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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 07/26/2023 and 09/13/2023 has/have been considered by the Examiner.
Status of the Claims
Claims 1-13 are currently pending. Claims 1-13 are currently rejected.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification fails to disclose how “a separation of the insertion device from the medical device releases a movement of the locking sleeve from its proximal position to a further proximal position, and wherein the movement of the locking sleeve from its proximal position to the further proximal position releases a movement of the insertion component retractor from its proximal position to a retracted position.” (See the last 7 lines of claim 1.)
Examiner notes [0172] of related PGPUB (US 20230364331 A1), which reads “The dead stop 206 may have the support surface 204.” , “When the locking sleeve 126 is in the proximal position, the locking sleeve 126 may be in direct contact with the support surface 204.”, and “Thus, in the further proximal position, the locking sleeve 126 may rest on the dead stop 206.”. No mechanism or means by which the movement from the proximal position to the further proximal position is described. Furthermore, it is unclear how the proximal position can be different from the further proximal position since it appears, based on the dead stop 206 being noted to include the support surface 204 (presumably meaning that the support surface 204 is part of the dead stop 206, or vice versa), the locking sleeve 126 being in direct contact with the support surface 204 in the proximal position, and the locking sleeve 126 resting on the dead stop 206 in the further proximal position. The specification seems to describe the same structure with two different names/portions, and thus the same position of the locking sleeve, with no clear understanding of how the two proximal positions differ or how the further proximal position is achieved.
Examiner further notes [0187-0189] of related PGPUB (US 20230364331 A1) which, while describing how a rotational movement of the locking sleeve 126 may release a movement of the insertion component retractor 120, still fail to provide a clear mechanism for how separation of the medical device and the insertion device release a movement of the locking sleeve 126 from the proximal position to the further proximal position.
The abstract of the disclosure is objected to because:
On line 1, “An insertion system (110) is disclosed.”, is a phrase which can be implied. (See MPEP § 608.01(b)(I)(C).)
The abstract exceeds 150 words.
The abstract is not limited to a single paragraph.
“(Figure 1)” is written below the Abstract with no apparent connection to the content of the Abstract.
“comprises” and “comprising” on lines 1 and 3, respectively, are legal phraseology.
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).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “a separation of the insertion device from the medical device releases a movement of the locking sleeve from its proximal position to a further proximal position, and wherein the movement of the locking sleeve from its proximal position to the further proximal position releases a movement of the insertion component retractor from its proximal position to a retracted position.” (See the last 7 lines of claim 1.) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Examiner notes that [0186] of related PGPUB (US 20230364331 A1) states that “A separation of the insertion device from the medical device releases a movement of the locking sleeve from its proximal position, as shown in FIG. 7D, to a further proximal position.” However, the locking sleeve 126 is not labeled in fig. 7D, and the proximal position being different than a further proximal position is also not shown. Examiner reiterates the apparent contradictions noted above in the objection to the specification regarding [0172], and further notes that support structure 204 appears to be the top face of dead stop 206 as labeled in fig. 1, thus the drawings further fail to support the movement of the locking sleeve 126 from a proximal position to a further proximal position, since both positions as described in [0172] would appear to be the same in light of the described structural engagement. The drawings also fail to show a mechanism, means, or structural relationship which would facilitate the claimed limitation of a separation of the insertion device from the medical device releasing a movement of the locking sleeve from its proximal position to a further proximal position.
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.
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:
“insertion component” in claims 1 and 7. The “insertion component” is interpreted in light of [0155] of the related PGPUB (US 20230364331 A1)
[0115] “The insertion component 118 may comprise a tip or a sharp end for inserting the medical device 112 into the body tissue. The insertion component 118 may be or may comprise an insertion cannula or an insertion needle.”
“holding elements” in claim 11. The “holding elements” are interpreted in light of [0060] of the related PGPUB (US 20230364331 A1)
[0060] “The holding element may be or may comprise at least one finger, gripper, hook, pincer or the like. Also other embodiments may be feasible.”
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 1-13 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the means by which the separation of the insertion device from the medical device releases a movement of locking sleeve from its proximal position to a further proximal position, and the means by which the movement of the locking sleeve to the further proximal position releases a movement of the insertion component retractor.
The claim language does not include the necessary features and/or arrangements to achieve the claimed results which are recited in the last 7 lines of claim 1. The insertion device is separable from the medical device, but it is unclear how the separation of these devices would release a movement of the locking sleeve as recited in the claim language.
For the purposes of examination, any movement of the locking sleeve further toward the guide sleeve, thereby placing the locking sleeve in a position which is more proximate the guide sleeve upon release of the medical device, is interpreted to meet the limitation.
Claim 4 line 4 recites “a movement of the insertion component retractor”. This limitation was already introduced on the second to last line of claim 1, from which claim 4 depends. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new limitation (in which case the naming convention should be altered to distinguish the limitation) or refer back to the same limitation earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 6 line 3 recites “movement of the insertion component retractor”. This limitation was already introduced on the second to last line of claim 1, from which claim 6 depends. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new limitation (in which case the naming convention should be altered to distinguish the limitation) or refer back to the same limitation earlier introduced (in which case the article “the” should be added to the start of the limitation). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 8 line 4-5 recites “a rotational movement of the locking sleeve”. This limitation was already introduced in line 2 of claim 7, from which claim 8 depends. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new limitation (in which case the naming convention should be altered to distinguish the limitation) or refer back to the same limitation earlier introduced (i in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 11 recites the limitation “movement of the locking sleeve in direction of the housing” in lines 4-5. The limitation “direction” is not clearly associated with any structure, nor does it have an article which should be included to properly introduce “a direction”. For the purposes of examination, this “direction” is interpreted to be any “direction”.
Claim 12 recites the limitation “the group” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation is interpreted to read “a group”.
Claim 13 recites the limitations “a distal position” of the cap in line 6, “a proximal position” of the cap in line 6, “a movement of the locking sleeve” in lines 8-9, and “a further proximal position” of the locking sleeve in line 9. These four limitations are all introduced in lines 12-18 in the insertion system of claim 1, which claim 13 includes. It is unclear whether the instance of these limitations in the claim 13 are meant to introduce a new structures/limitation (in which case the naming convention should be altered to distinguish the structures/limitations) or refer back to the same structures/limitations earlier introduced (in which case the articles should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 13 lines 1-2 recites “inserting a medical device using the insertion system according to claim 1”. However, as defined in claim 1 lines 1-2, (“An insertion system, the insertion system comprising a medical device and an insertion device”) the insertion system of claim 1 includes both an insertion device and a medical device. Thus, it is unclear whether “a medical device” in claim 13 is meant to refer back to “a medical device” of the insertion system of claim 1, or introduce a new medical device. If only one medical device is meant to be claimed, then the first lines of claim 13 should more clearly read “A method for using the insertion system according to claim 1, the method comprising the steps:”. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 2-13 are rejected for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
Allowable Subject Matter
Claims 1-13 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Raymond et al (US 20090124979 A1) is considered the closest prior art and discloses an insertion system (see figs. 1-17, and for example fig. 15, [0041] FIG. 15 is another cross-sectional view of the insertion device in FIG. 1 before actuation, taken along line 15-15 shown in FIG. 14.), the insertion system comprising a medical device (infusion device 102, fig. 1, [0058]) and an insertion device (insertion device 100, fig. 1, [0058]) for inserting the medical device (102) into a body tissue of a user, the insertion device comprising (see fig. 1 and [0058]):
i) an insertion component (needle 112) configured for inserting the medical device into the body tissue;
ii) an insertion component retractor (needle hub 110);
iii) a cap (actuator 104);
iv) a guide sleeve (sleeve 106, fig. 15 shows recess 170 of sleeve 106, [0074]) and an insertion sleeve (sleeve-engaging arms 196 of shuttle 116, fig. 14, [0082]) guided therein;
v) a locking sleeve (base-retaining arms 226 of shuttle 116, fig. 14, [0090]) positioned in the insertion sleeve; and
vi) an elastic member (retraction spring 114, fig. 14, [0058]) positioned between the locking sleeve and the insertion component retractor (see fig. 14);
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wherein, for inserting the medical device, the cap, the insertion component retractor, the locking sleeve and the insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position (see fig. 15 vs fig. 16),
wherein the insertion device is separable from the medical device (see [0105]), wherein the insertion system is configured such that a separation of the insertion device from the medical device releases a movement of the locking sleeve from its proximal position to a further proximal position (see [0105], arms 226 release set-engagement surface 228 from base 122 of infusion device 102).
However, Raymond is silent to wherein the movement of the locking sleeve from its proximal position to the further proximal position releases a movement of the insertion component retractor from its proximal position to a retracted position.
Instead, Raymond [0105] notes that the disengagement of the locking sleeve/arms 226 is prevented prior to the retraction of the needle.
Antonio et al (US 20170290533 A1), Halac et al (US 20170188912 A1), and Donnay et al (US 10010280 B2) also disclose insertion devices, but none teach “the insertion system is configured such that a separation of the insertion device from the medical device releases a movement of the locking sleeve from its proximal position to a further proximal position” and “wherein the movement of the locking sleeve from its proximal position to the further proximal position releases a movement of the insertion component retractor from its proximal position to a retracted position”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 04/16/2026
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