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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant's election with traverse of Species A in the reply filed on 08 December 2025 is acknowledged. The traversal is on the ground(s) that
Applicant believes the Restriction was not specific enough as to the particular reason for restriction
Applicant argues that the verbiage of “a search burden” was improper in the Restriction because a “serious” search burden is required for restriction
Applicant argues that the restriction did not provide any explanation of the relevant bases for search burden
Regarding the first point, MPEP809.02(a) provides the form paragraph FP8.01 for requiring and election of species. In the instructions for bracket 2, the form paragraph provides that a sufficient reason for why the species are independent or distinct may be a statement that the species are mutually exclusive and a description of the mutually exclusive characteristics. Both of these are provided in the Restriction mailed 07 October 2025. The listing of Species lists the mutually exclusive characteristics of each Species, and the sentence following the listing provides the statement that the features in the listing are mutually exclusive.
Regarding the second point, using the term “search burden” versus “serious” search burden was a typographical error due to updated form paragraph and MPEP issues. The template used in the office action was an outdated version of FP8.01 prior to the current version of the MPEP. The systemic issue is now fixed and should not happen again. Regardless of whether the statement of search burden included the term “serious” is a formality that does not change the facts of the case. In this case the Species A-D have mutually exclusive features that would require divergent searching, which the MPEP provides as sufficient basis to insist upon restriction.
Regarding the third point, particular examples of divergent searching were not provided because a search (and full examination of the claims on the merit) had not yet been conducted. Evidence regarding at least points c-e (and perhaps point b in some cases) could only be provided by conducting a search and examination on the merits. Now that a search has been conducted, it is clear that Species A-B require different text searching (point c) and different prior art would have been applicable to Species A relative to Species B-D. Specifically, the alignment differences between Species A-B (represented by generic claim 1) and Species C-D (represented by withdrawn claim 12) required different text searching. Species C-D also would have been rejected at least over Tumlinson 11806277, which was not sufficient to reject Species A-B (as represented by generic claim 1). Restriction between Species A-B would have also been supported by the range of prior art disclosing sample containers extending into the horn (short horn of Species A) versus the limited range of prior art disclosing both sample containers and drug delivery systems extending into the horn (long horn of Species B), and the two ranges being apparently mutually exclusive based on the search of record. However, claim 1 is not rejected over prior art, thus the claims drawn to Species B (claim 5) may be rejoined with the claims generic/drawn to Species A (claims 1-4 and 6-11) if claim 1 is allowed, since claim 1 is generic to both Species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5 and 12-20 are withdrawn. Claims 1-4 and 6-12 are examined.
Information Disclosure Statement
The information disclosure statement filed 02 May 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. A copy of the foreign reference WO2019018367A1 should be filed.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 98 and 226
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0042]: “liquid 94” appears to be in error for –liquid 98--
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – 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.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “mechanism for inducing vibration” in claim 1 (interpreted as ultrasonic transducer or equivalent; Applicant’s Specification, [0015]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 and 6-12 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding Claim 1, the recitation(s) “inducing vibrations in the needle” is unclear whether the needle is being vibrated, or something within/inside the needle is being vibrated (the needle being hollow with a lumen therein). If Applicant intends –inducing vibrations of the needle--, correction as such is recommended.
Regarding claim 3, “wherein mechanism” is unclear whether it is “the” mechanism of claim 1 or a different mechanism.
Regarding claim 7, the use of the terms “greater than" , “between”, or "less than" and "approximately" or "about" is indefinite because to give a measurement of "greater than/less than/between about/approximately" is not intuitive, not common sense, and can reasonably lead to different results. The word “about” can mean more or less than the stated value; thus it is unclear whether, for example, “of about 20 kHz to about 50 kHz” could include 19, 15, 51, or 60 Hz.
Dependent Claims 2-4 and 6-12 are also rejected for relying on at least one rejected claim above.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469) 295-9153. The examiner can normally be reached on 1000-1600 Eastern.
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, Devon Kramer can be reached on (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741