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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 and 12-14 in the reply filed on 03/30/2026 is acknowledged.
Claims 16, 18, 19, 21, and 23-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/30/2026.
Claims 1-10 and 12-14 are under current examination.
Claim Objections
Claims 12-14 are objected to because of the following informalities:
The examiner recommends amending the phrase “the other 10%” in claim 12, line 3 to “the remaining 10%”.
The examiner recommends amending the phrase “the other 90 number percent” in claim 13, line 3 to “the remaining 90%”.
The current phrasing of claim 14 is awkward because the group of plasticizers combines distinct Markush group formats and the list of acetate esters of glycerol reads in such a way to include substances that are not acetate esters of glycerol (e.g. TEC). The readability of claim 14 would be improved if the claim were amended to recite a consistent Markush group style and avoid listing substances that are not glycerol esters within the Markush group identifying the acetate esters of glycerol. Please refer to MPEP 2173.05(h): When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “A water insoluble micro-dispersion comprising … water”. The examiner considers this language to be internally contradictory, and therefore indefinite, because the phrase “water insoluble” is applied to the entire micro-dispersion composition as the claim is currently worded; however, water itself is necessarily dissolvable in water. In the interest of compact prosecution, the phrase water insoluble is interpreted to read on any water insoluble substance in the microdispersion.
Claim 2 recites “A water insoluble micro-dispersion comprising … water”. The examiner considers this language to be internally contradictory, and therefore indefinite, because the phrase “water insoluble” is applied to the entire micro-dispersion composition as the claim is currently worded; however, water itself is necessarily dissolvable in more water. In the interest of compact prosecution, the phrase water insoluble is interpreted to read on any water insoluble substance in the microdispersion.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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 6 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 6 recites “wherein water is present in an amount of at least about 98% by total weight of the microdispersion"; however, claim 1, from which claim 6 depends places an upper limit on water of “not more than about 98% by total weight of the composition”. Accordingly the scope of claim 6 is outside the scope of the claim 1 and thus claim 6 fails to include all the limitations of the claim upon which it depends.
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 § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2 and 3 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hayakawa et al. (WO2020162303; publication date: 08/13/2020; effective filing date of priority document: JP 2019-018101 02/04/2019) citing the US National Stage Application as an English translation: US 20220127435).
With regard to claim 2, Hayakawa discloses a 10 % aqueous dispersion of spherical calcium alginate beads (i.e. 10% dispersed particles of calcium alginate and 90% water; 0112). The particles are hydrophobized, i.e. water-insoluble. Figure 1, drawing sheet 1 establishes the particles to have micron size range, therefore the composition is a microdispersion.
With regard to claim 3, the composition does not contain a plasticizer.
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.
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.
Claims 1-10 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hayakawa et al. (WO2020162303; available as prior art under 35 USC §§ 102(a)(1) and (a)(2); publication date: 08/13/2020; effective filing date 02/04/2019; citing the US National Stage Application as an English translation: US 20220127435).
With regard to claims 1, 6, and 7, Hayakawa discloses example compositions having 41% wt water,1% ethylene glycol and 2% propylene glycol (both polyols, i.e. a total amount of 3% wt plasticizer), and 3% wt particles A1 or A6 (calcium alginate particles of micron size range; 0111-0112 and 0128-0131). The amount of calcium alginate particles fall within the range required by instant claim 1. The plasticizer is present in the composition at 100% by weight relative to the calcium alginate particles.
Claims 1, 6, and 7 are considered prima facie obvious because the amount of water falls just below the lower limit recited in the instant claims; however, Hayakawa teaches varied uses for the particles (0011) and teaches that the particles are preferably present in e.g. cosmetic compositions in amounts ranging from 0.5 to 50% wt (0105), with corresponding ranges in other ingredients, including water, also implicitly taught. In view of the many applications taught for the calcium alginate microparticles, the examiner does not consider the claimed range of 50-98% by weight water to patentably define over the cited prior art, absent criticality to some unexpectedly superior performance of the composition. Please refer to MPEP 2144.05(II): 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); see also In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") See also MPEP 2144.05(I): 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).
With regard to claims 2 and 3, as noted above Hayakawa anticipates claims 2 and 3 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103(a) over Hayakawa for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))). Moreover, as noted with regard to claim 1 above, Hayakawa teaches a wide range of applications for the particles and that a broad range in amount is suitable, 0.1 to 50% wt (0105) and thus implicitly teaches a range of 99.9 to 50% wt of other ingredients. This range overlaps with the range required by instant claim 2 for amount of calcium alginate particles. Many of the applications would employ aqueous compositions, including paints, emulsions, creams, sunscreens, aftershave, makeup bases, facial cleansers etc. therefore Hayakawa implicitly teaches a range for water overlapping with the range required by the instant claims (see MPEP 2144.05). These compositions do not require plasticizers and the examiner does not consider the range in amount of water recited in instant claim 2 to patentably define over the cited prior art in the absence of a persuasive showing of criticality to an unexpectedly superior property of the instant invention.
With regard to claims 4 and 5, as noted above, the example composition contains ethylene glycol + propylene glycol (plasticizers) in a weight ratio of 100% relative to the weight of the calcium alginate particles.
With regard to claims 8 and 9, as noted above, Hayakawa teaches a range in amount of calcium alginate particles of from 0.1 to 50% (0102). This range overlaps with the range required by the instant claims. See MPEP 2144.05(I): 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).
Claims 10, 12, and 13 recite limitations on the Dn50, Dn90, and Dn10 for the calcium alginate particles. Hayakawa teaches a particle size that is preferably 5 mm or less, and more preferably, in order of increasing preference: 1 mm or less, 500 μm or less, 100 μm or less, 60 μm or less, 30 μm or less, 15 μm or less, or 10 μm or less. The lower limit is preferably at least 0.1 μm, more preferably at least 0.5 μm, and even more preferably at least 1.0 μm. Thus, the examiner considers Hayakawa to teach a range of particle sizes, including the particle size parameters required by instant claims 10, 12, and 13, that embraces the ranges required by the instant claims. See MPEP 2144.05(I), as noted above.
With regard to claim 14, as noted above, Hayakawa discloses a polyol in an example composition.
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, 2, 4-10, and 12-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12,15-17, 19, 20, and 22-24 of copending Application No. 18292990 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
The claims of the ‘990 application embrace a water insoluble micro-dispersion comprising a) dispersed particles of alginic acid in an amount of about 1% to about 10% by total weight of the micro-dispersion, and b) a plasticizer in an amount of about 2% to about 6% by total weight of the micro-dispersion, and c) water in an amount of at least about 88% to not more than about 96% by total weight of the micro-dispersion. The amounts of each substance and particle size ranges required by the copending application overlap with the ranges for these parameters recited in the instant claims. See MPEP 2144.05(I). The plasticizer is a polyol or acetate esters of glycerol selected from mono-, di-, and tri-acetates of glycerol, TEC (triethyl citrate), dibutyl sebacate, and dibutyl phthalate.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
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