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 . Claims 1-3, 5-8, 10, 13-14 and 16-18 are pending and examined below.
Response to Arguments
Applicant's arguments filed 09/05/2025 have been fully considered but they are not persuasive. Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 7-12) and that the dependent claims rise and fall with the same arguments (pages 12-15). Applicant's arguments are moot due to the additional reference applied to the newly added limitations, as detailed in the rejection below.
Claim Objections
Claim 1 objected to because of the following informalities: Claim 1 uses the abbreviation “CBD”. It is recommended to use the full name of the abbreviated word when first introduced to avoid ambiguity. Appropriate correction is required.
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.
Claims 1-3, 5-8, 13-14 and 16-18 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 1 recites the limitation "liner" in lined 3-4. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same or different from “padded liner” from line 1. For the purpose of examination, they are regarded as the same.
All dependent claims of claim 1 are likewise rejected.
Claims 13-14, & 16-18 recites the limitation "the limb liner" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “the limb liner” is the same or different from “a padded product”. For the purpose of examination, they are considered the same.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-8, 10, 13-14 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arbogast et al. (US 20050101693 A1) hereinafter, Arbogast, in view of Brooke et al. (US 6328992 B1) hereinafter, Brooke, and further in view of Hansen et al. (US 20220273671 A1) hereinafter, Hansen.
Regarding claim 1, Arbogast teaches a padded liner (Fig. 12, Arbogast) for a prosthetic limb (abstract, Arbogast), wherein said padded liner has an exposed surface that contacts skin of a person wearing said padded liner (¶0091, Arbogast), said liner comprising:
at least one layer (gel, Fig. 12, Arbogast) of a thermoplastic elastomer (¶0086, Arbogast) that contains a styrene block copolymer (¶0125, Arbogast) combined with an oil mixture (¶0127, Arbogast), wherein
said oil mixture (¶0127, Arbogast) contains a first volume of a plasticizing oil (mineral oil, ¶0074, Arbogast), and a second volume of CBD oil (medicaments, ¶0129, Arbogast).
Arbogast discloses that medicaments may be added to the cushioning material to avoid infection or heal sores (¶0129, Arbogast). He does not specify it to be CBD oil. However, Brooke teaches a transdermal structure provided for delivering cannabis chemical(s) to one's bloodstream (abstract, Brooke) wherein
at least one layer of a thermoplastic elastomer that contains a styrene block copolymer (col. 3 lines 37-42, Brooke) combined with an oil mixture (col. 2 lines 60-61 & col. 3, lines 31-36, Brooke), wherein said oil mixture contains a first volume of a plasticizing oil (mineral oil, col. 2 lines 60-61, Brooke), and a second volume of CBD oil (col 2 lines 47-52 & col. 3 lines 31-33, Brooke),
said CBD oil have a molecular weight of between 310 g/mol and 320 g/mol (300 to 350 gm/mol, col. 2 line 57, Brooke), and wherein
said CBD oil is in a concentration that supersaturates said thermoplastic elastomer causing said CBD oil to bloom out of said thermoplastic elastomer and continuously form microdroplets of CBD oil on said exposed surface over a prolonged period of time (col. 5 lines 52-58 & col. 7 lines 31-41, Brooke).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arbogast by incorporating the above teachings as taught by Brooke in order to allow for controlled delivery of the active chemicals, such that plasma levels of the chemicals may be controlled in a safe, convenient and effective manner for the patient (col. 1 lines 63-65, Brooke).
Arbogast in view of Brooke does not teach a molecular weight of plasticizing oil. However, Hansen teaches therapeutic compositions for peripheral neuropathy (¶0002, Hansen) wherein
said plasticizing oil have a molecular weight of between 310 g/mol and 320 g/mol (250 and 450 g/mol, ¶0087, Hansen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arbogast and Brooke by incorporating the molecular weight of plasticizing oil as taught by Hansen as it is an inert excipient for pharmaceutical compositions (¶0126, Hansen).
Regarding claims 2 & 13, Arbogast does not teach an oil mixture of said plasticizing oil and said CBD oil. However, Brooke teaches
wherein oil mixture of said plasticizing oil (col. 2 lines 60-61, Brooke) and said CBD oil (col. 6, lines 25-34, Brooke) comprises at least eighty percent by weight of the thermoplastic elastomer by weight (col. 3 lines 31-36, Brooke).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arbogast by incorporating the teaching above as taught by Brooke in order to permit easy migration of the preparation to the patient's skin (col. 3 lines 47-48, Brooke).
Regarding claim 3, Arbogast does not teach CBD oil comprises at least five percent of said thermoplastic polymer. However, Brooke teaches
wherein said CBD oil comprises at least five percent (col. 6 lines 48, Brooke) of said thermoplastic polymer by weight.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arbogast by incorporating the teaching above as taught by Brooke in order to have the most effective cannabis mixture (col. 6 lines 46-50, Brooke).
Regarding claim 5, Arbogast teaches
further including at least one flexible substrate (elastic fabric, Figs. 12 & 20a, Arbogast) bonded to said thermoplastic elastomer (gel, Fig. 12, Arbogast).
Regarding claims 6 & 16, Arbogast teaches
wherein said styrene block copolymer is selected from a group consisting of styrene-ethylene-butylene-styrene, styrene-ethylene- propylene-styrene, styrene-ethylene-ethylene/propylene- styrene, styrene-isobutylene-styrene, styrene-butadiene- styrene, styrene-isoprene-styrene, and combinations thereof (styrene isobutylene styrene, ¶0077, Arbogast).
Regarding claims 7 & 17, Arbogast teaches
wherein said styrene block copolymer has an average molecular weight in excess of 150,000 g/mol (10,000 to 200,000, ¶0077, Arbogast).
Regarding claims 8 & 18, Arbogast teaches
wherein said plasticizing oil is selected from a group consisting of paraffinic oils and mineral oils (mineral oil, ¶0074, Arbogast).
Regarding claim 10, Arbogast teaches
a padded product (Fig. 12, Arbogast) that is worn in contact with a person's skin (¶0091, Arbogast), comprising:
at least one soft elastomeric layer (gel, Fig. 12, ¶0086, Arbogast), wherein said soft elastomeric layer is a thermoplastic elastomer (¶0086, Arbogast) that contains a styrene block copolymer (¶0125, Arbogast), plasticizing oil (mineral oil, ¶0074, Arbogast), and CBD oil (medicaments, ¶0129, Arbogast);
a flexible substrate (elastic fabric, Figs. 12 & 20a, Arbogast) that covers at least one surface of said soft elastomer layer (gel, Fig. 12, Arbogast), where said thermoplastic elastomer is bonded to said flexible substrate (Fig. 12, Arbogast).
Arbogast discloses that medicaments may be added to the cushioning material to avoid infection or heal sores (¶0129, Arbogast). He does not specify it to be CBD oil. However, Brooke teaches
said soft elastomeric layer is a thermoplastic elastomer that contains a styrene block copolymer (col. 3 lines 37-42, Brooke), plasticizing oil (mineral oil, col. 2 lines 60-61, Brooke), and CBD oil (col 2 lines 47-52 & col. 3 lines 31-33, Brooke); wherein
said CBD oil have a molecular weight of between 310 g/mol and 320 g/mol (300 to 350 gm/mol, col. 2 line 57, Brooke), and wherein
said CBD oil is in a concentration that supersaturates said thermoplastic elastomer causing said CBD oil to migrate out of said thermoplastic elastomer and continuously form microdroplets of CBD oil on said at least one surface over a prolonged period of time (col. 5 lines 52-58 & col. 7 lines 31-41, Brooke).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arbogast by incorporating the teachings above as taught by Brooke in order to allow for controlled delivery of the active chemicals, such that plasma levels of the chemicals may be controlled in a safe, convenient and effective manner for the patient (col. 1 lines 63-65, Brooke).
Arbogast in view of Brooke does not teach a molecular weight of plasticizing oil. However, Hansen teaches
wherein said plasticizing oil have a molecular weight of between 310 g/mol and 320 g/mol (250 and 450 g/mol, ¶0087, Hansen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arbogast and Brooke by incorporating the molecular weight of plasticizing oil as taught by Hansen as it is an inert excipient for pharmaceutical compositions (¶0126, Hansen).
Regarding claim 14, Arbogast does not teach CBD oil comprises between five percent and forty five percent of said thermoplastic elastomer by weight. However, Brooke teaches
wherein said CBD oil comprises between five percent and forty five (col. 6 lines 48, Brooke) of said thermoplastic polymer by weight.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arbogast by incorporating the teaching above as taught by Brooke in order to have the most effective cannabis mixture (col. 6 lines 46-50, Brooke).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774