Prosecution Insights
Last updated: May 04, 2026
Application No. 17/978,472

Method And Device For Drug Combination Design By High-Throughput Platform And Machine Learning For Optimizing

Non-Final OA §101§DP
Filed
Nov 01, 2022
Priority
Jul 19, 2022 — CN 202210845111.7
Examiner
VANNI, GEORGE STEVEN
Art Unit
1686
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
University Of Science & Technology Beijing
OA Round
1 (Non-Final)
67%
Grant Probability
Favorable
1-2
OA Rounds
6m
Est. Remaining
91%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allowance Rate
389 granted / 584 resolved
+6.6% vs TC avg
Strong +24% interview lift
Without
With
+24.4%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
42 currently pending
Career history
626
Total Applications
across all art units

Statute-Specific Performance

§101
26.2%
-13.8% vs TC avg
§103
25.4%
-14.6% vs TC avg
§102
6.6%
-33.4% vs TC avg
§112
13.9%
-26.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 584 resolved cases

Office Action

§101 §DP
DETAILED ACTION This application is being examined under AIA first-to-file provisions. Status of claims Canceled: none Pending: 1- 1 0 Withdrawn: none Examined: 1-10 Independent: 1 and 9 Allowable: none Rejections applied Abbreviations x 112/b Indefiniteness PHOSITA "a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention" x 112/b "Means for" BRI Broadest Reasonable Interpretation 112/a Enablement, Written description CRM "Computer-Readable Media" and equivalent language 112 Other IDS Information Disclosure Statement 102, 103 JE Judicial Exception x 101 JE(s) 112/a 35 USC 112(a) and similarly for 112/b, etc. x 101 Other N:N page:line Double Patenting MM/DD/ YYYY date format Priority As detailed on the 11/10/2022 filing receipt, this application claims priority to no earlier than 7/19/2022 . All claims have been interpreted as being accorded this priority date. Claim objections Claims 2-8 and 10 are objected to because of the following informalities. Appropriate correction is required. In each objection the claims are definite with respect to the issues cited here because interpretation would have been sufficiently clear to PHOSITA, but nonetheless the claims are objected to for consistency among the claims or as otherwise indicated. With regard to any suggested amendment below to overcome an objection, in the subsequent examination it is assumed that each amendment is made. However, equivalent amendments also would be acceptable. Any amendments in response to the following objections should be applied throughout the claims, as appropriate. The following issues are objected to: Claim Recitation Comment 2-8 and 10 The left margins of the claims should be aligned with claims 1 and 9. Claims should not be indented or left aligned according to dependency. Claim rejections - 112/b The following is a quotation of 35 USC 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. Claims 1-10 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable. The following issues cause the respective claims to be rejected under 112/b as indefinite: Claim Recitation Comment (suggestions in bold) 1, 9 S1: constructing an initial training data set for machine learning, training and optimizing ..., and selecting ... In claim 1 , grammatically, it is unclear whether the recited "training and optimizing..., and selecting..." ( i ) are required steps in a list of steps beginning with "constructing..." or (ii) are part of the intended use "for machine learning..." clause and so are not required steps. This ambiguity renders the claim indefinite. One option to overcome the rejection would be to enumerate the listed steps. A similar issue also renders claim 9 indefinite . 1 -2, 5, 9-10 S1... through In claim 1 , the recited "through" is not clearly interpretable. Possibly: "by," "using" or "with." The recited "through" is at least unclear as to whether it should be interpreted as equivalent to one of these examples or should be interpreted as, for example, "during" in a time sense or "through" in a spatial sense. Later instances of "through" similarly render their claims indefinite, i.e. claims 1 (S1 and S2), claim 2 (S12 and S13), claim 5 (S31), claim 9 (similarly to claim 1) and claim 10 (similarly to claim 2). 1 , 9 S2... efficient global optimization (EGO) algorithm First, in claim 1 , t he recited " efficient " is a term of relative or vague degree or form of association, neither defined in the specification ([ 10 ]) nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.) Although claims are interpreted in light of the specification, examples from the specification are not imported into the claims as limitations absent a clearly limiting definition in the specification. (MPEP 2145.VI pertains.) Claim 9 is rejected similarly. Second, claim 1 separately is rendered i ndefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here " algorithm ") and function and/or result (here " global optimization ") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. [10] ), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains. 1 S3... excellent target performance The recited "excellent" is a term of relative or vague degree or form of association, neither defined in the specification ([ 11, 108 ]) nor having a well-known and sufficiently particular definition in the art and in the instant context. 1 , 9 S4... obtained drug combinations In claim 1 , he recitation requires but lacks clear antecedent at least due to the recited "obtained" indicating a previous instance when the only previous instance is not clearly plural. Claim 9 is rejected similarly. 1 , 9 S4... a low-toxicity and high-efficiency drug combination In claim 1 , he recited " low-toxicity " and "high-efficiency" are t erm s of relative or vague degree or form of association, neither defined in the specification ([12]) nor having a well-known and sufficiently particular definition in the art and in the instant context. Claim 9 is rejected similarly. 2 S11: characterizing a plurality of D-amino acids with anti-biofilm performance by crystal violet staining... S12: ...characterizing antibiofilm performance of the D-amino acid mixtures... The relationship is unclear between at least "...characterizing... with anti-biofilm performance..." and "...characterizing antibiofilm performance..." The first is recited as requiring "crystal violet staining...," and it is not clear what the second requires and whether it differs from the first. 2 , 10 S11... top five D-amino acids in characterized performance results In claim 1 , t he relationship is unclear between "characterized performance results" and the earlier-recited "characterizing... with anti-biofilm performance." If the two instances are the same, then that relationship may be clarified. Relatedly, in a BRI as presently recited, "top five" reads to any ranking and is not clearly limited to ranking according to "anti-biofilm performance." Claim 10 is rejected similarly. 5 obtaining a true value of the candidate formula through experiments It is unclear what aspect, property, etc. of "the candidate formula" is required to correspond to the recited "true value." 9 -10 A device... comprising: a model training module, configured to construct ... Claim 9 is to a 101 machine or manufacture, i.e. a " device " in this instance, interpreted by statute according to its claimed physical structure , but it is not clear what is the structure associated with the recited " ... module, configured to construct..." Each later instance of "...module..." similarly renders the claim indefinite . MPEP 2106.03, 5th-6th paras. pertain. The recited " device " is interpreted as not clearly requiring structure linking the " device " to the recited instances of "module" with their recited process steps, e.g. "to construct...," in a structural sense appropriate to a claim to a machine or manufacture. PHOSITA may understand these elements to comprise software , but structure should be recited specifically corresponding to recited, stored software. While these instances of "module" may comprise software storage in some embodiments, it is not clear that all embodiments of these elements must comprise software storage corresponding to the recited process steps . This rejection might be overcome by, for example, reciting a data storage device, comprised by the " device ," and instructions stored therein and configured according to the recited steps. MPEP 2173.05(p ).II pertains regarding a claim directed to both product and process. Claim 10 is rejected similarly regarding its recited "characterize...," "combine...," "train..." and "tune..." 9-10 A device... by a high-throughput platform It is unclear whether the recited "device" comprises the recited " a high-throughput platform ." Relatedly, it is unclear what structure comprised by the recited "device" corresponds to the recited "characterize" and "combine..." Claim interpretations The following claim interpretations apply to all instances of the following terms throughout all claims: Claim Recitation Comment 1, 9 high-throughput platform Definite under 112/b after properly invoking 112/f . Recites means (or an equivalent, nonce term, here " platform ") and function and/or result (here "high-throughput") without reciting steps or structure to prevent invoking . However, clearly linked portion of the specification do disclose sufficient structure, material, or acts and not just desired results, as exemplified at [85, 104, 120] . MPEP 2181.III-IV pertain . No prior art has been applied to the following claims No prior art is applied to claims 1-10 . Close art, for example An ( as cited on the attached "Notice of References Cited" form 892 ), while addressing anti- biofilm research , does not teach the instant combination of particularly recited combination therapy, machine learning and optimization , and it is not clear that any combinable art of record would have rendered the claims obvious. Additionally relevant art is Hawas ( as cited on the attached "Notice of References Cited" form 892 ). Claim rejections - 101 35 USC 101 reads: 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. For each rejection below, dependent claims are rejected similarly as not remedying the rejection, unless otherwise noted. Matter belonging to no statutory category -- claims 9-10 Claims 9-10 are rejected under 35 USC 101 because the claimed invention s are directed to non-statutory subject matter. Claim 9 is to "a device ," which is not, in all embodiments within a BRI, interpreted as belonging to any category listed in 101. In a BRI, the claim reads on data and/or software comprising no structure other than data and/or software. The claim is not recited as a process, and the claim is not limited to any particular structure as a 101 machine or manufacture. The claim reads on transitory propagating signals which are not proper patentable subject matter because it does not fit within any of the four statutory categories of invention ( In re Nuijten , Federal. Circuit, 2006). In a BRI, each recited " module" read s on data or software in at least some embodiments. None of the dependent claims remedy this rejection. As appropriate, this rejection can be overcome by, for example, amending to recite structure such as non-transitory computer-readable storage medium comprising computer instructions stored and structurally configured to store the recited instances of "module" and to accomplish the recited steps. J udicial exceptions (JE) to 101 patentability Claims 1-10 are rejected under 35 USC 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to each claim as a whole, each claim is directed to one or more JEs (i.e. an abstract idea, a natural phenomenon, a law of nature and/or a product of nature), as identified below. Any elements or combination of elements beyond the JE(s) (i.e. "additional elements") are conventional and do not constitute significantly more than the JE(s). Thus, no claim includes additional elements amounting to significantly more than the JE(s), as explained below. In Alice , citing Mayo and Bilski , two Mayo/Alice questions determine eligibility under 101: First, is a claim directed to a JE? And second, if so, does the claim recite significantly more than the JE? MPEP 2106 organizes JE analysis into Steps 1, 2A (1st & 2nd prongs) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: www.uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials . Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter? -- MPEP 2106.I and 2106.03 [Step 1: claims 1-8 : YES ; claims 9-10: NO as described in the preceding 101 rejection ] Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- abstract idea -- MPEP 2106.I and 2106.04 Preliminarily, in a 1st prong of Step 2A, elements of independent claim 1 are interpreted as directed to the abstract idea of drug combination design including the JE elements of "S1" through "S4," each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of data. While manipulation of data is not per se directed to an abstract idea, in this instance the above-identified elements are directed to the abstract ideas identified below. BRIs of the claims are analogous to an abstract idea in the form of at least a mental process , at least equivalent to a computer-implemented process, including obtaining and comparing intangible data (e.g. Cybersource , Synopsys and Electric Power Group ). In a BRI, it is not clear that the claim embodiments are limited so as to require complexity precluding analogy to a mental process. BRIs of the claims also are analogous to an abstract idea in the form of a mathematical concept , including mathematical relationships and calculations, as found in the following case law, as cited and discussed above: collecting information, analyzing it, and displaying certain results of the collection and analysis ( Electric Power Group ) and/or obtaining and comparing intangible data (e.g. Cybersource , Ambry and Myriad CAFC ) and/or execution of an algorithm to implement mathematical relationships and/or formulas, including image processing (e.g. TLI , Digitech, Benson, Flook , Diehr , FuzzySharp , In re Grams and In re Abele all as cited in MPEP 2106). Instant examples of math concepts include the recited predicting, based on the optimal model, anti-biofilm performance of candidate mixtures through an efficient global optimization (EGO) algorithm , as well as relationships inherent in recitations as the only supported embodiments . The preceding case law examples are cited for the basic form of their identified abstract ideas, and analogy to these example abstract ideas need not be within the same technology field, 101 analysis generally being assumed to be neutral with respect to technology field. Regarding inherency of abstract ideas, MPEP 2106.04.II.A.1 includes: "the claims in Alice Corp. v. CLS Bank , 'described' the concept of intermediated settlement without ever explicitly using the words 'intermediated' or 'settlement'" (emphasis added, p. 1). Similarly, inherency can effectively be recitation, as in, for example, "By claiming simply 'crystalline paroxetine hydrochloride hemihydrate' with no reference to how it was produced, SKB effectively claimed 'crystalline paroxetine hydrochloride hemihydrate whether non-naturally occurring or arising through natural conversion.' Claim 1, as issued, therefore combines patentable and unpatentable subject matter, and is invalid under Section 101." (capitalization added, SmithKline Beecham Corp. v. Apotex Corp ., 365 F.3d 1306, 1321-33, Fed. Cir. 2004). In the instant type of data processing claims, the specification is not merely adding background explanation as to how a claimed process works, e.g. a physical process based on, involving or further explained by abstract ideas and natural laws. Rather, the specification is detailing the only disclosed way that a programmer may proceed from the recited inputs to the recited outputs, e.g. through actual performance of the disclosed judicial exceptions ( JEs ). Regarding the "Meaning of 'Recites,'" MPEP 2106.04.II.A.1 states: In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms "set forth" and "described" are thus both equated with "recite", their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr , 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo , 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims "set forth" an identifiable judicial exception. Alternatively, the claims in Alice Corp ., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words "intermediated" or "settlement." While the "set forth" language approximates explicit recitation, it also is fundamental that all recitation must be interpreted and that to be patent eligible a claim must satisfy 101 according to its properly interpreted scope, e.g. for all embodiments on which the claim reads, e.g. according to any inherency pertinent to a given claim and disclosure accompanying that claim, i.e. consistent with the "described" meaning of "recites" as in the MPEP. Thus, within a BRI, the identified abstract idea elements read on one or more embodiments which only involve manipulation of data. It is not clear than any improvement argument clearly on the record causes a claim not to be directed to a JE for all embodiments within the scope of the claim. As in Alice (at 306, as cited in the MPEP above) and Bilski (as cited in Alice , id ), an abstract idea may comprise multiple abstract elements or steps (i.e. from Alice: "a series of steps" at 306) and need not be a single equation, relationship or principle. It is not clear that the identified elements must represent other than an abstract idea according to any relevant analysis or case law. [Step 2A, 1st prong, abstract idea: claim 1 : YES] Step 2A, 2nd prong: If the claims recite a judicial exception under the 1st prong, then is the judicial exception integrated into a practical application? -- MPEP 2106.I and 2106.04(d) MPEP 2106.04(d ).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application: An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a); Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2); Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b); Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e). In Step 2A, 1st prong above, claim steps and/or elements were identified as part of one or more judicial exceptions ( JEs ). In Step 2B below, any remaining steps and/or elements are therefore in addition to the identified JE(s). Any such additional steps and additional elements are further discussed in Step 2B. Here in Step 2A, 2nd prong, no additional step or element clearly demonstrates integration of the JE(s) into a practical application. At this point in examination it is not yet the case that any of the Step 2A, 2nd prong considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record. For example, regarding the first consideration at MPEP 2106.04(d)(1) , the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement (e.g. specification: [5, 43, 80, 119, 139] ). [Step 2A, 2nd prong: claim 1 : NO] Step 2B: Do the claims recite a non-conventional arrangement of additional elements in addition to the identified JEs ? -- MPEP 2106.I and 2106.05 All elements of claim 1 are part of a JE as identified above such that no element is recited which is additional to the identified JE(s). Therefore, no claim recites significantly more than the identified JE(s), and it is not clear that any claim is otherwise sufficiently analogous to controlling case law identifying an example of an eligible claim. It is emphasized that, outside of an improvement argument, analysis of what is conventional generally pertains to the above-identified additional elements and not to elements identified as part of a JE. [Step 2B: claim 1 : NO] Summary and conclusion regarding claim 1 Summing up the above analysis of claim 1 , viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the identified JE(s), into patent eligible subject matter, and it is not clear that any claim is sufficiently analogous to controlling case law identifying an example of an eligible claim. Remaining claims Claims 2-8 add elements which also are part of the identified JEs for the same reasons described above regarding the independent claims and therefore do not provide the something significantly more necessary to satisfy 101. Elements of the following claims are additional elements but nonetheless are conventional elements of a laboratory or computing environment, conventional data gathering elements or conventional post-processing elements, as in the following specific examples which also are understood to be well-known and routine: claim 2 : " ...staining ..." and " characterizing anti - biofilm performance " are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified by An and by Hawas (as cited above) , and generally it is understood that the examples in the reference s are well-known and routine. claim 5 : "... obtaining... through experiments ..." is a conventional element of a laboratory and/or computing environment and/or conventional data gathering/input elements , as exemplified by An and by Hawas , and generally it is understood that the examples in the reference s are well-known and routine . claim 7 : S41-S42 are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, in view of the instant specification disclosures at [ 85, 104, 120 ] and as exemplified by An and by Hawas , and generally it is understood that the examples in the references are well-known and routine . S41-S42 read on embodiments relying on microarray printer technology, known well enough as not to require further disclosure for PHOSITA to understand and perform them. None of the dependent claim elements provides the something significantly more than the identified JE(s) necessary to satisfy 101. Conclusion No claim is allowed. A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication. Inquiries Information regarding the filing, management and status of patent applications which are published (available to all users) or unpublished (available to registered users) may be obtained from the Patent Center: https://patentcenter.uspto.gov . Further information is available at https://www.uspto.gov/patents/apply/patent-center , and information about filing in DOCX format is available at https://www.uspto.gov/patents/docx . The Electronic Business Center ( EBC ) at 866-217-9197 (toll-free) is available for additional questions, and assistance from a Customer Service Representative is available at 800-786-9199 (IN USA OR CANADA) or 571-272-1000. The examiner for this Office action, G. Steven Vanni, may be contacted at: (571) 272-3855 Tu-F 8-7 (ET). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062. /G. STEVEN VANNI/ Primary patents examiner, Art Unit 1686
Read full office action

Prosecution Timeline

Nov 01, 2022
Application Filed
Nov 22, 2022
Response after Non-Final Action
Mar 26, 2026
Non-Final Rejection — §101, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12614611
METHOD AND SYSTEM FOR IDENTIFICATION OF CANDIDATE TARGET SITES FOR COMBATING PATHOGENS
4y 4m to grant Granted Apr 28, 2026
Patent 12590337
METHOD FOR EVALUATING ANIMAL CHARACTERISTICS TO IDENTIFY DISCIPLINE SUITABILITY
6y 3m to grant Granted Mar 31, 2026
Patent 12577620
NASAL EPITHELIUM GENE EXPRESSION SIGNATURE AND CLASSIFIER FOR THE PREDICTION OF LUNG CANCER
4y 7m to grant Granted Mar 17, 2026
Patent 12567481
METHOD, DEVICE, AND COMPUTER PROGRAM FOR GENERATING PROTEIN SEQUENCES WITH AUTOREGRESSIVE NEURAL NETWORKS
5y 10m to grant Granted Mar 03, 2026
Patent 12553083
METHODS FOR NON-INVASIVE PRENATAL PATERNITY TESTING
5y 5m to grant Granted Feb 17, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

1-2
Expected OA Rounds
67%
Grant Probability
91%
With Interview (+24.4%)
4y 0m (~6m remaining)
Median Time to Grant
Low
PTA Risk
Based on 584 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month