DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on March 4, 2026 has been entered. The claims pending in this application are claims 1, 4, 7, 9-11, 13, 15, 17, 18, 21, and 23-25 wherein claim 25 has been withdrawn due to the restriction requirement mailed on June 4, 2025. Claims 1, 4, 7, 9-11, 13, 15, 17, 18, 21, 23, and 24 will be examined.
Claim Objections
Claim 4 or 7 or 10 is objected because of the following informality: “selectively transferring the plurality of polynucleotides to the receiving unit” should be “said selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit” in view of claim 1.
Claim 17 is objected to because of the following informality: “the cleaving the plurality of polynucleotides from the surface” should be “said cleaving the plurality of polynucleotides from the surface”.
Claim 24 is objected to because of the following informality: “transferring the plurality of polynucleotides to a receiving unit” should be “said transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit comprising a conducting member” in view of claim 21.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New Matter
Claims 1, 4, 7, 9-11, 13, 15, 17, 18, 21, 23, and 24 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 claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
A limitation “synthesizing a plurality of polynucleotides having predetermined sequences collectively encoding for the at least one nucleic acid sequence on a surface located within one or more channels of a structure such that each of the plurality of polynucleotides extends from the surface” are added to independent claims 1 and 21. Although the specification describes that
“[P]rovided herein are methods for collection of information, the method comprising: (a) providing a structure comprising a surface, wherein the structure comprises: a first plurality of polynucleotides having predetermined sequences collectively encoding for at least one nucleic acid sequence; and a second plurality of polynucleotides having predetermined sequences collectively encoding for the at least one nucleic acid sequence, wherein the first plurality of polynucleotides and the second plurality of polynucleotides both extend from the surface and both encode for the same at least one nucleic acid sequence; (b) selectively separating a region of the structure comprising the first plurality of polynucleotides and removing the first plurality of polynucleotides from the surface; and (c) sequencing and decrypting the at least one nucleic acid sequence to form at least one digital sequence encoding for an item of information. Further provided herein are methods, wherein a region of the structure comprising the first plurality of polynucleotides comprises a cluster of channels or wells” (see paragraphs [0007] of US 2023/0185971 A1, which is US application of this instant application), nowhere in the specification describes such limitation recited in claims 1 and 21 since the specification only describes that (1) a structure comprises a surface wherein the structure comprises a first plurality of polynucleotides having predetermined sequences collectively encoding for at least one nucleic acid sequence, a second plurality of polynucleotides having predetermined sequences collectively encoding for the at least one nucleic acid sequence, and the first plurality of polynucleotides and the second plurality of polynucleotides both extend from the surface and both encode for the same at least one nucleic acid sequence; and (2) a region of the structure
comprising the first plurality of polynucleotides comprises a cluster of channels or wells, and does not describe that a plurality of polynucleotides having predetermined sequences collectively encoding for the at least one nucleic acid sequence is synthesized on a surface of one or more channels of a structure. Furthermore, in applicant’s remarks filed on March 4, 2026, applicant does not indicate which parts in the specification support above claim limitation recited in claims 1 and 21.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application.” MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure” (emphasis added).
Scope of Enablement
Claims 1, 4, 7, 9-11, 13, 15, 17, 18, 21, 23, and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for performing converting, synthesizing, and depositing steps of claims 1 and 21, does not reasonably provide enablement for selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit using the methods recited in claims 1, 4, 7, 9-11, 13, 15, 17, and 18 and selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit comprising a conducting member using the methods recited in claims 21, 23, and 24. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The Nature of The Invention
The claims are drawn to a method for selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit
The invention is a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The Breadth of The Claims
Claims 1, 4, 7, 9-11, 13, 15, 17, and 18 encompass a method comprising converting at least one item of information in a form of at least one digital sequence to at least one nucleic acid sequence; synthesizing a plurality of polynucleotides having predetermined sequences collectively encoding for the at least one nucleic acid sequence on a surface located within one or more channels of a structure such that each of the plurality of polynucleotides extends from the surface; depositing a transfer media into a main channel of the structure, the transfer media containing a positive charge or a negative charge; directing the transfer media to a proximal opening of the one or more channels via a power unit and one or more interconnected conductor plates, the one or more interconnected conductor plates disposed above and surrounding a proximal edge of each channel of the one or more channels, the power unit suppling a voltage potential between the one or more interconnected conductor plates and the structure to attract the transfer media; and selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit, the transfer media configured to adhere, collect, and transfer the plurality of polynucleotides to the receiving unit in response to application of a force, wherein the force comprises magnetic force, electrostatic force, or a combination thereof. Claims 21, 23, and 24 encompass a method comprising converting at least one item of information in a form of at least one digital sequence to at least one nucleic acid sequence; providing a structure; synthesizing a plurality of polynucleotides having predetermined sequences collectively encoding for the at least one nucleic acid sequence on a surface located within one or more channels of the structure such that each of the plurality of polynucleotides extends from the surface; depositing a transfer media into a chamber of the structure, the transfer media containing a positive charge or a negative charge; directing the transfer media to a proximal opening of the one or more channels via a power unit and one or more interconnected conductor plates, the one or more interconnected conductor plates disposed above and surrounding a proximal edge of each channel of the one or more channels, the power unit suppling a voltage potential between the one or more interconnected conductor plates and the structure to attract the transfer media; and selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit comprising a conducting member, the transfer media configured to adhere, collect, and transfer the plurality of polynucleotides to the receiving unit in response to application of an electrostatic force or an applied voltage potential between the structure and the conducting member.
Working Examples
The specification provides 13 examples (see pages 23-27 of US 2023/0185971 A1, which is US publication of this instant case). However, the specification provides no working example for selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit using the methods recited in claims 1, 4, 7, 9-11, 13, 15, 17, and 18 and selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit comprising a conducting member using the methods recited in claims 21, 23, and 24.
The Amount of Direction or Guidance Provided and The State of The Prior Art
Although the specification provides 13 examples (see pages 23-27 of US 2023/0185971 A1, which is US publication of this instant case), the specification provides no working example for selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit using the methods recited in claims 1, 4, 7, 9-11, 13, 15, 17, and 18 and selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit comprising a conducting member using the methods recited in claims 21, 23, and 24. Furthermore, there is no experimental condition and/or experimental data in the specification to support the claimed invention. During the process of the prior art search, the examiner has not found any prior art which is related to selectively transfer the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit using the methods recited in claims 1, 4, 7, 9-11, 13, 15, 17, and 18 and selectively transfer the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit comprising a conducting member using the methods recited in claims 21, 23, and 24.
Level of Skill in The Art, The Unpredictability of The Art, and The Quantity of Experimentation Necessary
While the relative skill in the art is very high (the Ph.D. degree with laboratory experience), there is no predictability whether the plurality of polynucleotides can selectively transfer through the one or more channels via the transfer media to a receiving unit using the methods recited in claims 1, 4, 7, 9-11, 13, 15, 17, and 18 and the plurality of polynucleotides can selectively transfer through the one or more channels via the transfer media to a receiving unit comprising a conducting member using the methods recited in claims 21, 23, and 24.
First, although the specification teaches that “[A]n aqueous or gaseous transfer media that adheres to the polynucleotides is deposited. The channel is surrounded by interconnected conductor plates located above the channel. The transfer media comprises a charge (positive
or negative) that reacts with an electrostatic field created by the conductor plates. A voltage potential is applied between the interconnected conductor plates, resulting in attraction of the transfer media and transfer of the polynucleotides through an opening of the channel” (see paragraph [0198] of US 2023/0185971 A1, which is US publication of this instant case),
nowhere in the specification provides an example of the transfer media. Although claim 1 requires depositing a transfer media into a main channel of the structure wherein the transfer media containing a positive charge or a negative charge, directing the transfer media to a proximal opening of the one or more channels via a power unit and one or more interconnected conductor plates, the one or more interconnected conductor plates disposed above and surrounding a proximal edge of each channel of the one or more channels, the power unit suppling a voltage potential between the one or more interconnected conductor plates and the structure to attract the transfer media, and selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit, the transfer media configured to adhere, collect, and transfer the plurality of polynucleotides to the receiving unit in response to application of a force, wherein the force comprises magnetic force, electrostatic force, or a combination thereof, since the plurality of polynucleotides carries negative charges and claim 1 does not indicate how the transfer media adheres to the plurality of polynucleotides, if the transfer media contains only negative charges, the transfer media cannot directly adhere
to the plurality of polynucleotides due to its negative charges such that the plurality of polynucleotides cannot be used to adhere, collect, and transfer the plurality of polynucleotides to the receiving unit in response to application of electrostatic force and the methods recited in claims 1, 4, 7, 9-11, 13, 15, 17, and 18 cannot be performed. On other hand, since the plurality of polynucleotides carries negative charges and claim 1 does not indicate how the transfer media adheres to the plurality of polynucleotides, if the transfer media contains only positive charges, net charge of the plurality of polynucleotides may be zero due to an interaction between the positive charges of the transfer media and negative charges of the plurality of polynucleotides such that the plurality of polynucleotides cannot be move through the one or more channels via the transfer media to a receiving unit in response to application of electrostatic force and the methods recited in claims 1, 4, 7, 9-11, 13, 15, 17, and 18 cannot be performed. Furthermore,
although claim 1 requires synthesizing a plurality of polynucleotides having predetermined sequences collectively encoding for the at least one nucleic acid sequence on a surface located within one or more channels of a structure such that each of the plurality of polynucleotides extends from the surface, since claim 1 does not indicate how the plurality of polynucleotides is attached to a surface located within one or more channels of a structure, if the plurality of polynucleotides is attached to the surface located within the one or more channels of the structure by a covalently bond, the plurality of polynucleotides cannot detached from the surface located within the one or more channels of the structure in response to application of electrostatic force, it is unpredictable how the plurality of polynucleotides can be selectively transferred through the one or more channels via the transfer media to a receiving unit in response to application of electrostatic force using the methods recited in claims 1, 4, 7, 9-11, 13, 15, 17, and 18. In addition although it is known that a magnetic force can be used to isolate polynucleotides only when the polynucleotides are bound to the surface of magnetic particles (see abstract and column 2 of US Patent No.5,705,628), since claim 1 does not require that the plurality of polynucleotides is bound to the surface of magnetic particles, if the plurality of polynucleotides are not bound to the surface of magnetic particles, it is unpredictable how the plurality of polynucleotides can be selectively transferred through the one or more channels via the transfer media to a receiving unit in response to application of magnetic force using the methods recited in claims 1, 4, 7, 9-11, 13, 15, 17, and 18.
Second, although it is known that a process for the cleavage and deprotection of newly synthesized oligonucleotides from a solid support involves incubating the solid support in an environment comprising gaseous cleavage/ deprotection reagent such as gaseous ammonia or ammonium hydroxide vapors (see abstract from US Patent No. 5,514,789), since claim 17 does not indicate that a gaseous reagent is what kind of gaseous reagent, if the gaseous reagent is any kind of gaseous reagent such as oxygen or ozone, it is unpredictable how the plurality of polynucleotides can be cleaved by any kind of gaseous reagent such as oxygen or ozone.
Third, although the specification teaches that “[A]n aqueous or gaseous transfer
media that adheres to the polynucleotides is deposited. The channel is surrounded by interconnected conductor plates located above the channel. The transfer media comprises a charge (positive or negative) that reacts with an electrostatic field created by the conductor plates. A voltage potential is applied between the interconnected conductor plates, resulting in attraction of the transfer media and transfer of the polynucleotides through an opening of the channel” (see paragraph [0198] of US 2023/0185971 A1, which is US publication of this instant case), nowhere in the specification provides an example of the transfer media. Although claim 21 requires depositing a transfer media into a main channel of the structure wherein the transfer media containing a positive charge or a negative charge, directing the transfer media to a proximal opening of the one or more channels via a power unit and one or more interconnected conductor plates, the one or more interconnected conductor plates disposed above and surrounding a proximal edge of each channel of the one or more channels, the power unit suppling a voltage potential between the one or more interconnected conductor plates and the structure to attract the transfer media, and selectively transferring the plurality of polynucleotides through the one or more channels via the transfer media to a receiving unit, the transfer media configured to adhere, collect, and transfer the plurality of polynucleotides to the receiving unit comprising a conducting member, the transfer media configured to adhere, collect, and transfer the plurality of polynucleotides to the receiving unit in response to application of an electrostatic force or an applied voltage potential between the structure and the conducting member and claim 21 does not indicate how the transfer media adheres to the plurality of polynucleotides, if the transfer media contains only negative charges, the transfer media cannot directly attach to the plurality of polynucleotides due to its negative charges such that the plurality of polynucleotides cannot be used to adhere, collect, and transfer the plurality of polynucleotides to the receiving unit in response to application of electrostatic force and the methods recited in claims 21, 23, and 24 cannot be performed. On the other hand, since the plurality of polynucleotides carries negative charges and claim 21 does not indicate how the transfer media adheres to the plurality of polynucleotides, if the transfer media contains only positive charges, net charge of the plurality of polynucleotides may be zero due to an interaction between the positive charges of the transfer media and negative charges of the plurality of polynucleotides such that the plurality of polynucleotides cannot be move through the one or more channels via the transfer media to a receiving unit in response to application of electrostatic force and the methods recited in claims 21, 23, and 24 cannot be performed. Furthermore, although claim 21 requires synthesizing a plurality of polynucleotides having predetermined sequences collectively encoding for the at least one nucleic acid sequence on a surface located within one or more channels of a structure such that each of the plurality of polynucleotides extends from the surface, since claim 21 does not indicate how the plurality of polynucleotides is attached to a surface located within one or more channels of a structure, if the plurality of polynucleotides is attached to the surface located within the one or more channels of the structure by a covalently bond, the plurality of polynucleotides cannot detached from the surface located within the one or more channels of the structure in response to application of electrostatic force, it is unpredictable how the plurality of polynucleotides can be selectively transferred through the one or more channels via the transfer media to a receiving unit in response to application of electrostatic force using the methods recited in claims 21, 23, and 24.
Case law has established that “(t)o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright 990 F.2d 1557, 1561. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) it was determined that “[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art”. The amount of guidance needed to enable the invention is related to the amount of knowledge in the art as well as the predictability in the art. Furthermore, the Court in Genentech Inc. v Novo Nordisk 42 USPQ2d 1001 held that “[I]t is the specification, not the knowledge of one skilled in the art that must supply the novel aspects of the invention in order to constitute adequate enablement”.
In view of above discussions, the skilled artisan will have no way to predict the experimental results. Accordingly, it is concluded that undue experimentation is required to make the invention as it is claimed. These undue experimentation at least includes to test whether the plurality of polynucleotides can selectively transfer through the one or more channels via the transfer media to a receiving unit using the methods recited in claims 1, 4, 7, 9-11, 13, 15, 17, and 18 and the plurality of polynucleotides can selectively transfer through the one or more channels via the transfer media to a receiving unit comprising a conducting member using the methods recited in claims 21, 23, and 24.
Conclusion
In the instant case, as discussed above, the level of unpredictability in the art is high, the specification provides one with no guidance that leads one to claimed methods. One of skill in the art cannot readily anticipate the effect of a change within the subject matter to which the claimed invention pertains. Thus given the broad claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the large quantity of research required to define these unpredictable variables, the lack of guidance provided in the specification, the absence of any working example related to claimed invention and the no teaching in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation for one of skill in the art to perform the method of the claim as broadly written.
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.
Claim 24 is 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.
Claim 24 recites the limitation “the chamber” in the claim. There is insufficient antecedent basis for this limitation in the claim because there is no phrase “a chamber” before “the chamber”. Please clarify.
Response to Arguments
Applicant’s arguments with respect to claims 1-5, 7, 9-11, 13, 15, 17-19, and 21-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
No claim is allowed.
Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993)(See 37 CAR § 1.6(d)). The CM Fax Center number is (571)273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph.D., whose telephone number is (571)272-0746. The examiner can normally be reached on Monday-Friday from 9 A.M. to 5 P.M.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Dr. Anne Gussow, Ph.D., can be reached on (571)272-6047.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/FRANK W LU/Primary Examiner, Art Unit 1683 May 26, 2027
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