 3-6 recite the form of the DGLA corresponding to claims 2-5. Reference claim 7 recites the composition contains 0.01 to 50 wt % of the dihomo-γ-linolenic acid (DGLA), corresponding to claim 6 and 9-13. Reference claims 8-9 recite diseases which correspond to claims 7-8.
Reference claims 1-9 do not specifically recite the administered composition comprising 0.05 to 10 wt % or 0.05 to 7 wt % of the DGLA (claims 10-11)
It would have been obvious to one of ordinary skill in the art before the time of the invention to modify Reference claims 1-9 in order to select the optimum concentration of the DGLA administered through routine experimentation. One of ordinary skill in the art would have been motivated to modify Reference claims 1-9 with a reasonable expectation of success because Reference claim 6 recites the composition contains 0.01 to 50 wt % of the dihomo-γ-linolenic acid (DGLA), and Reference claims 8-9 recite the treatment of the same diseases as claimed, suggesting it would have been routine experimentation for one of ordinary skill in the art to determine the optimum concentration of the DGLA administered in order to treat the same diseases as claimed within the scope of Reference claims 1-9.
Claim 10-11 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,819,486 in view of Perricone (US 6,296,861, issued 02 Oct 2001, cited in PTO-892).
Reference claims 1-9 of the reference patent teach as above.
Reference claims 1-9 do not specifically recite the administered composition comprising 0.05 to 10 wt % or 0.05 to 7 wt % of the DGLA (claims 10-11). Reference claims 1-9 do not specifically recite the treatment suppresses the itch of the inflammatory disease (claim 14).
Perricone teaches as above.
It would have been obvious to one of ordinary skill in the art before the time of the invention to combine Reference claims 1-9 in view of Perricone in order to select the treatment suppresses the itch of the inflammatory disease and to select the optimum concentration of the DGLA administered through routine experimentation. Regarding the treatment suppressing the itch of the inflammatory disease, one of ordinary skill in the art would have expected that treating the underlying inflammatory disease would suppress its symptoms such as itching as Perricone teaches commercial hand lotion products provide soothing treatment. Regarding the selection of the optimum concentration of the DGLA administered through routine experimentation, Reference claim 6 recites the composition contains 0.01 to 50 wt % of the dihomo-γ-linolenic acid (DGLA), Reference claims 8-9 recite the treatment of the same diseases as claimed, and Perricone teaches generally the composition is topically applied to the affected skin areas in a predetermined or as-needed regimen, suggesting it would have been routine experimentation for one of ordinary skill in the art to determine the optimum concentration of the DGLA administered in order to treat the same diseases as claimed within the scope of Reference claims 1-9.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693