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 .
Applicant’s response and claim amendment filed on December 4, 2025 has been fully considered.
The previous claim rejection made under 35 U.S.C. 112 (b) as indicated n the Office action dated December 4, 2025 is maintained for reasons of record.
The previous claim rejection made under 35 U.S.C. 103 over Hannetel et al. (US 20090208568 A1) has been maintained for the reasons of record.
The previous claim rejection made under 35 U.S.C. 103 over Hannetel and further in view of Hakim (US 9949920 B2) has been maintained for reasons of record.
The previous claim objections have been withdrawn in view of applicant’s amendment made to claims 1 and 3.
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, 4, 7, 11, 12, 15, 17, 18, 21-23, 25 and 27 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.
The amended claim 1 recites “wherein the breakable capsule is configured so that there is at least up to a 60 % enlargement in a diameter of the capsule before breakage of the membrane.” The expression “at least up to a 60% enlargement” renders the claim vague and indefinite because it is not clear if the 60% enlargement should be the minimum or maximum limit.
For the sake of compact prosecution and prior art consideration only, it is assumed that the limitation is intended to describe the maximum limit of the expansion of the diameter, as the specification p. 18, line 24 discloses the flexibility of the capsule can be “up to 60 % of its diameter”. To overcome the rejection under § 112 (b), applicant must amend the claim to remove the ambiguity.
Regarding claims 1, 15, 25 and 27, the term "preferably” and/or the phrase “more preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The amendment filed on December 4, 2025 did not address all of the indefinite terms. See claim 1, lines 10, 11 and 13; claim 15, the 3rd line from the bottom; claim 25, the last line; claim 27, lines 2 and 3. The remaining claims are rejected for depending on the indefinite base claim(s).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “wherein the thickness of the membrane (2) is at least 150 µm”, and the claim also recites “wherein the thickness of the membrane (2) is at least 300µm”, which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 4 depends on claim 1 which requires “calcium, magnesium or salts thereof”; the dependent claim then requires “the amount of calcium and magnesium” be 0.01-3 wt % based on the total weight of the membrane. (emphasis inserted). Since there is no specific requirement requiring both calcium and magnesium in either claim, claim 4 is vague and indefinite.
For prior art consideration, the broader limitations have been considered for the prior art consideration for the sake of compact prosecution. Appropriate amendments must be made to overcome the above rejections.
Claim 15 recites “Kelco-Care dilutan gum”; Kelco-Care is a registered trademark.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the gelling agent and, accordingly, the identification/description is indefinite.
Claim 18 recites “wherein the core or the cosmetically acceptable excipient is a cosmetically acceptable carrier suitable for forming saline, aqueous, alcoholic and oily solutions; oily external phase, aqueous external phase and silicone external phase emulsions, aqueous and oily gels; and powders” The scope of the metes and bounds of the claim limitation is unclear since it is not whether the core or the cosmetically acceptable excipient requires all of the types of the listed formulations, i.e., “saline, aqueous, alcoholic or oily solutions…powders”.
Claim 3 includes “derivative of Carrageenan from algae” in a Markush group of calcium salts; it is not clear which derivative of the Carrageenan applicant would satisfy the calcium salt limitation.
The Markush groups in Claims 21 and 22 fail to include the conjunction “and” between the last two species; it is not clear whether all of the species are within the Markush groups.
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.
Claims 1, 3, 4, 11, 12, 15, 17, 18, 21-23, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hannetel et al. (US 20090208568 A1, published on August 20, 2009) (“Hannetel” hereunder).
Claim 1 is directed to a breakable capsule (1) characterized in that:
the diameter of the capsule is at least 7 mm, preferably between 7 mm and 30 mm;
the flexibility of the capsule is up to 20% the diameter of the capsule;
the burst strength of the capsule is from 12 to 25 gr/cm2 said capsule comprises a core (3) and an outer membrane (2) that surrounds the inner core (3), the outer membrane (2) being characterized in that: the membrane (2) comprises
at least 20% water by weight to the total weight of the membrane, preferably the water content by weight in the membrane (2) is between 40% and 99.5% to the total weight of the membrane (2), more preferably between 60% and 99.5%;
at least 0.2% of a gelling agent and at least 0.1% of a cosmetically acceptable excipient, to the total weight of the membrane, preferably wherein the gelling agent is between a range of 0.2% and 5% and the cosmetically acceptable excipient is in a range from 0.2% and 10%, both measured with respect to the total weight of the membrane;
calcium, magnesium or salts thereof
optionally an active ingredient in a concentration of at least 0.01% to 10% to the total weight of the membrane (2);
optionally a preservative, which concentration in the solution is between 0.01 and 5%;
And wherein the thickness of the membrane (2) is at least 150 μm wherein the thickness of the membrane (2) is at least 300 μm.
Hannetel teaches a gellan seamless breakable capsule useful in oral care, food application, pharmaceutical or cosmetic products. See [0004]. The capsule has a diameter up to 8 mm and the crush strength (i.e., burst strength), ranging from 0.01-5 kp (i.e., 10-5000 g/cm2). See [0005], [0018]. The capsule comprises a core and an outer membrane that surrounds the inner core; the outer membrane comprises 1-60 wt % of water, see [0051]; at least one gelling agent in the amount of 4-95 %, see [0019-20]. See also [0012], [0051]. The reference teaches that the membrane composition can further contain a sequestering agent, filler, plasticizing agent, etc., which are all considered cosmetically acceptable excipient. See [0023-0029]. The amount of the sequestering agent can be at most 2 % of the total dry weight of the shell, which meets the presently claimed range of at least 0.1 % of the total weight of the shell membrane. See [0026]. The reference further teaches that the capsule is immersed in an aqueous solution comprising calcium or magnesium ions, which cures the shell and provide satisfactory breakable capsules. See [00009]. It is viewed that the divalent ions are part of the cured capsule shell and meets the present claim limitation. See [0040]. The thickness of the shell is 10-500 microns. See [0053].
Although Hannetel does not specifically disclose the flexibility of the capsule as described in claim 1, the reference teaches all other structures of the claimed capsule, including the size, the thickness of the shell membrane, the specific composition of the shell membrane, and the suitability of the rupturable capsule which releases the core material for cosmetic purposes. Thus, it is viewed that the prior art capsule obviously has flexibility which is similar to that of the presently claimed capsule, unless shown otherwise.
Regarding claim 3, Hannetel teaches calcium chloride, calcium carbonate, calcium phosphate or calcium sulfate can be used. See [0037-0040]. Using any of the disclose divalent metal salts to cure the breakable capsule shell would have been prima facie obvious.
Regarding claim 4, although the reference does not specifically disclose the amount of the divalent ion(s) based on the total weight of the membrane, the reference teaches that a CaCl2 solution having 1 % produced a higher wet capsule strength than compared to a CaCl2 solution having 0.1 % concentration. See [0067-0069]. It is viewed that a targeted crush strength can be achieved by manipulation of the calcium salt concentration in the aqueous solution, which in turn would result in a higher concentration of the released calcium concentration on the shell membrane, unless shown otherwise.
Regarding claim 11, Hannetel teaches that the core of the breakable capsule according to the invention most preferably represent 70-80 % by weight of the total weight of the capsule. See [0055].
Regarding claims 12 and 17, Hannetel teaches that the core can include active agents such as flavoring agents, fragrance, or lipophilic vitamins and plant extracts. See [0061].
Regarding claim 15, the gelling agents used in the Hannetel invention include alginate, gellan gum, xanthan gum, Ghatti gum, etc., [0019]. The reference further teaches malltodextrin, dextrin, etc., which are among the suitable gelling agent for the present invention. See [0023].
Regarding claim 18, Hannetel teaches that medium chain triglycerides such as triglycerides of caprylic acid capric acid can be used as pharmaceutically or cosmetically suitable lipophilic solvents in the core of the capsule. See [0056].
Regarding claim 21, the plasticizers suitable for the Hannetel capsule include glycerol, polyethylene glycol, etc. See [0029].
Regarding claim 22, Hannetel teaches that the curing solution in which the capsule is immersed also contains pharmaceutically or cosmetically suitable preservatives or bactericides such as benzoate, parabens, etc., which are obviously released onto the outer membrane of the shell. See [0038].
Regarding claim 23, Hannetel teaches that the shell may comprise coloring agents; the core may also contain aromatic hydrocarbons such as phenols, aromatic acetals and ethers as flavoring or fragrance compositions. See [0049], [0057].
Regarding claim 25, the disintegration and absorption of the capsule when rubbed on the skin as described in the claim is a property of the presently claimed capsule. Since Hannetel teaches a breakable capsule comprising the same core and outer membrane components within the parameters of the present claim, it is viewed that the disclosed breakable capsule also will be ruptured and absorbed on the skin when the same force is applied.
Regarding claim 27, since the reference teaches a similar breakable capsule which comprises preservatives upon curing, the disclosed capsule would obviously have the similar degree of stability as described in the claim, unless shown otherwise.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hannetel as applied to claims 1, 3, 4, 11, 12, 15, 17, 18, 21-23, 25 and 27, and further in view of Hakim (US 9949920 B2, published on April 24, 2018).
Although Hannetel teaches using lipophilic agents including plant oils, essential oils, perfume and fragrance, the reference fails to disclose the specific actives of the present claim 7.
Hakim teaches sweet almond oil (Prunus Amygdalus Dulcis) contains a high content of vitamin E, which is a major antioxidant, and D and is rich in oleic acid and quickly absorbed by the skin. See col. 4, lines 1-14.
Given the teaching of Hannetel to incorporate plant oils as the actives in the breakable capsule, one of ordinary skill in the art before the effective filing date of the present application would have been obviously motivated to look to prior art such as Hakim for specific type of actives useful for oral care, food application, pharmaceutical or cosmetic products. Since Hakim teaches that sweet almond oil provides a high content of antioxidant and is rich in oleic and linoleic acids and quickly absorbed by the skin, one of ordinary skill in the art would have been obviously motivated to incorporate such beneficial cosmetic oil in the Hannetel capsule for topical use. Since both compositions in the references are cosmetically suitable, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references to make a breakable capsule which releases the fast-absorbing sweet almond oil upon application to skin, which protects the skin from damage caused by free radicals and moisturizes the skin.
Response to Arguments
Applicant's arguments filed on December 4, 2025 have been fully considered but they are not persuasive.
Applicant argues, “[t]he amendment provides evidence that the claimed structure provides different diameter expansions of the membrane of the capsule prior to breakage.” The statement is not well taken, as the claim language itself does not serve as evidence that the presently claimed capsule is different from the prior art. As indicated in the rejection, the examiner showed that the structure of the Hannatel capsule is very similar, as the diameter, member thickness, the burst strength, and the composition of the membrane meet the presently claimed limitations. Particularly, the reference teaches the same gelling agents and crosslinking agent which form the capsule membrane. The examiner asserts that the rejection is supported by sufficient facts to conclude that the flexibility of the disclosed capsule has to be same or similar to that of the presently claimed invention, and the burden is on the applicant to show otherwise.
Applicant asserts that the Office action has not addressed the limitation of claim 12. The argument is not well taken, as the claim merely requires that the active ingredient is in the core or in the core and in the membrane. The rejection specifically indicated that the reference teaches to include active ingredients in the core, which meets the first of the two alternative limitations of claim 12.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/GINA C JUSTICE/ Primary Examiner, Art Unit 1617