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 .
Election/Restrictions
Applicant's election with traverse of the elected species of R3-OH for the alcohol having an acid dissociable structure, wherein R3 is represented by formula (3-1) and as the protective group the formula (AL-3) with the substituents as defined in claim 7 in the reply filed on March 14, 2026 is acknowledged. The traversal is on the ground(s) that the non-elected species would appear to be part of an overlapping search area. This is not found persuasive in part as it relates to the alcohol having an acid dissociable group. However, this was not found persuasive at it relates to the protective groups because (AL-1) in in the general form of an ester and (AL-2) in the general from an ethe, both of which are in different classifications from (AL-3).
The requirement is still deemed proper and is therefore made FINAL.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: “METHOD FOR PRODUCING MONOMERIC COMPOUND”.
Status of Claims
Claims 1 – 7 are pending.
Claims 1 - 7 are rejected.
Claim Rejections - 35 USC § 112 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.
Claims 1- 7 are rejected under 35 U.S.C. 112(a), 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, at the time the application was filed, had possession of the claimed invention.
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.
In accordance with MPEP § 2163, specifically state that for each claim drawn to a single embodiment or species: (a) Determine whether the application describes an actual reduction to practice of the claimed invention; (b) If the application does not describe an actual reduction to practice, determine whether the invention is complete as evidenced by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole; (c) If the application does not describe an actual reduction to practice or reduction to drawings or structural chemical formula as discussed above, determine whether the invention has been set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that applicant was in possession of the claimed invention. (i) Determine whether the application as filed describes the complete structure (or acts of a process) of the claimed invention as a whole. (ii) If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated possession of the claimed invention. Below is such comparison.
I. Scope of claims: A method for producing a monomeric compound, comprising: reacting a formylhydroxy aromatic carboxylic acid and an alcohol having an acid- dissociable group structure to synthesize an ester body having the acid dissociable group, the method further comprising, in any order: protecting a hydroxyl group of the ester body; and converting a formyl group of the ester body to an alkene.
II. Scope of Disclosure: Page 97 of the original specification discloses the following:
Reduction to Practice
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III. Analysis of Fulfillment of Written Description Requirement
As stated supra, the MPEP states that written description for a single embodiment or species can be achieved if any description of sufficient, relevant, identifying characteristics that would lead on skilled in the art to the conclusion that the applicant was in possession of the claimed embodiment or species.
However, the expression “formylhydroxy aromatic carboxylic acid” is broad, because it is not clear what kind of ‘aromatic carboxylic acid’ the Applicant is intending to encompass with this broad expression [since any aromatic compound may fall within the broad definition of ‘aromatic carboxylic acid’]. Aromatic carboxylic acid is a general term used to describe many different forms of aromatic compounds including aromatics with more than one ring, 5-member aromatic ring, 7-member ring, 8-member aromatic ring, 5 or 6-member heterocyclic ring containing oxygen, nitrogen or sulfur. Therefore, the above expression, which is not described in any way to satisfy the statutory requirements within the purview of 35 USC. 112(a) because the specification does not provide essential description to carry out the invention. Thus the specification fails to provide adequate written for the process and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 112 Enablement
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.
Claims 1- 7 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for the method for producing a monomeric compound having the below structural
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wherein Ar has a structure corresponding to ring structure of structural unit A represented by formula (I)
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when n1 is 0 by a method that includes
esterification of
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with an alcohol represented by R3-OH, wherein R3 is an acid dissociable group represented by formulas (3-1) to (3-8) (para. [0032]), producing the ester body; protecting a hydroxyl group of the ester body with acetyl chloride; and converting the formyl group of the ester body to and alkene in the presence of a metal complex generated from zinc powder and dibromomethane. The specification does not reasonably provide enablement for the method wherein the “formylhydroxy aromatic carboxylic acid” is any aromatic carboxylic acid that includes aromatics with more than one ring, 5-member aromatic ring, 7-member ring, 8-member aromatic ring, 5 or 6-member heterocyclic ring containing oxygen, nitrogen or sulfur, it does not provide for a reaction with any alcohol having any acid dissociable group, it does not provide for any type of compound to react with the ester body to protect the hydroxyl thereof, it does not provide the process wherein formula (AL-3) (elected species) is used in a reaction to so attach to protect the hydroxyl of the ester, and there is no catalyst provided in the method to generate a Wittig olefination of the formyl group of the “formylhydroxy aromatic carboxylic acid”. 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 test for enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation (United States v. Telectronice, 8, USPQ2D 1217 (Fed. Cir, 1988). Whether undue experimentation is needed is not based upon a single factor but rather in a conclusion reached by weighing many factors. The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). The Federal Circuit has repeatedly held that "the specification 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, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)). Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the scope of the claims:
The nature of the claims are drawn to a method for producing a monomeric compound.
The scope of the invention in the claims is that any monomeric compound can be produced by reacting any formylhydroxy aromatic carboxylic acid and any alcohol having an acid dissociable group structure to synthesize an ester body having the acid dissociable group, the method further comprising, in any order: protecting a hydroxyl group of the ester body with any protecting group by any means; and converting a formyl group of the ester body to an alkene without a catalyst.
(3) The state of the prior art: The general state of the prior art is found in the teaching of Hatakeyama et al. (US 2014/0045122) and Delmas et al.(US 4,346,040).
Hatakeyama discloses the process for preparing monomer to be used to synthesize a polymer.
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Delmas discloses the process for converting an aldehyde into an alkene. In the process for converting an aldehyde into a corresponding alkene and of the type, wherein the aldehyde is placed in the presence of a phosphoric reagent and a base in solution in an organic aprotic solvent; the process comprising using a mineral base evincing in an aqueous medium a basic force less than or equal to that of the hydroxide ion or a strongly basic organic base of the nitrogen compounds family and adjusting the hydration rate of the reaction medium in such a manner that there are about 0.5 to 5 moles of water per mole of aldehyde.
(4) the predictability or unpredictability of the art: Chemistry is unpredictable. In reMarzocchi, 439 F2d 220, 169 USPQ 367 para. 3. However, the "predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or know results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. MPEP 2164.03.
(5) The relative skill of those in the art: One of ordinary skill is a practicing organic chemist.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided guidance for
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.
However, the specification does not provide guidance for the method wherein the “formylhydroxy aromatic carboxylic acid” is any aromatic carboxylic acid that includes aromatics with more than one ring, 5-member aromatic ring, 7-member ring, 8-member aromatic ring, 5 or 6-member heterocyclic ring containing oxygen, nitrogen or sulfur, it does not provide for a reaction with any alcohol having any acid dissociable group, it does not provide for any type of compound to react with the ester body to protect the hydroxyl thereof, it does not provide the process wherein formula (AL-3) (elected species) is used in a reaction to so attach to protect the hydroxyl of the ester, and there no catalyst provided to generate a Wittig olefination of the formyl group of the “formylhydroxy aromatic carboxylic acid”.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to reactants required in the process where a combination of reaction conditions are required to obtain a desired monomeric compound capable of polymerization and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YATE' K. CUTLIFF whose telephone number is (571)272-9067. The examiner can normally be reached Monday-Friday (8:30 - 5:30).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y. Goon can be reached at (571) 270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YATE' K CUTLIFF/Primary Examiner, Art Unit 1692