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 .
DETAILED ACTION
Claims 1, 2, 6-9, 13-30, 32, 33, 37-42, 44, 45, 47-52 and 54-63 are pending in the Claim Set filed 6/10/2026.
No claim has been amended.
Claims 7-9, 17-23, 25-29 and 38-41 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 3-5, 10-12, 31, 34-36, 43, 46, 53 and 64-91 are canceled.
Herein, claims 1, 2, 6, 13-16, 24, 30, 32, 33, 37, 42, 44, 45, 47-52 and 54-63.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 6/12/2025 and 6/10/2026 have been considered by the examiner and an initialed copy of the IDS is included with the mailing of this office action.
Withdrawn Rejections
The rejection of claims 1, 2, 6, 13-16, 24, 30, 32, 33, 37, 42, 44-52 and 54-63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-50 of copending Application No. 17967267 is withdrawn because a Terminal disclaimer was filed 6/10/2026 (Approved 6/17/2026). Applicant’s arguments are moot in view thereof.
The rejection of claims 1, 2, 6, 13-16, 24, 30, 32, 33, 37, 42, 44-52 and 54-63 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-60 of U.S. Patent No. 12527804 is withdrawn because a Terminal disclaimer was filed 6/10/2026 (Approved 6/17/2026). Applicant’s arguments are moot in view thereof.
Claim Rejections - 35 USC § 112
(Rejection is maintained)
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.
The rejection of claim 2 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 is maintained.
Claim 2 recites: The composition of claim 1, the modified oil phase further comprising an oil.
Claim 1 recites: a modified oil phase which encompasses an oil; thus, claim 1 already has an oil. Applicant is reminded that a claim in dependent form must further limit or add a limitation to 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.
Response to Arguments
Applicants argue in the reply filed 6/10/2026 regarding rejections under 35 U.S.C. § 112:
A review of Applicant's specification reveals that the terms "modified oil phase" and "modified polar continuous phase" (and for that matter "water") are
used in the context of the hydrophobic and hydrophilic phases of an emulsion. Thus, "modified oil phase" as this term is used in Applicant's specification to can lack an "oil", as an oil is defined in Applicant's specification.
An example demonstrating this usage is found in paragraph [0078], which teaches how to modify other constituents of the microemulsion when the "oil" is omitted from the "modified oil phase" as defined in Applicant's specification.
Paragraph [0078] states:
While not shown in FIG. 3, the oil may be reduced to the point of omission from the method 300 if the amount of the sugar or sugar alcohol is simultaneously increased. For example, if the microemulsion 336 is formed with 5 % oil by weight and 56 % sugar alcohol by weight, a MOIW
microemulsion could be formed with 3 % oil by weight and 58 % sugar or sugar alcohol by weight or with 0 % oil and up to 63 % sugar or sugar alcohol by weight.
Hence, it is quite possible and explicitly stated in Applicant's specification that the modified oil phase of claim 1 is not required to include the oil of claim 2, thus, claim 2 limits claim 1. In this instance, the phospholipid, polyethylene glycol derivative, alcohol, and alcohol-soluble species constitute the "modified oil phase" without the inclusion of an "oil" as defined in Applicant's specification. Applicant requests withdrawal of the§ 112 rejection of claim 2 for failing to further limit the subject matter of claim 1 as claim 2 further limits the subject matter of claim 1 by specifying that the modified oil phase further includes an "oil".
Applicants argue the Office is invited to review the emulsion art as a whole where it is evident that while every emulsion includes a "water phase" and an "oil phase", what is actually being described is a polar phase and a less polar phase, hence a "water phase" does not have to include water and an "oil phase" does not have to include oil. One of ordinary skill in the art would be familiar Regardless, it is the text of Applicant's specification that controls how claim terms are interpreted, and in this instance Applicant's claim 2 is narrowing in relation to claim 1 as the term "modified oil phase" is defined by the
specification as being able to include 0% of an oil as also defined in the specification.
Applicants argue in the present Office Action of January 20, 2026 the Examiner continues to maintain this rejection for improper reasons. On page 10 the Examiner acknowledges that "While applicant is correct in that 'modified oil phase' may not comprise an oil, the rejection under 35 U.S.C. 112(d) is made because 'modified oil phase' is reasonably interpreted to encompass an oil being present in the 'modified oil phase'. Hence, the Examiner has acknowledged that Applicant's specification explicitly establishes that the defined term "modified oil phase" is not required to contain an oil, as an oil is defined in Applicant's specification.
Applicants argue there is no standard of "reasonable interpretation" permitting the teachings of Applicant's specification to be ignored in favor of an arbitrary definition. The Office is not permitted to create a new standard of claim interpretation lacking legal basis. Instead, claims must be interpreted in view of the specification. A patent Applicant is the lexicographer of the technology being described in a patent. An interpretation of Applicant's claim term without grounding in the specification and arbitrarily created by the Office from whole cloth may not be used to interpret a claim in contradiction to the plain language of the specification as that language would be understood by one of ordinary skill in the art.
As previously stated, it is common in the emulsion art to refer to a phase lacking an oil as an "oil phase" if the "oil phase" is more hydrophobic than the
water phase. Applicants’ usage of the claim term "modified oil phase" is explicit from the teachings of Applicant's specification and must be adopted by the office.
Applicants’ arguments have been fully considered but they are not persuasive. While applicant is correct in that ‘modified oil phase’ may not comprise an oil, the rejection under 35 U.S.C. 112(d) is made because ‘modified oil phase’ is reasonably interpreted to encompass an oil being present in the ‘modified oil phase’. Where the oil is present, the addition of an oil in claim 2 would not further limit or add a limitation to the claim from which it depends. In the instant case, the ‘modified oil phase’ as recited in claim 1 is interpreted to comprise an oil, thus, claim 2 fails to further limit claim 1 because claim 1 already comprises an oil. Moreover, the language of a claim governs its scope. Claim 1 recites a modified oil-in-water microemulsion including a modified oil phase. A claim cannot simultaneously require an oil phase and encompass an embodiment with 0% oil. Claim 1 does not allow the removal of an element that is recited in the claim. The specification describes a broad invention that can have 0% oil; however, the scope of instant claim 1 is narrower by including the oil phase.
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). See MPEP 2145 VI. The specification cannot be used to read a recited limitation out of a claim.
Claim Rejections - 35 USC § 112
(Rejection is maintained)
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.
Claim 2 is 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 2 is indefinite in reciting that the modified oil phase “further comprising an oil” because it is unclear what is encompasses by the phrase. Base claim 1 recites a “modified oil phase”, which is reasonably interpreted to already comprise an oil making it unclear whether claim 2 is referring to the oil already present in the ‘modified oil phase’, or whether additional oil is being added to the “modified oil phase” and whether the added oil is the same or different from the oil that is already present in the ‘modified oil phase’, or if some other meaning is contemplated by the phrase. As written, one skilled in the art would not be reasonably apprised of the metes and bounds of the claim.
Response to Arguments
Applicants’ arguments directed to the 112 rejections are presented above.
The Office maintains the above rejection of claim 2 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 is maintained.
Claim 1 recites a “modified oil phase”, which is interpreted to already comprise an oil making it unclear whether claim 2 is referring to the oil already present in the ‘modified oil phase’, or whether additional oil is being added to the “modified oil phase” and whether the added oil is the same or different from the oil that is already present in the ‘modified oil phase’, or if some other meaning is contemplated by the phrase.
Accordingly, claim 1 does not allow the removal of an element that is recited in the claim. The specification describes a broad invention that can have 0% oil; however, the scope of claim 1 is narrower by including the oil phase. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). See MPEP 2145 VI. Thus, the specification cannot be used to read a recited limitation out a claim.
As written, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of claim 2.
Conclusions
Claim 2 is rejected.
Claims 1, 6, 13-16, 24, 30, 32, 33, 37, 42, 44, 45, 47-52 and 54-63 are allowed.
Claims 7-9, 17-23, 25-29 and 38-41 are withdrawn.
Non-elected claims are only considered for rejoinder when all claims directed to the elected invention are in condition for allowance MPEP 821.04.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thurman Wheeler whose telephone number is (571)-207-1307. The examiner can normally be reached Monday-Friday 10:00am-6:00pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619
Prosecution Insights