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 election without traverse of Group I, claims 1, 5-6, 15, 22 and 34-35 in the reply filed on 10 April 2026 is acknowledged. The election/restriction requirement is deemed proper and is therefore made FINAL. An Action on the merits of claims 1, 5-6, 15, 22 and 34-35 is contained herein.
Group II, claims 13-14, 21 and 24-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
This application is a 371 of PCT/PT2022/050018 filed 04/29/2022. This application claims foreign priority to SWITZERLAND 00470/21 filed 04/30/2021, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
The parent application SWITZERLAND 00470/21 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1, 5-6, 15, 22 and 34-35 of this application.
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.
Claim 34 is 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 34 is drawn to the composition of claim 1 comprising at least three compounds wherein for the first compound X is lactosyl, for the second compound X is hydrogen and for the third X is glucosyl. However, claim 1 is drawn to a composition wherein X is defined as only lactosyl. It is not clear what applicant intends in claim 34 since hydrogen and glucosyl are not defined as substitutions in claim 1.
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 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.
Claim 34 is rejected under 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.
Claim 34 is drawn to the composition of claim 1 comprising at least three compounds wherein for the first compound X is lactosyl, for the second compound X is hydrogen and for the third X is glucosyl. However, claim 1 is drawn to a composition wherein X is defined as only lactosyl. Therefore, claim 34 does not further limit claim 1.
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 § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless -
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim 15 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Kiyono (JP 2003192525 A, English Translation, pages 1-7; cited in IDS filed 4/10/2026).
Kiyono teaches a topical composition which has the sphingosine analog lactosyl ceramide as an essential component (paras 0007-0008; paras 0010, 0012).
To the extent that applicant may argue that Kiyono does not anticipate the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to make a composition using lactosyl ceramide as a component as taught by Kiyono.
The artisan would be motivated to make the claimed composition since Kiyono teaches that ceramide-like substances have been known to improve barrier function of the living body, and its invention has an effect of improving/preventing rough skin and improving wrinkles. The artisan would use lactosyl ceramide as a component in order to look for an alternative composition that has optimal barrier function improving properties.
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, 5-6, 22 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Hoon et al (KR 20150077214; English Translation, pages 1-14; cited in IDS filed 04/10/2026) in view of Elias et al (WO 94/00127; cited in IDS filed 04/10/2026).
Hoon’s invention is drawn to a skin-like lipid composition comprising a sugar ceramide (page 2, first para). The sugar ceramide in the composition can be a lactosyl ceramide (page 5, para 8; part of the limitation of claim 1 for X, O-CH2-CH(NHR2)-CHOH, and double bond, R3 and R4 is H; and limitation of claim 34). Hoon teaches that the sugar ceramide can be present in the composition in the range 0.015 to 2 wt% (page 3, fifth full para). The artisan can use this teaching as a starting point and adjust the amount of the compound of formula I to be in the percentage range recited in claim 6 for obtaining optimal beneficial effect in the applications taught by Hoon (page 3, second full para; page 4, third para). At page 5, para 8, Hoon teaches that the sugar of the sugar ceramide can be glucosyl (part of the limitation of claim 34).
Hoon does not teach a compound of instant formula I having either of the limitations wherein carbon-carbon bond is a double bond when R3 is H and R4 is OH, and carbon-carbon bond is a single bond when R3 is OH and R4 is H, and does not teach the limitations of claims 5, 22, part of claim 34 (X is H) and claim 35.
Elias teaches compositions for skin comprising the compound of formula shown at the top of page 7, line 1. This compound has some of the structural features of the compound of instant formula I (page 7, line 1 through page 9, line 16). In this compound X can be H, and the sugar can be lactosyl (page 7, line 17; as in claim 34 and page 9, line 15; as in claim 1). Elias also teaches substitutions which are recited in claims 1 and 5 (page 10, lines 1-30). The composition of Elias can also include therapeutic agents (page 11, line 19 through page 12, line 5; as in claim 22). Claim 35 recites intended effects. Since the combined teachings of the prior art render the compounds with substitutions of claim 5, the artisan would have a reasonable expectation that the composition as in claim 35 would have the effects recited in the claim.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, topical compositions comprising compounds that are structurally close to formula I are known in the art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Product improvement is the motivation. One of ordinary skill in the art would look for other alternative compounds of formula I and compositions comprising them that have optimal beneficial effects in the applications taught in the prior art.
Obviousness based on similarity of structure and function entails motivation to make the claimed compound in expectation that compounds similar in structure will have similar properties. Where prior art compound essentially brackets the claimed compounds and are well known agents for treating skin conditions/disorders, one of ordinary skill in the art would be motivated to make the compositions comprising the claimed compounds of formula I in searching for new agents. In re Payne, 606 F. 2d 303, 203, USPQ, 245, 254-55 (C.C.P.A. 1979).
Conclusion
1. Elected claims 1, 5-6, 15, 22 and 34-35 (Group I) are rejected.
2. Group II, claims 13-14, 21 and 24-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
Prosecution Insights