DETAILED ACTION
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 .
Claim(s) 1-10 is/are currently pending. Claim(s) 1-10 is/are currently amended. Claim 11 was cancelled. Claim(s) 1-10 is/are presently under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement (IDS)
Please also note, the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered (see e.g. Specification, [0008], [0056], [0062] et al.)
Drawings
The drawings were received on October 02, 2023. These drawings are accepted.
Specification & Claim Objections
The claims and/or disclosure is objected to because of the following informalities:
The use of the term(s) “LESCO”, “LEICA”, “GraphPad” and/or “Prism”, “ImageJ” and/or “Fiji”, which is/are trade names or a marks used in commerce, have been noted in this application. The term(s) should be accompanied by the generic terminology; furthermore the term(s) should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term(s).
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim 1 appears to contain typographical and/or grammatical error(s). Claim 1 recites the limitation "A method for treating bedsores, comprising administering a pharmaceutical composition comprises an effective amount of mangosteen fruit shell extract to a subject suffering from bedsores". Appropriate correction is required.
The above are considered necessary grammatical corrections; however, is not exhaustive of all possible informalities, as examination is not made for the purpose of securing grammatical perfection.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang, et al. (U.S. Patent No. 10,383,906 B2) in view of Bhattacharya, et al., “Pressure ulcers: Current understanding and newer modalities of treatment.” Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16.
The instant claim(s) is/are of record, drawn to the following: a method for treating bedsores comprising administering a pharmaceutical composition wherein the composition comprises an effective amount of mangosteen fruit shell extract.
Chang, et al. teaches use of mangosteen rind extract in preparation of medicine for treating skin diseases. Chang, et al. teaches “skin diseases” may comprise inflammatory diseases or conditions, bullous dermatosis, contact dermatitis, hypertrophic scarring, keloid formation, and scleroderma (Specification, col. 1, lines 32-39 & col. 3, lines 58-67 and col. 4, lines 1-39). Chang, et al. teaches administering a pharmaceutical composition comprising an effective amount of extract of mangosteen rind for treating an inflammatory disorder (see Whole Document; Specification, col. 2, lines 29-32) (broadly teaching an effective amount of mangosteen fruit shell extract, as required in claim(s) 1-10). Chang, et al. teaches the mangosteen fruit shell extract is a water and/or alcohol extract (Specification, col. 2, lines 47-49) (as required in claim 2). Chang, et al. teaches wherein the mangosteen fruit shell is the outer and/or inner shell of the mangosteen fruit shell (Specification, col. 2, lines 53-61) (as required in claim(s) 3-4). Chang, et al. teaches wherein the mangosteen fruit extract comprises α-mangostin and γ-mangostin (Specification, col. 3, lines 18-20) (as required in claim 5). Chang, et al., teaches wherein the composition is an external parenteral preparation (Specification, col. 3, lines 13-17) (as required in claim(s) 6-7). Chang, et al. teaches wherein the effective amount is 0.5% w/w to 10% w/w; 1% w/w to 8% w/w; and 1.25% w/w to 5% w/w (Specification, Examples 1-2; FIGs. 1-5) (broadly teaching claim(s) 8-10).
Chang, et al. is silent as to treatment of bedsores.
However, Bhattacharya, et al. teaches severity (grading) of pressure ulcers including: Grade-I (damage resulting in discoloration, pain and/or itchy skin); Grade-II (damage leading to skin loss that looks like an open wound or blister); Grade-III (damage appearing as a deep cavity like wound); and Grade-IV (damage resulting in tissue necrosis with possible infection) (pages 7-8; Table 2). Bhattacharya, et al. further teaches chronic pressure ulcers (i.e. bed sores) display high levels of inflammation (page 11).
It would have been obvious to one of person of ordinary skill in the art at
the time of the instant invention effective filing to have modified the use of mangosteen rind extract for treating skin diseases (i.e. inflammatory conditions) as taught by Chang, et al. for treating bed sores. A person of ordinary skill in the art would have been motivated to use a composition comprising mangosteen rind extract for treating bed sores, particularly where it was known in the art that bed sores are associated with ulceration of the skin resulting in inflammation and/or infection; thus, treatment of bed sores would involve treating the underlying inflammation and/or infection.
A person of ordinary skill in the art would have had a reasonable expectation of success for using mangosteen rind extract for treating bed sores, particularly where the same underlying mechanisms are involved (i.e. skin inflammation), as instantly claimed. Thus, it would have been obvious to a person of ordinary skill in the art to combine the teachings of the references to arrive at the instantly claimed invention(s) with a reasonable expectation of success.
The references is/are relied upon for the reasons discussed above. If not expressly taught by the references, based on the overall beneficial teaching provided by the references with respect to the ingredients of the composition(s) and/or method(s) of making and/or using disclosed therein, the adjustments of particular conventional working conditions (E.g. the percent by weight of each ingredient in the claimed compositions) in which to perform such method is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Thus, absent some demonstration of unexpected results or criticality from the claimed parameters, this optimization would have been obvious before the effective filing date of applicant’s claimed invention.
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 at the time the invention was filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within recited processes), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
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.
Claim(s) 1-10 is/are rejected on the ground of non-statutory double patenting as being unpatentable over claim(s) 1-8 of U.S. Patent No. 10,383,906 B2 (‘906 reference patent) in view of Bhattacharya, et al., “Pressure ulcers: Current understanding and newer modalities of treatment.” Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16.
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant 18,553,575 (instant ‘575) application is broadly drawn to a method for treating bedsores comprising administering a pharmaceutical composition wherein the composition comprises an effective amount of mangosteen fruit shell extract.
However, the ’906 reference patent is not patentably distinguishable from the instant ‘575 application, wherein the ‘906 reference patent recites a method comprising administering a pharmaceutical composition comprising an effective amount of mangosteen fruit shell extract to a subject suffering from skin diseases. (broadly teaching a method for treating inflammatory skin conditions (i.e. bed sores) ‘906 at claims 1-8).
The ‘906 reference patent is/are silent as to wherein the method is for treating bedsores. However, Bhattacharya, et al. teaches chronic pressure ulcers (i.e. bed sores) display high levels of inflammation (page 11) and that there is/are a severity (grading) of pressure ulcers including: Grade-I (damage resulting in discoloration, pain and/or itchy skin); Grade-II (damage leading to skin loss that looks like an open wound or blister); Grade-III (damage appearing as a deep cavity like wound); and Grade-IV (damage resulting in tissue necrosis with possible infection) (pages 7-8; Table 2).
Accordingly, it would have been obvious to one skilled in the art to combine the teachings of the reference patent(s) to produce the instant method for treating bedsores comprising administering a pharmaceutical composition wherein the composition comprises an effective amount of mangosteen fruit shell extract of the instant ‘575 application.
A person of ordinary skill in the art would have been motivated to combine the references because although the claims at issue are not identical, both sets of claims are drawn to treating inflammatory skin conditions with mangosteen fruit shell extract. Accordingly, practicing one invention would at least render obvious the other as claimed.
Claim 1-10 is/are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim(s) 1-11 of co-pending Application No. US 2024/0197803 A1 (co-pending ‘803 application) in view of Bhattacharya, et al., “Pressure ulcers: Current understanding and newer modalities of treatment.” Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16.
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant 18,553,575 (instant ‘575) application is broadly drawn to a method for treating bedsores comprising administering a pharmaceutical composition wherein the composition comprises an effective amount of mangosteen fruit shell extract.
The co-pending ‘803 application is not patentably distinguishable from the instant ‘575 application, wherein the co-pending ‘803 application broadly recites a method comprising administering a pharmaceutical composition comprising an effective amount of mangosteen fruit shell extract to a subject suffering from psoriasis, a chronic inflammatory skin-related disease (broadly teaching a method for treating inflammatory skin conditions (i.e. bed sores) ‘803 at claims 1-11).
The ‘803 reference patent is/are silent as to wherein the method is for treating bedsores. However, Bhattacharya, et al. teaches chronic pressure ulcers (i.e. bed sores) display high levels of inflammation (page 11) and that there is/are a severity (grading) of pressure ulcers including: Grade-I (damage resulting in discoloration, pain and/or itchy skin); Grade-II (damage leading to skin loss that looks like an open wound or blister); Grade-III (damage appearing as a deep cavity like wound); and Grade-IV (damage resulting in tissue necrosis with possible infection) (pages 7-8; Table 2).
Accordingly, it would have been obvious to one skilled in the art to combine the teachings of the reference patent(s) to produce the instant method for treating bedsores comprising administering a pharmaceutical composition wherein the composition comprises an effective amount of mangosteen fruit shell extract of the instant ‘575 application.
A person of ordinary skill in the art would have been motivated to combine the references because although the claims at issue are not identical, both sets of claims are drawn to treating inflammatory skin conditions with mangosteen fruit shell extract. Accordingly, practicing one invention would at least render obvious the other as claimed.
This is a provisional non-statutory double patenting rejection.
Claim 1-10 is/are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim(s) 1-11 of co-pending Application No. US 2024/0358787 A1 (co-pending ‘787 application) in view of Bhattacharya, et al., “Pressure ulcers: Current understanding and newer modalities of treatment.” Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16.
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant 18,553,575 (instant ‘575) application is broadly drawn to a method for treating bedsores comprising administering a pharmaceutical composition wherein the composition comprises an effective amount of mangosteen fruit shell extract.
The co-pending ‘787 application is not patentably distinguishable from the instant ‘575 application, wherein the co-pending ‘787 application broadly recites a method comprising administering a pharmaceutical composition comprising an effective amount of mangosteen fruit shell extract to a subject to promote wound healing in diabetes (broadly teaching a method for treating inflammatory skin conditions (i.e. bed sores) ‘787 at claims 1-11).
The ‘803 reference patent is/are silent as to wherein the method is for treating bedsores. However, Bhattacharya, et al. teaches chronic pressure ulcers (i.e. bed sores) display high levels of inflammation (page 11) and that there is/are a severity (grading) of pressure ulcers including: Grade-I (damage resulting in discoloration, pain and/or itchy skin); Grade-II (damage leading to skin loss that looks like an open wound or blister); Grade-III (damage appearing as a deep cavity like wound); and Grade-IV (damage resulting in tissue necrosis with possible infection) (pages 7-8; Table 2).
Accordingly, it would have been obvious to one skilled in the art to combine the teachings of the reference patent(s) to produce the instant method for treating bedsores comprising administering a pharmaceutical composition wherein the composition comprises an effective amount of mangosteen fruit shell extract of the instant ‘575 application.
A person of ordinary skill in the art would have been motivated to combine the references because although the claims at issue are not identical, both sets of claims are drawn to treating inflammatory skin conditions with mangosteen fruit shell extract. Accordingly, practicing one invention would at least render obvious the other as claimed.
This is a provisional non-statutory double patenting rejection.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vani G. Verkhovsky whose telephone number is (571)272-3777. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm EST.
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/V.G.V./Examiner, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655