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/Restriction filed on May 22, 2026 is acknowledged.
Claims 1-2, 4, 8, 10, 12, 16-17, 20, 23, 26, 28, 30, 32, 34, 37-38, 40, 44, 46-47, 49, 53-54, 57, 61-62, 64, 66, 68 and 70 are pending in this application.
Priority
Applicant claims foreign priority to CHINA 202110349993.3 (3/31/2021). The certified copy has been received by the Office. However, certified English translation has not been provided. Therefore, the foreign priority date has not been perfected. Thus, the priority date of instant application is 3/31/2022 until the foreign priority date is perfected.
Restriction
Applicant’s election without traverse of Group 1 (claims 1-2, 4, 8, 10, 12, 16-17, 20, 23, 26, 28, 30, 32 and 32) in the reply filed on May 22, 2026 is acknowledged. Applicant elected the following species:
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. Restriction is deemed to be proper and is made FINAL in this office action. Claims 34, 37-38, 40, 44, 46-47, 49, 53-54, 57, 61-62, 64, 66, 68 and 70 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 1-2, 4, 8, 10, 12, 16-17, 20, 23, 26, 28, 30 and 32 are examined on the merits in this office action.
Objections
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Claims 1, 10, 12 and 32 are objected to for the following minor informality: claim 1 contains the acronym “MMAE”; claim 10 contains the acronyms “DMF”, “DMA”, “DMSO” and “DCM”; claim 12 contains the acronyms “HATU”, “DIC”, “DCC”, “EDC”, “HCTU”, “DEPBT”, “EEDQ” and “CDI”, “DMF”, “DMA”, “DMSO”, “DCM”; claim 32 contains the acronym “TLC”, and an acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, i.e., monomethyl auristatin E (MMAE). The abbreviations can be used thereafter.
Rejections
35 U.S.C. 112(b)
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 1-2, 4, 8, 10, 12, 16-17, 20, 23, 26, 28, 30 and 32 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.
The terms “sufficient amount”, “appropriate amount”, “larger than the mole number” and “reduced pressure” in claim 1 steps (1)-(15) are relative terms which renders the claim indefinite. The terms “sufficient amount”, “appropriate amount”, “larger than the mole number” and “reduced pressure” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the metes and bounds of the claim is unclear. Because claims 2, 4, 8, 10, 12, 16-17, 20, 23, 26, 28, 30 and 32 depend from indefinite claim 1 and clarify the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
Claim 4 recites the limitation "the temperature" in 4(iv). There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from claim 1. Claim 1 does not recite “temperature”. Therefore, there is lack of antecedent basis.
Claim 1 recites, “…(3) after the reaction finishes, pouring the reaction solution of step (2) into a sufficient amount of first low-polarity solvent, discarding the filtrate after stirring, and solid residues being compound 2 after drying…” There is more than one interpretation of this recitation: 1) filtrate is discarded after stirring and the compound 2 is a solid left after drying; 2) filtrate and the solid residues of compound 3 are discarded. Applicant is required to clarify the point of confusion of this recitation.
Claim 1 recites, “A preparation and purification method of a compound…(1) dissolving a compound 1 in an appropriate amount of a first organic solvent…(4) dissolving the obtained compound 2 and an appropriate amount of compound 3 in a second organic solvent…(5) dissolving a first polypeptide condensing agent in an appropriate amount of third organic solvent…(8) after the reaction of step (7) finishes, adding a sufficient amount of second low polarity solvent…” and so on. It is unclear what solvents would be required for each step to produce the MMAE that Applicant is claiming. It is unclear what solvent is required to dissolve compound 1, and if the same organic solvents can be used throughout the claim or if different solvents are required for each step(s). It is unclear if an organic solvent was used in the first step that is different from what is encompassed by what Applicant is envisioning, whether or not the reaction would proceed to produce the final compound of Applicant’s claims. Because claims 2, 4, 8, 10, 12, 16-17, 20, 23, 26, 28, 30 and 32 depend from indefinite claim 1 without clarifying the point of confusion, these too are rejected under 35 U.S.C. 112(b).
35 U.S.C. 112(a)
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 1-2, 4, 8, 10, 12, 16-17, 20, 23, 26, 28, 30 and 32 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.
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 (1997); In re Gosteli, 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.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
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 at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (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 of the sequence, 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 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 constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court 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 preparation and purification method of a compound…wherein the method comprises the following steps:
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. The generic statements first organic solvent, second organic solvent, third organic solvent, first low polarity solvent, second low polarity solvent, fourth organic solvent, fifth organic solvent, sixth organic solvent do not provide ample written description for the compounds since the claims do not describe a single structural feature. The specification does not clearly define or provide examples of what qualify as solvents of the claimed invention.
As stated earlier, 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 claim 1 is broad generics with respect all possible solvents encompassed by the claims. The possible variations are limitless to any class of organic solvent and low polarity solvents. It must not be forgotten that the MPEP states that if a peptide is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond solvents disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus.
The specification is limited to dichloromethane, trichloromethane and carbon tetrachloride as the first and fifth organic solvent (see paragraphs [0023] and [0051] of instant specification, for example). The specification is limited to DMF, DMA, DMSO and DCM as the second and third organic solvent (see paragraphs [0031] and [0035] of instant specification, for example). The specification is limited to acetonitrile, trichloromethane and carbon tetrachloride as the fourth organic solvent (see paragraph [0047] of instant specification). The specification is limited to methanol, toluene and acetonitrile as the sixth organic solvent (see paragraph [0055] of instant specification). The specification is limited to n-hexane, petroleum ether and n-heptane as the first low-polarity solvent (see paragraph [0029] of instant specification). The specification is limited to methyl tert-butyl ether, ethyl acetate, dichloromethane and tetrahydrofuran as the second low-polarity solvent (see paragraph [0041] of instant specification). The specification does not describe any other organic solvents and low-polarity organic solvents utilized in the method steps to synthesize the MMAE of instant claims. Additionally, there may be some common organic solvents used in each step, but, Applicant has not defined the importance of each solvent used in each step. Description of dichloromethane, trichloromethane and carbon tetrachloride as the first and fifth organic solvent; DMF, DMA, DMSO and DCM as the second and third organic solvent; acetonitrile, trichloromethane and carbon tetrachloride as the fourth organic solvent; methanol, toluene and acetonitrile as the sixth organic solvent; n-hexane, petroleum ether and n-heptane as the first low-polarity solvent; and methyl tert-butyl ether, ethyl acetate, dichloromethane and tetrahydrofuran as the second low-polarity solvent is not sufficient to encompass numerous other organic solvents that belong to the same genus. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims 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.
Closest Art
Petit et al (US Patent No. 5635483, filed with IDS) teach method of making tetrapeptide bearing modified phenylamides (see Title). Petit et al teach the following:
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(see columns 4-10). Petit et al teach:
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(see column 9).
Senter et al (US 2005/0009751, filed with IDS) teach the following:
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and
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(see figure 3, and paragraphs [0342]-[0343]).
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
7/21/2026
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