DETAILED ACTION
This office action is in response to the Applicant’s filing dated July 16th, 2026.
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 .
Priority
This application has a PRO of 63/282,126 filed on November 22nd, 2021; a PRO of 63/256,456 filed on October 15th, 2021; a PRO of 63/254,434 filed on October 11th, 2021; a PRO of 63/194,814 filed on May 28th, 2021; a PRO of 63/191,879 filed on May 21st, 2021; a PRO of 63/191,834 filed on May 21st, 2021; a PRO of 63/191,817 filed on May 21st, 2021; a PRO of 63/191,848 filed on May 21st, 2021; a PRO of 63/154,512 filed on February 26th, 2021; and a PRO of 63/154,545 filed on February 26th, 2021.
Status of Claims
Claims 1, 4, 7, 13-14, 16-18, 349 and 679-680 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on July 16th, 2026. Acknowledgment is made of Applicant’s amendment of claims 4, 7, 13-14, 16-18, 349; and the cancelation of claims 2-3, 15, 19, 81, 104, 335, 349, 656 and 665.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on July 16th, 2026 is acknowledged.
Claim 1 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 16th, 2026.
Applicant’s election without traverse of (A) 1,2,3-propanetriol (herein referred to as glycerol), (B) the Brønsted base 1,3-dihydroxypropane-2-oxide, (C) the cation potassium, (D) the molecule vanillin, (E) and the anion 2-ethoxy-4-formylphenolate in the reply filed on July 16th, 2026 is acknowledged.
Claims 13-14, 17 and 349 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 16th, 2026.
A prior art search was conducted for the elected species.
In light of the prior art, the Examiner expanded the (B) Brønsted base to include 2-hydroxypropane-1-oxide, as well as the (D) molecule and the (E) anion to include the full scope of the composition of claim 1.
Claims 4, 7, 16, 18 and 679-680 read on the elected claims and will be examined herein.
Claim Rejections - 35 USC § 112(a) – Written Description
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 4, 7, 16, 18 and 679-680 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 is a written description rejection.
Regarding claims 4, 7, 16, 18 and 679-680, the Written Description Guidelines for examination of patent applications indicates, "the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical characteristics and/or other chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show applicant was in possession of the claimed genus." (Federal register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see especially page 1106 column 3) and (see MPEP 2164).
The instant claims are drawn to a method of administering a bioactive agent (molecule) to a subject comprising providing a composition comprising the bioactive agent and administering the composition to the subject. Thus, the claims encompass a method comprising administering a composition comprising all bioactive molecules, including future compounds that have yet to be discovered. Thus, the claims encompass a genus with no defining structural components of the bioactive agent. Bioactive molecules can be very diverse, some as small as vanillin while others can be very large, such as insulin.
In a review of the instant specification, the specification does not appear to provide guidance as to what structural components are critical to a desired function (see below). The specification discloses various broad chemical formulas that can make up a bioactive molecule (see page 5, lines 5-17), yet does not disclose a desired biological effect. Because there are an innumerably large number of bio-molecules/compounds within the scope of the generic claims, it would require extensive manpower to make and test each compound to determine which compound would possess the recited properties (i.e., function as a bioactive molecule) and be useful in the instantly claimed method.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a method of administering a bioactive agent (molecule) to a subject comprising providing a composition comprising the bioactive agent and administering the composition to the subject. Thus, the claims encompass a genus of molecules which function as bioactive agents with no other defined structural components to produce a composition useful for a specific purpose.
The claims are generic, broadly reciting a genus of “a bioactive agent (molecule)”
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claims 4, 7, 16, 18 and 679-680 are broad and generic, with respect to all possible compounds encompassed by the claims.
Applicant has failed to show that they were in possession of all the diverse compounds encompassed by a bioactive agent (molecule). The possible variation of any molecule that functions as a bioactive agent within the scope of the instant claims is limitless and would encompass compounds that function as a bioactive agent not yet discovered.
Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize all the compounds claimed to be useful in the compositions administered in the method of instant claims 4, 7, 16, 18 and 679-680.
Claim Rejections - 35 USC § 112(d)
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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 4, 7, 16 and 18 are rejected 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.
Regarding claims 4, 7, 16 and 18, the instant claims depend from claim 679.
35 U.S.C. 112(d) states 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. Claim 679 is not a claim previously set forth. Thus, instant claims 4, 7, 16 and 18 are rejected for improper dependent form.
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.
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 4, 16, 18 and 679-680 are rejected under 35 U.S.C. 103 as being unpatentable over Metcalf (WO 2020/123976 A1).
Regarding claims 4, 16, 18 and 679-680, Metcalf teaches a method of orally administering a composition (page 12, lines 5-20) comprising the solvent glycerol (page 16, lines 19-21), making up less than 50% of the composition (page 34, claim 1); the Brønsted base 2-hydroxypropane-1-oxide (page 22, lines 21-23); the cation potassium (page 9, lines 14-15), in the form of 0.5M potassium hydroxide (page 30, line 18); the anionic molecule 2-[(1R,6R)-6-isopropenyl-3-methylcyclohex-2-en-1-yl]-3-hydroxy-5-pentylphenolate and the molecule 2-[(1R,6R)-6-isopropenyl-3-methylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol (page 29, lines 20-23), at a ratio of between 1:10 to 1,000,000:1 (page 24, lines 19-20), the composition comprising 50-500mg of the anionic molecule (page 14, lines 26-27); 100nM-5M hydroxide (page 17, lines 24-26); and water (page 16, lines 22-23; page 25, lines 1-3).
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of the components taught by Metcalf as a starting point for optimizing the amounts individual components utilized to deliver a bioactive molecule since Metcalf teaches compositions comprising these components in similar amounts are useful for orally delivering bioactive molecules and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all of this would result in the method of instant claims 4, 16, 18 and 679-680 with a reasonable expectation of success.
Conclusion
Claims 4, 7, 16, 18 and 679-680 are rejected.
No claim is allowed
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
