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 .
Priority
This application claims priority to US 63/014202, filed 04/23/20 and EPO 20176133.5, filed 05/22/20.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/27/26 has been entered.
Reminder to Applicants
Applicants are respectfully reminded that the proper way of making amendments is to underline the added claim limitations and strikethrough the deleted limitations, etc. See MPEP 714. Applicants reply filed 03/27/26 has not properly marked up applicant’s amended claims so that any changes are clear to the examiner as applicants merely deleted material from the claims and inserted new limitations with no markings to make it clear what was deleted and/or added to claim set. In the future, if amendments are not in accordance with 37 CFR 1.121 (See MPEP 714) the office will notify applicants via a Notice of Non-Compliant Amendment.
Status of Claims
Claims 1-2, 4-5, and 13 are being examined in the application. Claims 3, 6-8, 11-12 remain withdrawn as being directed to a non-elected invention.
Claim Interpretation
Applicants have now amended the claims to require wherein the preservative agent and the polyglycerol ester are present in the composition in a synergistic mixture. The specification states at [0026] As used herein, a "synergistic interaction" refers to the fact that the preservative, when combined together the polyglycerol ester has a total antimicrobial/antifungal effect that is greater than the antimicrobial/antifungal properties of the preservative alone, or the polyglycerol ester alone. In other words, the preservative of the present disclosure operates
synergistically with the polyglycerol ester so as to have greater antimicrobial/antifungal activity in the presence of each against a certain microorganisms than in comparison to the antimicrobial activity of the preservative alone or the antimicrobial activity of the polyglycerol ester alone at the same concentrations.
Thus, applicants are their own lexicographer and have defined synergy to mean something different from the art known definition, specifically that the claimed combination of the polyglyceryl ester and the preservative two claimed agents only has to exhibit activity that is any degree greater than the antimicrobial/antifungal properties of the preservative alone, or the polyglycerol ester alone.
Thus, any increase in activity observed and/or expected with the combination over the preservative alone or the polyglycerol ester alone that is reported by the prior art would read on the claimed “synergistic effects” in the absence of evidence to the contrary.
The examiner is also broadly interpreting “acid compound” in claim 1 to include acids and/or any acid derivative, e.g. acids, salts of acids, esters of acids, amides of esters, anhydrides of acids. Thus, claim 4 further limits claim 1.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 recites that the weight ratio of the polyglyceryl-10 caprylate/caprate to the preservative agent is in the range of 0.0001 to 1. However, ratios are by definition the comparison of two or more numbers. Thus,by reciting that they are claiming a weight ratios in the range of… it appears that applicants mean weight ratios in a range of 0.001:1 to 1:1 in the claim because they are comparing the weight ratios of polyglycerol ester to the preservative agent. However, the ratios as written contain no value for the preservative agent. Rewriting the ratios as 0.001:1 to 1:1 would overcome this objection.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 2 is 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. Claim 2 recites the exact same ratio range which is already claimed in claim 1 from which claim 2 depends. Thus, this claim 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 § 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(s) 1-2, 4-5, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allef et al. (US20060198859) as evidenced by Smith, III et al. (US20150250697) and Elchemy (https://elchemy.com/blogs/chemical-market/potassium-sorbate-vs-sodium-benzoate).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1-2, 4-5, Allef teaches preservative compositions which can comprise the claimed organic acid, specifically the instantly claimed citric acid or the instantly elected benzoic acid in the form of a sodium benzoate salt which as evidenced by Elchemy is another known antimicrobial/preservative (see entire document; at a glance section; spectrum of activity section specifically bullet points relating to sodium benzoate), and a polyglyceryl ester (See entire document; e.g. formulations 11-12, [0020-0028]; [0030-0033]; [0035, polyglycerol esters]; [0041-0044]; [0048]). Allef teaches where their polyglyceryl esters can be the specifically claimed polyglyceryl fatty esters, specifically polyglyceryl esters containing 3 glycerol groups but they broadly teach wherein their compounds can contain up to 10 glycerol units and wherein the fatty acids used to form the esters are preferably caprylic and capric acid ([0027]; [0020]) and as such would broadly include the claimed polyglyceryl-10 caprylate/caprate (mixture of C8 and C10 carboxylic acids), which are instantly claimed because Allef teaches wherein their fatty acids/fatty esters are those having 6 to 14 carbon atoms in the fatty acid portion with up to 10 glyceryl units which encompasses the claimed polyglyceryl-10 caprylate/caprate and wherein their compositions can be used as preservatives (See entire document; e.g. formulations 11-12, [0020-0028]; [0030-0033]; [0035, polyglycerol esters]; [0041-0044]; [0048]).
Allef exemplifies a similar composition to that of the instant invention in formulation 12 which comprises polyglyceryl-3 caprylate and citric acid together in the composition in ratios of 0.5:0.42 which is 1.19:1 which is very close to the instantly claimed ratio of 1:1. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
Additionally, because one of ordinary skill in the art when forming the claimed composition would reasonably expect the combination of two known preservative/antimicrobial compounds when used as preservatives in combination with each other to exhibit preservative/antimicrobial activity which is greater than the antimicrobial/antifungal properties of the preservative when used alone, or the polyglycerol ester when used alone, which would mean that the composition of Allef would obviously read on “synergistic” limitation of the instant claims as they are currently written because it would be obvious to make the claimed combination of citric acid and the polyglyceryl-10 caprate/caprylate in the claimed ratios which are very close to the ratios taught in example 12 by substituting the polyglycerol-3 caprate/caprylate ester for the claimed polyglyceryl-10 caprate/caprylate would be expected to exhibit activity which is greater than the than citric acid alone, or the polyglycerol-3 caprate/caprylate ester alone and as such would read on the claimed synergistic mixture since applicant’s have defined synergy contrary to the art known definition in that even the slightest increase over the preservative agent alone or the polyglyceryl ester alone is synergistic as per applicant’s specification as discussed above.
Regarding claim 13, Allef teaches formulation 12, which is an anti-dandruff shampoo which is an end-use formulation comprising the preservative agent according to claim 1, and because its formulated into an anti-dandruff shampoo it is a personal care formulation/comprises a personal care formulation as is instantly claimed (See formulation 12), and it would be obvious to substitute the polyglyceryl-10 caprate/caprylate for the polyglyceryl-3-caprylate in example 12 in order to form the instantly claimed composition because Allef teaches that the claimed polyglyceryl-10 caprate/caprylate is one of their claimed/disclosed glyceryl fatty acid esters which is useful in their invention for use as a preservative/antimicrobial which is the same use of the instantly claimed compositions.
Regarding claims 1, 4-5, and 13, Allef additionally teaches wherein the preservative can be instantly elected benzoic acid, specifically sodium benzoate which is a salt of benzoic acid and wherein the benzoic acid/sodium benzoate can be used in combination with polyglyceryl-fatty acid esters and broadly teaches the now required by all claims polyglyceryl-10 caprate/caprylate, to form personal compositions and they specifically teach using their combinations of polyglyceryl fatty acid esters and acids (including the claimed acids) in personal care formulations, e.g. toothpastes and shampoos, etc. in mixing ratios of ester and salt which are not typically limited as they can vary over wide ranges (See entire document; formulations 11-12; [0020-0028]; [0030-0033]; [0035, polyglycerol esters]; [0037-0038]; [0040] [0041-0044]; [0048]; [0020]; [0027]).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)/Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
Allef does not exemplify the claimed polyglyceryl-10 caprate/caprylate in combination with the claimed acids, including the claimed citric acid or the instant elected benzoic acid/sodium benzoate.
It would be obvious to one of ordinary skill in the art at the time of the instant filing to substitute the polyglyceryl-10 caprate/caprylate for the polyglyceryl-3-caprylate in example 12 in order to form the instantly claimed composition because Allef teaches that the claimed polyglyceryl-10 caprate/caprylate is one of their claimed/disclosed glyceryl fatty acid esters which is useful in their invention for use as a preservative/antimicrobial which is the same use of the instantly claimed compositions.
It also would have been obvious to one of ordinary skill in the art at the time of the instant filing to have substituted the elected sodium benzoate of Example/Formulation 11 that is broadly taught by Allef into the formulation of 12 in place of the citric acid in order to form the claimed invention because Allef teaches using citric acid and sodium benzoate as preservatives in their compositions and as evidenced by Smith, III these preservatives are known in the art to be alternative preservatives for use in personal care compositions and as such are interchangeable alternatives for the same purpose (see Smith, III: [0047]).
It also would have been obvious to one of ordinary skill in the art to have optimized the ratio of the acid to the polyglyceryl-10 caprate/caprylate to read on the claimed 1:1 because this ratio is very close to the ratios disclosed by Allef in their example 12 and because it is known, “A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art 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. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments/Remarks
Applicant’s amendments to the claims have overcome the previous 102 rejections and as such these rejections are hereby withdrawn. Applicant’s amendments to the claims have prompted the new claim objections, 112(d) rejections and the updated/new 103 rejections presented herein. Applicant’s arguments have been fully considered but are not persuasive at this time. Applicant’s arguments insofar as they pertain to the new grounds of rejection are addressed herein.
Applicants argue that Allef teaches that the mixing ratio of the ester to the salt is basically unimportant and as such one of ordinary skill in the art would not find guidance to select the specifically curated ratios of the present invention. The examiner respectfully disagrees because firstly, applicants have defined synergy contrary to its art known meaning and as such applicants have not actually demonstrated any criticality of their argued “synergistic results” because applicant’s have defined synergy to only require the results to be more than the acid when used alone or the glyceryl ester when used alone, whereas the standard definition for synergy is when the observed result(s) is/are greater than the expected additive result of the combination. Thus, applicants have not demonstrated that their results are unexpectedly different from those achieved in the closest prior art Allef. Especially since Allef exemplifies using the glyceryl ester to the claimed acid in ratios very near to those now claimed, as 1.19:1 is very close to 1:1. Further, applicants have not demonstrated any criticality of their claimed ranges which demonstrate that the instantly claimed ranges are not merely optimization of the ranges disclosed in Allef.
Applicants then argue that Allef entirely fails to contemplate efficacy. The examiner respectfully disagrees and respectfully points out that this argument is also not persuasive for the reasons which are already discussed above which are incorporated herein. Especially since while applicants argue that they have surprisingly discovered synergy, they are not defining synergy in a way which would actually be unexpected as the combination of two preservatives/antimicrobials would be expected to exhibit more activity in a composition when used as preservatives/antimicrobials than either of the compounds used alone.
As Doering is no longer being used as prior art, the arguments against this reference are moot at this time.
Applicants argue that Allef fails to teach the claimed weight ratio of polyglyceryl-10 caprylate/caprate with the claimed preservative agents, specifically the elected acid in the claimed range and that this distinction is not trivial. They further argue that their ratios were carefully curated and are different from those of Allef which teaches that the ratios of the ester to the salt are not really important since the can be varied across a broad range. The examiner respectfully points out that as discussed elsewhere herein applicants have not demonstrated any criticality of their claimed range or that their claimed range achieves a different invention from that of Allef, e.g. that the result is difference in kind rather than degree, and the compositions of Allef do not already achieve applicant’s definition of synergy which is any increase over the polyglyceryl ester used alone or the acid used alone. The examiner also notes that applicants claimed range is incredibly broad and is from 1:1000 to 1:1 and applicants have not demonstrated that ratios containing higher amounts of the polyglycerol ester do not achieve their argued unexpected/synergistic results or that applicants results are not merely the results that would be achieve by combining the claimed polyglyceryl ester with the elected preservative, e.g. acids at any mixing ratio, e.g. that applicants argued unexpected results are not merely just the expected effects which occur with the claimed combination(s).
Applicants argue that their results are synergistic and that their data shows in every instance of table 2 each of the components when used alone show a log reduction lower than when the preservatives/acids were used in combination with the polyglyceryl esters. These results do not actually appear to be unexpected as asserted because as discussed above one of ordinary skill in the art would have expected a combination of two preservatives/antimicrobials to be more effective than when either component is used alone, e.g. one of ordinary skill in the art would have expected at least close to an additive result from the combination. Applicant’s have not clearly demonstrated that their argued synergistic results are actually synergistic, e.g. greater than the expected additive result, as true synergistic results would be unexpected. The burden is on applicant to demonstrate that their argued results/data in the specification is in fact unexpected and significant. The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). The examiner understands that applicants have defined synergy different/contrary to the art known definition. However, in defining synergy as such, applicants have not actually demonstrated that their argued combination do achieve “synergistic” results which are truly unexpectedly different from the compositions taught by Allef.
The examiner reviewed the data in table 2, and initially there are some issues because applicants have only tested PGE 125 ppm but they have used different concentrations in their examples which makes a direct comparison impossible. Secondly, because applicant’s have been their own lexicographer with respect to the term “synergistic” it is not clear from applicant’s data that there is any criticality to the claimed ratios or that not all ratios of polyglyceryl ester to the preservative/acid applicants would achieve applicant’s definition of synergy and that this is not just a property of the claimed combination(s). Thus, without any comparison data, applicants have not made it clear that their combinations are in fact patentably different/distinct and not obvious over those taught by the prior art as discussed above.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art 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. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN E HIRT/Primary Examiner, Art Unit 1616