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 .
Status of the Claims
Claims 5, 7, 12, 20 – 21, 27, 32, 36, 39, 41, 46, 54 – 56, 64 – 66 and 69 – 71 are pending and rejected.
Election/Restriction
Applicant’s election of species without traverse in the reply filed on May 15, 2026 is acknowledged. Applicant specifically elected the conjugate of formula (D-I) having the structure:
PNG
media_image1.png
469
794
media_image1.png
Greyscale
PNG
media_image2.png
1051
794
media_image2.png
Greyscale
PNG
media_image3.png
1247
793
media_image3.png
Greyscale
PNG
media_image4.png
387
794
media_image4.png
Greyscale
Examination: Applicant’s elected species are found to be free of prior art (not double patenting). The search has been extended to include the complete scope of the claims.
Priority
PNG
media_image5.png
116
406
media_image5.png
Greyscale
Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 12, 2023 and November 30, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement are being considered by the examiner.
Claim Objections
Claims 5 and 39 are objected to because of the following informalities:
Claim 5, page 3 line 5: The phrase “R4 is selected from -CO2H, -P(=O)(OH)2, -SO3H” is grammatically incorrect because it is missing a conjunction for the Markush group of alternatives. In order to overcome the objection, Applicant may amend the phrase as follows: “R4 is selected from -CO2H, -P(=O)(OH)2, and -SO3H”.
Claim 5, page 3 line 6: The phrase “R5 is selected from -COCH3, -COCF3, -SO2CH3” is grammatically incorrect because it is missing a conjunction for the Markush group of alternatives. In order to overcome the objection, Applicant may amend the phrase as follows: “R5 is selected from -COCH3, -COCF3, and -SO2CH3”.
Claim 39, page 9 line 4: The phrase “R4 is selected from -CO2H, -P(=O)(OH)2, -SO3H” is grammatically incorrect because it is missing a conjunction for the Markush group of alternatives. In order to overcome the objection, Applicant may amend the phrase as follows: “R4 is selected from -CO2H, -P(=O)(OH)2, and -SO3H”.
Claim 39, page 9 line 5: The phrase “R5 is selected from -COCH3, -COCF3, -SO2CH3” is grammatically incorrect because it is missing a conjunction for the Markush group of alternatives. In order to overcome the objection, Applicant may amend the phrase as follows: “R5 is selected from -COCH3, -COCF3, and -SO2CH3”.
Appropriate correction is required.
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.
Claims 5, 7, 12, 21, 27, 32, 36, 39, 41, 46, 54 – 56, 65 – 66 and 70 – 71 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
The present claims are drawn towards a method of synthesizing a conjugate of formula (D-I):
PNG
media_image6.png
90
158
media_image6.png
Greyscale
, wherein each A1 and A2 is independently selected from any one of formulas (A-I) – (A-XIII), L is a linker, each E comprises an Fc domain monomer or an albumin protein, and each squiggly line indicates that L is covalently attached to each E. The method comprises providing and combining a first composition and a second composition to form a mixture.
The present specification defines “[a] linker refers to a linkage or connection between two or more components in a conjugate…”. See, e.g., page 87, lines 29-30. The description also generically discloses the definition of L (linker) (see, e.g., page 37, lines 18-27):
PNG
media_image7.png
370
1028
media_image7.png
Greyscale
Specifically, the linker is
PNG
media_image8.png
348
816
media_image8.png
Greyscale
. See, e.g., Examples 1-2.
There is no guidance provided for any other structures that can be specifically used as linkers that covalently attaches each A1 and A2 to each E. Thus, the scope of the claims is directed towards a method of synthesizing a conjugate of formula (D-I) a wide array of covalent linkers that attach each A1 and A2 to each E.
MPEP §2163(II)(A)(3)(a)(ii) states the guidelines for the written description as presented below:
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 (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or 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 the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The generic definitions of linkers in the description fail to provide sufficient support to show that the Applicant was in possession of the full scope of the claimed invention. The description does not sufficiently describe the scope for all of the linkers that can be used to covalently attach each of A1 and A2 to each E that are encompassed by the present claims. Therefore, the “representative number of species” standard is used to determine whether the claims are adequately described. MPEP §2163(II)(A)(3)(a)(ii) recites the definition of “representative number of species” as:
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) … The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.").
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 … Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.”
The present specification does not sufficiently provide support for a number of species that are representative of the entire genus of all linkers encompassed in the conjugates of formula (D-I). Additionally, the specification lacks sufficient guidance for each of A1 and A2 of the conjugates of formula (D-I) that are covalently linked to each E via the linker, as encompassed in the scope of the present claims. According to the specification, the linker can be selected from:
PNG
media_image9.png
151
993
media_image9.png
Greyscale
PNG
media_image10.png
592
1028
media_image10.png
Greyscale
.
See, e.g., page 36 line 17 – page 37, line 17. There is a significant variation within all of the linkers and how each of A1 and A2 is covalently linked with each E to form the conjugates of formula (D-I). The present specification does not adequately describe any specific other structures to resemble the variation within the entire genus. A person having ordinary skill in the art would recognize that the Applicant was not in possession of the claimed method of synthesizing the full genus of the conjugates of formula (D-I). Thus, the present claims do not comply with the written description requirement. In order to overcome the rejection, Applicant may amend the structure of formula (D-I) in claims 5 and 39 to specify the structure of the linker
PNG
media_image8.png
348
816
media_image8.png
Greyscale
(see, e.g., Examples 1-2) that are properly supported by the present specification.
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.
Claims 5, 7, 12, 20 – 21, 27, 32, 36, 39, 41, 46, 54 – 56, 64 – 66 and 69 – 71 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claims 5 and 39 are rejected under 35 U.S.C. 112(b) as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. Claims 5 and 39 recite a method of synthesizing a conjugate of formula (D-I), the method comprising providing a first composition and a second composition (steps (a) and (b) in claims 5 and 39), and combining the first composition, the second composition, and a buffer to form a mixture (step (c)). The claims lack additional limitations to further synthesize the conjugate of formula (D-I) from said mixture obtained in step (c). Dependent claims 7, 12, 20 – 21, 27, 32, 36, 41, 46, 54 – 56, 64 – 66 and 69 – 71 do not clarify or remedy the deficiencies the independent claims 5 and 39, and are also considered incomplete.
In order to overcome the rejection, Applicant may amend claims 5 and 39 to recite additional step(s) to synthesize the conjugate of formula (D-I) from the mixture obtained in step (c).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 5, 7, 12, 20 – 21, 27, 32, 36, 39, 41, 46, 54 – 56, 64 – 66 and 69 – 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 84, 97, 108, 111, 159, 166, 172, 177, and 181 of copending Application No. 18/019,944 (U.S. Publication 2023/0364251 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The independent claim 84 in US ‘944 is directed to a method:
PNG
media_image11.png
1068
811
media_image11.png
Greyscale
The method comprises steps (a) and (b) providing a first composition comprising E and a second composition comprising a compound of formula (F-II-A) or (F-II-B):
PNG
media_image12.png
137
543
media_image12.png
Greyscale
, and
(c) combining the first composition, the second composition and a buffer to form a mixture.
MPEP §804(II)(B)(1)(3rd paragraph) states:
“The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim”.
MPEP §804(II)(B)(1)(5th paragraph) also states:
“In construing the claims of the reference patent or application, a determination is made as to whether a portion of the specification, including the drawings and claims, is directed to subject matter that is within the scope of a reference claim. For example, assume that the claim in a reference patent is directed to a genus of compounds, and the application being examined is directed to a species within the reference patent genus. If the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim”.
In the instant case, a portion of the disclosure of US ‘944 was analyzed to properly construe the scope of the conjugate of formula (M-II-A) in the claims. The disclosure of US ‘944 teaches several conjugates, including the conjugate of Example 11:
PNG
media_image13.png
504
704
media_image13.png
Greyscale
PNG
media_image14.png
338
1006
media_image14.png
Greyscale
See, Example 11, page 67. Because the above portion of the disclosure is an embodiment of the patent claims, the claims in US ‘944 render the instant claims unpatentable for anticipatory-type double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Sagar Patel/Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
Prosecution Insights