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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/12/2023, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
This application, filed on 06/21/2023, is a 371 of PCT/IB2020/001130, filed on 12/22/2020.
Status of the Claims
Claims 1-12 are pending.
Claim Rejections - 35 USC § 112-2nd Paragraph
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 1-12 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. Claims 2-12 depend from claim 1 and are therefore, also rejected under 35 USC 112, second paragraph, for the reasons set forth below.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Claim 1 is rendered indefinite because one skilled in the art cannot determine the metes and bounds of:
i) “a polysaccharide fatty acid ester that includes a fatty acid ester of inulin”; and
ii) “a multichain multi-hydrophilic group containing compound having a structure in which two N-acylamino acid salt molecules are linked with lysine”.
Claim 1 claims molecules without any description or reasonable reference and/or guidance to a chemical structure. Claim 1 is rendered indefinite because it is not clear to a person skilled in the art as to the chemical structures that are intended to encompassed by:
i) “a polysaccharide fatty acid ester that includes a fatty acid ester of inulin”; and
ii) “a multichain multi-hydrophilic group containing compound having a structure in which two N-acylamino acid salt molecules are linked with lysine”.
Thus, one skilled in the art would not be able to draw a clear distinction between what is and is not covered by the claim. It is recommended that claim 1 is amended to recite the particular structure that encompasses:
i) “a polysaccharide fatty acid ester that includes a fatty acid ester of inulin”; and
ii) “a multichain multi-hydrophilic group containing compound having a structure in which two N-acylamino acid salt molecules are linked with lysine”.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
Claim Rejections - 35 USC § 112-1st Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2-12 depend from claim 1 and are therefore, also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for the reasons set forth below.
M.P.E.P. § 2163 states:
“An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention…one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.”
The claimed invention:
Claim 1 claims molecules without any description or reasonable reference and/or guidance to a chemical structure. Claim 1 recites a genus of:
i) “a polysaccharide fatty acid ester that includes a fatty acid ester of inulin” (component B1); and
ii) “a multichain multi-hydrophilic group containing compound having a structure in which two N-acylamino acid salt molecules are linked with lysine” (component B2).
The Supporting Disclosure:
Applicants have not provided any specific definition for:
i) “a polysaccharide fatty acid ester that includes a fatty acid ester of inulin”; and
ii) “a multichain multi-hydrophilic group containing compound having a structure in which two N-acylamino acid salt molecules are linked with lysine”.
The specification only discloses:
i) that component B1 may consists of a fatty acid ester of inulin (see ¶s 0025, 0028-0029) alone or may comprise a fatty ester of inulin and a fatty acid ester of dextrin (see ¶s 0025, 0030-0031); and
ii) a compound of formula (I):
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, as an example of “a multichain multi-hydrophilic group containing compound” (see ¶ 0014).
The above disclosure, however, do not provide adequate support for a description of all the chemical structures or formulas that would meet the claimed: i) “a polysaccharide fatty acid ester that includes a fatty acid ester of inulin”; and ii) “a multichain multi-hydrophilic group containing compound having a structure in which two N-acylamino acid salt molecules are linked with lysine”. The claimed genus of: genus of: i) “a polysaccharide fatty acid ester that includes a fatty acid ester of inulin”; and ii) “a multichain multi-hydrophilic group containing compound having a structure in which two N-acylamino acid salt molecules are linked with lysine”, requires a definite chemical structure or formula.
However, in the instant case, the recited: i) “a polysaccharide fatty acid ester that includes a fatty acid ester of inulin”; and ii) “a multichain multi-hydrophilic group containing compound having a structure in which two N-acylamino acid salt molecules are linked with lysine”, lack chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities.
Accordingly, the claims fail to meet the requirements of 35 U.S.C. 112, first paragraph, and is, thus, properly rejected. Applicants may resolve the written description requirement by amending the claims to recite the particular structure that accomplishes the function of the claimed genus of “a propoxylated and ethoxylated nonionic surfactant”. Appropriate correction is required.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hirotaka et al (hereinafter “Hirotaka”, JP2010077097A, published 04/08/2010, Machine Translation) in view of Ehrhardt et al (hereinafter “Ehrhardt”, U.S. Patent No. 5,877,144, issued 03/02/1999).
Independent claim 1 recites:
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By way of a background, Applicants’ invention is directed to an oil-based cleansing composition comprising: i) an oil (see ¶ 0007 of the specification); ii) a fatty acid ester of inulin alone (see ¶s 0007, 0025 of the specification), or a fatty ester of inulin and a fatty acid ester of dextrin (see ¶s 0007, 0025 of the specification); and iii) a multichain multi-hydrophilic group containing compound (see ¶s 0007, 0014 of the specification).
In view of the ambiguity associated with independent claim 1 (see above rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph), and under the broadest reasonable interpretation (BRI), consistent with the specification, independent claim 1 is being interpreted as an oil-based cleansing composition comprising:
A) an oil;
B1) a fatty acid ester of inulin alone, or a fatty ester of inulin and a fatty acid ester of dextrin; and
B2) a multichain multi-hydrophilic group containing compound.
Similar to the Applicants’ invention (see discussions above), Hirotaka teaches an oil-based cleansing composition comprising:
A) an oil (see abstract, ¶ 0005, 0008-0010);
B) dextrin fatty acid ester selected from one or more of dextrin palmitate, dextrin (palmitate/2-ethylhexanoate), and dextrin myristate (see abstract, ¶ 0005, 0011); and
D) an anionic surfactant selected from one or more difatty acid acyl glutamic acid lysine salt (e.g., sodium diluramidoglutamide lysine), fatty acid salt, N-fatty acid acyl glutamic acid salt and N-fatty acid acyl methyl alanine salt (see abstract, ¶ 0005, 0014-0016). Sodium diluramidoglutamide lysine is an example of a multichain multi-hydrophilic group containing compound (see ¶s 0033-0034 and Table 1 of the specification).
Although Hirotaka does not explicitly employ a fatty acid ester of inulin in the formulation of a cleansing composition, the claimed invention would have been obvious over Hirotaka.
This is because at the time of the instant invention, it was known in the art that a fatty acid ester of inulin can be employed in the formulation of a cleansing composition. For example, Ehrhardt discloses that a fatty acid ester of inulin (see abstract, column2, lines 24-56), can be employed in the formulation of cosmetic products including but not limited to cleansing compositions (see column 2, lines 57-62).
Accordingly, at the time of the instant invention, one skilled in the art would have envisioned a cleansing composition comprising a fatty acid ester of inulin, from the disclosures of Hirotaka and Erhardt. A person of the ordinary skill in the art would have had a reasonable expectation that a cleansing composition comprising a fatty acid ester of inulin, would exhibit utility in cleansing.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Therefore, claim 1 is obvious over Hirotaka and Erhardt.
Regarding claim 2, Hirotaka (see ¶ 0017), teaches that other components that may be blended into the oil-based composition, include but not limited to stearyl trimethylammonium chloride:
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, which is also an electrolyte (a substance that ionizes into a cation and anion, see ¶ 0037 of the specification).
Regarding claim 3, Hirotaka and Erhardt combine to disclose a fatty acid ester of inulin and dextrin (see discussions above).
Regarding claim 4, Hirotaka teaches dextrin palmitate (see discussions above), and Erhardt teaches C2-C22 esters of inulin (see column 2, lines 28-46).
Regarding claim 5, Hirotaka teaches sodium diluramidoglutamide lysine (which reads on a compound of formula (1), see ¶s 0033-0034 and Table 1 of the specification).
Regarding claim 6, Hirotaka and Erhardt combine to disclose: i) stearoyl inulin (Erhardt, column 2, lines 28-46, Example 10); and ii) dextrin palmitate, sodium diluramidoglutamide lysine (Hirotaka, see discussions above).
Regarding claim 7, Hirotaka discloses octyl palmitate (see ¶ 0009).
Regarding claim 8, Hirotaka teaches that oil can be from 40-95% (see 0010), which encompasses the claimed 60-90%.
Regarding claim 9, Hirotaka (see ¶ 0017), teaches polyglycerin among additional components of the oi-based cleansing composition.
Regarding claims 10 and 12, Hirotaka (see ¶ 0027), discloses a method for applying the composition onto skin.
Regarding claim 11, since Hirotaka and Erhardt combine to teach a composition of claim 1 that can be applied onto skin (see discussions above), a composition of Hirotaka and Erhardt must necessarily exhibit the same recited property of providing a high cleansing ability and good spreadability to the skin on which it is applied. An inherent characteristic may “be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan.” Endo Pharm. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir. 2018).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). 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. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629