DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
2. Applicant’s election without traverse of Group I in the reply filed on 1 May 2026 is acknowledged.
Claims 35-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1 May 2026.
Claims 26-34 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statements filed 24 January 2024 and 2 April 2025 are acknowledged and shave been considered.
It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
4. The use of trade names or marks used in commerce (including but not necessarily limited to MAGNESPHERE), has been noted in this application. Any trade names or marks should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 33-34 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
This is a new matter rejection.
Claims 33-34 reach recite a specific percentage of ammonium hydrogen sulfite. A review of parent Application 13/754,631 (now U.S. Patent 9,315,853) yields no teachings of the claimed percentages of ammonium hydrogen sulfite. Further, the additional parent Applications issued as U.S. Patents 10,144,953 and 10,704,083 similarly fail to teach the claimed percentages of ammonium hydrogen sulfite. Thus, because the claimed percentages of ammonium hydrogen sulfite are not found in the listed parent Applications, the claims include new matter.
Double Patenting
7. 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.
8. Claims 26-28 and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,814,670 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions comprising the same reagents. Any additional limitations of the ‘670 claims are encompassed by the open claim language “comprising” found in the instant claims.
It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited patent.
Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
9. Claims 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,814,670 B2 as applied to claim 26 above, and further in view of Smith et al. (U.S. Patent Application Publication No. US 2002/0086326 A1, published 4 July 2002).
Regarding claims 29-30, the composition of claim 26 is discussed above.
The ‘670 claims do not require the claimed core or pores.
However, Smith et al. teach silica particles for binding nucleic acids (Abstract) having magnetic cores (paragraph 0032) and controlled pores (paragraph 0045), which have the added advantage of allowing isolation substantially free of contaminants (Abstract). Thus, Smith et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ‘670 claims with the teachings of Smith et al. to arrive at the instantly claimed compositions with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a compositions having the added advantage of allowing isolation substantially free of contaminants as explicitly taught by Smith et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Smith et al. could have been applied to the ‘670 claims with predictable results because the known techniques of Smith et al predictably result in beads useful for isolating nucleic acids.
10. Claims 26-28 and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,704,083 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite compositions comprising the same reagents. Any additional limitations of the ‘083 claims are encompassed by the open claim language “comprising” found in the instant claims.
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited patent.
Applicant again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
11. Claims 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,704,083 B2 as applied to claim 26 above, and further in view of Smith et al. (U.S. Patent Application Publication No.. US 2002/0086326 A1, published 4 July 2002) based on the citations and rationale provided above.
12. Claims 26-28 and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,144,953 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite compositions comprising the same reagents. Any additional limitations of the ‘953 claims are encompassed by the open claim language “comprising” found in the instant claims.
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited patent.
Applicant again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
13. Claims 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,144,953 B2 as applied to claim 26 above, and further in view of Smith et al. (U.S. Patent Application Publication No. US 2002/0086326 A1, published 4 July 2002) based on the citations and rationale provided above.
14. Claims 26-28 and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,315,853 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite compositions comprising the same reagents. Any additional limitations of the ‘853 claims are encompassed by the open claim language “comprising” found in the instant claims.
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited patent.
Applicant again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
15. Claims 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,315,853 B2 as applied to claim 26 above, and further in view of Smith et al. (U.S. Patent Application Publication No.. US 2002/0086326 A1, published 4 July 2002) based on the citations and rationale provided above.
16. Claims 26-28 and 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-10, 12-14, and 21-23 of copending Application No. 18/005,943.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite compositions comprising the same reagents. Any additional limitations of the ‘943 claims are encompassed by the open claim language “comprising” found in the instant claims.
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited Application.
Applicant again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
17. Claims 29-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-10, 12-14, and 21-23 of copending Application No. 18/005,943 as applied to claim 26 above, and further in view of Smith et al. (U.S. Patent Application Publication No.. US 2002/0086326 A1, published 4 July 2002) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Prior Art
18. The following prior art is cited but not relied upon for any rejection:
The instant claims are drawn to systems including a composition comprising small, single-stranded DNA of 200 or fewer nucleotides comprising sulfonated cytosine deoxynucleotides and a silica or a silica-coated solid support in an alcohol-free solution comprising ammonium hydrogen sulfite and at least 4.5 M guanidine hydrochloride.
Devos et al (U.S. Patent Application Publication No. US 2011/0009277 A1, published 13 January 2011) teach guanidium isothiocyanate (paragraph 0084) and bisulfite (paragraph 0052).
Jia (U.S. Patent Application Publication No. US 2006/0286577 A1, published 21 December 2006) teach bisulfite (Abstract) and 6 M guanidine HCl (paragraph 0126).
Dietrich et al (U.S. Patent Application Publication No. US 2011/0003292 A1, published 6 January 2011) teach the use of “bisulfite, hydrogen sulfite, disulfite, ammonium or guanindium sulfite and combinations thereof (claim 9 of Dietrich et al).”
However, none of the cited prior art teaches a composition comprising small, single-stranded DNA of 200 or fewer nucleotides in an alcohol-free solution comprising ammonium hydrogen sulfite and 5.5-7.5 M guanidine hydrochloride.
Conclusion
19. No claim is allowed.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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