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 .
Foreign Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/07/2023, 08/20/2024, and 07/01/2025 are being considered by the examiner. Many of the foreign patents only have English translations of the abstract, therefore, only the abstract is considered. Further, one of the foreign patents in the IDS filed on 08/07/2023 does not have an English translation and is not being considered.
Election/Restrictions
In regards to the restriction requirement, Applicant’s election of Group I – claims 1-9 and 13 in the reply filed on 03/03/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
In regards to the species requirement, Applicant's election with traverse of species A – composition 2B from the instant specification in the reply filed on 03/03/2026 is acknowledged. The traversal is on the ground(s) that none of the claims are currently directed towards different ingredients of national origin. Applicant further cites MPEP 806.04, “Where an application includes claims directed to different embodiments or species that could fall within the scope of a generic claim, restriction between the species may be proper if the species are independent or distinct”. This is not found persuasive because:
It is first noted that the claims do not include the limitation of “national” origin as claimed by Applicant. Further, in regards to the requirement for election of “ingredients of natural origin”, Applicant is reminded that the instant case is a 371 of a PCT and thus subject to restriction under PCT rule 13.1, as the examiner provided prior art and broke unity showing the technical feature of the instant claims is ‘common’ and not special (see page 7 of the restriction for the explanation made of Pujol et al).
Per Annex B Unity of Invention, (b) technical feature, Rule 13.2 states:
The expression "special technical features" is defined in Rule 13.2 as meaning those technical features that define a contribution which each of the inventions, considered as a whole, makes over the prior art.
As stated in the restriction/election requirement, the groups lack unity of invention because even though the inventions of these groups require the same technical feature, this technical feature is not a special technical feature as it does not make a contribution over the prior art. Therefore, the groups lack unity of invention.
Overall, Applicant’s argument is not found persuasive because unity was broken based off of the originally filed claims. Furthermore, over Pujol et al, the prior art below in the USC 103 rejections teaches the same issue with the amended claims, thus unity remains broken. Thus, the requirement is still deemed proper and is therefore made FINAL.
Upon further search and consideration, the species A) ingredients of natural origin has been broadened to include: the components of composition 2B from the instant specification, vegetable oil, fatty acids, algae extracts, plant exudates, seed extracts, microorganism exudates e.g. alcasealan (INCI: Alcaligenes Polysaccharides), hyaluronic acid, and organic compounds.
Claim Interpretation
In regards to claims 1-2, as to the limitation of ‘is stable in the form of an emulsion’ it is noted that the instant claims are composition claims and future intended use, such as use in an emulsion, is not given patentable weight. Thus any composition comprising the fatty phase and aqueous phase of instant claim 1 will meet this limitation.
In regards to claim 8, as to the limitations of ‘the fatty phase has a melting point of between 50oC and 100 oC, and at ambient temperature and atmospheric pressure, satisfies the following physiological criteria: a hardness (x) of between 2 and 14 N; and a tackiness (y) greater than or equal to -2N’ applicant is reminded this is a composition/product claim and the prior art teaches the fatty phase of the instant claim 1 from which claim 8 depends thereby since a product is not separable from its physical properties then it necessarily teaches the properties of the fatty phase as claimed by instant claim 8. Further, the prior art teaches a composition described by applicants instant application, but applicants observation that it also has ‘a hardness of between 2 and 14 N’ or ‘a tackiness greater than or equal to -2N’ does not give it patentable weight, since it is the same composition, as adding a characterization to a prior art patented invention is not patentable.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claims recite a composition comprising ‘a composition comprising at least one fatty phase and at least one aqueous phase…the composition comprises a percentage of ingredients of natural origin that is greater than or equal to 95%’. This judicial exception is not integrated into a practical application because the claims only recite natural products (i.e., natural origin), without any additional elements recited that are sufficient to amount to significantly more than the judicial exception. For example, as outlined by Pujol (US20200129413A1, published 04/30/2020, referenced in the ISR and previous office action) in the 35 U.S.C. 103 rejection below, a fatty phase and aqueous phase composition may be comprised of vegetable oil (claims 1, 5, and 7), specifically fatty acids, and natural texturizing agents such as microorganism exudates e.g. alcasealan (INCI: Alcaligenes Polysaccharides) ([0288]), and spring or floral water ([0032-0033]), and organic solid fats (claim 1 and 8) which are all natural ingredients meeting the limitations of instant claim 1 as outlined below. Thus, the limitations of the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims either only recite natural products, without any additional elements recited, or the additional elements (i.e., lipophilic gelling agent) do not change the structure, function, or other properties of the natural product as to integrate the judicial exception into a practical application. A detailed analysis follows.
The claimed invention is directed to a composition comprising: a composition comprising at least one fatty phase and at least one aqueous phase wherein at 60% or more of the droplets of the dispersed phase have a diameter greater than or equal 250 µm and the dispersed phase comprises from 1-60% of the composition, the composition is free of amodimethicone, and the composition comprises a >95% percentage of ingredients of natural origin. These compositions are not markedly different from their closest naturally occurring counterpart (i.e. vegetables) because there is no indication that the ingredients of natural origin (i.e. vegetable oil) which comprise the claimed composition has caused the composition to have any characteristics that are markedly different from the naturally occurring plants or organisms.
Claims 6 and 7 further add a hydrophilic gelling agent (i.e. microorganism exudates e.g. alcasealan (INCI: Alcaligenes Polysaccharides) as provided as an example by Pujol) and a lipophilic gelling agent (i.e. organic solid fats) to the composition. These additions to the composition do not provide any limitation that would cause the composition to have any characteristics that are different from the naturally occurring components (i.e. microorganisms). Again, as cited for example, Pujol claims a fatty phase contains at least one gelling agent and the gelling agent is selected from a group consisting of: organic or mineral, polymeric or molecular lipophilic gelling agents; fats solid at ambient temperature and pressure, and mixtures thereof (claim 1 and 8).
Under the 101 analysis for patent eligibility:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
The claims are drawn to a composition of matter.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claims are drawn to a product of nature, ingredients of natural origin, because there is no indication that the ingredients that comprise the claimed composition, have any characteristics that are different from the naturally occurring components. There is no indication in the record of any markedly different characteristics (either structural or functional) of the composition as broadly claimed.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the Judicial Exception into a practical application?
No. As stated above, claims 6 and 7 lists additional elements, however, the additional elements may contain natural products. Thus, claims 1-9 and 13 do not recite additional elements that are sufficient to amount to significantly more than the judicial exception, as there is no indication that naturally occurring components such as lipophilic gelling agent (i.e. organic fatty acids as evidenced in the example by Pujol) to have any characteristics that are different from the naturally occurring components.
Step 2B: Does the claim recite additional elements that amount to significantly more than the Judicial Exception?
Each of the elements recited in the claims are natural products and additional elements which do not integrate the judicial exception into a practical application. No other limitations are recited in instant claims 1-9 and 13 that would add significantly more to the Judicial Exception.
Accordingly, the claimed composition recites a natural product that is not markedly different in structure from naturally occurring elements and hence reads on patent ineligible subject matter under the above guidelines. See MPEP 2106.07.
To transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature. Essentially, appending conventional steps specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible. The Court provides long standing exceptions (laws of nature, natural phenomena, and abstract ideas) to categories of patent eligibility defined in 35 U .S.C.§ 101. A claim that recites a law of nature or natural correlation, with additional steps that involve well- understood, routine, conventional activity previously engaged in by researchers in the field is not patent-eligible, regardless of whether the steps result in a transformation for the reasons cited above.
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.
Claim(s) 1-9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pujol et al. (US20200129413A1, published 04/30/2020, referenced in the ISR and previous office action, hereafter Pujol) as evidenced by J.M.B. (B., J. M. (2017, January 5). ALCALIGENES polysaccharides. CosmetoScope. Retrieved from http://cosmetoscope.com/2017/01/alcaligenes-polysaccharides/, hereafter JMB).
As evidenced by JMB, Alcaligenes Polysaccharides is a water gelling agent (page 1, paragraph 1).
Pujol claims a dispersion containing a dispersed phase comprising drops and a continuous aqueous phase, wherein the drops comprise a fatty phase (claim 1; according to the claim limitations of the instant claim 1). Pujol claims the that at least 60% of the drops have a mean diameter larger than or equal to 100µm, specifically in the dispersed phase (claims 2-3; according to the claim limitations of the instant claim 1). Pujol claims a composition comprising the dispersion in association with a physiologically acceptable medium (claim 14; according to the claim limitations of the instant claim 1 ). Pujol teaches multiple example compositions comprising from 18 to 38% fatty phase, about 15% continuous phase, and q.s. water ([0363]; according to the claim limitations of the instant claim 1). Pujol teaches the continuous phase to comprise water, specifically natural spring water or floral water ([0032-0033]; according to the claim limitations of the instant claim 1). Pujol claims the fatty phase comprises a non-volatile hydrocarbon oil H1 and claims the oil to be a vegetable oil (claims 1 and 5; according to the claim limitations of the instant claims 1 and 4). Pujol further claims the hydrocarbon oil to be fatty acids, specifically oleic acid, eicosenoic acid, docosanoic acid, docosadienoic acid, and mixtures thereof (claim 1 and 7; according to the claim limitations of the instant claims 1 and 4). Pujol teaches the dispersions of the invention are composed of a population of monodisperse drops in particular such that they have a mean diameter D of 100µm to 3000µm, preferably 500 µm to 3000 µm ([0306]; according to the claim limitations of the instant claims 1 and 5). Pujol teaches the addition of hydrophilic texturizing agents, such as natural texturizing agents selected in particular from among algae extracts, plant exudates, seed extracts, microorganism exudates e.g. alcasealan (INCI: Alcaligenes Polysaccharides), and other natural agents in particular hyaluronic acid ([0288]; according to the claim limitations of the instant claims 1 and 6). Further, Pujol claims the fatty phase contains at least one gelling agent and the gelling agent is selected from a group consisting of: organic or mineral, polymeric or molecular lipophilic gelling agents; fats solid at ambient temperature and pressure, and mixtures thereof (claim 1 and 8; according to the claim limitations of the instant claims 4 and 7). Pujol claims the gelling agent comprising from 0.5 to 99% by weight of the fatty phase (claim 9; according to the claim limitations of the instant claim 4). Pujol claims the composition bases is an organic base ([0039]; according to the claim limitations of the instant claim 1). Pujol teaches the drops of the dispersion is free of shell or membrane, specifically a polymeric membrane and further the drops of a dispersion of the invention are not stabilized by means of a coacervate membrane (of the type anionic polymer (carbomer)/cationic polymer (amodimethicone) ([0044]). Pujol teaches the amodimethicone lacks compatibility with vegetable oils and leads to poor solubilization ([0060]; according to the claim limitations of the instant claim 1). Pujol claims the lipophilic fatty compound has melting point lower than 60° C and a hardness lower than or equal to 6 MPa ([0196]; according to the claim limitations of the instant claim 8). Pujol further teaches the dispersion do not comprise a surfactant ([0041]; according to the claim limitations of the instant claim 9). Lastly, Pujol teaches the first embodiment of the invention is free of a shell or membrane, in particular of a polymeric membrane or formed by interfacial polymerization. In particular, the drops of a dispersion of the invention are not stabilized by means of a coacervate membrane (of the type anionic polymer (carbomer)/cationic polymer (amodimethicone)) ([0043]; according to the claim limitations of the instant claims 1, 3, and 13). Pujol further teaches the lack of shell to mean the contact between the continuous aqueous phase and dispersed fatty phase is direct ([0045]; according to the claim limitations of the instant claims 1, 3, and 13).
Pujol does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Pujol with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[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. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
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 1-9, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8, 10, and 12 of copending Application No. 18/058557.
18/058557 claims a dispersion comprising a fatty phase, in the form of drops, dispersed in an continuous aqueous phase and wherein the fatty phase comprises at least one lipophilic gelling agent (claim 1; according to the claim limitations of the instant claims 1 and 7). Claim 1 of 18/058557 further claims the fatty phase has a melting point between 50°C and 100°C, preferably between 60°C and 90°C, and, at room temperature and atmospheric pressure, meets the following physical/chemical criteria: - a hardness (x) of between 2 and 14 N, preferably between 2.5 and 12 N, more preferably between 3 and 9 N, and most preferably between 4 and 6 N; and - an adhesiveness (y) greater than or equal to -2 N, or better still, greater than or equal to -1 N, and in particular greater than or equal to -0.6 N; and - the dispersion does not comprise amodimethicone (according to the claim limitations of the instant claims 1 and 8). Claim 4 of 18/058557 claims the dispersion does not comprise a shell, in particular a shell formed by a coacervate layer interposed between the dispersed fatty phase and the continuous aqueous phase (according to the claims limitations of the instant claims 3 and 13). Claim 5 of 18/058557 claims the drops having a diameter greater than or equal to 100 μm represent a volume greater than or equal to 60%, or even greater than or equal to 70%, preferably greater than or equal to 80%, and better still, greater than or equal to 90% of the total volume of the dispersed phase and/or at least 60%, or even at least 70%, preferably at least 80%, and better at least 90%, of the drops have an average diameter greater than or equal to 100 μm (according to the claim limitations of the instant claim 1). Claim 6 of 18/058557 claims the lipophilic gelling agent is selected from organic or inorganic, polymeric or molecular lipophilic gelling agents; solid fats at ambient temperature and pressure; and mixtures thereof (according to the claim limitations of the instant claims 1 and 7). Claim 8 of 18/058557 claims the continuous aqueous phase comprises at least one hydrophilic gelling agent, preferably selected from the group consisting of natural gelling agents; semi-synthetic gelling agents; synthetic gelling agents; and mixtures thereof, and preferably is selected from Carbomer, alkasealan (INCI: Alcaligenes Polysaccharides), and their mixture (according to the claim limitations of the instant claims 1 and 6). Claim 10 of 18/058557 claims the dispersion comprising from 1% to 60%, in particular from 5% to 50%, preferably from 10% to 40%, and more preferably from 15% to 30%, by weight of dispersed fatty phase relative to the total weight of the dispersion (according to the claim limitations of the instant claim 1). Claim 12 of 18/058557 claims he dispersion does not comprise surfactants (according to the claim limitations of the instant claim 9).
18/058557 does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of 18/058557 with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[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. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results. This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611