DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending. Claims 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-10 and 18-20 are currently under examination.
Response to Amendment
The Amendment filed 5/26/26 has been entered. Claims 1-20 are pending. Applicant’s amendment of the specification and claims 1, 6-7, and 18 have overcome the objections and 112(b) rejection previously set forth in the Non-Final Office Action mailed 2/24/26.
Response to Arguments
Applicant’s arguments, see pages 11-19, filed 5/26/26, with respect to the rejections of claims 1-10 and 18-20 under 35 USC 101 and 103, and nonstatutory double patenting have been fully considered are found unpersuasive, and the rejections documented in the Non-Final mailed 2/24/26 have been revised to address claim amendments filed 5/26/26 in this Final Office Action. More detailed responses to Applicant’s arguments are provided at the end of each maintained rejection.
Claim Rejections - 35 USC § 112 – Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 and 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This new 112(b) rejection is necessitated by claim 1 amendments filed 5/26/26.
Claim 1 lines 3-4 recite the limitation “the predicted outcome comprising an indication for administration of a therapy…” This limitation is unclear, as the skilled artisan would interpret the limitation as the colorectal cancer subject has already undergone therapy, thereby rendering the claim ii) “administering… a therapy” as repetitive. For purposes of compact prosecution, the claim is interpreted as: “i) receiving a prediction of an outcome of the colorectal cancer, the predicted outcome comprising an indication that the colorectal cancer subject is suitable for administration of a therapy, wherein the predicted outcome is generated by…”
Claims 2-10 and 18-20 directly or indirectly depend from claim 1 and are similarly indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 and 18-20 remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims have been evaluated using the 2019 Revised Patent Subject Matter Eligibility Guidance (see Federal Register Vol. 84, No. 4 Monday, January 7, 2019).
This 101 rejection is revised/updated in response to claim amendments filed 5/26/26.
Step 1: The claim is directed to the statutory category of a process.
Step 2A, prong one: The claim recites a judicial exception.
Claim 1 correlation of gene expression and colorectal cancer is considered as the judicial exception of Laws of Nature and Natural Phenomena (see MPEP 2106.04(b)). Claim 1 preamble “predicting an outcome” and last step of “determining the prediction” are considered as the judicial exception of Abstract ideas of Mental processes (see MPEP 2106.04(a)).
Step 2A, prong two: The judicial exception is not integrated into a practical application.
Claims 1-10 and 18-20 recite insignificant extra-solution activities directed towards mere data gathering at high levels of generality (see MPEP 2106.05(g)).
It is further noted that the claims are not directed to a particular treatment or prophylaxis (see MPEP 2106.04(d)(2)). Although claims 9-10 and 20 recite potential therapies, the Specification discloses embodiments of therapies (pages 2 and throughout) at high levels of generality that are not limited to a particular treatment or prophylaxis.
Step 2B: The claim does not provide an inventive concept.
MPEP 2106.05(d)):
The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S.
at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health
Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir.
2017);
ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs.
Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir.
2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115
USPQ2d 1152, 1157 (Fed. Cir. 2015);
iii. Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78,
115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123
USPQ2d at 1088 (Fed. Cir. 2017);
iv. Immunizing a patient against a disease, Classen Immunotherapies, Inc. v.
Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
v. Analyzing DNA to provide sequence information or detect allelic
variants, Genetic Techs. Ltd., 818 F.3d at 1377, 118 USPQ2d at 1546;
vi. Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119
USPQ2d at 1375;
vii. Amplifying and sequencing nucleic acid sequences, University of Utah
Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d
1241, 1247 (Fed. Cir. 2014); and
viii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d
at 1247.
The claims end with the judicial exceptions. Additionally, methods of predicting an outcome of a colorectal cancer subject are not inventive (Buerki et al. 2014; WO 2014/028884 A2). For the reasons set forth above, claims 1-10 and 18-20 are not directed to patent eligible subject matter.
Applicant’s Arguments and Response to Applicant’s Arguments
Applicant argues that the amended claim 1 limitations “integrate the alleged judicial exception into a practical application” and compare the instant “administration of a therapy” to the MPEP 2106.04(d)(2) example of “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype” (Remarks 5/26/26, page 12).
The Examiner respectfully disagrees with these assertions.
The amended claim 1 limitation of “receiving a prediction” is an additional extra-solution and data-gathering step wherein the “certain results of the collection and analysis” are displayed within the generated prediction. The prediction itself is also considered as a judicial exception, as it correlates gene expression (genotype) and colorectal cancer (phenotype) as a Law of Nature and Natural Phenomena generated through the collection and analysis of gathered data, which is an abstract mental process.
To this end, see MPEP 2106.04(a)(2)(III)(A) excerpt:
“In contrast, claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. Examples of claims that recite mental processes include:
• a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis,’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)” (emphasis added); and
MPEP 2106.05(a)(II) excerpt:
“Examples that the courts have indicated may not be sufficient to show an improvement to technology include:…
iii. Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48” (emphasis added).
Additionally, the amended claim 1 limitation of “administering, based on receiving the predicted outcome… the therapy to the colorectal cancer subject” does not integrate the judicial exceptions into a practical application. “The therapy” is not directed to a particular treatment or prophylaxis, and instead omits specification of molecular identities/structures, dosages/amounts, regimens, etc. See MPEP 2106.04(d)(2).
The argued MPEP 2106.04(d)(2) example specifies the administration of both a particular dosage (“lower than normal dosage”) and a class of medication based on the targeted function (“beta blocker medication”). Contrastingly, the instant claim 1 “administration of a therapy” does not indicate a dosage or a particular therapy. As stated in the Non-Final Rejection mailed 2/24/26 (pages 4-5), claims 9-10 and 20 and the Specification recite potential broad classes of therapies at high levels of generality that are considered as “merely instructions to ‘apply’ the exception in a generic way” per MPEP 2106.04(d)(2).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10 and 18-20 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Buerki et al. (2014; WO 2014/028884 A2; FOR citation N in PTO-892 filed 2/24/26).
This 103 rejection is revised/updated in response to claim amendments filed 5/26/26.
Relevant to claim 1, Buerki et al. Abstract teaches "Disclosed herein, in certain instances, are methods, systems and kits for the diagnosis, prognosis and determination of cancer progression of a cancer in a subject. Further disclosed herein, in certain instances, are methods, systems and kits for determining the treatment modality of a cancer in a subject. The methods, systems and kits comprise expression-based analysis of biomarkers. Further disclosed herein, in certain instances, are probe sets for use in assessing a cancer status in a subject."
Further relevant to claim 1, Buerki et al. teaches "the cancer may be a carcinoma… By way of non-limiting example, carcinomas include… colorectal cancer" (paragraph 0338).
Further relevant to claim 1, Buerki et al. teaches "Table 55: 2,040 biomarker library. For each feature, genomic category, associated Affymetrix probeset ID…" (paragraph 0154).
Further relevant to claim 1, Buerki et al. Table 55 teaches two immune defense genes (APOBEC3A, DHX9), two T-Cell receptor signaling genes (CD247, PDE4D), and three PDE4D7 correlated genes (ABCC5, PDE4D, TDRD1).
Further relevant to claim 1, Buerki et al. teaches "The present invention discloses systems and methods for diagnosing, predicting, and/or monitoring the status or outcome of a cancer in a subject using expression-based analysis of a plurality of targets. Generally, the method comprises (a) optionally providing a sample from a subject suffering from a cancer; (b) assaying the expression level for a plurality of targets in the sample; and (c) diagnosing, predicting and/or monitoring the status or outcome of the cancer based on the expression level of the plurality of targets" (paragraph 0165).
Further relevant to claim 1, Buerki et al. teaches “Disclosed herein in some embodiments is a method of diagnosing, prognosing, determining progression the cancer, predicting a therapeutic regimen or predicting benefit from therapy in a subject, comprising (a) assaying an expression level in a sample from the subject for a plurality of targets, wherein the plurality of targets comprises more than one target selected from Tables 2, 4, 11 or 55; and (b) diagnosing, prognosing, determining progression the cancer, predicting a therapeutic regimen or predicting benefit from therapy in a subject based on the expression levels of the plurality of targets” (paragraph 0004).
As discussed above within rejection of claim 1, and relevant to claim 2, Buerki et al. Table 55 includes the claimed genes.
Relevant to claims 3-4, Buerki et al. paragraphs 0301-0304 teach combination of gene expression and regression functions.
Relevant to claim 5, Buerki et al. paragraphs 0305-0306 teach "Additional Techniques and Tests" that "can be employed in combination with measurements of the target sequence expression."
Relevant to claim 6, Buerki et al. paragraphs 0343-0345 teach the TNM classification system.
The Buerki et al. teachings relevant to above rejections of claims 1-5 read upon the limitations of claim 7.
Relevant to claim 8, Buerki et al. paragraph 0417 teaches an embodiment wherein a biological sample is obtained from the subject before the start of the therapy.
Relevant to claim 9, Buerki et al. paragraphs 0354-0397 teach the claimed therapies.
Relevant to claim 10, Buerki et al. paragraphs 0397-0399 teach embodiments that read upon the limitations of claim 10.
Relevant to claim 18, Buerki et al. paragraphs 0400-0401 teach a patient report that reads upon the limitations of claim 18.
Relevant to claim 19, Buerki et al. Table 55 teaches two immune defense genes (APOBEC3A, DHX9), two T-Cell receptor signaling genes (CD247, PDE4D), and three PDE4D7 correlated genes (ABCC5, PDE4D, TDRD1).
Relevant to claim 20, Buerki et al. paragraph 0354 teaches an adjuvant therapy is chemotherapy and wherein an alternative therapy is immunotherapy.
Buerki et al. does not teach a specific embodiment having all the claimed elements. That being said, however, it must be remembered that "[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious." KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. AG. Pro, 425 U.S. 273, 282 (1976)). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious," the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR at 1741. The Court emphasized that "[a] person of ordinary skill is... a person of ordinary creativity, not an automaton." Id. At 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of various disclosed elements — including genes, clinical parameters, therapies, and techniques — for a method, to arrive at compositions "yielding no more than one would expect from such an arrangement."
Applicant’s Arguments and Response to Applicant’s Arguments
Applicant argues that Buerki et al. discloses colorectal cancer “only three times” with the first instance within “a laundry list of different cancers, without anything specific to this cancer or any other cancer in the list” (Remarks 5/26/26, page 15). Applicant further argues that the disclosure “does not in any way indicate – much less teach or suggest in an enabling manner – that the methods discloses in the reference are relevant to colorectal cancer” (Remarks 5/26/26, page 16).
Applicant further argues that impermissible hindsight bias contributed to the selection of instant genes from Buerki et al. Table 55. Applicant argues that “rather than simply reciting all the genes in this list, the prior art must suggest or render obvious this specific combination of target genes” (Remarks 5/26/26, pages 17-18).
The Examiner respectfully disagrees with these assertions.
Applicant is directed towards MPEP 2123 teachings of Rejection Over Prior Art’s Broad Disclosure Instead of Preferred Embodiments. This section teaches that “patents are relevant as prior art for all they contain” and that “nonpreferred and alternative embodiments constitute prior art”. Although Buerki et al. discloses colorectal cancer within alternative cancer embodiments, the skilled artisan would recognize that, per Buerki et al. disclosure, the enclosed methods are relevant to colorectal cancer.
Additionally, per MPEP 2141.02:
Ascertaining the differences between the prior art and the claims at issue requires interpreting the claim language, and considering both the invention and the prior art references as a whole… A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention… However, ‘the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….’ In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004) (emphasis added).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the reference teachings, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Buerki et al. discloses all instantly claimed genes within a single Table 55. The skilled artisan is “not an automaton” and would be able to use “ordinary creativity” to “simply [arrange] old elements [genes] with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement”.
The Examiner also directs Applicant to MPEP 2111.03(I):
The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (emphasis added).
Claim 1 recites that the method comprises “determining or receiving the result of a determination of six or more gene expression levels… wherein said six or more gene expression levels comprise…” genes selected from gene expression profiles. The language of claim 1 is open-ended through the recitations of “comprise” and “six or more”, and thus, the claim scope does not require a specific panel of genes or prior art rationale for the specific combination of the “six or more” genes, as the claim scope encompasses flexible combinations of genes. As discussed above, the Buerki et al. disclosure of Table 55 including the instantly claimed genes must be taken into consideration as a whole and the skilled artisan with “ordinary creativity” would be able to “simply [arrange] old elements [genes]” to arrive at the instant invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 and 18-20 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-10 of copending Application No. 17/908,279 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
This nonstatutory double patenting rejection is revised/updated in response to claim amendments filed 5/26/26.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘279 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-10, and 25-36 of copending Application No. 18/022,565 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
This nonstatutory double patenting rejection is revised/updated in response to claim amendments filed 5/26/26.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘565 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 18-22 of copending Application No. 18/023,598 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
This nonstatutory double patenting rejection is revised/updated in response to claim amendments filed 5/26/26.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘598 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 18, and 21 of copending Application No. 18/029,748 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
This nonstatutory double patenting rejection is revised/updated in response to claim amendments filed 5/26/26.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘748 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 16-17 of copending Application No. 18/707,820 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘820 application.
This nonstatutory double patenting rejection is revised/updated in response to claim amendments filed 5/26/26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 16-19 of copending Application No. 19/118,177 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘177 application.
This nonstatutory double patenting rejection is revised/updated in response to claim amendments filed 5/26/26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 13-16 of copending Application No. 19/111,568 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘568 application.
This nonstatutory double patenting rejection is revised/updated in response to claim amendments filed 5/26/26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 16-20 of copending Application No. 19/495,585 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘585 application.
This nonstatutory double patenting rejection is revised/updated in response to claim amendments filed 5/26/26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Arguments and Response to Applicant’s Arguments
Applicant did not provide arguments relevant to these rejections; therefore, these rejections are maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sarah J Kennedy whose telephone number is (571)272-1816. The examiner can normally be reached Monday - Friday 8a - 5p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH JANE KENNEDY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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