DETAILED ACTION
Acknowledgements
This Office Action is in reply to Applicant’s response filed 02 January 2026 (“Response”).
Claims 1, 3–4, 6–14, and 16–20 are currently pending and have been examined.
CLAIM INTERPRETATION AND 35 USC § 112(f)
The following is a quotation of 35 USC § 112(f) (emphasis added):
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
One exception to the broadest reasonable interpretation standard occurs when a claimed phrase is interpreted in accordance with 35 USC § 112(f) (“§ 112(f)”). See MPEP § 2181 et seq. To invoke § 112(f), a claimed phrase must meet the three prong analysis (“3 Prong Analysis”) as set forth in MPEP § 2181 I.
Use of the word “means” in a claim with functional language creates a rebuttable presumption that the claim limitation should be interpreted in accordance with § 112(f). The presumption that the claim limitation is interpreted under § 112(f) is rebutted when the claim limitation recites sufficient structure to perform the entire claimed function.
Absence of the word “means” in a claim creates a rebuttable presumption that the claim limitation is not to be interpreted in accordance with § 112(f). The presumption that the claim limitation is not interpreted under § 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure to perform the entire claimed function.
Claim limitations that use the word “means” are therefore being interpreted under § 112(f), except as otherwise indicated below. Conversely, claim limitations that do not use the word “means” are not being interpreted under § 112(f), except as otherwise indicated below.
The following phrases will be first identified and then analyzed using the MPEP’s 3 Prong Analysis to determine if the claimed phrase invokes § 112(f). If a phrase invokes § 112(f), the corresponding structure for the phrase will also be determined.
Functional Phrase #1
The first functional phrase to be considered is “computer readable program code embodied in the memory that is executable by the processor to perform operations comprising: […] normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product.” Claims 14 and 20 (“Functional Phrase #1” or “FP#1”).
Prong (A)
In accordance with the MPEP, Prong (A) requires “the claim limitation uses the term ‘means’ […] or a term used as a substitute for ‘means’ that is a generic placeholder […] for performing the claimed function.” MPEP § 2181 I. (“Prong (A)”).1
As an initial matter, the Examiner finds that FP#1 does not use the term “means.” Therefore the issue arising under Prong (A) then becomes whether or not the presumption that 35 USC § 112(f) is not invoked can be overcome.
With respect to the presumption that 35 USC § 112(f) is not invoked, “[t]he question is not whether a claim term recites any structure but whether it recites sufficient structure—a claim term is subject to § 112(f) if it recites ‘function without reciting sufficient structure for performing that function.’ Williamson, 792 F.3d at 1348 (emphasis added) (quoting Watts, 232 F.3d at 880).” Egenera, Inc. v. Cisco Systems, Inc., 972 F.3d 1367, 1374 (Fed. Cir. 2020).
“And, again, the question is not whether [the claim term] is utterly devoid of structure but whether the claim term recites sufficient structure to perform the claimed functions.” Egenera at 1374.
Moreover, in assessing whether or not FP#1 meets Prong (A), the Examiner must not only consider the introductory phrase “computer readable program code,” but the entire FP#1. “In assessing whether the claim limitation is in means-plus-function format, we do not merely consider the introductory phrase (e.g., ‘mechanical control assembly’) in isolation, but look to the entire passage including functions performed by the introductory phrase.” MTD Prods. Inc. v. Iancu, 933 F.3d 1336, 1342 (Fed. Cir. 2019) (emphasis added).
The Examiner has looked to both general and subject matter specific dictionaries2 and finds no evidence that the term “computer readable program code” has achieved recognition as a term denoting structure for performing the claimed function. Similarly, the Examiner’s review of the record and search of the prior art finds no evidence that this term has achieved recognition as denoting structure for performing the claimed function. Therefore, based upon consultation of dictionaries, a review of the record, and a search of the prior art patents in this field, the Examiner concludes that the term “computer readable program code” is not an art-recognized structure to perform the claimed function, and each of claims 14 and 20 does not recite any other structure that would perform this claimed function. Therefore, FP#1 meets Prong (A).
Prong (B)
In accordance with the MPEP, Prong (B) requires “the term ‘means’ […] or the generic placeholder is modified by functional language, typically, but not always linked by the transition word ‘for’ […] or another linking word or phrase, such as ‘configured to’ or ‘so that.’” MPEP § 2181 I. (“Prong (B)”).
Based upon the claim language itself, the Examiner finds the function of FP#1 is “normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product.” Claims 14 and 20 (“Function of FP#1”).
Because nothing in the Patent Under Reissue or the prosecution history of the Base Application suggests otherwise, the Function of FP#1 will have its ordinary meaning. “Ordinary principles of claim construction govern interpretation of this claim language […] and, for all the reasons discussed in the preceding two sections, we construe this function according to its ordinary meaning […].” Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327, 1333-34 (Fed. Cir. 2004)(citations omitted). “Ordinary principles of claim construction govern interpretation of the claim language used to describe the function.” Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 296 F.3d 1106, 1113 (Fed. Cir. 2002)(citations omitted).
Moreover, based upon consultation of dictionaries, a review of the record, and a search of the prior art patents in this field, the Examiner concludes that the Function of FP#1 is not coextensive with a general-purpose computer or microprocessor. Therefore, it appears special programming (or algorithm) is required for a general-purpose computer to perform the Function of FP#1.
Prong (C)
In accordance with the MPEP, Prong (C) requires “the term ‘means’ […] or the generic placeholder is not modified by sufficient structure […] for performing the claimed function.” MPEP § 2181 I. (“Prong (C)”).
Based upon a review of FP#1, the Examiner finds that FP#1 does not contain sufficient structure for performing the entire Function of FP#1.
In particular, based upon the express wording of FP#1, the Examiner finds that, to a POSITA, the claim language itself within FP#1 does not recite an algorithm for accomplishing the Function of FP#1 (i.e., “normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product”). For at least this reason, the Examiner finds that an algorithm to perform the entire Function of FP#1 is not expressly recited in either claim 14 or claim 20.
Moreover, the term “computer readable program code” is not sufficient structure for executing the claimed function, nor is it modified by sufficient structure for executing the function (e.g., “embodied in the memory that is executable by the processor” is also not sufficient structure for performing the claimed function).
Because FP#1 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that FP#1 meets Prong (C). Because FP#1 meets the 3 Prong Analysis as set forth in MPEP § 2181 I., the Examiner concludes that FP#1 invokes § 112(f).
Corresponding Structure for Functional Phrase #1
“The next step in construing a means-plus-function claim limitation is to look to the specification and identify the corresponding structure for that function.” In re Aoyama, 656 F3d 1293, 1297 (Fed. Cir. 2011) quoting Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327, 1333 (Fed. Cir. 2004). “Under this second step, structure disclosed in the specification is ‘corresponding’ structure only if the specification or prosecution history clearly links or associates that structure to the function recited in the claim.” Aoyama, 656 F3d at 1297 quoting Med. Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1210 (Fed. Cir. 2003).
Furthermore, if the claimed phase is meant to cover software, “[i]t is well-established that the corresponding structure for a function performed by a software algorithm is the algorithm itself.” EON Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 621, 114 USPQ2d 1711, 1714 (Fed. Cir. 2015). In other words, “[i]f special programming is required for a general-purpose computer to perform the corresponding claimed function, then the default rule requiring disclosure of an algorithm applies.” Ergo Licensing, LLC v. CareFusion 303, Inc., 673 F.3d 1361, 1365 (Fed. Cir. 2012).
Based upon a review of Applicant’s disclosure, and for the reasons given below, the Examiner is unable to locate a clear link or association of the Function of FP#1 to sufficient corresponding structure (i.e., a sufficient algorithm) found in the original disclosure.
For example, Applicant’s specification discloses “Due to different distances and angles between the cameras 50a, 50b, 50c, and 50d and the fingers 34a and 34b, the images may be processed to normalize the differences between angle of view and distance to the camera.” Specification at ¶ [0053]. This disclosure is insufficient because the specification does not clearly link or associate sufficient structure, e.g., an algorithm, to the claimed function.
Because the original disclosure fails to clearly link or associate the Function of FP#1 to sufficient corresponding structure, each of claims 14 and 20 is indefinite under 35 USC § 112(b). A rejection under 35 USC § 112(b) is set forth below for claims 14 and 20.
Claim Rejections – 35 USC § 101
35 USC § 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, 3–4, 6–14, and 16–20 are rejected under 35 USC § 101 because the claimed invention is directed to an abstract idea without significantly more.
In accordance with MPEP § 2106,3 the Examiner’s analysis in this section uses the following MPEP Steps of Table 1 (below) to determine whether a claim recites the following items:
MPEP Step
Does the claim recite ___?
MPEP §
1
A process, machine, manufacture, or composition of matter
2106.03
2A, Prong 1
A judicial exception, such as a law of nature or any of the following groupings of abstract ideas:
1) Mathematical concepts, such as mathematical formulas;
2) Certain methods of organizing human activity, such as a fundamental economic practice; or
3) Mental processes, such as an observation or evaluation performed in the human mind.
2106.04(a)(2)
2A, Prong 2
Any additional elements that integrate the judicial exception into a practical application
2106.04(d) and 2106.05(a)–(c), (e)–(h)
2B
Any additional elements beyond the judicial exception that, alone or in combination, provide an “inventive concept” or “significantly more”
2106.05
Table 1: MPEP Eligibility Steps
MPEP Step 1 (Claims 1–20)
Each of claims 1, 3–4, 6–14, and 16–20 falls within one of the four statutory categories. See MPEP § 2106.03. For example, each of claims 14 and 16–19 falls within category of machine, i.e., a “concrete thing, consisting of parts, or of certain devices and combination of devices.” Digitech, 758 F.3d at 1348–49 (quoting Burr v. Duryee, 68 U.S. 531, 570, 17 L. Ed. 650, 657 (1863)); each of claims 1, 3–4, and 6–13 falls within category of process; and claim 20 is directed to a “computer program product, comprising: a non-transitory computer readable storage medium” and therefore falls within category of manufacture.
MPEP Step 2A – Prong 1 (Exemplary Claim 1)
Claim 1 is directed to an abstract idea. The abstract idea is set forth or described by the following italicized limitations:
1. A method comprising:
receiving an image of a drug product held by a drug product package filling system from one camera of a plurality of cameras;
normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product;
determining whether the drug product matches an intact profile or a defective profile based on the normalized image using a first Artificial Intelligence (AI) system; and
determining, when the drug product matches the intact profile, a type of the drug product based on the normalized image using a second AI system.
For the reasons below, the italicized limitations above represent at least a mental process (i.e., a process that can be performed mentally and/or with pen and paper). Therefore, the italicized limitations fall within the subject matter groupings of abstract ideas enumerated in MPEP § 2106.04(a).
Applicant is respectfully reminded, “[t]he courts consider a mental process (thinking) that ‘can be performed in the human mind, or by a human using a pen and paper’ to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011).” MPEP § 2106.04(a)(2)III. (emphasis added).
“Accordingly, the ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” Id.
Moreover, “[t]he courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation[, …] [n]or do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer.” Id.
Furthermore, in accordance with MPEP § 2106.04 II.B., although the claim may have limitations directed to multiple abstract ideas (i.e., multiple categories), for purposes of Prong 2 and Step 2B (below), the claim is being treated as directed to a single abstract idea. See MPEP § 2106.04 II.B. (“During examination, examiners should apply the same eligibility analysis to all claims regardless of the number of exceptions recited therein. Unless it is clear that a claim recites distinct exceptions, such as a law of nature and an abstract idea, care should be taken not to parse the claim into multiple exceptions, particularly in claims involving abstract ideas. Accordingly, if possible[,] examiners should treat the claim for Prong Two and Step 2B purposes as containing a single judicial exception.”).
The limitation “receiving an image of a drug product held by a drug product package filling system from one camera of a plurality of cameras” is a mental process, since such “receiving” can be performed mentally, i.e., through an evaluation and/or observation of the image.
The limitation “determining whether the drug product matches an intact profile or a defective profile based on the normalized image […]” is a mental process, since such “determining” could be performed mentally by evaluating the drug product and requisite profiles.
The limitation “determining, when the drug product matches the intact profile, a type of the drug product based on the normalized image […]” is a mental process, since such “determining” could be performed mentally by an observation that the drug product is a particular type.
MPEP Step 2A – Prong 2 (Exemplary Claim 1)
Claim 1 does not include additional elements (when considered individually, as an ordered combination, and/or within the claim as a whole) that are sufficient to integrate the abstract idea into a practical application. The term “additional elements” is used for features, limitations, or steps that the claim recites beyond the identified abstract idea.4 The additional elements are represented by the following underlined limitations:
1. A method comprising:
receiving an image of a drug product held by a drug product package filling system from one camera of a plurality of cameras;
normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product;
determining whether the drug product matches an intact profile or a defective profile based on the normalized image using a first Artificial Intelligence (AI) system; and
determining, when the drug product matches the intact profile, a type of the drug product based on the normalized image using a second AI system.
The first additional element is “using a first Artificial Intelligence (AI) system.” This element(s) amounts to mere use of a generic computer component as a tool to perform the abstract idea. Therefore, this element(s) individually does not provide a practical application.
The second additional element is “using a second AI system.” This element(s) amounts to mere use of a generic computer component as a tool to perform the abstract idea. Therefore, this element(s) individually does not provide a practical application.
The third additional element is “normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product.” Upon review of Applicant’s original disclosure, the Examiner finds that the specification does not include a discussion that identifies this additional element of claim 1 as an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the additional element over the prior art. Furthermore, this additional element is no more than a general link to imaging technology. Therefore, this additional element, either alone or in combination, does not provide a practical application of the claims or provide an inventive concept.
In view of the above, the three “additional elements” individually do not provide a practical application of the abstract idea. Furthermore, the three “additional elements” in combination amount to a plurality of generic computer components used as a tool(s) to perform the abstract idea. Therefore, these elements in combination do not provide a practical application. The combination of additional elements does no more than generally link the use of the abstract idea to a particular technological environment, i.e., an AI/imaging environment, and for this additional reason, the combination of additional elements does not provide a practical application of the abstract idea.
Moreover, upon review of Applicant’s original disclosure, the Examiner finds that the specification does not include a discussion that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art.
In view of the above analysis, the Examiner concludes that the additional elements recited in claim 1: (1) do not improve the functioning of a computer or other technology; (2) are not a particular machine (e.g., an AI system is a generic computing element); (3) do not effect a transformation of a particular article to a different state; or (4) do not add meaningful limitations 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. See MPEP §§ 2106.05(a)–(c), (e)–(h).
MPEP Step 2B (Exemplary Claim 1)
MPEP § 2106.05 II. states, “in Step 2B, examiners should: […] Carry over their identification of the additional element(s) in the claim from Step 2A Prong Two; [and] Carry over their conclusions from Step 2A Prong Two on the considerations discussed in MPEP §§ 2106.05(a) - (c), (e) (f) and (h).”
Therefore, in accordance with MPEP § 2106.05 II., noted above, the Examiner maintains that the additional elements include the following limitations:
(1) “using a first Artificial Intelligence (AI) system;”
(2) “using a second AI system;” and
(3) “normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product.”
Moreover, in accordance with MPEP § 2106.05 II., noted above, the Examiner also maintains each conclusion from § MPEP Step 2A – Prong 2 (above) on the considerations discussed in MPEP §§ 2106.05(a)–(c), (e) (f) and (h).
Furthermore, the Examiner finds that the additional elements of at least claim 1, i.e., first and second AI systems, when considered alone and in combination, were well-understood, routine, and conventional as of the effective filing date of the instant application. The Examiner’s finding regarding well-understood, routine, and conventional includes the following evidence: the Examiner’s takes Official Notice that AI systems were well-understood, routine, and conventional as of the effective filing date of the instant application.
For the reasons given above, claim 1 does not include additional elements, when considered individually and as an ordered combination, that are sufficient to amount to significantly more than the abstract idea.
Dependent Claims 3–4 and 6–13
Dependent claims 3–4 and 6–13 fail to cure the deficiencies of independent claim 1 (set forth above) and are rejected accordingly.
Particularly, claims 3–4 and 6–13 recite more language directed to the abstract idea, i.e., more language directed to a mental process, as indicated by italicized text below:
3. The method of Claim 1, [receiving an image of a drug product held by a drug product package filling system] wherein the drug product package filling system comprises a plurality of fingers and the drug product is held on one of the plurality of fingers.
4. The method of Claim 3, wherein the drug product is held on one of the plurality of fingers using suction.
6. The method of Claim 1, further comprising: generating embeddings for a plurality of features of the drug product, respectively, using the second AI system; and determining a similarity between the embeddings for the plurality of features of the drug product and feature embeddings for a plurality of drug product types; wherein determining the type of the drug product comprises determining the type of the drug product based on the similarity between the embeddings for the plurality of features of the drug product and the feature embeddings for the plurality of drug product types.
7. The method of Claim 6, wherein the plurality of features of the drug product comprise drug product shape, drug product size, drug product color, an etching on the drug product, an imprint on the drug product, an area of the drug product, and/or a label on the drug product.
8. The method of Claim 6, wherein the plurality of drug product types comprises a plurality of drug product names and/or a plurality of National Drug Code (NDC) identifiers.
9. The method of Claim 1, further comprising: augmenting data associated with one or more of a plurality of features of the drug product; and generating embeddings for the plurality of features of the drug product, respectively, using the first AI system responsive to augmenting the data associated with the one or more of the plurality of features of the drug product.
10. The method of Claim 9, wherein the plurality of features of the drug product comprises drug product shape, drug product size, drug product color, an etching on the drug product, an imprint on the drug product, an area of the drug product, a label on the drug product, cracks in the drug product, uneven surfaces of the drug product, chips in the drug product surface, color deviations in the drug product, shape deviations in the drug product, lamination of the drug product, irregular edges of the drug product, dents in the drug product, splits in the drug product, joints in the seams in the drug product, residue on the drug product, deformation of the drug product, and/or bubbles inside the drug product; wherein the first AI system comprises a plurality of neural network models, the plurality of neural network models differing from each other with respect to node weights and/or activation functions; and wherein the method further comprises: determining, using each of the plurality of neural network models, a similarity between the embeddings for the plurality of features of the drug product and feature embeddings for a plurality of intact and defective drug product types, respectively; wherein determining whether the drug product matches the intact profile or the defective profile comprises determining, using each of the plurality of neural network models, whether the drug product matches the intact profile or the defective profile based on the similarity between the embeddings for the plurality of features of the drug product and feature embeddings for a plurality of intact and defective drug product types, respectively.
11. The method of Claim 10, wherein at least one of the plurality of neural network models comprises an AI framework different than others of the plurality of neural network models.
12. The method of Claim 10, wherein the first AI system further comprises a K nearest neighbor neural network model; wherein the method further comprises: generating embeddings for a plurality of features of the drug product, respectively, using the K nearest neighbor neural network model; and determining a similarity between the embeddings for the plurality of features of the drug product and the feature embeddings for the plurality of intact and defective drug product types, respectively; wherein determining whether the drug product matches the intact profile or the defective profile comprises determining whether the drug product matches the intact profile or the defective profile based on a number of the K most similar feature embeddings of the plurality of intact and defective drug product types that are intact and a number of the K most similar feature embeddings of the plurality of intact and defective drug product types that are defective.5
13. The method of Claim 12, further comprising: aggregating the determinations of the plurality of neural network models and the K nearest neighbor network model on whether the drug product matches the intact profile or the defective profile; and determining whether the drug product matches the intact profile or the defective profile based on the aggregation of the determinations of the plurality of neural network models and the K nearest neighbor network model.
The additional element of claims 5, 6, 9, and 12 do not make their respective claims patent eligible for the same reasons given for those elements above in the discussion of claim 1.
As noted above, claim 10 includes the additional element “a plurality of neural network models, the plurality of neural network models differing from each other with respect to node weights and/or activation functions” and using the plurality of models. This element(s) amounts to mere use of a generic computer component as a tool to perform the abstract idea. Therefore, this element(s) individually and in combination does not provide a practical application or an inventive concept. Moreover, upon review of Applicant’s original disclosure, the Examiner finds that the specification does not include a discussion that identifies this additional element of claim 10 as an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. In fact, Applicant’s specification does not set forth technical implementation details of the “plurality of neural network models” with any particular “weights and/or activation functions,” as claimed. For example, in Applicant’s figure 6 a plurality of models is shown by a plurality of generic boxes labeled “Drug Product Integrity Model,” 235a–235n, with no sufficient accompanying disclosure of what technical features are encompassed by these boxes such that a POSITA would recognize this claim language as a practical application or an inventive concept, rather than merely an equivalent to the words “apply it.” The same analysis applies to the additional element of claim 11.
Claims 14 and 16–20
Claims 14 and 16–20 contain language similar to claims 1, 3–4, and 6–13 as discussed in the preceding sections, and for reasons similar to those discussed above, claims 14 and 16–20 are also rejected under 35 USC § 101. In addition to that already discussed above, claim 14 includes an additional element of “a processor; and a memory coupled to the processor and comprising computer readable program code embodied in the memory that is executable by the processor to perform operations comprising.” This element, individually and in combination with other additional elements in the claim, does not provide a practical application or an inventive concept because it amounts to claiming a generic computer component(s) used as a tool(s) to implement the abstract idea. In addition to that already discussed above, claim 20 includes an additional element of “[a] computer program product, comprising: a non-transitory computer readable storage medium comprising computer readable program code embodied in the medium that is executable by a processor to perform operations comprising.” This element, individually and in combination with other additional elements in the claim, does not provide a practical application or an inventive concept because it amounts to claiming a generic computer component(s) used as a tool(s) to implement the abstract idea.
CLAIM REJECTIONS – 35 USC § 112(a)
The following is a quotation of 35 USC § 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.
Claims 1, 3–4, 6–14, and 16–20 are rejected under 35 USC § 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
New Matter
Claim 1 does not comply with the written description requirement because it contains new matter. Particularly, for the reasons set forth below, the following limitation introduces new matter, “normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product.”
Applicant’s specification discloses “Due to different distances and angles between the cameras 50a, 50b, 50c, and 50d and the fingers 34a and 34b, the images may be processed to normalize the differences between angle of view and distance to the camera.” Specification at ¶ [0053]. However, this disclosure supports “normalize[ing] the differences between angle of view and distance to the camera,” not the images, as claimed.
Dependent claims 3–4 and 6–13 fail to cure this deficiency of independent claim 1 (set forth directly above) and are rejected accordingly.
Claims 14 and 16–20 contain language similar to claims 1, 3–4, and 6–13 as discussed in the preceding paragraphs, and for reasons similar to those discussed above, claims 14 and 16–20 are also rejected under 35 USC § 112 as failing to comply with the written description requirement.
No Algorithm To Satisfy The Written Description Requirement
Claim 1 does not comply with the written description requirement because it recites a computer-implemented feature without an algorithm disclosed for achieving the particular computer-implemented feature. This rejection applies regardless of whether § 112(f) is invoked.6
Particularly, claim 1 recites the following computer-implemented feature:
“normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product.”
Applicant is respectfully reminded, for computer-implemented claims, “examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter.” MPEP § 2161.01 I.
Applicant’s specification does not describe an algorithm that performs “normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product,” in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. For example, Applicant’s specification discloses “Due to different distances and angles between the cameras 50a, 50b, 50c, and 50d and the fingers 34a and 34b, the images may be processed to normalize the differences between angle of view and distance to the camera.” Specification at ¶ [0053]. However, such disclosure is not an algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed feature in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter.
Applicant is also reminded, “[i]f the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how to program the disclosed computer to perform the claimed function, a rejection under 35 USC 112(a) or pre-AIA 35 USC 112, first paragraph, for lack of written description must be made.” MPEP § 2161.01 I. Phrased another way, “[i]t is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding ‘whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved’).” MPEP 2161.01 I (last paragraph).
Therefore, because an algorithm for the computer-implemented feature “normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product” is not disclosed in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter, and in accordance with MPEP § 2161.01, claim 1 is rejected for lack of written description.
Dependent claims 3–4 and 6–13 fail to cure this deficiency of independent claim 1 (set forth directly above) and are rejected accordingly.
Claims 14 and 16–20 contain language similar to claims 1, 3–4, and 6–13 as discussed in the preceding paragraphs, and for reasons similar to those discussed above, claims 14 and 16–20 are also rejected under 35 USC § 112 as failing to comply with the written description requirement.
CLAIM REJECTIONS – 35 USC § 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 14 and 16–20 are rejected under 35 USC § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Insufficient Disclosure Of Corresponding Structure
As noted above, FP#1 invokes 35 USC § 112(f). See above section titled “CLAIM INTERPRETATION AND 35 USC § 112(f).”
However, for each functional phrase, the Original Disclosure fails to disclose the corresponding structure for performing the entire claimed function and to clearly link the structure to the function. See above subsection titled “Corresponding Structure for Functional Phrase #1” for an explanation of why the Original Disclosure does not include the corresponding structure. Therefore, claims 14 and 16–20 are indefinite and are rejected under 35 USC § 112(b).
Conclusion of 35 USC § 112(b) Rejection
The Examiner has considered all limitations in the Examined Claims even though some claim limitations are indefinite. See MPEP § 2143.03 I. ¶1 noting that “[a] claim limitation which is considered indefinite cannot be disregarded.” However, the Examiner concludes that because claims 14 and 16–20 are indefinite under § 112(b), these claims, by definition, cannot be properly construed. See e.g. Honeywell International Inc. v. ITC, 341 F.3d 1332, 1342 (Fed. Cir. 2003) (“Because the claims are indefinite, the claims, by definition, cannot be construed.”). Therefore in accordance with MPEP § 2173.06 and the USPTO’s policy of trying to advance prosecution by providing prior art rejections (or indicating allowance of the claims) even though certain claims are indefinite, these indefinite claims are construed and the prior art is currently applied as much as practically possible. Applicant is reminded that when a particular § 112(b) rejection is overcome by Applicant, and the claim limitation can then be properly construed, the Examiner will reevaluate the prior art using this proper claim construction and then reassess the patentability of the claim over the prior art.
Allowable Subject Matter
The pending claims are allowable over the prior art of record. The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not disclose “normalizing the image based on a distance and an angle between the one camera from which the image is received and the drug product relative to distances and angles between other ones of the plurality of cameras and the drug product,” as claimed.
Response to Arguments
With respect to eligibility, Applicant argues that the new “normalizing” claimed is not a mental step. Response at p. 4. The Examiner agrees. Applicant also argues that such normalizing is a practical application and inventive concept. The Examiner disagrees. The specification does not show that the claimed normalizing is an improvement to technology. In fact, the specification does not include any specific technological implementation details for the normalizing feature. Therefore, the rejection is maintained. Applicant’s other arguments are moot.
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 JACOB C. COPPOLA whose telephone number is (571)270-3922. The examiner can normally be reached Monday-Friday 5:30-1:304:00 PM.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew J. Fischer can be reached at (571) 272-6779. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/JACOB C. COPPOLA/Primary Examiner, Art Unit 3992
1 See also Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015) (en banc) quoting Watts v. XL Sys., Inc., 232 F.3d 877, 880 (Fed Cir. 2000) where the CAFC set forth the standard for determining if a functional phase overcomes the presumption that § 112 ¶ 6 is not invoked (i.e., invokes 112 ¶ 6) when a phrase does not use the word “means.”
2 Microsoft Computer Dictionary (5th ed. 2002) (Microsoft Press); Electrical Engineering Dictionary (CRC Press, 2000); The American Heritage Dictionary of the English Language (5th ed. 2011).
3 See, e.g., the flowchart, titled Subject Matter Eligibility Test For Products and Processes, found in § 2106 III.
4 See, e.g., MPEP § 2106.05 II. (“additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s)”).
5 See attached NPL titled “What’s the best way to find KNN by hand?” evidencing that a K nearest neighbor model can be implemented mentally using pen and paper.
6 This rejection does not rely on 35 USC § 112(f) being invoked. See MPEP § 2161.01 (“[C]laims with computer-implemented functional claim limitations may invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. […]. Even if a claim is not construed as a means-plus-function limitation under 35 U.S.C. 112(f), computer-implemented functional claim language must still be evaluated for sufficient disclosure under the written description and enablement requirements of 35 U.S.C. 112(a).” (emphasis added)).