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 Claims
Claims 1-12 are pending in the instant application.
Domestic Benefit
Acknowledgement is made of Applicant’s claim for Domestic Benefit based on the U.S. Provisional Application No. 63/628,747, filed on August 17th, 2023. Claims 1-12 are fully supported by this application, and will be evaluated with an effective filing date of August 17th, 2023.
Information Disclosure Statement
The Information Disclosure Statement received April 6th, 2026 has been fully considered, except where marked with a strikethrough.
Specification
The disclosure is objected to because of the following informalities:
Atom labels in the first structure shown at Page 17 of the instant disclosure are illegible.
The reaction scheme at Page 18 of the instant disclosure is illegible.
Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
Drawings
Acknowledgement is made of the drawings received December 13th, 2024. These drawings are acceptable.
Claim Objections
Claims 1-4 are objected to because of the following informalities:
Claims 1 and 2 do not end with a period. Per MPEP 608.01(m), “Each claim begins with a capital letter and ends with a period.”
The reaction scheme presented at Claim 2 is illegible, especially with respect to individual atom labels shown in the various structures, and the reagents and solvents shown above or below the reaction arrows.
Per MPEP 2173.05(s), “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)”. In the instant case, reference to Figures 1 and 2 in Claims 3 and 4, respectively, is improper.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 and 5-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 2 are product-by-process claims. Per MPEP 2113, I., “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)”.
Therefore, Claims 1 and 2 are drawn to a composition comprising a target material. Based on the instantly recited limitations, a person having ordinary skill in the art would not be able to reasonably ascertain the metes and bounds of the limitation “target material”, and therefore these claims are rendered indefinite. Dependent Claims 5-12 do not further clarify the limitation “target material” and therefore are also rendered indefinite. Appropriate clarification is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4 and 9-12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 is drawn to the process of Claim 1. The limitation “wherein the composition that is produced is denoted TC220 and is set forth in Figure 1” fails to further limit the process of Claim 1, as the process, as recited, leads to a single product that matches the structure set forth in Figure 1.
Claim 4 is drawn to the process of Claim 2. The limitation “wherein the composition that is produced is denoted TC221 and is set forth in Figure 2” fails to further limit the process of Claim 2, as the process, as recited, leads to a single product that matches the structure set forth in Figure 2.
Claim 7 is drawn to a Dosage Unit Form comprising the composition produced by the process of claim 1. Dependent Claims 9 and 11 are drawn to the same Dosage Unit Form, further reciting only an intended use thereof. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In the instant case, the statements of intended use recited at Claims 9 and 11 do not alter the structure of the composition to which they are drawn, and therefore do not properly further limit Claim 7, from which they depend.
Similarly, Claim 8 is drawn to a Dosage Unit Form comprising the composition produced by the process of claim 2. Dependent Claims 10 and 12 are drawn to the same Dosage Unit Form, further reciting only an intended use thereof. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In the instant case, the statements of intended use recited at Claims 10 and 12 do not alter the structure of the composition to which they are drawn, and therefore do not properly further limit Claim 8, from which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claims 2, 4, 6, 8, 10, and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Torgov et. al. (US 11,884,688 B2; filed August 1st, 2022; hereinafter referred to as Torgov).
The applied reference has a common applicant and joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
As noted previously, Claim 2 is a product-by-process claim. Therefore, instant Claims 2 and 4 are drawn to a composition that is denoted TC221 and set forth in Figure 2, as stated at instant Claim 4. As disclosed at Figure 2, TC221 has the following structure:
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At Column 10, Lines 63-65, Torgov teaches “a BAA comprising tyrosine is denoted as BTS(OMe) and has the following chemical formula set forth in FIG. 3.” Figure 3 discloses the same structure as TC221, as noted above.
Regarding instant Claim 6, the instant disclosure states at Page 16, Second Paragraph “The terms ‘kit’ and ‘article of manufacture’ can be used as synonyms.” At Page 16, Third Paragraph, the instant disclosure states, “In another embodiment of the invention, an article(s) of manufacture containing compositions, such as TC220(s) & TC221(s) of the disclosure.” Therefore, as instantly recited at Claim 6, a kit comprising the composition produced by the process of claim 2 requires only TC221. Therefore, Claim 6 is additionally anticipated by the teaching of BTS(OMe) by Torgov, as noted above. Additionally, at Column 15, Lines 35-50, Torgov teaches a composition comprising a compound of this structure as a composition of Claim 2. At Column 17, Line 6, Torgov teaches a kit comprising this composition.
Regarding instant Claim 8, at Column 17, Lines 11-12, Torgov teaches a kit comprising the composition of Claim 2. As noted above, this composition is taught as comprising a compound of the same structure as TC221, as noted above. Further, regarding instant Claims 10 and 12, “wherein the Dosage Unit Form is used in Boron Neutron Capture Therapy (BNCT)” and “wherein the Dosage Unit Form is used in Proton Born Fusion Therapy (PBFT)” are statements of intended use. Pe MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In the instant case, the statements of intended use do not alter the structure of the composition to which they are drawn, and therefore, instant Claims 10 and 12 are further anticipated by Torgov.
Claims 2, 4, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry File 2896828-36-5 (entered into STN February 21st, 2023; hereinafter referred to as CAS Registry File).
CAS Registry File teaches a compound of the formula:
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This is the same formula instantly disclosed as TC221, for example, at Figure 2.
As noted previously, Claim 2 is a product-by-process claim. Therefore, instant Claims 2 and 4 are drawn to a composition that is denoted TC221 and set forth in Figure 2, as stated at instant Claim 4. As disclosed at Figure 2, TC221 has the following structure:
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No other compositional ingredients are disclosed as TC221. Therefore, the compound taught by CAS Registry File anticipates Claims 2 and 4.
Regarding instant Claim 6, the instant disclosure states at Page 16, Second Paragraph “The terms ‘kit’ and ‘article of manufacture’ can be used as synonyms.” At Page 16, Third Paragraph, the instant disclosure states, “In another embodiment of the invention, an article(s) of manufacture containing compositions, such as TC220(s) & TC221(s) of the disclosure.” Therefore, as instantly recited at Claim 6, a kit comprising the composition produced by the process of claim 2 requires only TC221. Therefore, Claim 6 is additionally anticipated by CAS Registry File.
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 2, 4, 6, 8, 10, and 12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11,884,688. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a common composition.
Instantly, Claim 2 is a product-by-process claim. Per MPEP 2113, I., “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”.
As recited at Claim 4, the composition as produced by the process as recited at instant Claim 2 is denoted TC221. TC221 is shown to have the following structure at Figure 2:
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Claims 1 and 3 U.S. Patent No. ‘688 are drawn to a composition of BTS(OMe). At Figure 3, U.S. Patent No. ‘688 teaches BTS(OMe) has the structure:
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This is the same structure as instantly represented by TC221. Therefore, Claims 1 and 3 of U.S. Patent No. ‘688 read on instant Claims 2 and 4.
Regarding instant Claim 6, the instant disclosure states at Page 16, Second Paragraph “The terms ‘kit’ and ‘article of manufacture’ can be used as synonyms.” At Page 16, Third Paragraph, the instant disclosure states, “In another embodiment of the invention, an article(s) of manufacture containing compositions, such as TC220(s) & TC221(s) of the disclosure.” Therefore, as instantly recited at Claim 6, a kit comprising the composition produced by the process of claim 2 requires only TC221. Therefore, Claims 1 and 3 of U.S. Patent No. ‘688 read on instant Claim 6.
With respect to instant Claim 8, “Dosage Unit Form” is defined at the last paragraph of Page 23 of the instant specification as “physically discrete units suited as unitary dosages for the mammalian subjects to be treated; each unit containing a predetermined quantity of active compound calculated to produce the desired therapeutic effect in association with the required pharmaceutical carrier.” No limitations, however, are instantly recited that limits the composition to a specific amount or to be in the presence of any pharmaceutically carrier. Therefore, instant Claim 8 is drawn broadly to a composition comprising TC221, as noted above. With respect to Claims 10 and 12, “wherein the Dosage Unit Form is used in Boron Neutron Capture Therapy (BNCT)” and “wherein the Dosage Unit Form is used in Proton Born Fusion Therapy (PBFT)” are statements of intended use. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In the instant case, the statements of intended use do not alter the structure of the composition to which they are drawn, and therefore, do not make these claims patentably distinct to the composition claims 1 and 3 of U.S. Patent No. ‘688.
Claims 2, 4, 6, 8, 10, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-11 of U.S. Patent No. 12,319,707. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and patented claims are drawn to a common composition.
As noted above, instant Claims 2 and 4 are drawn to a composition defined by TC221 that is:
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Claim 8 of U.S. Patent ‘707 is drawn to a composition comprising this same chemical structure.’
Regarding instant Claim 6, drawn to a kit comprising a composition of the above structure, Claim 9 of U.S. Patent No. ‘707 is drawn to a kit comprising a composition of this same structure.
Regarding instant Claims 8, 10, and 12, drawn to a Dosage Unit Form comprising the aforementioned composition, Claims 10-11 of U.S. Patent No. ‘707 are drawn to a Dosage Unit Form comprising the same. With respect to Claims 10 and 12, “wherein the Dosage Unit Form is used in Boron Neutron Capture Therapy (BNCT)” and “wherein the Dosage Unit Form is used in Proton Born Fusion Therapy (PBFT)” are statements of intended use. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In the instant case, the statements of intended use do not alter the structure of the composition to which they are drawn, and therefore, do not make these claims patentably distinct to the Dosage Unit Form of claims 10-11 of U.S. Patent No. ‘707.
Conclusion
Claims 1-12 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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