Prosecution Insights
Last updated: August 17, 2026
Application No. 18/873,638

IDENTIFICATION AND CHARACTERIZATION OF PANCREATIC CYSTIC LESIONS

Non-Final OA §101§102
Filed
Dec 10, 2024
Priority
Jun 19, 2022 — EU 22179768.1 +1 more
Examiner
VILLECCO, JOHN M
Art Unit
Tech Center
Assignee
Bayer Aktiengesellschaft
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
10m
Est. Remaining
74%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allowance Rate
492 granted / 764 resolved
+4.4% vs TC avg
Moderate +10% lift
Without
With
+9.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
7 currently pending
Career history
768
Total Applications
across all art units

Statute-Specific Performance

§101
7.2%
-32.8% vs TC avg
§103
36.8%
-3.2% vs TC avg
§102
20.8%
-19.2% vs TC avg
§112
28.4%
-11.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 764 resolved cases

Office Action

§101 §102
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 . Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Specification The abstract of the disclosure is objected to because: A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives. Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps. Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Duplicate claim warning Applicant is advised that should claims 4, 6, and 8 be found allowable, claims 5, 7, and 9, respectively will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim Objections Claims 1, 6, and 8 are objected to because of the following informalities: In line 2, applicant refers to “cystic lesions”, while in lines 7-10 applicant refers to “cysts”, while it is clear they are referring to the same thing, applicant should maintain consistency among claim terms. Therefore, applicant should stick with “cystic lesions” in lines 7-10, or change “cystic lesions” to “cysts” in line 2. Applicant is reminded of maintaining antecedent basis among claim terms – i.e. the first time a term is claimed, it is preceded by “a”. Subsequent recitations should be preceded by “the” or “said”. In line 2, applicant refers to “the pancreas”, while in lines 3-4 applicant refers to “the pancreas”, while it is clear they are referring to the same thing, applicant should maintain consistency among claim terms. Therefore, applicant should change “the pancreas” in lines 2 to “a pancreas”, and change “a pancreas” to “the pancreas” in lines 3-4. Applicant is reminded of maintaining antecedent basis among claim terms – i.e. the first time a term is claimed, it is preceded by “a”. Subsequent recitations should be preceded by “the” or “said”. As for claim 6, in lines 1-2, applicant recites the phrase “at least one radiological”. This appears to be a typographical error and that the applicant meant to use the phrase – at least one radiological image –. As for claim 8, in line 2, applicant recites the phrase “at least one radiological”. This appears to be a typographical error and that the applicant meant to use the phrase – at least one radiological image –. Appropriate correction is required. 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 3, 8, and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because signals per se do not fall into one of the four statutory categories. Claims 3, 8, and 9 recite, inter alia, “A computer-readable medium…” After close inspection, the Examiner respectfully notes that the disclosure, as a whole, does not definitively describe what can and cannot be considered the “computer readable medium”. Applicant’s specification discusses the “computer readable medium” in paragraphs 0019. However, applicant never discloses what the “computer readable medium” is. Thus, the “computer readable medium” could be transitory forms – such as a signal. An Examiner is obliged to give claims their broadest reasonable interpretation consistent with the specification during examination. The broadest reasonable interpretation of a claim drawn to a computer program product (also called a computer readable medium, machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal, per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. Therefore, given the non-definitive disclosure and the broadest reasonable interpretation, the computer readable medium of the claim may include transitory propagating signals. As a result, the claim pertains to non-statutory subject matter. However, the Examiner respectfully submits a claim drawn to such a computer program product or computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation “non-transitory” to the claim. Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. For additional information, please see the Patents’ Official Gazette notice published February 23, 2010 (1351 OG 212). 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. Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaufman et al. (U.S. Publ. No. 2020/0226748). Regarding claim 1, Kaufman discloses a system for performing virtual pancreatography. More specifically and as it relates to the applicant’s claims, Kaufman discloses a computer-implemented method (see Figure 21 and paragraphs 0137-0139 where a computer implements the methos of the invention) for identifying and characterizing cystic lesions of the pancreas (see paragraph 0044), comprising: receiving at least one radiological image (see paragraph 0044 where computed tomography (CT) or magnetic resonance images are received; also see Figure 1, step 105; and paragraph 0046 where the images are received), the at least one radiological image showing a pancreas of an examination object (see paragraphs 0044-0045 where the images are pancreatic images), segmenting the pancreas from the at least one radiological image (see Figure 1, step 110; and steps 2010 and 2015 of Figure 20A; also see paragraphs 0135 and 0046; where the pancreas is segmented into foreground and background), segmenting parts of the pancreas from the at least one radiological image (see paragraph 0046 where the segmenting segments out different parts of the pancreas), identifying one or more cysts in the identified parts of the pancreas (see paragraphs 0046 and 0135 where cystic lesions are identified), classifying the one or more cysts (see 0046, 0048, 0049, 0051, 0058, 0068, and 0135 where the identified cysts are classified) determining one or more measurement values for the one or more cysts (see paragraph 0044 and 0050 and 0098 where measurements of the cysts can be obtained), displaying at least one representation of the pancreas, the one or more cysts having been labeled in the at least one representation (see Figures 5 and 6, and paragraphs 0050, 0090, 0092, 0095, 0103; where the pancreas images are displayed with overlay of segmentation outlines include lesions). As for claim 2, Kaufman discloses a system for performing virtual pancreatography. More specifically and as it relates to the applicant’s claims, Kaufman discloses a system (system, Fig. 21) comprising a processor (computer/processor, 2110; see Fig. 21 and paragraph 0137), memory (computer accessible medium, 2115; see Fig. 21 and paragraph 0138), and a program (executable instructions, 2120; see Fig. 21 and paragraph 0138) stored in the memory for execution by the processor, the program including instructions that when executed by the processor cause the system to: load at least one radiological image into the memory (see paragraph 0044 where computed tomography (CT) or magnetic resonance images are received; also see Figure 1, step 105; and paragraph 0046 where the images are received), the at least one radiological image showing a pancreas of an examination object (see paragraphs 0044-0045 where the images are pancreatic images), segment the pancreas from the at least one radiological image, (see Figure 1, step 110; and steps 2010 and 2015 of Figure 20A; also see paragraphs 0135 and 0046; where the pancreas is segmented into foreground and background) segment parts of the pancreas in the at least one radiological image (see paragraph 0046 where the segmenting segments out different parts of the pancreas), identify one or more cysts in the identified parts of the pancreas (see paragraphs 0046 and 0135 where cystic lesions are identified), classify the one or more cysts (see 0046, 0048, 0049, 0051, 0058, 0068, and 0135 where the identified cysts are classified), determine one or more measurement values for the one or more cysts (see paragraph 0044 and 0050 and 0098 where measurements of the cysts can be obtained), display at least one representation of the pancreas, the one or more cysts having been labeled in the at least one representation(see Figures 5 and 6, and paragraphs 0050, 0090, 0092, 0095, 0103; where the pancreas images are displayed with overlay of segmentation outlines include lesions). With regard to claim 3, Kaufman discloses a system for performing virtual pancreatography. More specifically and as it relates to the applicant’s claims, Kaufman discloses a computer-readable medium (computer accessible medium, 2115; see Fig. 21 and paragraph 0138) storing instructions (executable instructions, 2120; see Fig. 21 and paragraph 0138), wherein the instructions are executable by a system (system, Fig. 21), comprising a processor (computer/processor, 2110; see Fig. 21 and paragraph 0137) to cause the system to: load at least one radiological image into the memory (see paragraph 0044 where computed tomography (CT) or magnetic resonance images are received; also see Figure 1, step 105; and paragraph 0046 where the images are received), the at least one radiological image showing a pancreas of an examination object (see paragraphs 0044-0045 where the images are pancreatic images), segment the pancreas from the at least one radiological image, (see Figure 1, step 110; and steps 2010 and 2015 of Figure 20A; also see paragraphs 0135 and 0046; where the pancreas is segmented into foreground and background) segment parts of the pancreas in the at least one radiological image (see paragraph 0046 where the segmenting segments out different parts of the pancreas), identify one or more cysts in the identified parts of the pancreas (see paragraphs 0046 and 0135 where cystic lesions are identified), classify the one or more cysts (see 0046, 0048, 0049, 0051, 0058, 0068, and 0135 where the identified cysts are classified), determine one or more measurement values for the one or more cysts (see paragraph 0044 and 0050 and 0098 where measurements of the cysts can be obtained), display at least one representation of the pancreas, the one or more cysts having been labeled in the at least one representation(see Figures 5 and 6, and paragraphs 0050, 0090, 0092, 0095, 0103; where the pancreas images are displayed with overlay of segmentation outlines include lesions). Regarding claims 4, 6, and 8, (which are respectively dependent upon claims 1, 2, and 3), Kaufman discloses that the segmentation of the pancreas from the at least one radiological comprises at least one of an identification and segmentation of a main pancreatic duct (see paragraph 0096 and 0098 where the pancreatic ducts are identified and segmented) and a determination of a centerline in the main pancreatic duct (see paragraph 0099 and Figures 11 and 12). As for claims 5, 7, and 9, (which are respectively dependent upon claims 1, 2, and 3), Kaufman discloses that the segmentation of parts of the pancreas from the at least one radiological comprises at least one of an identification and segmentation of a main pancreatic duct (see paragraph 0096 and 0098 where the pancreatic ducts are identified and segmented) and a determination of a centerline in the main pancreatic duct (see paragraph 0099 and Figures 11 and 12). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kaufman (U.S. Publ. No. 2024/0008801) discloses obtaining the centerline of the pancreas ducts. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN M VILLECCO whose telephone number is (571)272-7319. The examiner can normally be reached Mon-Thurs 6:00 AM-4:00 PM EST. 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JOHN VILLECCO/Supervisory Patent Examiner, Art Unit 2661
Read full office action

Prosecution Timeline

Dec 10, 2024
Application Filed
Jul 30, 2026
Non-Final Rejection mailed — §101, §102 (current)

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Prosecution Projections

1-2
Expected OA Rounds
64%
Grant Probability
74%
With Interview (+9.5%)
2y 6m (~10m remaining)
Median Time to Grant
Low
PTA Risk
Based on 764 resolved cases by this examiner. Grant probability derived from career allowance rate.

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