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 .
The Amendment filed 12/2/25 has been received, entered into the record, and carefully considered. The following information provided in the amendment affects the instant application by:
Claims 1 and 14 have been amended.
Claims 2, 3, and 15-20 have been canceled.
Remarks drawn to rejections of Office Action mailed 9/3/2025 include:
Drawing objections: which have been overcome by applicant’s amendments and have been withdrawn.
112 1st rejections: which have been overcome in part by applicant’s amendments and have been withdrawn in part. The claims are still rejected for “prevention” as set forth below.
102(a)(1) rejection: which have been overcome by applicant’s amendments and have been withdrawn.
Provisional Double Patenting Rejection over 18/248,441: which has been maintained for reasons of record.
Provisional Double Patenting Rejection over 18/249,246: which has been maintained for reasons of record.
Provisional Double Patenting Rejection over 18/249,245: which has been maintained for reasons of record.
Provisional Double Patenting Rejection over 17/776,729: which has been maintained for reasons of record.
An action on the merits of claims 1, 4-14, and 21 is contained herein below. The text of those sections of Title 35, US Code which are not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claim 14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating the diseases listed in the claim, does not reasonably provide enablement for preventing the same. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
Undue experimentation is a conclusion reached by weighing the noted factual considerations set forth below as seen in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). A conclusion of lack of enablement means that, based on the evidence regarding a fair evaluation of an appropriate combination of the factors below, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
These factors include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on
the content of the disclosure.
The breadth of the claims/Nature of the Invention:
The claims are drawn to methods of treating or preventing various disease. Applicants define prevention on page 28 of their specification as that which can, but is not required to be complete or absolute. As such, applicants are defining prevention to include non-preventative therapy. This portion which does include absolute prevention, would not be enabled as it would not be expected to occur for reasons below. Any therapy which merely reduces the number or severity of symptoms, or which is effective for a period shorter than the subject's remaining lifespan, is considered to be ineffective at preventing a disorder.
The state of the prior art:
Prevention of any disorder in the sense being used herein is not a recognized clinical outcome in the art. Applicants appear to be relying on the amino acids therapeutic utility to impart a use to the compounds herein.
The level of predictability in the art:
Regarding prevention, prevention of a disease is not the same as treatment of said disease. In order to prevent a disease, as opposed to merely delaying or reducing its symptoms, a dosing must either render the subject completely resistant to said disease after a single treatment or a limited number of treatments, or else, when continued indefinitely, continue to completely suppress the occurrence of said disease. In order to practice a preventative method, one of skill in the art must know the answer to several questions in addition to the effectiveness of the therapy in short-term relief of symptoms, including: 1) What is the duration of a single course of therapy? How often must the therapy be administered to completely suppress the disease? 2) Does the subject develop tolerance to the therapy over time? Does the disease eventually progress to a point where the therapy is unable to completely suppress all symptoms? For example, will a metastatic cancer eventually adapt to overcome treatments directed to preventing it from metastasizing into the bone? Or will a case of osteoporosis or rheumatoid arthritis ultimately progress to a point where symptoms develop regardless of which therapy is administered. 3) What are the long-term effects of the therapy? Does it cause progressive damage to the kidneys, liver, or other organs? Does the active agent accumulate in the subject's tissues? Is the minimum dose necessary to completely prevent the disease safe for long-term administration? Are there any steps that can be taken to reduce side effects? Additionally, because various physiological systems are interdependent and affect one another, any hypothetical preventative treatment would have to be broad-based and treat all of the various causes of a disorder. For example, because osteoporosis is, in the majority of cases, caused at least in part by a reduction in estrogen levels, a true preventative treatment for osteoporosis must be capable of preventing or reversing menopause in a subject. For this reason, many therapies which are suitable for short-term relief of symptoms are not suitable for lifelong prevention of disease. For example, antibiotics, chemotherapeutics, and antiviral drugs are not normally administered to healthy subjects in order to prevent the development of infection or cancer. Furthermore, a tissue can degenerate for a variety of reasons, including but not limited to, exposure to toxins, chronic viral infection, autoimmune attack, and deposition of amyloid protein. To be fully successful, a preventative method would have to guard against all of these possible insults.
The amount of direction provided by the inventor:
Applicant's specification provides for various diseases that can be treated with specific amino acids. However, no guidance is given in the specification suggesting any reason to believe that administration the claimed compounds can completely prevent any of the claimed conditions.
The existence of working examples:
No working examples are given for the prevention of any disease. Note that lack of working examples is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art such as the treatment of broad categories of disease with a single agent. See MPEP 2164.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
As mentioned above, the short-term usefulness of a therapy for relief of symptoms is no guarantee of its long-term usefulness for prevention of disease. Because no guidance is given for the use of the claimed therapeutic method for the long-term prevention of disease, one skilled in the art wishing to practice the invention would be unable to do so without first gathering information as to the long-term effectiveness of the therapy. In particular, one skilled in the art, in order to practice the invention for prevention of disease, would need to know whether the preventative effect remains potent over the long term. In order to answer these questions in the absence of any existing data, one skilled in the art, in order to practice the invention, would undertake long-term animal tests, preferably over a period of years, preferably involving a relatively long-lived experimental animal such as dogs or monkeys, or a human clinical trial. Animal experiments include, along with induction of the disease state, administration of the potential pharmaceutical compound and collection and analysis of data, additional burdens associated with compliance with animal welfare regulations, care, feeding, and other maintenance of the animals, dissection of dead animals to collect data, and disposal of dead animals after the protocol is finished. Administering the claimed compounds for a period of years to a suitable subject population is an undue amount of experimentation needed in order to practice the full range of the claimed invention. As prevention in the full sense is an extremely high bar for any clinical outcome, there is no reason to believe that the therapy would be successful, and any actual success would be a surprising and unpredictable result.
Applicants stated they believed their amendments would overcome the previous rejection, but applicants did not address the “prevention” portion, and the claims remain rejected.
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.
The provisional rejection of claims 1, 4-6, and 8-14 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-20 of copending Application No. 18/248,441 (reference application) is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds set forth in ‘441 would anticipate the compounds claimed herein. For example, claim 7 of ‘441 is drawn to the compound:
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which would anticipate compounds of claims 5+ herein where R2 is H; R4 is methyl; and R1 is taurine linked via an amide linkage (see claim 6 herein). Likewise, claim 8 of ‘441 is drawn to compounds:
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which would anticipate claims 1+ herein wherein R2 is H; R4 is methyl; R3 is a C8 unsaturated hydrocarbon chain; and R1 is taurine (see claim 1 herein). Both applications are also drawn to pharmaceutical compositions comprising the same and methods of treating a disease. As such, a skilled artisan would see the applications are substantially overlapping.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments filed 12/2/25 have been considered but are not persuasive. First – it is noted that the examiner believes when applicants kept stating “’244” in their response they intended to state and address this ‘441 application. As it relates to this argument, applicants argue that ‘441 does not teach to treat or prevent a disease as in claim 14 herein. The examiner disagrees as claim 19 of ‘441 is drawn to enhancing oral health and claim 18 is drawn to improving a skin condition using a composition comprising the compound of claim 1. Claim 1 of ‘441 comprises formula II which would read on the present compound of formula I of claim 1; formula II of claim 5; and formulas I and II of claims 12 and 14. Applicants also state that ‘441 does not teach compositions – yet claims 9-12 therein are drawn to compositions. Applicants argue ‘441 does not teach or suggest two specific amino acid modified sophorolipids in combination as in present claim 5. It is noted that claim 5 herein is not drawn to two specific amino acid modified sophorolipids in combination as asserted, but rather the compound of formula II, which is anticipated by at least claim 7 of ‘441. As such, the rejection is maintained over the recited claims.
The provisional rejection of claims 5 and 7 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 21 of copending Application No. 18/249,246 (reference application) is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds set forth in the compositions and methods of ‘246 would anticipate the compounds claimed herein. For example, claim 1 of ‘246 is drawn to composition comprising the compounds:
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or
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wherein R is arginine, lysine, or histidine. These compounds used in the compositions (and methods) of ‘246 would anticipate compounds of claims 5 and 7 herein wherein the R2 groups are H; R4 is methyl; and R1 is an amino acid. Claim 7 provides the amino acid is lysine. As such, a skilled artisan would see the applications are substantially overlapping.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants arguments as it relates to taurine containing amino acids is moot as these claims are not rejected herein. Applicants arguing that the present application is silent to methionine or glutamine modified sophorolipids, it is noted these claims also contain lysine as a possible amino acid which is clearly disclosed herein rendering them obvious as they are indeed overlapping and claiming the same compounds.
The provisional rejection of claims 1, and 4-14 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/249,245 (reference application) is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds set forth in ‘245 would anticipate the compounds claimed herein. For example, claim 1 of ‘245 is drawn to composition comprising the compounds:
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wherein R1 is optionally an amino acid linked via an amide linkage where X is NH. The specification of ‘245 provides guidance for these amino acid linked sophorolipids as the specification provides for various compounds having the amino acid glutamine linked via an amide bond (see compound 18 for example). As such, a skilled artisan would see the applications are substantially overlapping.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments filed 12/2/25 have been considered but are not persuasive. Applicants argue that ‘245 is drawn to amino acids and does not specify any particular amino acids claimed herein. However, claims 5 and 12 herein also are drawn to amino acids broadly. Further, the present narrowing amino acids would have been prima facia obvious since they are all embraced by the ‘245 claims to amino acids.
The provisional rejection of claims 5 and 7 on the ground of nonstatutory double patenting as being unpatentable over claims 55-57 of copending Application No. 17/776,729 (reference application) is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds set forth in ‘729 and those claimed herein are substantially overlapping. For example, claim 55 of ‘729 is drawn to compounds:
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wherein R1 is optionally H and R2 is optionally
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or
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wherein R3 a functional group derived from arginine, lysine, histidine, or glycine. As such, a skilled artisan would see the applications are substantially overlapping.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments filed 12/2/25 have been considered but are not persuasive. Applicants arguments as it relates to taurine containing amino acids is moot as these claims are not rejected herein. Applicants arguing that the present application is silent to methionine or glutamine modified sophorolipids, it is noted these claims also contain lysine as a possible amino acid which is clearly disclosed herein rendering them obvious as they are indeed overlapping and claiming the same compounds. Applicants argue ‘729 does not teach or suggest two specific amino acid modified sophorolipids in combination as in present claim 5. It is noted that claim 5 herein is not drawn to two specific amino acid modified sophorolipids in combination as asserted, but rather the compound of formula II. As such, the rejection is maintained over the recited claims.
Allowable Subject Matter
Claim 21 is allowed.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693