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
The amendment filed on 8-19-2025 is acknowledged. Claims 1 and 7 have been amended. Claims 2-4 have been canceled. Claims 1, 6-10, 12-18 and 20-23 are pending. Claims 8-10, 12-18 and 20-23 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1 and 6-7 are currently under examination.
Claim Objections Withdrawn
The objection to claims 2 and 3 for utilizing the acronym “Omp” without defining it upon its first recitation is withdrawn. Cancellation of said claims has rendered the objection moot.
Claim Rejections Withdrawn
The rejection of claims 1-2, 4 and 6 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of the amendment thereto.
The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…specifically binds antigen(s) from Acinetobacter baumannii wherein the polyclonal antibody shows limited cross-reactivity to antigens form other gram-negative bacteria.” is withdrawn in light of the amendment thereto.
The rejection of claim 2 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…specifically binds to Omp22 from A. baumannii.” is withdrawn. Cancellation of said claim has rendered the rejection moot.
The rejection of claims 1-4 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Institute of Medical Biology Chinese (CN105497884A – IDS filed on 9-23-2022) is withdrawn in light of the amendment thereto.
The rejection of claims 1-4 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al. (Scientific Reports 6:20724, pages 1-12) is withdrawn in light of the amendment thereto.
The rejection of claims 1-4 and 6-7 under 35 U.S.C. 103 as being unpatentable over Institute of Medical Biology Chinese (CN105497884A – IDS filed on 9-23-2022) is withdrawn in light of the amendment thereto.
The rejection of claims 1-4 and 6-7 under 35 U.S.C. 103 as being unpatentable Huang et al. (Scientific Reports 6:20724, pages 1-12) is withdrawn in light of the amendment thereto.
Claim Rejection Maintained
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.
The rejection of claim 7 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 is maintained for reasons of record. 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 instant claims are drawn to polyclonal antibodies by the Omp22 with the amino acid sequence of SEQ ID NO:2 wherein said polyclonal antibodies not only bind to one or more Acinetobacter baumannii antigens as well as having no cross-reactivity to antigens from Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Citrobacter freundii, Enterobacter cloacae, Enterobacter aerogenes, Klebsiella oxytoca, Morganella morganii, Proteus mirabilis and Salmonella enterica and shows a mean sensitivity of 85.5% and a mean specificity of 99.5% for A. baumannii in a panel of clinical isolates by indirect-ELISA.
The specification discloses SEQ ID NO:2 that corresponds to the Acinetobacter baumannii Omp22 and its use to produce polyclonal antibodies in rabbits. The use of the Omp22 protein with the sequence of SEQ ID NO:2 to produce antibodies in rabbits meets the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph to the degree it reads on the production of the polyclonal antibodies to itself. However, the aforementioned claim encompasses the production of said polyclonal antibodies in any animal wherein the resulting antibodies show a mean sensitivity of 85.5% and a mean specificity of 99.5% for A. baumannii in a panel of clinical isolates by indirect-ELISA. None of these antigens meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. The specification provides insufficient written description to support the genus encompassed by the rejected claims. While the specification discloses the use of the Omp22 of SEQ ID NO:2 to produce polyclonal antibodies in rabbits, this disclosure is insufficient to provide proper description for the instant claim as it is well settled within the art that immune responses to a given antigen varies not only from species to species but from animal to animal within a given species. Given this variability it would be impossible to predict which “animal” would produce polyclonal antibodies with the claimed characteristics when immunized with the Omp22 of the instant claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Based on the instant specification, the skilled artisan cannot envision the detailed chemical structure of the encompassed polypeptides, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The nucleic acid/protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does 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 USPQ2datl966.
An adequate written description of a DNA, such as the cDNA of the recombinant plasmids and microorganisms of the '525 patent, "requires a precise definition, such as by structure, formula, chemical name, or physical properties," not a mere wish or plan for obtaining the claimed chemical invention. Fiers v. Revel, 984 F.2d 1164, 1171, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). Accordingly, "an adequate written description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself." Id. at 1170, 25 USPQ2d at 1606.
The name cDNA is not itself a written description of that DNA; it conveys no distinguishing information concerning its identity. While the example provides a process for obtaining human insulin-encoding cDNA, there is no further information in the patent pertaining to that cDNA's relevant structural or physical characteristics; in other words, it thus does not describe human insulin cDNA. Describing a method of preparing a cDNA or even describing the protein that the cDNA encodes, as the example does, does not necessarily describe the cDNA itself. No sequence information indicating which nucleotides constitute human cDNA appears in the patent, as appears for rat cDNA in Example 5 of the patent. Accordingly, the specification does not provide a written description of the invention of claim 5.
To adequately describe the claimed genus of polyclonal antibodies with the claimed immunological characteristics, Applicant must adequately describe the means by which said antibodies were produced (i.e. animal used etc.) and the purification steps utilized to eliminate cross-reactive antibodies. The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of polyclonal antibodies to which the claims are drawn, such as a correlation between the structure (immunoepitopes) and its recited function (having a mean sensitivity of 85.5% and a mean specificity of 99.5% for A. baumannii in a panel of clinical isolates by indirect-ELISA), so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of Acinetobacter baumannii polyclonal antibodies. The specification is silent with regard to any of the Acinetobacter baumannii polyclonal antigens raised against the Omp22 with the sequence of SEQ ID NO:2 that possess the claimed immunological characteristics. Therefore, the specification fails to adequately describe at least a substantial number of members of the genus of non-cross-reactive Acinetobacter baumannii polyclonal antibodies to which the claims refer.
MPEP § 2163.02 states, “[a]n 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' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the 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. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"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)”
And:
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. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
As evidenced by the teachings of Skolnick et al., the art is unpredictable. Skolnick et al. (Trends in Biotechnology 18: 34-39, 2000) discloses the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based upon sequence homology is inaccurate, in part because of the multifunctional nature of proteins (see, e.g., the abstract; and page 34, Sequence-based approaches to function prediction). Even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan's best guess as to the function of the structurally related protein (see, in particular, the abstract and Box 2). Thus, one skilled in the art would not accept the assertion, which is based only upon an observed similarity in amino acid sequence that a variant of a given polypeptide would necessarily induce a given immune response. Therefore, because the art is unpredictable, in accordance with the Guidelines, the description of claimed antibodies is not deemed representative of the genus of peptides to which the claims refer.
Antibodies specifically bind to given "immuno-epitopes" of the antigen and while all proteins will induce the production of antibodies, proteins with differing amino acid sequences will induce different antibodies. It is impossible to predict which proteins will induce protective antibodies. Since the change of a single amino acid in the protein sequence of the antigen can effectively abolish the interaction between an antigen and an antibody (Colman Res. Immunology, Jan 1994, Vol. 145, pages 33-36) a difference in even a single amino acid could radically affect the ability of a given antigen to induce protective immunity (or any other specific immune response),
Consequently, for the reasons set forth above, the specification fails to adequately describe at least a substantial number of members of the genus of Acinetobacter baumannii polyclonal antibodies to which the claims refer. Therefore, the instant claims fail to meet the written description requirements.
New Grounds of Rejection
35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Institute of Medical Biology Chinese (CN105497884A – IDS filed on 9-23-2022) and SeraCare (Guide to Polyclonal Antibody Purification, pages 1-6).
The Academy of Medical Sciences (hereinafter 'IMBCAMC') discloses a polyclonal antibody (pAb) which specifically binds specifically binds to Omp22 from A. Baumannii (see abstract and paragraph [0011]), wherein the polyclonal antibody shows limited cross-reactivity to antigens from other gram-negative bacteria (see abstract of English translation). IMBCAMC further disclose the use of the outer membrane protein Omp22 of the Acinetobacter baumannii to produce a specific antibody that can be used for preventing the Acinetobacter baumannii infection." (see paragraph [0011] of English translation) and that said Omp22 has the sequence of SEQ ID NO:2 (see page 8). Finally, IMBCAMC disclose that mice are immunized with a Omp22 recombinant protein mixed with sodium hydroxide aluminum adjuvant and the resulting serum is titered on an ELISA to create higher specific antibody level in Omp22 immunized mice. With regard to the limitation regarding “limited cross-reactivity” it is deemed that since both IMBCAMC and the instant claims utilize the same immunogen, the resulting polyclonal antibodies would necessarily have the same immunological characteristics as the antibodies of the rejected claims.
IMBCAMC differs from the rejected claims in that they don’t explicitly disclose the purification of their polyclonal antibodies to remove cross-reactive antibodies to other gram-negative bacteria (i.e. Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Citrobacter freundii, Enterobacter cloacae, Enterobacter aerogenes, Klebsiella oxytoca, Morganella morganii, Proteus mirabilis and Salmonella enterica) or the use of rabbits to produce their polyclonal antibodies.
As evidenced by SeraCare, it is standard practice within the art to remove cross-reactive antibodies from polyclonal antibody preparations. Consequently, it would have been obvious for the skilled artisan to remove cross-reactive antibodies from the polyclonal antibody preparations of IMBCAMC.
With regard to the use of rabbits as the antibody source, the KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that IMBCAMC demonstrates the production of anti-Omp22 antibodies in a mammal (mouse) and the use of various mammals including rabbits is well established in the art, the production of anti-Omp22 antibodies in rabbits is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 November 24, 2025