DETAILED ACTION
The present Office Action is responsive to the Amendment received on July 21, 2026.
Preliminary Remark
Claims 1-28 are canceled.
Claims 42-48 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 with1 traverse in the reply filed on March 11, 2026.
Claim Objections
The objection made to claim 29 for reasons discussed in the Office Action mailed on May 13, 2026 is withdrawn in view of the Amendment received on July 21, 2026.
Claim Rejections - 35 USC § 112
The rejection of claims 29-41 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to particularly point out and distinctly claim the subject matter, made in the Office Action mailed on May 13, 2026 is withdrawn in view of the Amendment received on July 21, 2026.
Rejection - Maintained
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.
The New Matter rejection of claims 29, 30, and 32-41 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, made in the Office Action mailed on May 13, 2026 is maintained for the reason of record.
Applicants’ claim amendment and arguments presented in the Amendment received on July 21, 2026 have been carefully considered but they have not been found persuasive for the reasons discussed in the, “Response to Arguments” section.
The Rejection:
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. This is a New Matter Rejection.
Claims 29-41 have been added subsequent to the filing of the application.
Independent claim 29 seeks to broaden the scope of the originally filed invention, said invention directed to a method of using non-native enzymes by their production in a microorganism which is added to a nucleic acid manipulation reaction without purification, to the method of using a non-native protein in the same reaction.
The specification as originally filed supports for the method pertaining only to the use of non-native enzymes, but not to the genus of non-native proteins.
There is no literal support to justify the now broader scope of using any non-native proteins as presently claimed in the drawings or specification. As well, the specification does not disclose any species that are embraced by the adoption of the boarder term, “protein.”
However, there are species of such proteins which could be utilized in a nucleic acid manipulation process, such as single-stranded binding proteins (SSBs), RNA-binding proteins, and transcription factors, for which the specification does not demonstrate contemplation.
In addition, claim 35 claims multiple non-native proteins which are transformed into a single microorganism. The specification appears to support different microorganism, each containing their respective non-native enzymes2. However, the specification does not provide any description of a single cellular reagent derived from a single microorganism that contains more than one non-native enzymes that are used in a nucleic acid manipulation process.
Claim 39 contains new matter as the claim seeks to capture a single microorganism expressing additional reagents that carry out the nucleic acid manipulation process other than the non-native enzyme. As discussed for claim 35, there is no apparent support for this embodiment in the application as filed. Applicants are requested to point to the application where such support is found.
Therefore, the application as filed contains new matter that must be removed.
Response to Arguments:
Applicants traverse the rejection.
Applicants state that claim 29 has been amended to delete the term, “non-native” from the phrase, “non-native protein” to generically capture, “protein” (page 6, bottom paragraph to page 7, 1st paragraph).
Applicants contend that support for the claimed method pertaining to the production of a “protein” (instead of non-native protein) is properly supported in various sections of the specification in the counterpart PCT publication.
The Office respectfully disagrees.
I – Re: section [0003]:
Applicants state that section [0003] of the specification provides a “[l]iteral support for protein production (page 7, Response).
However, section [0003] of the specification discusses background of protein typically being required to be purified/isolated for use in molecular biology techniques, and does not provide any context in which the presently claimed method that employs any protein used without purification from a microorganism from which it is produced.
II – Re: section [0027]:
This section of the specification refers to Figure 19 that provides data for an in vitro transcription reaction using lyophilized BL21 bacteria expression T7 RNA polymerase. As know, T7 RNA is an enzyme, and while broadly categorized as a “protein,” the specification as filed does not show contemplation that proteins other than enzymes are used without a prior purification step.
III – Re: section [0125], Example 1:
Applicants state that example 1 pertains to the determination of feasibility in using bacteria that expresses heterologous proteins directly as reagents in molecular biology reactions, PCR, using fresh cultures of bacteria expressing RTX Exo- polymerase.
Again, the example employs a microorganism that expresses an enzyme, that is, a polymerase. Presently, the claims have been amended to use a microorganism that expresses a genus of protein that include more than enzymes without prior purification. As stated previously and in the rejection of record, there was no show of such contemplation by way of description, figures, or claims.
Applicants contend the method of utilizing a protein as presently claimed “do not impose on the skilled person to necessarily make and use each and every protein” and “[c]arrying out the presently claimed steps would not be considered new matter, based on the detailed description provided in the present specification on how to carry out the claimed methods, including examples of specific reagents and preparations.” (page 7, Response)
This contention has been carefully considered but has not been found persuasive. The argument that one necessarily make and use each and every protein is not pertinent to new matter rejection. A new matter rejection is based on whether Applicants, at the time the application was filed, had contemplated the invention as presently claimed.
The specification is clear that the method of present invention is directed to the ability to utilize an enzyme produced from a microorganism expressing said enzyme without purification.
This specification clearly lays out this foundation:
PNG
media_image1.png
733
893
media_image1.png
Greyscale
The specification discusses Applicants’ invention based on this backdrop:
PNG
media_image2.png
375
885
media_image2.png
Greyscale
While the specification may have discussed the need for proteins (in general) to be isolated prior to their use in a molecular biology application (section [0003]), the specific improvement and application based on this limitation was for expression enzymes, not every protein, expressed by a microorganism without prior purification, in an assay.
To this end, Applicants’ specification and discussions relate only to enzymes, with no other contemplation suggesting the extension of their invention to any proteins that can be expressed in a microorganism.
Therefore, Applicants’ arguments are not found persuasive and the rejection is maintained.
The written description (i.e., possession) rejection of claims 29, 30, and 32-41 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, made in the Office Action mailed on May 13, 2026 is maintained for the reasons of record.
Applicants’ arguments presented in the Amendment received on July 21, 2026 have been carefully considered but they have not been found persuasive for the reasons discussed in the, “Response to Arguments” section.
The Rejection:
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. This is a Written Description Rejection.
The presently rejected claims embrace a method of utilizing a genus of non-native proteins as discussed above, for which the application as filed fail show demonstration of possession of a reasonable number of species.
The written description requirement ensures that, “an applicant invented the subject matter which is claimed. Further, the written description requirement for a claimed genus may be satisfied through a sufficient description of a representative number of species by 1) reduction to practice; 2) reduction to drawing; or 3) disclosure of relevant identifying characteristics (i.e., structure of other physical and/or chemical properties, functional characteristics coupled with a known or disclosed correlation between function and structure) (MPEP 2163 at II(A)(3)(a)(ii)).
Reduction to Practice
The specification discloses a specific type of proteins that are limited to the class of enzymes. No other demonstration nor contemplation is shown.
Reduction to Drawing
There are no species directed to a class of proteins other than enzymes.
Disclosure of Relevant Identifying Characteristics
While one could argue that a skilled artisan would be able to identify the “representative number of species” of the remaining polymorphisms within the DGAT gene by comparing an isolated sequence against the reference sequence, such method would not satisfy the written description for the genus claims when, “the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art” (MPEP 2163(I)(A)). For the claims at issue, such essential or critical feature is the protein classes other than enzymes. Applicants have not disclosed enough number of species within the claimed genus.
As stated in University of California v. Eli Lilly and Co. at page 1404:
An adequate written description of a DNA ... "requires a precise definition, such as by structure, formula, chemical name, or physical properties," not a mere wish or plan for obtaining the claimed chemical invention. Fiers v. Revel, 984 F.2d 1164, 1171, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). Accordingly, "an adequate written description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself." Id. at 1170, 25 USPQ2d at 1606.
Therefore, for the foregoing reasons, the genus embraced by the claims is not sufficiently described by the number of species disclosed in the specification, and therefore, the specification lacks written description of the claims.
Response to Arguments:
Applicants traverse the rejection.
Applicants contend that addressing “possession” may be shown in any number of ways and an Applicant need not describe every claim feature exactly because there is no in haec verba requirement, but that in order to satisfy the written description requirement, all that is required is a “reasonable clarity” (page 9, Response).
Applicants refer to the Amgen v. Sanofi et al. (citation omitted), contending that the Supreme Court stated that the specification does not always need to “describe with particularity how to make and use every single embodiment within a claimed class” (page 9, Response), but may be made in “any way through express words, structures, figures, diagrams, and/or formulae” (MPEP 2163(1), 2163.02).
These arguments have been carefully considered but they have not been found persuasive.
While the specification need not describe “every single” embodiment within the claimed class, the written description requirement does require that Applicants demonstrate possession of for a claimed breadth based on showing of a reasonable number of species (MPEP 2163 at II(A)(3)(a)(ii)).
The reasonable number of species, is also not just any protein that can be transformed into a microorganism to be expressed. If Applicants’ claim were to be directed to a generic method of expressing any protein via a microorganism, then such a claim would not be subject to the present requirement as the art is replete with guidance for performing such a method.
The reasonable number of species in the present application, however, are the species of proteins, other than enzymes, that can be utilized in a “nucleic acid manipulation process”, without purification from a microorganism from which they were expressed.
To this end, Applicants have no additional species other than enzymes whatsoever.
More importantly, the Office contends that the actual breadth the Office has conceded, that is, conceding breadth directed to a broad class of “enzymes”, more closely follows the guidelines of Amgen v. Sanofi et al., based on showing of some species of enzymes, such as polymerase.
Therefore, for these reasons, Applicants’ arguments are not found persuasive and the rejection is maintained.
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.
The effective filing date of the instantly rejected claims is the actual filing date of the instant application, October 3, 2023. This is because the claims are not supported by the application as originally filed nor by any of the parent applications (see above new matter rejection).
The rejection of claims 29, 30, and 32-41 under 35 U.S.C. 102(a)(1) as being anticipated by Ellington et al. (US 2020/0399679 A1, published December 24, 2020), made in the Office Action mailed on May 13, 2026 is maintained for the reasons of record.
Applicants’ arguments presented in the Amendment received on July 21, 2026 is not found persuasive because the new matter rejection is maintained, resulting in the effective filing date of the instant application being October 2, 2023.
The rejection is reproduced below.
The Rejection:
With regard to claim 29, Ellington et al. teach a method of utilizing a protein in a nucleic acid manipulation process (“method of utilizing an enzyme in a nucleic acid manipulation process”, see claim 1), comprising the steps:
transforming a microorganism with a non-native protein (“transforming a microorganism with a non-native enzyme”, see claim 1(a));
inducing expression of the protein in the microorganism, thereby producing the non-native protein (“inducing the expression of the enzyme in the microorganism, thereby producing the non-native enzyme”, see claim 1(b));
dehydrating the microorganism of step (c) (“the cellular reagent can be dehydrated”, section [0092]; “[l]yophilized cellular reagents have the added advantage of biosafety; E. coli lyophilized without excipients (such as trehalose) do not retain viability … and therefore are safer for distribution and use”, section [0144]);
rehydrating the microorganism (“[r]hydrated lyophilized bacteria …”, section [0145]);
combining the microorganism of step (d) with a non-naturally occurring nucleic acid, including the non-naturally occurring protein, wherein the non-native protein is not purified from the microorganism prior to combining the microorganism with the nucleic acid (“adding the microorganism of step b) directly to a non-naturally occurring nucleic acid manipulation process, wherein the non-native enzyme is not purified prior to addition to the nucleic acid manipulation process”, see claim 1(d), “the process is nucleic acid amplification3”, see claim 2); and
carrying out a nucleic acid manipulation process using the non-native protein (“carrying out the nucleic acid manipulation process using the enzyme”, see claim 1(d)).
With regard to claim 30, the protein is necessary for the nucleic acid manipulation process (see claim 2).
With regard to claim 32, the process of a nucleic acid amplification (see claim 4).
With regard to claim 33, the nucleic acid amplification is thermostable amplification (see claim 5).
With regard to claim 34, the nucleic acid amplification is isothermal amplification (see claim 6).
With regard to claim 35, more than one protein is transformed (see claim 7).
With regard to claim 36, multiple proteins are transformed in multiple microorganisms and added to the non-naturally occurring nucleic acid manipulation process (see claim 8).
With regard to claim 37, the nucleic acid manipulation process comprises further components needed to carry the nucleic acid manipulation (see claim 9).
With regard to claim 38, the further components are provided exogenously during the nucleic acid manipulation process (see claim 10).
With regard to claim 39, the further components are naturally occurring products are produced by the microorganism (see claim 11).
With regard to claims 40 and 41, the microorganism is prokaryotic or eukaryotic (see claims 16 and 17).
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.
The rejection of claims 29-41 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,807,901 (herein, “the 901 patent”), made in the Office Action mailed on May 13, 2026 is maintained for the reasons of record.
Applicants has not filed a Terminal Dislcaimer or provided any argument identifying any supposed error in the rejection.
Therefore, the rejection is maintained for the reasons already of record.
The Rejection:
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With regard to instant claim 29, claims of the ‘901 patent also claims a method of utilizing a protein (i.e., enzyme) in a nucleic acid manipulation process, comprising:
transforming a microorganism with a non-native protein (see claim 1(a), “enzyme” being the protein);
inducing expression of the protein in the microorganism, thereby producing the non-native protein (see claim 1(b));
dehydrating or freeze-drying the microorganism without using an excipient (see claim 1(c));
rehydrating the microorganism of step c) (see claim 1(d));
combining the microorganism of step d) with a non-naturally occurring nucleic acid, including the non-native protein, wherein the non-native protein is not purified from the microorganism prior to combining the microorganism with the nucleic acid (see claim 1(e)); and
carrying out a nucleic acid manipulation process using the non-native protein and non-naturally occurring nucleic acid, wherein the non-native protein is utilized in performing the nucleic acid manipulation process (see claim 1(f)).
With regard to instant claims 30-40, claims 2-12 are verbatim.
With regard to claim 41, while the claims of the ‘901 do not explicitly claim that the microorganism is eukaryotic, given the maturity of the art in the recombinant cloning, one of ordinary skill in the art before the effective filing date would have reasonably expected that other microorganism used for the purpose of producing recombinant proteins, would have also yielded the same predictable outcome.
In KSR, the Supreme Court particularly emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art,” Id. at 415, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
Therefore, the invention as claimed is deemed prima facie obvious over the claims of the ‘901 patent.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
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.
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.
/YOUNG J KIM/Primary Examiner
Art Unit 1637 October 2, 2026
/YJK/
1 The Non-Final Rejection mailed on May 13, 2026 properly responded to Applicants’ traversal, but inadvertently used a wrong form paragraph for withdrawing the non-elected invention (as being non-elected without traverse), which is corrected herein.
2 The rejection based on the rationale discussed for claim 35 has been withdrawn.
3 Nucleic acid amplification necessarily includes non-naturally occurring nucleic acids in the form of primers and/or probes.
Prosecution Insights