DETAILED ACTION
Status of the Claims
Claims 1-18 are currently pending and are examined herein.
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The present application is a CON of 16/231,099 (filed on 12/21/2018, now U.S. patent 11,633,474 B2), which is a CON of 13/791,615 (filed on 03/08/2013, now U.S. patent 10,206,998 B2), which is a CIP of 13/738,861 (filed on 01/10/2013, now abandoned). However, the limitations of claim 12 (and its dependent claims 13-17) regarding the blocked-site negative selection of candidate bifunctional targeted therapeutics is not disclosed in the 13/738,861 application or earlier applications, and appears to have been added in the continuation-in-part 13/791,615 application. Therefore 03/08/2013 is the earliest possible date for the purposes of prior art concerning claims 12-17.
Claim Objections
Claim 14 is objected to because of the following informalities: the claim recites the phrase “collecting those those candidate bifunctional targeted therapeutics”, which appears to be a typographical error for “collecting those candidate bifunctional targeted therapeutics”. Appropriate correction is required.
Claim Rejections - 35 USC § 112/1st Paragraph
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.
Written Description
Claims 1-5, 10-15, and 18 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 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 or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As per MPEP 2163(I), "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed.
As per MPEP 2163.02, 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 re Gosteli, 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 re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the 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").
Finally, MPEP 2163.04 describes the burden on the examiner with regard to the Written Description requirement, stating that in rejecting a claim, the examiner must set forth express findings of fact which support the lack of written description conclusion. These findings should:
(A) Identify the claim limitation(s) at issue; and
(B) Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.
Claim 1 recites a “second portion capable of eliciting an immune response through interaction with one or more components of the immune system”. Applicant does not recite the compositions with any degree of structural or specificity other than in the most generic terms and instead recites the desired function of said second portion. A patent Applicant is free to recite features of a composition either structurally or functionally. See In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 228 (CCPA 1971) ("[T]here is nothing intrinsically wrong with [defining something by what it does rather than what it is] in drafting patent claims."). Yet, choosing to define an element functionally, i.e., by what it does, carries with it a risk, as the CCPA stated in Swinehart, 439 F.2d at 213, 169 USPQ at 228, “where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on.” See also In re Hallman, 655 F.2d 212, 215, 210 USPQ 609, 611 (CCPA 1981); In re Ludtke, 441 F.2d 660, 663-64, 169 USPQ 563, 565-67 (CCPA 1971).
In the present case, the disclosure as originally filed refers to this second portion as an “immune effector” (e.g., as per para 0017 and/or 0080) only by it being “capable of stimulating an immune response in the patient”. The specification gives examples for said second portion as binding to components of the complement system (e.g., as per para 0023 and/or 0092), binding to the constant region of the heavy chain of an antibody such as IgG1, 2, 3, or 4, to the CH1 region, or to an Fc region (e.g., as per para 0029). No actual reduction to practice is given for said second portion.
However, it is noted that possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that applicant had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention. See, e.g., Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323, 56 USPQ2d 1481, 1483 (Fed. Cir. 2000) (the written description "inquiry is a factual one and must be assessed on a case-by-case basis"); see also Pfaff v. Wells Elec., Inc., 55 U.S. at 66, 119 S.Ct. at 311, 48 USPQ2d at 1646 ("The word ‘invention’ must refer to a concept that is complete, rather than merely one that is ‘substantially complete.’ It is true that reduction to practice ordinarily provides the best evidence that an invention is complete. But just because reduction to practice is sufficient evidence of completion, it does not follow that proof of reduction to practice is necessary in every case. Indeed, both the facts of the Telephone Cases and the facts of this case demonstrate that one can prove that an invention is complete and ready for patenting before it has actually been reduced to practice.").
While appearing to have sufficient written description support for some species of the second portion (“immune effector”), as detailed above, the specification fails to provide an adequate number of representative species to allow the skilled artisan to immediately envision the entire genus of all items that may “elicit an immune response through interaction with one or more components of the immune system”.
Claim Rejections - 35 USC § 112/2nd Paragraph -- Indefiniteness
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 11 and 18 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 pre-AIA the applicant regards as the invention.
Claim 11 recites the limitation "said soluble agent" of claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "said elicited immune response". There is insufficient antecedent basis for this limitation in the claim.
As per MPEP 2173: It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter. Therefore, claims that do not meet this standard must be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph as indefinite. Further, as per MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. As currently written, the metes and bounds of the rejected claims are unascertainable for the reasons set forth above, thus the above claim(s) and all dependent claims are rejected under 35 USC 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections – 35 U.S.C. 102
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 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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Tai et al.
Claims 1-2 and 4-11 are rejected under 35 U.S.C. 102(b) as being anticipated by Tai et al. (Biochemistry, 1990, 29(35):8024-8030) as evidenced by Huston et al. (Proc. Natl. Acad. Sci., 1988, 85:5879-5883).
Regarding claim 1, Tai discloses a method for generation of a bifunctional targeted therapeutic that targets an agent of interest (e.g., as per the Abstract), the method comprising:
identifying a first protein capable of specifically interacting with the agent of interest and identifying a first mRNA that encodes for said first protein (e.g., a scFv against digoxin as per the Protein Design and Gene Synthesis sections on p. 8025, as per Huston in the Protein Design and Gene Synthesis section on pp. 5879-5880);
identifying non-antibody second portion capable of eliciting an immune response through interaction with one or more components of the immune system and identifying a second mRNA that encodes for said non-antibody second portion (e.g., Fragment B of staphylococcal protein A as per the Protein Design and Gene Synthesis sections on p. 8025);
generating a first and a second cDNA corresponding to each of said first and said second mRNAs (e.g., as per the Gene Synthesis and Expression Vector Construction section on p. 8025);
fusing said first and said second cDNA to the first and second ends of a bridge cDNA to generate a fused cDNA and translating said fused cDNA into a corresponding fused protein (e.g., in E. coli as per the Expression Vector Construction and Fusion Protein Folding and Isolation sections on p. 8025),
wherein a first portion of said fused protein is capable of interacting with said agent of interest and a second portion of said fused protein is capable of eliciting an immune response (e.g., as per the Dual Activity of Fusion Protein section on p. 8029),
thereby generating a bifunctional targeted therapeutic that targets said agent of interest (e.g., as per the Dual Activity of Fusion Protein section on p. 8029).
Regarding claim 2, Tai discloses the above, wherein said non-antibody second portion is a second protein (e.g., Fragment B of staphylococcal protein A as per the Protein Design and Gene Synthesis sections on p. 8025).
Regarding claim 4, Tai discloses the above, further comprising screening the bifunctional targeted therapeutic against said agent of interest and said one or more components of the immune system (e.g., as per the Dual Activity of Fusion Protein section on p. 8029).
Regarding claim 5, Tai discloses the above, wherein said non-antibody second portion has a known mRNA sequence (e.g., Fragment B of staphylococcal protein A as per the Protein Design and Gene Synthesis sections on p. 8025).
Regarding claim 6, Tai discloses the above, wherein said second protein is capable of binding to the heavy chain of an antibody (e.g., as per the Affinity and Specificity for Fc section on pp. 8028-8029).
Regarding claim 7, Tai discloses the above, wherein said second protein is capable of binding to the constant region of the heavy chain of said antibody (e.g., as per the Affinity and Specificity for Fc section on pp. 8028-8029).
Regarding claim 8, Tai discloses the above, wherein said second protein is capable of binding to the CH1 region of the heavy chain (e.g., as per the Affinity and Specificity for Fc section on pp. 8028-8029).
Regarding claim 9, Tai discloses the above, wherein said non-antibody second portion is capable of binding to an IgG antibody (e.g., as per the Affinity and Specificity for Fc section on pp. 8028-8029).
Regarding claim 10, Tai discloses the above, wherein agent of interest is a selected from the group consisting of animal toxins, insect toxins, plant toxins, algae-derived toxins, fungi-derived toxins, bacterial-derived toxins, biowarfare agents, and biopathway modulators (e.g., digoxin as per footnote 3 on p. 8025).
Regarding claim 11, Tai discloses the above, wherein said agent of interest targets one or more of the blood, blood vessels, nervous tissue, and muscle tissue, wherein said soluble agent targets one or more ion channels, wherein said soluble agent induces muscle paralysis, wherein said soluble agent prevents blood clotting, or wherein said soluble agent induces increased gastrointestinal water secretion (e.g., digoxin is known to target Na+/K+ ion channels).
Claim Rejections - 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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Tai et al., Sexton et al., and Lipovsek et al.
Claims 1-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tai et al. (Biochemistry, 1990, 29(35):8024-8030) as evidenced by Huston et al. (Proc. Natl. Acad. Sci., 1988, 85:5879-5883) in view of Sexton et al. (U.S. PGPub 2007/0004910 A1) and further in view of Lipovsek et al. (J. Immuno. Meth., 2004, 290:51-67).
Tai is relied on as above. It is noted that the reference is silent as to the precise screening limitations as per claims 3, 12, and 14, and specifically in the linking of proteins to their cognate mRNAs and negative selection using pre-blocking of the target’s epitope. However, such was known in the art.
Regarding claims 12-14, Sexton discloses immobilizing the target on beads (e.g., as per para 0267), blocking a site on said agent of interest with which said first protein interacts and depleting candidate binders that do not bind to said blocked and immobilized agent of interest (e.g., as per para 0270).
It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to conduct such a negative selection experiment to remove candidate binders that do not bind to the region of interest. One of ordinary skill in the art would have been motivated to do so since this would reasonably remove candidate binders that bind elsewhere, therefore improving specificity. Further, as per MPEP 2143(I)(A), the rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. In the instant case, all of the elements of the negative selection step in panning were well known in the art, as per Tai and Sexton, the mere combining of the individual elements in one embodiment in the manner of the claimed invention results in no change in the elements respective functions, and the combination yields nothing more than predictable results.
Regarding claim 3, Lipovsek discloses the above, wherein said first protein is identified by screening a library comprising proteins linked to their cognate mRNAs to identify one or more proteins that interact with the agent of interest (e.g., as per the Abstract).
It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to select for candidate binders toward the first protein capable of specifically interacting with the agent of interest and the second protein capable of eliciting an immune response (e.g., by binding to Fc). One of ordinary skill in the art would have been motivated to do so since Lipovsek specifically reports that ribosome and mRNA display methods are beneficial over phage display as being less laborious and allowing for larger libraries (e.g., as per the left column on p. 52).
Given the teachings of the prior art and the level of the ordinary skilled artisan at the time of the applicant’s invention, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Regarding claim 15, Tai discloses the above, wherein said component of the immune system is an antibody (e.g., as per the Affinity and Specificity for Fc section on pp. 8028-8029).
Regarding claim 16, Tai discloses the above, wherein said antibody is an IgG antibody (e.g., as per the Affinity and Specificity for Fc section on pp. 8028-8029).
Regarding claim 17, Tai discloses the above, wherein said antibody is an IgG isotype 1, 2, 3, or 4 antibody (e.g., as per the Affinity and Specificity for Fc section on pp. 8028-8029).
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
U.S. 10,206,998 B2
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,206,998 B2 (the ‘998 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 1, the claims of the ‘998 patent disclose a method for generation of a bifunctional targeted therapeutic that targets an agent of interest, the method comprising identifying a first protein capable of specifically interacting with the agent of interest and identifying a first mRNA that encodes for said first protein, identifying non-antibody second portion capable of eliciting an immune response through interaction with one or more components of the immune system and identifying a second mRNA that encodes for said non-antibody second portion, generating a first and a second cDNA corresponding to each of said first and said second mRNAs, fusing said first and said second cDNA to the first and second ends of a bridge cDNA to generate a fused cDNA and translating said fused cDNA into a corresponding fused protein, wherein a first portion of said fused protein is capable of interacting with said agent of interest and a second portion of said fused protein is capable of eliciting an immune response, thereby generating a bifunctional targeted therapeutic that targets said agent of interest (e.g., as per claim 1 of the ‘998 patent).
Regarding claim 2, the claims of the ‘998 patent disclose the above, wherein said non-antibody second portion is a second protein e.g., as per claim 2 of the ‘998 patent).
Regarding claim 3, the claims of the ‘998 patent disclose the above, wherein said first protein is identified by screening a library comprising proteins linked to their cognate mRNAs to identify one or more proteins that interact with the agent of interest (e.g., as per claim 1 of the ‘998 patent).
Regarding claim 4, the claims of the ‘998 patent disclose the above, further comprising screening the bifunctional targeted therapeutic against said agent of interest and said one or more components of the immune system (e.g., as per claim 3 of the ‘998 patent).
Regarding claim 5, the claims of the ‘998 patent disclose the above, wherein said non-antibody second portion has a known mRNA sequence (e.g., as per claim 4 of the ‘998 patent).
Regarding claim 6, the claims of the ‘998 patent disclose the above, wherein said second protein is capable of binding to the heavy chain of an antibody (e.g., as per claim 5 of the ‘998 patent).
Regarding claim 7, the claims of the ‘998 patent disclose the above, wherein said second protein is capable of binding to the constant region of the heavy chain of said antibody (e.g., as per claim 6 of the ‘998 patent).
Regarding claim 8, the claims of the ‘998 patent disclose the above, wherein said second protein is capable of binding to the CH1 region of the heavy chain (e.g., as per claim 7 of the ‘998 patent).
Regarding claim 9, the claims of the ‘998 patent disclose the above, wherein said non-antibody second portion is capable of binding to an IgG antibody (e.g., as per claim 8 of the ‘998 patent).
Regarding claim 10, the claims of the ‘998 patent disclose the above, wherein agent of interest is a selected from the group consisting of animal toxins, insect toxins, plant toxins, algae-derived toxins, fungi-derived toxins, bacterial-derived toxins, biowarfare agents, and biopathway modulators (e.g., as per claim 9 of the ‘998 patent).
Regarding claim 11, the claims of the ‘998 patent disclose the above, wherein said agent of interest targets one or more of the blood, blood vessels, nervous tissue, and muscle tissue, wherein said soluble agent targets one or more ion channels, wherein said soluble agent induces muscle paralysis, wherein said soluble agent prevents blood clotting, or wherein said soluble agent induces increased gastrointestinal water secretion (e.g., as per claim 9 of the ‘998 patent).
Regarding claim 12, the claims of the ‘998 patent disclose the above, wherein said screening comprises immobilizing said agent of interest on a solid support, blocking a site on said agent of interest with which said first protein interacts, exposing a plurality of candidate bifunctional targeted therapeutics to said blocked and immobilized agent of interest, identifying those candidate bifunctional targeted therapeutics that bind to said blocked and immobilized agent of interest and those that do not bind to said blocked and immobilized agent of interest; and collecting those candidate bifunctional targeted therapeutic that do not bind to said blocked and immobilized agent of interest (e.g., as per claim 10 of the ‘998 patent).
Regarding claim 13, the claims of the ‘998 patent disclose the above, further comprising screening said collected candidate bifunctional targeted therapeutics for interaction with one or more components of the immune system (e.g., as per claim 11 of the ‘998 patent).
Regarding claim 14, the claims of the ‘998 patent disclose the above, wherein screening of said collected bifunctional targeted therapeutics comprises immobilizing a component of the immune system on a solid support, exposing said collected candidate bifunctional targeted therapeutics to said immobilized component of the immune system, identifying those candidate bifunctional targeted therapeutics that bind to said immobilized component of the immune system and those that do not bind to said immobilized component of the immune system, and discarding those candidate bifunctional targeted therapeutics that do not bind to said immobilized component of the immune system and collecting those candidate bifunctional targeted therapeutics that do bind to said component of the immune system (e.g., as per claim 12 of the ‘998 patent).
Regarding claim 15, the claims of the ‘998 patent disclose the above, wherein said component of the immune system is an antibody (e.g., as per claim 13 of the ‘998 patent).
Regarding claim 16, the claims of the ‘998 patent disclose the above, wherein said antibody is an IgG antibody (e.g., as per claim 14 of the ‘998 patent).
Regarding claim 17, the claims of the ‘998 patent disclose the above, wherein said antibody is an IgG isotype 1, 2, 3, or 4 antibody (e.g., as per claim 15 of the ‘998 patent).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY FLINDERS whose telephone number is (571)270-1022. The examiner can normally be reached M-F 10-6:00 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, Heather Calamita can be reached on (571)272-2876. 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.
/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684
Prosecution Insights