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 (IDS) submitted on 10/18/23 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Preliminary Amendment
The preliminary amendment filed 11/20/23 has been entered. Claims 1-10 are cancelled. Claims 11-30 are newly presented. Therefore, claims 11-30 are currently pending.
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, the:
The proximal and distal needle holders holding the proximal and distal needle tips (see 112b rejection below)
The medicament cartridge and the septum of the medicament cartridge are not shown and are claimed in at least the independent claims 1 and 27
The bellows extending from the proximal needle tip to the distal needle tip in at least claim 18 (see 112b rejection below)
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 Objections
Claim 15 is objected to because of the following informalities:
Claim 15 line 5 reads “such that a a guided feature” but should likely read “such that a [[a]] guided feature” because there appears to be a typo where “a” was accidentally entered into the language twice
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:
Claim 15 lines 5-6: “a guided feature on the distal needle holder is guided by a corresponding guide feature of the drug delivery device”. Therefore, claim 15 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a guided feature” is considered a generic placeholder for “means” because “a guided feature” has no specific structural meaning
Prong 2: functional language—is guided
Prong 3: not modified by other structural language in the claims—no structure is recited for how the guided feature of the distal needle holder functions in order to be “guided” by a corresponding guide feature of the drug delivery device. Only the desired outcome of “is guided” is recited.
According to Applicant’s disclosure under 112(f), the guided feature that “is guided” by a corresponding guide feature is interpreted as a groove/rib/surface or equivalent (see Applicant disclosure [0044] and [0048]).
Claim 16 lines 5-6: “a guided feature on the proximal needle holder is guided by a corresponding guide feature of the drug delivery device”. Therefore, claim 15 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a guided feature” is considered a generic placeholder for “means” because “a guided feature” has no specific structural meaning
Prong 2: functional language—is guided
Prong 3: not modified by other structural language in the claims—no structure is recited for how the guided feature of the proximal needle holder functions in order to be “guided” by a corresponding guide feature of the drug delivery device. Only the desired outcome of “is guided” is recited.
According to Applicant’s disclosure under 112(f), the guided feature that “is guided” by a corresponding guide feature is interpreted as a groove/rib/surface or equivalent (see Applicant disclosure [0044] and [0048]).
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
A guiding surface adapted to be guided by corresponding surfaces in claims 20 and 21 because the guiding feature has further structure recited to define specifically a guiding “surface”
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 11-26 and 28 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.
Regarding claim 11, lines 3-5 read “wherein the spring is arranged between a distal needle holder holding the distal needle tip and a proximal needle holder holding the proximal needle tip.” However, in view of Applicant disclosure, it is unclear to the examiner how the needle holders are “holding” the needle tips. In Figs. 5-6, Applicant shows the distal (4) and proximal (5) needle holders, affixed to the distal and proximal ends of the needle such that the distal (2) and proximal (3) tips extend beyond the ends of the holders. Further, it seems that the holders “holding” the needle tips would impede device functioning such as when the needle moves to penetrate an injection site and/or a septum of a medicament cartridge. Thus, claim 11 borders on an enablement issue under 112a as it is unclear to the examiner how claim 11 having holders “holding” the needle tips would be achieved in view of the specification (if the holders are “holding” the needle tips, the needle tips are completely covered by the holders and therefore could not achieve device functions such as piercing a septum or being inserted into an injection site). However, it seems most likely to the examiner that the language of claim 11 was an accidental oversight and should likely read “wherein the spring is arranged between a distal needle holder holding the distal needle [[tip]] end and a proximal needle holder holding the proximal needle [[tip]] end”.
Therefore, for purposes of examination, the examiner interprets claim 11 lines 3-5 to recite “wherein the spring is arranged between a distal needle holder holding the distal needle [[tip]] end and a proximal needle holder holding the proximal needle [[tip]] end”.
Applicant could remedy this 112b rejection by showing on the drawings where the holder structures are shown “holding” the needle tips or pointing to areas of the disclosure that support the holders holding, specifically, the needle tips, not the ends. Applicant could also remedy the rejection by amending the claim language as interpreted by the examiner.
Due to claim dependency, claims 12-26 are subsequently rejected under 112b.
Regarding claim 18, lines 1-2 recite “wherein the expandable elastomer body comprises bellows extending between the proximal needle tip and the distal needle tip”. However, in view of Applicant disclosure, it is unclear to the examiner how the bellows extend between the proximal needle tip and the distal needle tip because the bellows are shown only to extend between the proximal and distal needle holders (see at least FIGs. 5-6 showing bellows 8 only extending between the proximal needle holder and the distal needle holder). Further, it seems that the bellows extending to the needle tips would impede device functioning such as when the needles move to penetrate an injection site and/or a septum of a medicament cartridge. Thus, claim 18 borders on an enablement issue under 112a as it is unclear to the examiner how claim 18 is achieved in view of the specification (if bellows extended to the needle tips, the needle tips, at least some point in time, would be covered by the bellows). However, it seems most likely to the examiner that the language of claim 18 was an accidental oversight and should likely read “wherein the expandable elastomer body comprises bellows extending between the proximal needle [[tip]] holder and the distal needle [[tip]] holder”.
Therefore, for purposes of examination, the examiner interprets claim 18 to recite “wherein the expandable elastomer body comprises bellows extending between the proximal needle [[tip]] holder and the distal needle [[tip]] holder”.
Applicant could remedy this 112b rejection by showing on the drawings where the bellows structure is shown extending between the needle tips or pointing to areas of the disclosure that support the bellows extending specifically to the needle tips, not the holders. Applicant could also remedy the rejection by amending the claim language as interpreted by the examiner.
Regarding claim 28, lines 2-3 recite “a distal needle holder holding the distal needle tip and a proximal needle holder holding the proximal needle tip”. Similar to claim 11, it is unclear to the examiner how the proximal and distal holders are “holding” the needle tips (see 112b rejection of claim 11 above for further explanation). Therefore, for purposes of examination, the examiner interprets claim 28 lines 2-3 to read “a distal needle holder holding the distal needle [[tip]] end and a proximal needle holder holding the proximal needle [[tip]] end”.
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.
Claims 11-14, 23-24, 26-28, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen (U.S. Patent No. 6,605,067).
Regarding claim 11, Larsen discloses a method comprising:
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Activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) a drug delivery device (see col. 4 lines 62-65: threads for connecting onto drug delivery device) to cause a proximal needle tip (tip of needle 22, see ‘Modified FIG. 7’ above) of a needle (22, see col 6 lines 6-15) and a distal needle tip (tip of needle 24, see ‘Modified FIG. 7’ above) of the needle (24, see col 6 lines 7-24: needle 22/26/24 integrally formed as one “needle”) to be moved away from one another by a spring (31, see col 6 lines 25-54 and movement as shown in transition between FIGs. 6&7), wherein the spring (31) is arranged between (see ‘Modified FIG. 7’ above) a distal needle holder (27) holding (see col 6 lines 15-24: distal end of needle 24 fixed in 27 and thus 27 must be “holding” the needle) the distal needle [[tip]] end (end of needle 24) and a proximal needle holder (19) holding (see col 6 lines 6-24: end of needle 22 fixed to 19 and thus 19 must be “holding” the needle) the proximal needle [[tip]] end(end of needle 22); and
dispensing drug from a medicament cartridge in the drug delivery device (see col 1 lines 10-20 & col 2 lines 54-67) through a fluid channel (26, see col 6 lines 15-24: 26 connects needles 22/24) between (see ‘Modified FIG. 7’ above) the distal needle tip (tip of needle 24) and the proximal needle tip (tip of needle 22), wherein the proximal needle tip (tip of needle 22) is adapted to pierce a septum of the medicament cartridge (see col 6 lines 6-15).
Regarding claim 12, Larsen discloses the method of claim 11, and Larsen further discloses wherein the activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) comprises:
releasing the proximal needle holder, thereby causing the spring to bias the proximal needle tip and the distal needle tip to move away from one another, and/or
releasing (see col 6 lines 25-54: removal of pin releases 27 to move in distal direction to pierce injection site) the distal needle holder (27), thereby causing the spring (31) to bias the proximal needle tip (tip of needle 22) and the distal needle tip (tip of needle 24) to move away from one another (such as shown from FIG. 7 to 6 or as described in at least col 6 lines 25-54).
Regarding claim 13, Larsen discloses the method of claim 11, and Larsen discloses further comprising: causing the distal needle tip (tip of needle 24) to be inserted into an injection site (see col 6 lines 25-54) before dispensing the drug from the medicament cartridge (see col 6 lines 25-54: distal holder 27 is released to pierce injection site “ready for injection”. Thus, injection site MUST BE pierced prior to delivery of drug as described in at least col 1 lines 10-20 & col 2 lines 54-67).
Regarding claim 14, Larsen discloses the method of claim 13, and Larsen discloses further comprising preventing (at least by way of the spring force that drives distal needle holder to penetrate the injection site when the device is held against the injection site as described in col 6 lines 25-54) the distal needle holder (27) from retracting (when pin is released, spring force acts completely against the needle holder and would therefore prevent the holder from being retracted by an amount equal to the spring force. See col 6 lines 25-54), when the distal needle tip (tip of needle 24, see FIG.7) is pushed against the injection site (see col 6 lines 25-54).
Regarding claim 23, Larsen discloses the method of claim 11, and Larsen further discloses wherein the distal needle tip (tip of needle 24) and the proximal needle tip (tip of needle 22) point (see FIG. 7) in opposite directions (as shown in FIG. 7 and described in col 6 lines 6-15: needles penetrate opposite sites), and/or wherein the spring is adapted to act in two directions.
Regarding claim 24, Larsen discloses the method of claim 11, and Larsen further discloses wherein the fluid channel (26, see FIG. 7) is flexible (see FIG. 7 and FIG. 6 showing channel 26 in compressed and expanded configurations, thus, channel MUST BE flexible. See also col 6 lines 25-54: needle has desired elasticity for moving between compressed and expanded configurations and thus such an elasticity is inherently flexible).
Regarding claim 26, Larsen discloses the method of claim 24, and Larsen further discloses wherein the flexible fluid channel (26, see FIG. 7) is formed as a helical spring or as an S-shaped spring (see s-shape in FIG. 7 and see col 5 lines 38-60: s-shape described and see col 6 lines 49-54: needle 26 inherently acts as spring by providing force via elasticity).
Regarding claim 27, Larsen discloses a method comprising:
activating a drug delivery device (such as by pressing to injection site and removing a pin blocking the holder 27, see FIG. 7 and col 6 lines 25-54) to cause a proximal needle tip (tip of needle 22, see ‘Modified FIG. 7’ above) of a needle (22) to move relative (see movement from FIG. 7 to FIG. 6 and as described in col 6 lines 25-54) to a distal needle tip (tip of needle 24, see ‘Modified FIG. 7’ above) of the needle (24, see col 6 lines 7-24: needle 22/26/24 integrally formed as one “needle”) in order to pierce a septum of a medicament cartridge in the drug delivery device (see col 6 lines 6-15); and
dispensing drug from the medicament cartridge in the drug delivery device (see col 1 lines 10-20 & col 2 lines 54-67) through a fluid channel (26, see col 6 lines 15-24: 26 connects needles 22/24) between the distal needle tip (tip of needle 24) and the proximal needle tip (tip of needle 22).
Regarding claim 28, Larsen discloses the method of claim 27, and Larsen further discloses wherein the activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) comprises:
releasing energy (see col 6 lines 25-54: holder 37 forced into housing and held by pin which would force spring 31 into compressed/ biased/ stored energy configuration as shown in FIG.7. Energy is released upon removal of pin out of slot 25 such that the spring drives holder 27 to allow needle to penetrate injection site) stored in a spring (31) arranged between (see FIG. 7) a distal needle holder (27) holding (see col 6 lines 15-24: distal end of needle 24 fixed in 27 and thus 27 must be “holding” the needle) the distal needle [[tip]] end (end of needle 24) and a proximal needle holder (19) holding (see col 6 lines 6-24: end of needle 22 fixed to 19 and thus 19 must be “holding” the needle) the proximal needle [[tip]] end (end of needle 22) such that the spring (31) biases the proximal needle tip (tip of needle 22, see ‘Modified FIG. 7’ above) and the distal needle tip (tip of needle 24, see ‘Modified FIG. 7’ above) to move away from one another (as seen from FIG. 7 to FIG. 6 and biasing described in col 6 lines 25-54).
Regarding claim 30, Larsen discloses the method of claim 27, and Larsen further discloses wherein the distal needle tip (tip of needle 24) and the proximal needle tip (tip of needle 22) point (see FIG. 7) in opposite directions (as shown in FIG. 7 and described in col 6 lines 6-15: needles penetrate opposite sites), and/or wherein the spring is adapted to act in two directions.
Claims 11, 24, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen (U.S. Patent No. 6,605,067).
Regarding claim 11, Larsen discloses a method (see FIG. 4 &5) comprising:
Activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) a drug delivery device (see col. 4 lines 62-65: threads for connecting onto drug delivery device) to cause a proximal needle tip (tip of 22, see FIG. 5) of a needle (22) and a distal needle tip (tip of needle 24) of the needle (24, see col 6 lines 7-24: needle 22/26/24 integrally formed as one “needle”) to be moved away from one another (see movement from FIG. 5 to FIG. 4 and description in col 6 lines 25-54) by a spring (see col 6 lines 49-54: needle 26 inherently acts as spring by providing force via elasticity), wherein the spring (elastic force inherently in needle 26) is arranged between (see portion of needle 26 in housing chamber between the needle holders in FIG. 5) a distal needle holder (27) holding (see col 6 lines 15-24: distal end of needle 24 fixed in 27 and thus 27 must be “holding” the needle) the distal needle [[tip]] end (end of needle 24) and a proximal needle holder (19) holding (see col 6 lines 6-24: end of needle 22 fixed to 19 and thus 19 must be “holding” the needle) the proximal needle [[tip]] end (end of needle 22); and
dispensing drug from a medicament cartridge in the drug delivery device (see col 1 lines 10-20 & col 2 lines 54-67) through a fluid channel (channel of 26, see col 6 lines 15-24: 26 connects needles 22/24) between the distal needle tip (tip of needle 24) and the proximal needle tip (tip of needle 22), wherein the proximal needle tip (tip of needle 22) is adapted to pierce a septum of the medicament cartridge (see col 6 lines 6-15).
Regarding claim 24, Larsen discloses the method of claim 11, and Larsen further discloses wherein the fluid channel (channel of 26, see col 6 lines 15-24: 26 connects needles 22/24) is flexible (see FIG. 5 and FIG. 4 showing channel of 26 in compressed and expanded configurations, thus, channel MUST BE flexible. See also col 6 lines 25-54: needle has desired elasticity for moving between compressed and expanded configurations and thus such an elasticity is inherently “flexible”).
Regarding claim 25, wherein the spring (see col 6 lines 49-54: needle 26 inherently acts as spring by providing force via elasticity and FIG.5) is formed by the flexible fluid channel (channel of 26, see col 6 lines 15-24: 26 connects needles 22/24).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen as applied to claim 11 above, and further in view of Gratwohl et al. (U.S. Patent No. 8,052,653), hereinafter Gratwohl.
Regarding claim 15, Larsen discloses the method of claim 11, and Larsen further discloses wherein activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) the drug delivery device (see col. 4 lines 62-65: threads for connecting onto drug delivery device) to cause the proximal needle tip (tip of needle 22, see ‘Modified FIG. 7’ above) and the distal needle tip (tip of needle 24, see ‘Modified FIG. 7’ above) to move away from one another (see col 6 lines 25-54 and movement as shown in transition between FIGs. 6&7) comprises:
Biasing (see col 6 lines 25-27: 27 is forced into the housing 23 and would therefore provide a biasing force), by the spring (see col 6 lines 49-54: spring 31 provided as shown in Fig.6/7 and by this location would inherently be biased by the step described in col 6 lines 25-27), the distal needle holder (27) away from (see col 6 lines 25-54) the proximal needle holder (19).
Larsen is silent to the spring biasing the proximal and distal needle holders away from each other “such that a a guided feature on the distal needle holder is guided by a corresponding guide feature of the drug delivery device.”
However, Gratwohl teaches a method comprising activating a drug delivery device (see Fig. 2 and col 1 lines 15-28), the drug delivery device comprising a distal needle holder (5), where the distal needle holder (5) is biased by a spring (6, see col 6 lines 26-52) such that a a guided feature (5a/5b, see Fig.7 and ) on the distal needle holder (5) is guided by (see col. 6 lines 26- col. 7 line 35) a corresponding guide feature (recesses 4a/4b, see Fig. 6D, aligning with 112f interpretation above including “grooves” and see col 6 line 61- col. 7 line 11) of the drug delivery device (as in Fig. 2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal needle holder and drug delivery device disclosed by the method of Larsen to include a guided feature and a corresponding guide feature, respectively, as taught by Gratwohl for the purpose of guiding the holder along the device until a stop point (see col 6 line 61- col. 7 line 11), which would be advantageous to Larsen because a stop point for the distal needle holder relative the drug delivery device could define/set a depth of needle insertion/injection, or to prevent the distal needle holder from rotating (see col. 7 lines 12-35), thus achieving the spring biasing the proximal and distal needle holders away from each other “such that a a guided feature on the distal needle holder is guided by a corresponding guide feature of the drug delivery device.”
Regarding claim 16, Larsen discloses the method of claim 11, and Larsen further discloses wherein activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) the drug delivery device (see col. 4 lines 62-65: threads for connecting onto drug delivery device) to cause the proximal needle tip (tip of needle 22, see ‘Modified FIG. 7’ above) and the distal needle tip (tip of needle 24, see ‘Modified FIG. 7’ above) to move away from one another (see col 6 lines 25-54 and movement as shown in transition between FIGs. 6&7) comprises:
Biasing (see col 6 lines 25-27: 27 is forced into the housing 23 and would therefore provide a biasing force), by the spring (see col 6 lines 49-54: spring 31 provided as shown in Fig.6/7 and by this location would inherently be biased by the step described in col 6 lines 25-27), the proximal needle holder (19) away from (see col 6 lines 25-54) the distal needle holder (27).
Larsen is silent to the spring biasing the proximal and distal needle holders away from each other “such that a guided feature on the proximal needle holder is guided by a corresponding guide feature of the drug delivery device.”
However, Gratwohl teaches a method comprising activating a drug delivery device (see Fig. 2 and col 1 lines 15-28), the drug delivery device comprising a proximal needle holder (2 formed of base 9 and retaining region 10, see col 6 lines 19-20) biased by a spring (see col 8 lines 23-36) such that a guided feature (see grooves 11 in base 9 in at least fig. 16, aligning with 112f interpretation above) on the proximal needle holder is guided by (see col 7 line 66- col. 10 line 5 and see FIG. 16 for side-by- side interaction shown between proximal needle holder 2, including base 9, and the protrusions 16 of guide feature 7) a corresponding guide feature (7, a rib having protrusions 16, aligning with 112f interpretation above) of the drug delivery device (as seen in FIG. 2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal needle holder and drug delivery device disclosed by the method of Larsen to include a guided feature and a corresponding guide feature, respectively, as taught by Gratwohl for the purpose of forming a locking mechanism that allows the device to move to the releasing position only once such that the user is further protected from inadvertent needle sticks (see col 8 line 41- col 9 line 4), thus achieving the spring biasing the proximal and distal needle holders away from each other “such that a guided feature on the proximal needle holder is guided by a corresponding guide feature of the drug delivery device.”
Claims 17-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen as applied to claim 11 above, and further in view of Haber et al. (U.S. Patent No. 4,927,019), hereinafter Haber.
Regarding claim 17, Larsen discloses the method of claim 11, and Larsen further discloses wherein the fluid channel (26, see col 6 lines 15-24: 26 connects needles 22/24) is arranged within (see Fig.7) the expandable (see compressed configuration in Fig. 7 and expanded configuration in Fig. 6. Thus, the spring body is expandable) spring body (31).
Larsen is silent to wherein the fluid channel is arranged within “an expandable elastomer body”.
However, Haber teaches a method comprising activating a drug delivery device (see col. 3 lines 40-51 & col. 8 lines 7-41: assembling the needle portion onto the syringe portion to penetrate skin of patient for drug delivery/ fluid infusion) with a proximal needle tip (proximal tip of needle 98, see ‘Modified FIG. 21’ below) caused to be moved away from (see transition from FIG. 21 to FIG. 20 and see col. 8 lines 22-41: a force must be applied to move bellows to compressed position as shown in FIG. 21. Therefore, the bellows must cause the needle tips to be “moved away” from each other at rest) a distal needle tip (distal tip of needle 96, see ‘Modified FIG. 21’ below) by an expandable elastomer body (bellows 95),
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wherein the expandable elastomer body (95) is arranged between (as shown in ‘Modified FIG. 21’ above) a distal needle holder (see ‘Modified FIG. 21’ above) holding a distal needle tip (tip of needle 96) and a proximal needle holder (see ‘Modified FIG. 21’ above) holding a proximal needle tip (tip of needle 98); dispensing a drug from a medicament cartridge (106, see FIG. 21) in the drug delivery device (see col. 3 lines 40-51 & col 8 lines 22-41) through a fluid channel (channel formed between proximal needle 98 and distal needle 96 to perform injection, see col 8 lines 37-41); wherein the fluid channel (channel formed between proximal needle 98 and distal needle 96 to perform injection) is arranged within (see “modified FIG. 21’ above with fluid channel radially within bellows) the expandable elastomer body (bellows 95).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable spring body between the proximal and distal needle holders as disclosed in the method of Larsen to include an expandable elastomer body as taught by Haber for the purpose of keeping the needle shielded and sterile during packaging and assembly (see Haber col 7 line 38- col. 8 line 41), which would be advantageous to Larsen that has the exposed distal needle tip during assembly such as when forcing the distal needle holder (27) into the housing (see Larsen col 6 lines 25-48), thus achieving wherein the fluid channel is arranged within “an expandable elastomer body”.
Regarding claim 18, the modified method of Larsen teaches the method of claim 17, and Larsen further discloses wherein the expandable (see compressed configuration in Fig. 7 and expanded configuration in Fig. 6. Thus, the spring body is expandable) spring body (31, see FIG. 7) extends between (see FIG. 7) the proximal needle [[tip]] holder (19) and the distal needle [[tip]] holder (27).
Larsen is silent to the expandable body being an expandable elastomer body, “wherein the expandable elastomer body comprises bellows” extending between the proximal needle [[tip]] holder and the distal needle [[tip]] holder”.
However, Haber teaches a method comprising activating a drug delivery device (see col. 3 lines 40-51 & col. 8 lines 7-41: assembling the needle portion onto the syringe portion to penetrate skin of patient for drug delivery/ fluid infusion) with a proximal needle tip (proximal tip of needle 98, see ‘Modified FIG. 21’ above) caused to be moved away from (see transition from FIG. 21 to FIG. 20 and see col. 8 lines 22-41: a force must be applied to move bellows to compressed position as shown in FIG. 21. Therefore, the bellows must cause the needle tips to be “moved away” from each other at rest) a distal needle tip (distal tip of needle 96, see ‘Modified FIG. 21’ above) by an expandable elastomer body (bellows 95), wherein the expandable elastomer body (bellows 95) comprises bellows (see col 8 lines 22-41) extending between a proximal needle [[tip]] holder (see ‘Modified FIG. 21’ above) and a distal needle [[tip]] holder (see ‘Modified FIG. 21’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable spring body between the proximal and distal needle holders as disclosed in the method of Larsen to include an expandable elastomer body comprising bellows as taught by Haber for the purpose of keeping the needle shielded and sterile during packaging and assembly (see Haber col 7 line 38- col. 8 line 41), which would be advantageous to Larsen that has the exposed distal needle tip during assembly such as when forcing the distal needle holder (27) into the housing (see Larsen col 6 lines 25-48), thus achieving the expandable body being an expandable elastomer body, “wherein the expandable elastomer body comprises bellows” extending between the proximal needle [[tip]] holder and the distal needle [[tip]] holder”.
Regarding claim 19, the modified method of Larsen teaches the method of claim 17, and Larsen further discloses wherein activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) the drug delivery device (see col. 4 lines 62-65: threads for connecting onto drug delivery device) to cause the proximal needle tip (tip of needle 22, see FIG. 7) and the distal needle tip (tip of needle 24) to move away from one another (see col 6 lines 25-54 and movement as shown in transition between FIGs. 6&7) comprises: guiding the distal needle holder (27) by the spring body (31, see col 6 lines 25-54).
Larsen is silent to guiding the distal needle holder by the “elastomer” body.
However, Haber teaches a method comprising activating a drug delivery device (see col. 3 lines 40-51 & col. 8 lines 7-41: assembling the needle portion onto the syringe portion to penetrate skin of patient for drug delivery/ fluid infusion) with a proximal needle tip (proximal tip of needle 98, see ‘Modified FIG. 21’ above) caused to be moved away from (see transition from FIG. 21 to FIG. 20 and see col. 8 lines 22-41: a force must be applied to move bellows to compressed position as shown in FIG. 21. Therefore, the bellows must cause the needle tips to be “moved away” from each other at rest) a distal needle tip (distal tip of needle 96, see ‘Modified FIG. 21’ above) comprising guiding (see col 7 line 38- col 8 line 41: base 110 with distal needle holder is guided by bellows during attachment process) a distal needle holder (see ‘Modified FIG. 21’ above) by an elastomer body (bellows 95).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable spring body guiding the distal needle holder as disclosed in the method of Larsen to include an expandable body as taught by Haber for the purpose of keeping the needle shielded and sterile during packaging and assembly (see Haber col 7 line 38- col. 8 line 41), which would be advantageous to Larsen that has the exposed distal needle tip during assembly such as when forcing the distal needle holder (27) into the housing (see Larsen col 6 lines 25-48), thus achieving guiding the distal needle holder by the “elastomer” body.
Regarding claim 22, the modified method of Larsen teaches the method of claim 17, but Larsen is silent to “wherein the expandable elastomer body is configured to support the spring.”
However, Haber teaches a method comprising activating a drug delivery device (see col. 3 lines 40-51 & col. 8 lines 7-41: assembling the needle portion onto the syringe portion to penetrate skin of patient for drug delivery/ fluid infusion) with a proximal needle tip (proximal tip of needle 98, see ‘Modified FIG. 21’ above) caused to be moved away from (see transition from FIG. 21 to FIG. 20 and see col. 8 lines 22-41: a force must be applied to move bellows to compressed position as shown in FIG. 21. Therefore, the bellows must cause the needle tips to be “moved away” from each other at rest) a distal needle tip (distal tip of needle 96, see ‘Modified FIG. 21’ above) by an expandable elastomer body (bellows 95), wherein the expandable elastomer body (bellows 95) is configured to support a spring (see col 8 lines 3-6: bellows biased to longitudinally expanded position and must be “forced” to compress. Thus, bellows inherently provide some degree of elasticity in the longitudinal direction and are thus “configured to” support a spring disposed along the same longitudinal direction because the bellows are providing a supplementary elastic force along the same direction).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable spring body between the proximal and distal needle holders as disclosed in the method of Larsen to include an expandable elastomer body configured to support a spring as taught by Haber for the purpose of keeping the needle shielded and sterile during packaging and assembly (see Haber col 7 line 38- col. 8 line 41), which would be advantageous to Larsen that has the exposed distal needle tip during assembly such as when forcing the distal needle holder (27) into the housing (see Larsen col 6 lines 25-48), and for providing a supplementary force along the longitudinal direction (see Haber col 8 lines 3-6), thus achieving “wherein the expandable elastomer body is configured to support the spring.”
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Haber as applied to claim 17 above, and further in view of Gratwohl (U.S. Patent No. 8,052,653).
Regarding claim 20, the modified method of Larsen teaches the method of claim 17, but Modified Larsen is silent to “wherein at least one of the distal needle holder, the proximal needle holder, or the expandable elastomer body has a guiding surface adapted to be guided by corresponding surfaces within the drug delivery device.”
However, Gratwohl teaches a method comprising activating a drug delivery device (see Fig. 2 and col 1 lines 15-28), the drug delivery device comprising a distal needle holder (5), wherein the distal needle holder (5) has a guiding surface (5a/5b, see Fig.7 and col 7 lines 12-15) adapted to be guided by (see col. 6 lines 26- col. 7 line 35) corresponding surfaces (recesses 4a/4b, see Fig. 6D, aligning with 112f interpretation above including “grooves” and see col 6 line 61- col. 7 line 11) within the drug delivery device (as in Fig. 2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal needle holder and drug delivery device disclosed by the method of Larsen to include a guided surface and a corresponding guiding surface, respectively, as taught by Gratwohl for the purpose of guiding the holder along the device until a stop point (see col 6 line 61- col. 7 line 11), which would be advantageous to Larsen because a stop point for the distal needle holder relative the drug delivery device could define/set a depth of needle insertion/injection, or to prevent the distal needle holder from rotating (see col. 7 lines 12-35), thus achieving “wherein at least one of the distal needle holder, the proximal needle holder, or the expandable elastomer body has a guiding surface adapted to be guided by corresponding surfaces within the drug delivery device.”
Regarding claim 21, the modified method of Larsen teaches the method of claim 20, but Larsen is silent to “wherein the guiding surface is cylindrical”.
However, Gratwohl teaches a method comprising activating a drug delivery device (see Fig. 2 and col 1 lines 15-28), the drug delivery device comprising a distal needle holder (5), wherein the distal needle holder (5) has a guiding surface (5a/5b, see Fig.7 and col 7 lines 12-15), wherein the guiding surface is cylindrical (see FIG. 7 and col 7 lines 12-15: axial groove 5b extends along the outer surface of cylindrical tube and thus is cylindrical in as much as is disclosed by Applicant in FIG. 2 and [0039]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal needle holder and drug delivery device disclosed by the method of Larsen to include a cylindrical guiding surface and a corresponding guiding surface, respectively, as taught by Gratwohl for the purpose of guiding the holder along the device until a stop point (see col 6 line 61- col. 7 line 11), which would be advantageous to Larsen because a stop point for the distal needle holder relative the drug delivery device could define/set a depth of needle insertion/injection, or to prevent the distal needle holder from rotating (see col. 7 lines 12-35), thus achieving “wherein the guiding surface is cylindrical.”
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Larsen as applied to claim 27 above, and further in view of Haber (U.S. Patent No. 4,927,019).
Regarding claim 17, Larsen discloses the method of claim 11, and Larsen further discloses wherein the fluid channel (26, see col 6 lines 15-24: 26 connects needles 22/24) is arranged within (see Fig.7) the expandable (see compressed configuration in Fig. 7 and expanded configuration in Fig. 6. Thus, the spring body is expandable) spring body (31).
Larsen is silent to wherein the fluid channel is arranged within “an expandable elastomer body”.
However, Haber teaches a method comprising activating a drug delivery device (see col. 3 lines 40-51 & col. 8 lines 7-41: assembling the needle portion onto the syringe portion to penetrate skin of patient for drug delivery/ fluid infusion) with a proximal needle tip (proximal tip of needle 98, see ‘Modified FIG. 21’ below) caused to be moved away from (see transition from FIG. 21 to FIG. 20 and see col. 8 lines 22-41: a force must be applied to move bellows to compressed position as shown in FIG. 21. Therefore, the bellows must cause the needle tips to be “moved away” from each other at rest) a distal needle tip (distal tip of needle 96, see ‘Modified FIG. 21’ below) by an expandable elastomer body (bellows 95),
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wherein the expandable elastomer body (95) is arranged between (as shown in ‘Modified FIG. 21’ above) a distal needle holder (see ‘Modified FIG. 21’ above) holding a distal needle tip (tip of needle 96) and a proximal needle holder (see ‘Modified FIG. 21’ above) holding a proximal needle tip (tip of needle 98); dispensing a drug from a medicament cartridge (106, see FIG. 21) in the drug delivery device (see col. 3 lines 40-51 & col 8 lines 22-41) through a fluid channel (channel formed between proximal needle 98 and distal needle 96 to perform injection, see col 8 lines 37-41); wherein the fluid channel (channel formed between proximal needle 98 and distal needle 96 to perform injection) is arranged within (see “modified FIG. 21’ above with fluid channel radially within bellows) the expandable elastomer body (bellows 95).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable spring body between the proximal and distal needle holders as disclosed in the method of Larsen to include an expandable elastomer body as taught by Haber for the purpose of keeping the needle shielded and sterile during packaging and assembly (see Haber col 7 line 38- col. 8 line 41), which would be advantageous to Larsen that has the exposed distal needle tip during assembly such as when forcing the distal needle holder (27) into the housing (see Larsen col 6 lines 25-48), thus achieving wherein the fluid channel is arranged within “an expandable elastomer body”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hirsiger et al. (U.S. PGPUB No. 20030168366) teaches bellows (11, see Fig. 1) between a proximal (2)and distal (12) needle holder and teaches that bellows can be provided in combination with spring elements to achieve a desired elastic force along a longitudinal direction (see [0011])
Erez et al. (U.S. Patent No. 6,290,683) teaches bellows (20, see FIG.2) between a proximal (22) and distal (18) needle holder and teaches that bellows and springs are obvious variants (see col 2l ines 42-45 and that modifying the number of helical coils of a spring or the length of the bellows sets a penetration depth (see col 5 lines 20-25)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783