DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 4, 5, 10, and 13-17 are pending. Claims 2, 3, 6-9, 11, and 12 are cancelled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 13, 2026 has been entered.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/JP2021/009075, filed on March 8, 2021. This application also claims the benefits of foreign priority to JP2020-040142, filed on March 9, 2020.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant' s amendments and/or remarks.
Claim Objections
Claim 17 is objected to because of the following informalities:
For clarity, claim 17 should read:
“…wherein the ceramide NDS in the ceramide growth promoting agent has an acyl chain length of C18, and wherein, upon topical application of the ceramide growth promoting agent on skin of a human subject, ceramide NDSs having acyl chain lengths of C14, C16, C20, C22, C24, and C26 are increased within skin stratum corneum.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
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 15 and 16 are 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 15 and 16 recite “The method according to claim 2…”, however, claim 2 has been cancelled. Therefore, claims 15 and 16 are in improper dependent form as they are dependent on a non-existing claim.
Note: Even if claims 15 and 16 were intended to be dependent on claim 1 instead, the resulting claims would be a substantial duplicate of claims 4 and 5, respectively.
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.
Note on 35 USC § 103 Rejections
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.
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.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over
Kaneko et al. (Kaneko) (US6355232B1; published March 12, 2002)
According to MPEP § 2114, section II:
“‘[A]pparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim.”
This can also be translated to a composition claim. A composition claim covers what a composition is, not what a composition does. Therefore, a claim containing a recitation with respect to the manner in which a claimed composition is intended to be employed does not differentiate the claimed composition from a prior art compound if the prior art composition teaches all the structural limitations of the claim.
Further note: instant claim 10 does not explicitly identify other components within the skin cosmetic, skin protective agent, lip care preparation, skin cleanser, or bath agent other than the ceramide growth promoting agent. Therefore, the skin cosmetic, skin protective agent, lip care preparation, skin cleanser, or bath agent of instant claim 10 can also be interpreted to simply be a ceramide growth promoting agent comprising a ceramide NDS such that 0.01 mass % to 5 mass % of the composition is made up of the ceramide NDS.
Although Kaneko does not explicitly disclose a specific working example of a composition comprising a ceramide NDS in an amount of 0.01 mass % to 5 mass % based on a total amount of the composition (i.e., Kaneko does not anticipate instant claim 10), Kaneko does teach that their invention encompasses instant claim 10:
Kaneko teaches that an embodiment of their invention (herein, referred to as embodiment-A) is a cosmetics product (i.e., a composition) wherein 0.01 – 20% of the product’s mass (preferably 0.05 to 10%, most preferably 0.1 to 5%) is made up of
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(herein, referred to as ceramide-Kaneko; see col. 4, lines 29-39).
According to MPEP § 2112, section I:
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Therefore, even though Kaneko does not disclose that embodiment-A is a composition comprising ceramide-Kaneko wherein ceramide-Kaneko is a ceramide growth promoting agent, this “ceramide growth promoting” property is inherent to ceramide-Kaneko as supported by the instant specification. In instant example 1, the ceramide growth promoting agent comprises (2S, 3R)-2-octadecanoylaminooctadecane-1,3-diol as the ceramide NDS component which has the following structure:
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and is encompassed by the following formula:
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(i.e., structure of ceramide-Kaneko).
Therefore, Kaneko disclosing a composition comprising
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(i.e., ceramide-Kaneko which is the same as (2S, 3R)-2-octadecanoylaminooctadecane-1,3-diol) wherein ceramide-Kaneko is in a most preferably amount of 0.1 mass % to 5 mass % based on a total amount of the composition is also inherently disclosing and encompassing a composition which is a ceramide growth promoting agent comprising (2S, 3R)-2-octadecanoylaminooctadecane-1,3-diol in an amount of 0.1 mass % to 5 mass % based on a total amount of the composition.
Therefore, instant claim 10 is rendered obvious.
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 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claim 11 of U.S. Patent Application No. 6,355,232 B1 (‘232B1).
According to MPEP § 2114, section II:
“‘[A]pparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim.”
This can also be translated to a composition claim. A composition claim covers what a composition is, not what a composition does. Therefore, a claim containing a recitation with respect to the manner in which a claimed composition is intended to be employed does not differentiate the claimed composition from a prior art compound if the prior art composition teaches all the structural limitations of the claim.
Further note: instant claim 10 does not explicitly identify other components within the skin cosmetic, skin protective agent, lip care preparation, skin cleanser, or bath agent other than the ceramide growth promoting agent. Therefore, the skin cosmetic, skin protective agent, lip care preparation, skin cleanser, or bath agent of instant claim 10 can also be interpreted to simply be a ceramide growth promoting agent comprising a ceramide NDS such that 0.01 mass % to 5 mass % of the composition is made up of the ceramide NDS.
Although ‘232B1 does not explicitly disclose a claim directed to a composition comprising a ceramide NDS in an amount of specifically 0.01 mass % to 5 mass % based on a total amount of the composition, ‘232B1 does disclose that the invention encompasses instant claim 10 (see claim 11 of ‘232B1).
‘232B1 discloses that the claimed invention encompasses:
A composition comprising ceramide-Kaneko and a cosmetically or pharmaceutically acceptable vehicle therefore wherein the ceramide-Kaneko is in an amount of from about 0.01 to about 20% (see claim 11 of ‘232B1);
Note: claim 11 of ‘232B1 is dependent on claim 1 which recites a protective agent for skin or hair which comprises ceramide-Kaneko. Since no other components were explicitly disclosed in the protective agent, Examiner also interprets claim 1 of ‘232 B1 to include only the compound, ceramide-Kaneko. Hence, Examiner interprets claim 11 of ‘232B1 to also include a composition comprising the compound, ceramide-Kaneko, and a cosmetically or pharmaceutically acceptable vehicle therefore wherein the ceramide-Kaneko is in an amount of from about 0.01 to about 20%.
According to MPEP § 2112, section I:
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Therefore, even though ‘232B1 does not disclose that the composition of claim 11 comprises ceramide-Kaneko wherein ceramide-Kaneko is a ceramide growth promoting agent, this “ceramide growth promoting” property is inherent to ceramide-Kaneko as supported by the instant specification. In instant example 1, the ceramide growth promoting agent comprises (2S, 3R)-2-octadecanoylaminooctadecane-1,3-diol as the ceramide NDS component which has the following structure:
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and is encompassed by the following formula:
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(i.e., structure of ceramide-Kaneko).
Therefore, ‘232B1 disclosing a composition comprising
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(i.e., ceramide-Kaneko which is the same as (2S, 3R)-2-octadecanoylaminooctadecane-1,3-diol) wherein ceramide-Kaneko is in an amount of 0.01 mass % to 20 mass % based on a total amount of the composition is also inherently disclosing and encompassing a composition which is a ceramide growth promoting agent comprising (2S, 3R)-2-octadecanoylaminooctadecane-1,3-diol in an amount of 0.01 mass % to 5 mass % based on a total amount of the composition.
Therefore, instant claim 10 is not patentably distinct from claim 11 of ‘232B1.
Allowable Subject Matter
Claims 1, 4, 5, 13, and 14 allowed. Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 4, 5, 13, and 14 allowed. Claim 17 is objected to. Claims 10, 15, and 16 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY H. MURRAY can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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