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, filed 07/01/2022 is a National Stage entry of PCT/EP2020/088034, International Filing Date: 12/30/2020. PCT/EP2020/088034 claims foreign priority to 20150243.2, filed 01/03/2020. A certified copy of the foreign priority application is of record.
Status of Claims
Claims 1-31 and 34 are pending as of the response filed on 9/3/25. Claims 32-33 have been canceled.
Applicant's election with traverse of invention I, claims 1-18, 30-31, and 34 in the reply filed on 9/3/25 is acknowledged. The traversal is on the ground(s) that both inventions include reversibly conjugating moieties, -L1- and -L*-, wherein the moiety -L*- rearranges into -L1-. Applicant has further explained Fig. 1 describes how a compound according to claim 19 (Group II) is converted into a compound according to claim 28, which will subsequently rearrange into a compound according to claim 1, and as such moieties -L1- and -L*- are not part of separate inventions but rather form a single inventive concept under PCR Rule 13.1. This is not found persuasive because as shown in the claims, the moieties -L1- and -L*- , which are included in inventions I and II respectively, are structurally distinct from each other, and thus lack a shared technical feature. For instance, -L*- of claim 19 as shown in formula (II) includes the functional group
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, which is completely lacking for -L1- of claim 1. Similarly, -L1- of formula (I) includes the group
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, which is completely absent for -L*-. Therefore, while Applicant’s discussion of the intermolecular arrangement is interesting, it is maintained that inventions I and II lack unity of invention, as the moiety -L1- included for invention I is completely structurally distinct from the moiety -L*- of invention II.
The requirement is still deemed proper and is therefore made FINAL.
Claims 19-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/3/25.
Claims 1-18, 30-31, and 34 were examined and are rejected.
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.
Claim 1-18, 30-31, and 34 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.
Independent claim 1 is drawn to a conjugate comprised of a moiety comprising at least one moiety -D conjugated via at least one moiety -L1-L2- to at least one moiety Z, with -D defined as a primary or secondary amine containing moiety of a drug D-H. The conjugate of claim 1 encompasses potentially millions of drugs that meet D-H, including small molecules, medium size molecules, oligonucleotides, peptide nucleic acids, peptides, and protein drug moieties (see claim 2). 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. 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.” See 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 2163 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. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Although the MPEP does not define what constitute a sufficient number of representatives, the Courts have indicated what doesn’t constitute a representative number of species to adequately describe a broad genus. The originally filed disclosure discloses conjugate species wherein -D represents ubiquitin or the protein HHCMET, but there is no description of conjugates having -D represented by the millions of other potential drugs. 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."). For these reasons, the claimed invention lacks written description. The claim(s) contains subject matter which was not described in the specification and the few examples 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. For written description, the analysis (a) considers actual reduction to practice, (b) disclosure of drawing or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed and (d) Representative number of examples.
(a) Actual reduction to practice/ (b) Disclosure of drawing or structural chemical formulas:
The originally filed disclosure discloses example conjugates wherein -D is ubiquitin or the protein HHCMET.
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed:
The claims are drawn to conjugates of formula (I), which broadly discloses the structures, in generic structural terms; for instance, -D of formula (I) is defined as any primary or secondary amine or any drug -DH; L1 is defined by formula (I); L2 is any spacer moiety or a single bond; and Z is any polymer moiety or a C8-24 alkyl.
(d) Representative number of examples:
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad. In the instant case, the conjugate encompasses at least one moiety -D conjugated via at least one moiety -L1-L2- to at least one moiety -Z, wherein -D is any primary or secondary amine of any drug -DH; -L1- is defined by formula (I); -L2- is a single bond or spacer moiety; and Z is any polymeric moiety or a C8-24 alkyl. However, the specification fails to provide a representative number of examples for these. The specification provides a few examples of conjugates wherein -D is ubiquitin or the protein HHCMET. Additionally, the conjugates described in the specification are composed of limited species for -L1-L2- and Z, as shown:
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. No other examples or description of conjugates wherein -D is anything other than ubiquitin or HHCMET are provided. 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."). For these reasons, the claimed invention lacks written description. The claim(s) contains subject matter which was not described in the specification in such a way to reasonably convey to one of ordinary skill in the art that the inventor, at the time the application was filed, had possession of the claimed invention. Claims 2-18, 30-31, and 34 are similarly rejected as these claims depend from claim 1.
Claim 34 is drawn to a method of preventing a disease or treating a patient suffering from a disease that can be prevented or treated with D-H comprising administering the conjugate of claim 1 to a patient. Given that D-H as recited by claim 1 is any primary or secondary amine containing drug D-H, the conjugate of claim 1 encompasses millions of drugs that meet D-H, including small molecules, medium size molecules, oligonucleotides, peptide nucleic acids, peptides, and protein drug moieties (see claim 2). The specification doesn’t provide any examples or diseases that are treated or prevented with the claimed conjugates; there is no discussion or disclosure of any specific diseases that one of ordinary skill in the art would have a reasonable expectation of success in treating or preventing with the claimed conjugates. The specification doesn’t provide any guidance as to which diseases could be prevented or treated with the claimed conjugates. Similar to the reasons discussed above, the method of claim 34 lacks sufficient written description, and the specification doesn’t provide sufficient evidence that the inventor, at the time the application was filed, had possession for preventing or treating any disease.
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 1-18, 30-31, and 34 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.
Independent claim 1 is drawn to a conjugate comprised of a moiety comprising at least one moiety -D conjugated via at least one moiety -L1-L2- to at least one moiety Z. The claim is indefinite, as formula (I) which represents -L1- shows just one point of connection to the moiety -D, when -L1- must be connected to two moieties, -D and -L2-. Formula (I) displays a dotted line to represent the point of connection to -D, but doesn’t show the point of connection to the second moiety, -L2-. The metes and bounds of the claim as such aren’t clear. Claims 2-18, 30-31, and 34 are similarly rejected as they depend from claim 1 and don’t provide additional clarity.
Claim 12 depends directly from claim 1 and recites -L1- of formula (I-d):
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. However, this structure is not included within -L1- as defined by claim 1. Specifically, (I-d) has two points of connection via dotted lines, while -L1- of claim 1, as represented by formula (I) only shows one point of connection to the rest of the conjugate via dotted lines. Moreover, the group
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as shown for (I-d) isn’t included within the alternate groups for X1 of formula (I). There is insufficient antecedent basis for this limitation in the claim, and the claim is indefinite.
Information Disclosure Statements
The IDS filed on 7/1/22 and 9/3/25 have been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627