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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
This application is a 371 of PCT/EP2022/082692 filed 11/22/2022.
This application also claims foreign benefit of EPO EP21211909.3 filed 12/02/2021.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Accordingly, claims 1-25 of the instant application are afforded the effective filing date of 11/22/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 05/30/2024 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 11, 12, and 22, drawn to a method for therapeutic and/or cosmetic treatment of skin with impaired barrier function, in the reply filed on 06/03/2026 is acknowledged.
In the recent set of claims filed 06/03/2026, Applicant has amended claims 2-8, 10, 16-21, and 25 from composition claims to method claims that are dependent from claim 11. Thus, claims 2-8, 10, 16-21, and 25 are hereby rejoined with claims 11, 12 and 22 of Group II.
Claims 1, 9, 13-15, 23 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups/inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/03/2026.
Status of the Claims
Claims 1-25 are pending in this instant application, of which claims 1, 9, 13-15, 23 and 24 are withdrawn at this time being drawn to a nonelected groups/inventions.
Claims 2-8, 10-12, 16-22, and 25 are examined herein on the merits for patentability.
Claim Objections
Claim 4 is objected to because of the following informalities: the recitation of “a phosphoglyceride selected from the following group: …” followed by “or a mixture of these systems,” “and/or”, and then “or nonhydrogenated form” is an improper Markush language. When materials recited in a claim are so related as to constitute a proper Markush groups, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: the recitation of “negatively charged phospholipids selected from the following groups: …” followed by “or phosphatidylserine” and “or a combination thereof” is an improper Markush language. When materials recited in a claim are so related as to constitute a proper Markush groups, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: the recitation of “at least one following formula constituents: …” followed by multiple “and/or” and “including water” and “or pharmaceutical ingredients, or a combination thereof” is an improper Markush language. When materials recited in a claim are so related as to constitute a proper Markush groups, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: please add a “The” before “Method” in line 1 of claim 22. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: please remove the recitation of “wherein a composition as claimed in claim 11 is topically applied to the skin” in the last line of claim 22 because this recitation is a redundancy due to the recitation being already recited in the method of claim 11. 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 3-4, 7-8, 10-11, 16-18, 20-22, and 25 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.
Regarding claim 3, the recitation of “it is” renders claim 3 indefinite because the metes and bounds of “it is” is unclear. It is not clear what “it is” is referencing to or what is encompassed by the phrase “it is.” Is “it is” referencing to the composition, the method, or something else? Clarification by amendment in claim 3 is required.
Regarding claim 4, the recitation of “or a mixture of these systems” renders claim 4 indefinite because the metes and bounds of “a mixture of these systems” is unclear. It is not clear what “these systems” encompassed, as claim 4 is not drawn to any systems. Thus, it is also unclear what components are encompassed by the mixture. Clarification by amendment in claim 4 is required.
Regarding claim 7, the recitation of “the starting material” renders claim indefinite because there is lack of antecedent basis for the starting material in claim 11. Thus, is it not clear what the starting material is claim 7 referencing to, as claim 11 (to which claim 7 depends from) does not contain a starting material. Clarification by amendment in claim 7 is required.
Regarding claim 8, the recitation of “the percents by weight of CaCl2·2H2O” renders claim 8 indefinite because there is lack of antecedent basis for the percents by weight of CaCl2·2H2O in claim 8 or claim 11 (to which claim 8 depends from). Thus, it is not clear what the percents by weight of CaCl2·2H2O is claim 8 referencing to, as neither claim 8 nor claim 11 contains percents by weight of CaCl2·2H2O. Clarification by amendment in claim 8 is required.
Regarding claim 10, the recitation of “it is” renders claim 10 indefinite because the metes and bounds of “it is” is unclear. It is not clear what “it is” is referencing to or what is encompassed by the phrase “it is.” Is “it is” referencing to the composition, the method, or something else? Clarification by amendment in claim 10 is required.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted step is: Claim 11 provides for “a method for therapeutic and/or cosmetic treatment of skin with impaired barrier function, including the skin of a diabetes patient or prediabetes patient, wherein a composition as claimed in claim 1 having an active content of divalent calcium (Ca2+) and in which the divalent calcium is present in the composition as a phospholipid complex is topically applied to the skin,” but since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. The scope of claim 11 is unclear because there is no active step to whom the method for therapeutic and/or cosmetic treatment of skin with impaired barrier function, is directed to. Also, there is no active step on how and where the composition is administered. Therefore, claim 11 ais indefinite because the claims do not set forth any steps involved in the method of treatment.
It is suggested that Applicant amend claim 11 to proper method claim. For example, it is suggested that claim 11 be amended to “A method for therapeutic and/or cosmetic treatment of skin with impaired barrier function of a diabetes patient or prediabetes patient, the method comprising topically applying to the skin of the patient in need thereof, a composition comprising an active content of divalent calcium (Ca2+), wherein the divalent calcium is present in the composition as a phospholipid complex.”
Regarding claim 16, the recitation of “it is” renders claim 16 indefinite because the metes and bounds of “it is” is unclear. It is not clear what “it is” is referencing to or what is encompassed by the phrase “it is.” Is “it is” referencing to the composition, the method, or something else? Clarification by amendment in claim 16 is required.
Regarding claims 11, 17, 21, and 22: 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 11 recites the broad recitation “skin with impaired barrier function, and the claim also recites “including the skin of a diabetes patient or prediabetes patient,” which is the narrower statement of the limitation.
claim 17 recites the broad recitation “one or two phospholipids, and the claim also recites “namely with negative charges of the phospholipids,” which is the narrower statement of the limitation.
claim 21 recites the broad recitation “polar and apolar solvents,” and the claim also recites “including water,” which is the narrower statement of the limitation.
claim 22 recites the broad recitation “by skin changes or skin irritation,” and the claim also recites “including of bacterial origin,” which is the narrower statement of the limitation.
claim 22 recites the broad recitation “pigment disorders,” and the claim also recites “(diabetic dermophathy),” which is the narrower statement of the limitation.
claim 22 recites the broad recitation “itching,” and the claim also recites “(pruritus diabeticorum),” which is the narrower statement of the limitation.
claim 22 recites the broad recitation “redness,” and the claim also recites “(including necrobiosis lipoidica diabeticorum, pseudoacanthosis nigricans, bullosis diabeticorum, rubeosis diabeticorum, scleredema diabeticorum),” which are the narrower statements of the limitation.
The claim(s) 11, 17 and 21-22 are 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.
Regarding claim 18, the recitation of “type 2 diabetes patients are concerned” renders claim 18 indefinite because the metes and bounds of “type 2 diabetes patients are concerned” is unclear, as what is of “concerned” with respect to type 2 diabetes patients. If Applicant intends to limit the patient to type 2 diabetes patients, it is suggested that claim 18 be amended to “wherein the diabetes patients are type 2 diabetes patients.”
Regarding claim 20, the recitation of “the percents by weight of CaCl2·2H2O” renders claim 20 indefinite because there is lack of antecedent basis for the percents by weight of CaCl2·2H2O in claim 20 or claim 11 (to which claim 20 depends from). Thus, it is not clear what the percents by weight of CaCl2·2H2O is claim 20 referencing to, as neither claim 20 nor claim 11 contains percents by weight of CaCl2·2H2O. Clarification by amendment in claim 20 is required.
Regarding claim 21, the recitation of “it is” renders claim 21 indefinite because the metes and bounds of “it is” is unclear. It is not clear what “it is” is referencing to or what is encompassed by the phrase “it is.” Is “it is” referencing to the composition, the method, or something else? Clarification by amendment in claim 21 is required.
Regarding claim 22, the parenthetical recitations (diabetic dermopathy),” “(pruritus diabeticorum),” and “(including necrobiosis lipoidica diabeticorum, pseudoacanthosis nigricans, bullosis diabeticorum, rubeosis diabeticorum, scleredema diabeticorum)” in claim 22 is indefinite because it is unclear if the text within the parenthesis are alternative limitations of the claims or merely descriptors of other elements of the claims. It is noted that [p]arenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
Regarding claim 22, the recitation of “of a combination of these indications” render claim 22 indefinite because the metes and bounds of “a combination of these indications” is unclear. It is not clear what “these indications” encompassed, as claim 22 is not drawn to any “indications.” Thus, it is also unclear what components are encompassed by the combination. Clarification by amendment in claim 22 is required.
Regarding claim 25, the phrase "such structures” render the claim(s) 25 indefinite because the claim(s) 25 include(s) elements not actually disclosed (those encompassed by "the like" or variation of “the like” such as “such structures”), thereby rendering the scope of the claim(s) 25 unascertainable. See MPEP § 2173.05(d). It unclear what “such structures” or how like or dislike, or similar or dissimilar does the neutral aggregate need to be, so as to be considered “such structures”.
As a result, claims 3-4, 7-8, 10-11, 16-18, 20-22, and 25 do not clearly set forth the metes and bounds of patent protection desired.
Claim Rejections - 35 USC § 101
Claim 11 is also rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3, 16, and 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 3 and 16 are not further limiting from claim 11 because the recitations of “it is for the treatment of diabetes patients” and “it is for the topical treatment of the skin of diabetes patients or prediabetes patients” as recited in claims 3 and 16, respectively does not further limit of the scope of the method of claim 11, as claim 11 already recites “including the skin of a diabetes patient or prediabetes patient.”
Claim 22 is not further limiting from claim 11 because the recitations of “for therapeutic and/or cosmetic treatment of the skin of a diabetes patient or prediabetes patient, for stabilization, prevention, reduction or elimination of dry skin or moisturization of dry skin and/or for restoration of the barrier function, for stabilization, prevention, reduction or elimination of skin infections caused by damaged barrier function, by skin changes or skin irritation, including of bacterial origin, or for stabilization, prevention, reduction or elimination of fungal infections, of pigment disorders (diabetic dermopathy), of blistering, of itching (pruritus diabeticorum), of redness (including necrobiosis lipoidica diabeticorum, pseudoacanthosis nigricans, bullosis diabeticorum, rubeosis diabeticorum, scleredema diabeticorum), or of wrinkling, or of a combination of these indications” are recitations of intended use and thus, do not further limit method of claim 11, as the same composition is used and the subject matter of claim 22 does not change the patient/subject or structurally differentiate of the subject matter of claim 11, thereby claim 22 is not structurally limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Claim(s) 2-8, 10-12, 16, and 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanojo et al (US 2008/0183250 A1) in view of Perricone (US 2014/0271732 A1) and Subramaniam et al (International Journal of Molecular Sciences, 17 June 2021, 22(6486): 1-14).
Regarding claim 11, Tanojo teaches a method of restoring skin barrier function of skin of a subject having skin disorders including inflammation, blisters and erythema, the method comprising topically applying a composition containing divalent cations such as calcium ions to the skin of the subject (Abstract; [0010]-[0036], [0042]-[0084], [0194]-[0226]; Examples 1-4; claims 1-42). Tanojo teaches the composition further contains phospholipids ([0080]; Examples 1-4).
While Tanojo does not expressly teach that the divalent calcium ions are in a phospholipid complex and that the subject include diabetes patients or prediabetes patient, it would have been obvious that the divalent calcium ions in the composition of Tanojo is in a calcium ion-phospholipid complex in view of the guidance from Perricone, as well as, alternatively, it would also have been obvious to topically apply the composition of Tanojo to the skin of a diabetic subject having skin disorders including inflammation, blisters and erythema to restore skin barrier function of the skin of the subject in view of the guidance from Subramaniam.
Perricone teaches a method of wound healing in a subject having diabetic ulcers, the method comprising topically applying to a skin of a subject having diabetes, a composition comprising a drug-phospholipid complex, wherein the phospholipid acts as a carrier for drug (Abstract; [0014], [0025], [0031]-[0056], [0068]-[0084], [0093]-[0095]).
Subramaniam teaches the use of calcium ions (Ca2+) to promote wound healing in patients having diabetic ulcers (Abstract; Introduction; pages 4-11). Subramaniam also teaches that calcium ions are known to form complex with phospholipids (page 7).
It would have been obvious to one of ordinary skill in the art that the composition that is applied to the skin of the subject of Tanojo contains calcium ions in a phospholipid complex and that the method of restoring skin barrier function of skin of Tanojo would include skin of a diabetes patient, and produce the claimed method. One of ordinary skill in the art would have been motivated to do so because Perricone established that phospholipid is normally used as a carrier drugs to from drug-phospholipid complex and such drug-phospholipid complex can be topically applied to a skin of a subject having diabetic ulcers to so promote wound healing, which is also acknowledged by Subramaniam, expressly teaching that calcium ions (an active ingredient) are known to form complex with phospholipids, and said calcium ions are known to be used in promoting would healing in patients having diabetic ulcers. One of ordinary skill in the art would have reasonable expectation of success in do so because Tanojo also suggested that calcium ions (calcium chloride) form complex with lipids in a topical formulation containing calcium ions and lipids (Tanojo: [0236]), and as discussed above, Subramaniam, established that calcium ions are known to form complex with phospholipids and said calcium ions are known active ingredient for use in promoting wound healing in patients having diabetic ulcers. Thus, an ordinary artisan provided the guidance from the combined teachings of Tanojo, Perricone, and Subramaniam would have used the composition containing calcium ions-phospholipid complex of Tanojo for restoring skin barrier function or wound healing of skin in a patient including patients having diabetes per Perricone and Subramaniam, and achieve Applicant’s claimed method with reasonable expectation of success.
Regarding claim 2, Perricone provides the guidance for the phospholipids to be one phospholipid or a mixture of phospholipids ([0031]-[0034], [0039]-[0056, [0065]-[0072]).
Regarding claims 3 and 16, as discussed above, Perricone and Subramaniam teach the patients include diabetes patients.
Regarding claim 4, Perricone provides the guidance for phospholipids to be phosphatidylcholine or lecithin ([0031]-[0034], [0039]-[0056, [0065]-[0072]).
Regarding claims 5 and 6, Tanojo teaches the composition contains about 0.01-8% w/w divalent calcium cations, and from 0.01% to 20% by weight of phospholipids ([0042]-[0054], [0079]-[0083], [0226]; Examples 1-4), which overlaps the claimed molar ratios as recited in claims 5 and 6. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the molar ratio of divalent calcium to phospholipid in the calcium-phospholipid complex of the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 7, Tanojo teaches the composition is in the form of a gel formulation ([0053]-[0054], [0058]-[0065], [0211]; claim 21).
Regarding claim 8, Tanojo teaches the composition contains about 0.01-8% w/w divalent calcium cations ([0042]-[0054], [0226]; Examples 1-4), which overlaps the claimed weight% range for divalent calcium of claim 8. Thus, as discussed above, the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight% of divalent calcium in the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 10, Tanojo teaches the composition contains from 0.01% to 20% by weight of phospholipids ([0079]-[0083]; Examples 1-4), which overlaps the claimed weight% range for phospholipid of claim 10. Thus, as discussed above, the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight% of phospholipids in the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 12, Tanojo teaches the composition is formulated in the form of an ointment, cream, lotion, or a paste ([0060], [0194], [0211]-[0213]; Examples 1-4).
Regarding claim 18, as discussed above, Perricone and Subramaniam teach diabetes patients, thereby would include and render obvious type 2 diabetes patients.
Regarding claim 19, Perricone teaches the phospholipid includes phosphatidylinositol, or phosphatidic acid (Perricone: [0040]). Tanojo teaches the composition contains about 0.01-8% w/w divalent calcium cations, and from 0.01% to 20% by weight of phospholipids (Tanojo: [0042]-[0054], [0079]-[0083], [0226]; Examples 1-4), which overlaps the claimed molar ratios as recited in claim 19. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the molar ratio of divalent calcium to phospholipid in the calcium-phospholipid complex of the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 20, Tanojo teaches the composition contains about 0.01-8% w/w divalent calcium cations ([0042]-[0054], [0226]; Examples 1-4), which overlaps the claimed weight% range for divalent calcium of claim 20. Thus, as discussed above, the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight% of divalent calcium in the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 21, Tanojo teaches the composition is formulated in the form of an ointment, cream, lotion, or a paste ([0060], [0194], [0211]-[0213]; Examples 1-4). Tanojo teaches the composition further contains hydrophilic or lipophilic gelling agents, preservatives, antioxidants, solvents, fragrances, fillers, pigments, odor absorbers and dyestuffs ([0061]).
Regarding claim 22, Tanojo teaches the composition the composition is used for reducing dry skin and restoring of barrier function of the skin (Abstract; [0010], [0022]-[0049]; Examples 6-7; claims 30-32).
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 before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 17 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanojo et al (US 2008/0183250 A1) in view of Perricone (US 2014/0271732 A1) and Subramaniam et al (International Journal of Molecular Sciences, 17 June 2021, 22(6486): 1-14), as applied to claim 11 above, and further in view of Melcrova et al (Scientific Reports, 1 December 2016, 6(68035): 1-12).
The method of claim 11 is discussed above, said discussion being incorporated herein its entirety.
Regarding claims 17 and 25, Melcrova teaches calcium cation complex with phospholipids to form neutral complex or neutral precipitate (aggregate) in which the calcium cation is in the center between phospholipids vesicles (pages 1-8).
It would have been obvious to one of ordinary skill in the art that the calcium complex with phospholipids of Tanojo would form neutral complex or neutral aggregate, because such neutral complex or neutral aggregate would have been an implicit result when bivalent calcium ions is complex with the phospholipids, as Melcrova established that calcium cation complex with phospholipids to form neutral complex or neutral precipitate (aggregate) in which the calcium cation is in the center between phospholipids vesicles.
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 before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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