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 .
Response to Election/Restrictions
Applicant’s election without traverse of liposomal trans-crocetin as the compound form and acute respiratory distress syndrome (ARDS) as the disease in the reply filed on 10/16/2025 is acknowledged.
In response to Applicants statement with regards to restriction practice, Examiner notes that there is no restriction, just a species election.
Claim Rejections - 35 USC § 112 – Scope of Enablement
The following is a quotation of the first paragraph of 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 187-190, 193-199, and 203-207 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for increasing the delivery of oxygen to the body, does not reasonably provide enablement for preventing or treating a disease or condition in a subject generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
To be enabling, the specification of the patent 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 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
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 the 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).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 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, state and predictability of the art, and relative
skill level
The invention relates to prevention and treatment of diseases and conditions. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art.
The breadth of the claims
Since the instant specification provides no limiting definition of the term “prevention”, the term will be interpreted expansively. The term “prevention” may vary widely in meaning, from “preventing” a disease from occurring to “preventing” it from progressing. Nor is the term limited by any time frame.
The claims are thus very broad insofar as they suggest that one will not experience the disease when taking the claimed agent; that should one get the disease, it will not worsen; or that following its treatment, it will not recur. While such “prevention” might theoretically be possible under strictly controlled laboratory conditions, as a practical matter it is nearly impossible to achieve in the “real world” in which patients live.
Additionally, there are no limitations with regards to the diseases or conditions claimed, thus, the claims are directed to any potential patient.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful therapeutic protocols for preventing or treating all disease or conditions, other than treatment of severe grade sepsis, ARDS, and COVID-19. The latter are corroborated by the working examples.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used to prevent or treat any disease or condition as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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.
Claims 187-190, 193-199, and 201-208 are rejected under 35 U.S.C. 103 as being unpatentable over Grainer (US 8017653) in view of Lockwood (US2007/0015735).
Grainer teaches pharmaceutical composition comprising trans-crocetin having a formula YZ-TCRO-ZY, where Y is a cation, Z is apolar group, TCRO is trans-carotenoid (col 2 lines 40-48 and col 9 line 67 – col 10 line 1 and col 13 lines 30-40). Dosages are based on body weight, but up to about 500 mg per kg, with advantageously from about 0.01-30mg/kg body weight, with oral administration taught as a suitable route (col 11 lines 29-41) where the formulations can be any known in the art of pharmacy (col 10 liens 32-41). The formulations improve diffusivity of oxygen between red blood cells and body tissue (abstract). Conditions to be treated include respiratory disease, such as ARDS (col 11, lines 9-14).
Grainer does not teach liposomal formulations or multivalent forms.
Lockwood teaches liposome compositions of carotenoids (¶ 201). Lockwood also teaches the use of multivalent counterions, such as calcium (¶ 95).
Lockwood does not teach trans-crocetin as the carotenoids.
It would have been obvious to one of ordinary skill in the art to follow the teaching of Grainer by modifying the formulations of Grainer by incorporating the actives into known pharmaceutical forms, such as liposomal carotenoids as taught by Lockwood.
It would have further been obvious to vary the dosage form based on the disclosed ranges of Grainer, but to modify based on the difference in pharmacological properties of the liposomal form versus other forms, and then based on the condition to be treated, such as ARDS. See MPEP 2144.05(I) and (II).
Finally, where Grainer teaches any counter ions would be suitable, it would have been obvious to modify the trans-crocetin forms by adding multivalent counter ions, as taught by Lockwood.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon-Fri (8am-5pm + mid-day flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
1 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”.