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 .
Response to Amendment
This communication is in response to the amendment filed on 16 June 2026.
Claims 8 and 20 are canceled.
Claims 1, 9, and 13 are amended.
Claims 1-7 and 9-19 have been examined.
Response to Arguments
In response to Applicant’s remarks filed on 16 June 2026:
a. Applicant's arguments with respect to the 35 U.S.C. 101 rejections of the pending claims have been fully considered but are not deemed persuasive.
On pages 9-12 of Applicant’s remarks, Applicant argues against the 35 U.S.C. 101 rejections of the pending claims. Applicant argues that claim 1 does not recite an abstract idea under Step 2A, Prong One and/or does recite a practical application under Step 2A, Prong Two.
The Office respectfully disagrees with the above remarks. Regarding the analysis at Step 2A, Prong One; Applicant states the following: “A human using pencil and paper cannot display two different language versions of the same document to two different users in real-time as responses are being entered. Nor can a human dynamically overlay translated content onto a validated instrument while preserving the original validated structure. The claimed real-time, key-based architecture for real-time dual-language presentation represents a technical capability that constitutes a technical improvement to a practical application” (remarks, page 12, first full paragraph). Applicant is advised of the following:
“Claims in a pending application must be ‘given their broadest reasonable interpretation consistent with the specification.’” MPEP § 2111 citing Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005)..
With regards to subject matter eligibility analysis, “It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility. The BRI sets the boundaries of the coverage sought by the claim and will influence whether the claim seeks to cover subject matter that is beyond the four statutory categories or encompasses subject matter that falls within the exceptions.” MPEP 2106(II).
“Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible,” MPEP 2106.05(f) citing Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. Accordingly, “Claims can recite a mental process even if they are claimed as being performed on a computer” (MPEP § 2106.04(a)(2)(III)(C)).
Applicant has failed to construe the claims under the broadest reasonable interpretation (BRI). When interpreted under the BRI, the claimed validated instrument encompasses a simple document with just a few lines of text. As detailed below in the claim rejections under 35 U.S.C. 101, for such a simple document, a can mentally perform the claimed operations of determining a secondary language, generating a translation export object, extracting source text, inserting the translation object, and causing an administrator version of the validated instrument to include the one or more answers in the primary language. Hence, these operations are an abstract idea under the “Mental Processes” grouping. Accordingly, the claims recite an abstract idea.
With regards to the analysis at Step 2A, Prong Two; Applicant emphasizes that the claimed invention a) dynamically inserts translated content in real-time while preserving the integrity of the validated instrument and b) stores user responses as language-independent data tokens. This enables the purported practical application of dual-language presentation to different users (remarks, page 11, first full paragraph). Element (a) is part of the abstract idea. “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements…In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception.” MPEP 2106.05(a), (emphasis added). Element (b) amounts to no more than data storage, which is mere data gathering that the courts have deemed to be insignificant extra solution activity and well-understood, routine, and conventional subject matter; as detailed below. Therefore, these elements cannot be deemed a practical application. As detailed below in the claim rejections under 35 U.S.C. 101, the additional elements amount to no more than insignificant extra-solution activity; well-understood, routine, and conventional subject matter; and/or generic computer implementation. Looking at the additional elements as a whole adds nothing beyond the additional elements considered individually—they still represent insignificant extra-solution activity; well-understood, routine, and conventional subject matter; and/or generic computer implementation. Hence, the claims as a whole, looking at the additional elements individually and in combination, do not amount to a practical application nor significantly more than the abstract idea. These claims are not patent eligible.
Claims 9 and 13 recite limitations similar to those of claim 1 and are ineligible under 35 U.S.C. 101 for the same reasons that claim 1 is ineligible, as set forth above.
Claims 2-7, 10-12, and 14-19 are ineligible under 35 U.S.C. 101 for the same reasons that claims 1, 9, and 13 are ineligible, as set forth above, and for the additional reasons detailed below in the claim rejections under 35 U.S.C. 101.
b. Rejections of the pending claims under 35 U.S.C. 103 are withdrawn in view of Applicant’s amendments and remarks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-7 and 9-19 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
As to claims 1, 9, and 13, these claims now recite a validated instrument: “being defined by a data structure that is validated for clinical use such that a validation is bound to the data structure and is untransferable to any copies or reproductions of the data structure.” On page 9 of the remarks dated 16 June 2026, Applicant states “The originally filed Specification and Drawings fully support the subject matter of the amended claims, and in particular by the features of cancelled claims 8 and 20.” However, the originally filed specification and drawings do not appear to support the above newly-added limitation in the manner required by 35 U.S.C. 112(a). There is no mention of a validation being “bound” to the data structure nor being “untransferable to any copies or reproductions of the data structure.” Hence, these newly-added limitations are deemed to introduce new matter. See MPEP 2163.04(I)(B).
In addition, claims 1 and 13 recite the following newly-added limitation: “displaying the validated instrument with the first translation export object to a user while the user completes the validated instrument without generating a copy or reproduction of the validated instrument and while maintaining the validation bound to the validated instrument.” On page 9 of the remarks dated 16 June 2026, Applicant states “The originally filed Specification and Drawings fully support the subject matter of the amended claims, and in particular by the features of cancelled claims 8 and 20.” However, the originally filed specification and drawings do not appear to support the above newly-added limitation in the manner required by 35 U.S.C. 112(a). There is no mention of displaying the validated instrument “without generating a copy or reproduction of the validated instrument and while maintaining the validation bound to the validated instrument.” Hence, these newly-added limitations are deemed to introduce new matter. See MPEP 2163.04(I)(B).
As to claims 2-7, 10-12, and 14-19, they depend from claims 1, 9, and 13, respectively, and these dependent claims inherit the deficiencies of their parent claims.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
As to claims 1 and 13, these claims recite “determining a secondary language associated with a user.” The claimed “determining” amounts to no more than an evaluation of judgement, which can be mentally performed by a human with the aid of pencil and paper. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind (and/or with a pencil and paper) but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
These claims also recite “utilizing the translation key to generate a first translation export object that includes source text in the secondary language.” Read in light of the instant specification, the claimed “first translation export object” amounts to no more than text (see instant spec. para. 0077). With the aid of pencil and paper, a human can mentally generate a first translation export object in the manner claimed. Hence, this limitation is also an abstract idea under the “Mental Processes” grouping.
These claims also recite “extracting the source text from the validated instrument.” Read in light of the instant specification, the claimed “validated instrument” can be a questionnaire or a schedule drafted in a primary language (see instant spec. para. 0038). Under the broadest reasonable interpretation (BRI), the claimed “validated instrument” encompasses a simple document with just a few lines of text. With the aid of pencil and paper, a human can mentally extract source text from the validated instrument in the manner claimed. Hence, this limitation is also an abstract idea under the “Mental Processes” grouping.
These claims also recite “inserting the first translation export object into the arrangement within the validated instrument.” With the aid of pencil and paper, a human can mentally perform the claimed “inserting.” Hence, this limitation is also an abstract idea under the “Mental Processes” grouping. Hence, these claims recite an abstract idea.
These claims also recite “causing an administrator version of the validated instrument to include the one or more answers in the primary language.” This limitation amounts to no more than insertion of data, i.e. inserting the one or more answers into the validated instrument. With the aid of pencil and paper, a human can mentally perform the claimed “causing.” Hence, this limitation is also an abstract idea under the “Mental Processes” grouping. Hence, these claims recite an abstract idea.
This judicial exception is not integrated into a practical application. Other than the abstract idea, the claims recite the following:
a) “retrieving, for a clinical study, a validated instrument, the validated instrument being drafted in a primary language and being defined by a data structure that is
validated for clinical use such that a validation is bound to the data structure and is untransferable to any copies or reproductions of the data structure;”
b) “obtaining a translation key that defines an arrangement of source text within the validated instrument;”
c) “receiving as input, one or more answers to the validated instrument from the
user”;
d) “displaying the validated instrument with the first translation export object to a user while the user completes the validated instrument without generating a copy or reproduction of the validated instrument and while maintaining the validation bound to the validated instrument;” and “wherein displaying the validated instrument with the first translation export object and causing the administrator version to include the one or more answers in the primary language are performed in real-time”;
e) “a non-transitory computer readable medium configured to store processor-readable instructions”; and
f) “a processor operatively connected to the non-transitory computer readable medium, and configured to execute the instructions to perform operations.”
Limitations (a) through (c) amount to no more than mere data gathering, which has been deemed by the courts to be insignificant extra-solution activity. See MPEP 2106.05(g). Limitation (d) amounts to no more than merely outputting a result, which has been deemed by the courts to be insignificant extra-solution activity. See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015); Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). See MPEP 2106.05(g). Limitations (e) and (f) are recited at a high level of generality, i.e. as generic computer components performing generic computing functions. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Looking at the additional elements as a whole adds nothing beyond the additional elements considered individually—they still represent insignificant extra-solution activity and/or generic computer implementation. Hence, the claim as a whole, looking at the additional elements individually and in combination, does not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Limitations (a) through (c) amount to no more than mere data gathering, which has been deemed by the courts to be insignificant extra-solution activity. See MPEP 2106.05(g). In addition, the courts have deemed receiving data to be well-understood, routine, and conventional activity, as in the following cases: Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015) (storing and retrieving information in memory). See MPEP 2106.05(d)(II). Limitation (d) amounts to no more than merely outputting a result, which has been deemed by the courts to be insignificant extra-solution activity. See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015); Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). Furthermore, Applicant’s specification provides few details about the claimed “displaying” or its functions (see para. 0095 of Applicant’s published specification). This indicates that this feature is well known in the art. Cf Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) (explaining that "a patent need not teach, and preferably omits, what is well known in the art"). As a result, the written description adequately supports that additional element (d) is conventional and performs well-understood, routine, and conventional activities. See MPEP § 2106.07(a)(III)(A)1. As discussed above with respect to integration of the abstract idea into a practical application, additional elements (e) and (f) amount to no more than mere field of use limitations and instructions to apply the exception using generic computer components. Mere instructions to apply an exception using conventional computer components and functions cannot provide an inventive concept. Looking at the additional elements as a whole adds nothing beyond the additional elements considered individually—they still represent insignificant extra-solution activity; well-understood, routine, and conventional subject matter; and/or generic computer implementation. Hence, the claim as a whole, looking at the additional elements individually and in combination, does not amount to significantly more than the abstract idea. These claims are not patent eligible.
As to claim 9, this claim recites the following: “generating a translation key to identify one or more text data objects, the one or more text data objects corresponding to text in the validated instrument in the primary language; generating, based on the translation key, a translation export object that includes the one or more text data objects; obtaining a secondary language for the validated instrument; and obtaining a translated text object that includes text in the secondary language corresponding to the one or more text data objects in the translation export object.” Read in light of the instant specification, the claimed “translation export object” amounts to no more than text (see instant spec. para. 0077) and the claimed “validated instrument” can be a questionnaire or a schedule drafted in a primary language (see instant spec. para. 0038). Under the broadest reasonable interpretation (BRI), the claimed “validated instrument” encompasses a simple document with just a few lines of text. With the aid of pencil and paper, a human can mentally generate a translation key, generate a translation export object, obtain a secondary language, and obtain a translated text object, as claimed. Hence, these limitations are an abstract idea under the ”Mental Processes” grouping.
This claim also recites “upon a request from a user associated with the secondary language, inserting, in real-time, the translated text object into an arrangement within the validated instrument defined by the translation key without generating a copy or reproduction of the validated instrument and while maintaining the validation bound to the validated instrument.” This limitation amounts to no more than insertion of data, i.e. inserting the translated text object into the validated instrument. With the aid of pencil and paper, a human can mentally perform the claimed “inserting.” Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. Other than the abstract idea, the claims recite the following:
a) “retrieving, for a clinical study, a validated instrument, the validated instrument being drafted in a primary language and being defined by a data structure that is
validated for clinical use such that a validation is bound to the data structure and is untransferable to any copies or reproductions of the data structure;” and
b) “storing the translated text object and the translation key in one or more data store”;
c) “displaying the validated instrument with the translated text object to the user in real-time while the user completes the validated instrument.”
Limitations (a) and (b) amount to no more than mere data gathering, which has been deemed by the courts to be insignificant extra-solution activity. See MPEP 2106.05(g). Limitation (c) amounts to no more than merely outputting a result, which has been deemed by the courts to be insignificant extra-solution activity. See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015); Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). See MPEP 2106.05(g). Looking at the additional elements as a whole adds nothing beyond the additional elements considered individually—they still represent insignificant extra-solution activity. Hence, the claim as a whole, looking at the additional elements individually and in combination, does not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Limitations (a) and (b) amount to no more than mere data gathering, which has been deemed by the courts to be insignificant extra-solution activity. See MPEP 2106.05(g). In addition, the courts have deemed receiving data to be well-understood, routine, and conventional activity, as in the following cases: Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015) (storing and retrieving information in memory). See MPEP 2106.05(d)(II). Limitation (c) amounts to no more than merely outputting a result, which has been deemed by the courts to be insignificant extra-solution activity. See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015); Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). Furthermore, Applicant’s specification provides few details about the claimed “displaying” or its functions (see para. 0095 of Applicant’s published specification). This indicates that this feature is well known in the art. Cf Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) (explaining that "a patent need not teach, and preferably omits, what is well known in the art"). As a result, the written description adequately supports that additional element (c) is conventional and performs well-understood, routine, and conventional activities. See MPEP § 2106.07(a)(III)(A)2. Looking at the additional elements as a whole adds nothing beyond the additional elements considered individually—they still represent insignificant extra-solution activity; and/or well-understood, routine, and conventional subject matter. Hence, the claim as a whole, looking at the additional elements individually and in combination, does not amount to significantly more than the abstract idea. These claims are not patent eligible.
As to dependent claims 2, 5-6, 10, 14, and 17-18, these claims merely recite certain details of what the translation key includes/defines (claims 2, 10, and 14) and/or certain data formats and/or arrangements of data (claims 5-6 and 17-18). With the aid of pencil and paper, a human can mentally perform these limitations. Hence, these claims remain directed to an abstract under the “Mental Processes” grouping, without significantly more.
As to dependent claims 3-4 and 15-16, these claims recite “navigating a database utilizing the entity property path to determine the first translation export object” (claims 3 and 15) and “accessing an International Organization Standard (ISO) 639-1 standard language code stored within a token associated with the user” (claims 4 and 16). These limitations amount to mere data gathering, which is insignificant extra solution activity, as in the cases cited above in the parent claim. In addition, the courts have deemed receiving data to be well-understood, routine, and conventional activity, as in the following cases: Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015) (storing and retrieving information in memory). See MPEP 2106.05(d)(II). Hence, these limitations cannot be deemed a practical application nor an inventive concept. See MPEP 2106.05(h). Looking at the additional elements as a whole adds nothing beyond the additional elements considered individually—they still represent insignificant extra-solution activity; well-understood, routine, and conventional subject matter; and/or generic computer implementation. Hence, the claims as a whole, looking at the additional elements individually and in combination, do not amount to a practical application nor an inventive concept. These claims are not patent eligible.
As to claims 7 and 19, these claims recite display of the first translation object in the manner recited in the claim. This amounts to merely displaying a result, which is insignificant extra solution activity. See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015); Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). Furthermore, Applicant’s specification provides few details about the claimed “displaying” or its functions (see para. 0095 of Applicant’s published specification). This indicates that this feature is well known in the art. Cf Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) (explaining that "a patent need not teach, and preferably omits, what is well known in the art"). As a result, the written description adequately supports that the displaying limitation of this claim is conventional and performs well-understood, routine, and conventional activities. See MPEP § 2106.07(a)(III)(A)3. Looking at the additional elements as a whole adds nothing beyond the additional elements considered individually—they still represent insignificant extra-solution activity; well-understood, routine, and conventional subject matter; and/or generic computer implementation. Hence, the claim as a whole, looking at the additional elements individually and in combination, does not amount to a practical application nor an inventive concept. This claim is not patent eligible.
As to dependent claim 11, this claim recites exporting text data objects and receiving translated text from a secondary system. These limitations are recited at a high level of generality and amount to mere data gathering. As set forth above in the parent claim, the courts have ruled mere data gathering to be insignificant extra solution activity and well understood, routine, and conventional activity in the computing arts. Hence, these limitations cannot be deemed a practical application nor an inventive concept. This claim is not patent eligible.
Conclusion
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 extension fee 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 date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAR MIAN whose telephone number is (571)270-3970. The examiner can normally be reached Monday to Friday, 10 am to 6:30 pm.
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/Umar Mian/
Primary Examiner, Art Unit 2163
1 MPEP § 2106.07(a)(III)(A) explains that a specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional ( or an equivalent term) or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a).
2 MPEP § 2106.07(a)(III)(A) explains that a specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional ( or an equivalent term) or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a).
3 MPEP § 2106.07(a)(III)(A) explains that a specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional ( or an equivalent term) or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a).