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 .
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.
Election/Restrictions
Applicant’s election in the reply filed on 14 May 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)).
Applicants provided a compliant species election of:
“omeprazole treated with hydrogen chloride” as the species of “omeprazole browning substance”; and
“pancreatic cancer” as the species of “cancer”.
This elected species election is free of the prior art.
The Examiner extended the Markush search to the full scope of instant claims 1, 7, and 12 but did not find any prior art.
Examiner will maintain the Election of Species Requirement until Applicants amend/narrow their claims to overcome the various rejections under 35 USC 112, below.
Current Status of 18/694,723
This Office Action is responsive to the amended claims of 22 March 2024.
Claims 1-13 have been examined on the merits. Claims 1-12 are original. Claim 13 is new.
Priority
The effective filing date of the instant application is: 23 September 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 22 March 2024, is in compliance with the provisions of 37 CFR 1.9
Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 6 is objected to because of the right parenthetical immediately following embodiment 5-FU (see fourth line of claim 6). Limitations should not have parentheticals surrounding them-else it rises to indefiniteness (see, for example, below). However, this is an objection rather than an indefiniteness rejection since there’s only a right parenthetical and no sign of its left-parenthetical “mate”. Please remove the right parenthetical to render moot this objection. The same right parenthetical is present after 5-FU within claim 12 and hence claim 12 is similarly objected.
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 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection constitutes a written description possession rejection.
MPEP 2163 indicates that 35 USC 112 requires that the Specification contain a written description of the invention indicating that Applicants were in possession of the claimed invention at the time of filing their application. This requirement is separate and distinct from the enablement requirement.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991).
Under certain circumstances, omission of a limitation can raise an issue regarding whether the inventor had possession of a broader, more generic invention. See MPEP 2163.
The Examiner finds that Applicants short 8-page Specification does not adequately prove Applicants were in possession of the species of the broadly claimed genus: “omeprazole browning substance” / “acid degradation substance”. While Applicants’ Specification does provide evidence Applicants had possession of the following species of “omeprazole browning substance” / “acid degradation substance”: omeprazole treated with hydrogen chloride; omeprazole treated with sodium hydroxide; omeprazole treated with acetic acid; and/or omeprazole treated with lactic acid (Figs 1-7 and Examples 1-3 pages 6-8 of Specification), these species do not represent the broad genus of “omeprazole browning substance” / “acid degradation substance” as claimed in instant claims 1, 7, and 13. As such, the Office finds lack of possession for the full scope of the broad genus of “omeprazole browning substance” / “acid degradation substance” of instant claims 1, 7, and 13.
Hence, claims 1, 7, and 13 are rejected as lacking possession/written description under 35 USC 112(a).
Claims 2-6 are similarly rejected under 35 USC 112(a) since these claims refer back to rejected claim 1 but do not remedy the rationale underpinning the basis for rejecting claim 1.
Claims 8-12 are similarly rejected under 35 USC 112(a) since these claims refer back to rejected claim 7 but do not remedy the rationale underpinning the basis for rejecting claim 7.
How to revise the claims to render moot this rejection: Applicants should narrow the genus of “omeprazole browning substance” / “acid degradation substance” to the species (as described and underlined, above) of Examples 1-3 and Figs 1-7 of their Specification.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification and/or prior art, while being enabling for treating breast cancer and pancreatic cancer with omeprazole treated with hydrogen chloride; omeprazole treated with sodium hydroxide; omeprazole treated with acetic acid; and/or omeprazole treated with lactic acid (instant Specification Figs 1-7 and Examples 1-3 pages 6-8), does not reasonably provide enablement for treating or preventing all cancers (BRI of instant claims 1, 7, and 13) with full scope of omeprazole browning substance/acid substance. 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 and/or use the invention commensurate in scope with these claims.
The Wands Factors used in an (scope of) enablement rejection include (per MPEP 2164.01(a)):
The breadth of the claims:
The broadest reasonable interpretation (BRI) of claims 1-13 are drawn to composition claims (claims 1-12) and a method claim (claim 13) drawn to a pharmaceutical composition for prevention or treatment of cancer by administering “omeprazole browning substance” / “acid degradation substance” and anticancer adjuvant comprising same. The method claim is drawn to use of said composition/adjuvant to treat or prevent cancer.
The nature of the Invention:
The invention is drawn to biomedicine, and more particularly to pharmaceutical uses of acid degradation substances of omeprazole.
The state of the prior art:
While the underlying omeprazole compound is known, pharmaceutical uses to treat or prevent cancer by administering the acid degradation substance of omeprazole to a patient in need of cancer treatment is not known.
Moreover, not all cancers can be treated or prevented. For example, the reference PANCREATIC (“Four in ten pancreatic cancers could be prevented by lifestyle changes.” eCancer. Published: 3 July 2014. Accessed 29 July 2026. Available from: < https:// ecancer.org/en/news/5909-four-in-ten-pancreatic-cancers-could-be-prevented-by-lifestyle-changes > / ), indicates that pancreatic cancer cannot be entirely (100%) prevented (see title). Moreover, the reference RENAL (Robinson, Shayne. “Weighty Matters: The Kidney Cancer-Obesity Connection.” Weill Cornell Medicine. Genitourinary Oncology. Published: 17 March 2016. Accessed 29 July 2026. Available from: < https:// weillcornellgucancer.org/2016/03/17/weighty-matters-the-kidney-cancer-obesity-connection/ > ), discloses that maintaining a healthy weight can eliminate 24 % of all kidney cancers (see page 1). However, none of these exemplary cancers can be 100% prevented.
Thus, the prior art supports the notion that the broad scope of claimed “cancers” cannot be prevented (wherein prevention is 100% prevention since anything less is not truly “prevented”).
Furthermore, there is no known prior art teaching or anticipating the instantly claimed omeprazole browning substance/acid degradation substance.
The level of one of ordinary skill:
The level of one of ordinary skill in the art includes knowledge to treat cancer with omeprazole (see “Abstract” of reference “JIN”: Jin, Un-Ho, et al. “Omeprazole Inhibits Pancreatic Cancer Cell Invasion through a Nongenomic Aryl Hydrocarbon Receptor Pathway.” Chem. Res. Toxicol. (March 31, 2015), 28, pp. 907-918). Moreover, it is reasonable to engage in a reasonable amount of experimentation to use omeprazole itself to treat breast cancer and pancreatic cancer (“Abstract” of JIN reference).
Preventing cancer is an unpredictable process requiring extensive and burdensome experimentation involving pre-clinical and clinical trials matching drug to mechanisms of action and eventually to cancer treated.
The level of predictability in the art:
The art is predictable to use omeprazole to treat breast cancer and pancreatic cancer (“Abstract” of JIN). However, the art is not predictable in preventing the broad scope of cancers as encompassed by the BRI of instant claims 1, 7, and 13.
Preventing cancer is an unpredictable process requiring extensive and burdensome experimentation involving pre-clinical and clinical trials matching drug to mechanisms of action and eventually to cancer treated.
The amount of direction provided by the inventor:
Inventors have provided direction as to treating a pancreatic cancer cell line (MIA PaCa2) with their claimed omeprazole browning substance / acid degradation substance in Example 3 (page 7) of their Specification.
Moreover, Applicants have provided direction as to making and use of omeprazole treated with hydrogen chloride; omeprazole treated with sodium hydroxide; omeprazole treated with acetic acid; and/or omeprazole treated with lactic acid (instant Specification Figs 1-7 and Examples 1-3 pages 6-8) to treat said pancreatic cancer cell line (Example 3 page 7 of Specification).
The existence of working examples; and
The Specification has provided direction as to treating a pancreatic cancer cell line (MIA PaCa2) with Applicants’ claimed omeprazole browning substance / acid degradation substance in Example 3 (page 7) of their Specification. However, the Specification does not provide working examples of treating (or preventing) the full scope of “cancers” of the instant claims with the full scope of any omeprazole browning substance/acid degradation substance.
Moreover, Applicants have provided direction as to making and use of omeprazole treated with hydrogen chloride; omeprazole treated with sodium hydroxide; omeprazole treated with acetic acid; and/or omeprazole treated with lactic acid (instant Specification Figs 1-7 and Examples 1-3 pages 6-8) to treat said pancreatic cancer cell line (Example 3 page 7 of Specification).
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The Specification has provided direction as to treating a pancreatic cancer cell line (MIA PaCa2) with Applicants’ claimed omeprazole browning substance / acid degradation substance in Example 3 (page 7) of their Specification.
However, the Specification does not provide working examples of treating (or preventing) the full scope of “cancers” of the instant claims with the full scope of any omeprazole browning substance/acid degradation substance.
As such, it would be unreasonable experimentation to test the full scope of every cancer against the full scope of Applicants’ claimed omeprazole browning substance / acid degradation substance to see if it successfully treats and / or prevents every cancer as instantly claimed.
Therefore, claims 1-13 are rejected as lacking scope of enablement for preventing every cancer or treating every cancer with the full scope of any omeprazole browning substance.
How to render moot this rejection: delete “prevent” (and synonyms) from all (emphasis) claims. Also, narrow the scope of cancers treated to breast cancer (JIN reference) and pancreatic cancer (JIN reference and from Examples in Applicants’ Specification). And, narrow the omeprazole browning substance to omeprazole treated with hydrogen chloride; omeprazole treated with sodium hydroxide; omeprazole treated with acetic acid; and/or omeprazole treated with lactic acid (based on guidance provided in Specification).
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 1-13 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 contains the limitation “acid degradation substance” within parentheticals. This renders the metes and bounds of claim 1 undefined (hence rendering claim 1 indefinite under 35 USC 112(b)): the artisan does not know if the limitations within parentheticals are merely exemplary or are required limitations of the claim. Limitations are not permitted in parentheticals. However, only abbreviations are permitted within parentheticals.
Claims 7 and 13 are rejected as indefinite under 35 USC 112(b) for the same rationale.
Claims 2-6 are similarly rejected as indefinite under 35 USC 112(b) since these claims refer back to rejected claim 1 but do not remedy the rationale underpinning the basis for rejecting claim 1.
Claims 8-12 are similarly rejected as indefinite under 35 USC 112(b) since these claims refer back to rejected claim 7 but do not remedy the rationale underpinning the basis for rejecting claim 7.
Conclusion
No claims are presently allowable as written.
There is no known prior art reference that either teaches or anticipates a pharmaceutical composition comprising omeprazole browning substance or a pharmaceutically acceptable salt thereof, or a method of use thereof to treat cancer, according to the instant claims.
While reference JIN (Jin, Un-Ho, et al. “Omeprazole Inhibits Pancreatic Cancer Cell Invasion through a Nongenomic Aryl Hydrocarbon Receptor Pathway.” Chem. Res. Toxicol. (March 31, 2015), 28, pp. 907-918), discloses that omeprazole pharmaceutical composition can inhibit pancreatic cancer (see “Abstract”), it is silent as to “browning substance” / ”acid degradation substance” as required by the instant claimed invention. It is also silent as to Maillard reactions.
Due to a review of the Specification, Written Opinion, Applicant-provided art, and the Examiner’s own prior art searches (see “SEARCH 6”-“SEARCH 7” in enclosed search notes), the Examiner interprets administration of omeprazole HCl (in prior art) as distinct from the instant invention which is drawn to a novel and nonobvious approach of administering omeprazole browning substance (equivalent to “acid degradation substance” of omeprazole) to the subject to treat a disease: cancer.
A review of the prior art shows that acid degradation substances are seen as impeding medicinal value of the drug (omeprazole); the artisan views acid degradation substances as break-down products of the drug (here, omeprazole). There is no known rationale to administer an acid degradation substance of omeprazole to a subject to treat or prevent a cancer as per the instant claimed invention.
There is no known rationale (and no known prior art reference providing said rationale) that would permit modifying the teachings of JIN to arrive at the instant invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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