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 and Status of the Claims
2. This action is in response to papers filed 1 May 2026 in which claims 49-56 were amended, claims 2-12 and 34 were canceled, and no new claims were added. All of the amendments have been thoroughly reviewed and entered.
3. Applicant’s election of Group II in the reply filed on 1 May 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant has cancelled all non-elected claims. Therefore, claims 49-56 are under prosecution.
Information Disclosure Statement
4. The Information Disclosure Statement filed 25 April 2023 is acknowledged and has 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
5. The use of trade names or marks used in commerce (including but not necessarily limited to USER and QIAquick), 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.
7. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Kits and Methods for Enzyme Stalling.
Claim Interpretation
8. The instant claims recite a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
9. A. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
B. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The limitation “one or more spacers configured to stall…” in claims 53 and 54; and
The limitations “L is configured to bind…” in claim 55.
C. However, neither of these claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because there is no corresponding structure described in the specification as performing the claimed function of equivalents thereof.
D. If Applicant does intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, Applicant may present a sufficient showing that the specification recites sufficient structure to perform the claimed function so as to allow the claims to be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
10. 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.
11. Claims 53-55 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first 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.
A. The MPEP provide guidance regarding determining whether the specification provides a written description of the means-plus-function claims.
37 CFR 1.75(d)(1) provides, in part, that “the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.” In the situation in which the written description only implicitly or inherently sets forth the structure, materials, or acts corresponding to a means- (or step-) plus-function, and the examiner concludes that one skilled in the art would recognize what structure, materials, or acts perform the function recited in a means- (or step-) plus-function, the examiner should either: (A) have the applicant clarify the record by amending the written description such that it expressly recites what structure, materials, or acts perform the function recited in the claim element; or (B) state on the record what structure, materials, or acts perform the function recited in the means- (or step-) plus-function limitation. Even if the disclosure implicitly sets forth the structure, materials, or acts corresponding to a means- (or step-) plus-function claim element in compliance with 35 U.S.C. 112, first and second paragraphs, the USPTO may still require the applicant to amend the specification pursuant to 37 CFR 1.75(d) and MPEP § 608.01(o) to explicitly state, with reference to the terms and phrases of the claim element, what structure, materials, or acts perform the function recited in the claim element. See 35 U.S.C. 112, sixth paragraph (“An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.” (emphasis added)); see also B. Braun Medical, 124 F.3d at 1424, 43 USPQ2d at 1900 (holding that “pursuant to this provision [35 U.S.C. 112, sixth paragraph], structure disclosed in the specification is corresponding’ structure only if the specification or prosecution history clearly links or associates that structure to the function recited in the claim. This duty to link or associate structure to function is the quid pro quo for the convenience of employing 112, paragraph 6.”); Medical Instrumentation and Diagnostic Corp. v. Elekta AB, 344 F.3d 1205, 1218, 68 USPQ2d 1263, 1268 (Fed. Cir. 2003)(Although one of skill in the art would have been able to write a software program for digital to digital conversion, such software did not fall within the scope of “means for converting” images as claimed because nothing in the specification or prosecution history clearly linked or associated such software with the function of converting images into a selected format.); Wolfensperger, 302 F.2d at 955, 133 USPQ at 542 (just because the disclosure provides support for a claim element does not mean that the USPTO cannot enforce its requirement that the terms and phrases used in the claims find clear support or antecedent basis in the written description). MPEP § 218(1IV).
B. The specification does not provide clear support or antecedent basis for the claimed “one or more spacers configured to stall…” in claims 53 and 54; and
the limitation “L is configured to bind…” in claim 55. A review of the specification yields no teaching of anything that is “configured to stall” or “configured to bind.”
In addition, a review of parent applications 16/243,357 (now U.S. Patent No. 11,560,598) and 14/773,164 (now U.S. Patent No. 10,221,450) provides no teaching of the cited limitations in their respective originally filed specifications. While the ‘450 Patent does include claims reciting spacers “configured” to stall, these limitations were not present in the originally filed specification or claims. Therefore, neither the instant or parent specifications provide a written description for Claims 53-55 as required under 35 U.S.C. 112, first paragraph.
C. In addition, Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the subject matter not disclosed in the prior-filed application as discussed above.
D. Further, because the cited limitations were not present in either the instant or parent specifications as originally filed, the limitations constitute new matter.
E. If Applicant provides convincing evidence that the specification, as originally filed, inherently provides support, Applicant must either (A) clarify the record by amending the written description such that it expressly recites what structure, materials, or acts perform the function recited in the claim element; or (B) state on the record what structure, materials, or acts perform the function recited in the means- (or step-) plus-function limitation (see above).
12. 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.
12. Claims 53-55 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.
A. The specification does not provide clear support or antecedent basis for the claimed “one or more spacers configured to stall…” in claims 53 and 54; and
The limitations “L is configured to bind…” in claim 54. A review of the specification yields no teaching of anything that is “configured to stall” or “configured to bind.” Thus, the specification provides no guidance as to what structural components are encompassed by the claimed limitations. Because the courts haves stated that an apparatus is defined by its structure and because the specification provides no guidance regarding what structures perform the claimed functions, the claims do not particularly pointing out and distinctly claim the subject matter which the applicant regards as his invention as required under 35 U.S.C. 112, second paragraph. Therefore the claims are indefinite.
B. Furthermore, because the specification does not meet the description requirement under 35 U.S.C. 112, First Paragraph as discussed above, the meets and bounds of the claimed means are unclear.
Whether a claim reciting an element in means- (or step-) plus-function language fails to comply with 35 U.S.C. 112, second paragraph, because the specification does not disclose adequate structure (or material or acts) for performing the recited function is closely related to the question of whether the specification meets the description requirement in 35 U.S.C. 112, first paragraph. See In re Noll, 545 F.2d 141, 149, 191 USPQ 721, 727 (CCPA 1976) (unless the means-plus-function language is itself unclear, a claim limitation written in means-plus- function language meets the definiteness requirement in 35 U.S.C. 112, second paragraph, so long as the specification meets the written description requirement in 35 U.S.C. 112, first paragraph). MPEP § 2181 (II).
Claim Rejections - 35 USC § 103
13. 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 negated by the manner in which the invention was made.
14. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 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 pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
15. Claims 49-50 and 52-54 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Kurn (U.S. Patent Application Publication No. US 2011/0105364 A1, published 5 May 2011).
Regarding claim 49, Maglia et al. teach kits (paragraph 0174) including a transmembrane pore and a nucleic acid handling enzyme, as well as nucleotides and additional reagents and instruments (paragraphs 0173-0174). Maglia et al. further teach helicases (paragraph 0172), and nucleic acid sequences comprising modified nucleotides having biotin linkers (paragraph 0071), and that the kits have the added advantage of allowing enhanced translation of the analyte through the nanopore (paragraph 0001). Thus, Maglia et al. teach the known techniques discussed above.
Maglia et al. do not explicitly teach the biotin link is to a spacer (i.e., oligonucleotide).
However, Kurn teaches kits (Abstract) comprising nanopores (paragraph 0101), helicases (paragraph 0057) and spacers (i.e., oligonucleotides) comprising a modified nucleotide, in the form of a nucleotide linked to biotin through a spacer linker, which have the added advantage of allowing next generation sequencing (paragraph 0126). Thus, Kurn teaches 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 combined the teachings of Maglia et al. and Kurn to arrive at the instantly claimed kit with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a kit having the added advantages of allowing enhanced translation of an analyte through the nanopore as explicitly taught by Maglia et al. (paragraph 0001) and allowing next generation nucleic acids sequencing as explicitly taught by Kurn (paragraph 0126). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in components useful for nanopore sequencing.
Regarding claims 50 and 52-54, the kit of claim 49 is discussed above.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph).
Specifically, both Maglia et al. and Kurn teach nucleotides having biotin linked thereto (paragraph 0071 and 0126, respectively). Neither of the instant claims provide further guidance as to a specific location require for helicase stalling; therefore, the biotinlyated nucleotides are believed to cause stalling.
In addition, it is noted that Figure 13 and page 6 of the instant specification indicates that labelling at the 5’ end, as is explicitly taught by Kurn (paragraph 0126), results in stalling of the helicase (i.e., claims 50, 52, and 54) in the presence of a helicase cofactor (i.e., claim 53).
It is further noted that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04.
Thus, placement of the biotins at any position along the oligonucleotide spacers is obvious.
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, counsel’s mere arguments cannot take the place of evidence in the record.
16. Claim 51 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Kurn (U.S. Patent Application Publication No. US 2011/0105364 A1, published 5 May 2011) as applied to claim 49 above, and further in view of Oliver (U.S Patent Application Publication No. US 2010/0243449 A1, published 30 September 2010).
Regarding claim 51, the kit of claim 49 is discussed above in Section 15.
While Kurn further teaches adapters (paragraph 0126), neither Kurn nor Maglia et al. teach the claimed adaptors.
However, Oliver teaches molecules for use in nanopore translocation (Abstract), wherein the molecules are polynucleotides comprising a single stranded region 2100, a spacer (i.e., linker) region 2300, and a double stranded portion 2200 (Figure 22b and paragraph 0224). Oliver also teaches the molecules have the added advantage of improving the signal to noise ratio (Abstract). Thus, Oliver teaches 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 combined the teachings of Oliver with Maglia et al. and Kurn to arrive at the instantly claimed kit with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a kit having the added advantages of improving signal to noise ratios as explicitly taught by Oliver (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Oliver could have been combined with the cited prior art with predictable results because the known techniques of the Oliver predictably result in adaptors useful for nanopore sequencing.
Double Patenting
17. 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.
18. Claims 49-50 and 52-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,252,717 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Kurn (U.S. Patent Application Publication No. US 2011/0105364 A1, published 5 May 2011).
Both sets of claims are drawn to kits comprising a transmembrane pore and a helicase. Any additional limitations of the ‘717 claims are encompassed by the open clam language “comprising” found in the instant claims.
The ‘717 claims do not include the spacers.
However, the spacers and the additional limitations, as well as the rationale for combining, is taught by the cited prior art as discussed above.
19. Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,252,717 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Kurn (U.S. Patent Application Publication No. US 2011/0105364 A1, published 5 May 2011) as applied to claim 49 above, and further in view of Oliver (U.S Patent Application Publication No. US 2010/0243449 A1, published 30 September 2010) based on the citations and rationale provided above.
20. Claims 49-50 and 52-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,258,591 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Kurn (U.S. Patent Application Publication No. US 2011/0105364 A1, published 5 May 2011).
Both sets of claims are drawn to kits comprising a transmembrane pore and a helicase. Any additional limitations of the ‘591 claims are encompassed by the open clam language “comprising” found in the instant claims.
The ‘591 claims do not include the spacers.
However, the spacers and the additional limitations, as well as the rationale for combining, is taught by the cited prior art as discussed above.
21. Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,258,591 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Kurn (U.S. Patent Application Publication No. US 2011/0105364 A1, published 5 May 2011) as applied to claim 49 above, and further in view of Oliver (U.S Patent Application Publication No. US 2010/0243449 A1, published 30 September 2010) based on the citations and rationale provided above.
22. Claims 49-50 and 52-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 9,751,915 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Kurn (U.S. Patent Application Publication No. US 2011/0105364 A1, published 5 May 2011).
Both sets of claims are drawn to kits comprising a transmembrane pore and a helicase. Any additional limitations of the ‘915 claim is encompassed by the open clam language “comprising” found in the instant claims.
The ‘915 claim does not include the spacers.
However, the spacers and the additional limitations, as well as the rationale for combining, is taught by the cited prior art as discussed above.
23. Claim 51 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 9,751,915 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Kurn (U.S. Patent Application Publication No. US 2011/0105364 A1, published 5 May 2011) as applied to claim 49 above, and further in view of Oliver (U.S Patent Application Publication No. US 2010/0243449 A1, published 30 September 2010) based on the citations and rationale provided above.
Claim Objections
24. Claim 56 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
25. No claim is allowed.
26. 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.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights