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 .
DETAILED ACTION
Responsive to communication entered 09/04/2025.
Priority
This application, Pub. No. US 2022/0372171 A1, published 11/24/2022, is a § 371 National Stage of International Patent Application No. PCT/US2020/051580, filed 09/18/2020, Pub. No. WO 2021/055808 A1, which claims priority to US provisional application No. 62/903,404, filed·09/20/2019.
Status of Claims
Claims 1-16 and 18-21 are currently pending. Claims 1-22 have been originally filed. Claims 5, 7, 9, 10, 12, 14, 16, 18, 19, and 21 have been amended; and Claims 17 and 22 have been cancelled, as set forth in Applicant’s Preliminary amendment filed 09/19/2022. Claims 1-16 and 18-21 have been subject to election/restriction requirement mailed 05/09/2025. Claims 12-16 and 18-21 are withdrawn from further consideration. Claims 1-11 are examined.
Election/Restrictions
Applicant's election, without traverse, of Group I, Claims 1-11, drawn to a polyclonal antibody composition, and, without traverse, the species (1) a compound of formula (I), in the reply filed on 09/04/2025 is acknowledged.
Although in the previous Office Action Applicant was required to elect each of the species (1)-(2) for the elected Group I, no species (2) of a solid support was elected.
Upon further consideration, the restriction requirement between inventions species (2), as set forth in the Office action mailed on 05/09/2025, is hereby withdrawn. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Applicant identified Claims 1-11 as encompassing the elected species (1).
Claims 12-16 and 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/04/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/13/2023, 11/29/2023 and 04/15/2024 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statements are being considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 112 that form the basis for the rejections under this section made in this Office action.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-11 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 claims, as recited in the independent Claim 1, are drawn to:
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MPEP § 2163 states that to satisfy the written description requirement, Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.” In reGosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In reKaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).” Emphasis added.
MPEP § 2163 further states that disclosure of an antigen fully characterized by its structure does not provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional:
“…disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)(“knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011) (patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties).” Emphasis added.
See also a memorandum “Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials”, https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf, in which the USPTO adopts the Federal Circuit’s decision Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The USPTO explains in the memorandum, the Federal Circuit’s decision in Amgen clarifies “the law of written description as it applies to antibodies.” In particular, as the USPTO points out, the “Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself.” The USPTO also emphasizes that “the in Amgen court expressly stated that the so-called ‘newly characterized antigen’ test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody.” The newly characterized antigen test allowed the description of a new antigen or target combined with routine and conventional methods of making antibodies to substitute for written description of the antibodies themselves, i.e., antibodies that may bind and inhibit that target. As the USPTO explains, the Federal Circuit rejected such an approach as contrary to the quid pro quo of the patent system: “Citing its decision in Ariad Pharm., Inc. v. Eli Lilly & Co., the court also stressed that the ‘newly characterized antigen’ test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent.” In the case of claims that are drawn to antibodies, “35 U.S.C. § 112(a) requires adequate written description of the antibody itself.”
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. For a claimed genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, 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 Applicant was in possession of the claimed genus:
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) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that “only describe[d] one type of structurally similar antibodies” that “are not representative of the full variety or scope of the genus.”). 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.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). Emphasis added.
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), the following is noted:
To show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358). Emphasis added.
An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (see Amgen at page 1361). Emphasis added.
In Ariad, the court further noted that the written description plays a particularly important role in the biological arts, where patentees might otherwise be tempted to claim a genus of compounds by its function or result:
“The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts. 5 See Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, 1, “Written Description” Requirement, 66 Fed. Reg. 1099, 1105-1106 (Jan. 5, 2001). This situation arose not only in Eli Lilly but again in University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 [69 USPQ2d 1886] (Fed. Cir. 2004). In Rochester, we held invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by administering a non-steroidal compound that selectively inhibits the COX-2 enzyme. Id. at 918. We reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification's function description, the specification did not provide an adequate written description of the claimed invention. Id. at 927-28. Such claims merely recite a description of the problem to be solved while claiming all solutions to it and, as in Eli Lilly and Ariad's claims, cover any compound later actually invented and determined to fall within the claim's functional boundaries—leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). Emphasis added.
It is the Examiner’s position that the instant specification fails to provide adequate written description and clear guidance for the claimed polyclonal antibody compositions.
The Examiner’s position is based on the following facts and considerations.
First, the disclosure is limited to the only specific example of an immunogen of the formula (I):
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This single example is not sufficient to represent a genus of compounds of formula (I) because one of ordinary skill in the art would have known that the structure of a linker for coupling a hapten with an antigenic carrier is essential for selectivity of the generated antibody. See, for example, Szurdoki et al., “Important Factors in Hapten Design and Enzyme-Linked Immunosorbent Assay Development,” Immunoanalysis of Agrochemi-cals; Nelson, J., et al.; ACS Symposium Series, 1995, vol. 586, Chapter 4, pp. 39-63:
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Page 49.
Second, although methods of making an antibody against an immunogen of the identified chemical structure meet the written description requirement because making antibodies were routine in the art at the time the application was filed, the claims are not drawn to a process of making the product but to the product itself.
Third, an immunogen structure cannot identify an antibody structure because, as evidenced by Goldsby et al., “Immunology,” W.H. Freeman & Co., N.Y., 2003, p. 69, when a conjugate of a hapten with a large carrier protein is used for raising antibodies, the antibodies are produced to the carrier, the hapten and their conjugate:
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Fourth, as to concern a compound of formula (II), which is a small molecule (= hapten), one of skill in the art would have known that haptens are not immunogenic, meaning they cannot independently provoke an immune response. However, when haptens bind to larger carrier proteins, they form a complex that the immune system recognizes as foreign, triggering an immune response:
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See also Gandhi et al., “Development and Validation of an Immunoassay for Tenofovir in Urine as a Real-Time Metric of Antiretroviral Adherence,” eClinicalMedicine, 2018, vol. 2, pp. 22 – 28 (IDS submitted 11/29/2023):
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Page 24, right column, 1st paragraph; Emphasis added.
Fifth, recent court cases have indicated that recitation of an antibody which has specific functional properties in the absence of knowledge of the antibody sequences that give rise to said functional properties do not satisfy the requirements for written description. See for example AbbVie Deutschland GmbH v. Janssen Biotech. Inc. 759 F.3d 1285 (Fed. Cir. 2014) as well as Amgen v. Sanofi, (Fed Cir, 2017-1480, 10/5/2017). In Amgen, the court indicates that that it is improper to allow patentees to claim antibodies by describing something that is not the invention, i.e., the antigen, as knowledge of the chemical structure of an antigen does not give the required kind of structure-identifying information about the corresponding antibodies, with the antibody-antigen relationship be analogized as a search for a key on a ring with a million keys on it. Office guidance has been updated to reflect that adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional. See the Memorandum dated February 22, 2018 entitled “Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials” available at https://www.uspto.gov/sites/default/files/documents/ amgen22feb2018.pdf. “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)) (emphasis added). “[A] sufficient description of a genus . . . requires the disclosure of either a representative number* of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added). It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” (AbbVie, 759 F.3d at 1298, reiterating Enzo Biochem, Inc., 323 F.3d at 964) (emphasis added).
In conclusion, since knowledge of the chemical structure of an immunogen does not give the required kind of structure-identifying information about the corresponding antibodies, with the antibody-immunogen relationship be analogized as a search for a key on a ring with a million keys on it, and the characteristics defining the genus of antibodies, as claimed are unknown as this only sets forth what the antibodies do and not what they are, it is deemed that the specification fails to provide adequate written description for the scope of Claims 1-11 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 claimed invention.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an
application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Gandhi et al., “Development and Validation of an Immunoassay for Tenofovir in Urine as a Real-Time Metric of Antiretroviral Adherence,” eClinicalMedicine, 2018, vol. 2, pp. 22 – 28; Available online 31 August, 2018 (IDS submitted 11/29/2023).
Gandhi et al., throughout the publication teach a polyclonal antibody composition comprising a heterogeneous population of mammalian antibodies that specifically bind tenofovir (TFV) or a tenofovir derivative, wherein the heterogeneous population of mammalian antibodies is generated against immunogens based on TFV's molecular structure:
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Abstract; Emphasis added.
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Page 24; Emphasis added.
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Applicant is reminded that a rejection based alternatively on 35 U.S.C. 102 or 103 for product-by-process claims has been approved by the courts. See MPEP § 2113:
“[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Office personnel should note that reliance on the alternative grounds of 35 U.S.C. 102 or 35 U.S.C. 103 does not eliminate the need to explain both the anticipation and obviousness aspects of the rejections.” Emphasis added.
The Examiner notes that the Gandhi et al.’ publication is co-authored by the inventors of the instant application. Since the polyclonal antibody composition, taught by Gandhi et al., has the same lower limit of quantification [LLOQ] of 1000 ng/mL in enzyme-linked immunosorbent assay (ELISA) as the polyclonal antibody composition disclosed in the instant application (See Example 1, paragraph [0102]), it is reasonable to conclude that the instantly claimed polyclonal antibody composition and the polyclonal antibody composition, taught by Gandhi et al., are identical.
Claims 1, 2, 5, 6 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Daughtridge et al., WO 2019/075487 A1, published 04/18/2019 (IDS submitted 01/13/2023).
With regard to Claims 1, 2 and 9, Daughtridge et al., throughout the publication, and, for example, at pages 78-79 in Examples 1 and 2, Fig. 1, teach polyclonal antibodies
generated against a compound of formula (I), wherein R1 and R2 are hydrogen:
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Emphasis added.
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With regard to Claims 5 and 6, Daughtridge et al., at page 37, teach that thiol-maleimide bioconjugation is one of the most widely used approaches due to its fast reaction rates and mild conjugation conditions. One of skill in the art would have known that thiol-maleimide bioconjugation is based on the following linkage group:
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With regard to Claims 3 and 4, at pages 18-21, Daughtridge et al. teach polyclonal antibodies generated against a compound of formula (I), wherein R1 and R2 are —CH2OC(O)OCH(CH3)2:
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Emphasis added.
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Emphasis added.
With regard to Claims 10 and 11, Daughtridge et al., at page 48, teach:
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Emphasis added.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as obvious over Daughtridge et al., WO 2019/075487 A1, published 04/18/2019 (IDS submitted 01/13/2023), in view of Papkovsky et al., US 2012/0289681 A1, published 11/15/2012.
At page 37, lines 21-22, 31-32, Daughtridge et al. teach linking through lysine residues but do not specifically teach an isothiocyanate linker (NCS) for attaching a small molecule hapten to a large carrier protein, creating an immunogen that can provoke an immune response. However, as evidenced by Papkovsky et al., both NCS and maleimide employed in the instant application, are common linkers used for conjugation. See paragraph [0048] and FIG. 1:
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One of skill in the art would have known that the isothiocyanate group of the modified hapten reacts with the accessible amine groups (e.g., from lysine residues) on the carrier protein to form a stable thiourea linkage:
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As such, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to use NCS, which is a well-known common linker used for conjugation with the accessible amine groups.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GALINA M YAKOVLEVA whose telephone number is (571)270-3282. The examiner can normally be reached on M-F 8:30 AM-5:00 PM.
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, GREGORY S EMCH can be reached on (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GALINA M. YAKOVLEVA/Primary Examiner, Art Unit 1678