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 .
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:
“an insertion mechanism” in claims 3 and 15
“a retraction mechanism” in claims 3 and 15
“a shift mechanism” in claims 3 and 15
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.
Regarding “an insertion mechanism” in claims 3 and 15, 112(f) is invoked because: (i) it uses a generic placeholder (mechanism), (ii) it is coupled with functional language (insertion), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 5 and para. 0049 disclose the insertion mechanism 120 as, for example, a compression spring. Examiner is interpreting the limitations as this structure and equivalents thereof.
Regarding “a retraction mechanism” in claims 3 and 15, 112(f) is invoked because: (i) it uses a generic placeholder (mechanism), (ii) it is coupled with functional language (retraction), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 5 and para. 0049 disclose the retraction mechanism 124 as, for example, a compression spring. Examiner is interpreting the limitations as this structure and equivalents thereof.
Regarding “a shift mechanism” in claims 3 and 15, 112(f) is invoked because: (i) it uses a generic placeholder (mechanism), (ii) it is coupled with functional language (shift), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 5 and para. 0049 disclose the shift mechanism 118 as, for example, a compression spring. Examiner is interpreting the limitations as this structure 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.
Claim 19 is 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.
Regarding claim 19, the phrase “the shift head infusion assembly comprising an infusion head and an infusion cannula coupled to and movable with the infusion head” in lines 5-6 renders the claim indefinite because it is unclear. It is unclear how the infusion cannula is coupled to and movable with the infusion head. Para. 0050 and Fig. 6 disclose the infusion head assembly 130 comprising the infusion head 132 and infusion cannula 134. Fig. 27 then shows the inserted configuration where the entire infusion head assembly moves to insert the infusion cannula 134. Thus, it is unclear how the infusion cannula is movable within the infusion head 132. Examiner further notes the infusion cannula 134 does not appear to move relative to any structure of the infusion head assembly 130. Examiner is interpreting this limitation as the infusion cannula is coupled to the infusion head and movable within the housing.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 11-14, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (C.N Patent Pub. No. 110585512 A, “Liu”).
Regarding claim 1, Liu discloses (Claim 1) an inserter device (see Fig. 1-2) comprising:
a disposable portion (2,5 in Fig. 1-2, see para. 049) comprising:
a disposable housing (21 in Fig. 6 and 51 in Fig. 12);
an insertion needle (222 in Fig. 6 and 17);
an infusion cannula (232 in Fig. 6 and 17) detachably coupled to the disposable housing (21 and 51) and the insertion needle (222, see Fig. 17 and para. 072 – needle 222 and launcher 21 detach from the infusion cannula 232 when they retract), the infusion cannula (232) configured to be inserted into a subcutaneous space of a patient (see Fig. 17 and para. 072);
a reusable portion (1, 3, 4 in Fig. 1-3) configured to detachably couple to the disposable portion (2, 5, see para. 049), the reusable portion (1, 3, 4) comprising:
a reusable housing (11, 14 in Fig. 3 and 41 in Fig. 11); and
an actuator (120 in Fig. 1-2 and 4) movable relative to the reusable housing (11, 14, and 41, see para. 055 and 071 – pressing member 120 can be pressed inwardly relative to housing components 11, 14,and 41 as seen between Fig. 16-17);
wherein the reusable portion (1, 3, 4) is operable to, in response to movement of the actuator (120) relative to the reusable housing (11, 14, and 41), automatically move the disposable portion (2, 5) from a stowed configuration (see Fig. 16) in which the infusion cannula (232) and the insertion needle (222) are positioned within the reusable housing (11, 14, 41) to an insertion configuration in which the infusion cannula (232) and the insertion needle (222) extend from the reusable housing (11, 14, 41 see para. 069-071 – see Fig. 16 for stowed configuration, upon pressing of pressing portion 120, the disposable portion especially launcher 21 of portion 2 moves the infusion cannula 232 and needle 222 from stowed configuration to an insertion configuration with both inserted into the patient and extending from the housing 11, 14, 41);
wherein the reusable portion (1, 3, 4) is further operable to thereafter automatically move the insertion needle (222) from the insertion configuration to a retracted configuration (see Fig. 17) in which the insertion needle (222) is positioned within the disposable housing (21, 51, see Fig. 17 and para. 071-072 – after insertion, insertion needle 222 is automatically retracted to the configuration seen in Fig. 17 with needle 222 positioned within at least launcher 21).
Regarding claim 2, Liu discloses (Claim 2) the inserter device of claim 1, wherein the reusable portion (1, 3, 4) further comprises a push plate (122 in Fig. 3-4) movable relative to the reusable housing (11, 14, and 41) and configured to detachably couple to the disposable portion (2,5, examiner notes a plate is being interpreted as a flat, thin strip of material used to join parts of a machine under BRI, see Fig. 16-17 and para. 055 and 070-071 – the arm 122 is seen in Fig. 3-4 as a flat, thin strip of material that is used to join parts of a machine and is thus interpreted as a plate, arm 122 of trigger 12 is movable relative to housing 11, 14, and 41 as seen between Fig. 16-17 and configured to detachably couple to the launcher 21 through blocking portion 123), wherein the reusable portion (1, 3, 4) is operable to, in response to movement of the actuator (120) relative to the reusable housing (11, 14, and 41), automatically move the push plate (122) and the disposable portion (2, 5) from the stowed configuration (see Fig. 16) to the insertion configuration (see para. 070-071 and Fig. 16-17 – movement of pressing portion 120 automatically moves the arm 122 which unblocks the launcher 21 and thus moves the arm 122 and launcher 21 from the stowed configuration in Fig. 16 to the insertion configuration).
Regarding claim 3, Liu discloses (Claim 3) the inserter device of claim 2, wherein the reusable portion (1, 3, 4) further comprises:
an insertion mechanism (43 in Fig. 16) operable to, in response to movement of the actuator (120) relative to the reusable housing (11, 14, 41), automatically move the push plate (122) and the disposable portion (2, 5) from the stowed configuration (see Fig. 16) to the insertion configuration (examiner notes the insertion mechanism is being interpreted under 112(f) as a compression spring or equivalent structures, see para. 070-071 – elastic member 43 is a compression spring that is operable in response to pressing of pressing portion 120 which moves arm 1122, to move the disposable portion especially launcher 21 from stowed configuration in Fig. 16 to insertion configuration);
a retraction mechanism (24 in Fig. 16) operable to automatically move the insertion needle (222) from the insertion configuration to the retracted configuration (see Fig. 17, examiner notes the retraction mechanism is being interpreted under 112(f) as a compression spring or equivalent structures, see para. 072 – elastic member 24 is a compression spring that automatically retracts needle 222); and
a shift mechanism (15 in Fig. 4 and 16) operable to inhibit operation of the retraction mechanism (24) in the stowed configuration (see Fig. 4 and 16) and permit operation of the retraction mechanism (24) in the insertion configuration (examiner notes the shift mechanism is being interpreted under 112(f) as a compression spring or equivalent structures, see Fig. 4, para. 055 and 069-072 – elastic member 15 is a compression spring that urges arm 122 and blocking part 123 into engagement with launcher 21 and thus inhibits operation of the retraction spring 24 in the stowed configuration and permits operation of retraction spring 24 in the insertion configuration as it is compressed to initiate insertion of the needle 222 which is required to permit the retraction spring 24 to actuate).
Regarding claim 11, Liu discloses (Claim 11) the inserter device of claim 3, wherein the shift mechanism (15) comprises a compression spring (see Fig. 4 and Fig. 16-17 and para. 055 – spring 15 is compressed to store potential energy and returns to its original length once the compressive force is removed).
Regarding claim 12, Liu discloses (Claim 12) the inserter device of claim 3, wherein the disposable portion (2, 5) further comprises an infusion head (5 in Fig. 1 and 15) coupled to the infusion cannula (232, see Fig. 15, see para. 068), the infusion head (5) comprising an adhesive surface (523a in Fig. 12-13) configured to couple the infusion head (5) to the patient when the infusion cannula (232) is inserted into the subcutaneous space of the patient (see Fig. 16 and para. 068).
Regarding claim 13, Liu discloses (Claim 13) the inserter device of claim 3, wherein the disposable portion (2, 5) further comprises a cover (54 in Fig. 12) detachably coupled to the disposable housing (21 and 51) and preserving sterility of the insertion needle (222, see Fig. 12 and para. 063 – the protective film 54 is detachably coupled to at least the body 51 in Fig. 12 and covers the opening in body 51 thus preserving sterility of insertion needle 222), the cover (54) configured to be detached from the disposable housing (21, 51) before coupling the disposable portion (2, 5) to the reusable portion (1, 3, 4, see para. 049, 051, 063 – protective film 54 may be detached from body 51, this detachment is capable of being configured to occur before the coupling of the disposable and reusable portions).
Regarding claim 14, Liu discloses (Claim 14) an inserter device (see Fig. 1-2) comprising:
a reusable portion (1, 3, 4 in Fig. 1-3) configured to detachably couple to a disposable portion (2,5 in Fig. 1-2, see para. 049), the disposable portion (2, 5) comprising a disposable housing (21 in Fig. 6 and 51 in Fig. 12), an insertion needle (222 in Fig. 6 and 17), and an infusion cannula (232 in Fig. 6 and 17) detachably coupled to the disposable housing (21, 51) and the insertion needle (222, see Fig. 17 and para. 072 – needle 222 and launcher 21 detach from the infusion cannula 232 when they retract), the infusion cannula (232) configured to be inserted into a subcutaneous space of a patient (see Fig. 17 and para. 072), the reusable portion (1, 3, 4) comprising:
a reusable housing (11, 14 in Fig. 4 and 41 in Fig. 11); and
an actuator (120 in Fig. 1-2 and 4) movable relative to the reusable housing (11, 14, and 41, see para. 055 and 071 – pressing member 120 can be pressed inwardly relative to housing components 11, 14,and 41 as seen between Fig. 16-17);
wherein the reusable portion (1, 3, 4) is operable to, in response to movement of the actuator (120) relative to the reusable housing (11, 14, and 41), automatically move the disposable portion (2, 5) from a stowed configuration (see Fig. 16) in which the infusion cannula (232) and the insertion needle (222) are positioned within the reusable housing (11, 14, 41) to an insertion configuration in which the infusion cannula (232) and the insertion needle (222) extend from the reusable housing (11, 14, 41 see para. 069-071 – see Fig. 16 for stowed configuration, upon pressing of pressing portion 120, the disposable portion especially launcher 21 of portion 2 moves the infusion cannula 232 and needle 222 from stowed configuration to an insertion configuration with both inserted into the patient and extending from the housing 11, 14, 41);
wherein the reusable portion (1, 3, 4) is further operable to thereafter automatically move the insertion needle (222) from the insertion configuration to a retracted configuration (see Fig. 17) in which the insertion needle (222) is positioned within the disposable housing (21, 51, see Fig. 17 and para. 071-072 – after insertion, insertion needle 222 is automatically retracted to the configuration seen in Fig. 17 with needle 222 positioned within at least launcher 21).
Regarding claim 19, Liu discloses (Claim 19) an inserter device (see Fig. 1-2) comprising:
a housing (11, 14 in Fig. 4);
an insertion needle (222 in Fig. 6 and 17);
a shift head infusion assembly (23 in Fig. 6) detachably coupled to the housing (11, 14) and the insertion needle (222, see Fig. 17 and para. 059 and 071-072 – infusion cannula 232 and its head 231 detachably couple to housing 11 and 14 and insertion needle 222 as they both detach after insertion as seen in Fig. 17), the shift head infusion assembly (23) comprising an infusion head (231 in Fig. 6) and an infusion cannula (232 in Fig. 6) coupled to and movable with the infusion head (231, examiner is interpreting this limitation in light of the 112(b) rejection above as the infusion cannula is coupled to the infusion head and movable within the housing, see Fig. 6 and 17 and 059 and para. 071-072 – infusion cannula 232 is coupled to its head 231 and both are movable within the housing 11 and 14 during insertion), the infusion cannula (232) configured to be inserted into a subcutaneous space of a patient (see Fig. 17 and para. 071-072); and
an actuator (120 in Fig. 1-2 and 4) movable relative to the housing (11, 14, see Fig. 16-17 and para. 055 and 071);
wherein the inserter device is operable to, in response to movement of the actuator (120) relative to the housing (11, 14, see para. 071), automatically move the shift head infusion assembly (23) from a stowed configuration (see Fig. 16) in which the infusion cannula (232) and the insertion needle (222) are positioned within the housing (11, 14) to an insertion configuration in which the infusion cannula (232) and the insertion needle (222) extend from the housing (11, 14, see para. 069-071 – see Fig. 16 for stowed configuration, upon pressing of pressing portion 120, launcher 21 is released which moves the infusion cannula 232 and needle 222 from stowed configuration to an insertion configuration with both inserted into the patient and extending from the housing 11, 14);
wherein the inserter device is further operable to thereafter automatically move the insertion needle (222) from the insertion configuration to a retracted configuration (see Fig. 17) in which the insertion needle (222) is positioned within the housing (11, 14, see Fig. 17 and para. 072).
Allowable Subject Matter
Claims 4-10 and 15-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Liu et al. (C.N Patent Pub. No. 110585512 A, “Liu”) and Lanigan et al. (U.S Patent Pub. No. 20200289748 A1, “Lanigan”).
Liu discloses the inserter of claims 1-3 and 14 as discussed above. Regarding claims 4 and 15, while Liu discloses the shift mechanism (15) as interpreted under 112(f) as the compression spring (15) and the push plate (122) as the arm (122), Liu fails to disclose a shift that is movable relative to the push plate (122) and one in which the spring (15) urges away from the push plate (122). While spring (15) does urge the pressing portion (120) in an outward direction as seen in Fig. 4, pressing portion is already interpreted as the actuator and is integrally formed with the arm (122) such that they cannot move relative to one another. There is no reference that teaches or discloses an inserter having a shift mechanism, push plate, and shift plate as claimed in claims 4 and 15.
Lanigan discloses an inserter assembly (Fig. 64) comprising a disposable portion (1002 in Fig. 64-65B) and a reusable portion (1000 in Fig. 64 and 70A-70B, see para. 0312), wherein the disposable portion (1002 in Fig. 65A-65B) comprises a disposable housing (1008 in Fig. 65A-65B), an insertion needle (132 in Fig. 65A-65B), and an infusion cannula (104 in Fig. 65A-65B) wherein the infusion cannula (104) is detachably coupled to the disposable housing (1008) and the insertion needle (132, see Fig. 100 and para. 0372). The reusable portion (1000 in Fig. 70A-70B) comprises a reusable housing (116 and 120 in Fig. 70A-70B) and an actuator which may either be the exterior housing (116) itself or a discrete manual trigger such as a button or deformable section included on the exterior housing (116, see para. 0256 and 0348). Wherein the reusable housing (116, 120) is operable to, in response to movement of the actuator (116) relative to the reusable housing (120, see Fig. 92 and 99A), automatically move the disposable portion (1002) from a stowed configuration (see Fig. 88 and 92) to an inserted configuration (see para. 0365-0368), and thereafter, the reusable portion (1000) is operable to automatically move the insertion needle (132) from the insertion configuration to a retraction configuration (see Fig. 99A-99B) in which the needle (132) is positioned within the disposable housing (1008 in Fig. 99A-99B, see para. 0371-0372). Lanigan further discloses a compression spring (1108 in Fig. 88) as the insertion mechanism and a compression spring (1104 in Fig. 88) as the retraction mechanism, while Lanigan discloses a mechanism that inhibits operation of the retraction mechanism (1104) in the stowed configuration and allows operation of the retraction mechanism (1104) in the insertion configuration (see para. 0333 and 0350), this mechanism is a snap-engagement mechanism rather than a compression spring. Thus, Lanigan fails to disclose the shift mechanism as interpreted under 112(f) as a compression spring or equivalent structures.
There is no reference that teaches or discloses an inserter having a shift mechanism, push plate, and shift plate as claimed in claims 4 and 15.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. 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.
/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
Prosecution Insights