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
This office action is in response to applicant’s reply filed on August 19, 2025.
Restrictions/Elections.
Applicant's election with traverse of Group II (Claims 6-20) in the reply filed on August 19, 2025, is acknowledged.
The traversal is on the ground(s) that there is no burden to search both groups.
Applicant’s arguments are convincing, so both groups are under examination.
Applicant election of “hydroxymaleate oltipraz complex” is also acknowledged. Since the species is free of prior art, the examination was expanded to entire genus of oltipraz-complexes.
Applicant election of: “preventing, treating, ameliorating the symptoms of, lessening the severity and/or shortening the duration of mucositis for a human or non-human animal patient in need thereof” is also acknowledged.
Status of Claims
Claims 1-20 are currently pending and are the subject of this office action.
Claims 1-20 are presently under examination.
Due to Applicant’s election of “mucositis” as the species corresponding to the disease being treated, the examination of the instant claims is restricted to mucositis. All other diseases within the claims are not being examined, since they are not considered part of the elected invention, as such it is suggested that Applicant amends the claims accordingly to remove all non-elected inventions (see Improper Markush Group rejection below).
Priority
The present application is a CON of PCT/IB2021/000153 filed on 03/16/2021, which claims priority to provisional application No. 62/990,352 filed on 03/16/2020.
Claim Rejections- Improper Markush Group.
Claims 1-18 and 20 are rejected under Improper Markush Group.
The improper Markush Group Rejection is based on a judicially approved doctrine when the claim contains an improper grouping of alternatively useable species. A Markush claim contains an "improper Markush grouping" if: (1) the species of the Markush group do not share a single structural similarity," or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
Claims 1-18 and 20 are rejected on the grounds of containing “improper Markush grouping”, which contain species that fail to share a common use.
Claims 1-18 and 20 encompass a wide variety of diseases (i.e. treating and/or preventing mucositis, treating a patient undergoing radiotherapy, preventing or treating viral infections, treating or preventing stroke, etc.) which are known to have different etiologies and pathophysiologies, have different stages of progression and require different treatments and patient populations.
To overcome this rejection, Applicant should amend the above claims (1-18 and 20) so they only recite treating, ameliorating the symptoms of, lessening the severity and/or shortening the duration of mucositis as the only disease being treated.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of mucositis, does not reasonably provide enablement for the prevention of mucositis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 1-20 recite:
A method for preventing or treating mucositis comprising the administration of a composition comprising the administration of oltipraz
2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D.
The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
First, the term prevention is synonymous with the term curing, and both circumscribe methods of treatment having absolute success (100% success). Humans in need of prevention of mucositis do not yet suffer from mucositis, and if they were to be administer oltipraz according to the instant claims, they will never ever suffer from a mucositis. The general knowledge of the prior art clearly indicates that the art of preventing any diseases including mucositis, is highly unpredictable.
Second, an extensive search of the prior art reveals that there are no references disclosing any type of prevention of mucositis with any drug.
4. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 cites: “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“Nascent technology, however, must be enabled with a specific and useful teaching.’ The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee’s instruction. Thus, the public’s end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.”
The specification teaches some examples (see Examples 1-15) that correlate with the treatment of mucositis comprising the administration of oltipraz.
Thus, while the specification provides a procedure for treating mucositis, the specification appears to be silent on a nexus between:
treating mucositis and preventing mucositis.
As such, if there is no correlation then the examples do not constitute working examples.
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the prevention (100% success) of mucositis, is required for practice of the claimed invention.
5. The Quantity of experimentation necessary
Because of the known unpredictability of the art (see section 3) and in the absence of experimental evidence commensurate with the claims (see section 4), the skilled in the art will not accept that the administration of a composition comprising oltipraz, can prevent (100% success) mucositis as inferred by the claims and contemplated by the specification.
6. Conclusion
Accordingly, the inventions of claims 1-20 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention, a person of ordinary skill in the art would have to engage in undue experimentation with no reasonable expectation of success.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-23 of U.S. Patent No. 12,312,343. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the claims of the ‘343 patent recite similar methods for treating mucositis comprising the administration of a composition comprising one or more oltipraz-complexes, wherein the one or more oltipraz-complexes have an excess of one rotamer.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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, Amy L. Clark can be reached on 571 272-1310. 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.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
August 20, 2025.