DETAILED ACTION
Status of Claims
Claims 1-19 are currently pending. Claims 1-6, 11-12 and 14-18 are currently under consideration and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claims 7-10, 13 and 19 are withdrawn from consideration. 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 Office Action: Non-Final.
Election/Restrictions
Applicant’s election of the claims of Group I (claims 1-6, 11-12 and 14-18) in the response filed on December 10, 2025 (to the October 01, 2025 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claims of Group II (claims 7-10 and 19) and Group III (claim 13) are withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant has elected the claims of Group I with traverse. The traverse is based on applicant’ argument:
The applicant TRAVERES the Examiner's proposed division of the claims into the aforesaid groups, and assert that a concurrent search of the prior art could be made extending to the subject matter of all claims, without causing an undue burden on the Examiner. Hence, reconsideration of the requirement and its withdrawal is requested.
12/10/2025 Remarks, p. 2, par. 2.
In response: the establishment of burden on the Office applies to US cases only. The instant application is a national stage entry of an international application under 35 U.S.C. § 371. As a result, lack of unity practice is observed for restriction purposes.
Accordingly, the October 01, 2025 Requirement for Restriction is made FINAL, and claims 1-6, 11-12 and 14-18 are examined as follows.
Claim Objections
The following claims are objected to because of the following informalities: Claim 2 is objected to because the claim should read:
2. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 1, wherein the hydroxypropyltrialkylammonium hyaluronate and/or salt thereof is selected from the group consisting of: hydroxypropyltrimonium hyaluronate and/or salt thereof; hydroxypropyltriethylammonium hyaluronate and/or salt thereof; hydroxypropyltripropylammonium hyaluronate and/or salt thereof; and hydroxypropyltributylammonium hyaluronate and/or salt thereof.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112(d)- Not Further Limiting
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 35 U.S.C. § 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 14 is rejected under 35 U.S.C. § 112(d) or 35 U.S.C. § 112 (pre-AIA ), 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 14 is drawn to:
14. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 4 having a degree of cationization of at least 1.5.
which is depends on claim 4, which is drawn to:
4. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 1 having a degree of cationization of at least 1.5.
wherein both claims 4 and 14 are drawn to a “hydroxypropyltrialkylammonium hyaluronate and/or salt thereof” having a “degree of cationization of at least 1.5.” Therefore, claim 14 is not further limiting of claim 4. 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 U.S.C. § 102
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 –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 6 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by CHEN (CN 112190502 A, Publ. Jan. 08, 2021; Filed Sep. 21, 2020; as evidenced by English language translation of CN 112190502 A; on 08/29/2013 IDS; hereinafter, “Chen”).
Paragraph numbers for Chen refer to English language translation of CN 112190502 A.
Chen is directed to a hyaluronic acid quaternary ammonium salt compound. Chen, title & abstract. In this regard, Chen teaches a “hyaluronic acid quaternary ammonium salt complex” having “general formula (1),” wherein “the degree of substitution of the quaternary ammonium cation is preferably greater than 0.4 and less than 1.5”:
[0010] The hyaluronic acid quaternary ammonium salt complex of the present invention is also characterized in that the quaternary ammonium cation group is represented by the general formula (1),
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[0011] In the formula, R1 to R3 represent a hydrocarbon group having 1 to 4 carbon atoms, and X-represents a lactate ion or a chloride ion.
[0012] The hyaluronic acid quaternary ammonium salt complex of the present invention is also characterized in that the quaternary ammonium cation group is selected from 2-hydroxypropyltrimethylammonium ions with monovalent positive charge, 2-hydroxypropyltriethyl Ammonium ion, 2-hydroxypropyltripropylammonium and/or 2-hydroxypropyltributylammonium ion, preferably 2-hydroxypropyltrimethylammonium ion with a monovalent positive charge.
[0013] The hyaluronic acid quaternary ammonium salt complex of the present invention is also characterized in that the degree of substitution of the quaternary ammonium cation is preferably greater than 0.4 and less than 1.5, between 0.4 and 1.5.
Chen, par. [0010]-[0013], and Fig. 1 from p. 3 of CN 112190502 A.
Regarding independent claim 1 and the requirements:
1. A hydroxypropyltrialkylammonium hyaluronate and/or salt thereof, having a degree of cationization of more than 1.4.
Chen clearly teaches a “hyaluronic acid quaternary ammonium salt complex” having “general formula (1),” wherein “the degree of substitution of the quaternary ammonium cation is preferably greater than 0.4 and less than 1.5” (Chen, par. [0010]-[0013], and Fig. 1), WHEREBY it is noted:
a “hyaluronic acid quaternary ammonium salt complex” having “general formula (1)” (Chen, par. [0010]-[0011], and Fig. 1) reads on a “hydroxypropyltrialkylammonium hyaluronate and/or salt thereof” of claim 1;
wherein “degree of substitution of the quaternary ammonium cation is preferably greater than 0.4 and less than 1.5” (Chen, par. [0013]) reads on “a degree of cationization of more than 1.4” of claim 1 (see MPEP § 2131.03 regarding prior art anticipating claimed numerical ranges).
Thus, Chen anticipates claim 1.
Regarding claims 2-3 and 6 and the requirements:
2. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 1, wherein the hydroxypropyltrialkylammonium hyaluronate and/or salt thereof is selected from the group consisting hydroxypropyltrimonium hyaluronate and/or salt thereof; hydroxypropyltriethylammonium hyaluronate and/or salt thereof; hydroxypropyltripropylammonium hyaluronate and/or salt thereof; and hydroxypropyltributylammonium hyaluronate and/or salt thereof.
3. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 2, wherein the hydroxypropyltrialkylammonium hyaluronate and/or salt thereof is hydroxypropyltrimonium hyaluronate and/or salt thereof.
[…]
6. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 1, comprising or consisting of the chloride salt of hydroxypropyltrialkylammonium hyaluronate.
Chen teaches:
a “hyaluronic acid quaternary ammonium salt complex” selected from “2 hydroxypropyltrimethylammonium ions with monovalent positive charge” (Chen, par. [0012]), which reads on a “hydroxypropyltrimonium hyaluronate and/or salt thereof” of claims 2-3, and a “hydroxypropyltrialkylammonium hyaluronate” of claim 6; and
a “hyaluronic acid quaternary ammonium salt complex” having “general formula (1),” wherein “X-represents a […] a chloride ion” (Chen, par. [0010]-[0011], and Fig. 1), which reads on a “chloride salt” of claim 6.
Thus, Chen anticipates claims 2-3 and 6.
Claim Rejections – 35 U.S.C. § 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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.
Claims 1-6, 11-12 and 14-18 are rejected under 35 U.S.C. § 103 as being unpatentable over CHEN (CN 112190502 A, Filed Sep. 21, 2020; as evidenced by English language translation of CN 112190502 A; on 08/29/2013 IDS; hereinafter, “Chen”).
The teachings of Chen, as set forth in the above rejection of claims 1-3 and 6 under 35 U.S.C. § 102 (a)(2) are hereby incorporated. However, Chen DOES NOT EXPRESSLY TEACH the requirements of claims 4 and 14-16 for a particular“degree of cationization,” claims 5 and 17-18 for a particular “average molecular weight,” or claims 11-12 for a “cosmetic composition,” which are well within the purview of an ordinarily skilled artisan in light of Chen’s broader disclosure. In this regard, it is noted that a reference is analyzed using its broadest teachings. MPEP § 2123 [R-5] states: “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Regarding claims 4 and 14-16 and the requirements:
4. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 1 having a degree of cationization of at least 1.5.
[…]
14. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 4 having a degree of cationization of at least 1.5.
15. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 4 having a degree of cationization of at least 1.6.
16. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 4 having a degree of cationization of at least 1.7.
In this regard, it is noted that MPEP § 2144.05 (I), states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. 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).” Chen teaches a “hyaluronic acid quaternary ammonium salt complex” having “general formula (1)” (Chen, par. [0010]-[0011], and Fig. 1) selected from “2 hydroxypropyltrimethylammonium ions with monovalent positive charge” (Chen, par. [0012]) wherein “degree of substitution of the quaternary ammonium cation is preferably greater than 0.4 and less than 1.5” (Chen, par. [0013]). However, Chen also teaches that “the surface of human skin and hair is usually negatively charged” while “introduced quaternary ammonium-containing cationic groups into HA to improve HA on the surface of skin and hair Adhesion, thereby improving HA moisturizing, lubricating, nourishing and repairing effects”:
[0006] The natural HA produced by extraction or fermentation has extremely high hydrophilicity and viscoelasticity. It has many functions such as moisturizing, lubricating, nourishing, and repairing when applied to the skin surface. However, because the surface of human skin and hair is usually negatively charged, and natural HA is a negatively charged polyanionic polysaccharide, it is difficult to adsorb on the surface of hair and skin to function. CN101316864 (Shiseido, Japan), CN101715457A (Kewpie, Japan), CN107739417A (Yangzhou Zhongfu Biotechnology Co., Ltd.), CN107556402A (Chongqing Technology and Business University), etc. introduced quaternary ammonium-containing cationic groups into HA to improve HA on the surface of skin and hair Adhesion, thereby improving HA moisturizing, lubricating, nourishing and repairing effects. Cationization strengthens the adhesion of HA to skin and hair, but after the degree of cationization is increased to a certain level, satisfactory moisturizing effect and smoothness cannot be obtained. In order to solve this problem, on the basis of the prior art of the present invention, monovalent anion lactic acid is introduced into cationized HA to replace halide ions and form salts with part of quaternary ammonium cations, which overcomes the defects of the prior art and makes the higher degree of substitution Cationized HA can also obtain satisfactory moisturizing effect and smoothness. The hyaluronic acid quaternary ammonium salt complex prepared by the invention has high adhesion and high moisturizing properties, and can be widely used for preparing care products and cosmetics for improving skin and hair and repairing the stratum corneum.
(Chen, par. [0006]), while broadly teaching “[t]he hyaluronic acid quaternary ammonium salt complex of the present invention is characterized in that: (j) the substitution degree of quaternary ammonium cation is 0.1-2.0”:
[0009] The hyaluronic acid quaternary ammonium salt complex of the present invention is characterized in that: (j) the substitution degree of quaternary ammonium cation is 0.1-2.0; (2:) 20% to 80% of the quaternary ammonium cation groups form a salt with lactic acid.
(Chen, par. [0009]). In this respect, it is further noted, “[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and also MPEP § 2144.05(II)(A). In the instant case, “degree of substitution” or “degree of cationization” is clearly a result-effective variable, for which Chen teaches a “substitution degree of quaternary ammonium cation is 0.1-2.0” (Chen, par. [0009]) for “introduce[ing] quaternary ammonium-containing cationic groups into HA to improve HA on the surface of skin and hair Adhesion, thereby improving HA moisturizing, lubricating, nourishing and repairing effects” (Chen, par. [0006]). Therefore, it would have been customary for an artisan of ordinary skill to select an appropriate “degree of substitution” or “degree of cationization” per Chen’s broader disclosure in optimizing an HA for adhesion in order to obtain advantageous moisturizing, lubricating, nourishing and repairing effects, thus rendering the range requirements of claims 4 and 14-16 obvious.
Thus, Chen renders claims 4 and 14-16 obvious.
Regarding claims 5 and 17-18 and the requirements:
5. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according claim 1, wherein the hydroxypropyltrialkylammonium hyaluronate and/or salt thereof is prepared from a hyaluronic acid or a salt thereof having an average molecular weight of about 10 kDa to about 200 kDa.
[…]
17. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according claim 5, wherein the hydroxypropyltrialkylammonium hyaluronate and/or salt thereof is prepared from a hyaluronic acid or a salt thereof having an average molecular weight of about 15 kDa to about 150 kDa.
18. The hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according claim 5, wherein the hydroxypropyltrialkylammonium hyaluronate and/or salt thereof is prepared from a hyaluronic acid or a salt thereof having an average molecular weight of about 20 kDa to about 100 kDa.
Chen teaches “[t]he average molecular weight range of hyaluronic acid and/or its salt is selected from 10 kDa to 7000 kDa, preferably 200 kDa to 2000 kDa, more preferably 400 kDa to 1000 kDa”:
[0024] In step G) of the above preparation method, hyaluronic acid and/or its salt is selected from hyaluronic acid, sodium hyaluronate, potassium hyaluronate, zinc hyaluronate, calcium hyaluronate, magnesium hyaluronate, ammonium hyaluronate And/or one or a mixture of two or more of tetrabutylammonium hyaluronic acid; preferably sodium hyaluronate. The average molecular weight range of hyaluronic acid and/or its salt is selected from 10 kDa to 7000 kDa, preferably 200 kDa to 2000 kDa, more preferably 400 kDa to 1000 kDa.
Chen, par. [0024]. See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, Chen renders claims 5 and 17-18 obvious.
Regarding claims 11-12 and the requirements:
11. A cosmetic composition comprising the hydroxypropyltrialkylammonium hyaluronate and/or salt thereof according to claim 1 and a suitable carrier.
12. The cosmetic composition according to claim 11, wherein the cosmetic composition is a hair care or a skin care composition.
Chen teaches a “hyaluronic acid quaternary ammonium salt complex” added to “commonly used ingredients of cosmetics”:
[0033] The hyaluronic acid quaternary ammonium salt complex of the present invention is added to the commonly used ingredients of cosmetics and formulated into various forms such as solutions, gels, ointments, creams or emulsions, and can be used to prepare daily-use bath products, such as body wash, shampoo, care Hair conditioner, cleanser, shampoo, conditioner, shaving cream, shaving foam, shaving lotion, etc.; also can prepare daily care products, such as moisturizer, moisturizing spray, moisturizing facial mask, toner, toner, Skin lotion, exfoliating gel, acne gel, face cream, body cream, hand cream, foot cream, repair essence, moisturizer, moisturizing cream, repair cream, moisturizing lipstick, lip gioss, lip glaze, hair removal cream, Styling gel, hair repair gel, hair softener, etc.
(Chen, par. [0033]), wherein “various forms such as solutions, gels, ointments, creams or emulsions” are encompassed by a “suitable carrier” of claim 11 for a “cosmetic composition” of claims 11-12. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.
Thus, Chen renders claims 11-12 obvious.
Conclusion
Claims 1-6, 11-12 and 14-18 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611