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 .
This is the first office action on the merits in response to the above identified patent application filed on 01/26/2024. Claims 1-10 are pending and being examined.
Claim Objections
Claims 1-5 and 8 are objected to because of the following informalities:
Claim 1, line 3: “to expel fluid” is believed to be in error for --to expel the fluid-- (see claim 1, line 2)
Claim 1, line 6: the limitation “a coiled band” should be changed to “a band” in order to provide proper antecedent basis for “the band”, which is used throughout all the claims
Claim 1, line 8: “toward the distal end of the reservoir” is believed to be in error for --toward a distal end of the reservoir--
Claims 2-5, line 1: “A fluid device as claimed in claim __” is believed to be in error for --The fluid device as claimed in claim __--
Claim 2, line 2: the claim is missing a period (.) after “plastic film”
Claim 4, line 3: “a bottom edge” is believed to be in error for --the bottom edge-- (see claim 4, line 2)
Claim 4, line 4: “a top edge” is believed to be in error for --the top edge-- (see claim 4, line 2)
Claim 5, line 2: “its top edge and its bottom edge” is believed to be in error for --the top edge and the bottom edge-- (see claim 4, line 2)
Claim 8, line 3: “its nested configuration” is believed to be in error for --the nested configuration-- (see claim 1, line 7)
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:
“motor and drive assembly” in claim 5
“bearing assembly” in claims 6-7
“slider assembly” in claim 8
“planetary gear mechanism” in claim 10.
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 5 and 9-10 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 5, claim limitation “a motor and drive assembly” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The limitation is recited only in paragraph [0010] of the specification, "The band drive gear is configured to be controllably rotated by a motor and drive assembly of the fluid delivery device", but no further information is given in regards to the structure of said "motor and drive assembly". Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Furthermore, it is not known whether “a motor and drive assembly” comprises two separate elements, or a single unified element. If Applicant intended for the limitation to mean two separate elements, then the limitation should be rewritten as “a motor and a drive assembly”. In either case, the limitation is indefinite because “drive assembly” in the context of a motor is not defined in the specification. Note that “drive assembly” in the context of a motor is believed to be distinct from “a plunger drive assembly”, which is not being interpreted under 35 U.S.C. 112(f).
Claim 9 recites the limitations "the slider assembly", "the top opening", and "the base receptacle" in lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Claim 10 is also rejected because it depends upon claim 9.
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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Judson (US 2019/0046733 A1).
Regarding claim 1, Judson teaches (Figs. 17 and 21-27) a fluid delivery device (20B – Fig. 21) with a syringe barrel (22 – Fig. 21) having a reservoir (24 – Fig. 17) that can contain fluid (medicament 25 – Fig. 17) and a plunger (26 – Fig. 17) that translates within the reservoir (24) along a longitudinal reservoir axis (parallel to axial length 49 – Fig. 17) thereof to expel fluid from the reservoir (24) and out of the syringe barrel (22) via an outlet (28 – Fig. 21), the fluid delivery device (20B) further comprising:
a plunger drive assembly (32B – Figs. 21-22) mounted at a proximal end (Fig. 21: right end) of the reservoir (24) and comprising a coiled band (40B – Figs. 22-23 and 26-27) coupled to a band drive gear (122B – Figs. 22-23) such that, when the band drive gear (122B) is rotated in a first rotational direction, the band (40B) moves from a nested configuration (shown as retracted portion 54B – Fig. 27) to an extended configuration (shown as extended portion 52B – Figs. 26-27) that extends from the proximal end of the reservoir (24) toward the distal end (Figs. 21: left end) of the reservoir (24) and engages the plunger (26) to translate the plunger (26) along the longitudinal reservoir axis toward the distal end of the reservoir (24) – (¶ [0147], ll. 8-9);
wherein the extended configuration (52B) comprises the band (40B) uncoiled into a spiral configuration (¶ [0143], ll. 6-7: “the extended portion 52B defining a helix of drive ribbon 40B”) comprising plural revolutions in the band (40B).
Regarding claim 2, Judson teaches the invention as claimed and as discussed above for claim 1, and Judson further teaches (Figs. 22-23 and 26-27) the band (40B) is a flexible material chosen from a sheet metal (¶ [0098], l. 2: “thin metal strip”) and a plastic film (¶ [0097], l. 2: “flexible polymeric ribbon”).
Regarding claim 3, Judson teaches the invention as claimed and as discussed above for claim 1, and Judson further teaches (Figs. 22-23 and 26) the band (40B) comprises slots (78B) that are engaged by teeth (shown in Figs. 23 and 26) provided in the band drive gear (122B) to controllably extend the band (40B).
Regarding claim 4, Judson teaches the invention as claimed and as discussed above for claim 1, and Judson further teaches (Figs. 24-26) the band (40B – Fig. 26) is a flat strip of flexible material (as shown in Figs. 24-25) comprising a top edge (56B – Fig. 24) and a bottom edge (58B – Fig. 24) that are each provided with interlocking teeth (154 and in-between holes 156) configured such that the interlocking teeth (154) on a bottom edge (58B) of a revolution in the band (40B) engage recesses (56B) on a top edge (56B) of an adjacent revolution in the band (40B) – (¶ [ 0134], ll. 1-5).
Regarding claim 5, Judson teaches the invention as claimed and as discussed above for claim 4, and Judson further teaches (Figs. 21-22 and 24-27) the width (Fig. 24: measured from 164 to 170. Note that 164 points to two locations) of the band (40B – Figs. 21 and 26-27) between its top edge (56B – Fig. 24) and its bottom edge (58B – Fig. 24) corresponds to an incremental distance of travel along the longitudinal reservoir axis for each of the revolutions (shown in Figs. 26-27, in which band 40B moves in the up direction), the band drive gear (122B – Figs. 22-23) configured to be controllably rotated by a motor and drive assembly (34B – Figs. 22 and 26) of the fluid delivery device (20B – Fig. 21) to extend the band (40B) a selected distance determined based on the incremental distance and a selected number of revolutions (intended use – motor 34B is capable of extending band 40B a selected distance).
Regarding claim 6, Judson teaches the invention as claimed and as discussed above for claim 1, and Judson further teaches (Figs. 17, 22, 24, and 26) a distal end (171 – Fig. 24) of the band (40B – Figs. 22 and 26) is rotatably connected (¶ [0149], ll. 1-4) to a back side (Figs. 22 and 26: bottom side) of a bearing assembly (comprising 80B and 84B – Figs. 22 and 26) provided at the proximal end (Fig. 17: right end) of the plunger (26 – Fig. 17) – (¶ [0100], ll. 2-5), the bearing assembly (80B, 84B) having a front side (Figs. 22 and 26: top side) that abuts the plunger (26 – Fig. 17. In this case, 84B abuts plunger 26) and applies a force to translate the plunger (26) toward the distal end (Fig. 17: left end) of the reservoir (24 – Fig. 17) when the band (40B) is extended (¶ [0100], ll. 16-21).
Regarding claim 7, Judson teaches the invention as claimed and as discussed above for claim 1, and Judson further teaches (Figs. 17, 22, 24, and 26) a distal end (171 – Fig. 24) of the band (40B – Figs. 22 and 26) is rotatably connected (¶ [0149], ll. 1-4) to a back side (Figs. 22 and 26: bottom side) of a bearing assembly (comprising 80B and 84B – Figs. 22 and 26) provided at the proximal end (Fig. 17: right end) of the plunger (26 – Fig. 17) – (¶ [0100], ll. 2-5), the bearing assembly (80B, 84B) having a front side (Figs. 22 and 26: top side) connected to the plunger (26 – Fig. 17) to translate the plunger (26) toward the distal end (Fig. 17: left end) of the reservoir (24 – Fig. 17) when the band drive gear (122B – Fig. 22) is rotated in the first rotational direction to extend the band (40B), and to translate the plunger (26) toward the proximal end (Fig. 17: right end) of the reservoir (24) when the band drive gear (122B) is rotated in a second rotational direction to retract the band (40B) – (¶ [0117], ll. 8-12 teaches rotation to advance the ribbon and rotation to retract the ribbon).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Judson (US 2019/0046733 A1 - referred to as "Judson '733"), in view of Judson (US 2021/0379289 A1 - referred to as "Judson '289").
Regarding claim 8, Judson ‘733 teaches the invention as claimed and as discussed above for claim 1, and Judson ‘733 further teaches (Figs. 22 and 26-27) the plunger drive assembly (32B – Fig. 22) further comprises a base receptacle (104B) comprising a bottom surface and circumferential side walls (Fig. 22 shows a bottom surface and outer circumferential side walls) for containing the band (40B – Figs. 22 and 26-27) in its nested configuration (shown by 54B in Fig. 27), the base receptacle (104B) further comprising a slider assembly (comprising inner circumferential side wall of 104B and 88B – Fig. 22) affixed thereto and extending toward a top opening of the base receptacle (opening defined by top edge of 104B), the slider assembly (104B, 88B) configured to initially receive a distal end of the band (40B) – (as shown in Figs. 23 and 27).
However, Judson ‘733 does not teach that the slider assembly is configured to surround at least one revolution of the band as the band is extended and before that revolution exits the top opening of the base receptacle while a later revolution is being formed in the slider assembly.
Judson ‘289 teaches (Figs. 164) a similar fluid delivery device (330) comprising a plunger drive assembly mounted at a proximal end (left end) of a reservoir (334) and comprising a coiled band (370) and a band drive dear (376) such that, wherein the band drive gear (370) is rotated in a first rotational direction, the band moves from a nested configuration to an extended configuration that extends from the proximal end of the reservoir (334) toward the distal end (right end) of the reservoir (334) and engages a plunger (380 – see ¶ [0341], l. 8) to translate the plunger (380) along a longitudinal reservoir axis (horizontal axis of 334) toward the distal end of the reservoir (334) – (¶ [0341], ll. 5-6);
wherein the plunger drive assembly further comprises a base receptacle (366) comprising a bottom surface and circumferential side walls (as shown in Fig. 164, additional views of base 366 are shown in Figs. 165-170) for containing the band (370) in its nested configuration, the base receptacle (366) further comprising a slider assembly (372) affixed thereto and extending toward a top opening of the base receptacle (opening defined by right edge of 366); and further teaches:
the slider assembly (372) configured to initially receive a distal end (left end) of the band (370) and to surround at least one revolution of the band (370) as the band (370) is extended and before that revolution exits the top opening of the base receptacle (372) while a later revolution is being formed in the slider assembly (372) – (¶ [0346], ll. 8-10: “The proximal end of thrust member 372 forms a cylindrical skirt 404 that functions as a storage bobbin for the retracted portion of drive ribbon 370”).
It is noted that Judson ‘733 also refers to its slider assembly (ref. no. “88B”) as a “thrust member” (¶ [0143], l. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Judson ‘733 by replacing its slider assembly with a slider assembly configured to surround at least one revolution of the band as the band is extended and before that revolution exits the top opening of the base receptacle while a later revolution is being formed in the slider assembly, because it has been held that a simple substitution of one known element (in this case, a slider assembly configured to surround at least one revolution of the band…, as taught by Judson ‘289) for another (in this case, the slider assembly of Judson ‘733) to obtain predictable results (in this case, to provide a similar interchangeable slider assembly for functioning as a thrust member), was an obvious extension of prior art teachings, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I) (B).
Allowable Subject Matter
Claims 9-10 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, and rewritten to overcome the claim objections and the 35 U.S.C. 112(b) rejections listed above.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance:
Regarding dependent claim 9, the prior art of record (as listed in the 35 U.S.C. 102 and 35 U.S.C. 103 sections above) does not teach, in combination with the other limitations of the dependent claim, “to controllably extend the band into the slider assembly and out of the top opening of the base receptable when the band drive gear is rotated in the first direction”.
As discussed in the 35 U.S.C. 102 and 35 U.S.C. 103 sections, Judson ‘733 teaches a slider assembly 88B and Judson ‘289 teaches a slider assembly 372. There is nothing in either slider assemblies 88B or 372 that would allow the band to extend into said slider assemblies. In Judson ‘733, the band 40B surround slider assembly 88B (as shown in Figs. 23 and 27) the entire time, thus precluding the bands from extending into slider assembly 88B. In Judson ‘289, the bands are already located within slider assembly 372 (as discussed in ¶ [0346], ll. 8-10); thus, the bands do not extend into slider assembly 372.
Dependent claim 10 would be allowable by virtue of dependence upon claim 9.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see attached form PTO-892 “Notice of References Cited”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY NG whose telephone number is (571)272-2318. The examiner can normally be reached M-F 9:30 AM - 6:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at 571-272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY NG/Examiner, Art Unit 3741
/GERALD L SUNG/Primary Examiner, Art Unit 3741
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