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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
Withdrawn Rejections:
Applicant's amendments and arguments filed on 03/02/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicant’s elect specific ammonium salt as example 10g (table in [0380] of PGPub) with cation protonated N.N-dimethylaminopropyl oleic acid amide and anion deprotonated [(ricinoleic acid)2-stearic acid] estolide trimer is free of art, and the examination moves to the next species at the examiner’s choice, lauryl trimethyl ammonium]+ Estolide-COO- in the following 103 rejection. Claims 60, 62-63, 65-68, 71, 76, 90-97 and 108 read on the examined species (lauryl trimethyl ammonium]+ Estolide-COO-) and are under examination, claims 69-70, 73-75, 77-84, 98-107 and 109-110 do not read on the examined species (lauryl trimethyl ammonium]+ Estolide-COO-) and are withdrawn from consideration.
Claims 60, 62-63, 65-71, 73-110 are pending, claims 60, 62-63, 65-68, 71, 76, 90-97 and 108 are under examination.
Claims Objection
Claim 65 is objected for the following format issue. The status of claim is currently amended, however, however, there is no marking of change. Applicants need change status of claim, or marking the change of claim. Proper correction is required.
Claim Rejections - 35 USC § 112
Claims 60, 62-63, 65-68, 71, 76, 90-97 and 108 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of an organic ammonium salt in claims is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: an organic ammonium salt in claim 60 encompasses numerous different structures of cation and anion which do not share single structural similarity and common use. For example, as recited in applicant’s speciation, the cation has numerous varied structure such as histidine, N.N-dimethylaminopropyl oleic acid amide and quaternized cellulose; the anion varies from trimer acid ([(ricinoleic acid)2-stearic acid] estolide trimer), dendrimeric acid and structures defined by formula (v) and (VII). Thus, an organic ammonium salt from those cation and anion do not share substantial structural feature. Furthermore, since applicants failed to provide working examples with numerous different structures and demonstrated am common use among them, and the stricture and activity relationship has not been established. Thus, there is no evidence to show all the claimed compound have common use. This is indefinite.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Response to Argument:
Applicants argue that there is shared similar structure feature and common use in hair treatment.
In response to this argument: this is not persuasive. As discussed in the above rejections, the improper Markush grouping rejection is based on the rational that the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: as recited in applicant’s speciation, the cation has numerous varied structure such as histidine, N.N-dimethylaminopropyl oleic acid amide and quaternized cellulose; the anion varies from trimer acid ([(ricinoleic acid)2-stearic acid] estolide trimer), dendrimeric acid and structures defined by formula (v) and (VII). Thus, an organic ammonium salt from those cation and anion do not share substantial structural feature. Furthermore, since applicants failed to provide working examples with numerous different structures and demonstrated am common use among them, and the stricture and activity relationship has not been established. Thus, there is no evidence to show all the claimed compound have common use. This is indefinite and the improper Markush grouping rejection is still proper.
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 of this title, 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 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 60, 62-63, 65-68, 71, 76, 90-97 and 108 are rejected under 35 U.S.C. 103 as being unpatentable over Ishell et al. (US6051214).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Ishell et al. teaches shampoo composition comprising water, fatty acid estolide (Estolide-COOH) having the following formula and the pH is from about 4.5 to 8.5 (claims 1-4; column 2, line 5-31; column 5, line 50-55). The composition further comprises conditioner such as lauryl trimethyl ammonium chloride (column 4, line 43-67), and pH adjusting agent such as sodium hydroxide and sodium carbonate (column 5, line 25-30).
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Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Ishell et al. is that Ishell et al. is not specific enough for anticipation.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Ishell et al. teaches aqueous shampoo composition at pH 4.5-8.5 comprising lauryltrimethyl ammonium chloride ( [lauryl trimethyl ammonium]+Cl-) and Estolide-COOH. When pH is at or above 7 and sodium hydroxide is used as pH adjuster, Estolide-COOH is deprotonated and is in the form of Estolide-COO-Na+. Thus, there are [lauryltrimethyl ammonium]+Cl- and Estolide-COO-Na+ in the aqueous shampoo composition, and the equilibrium of the two species in the liquid shampoo results in the formation of [lauryltrimethyl ammonium]+ Estolide-COO- ( [lauryltrimethyl ammonium]+Cl- + Estolide-COO-Na+
⇋
lauryl trimethyl ammonium]+ Estolide-COO- + Na+Cl-). This is evidenced by applicant’s specification (page 124, line 15-20, example 10.m), when sodium salt of Estolide-COOH is used, true salt of [lauryltrimethyl ammonium]+ and Estolide-COO- is formed.
Since claims 60, 62-63, 65-68, 71, 76, 90-97 and 108 read on the [lauryltrimethyl ammonium]+ Estolide-COO-, the limitation is met.
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.
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 the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that Claims 98-99, 102-15, 107 and 109-110 read on the elected species example 10g (table in [0380] of PGPub) with cation protonated N.N-dimethylaminopropyl oleic acid amide and anion deprotonated [(ricinoleic acid)2-stearic acid] estolide trimer and should not be withdrawn.
In response to this argument: this is not persuasive. Applicant’s elected species is free of art and the examination moves to the next species at the examiner’s choice, lauryl trimethyl ammonium]+ Estolide-COO- in the following 103 rejection. Claims 60, 62-63, 65-68, 71, 76, 90-97 and 108 read on the examined species (lauryl trimethyl ammonium]+ Estolide-COO) and are under examination, claims 69-70, 73-75 and 77-84, 98-107 and 109-110 do not read on the examined species (lauryl trimethyl ammonium]+ Estolide-COO) and are withdrawn from consideration. Once the rejection of the examined species is overcome, the examination extends to other species encompassed in claim 60.
Applicants argue about hindsight and lauryl trimethyl ammonium chloride is optional ingredients. All related arguments are incorporated herein by reference.
In response to this argument: this is not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). MPEP 2123, “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
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A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also > Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); < Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998). Therefore, lauryl trimethyl ammonium chloride is properly relied on. As discussed in the above 103 rejection, Ishell et al. teaches aqueous shampoo composition at pH 4.5-8.5 comprising lauryltrimethyl ammonium chloride ( [lauryl trimethyl ammonium]+Cl-) and Estolide-COOH. When pH is at or above 7 and sodium hydroxide is used as pH adjuster, Estolide-COOH is deprotonated and is in the form of Estolide-COO-Na+. Thus, there are [lauryltrimethyl ammonium]+Cl- and Estolide-COO-Na+ in the aqueous shampoo composition, and the equilibrium of the two species in the liquid shampoo results in the formation of [lauryltrimethyl ammonium]+ Estolide-COO- ( [lauryltrimethyl ammonium]+Cl- + Estolide-COO-Na+
⇋
lauryl trimethyl ammonium]+ Estolide-COO- + Na+Cl-). This is evidenced by applicant’s specification (page 124, line 15-20, example 10.m), when sodium salt of Estolide-COOH is used, true salt of [lauryltrimethyl ammonium]+ and Estolide-COO- is formed. Therefore, the 103 rejection is still proper.
Applicants argue about experimental data 10.m and 10.l in the specification.
In response to this argument: this is not persuasive. As discussed in the above 103 rejection and response to argumnmet, prior art teaches [lauryltrimethyl ammonium]+Cl- and Estolide-COO-Na+ in the aqueous shampoo composition, and the equilibrium of the two species in the liquid shampoo results in the formation of [lauryltrimethyl ammonium]+ Estolide-COO- ( [lauryltrimethyl ammonium]+Cl- + Estolide-COO-Na+
⇋
lauryl trimethyl ammonium]+ Estolide-COO- + Na+Cl-). Applicant’s data of 10.m. exactly provides evidence of formation of salt of [lauryltrimethyl ammonium]+ and Estolide-COO-. Thus, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
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.
Claims 60, 62-63, 65-68, 71, 76, 90-97 and 108 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42-62 of copending Application No. 17786081 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches in claim 40 compound of formula (I), R1(-F)X, (same as compound of formula (i) in applicant’s claim 60); moiety of (-C(O)-X-R6)m-C(O)-X-R7 (IVa) (when X is O) read on the moiety of (VIII) in applicant’s claim 60; thus, the reference application teaches the same or substantially the same applicant’s claimed organic ammonium salt.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 60, 62-63, 65-68, 71, 76, 90-97 and 108 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 107-147 of copending Application No. 17786128 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches in claim 107 Quaternary ammonium compounds with anionic formula (V) -R6(-C(O)-X-R6)m-C(O)-X-R11 which (when X is O) read on formula (VIII) of applicant’s claim 60 ; thus, the reference application teaches the same or substantially the same applicant’s claimed organic ammonium salt.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Argument:
Applicants argue that the rejection is held in abeyance.
In response to this argument: this is not persuasive. Since no Td is filed, the double patenting rejection is proper and maintained for record.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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